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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
September 10, 2011

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Coronary Artery Calcium Might Help Identify Low-Risk Patients Who Would
   Benefit from Statins
NSAID Use Linked to Increased Risk for Spontaneous Abortion
Rosuvastatin Fails to Outperform Atorvastatin in High-Risk Patients
Again, Soy Didn't Prevent Menopausal Bone Loss or Vasomotor Symptoms
Par Pharmaceutical Engaged in Illegal Drug-Switching Scheme, U.S. Says
Avastin for Age Related Macular Degeneration Could Save More than $1B
Quality Problems More Likely in Offshore Drug Plants
Meta-Analysis: Chocolate Appears to Be Heart-Healthy
Ambulatory BP Monitoring Appears to Be Cost-Effective for Diagnosing Hypertension
Minimal Physical Activity Confers Mortality Benefit
Duodenal Switch Surgery Riskier Than Gastric Bypass
Does Gabapentin Prevent Postherpetic Neuralgia?
An Ounce of Prevention . . . Is Money in the Bank
Valproate Does Not Prevent Agitation in Alzheimer Disease Patients
"It's a _____!": A Noninvasive Method for Determining Fetal Sex
Sorting Out the Value of Mammography
FDA Wants To Make It Safer To Split Tablets
Florida Shutting Down 'Pill Mill' Clinics
FDA Chemist Reaping $3.77 Million in Profits Nearing Plea Over Insider Trading Charges
Long-Term Effects of Eating Disorders on Fertility and Pregnancy
Consumer Behavior Tracked After Mandated Calorie Labeling of Fast Foods
Fewer Visits, Fewer Meds, More Risk Factors Hamper Hypertension Control
Intensive Glucose-Lowering Treatment Does Not Lower 5-Year Mortality
Stopping Aspirin Raises Risk for Nonfatal Myocardial Infarction in Patients
   with Cardiovascular Disease

Worsening Diastolic Function Predicts Heart Failure
Patients Comprehend Clinical Data Best When Expressed as Percentagesx
Red Wine May Aid Weight Control
Fatal Outcomes of Eating Disorders

Lancet 2011 Aug 20; 378:684
Coronary Artery Calcium Might Help Identify Low-Risk Patients Who Would Benefit from Statins
CAC might be more useful than high-sensitivity C-reactive protein.
     In the placebo-controlled JUPITER trial (JW Gen Med Nov 18 2008), rosuvastatin (Crestor) significantly lowered the incidence of adverse cardiovascular events in healthy patients with normal levels of LDL cholesterol (<130 mg/dL) and elevated levels of high-sensitivity C-reactive protein (hsCRP; ≥2 mg/L). These results — if applied widely — would result in statin therapy for millions of patients at relatively low cardiovascular risk. But, because absolute event rates were low, most such patients would derive no benefit. To determine whether computed tomography (CT)-identified coronary artery calcium (CAC) might define a subgroup of JUPITER-eligible patients who would be most likely to benefit from statin therapy, investigators identified 950 participants in a prospective cohort study of subclinical atherosclerosis who met JUPITER criteria; baseline CT-based CAC analysis was performed in each participant.
     During a median follow-up of 6 years, the 25% of patients with baseline CAC scores >100 accounted for 74% of adverse coronary events and 60% of cardiovascular events. Relatively few events occurred in the 47% of patients with CAC scores of zero. Applying the effect of rosuvastatin treatment from the JUPITER trial to this study population, the number needed to treat (NNT) to prevent one adverse coronary event was 549 for CAC scores of zero, 94 for scores of 1–100, and 24 for scores >100. To prevent one adverse cardiovascular event, the NNTs were 124, 54, and 19.
     Comment: Coronary artery calcium probably is more useful than hsCRP in targeting statins and other interventions to low-risk patients who could derive the most benefit. However, clinical trials are required to confirm this assumption, and clear risk-stratification algorithms remain to be established.
Bruce Soloway, MD Published in Journal Watch General Medicine August 30, 2011
     Citation(s):Blaha MJ et al. Associations between C-reactive protein, coronary artery calcium, and cardiovascular events: Implications for the JUPITER population from MESA, a population-based cohort study. Lancet 2011 Aug 20; 378:684.
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NSAID Use Linked to Increased Risk for Spontaneous Abortion
     Use of any nonaspirin nonsteroidal anti-inflammatory drug during pregnancy increases the risk for spontaneous abortion more than twofold, according to a case-control study in the Canadian Medical Association Journal.
     Researchers used the Quebec Pregnancy Registry to identify some 4700 women who had a spontaneous abortion by 20 weeks' gestation. Each case was matched to 10 controls who did not have spontaneous abortions. Exposure to a nonaspirin NSAID during pregnancy was noted in some 7.5% of cases, but in only 2.6% of controls.
     After adjustment for potential confounders such as history of rheumatoid arthritis or systemic lupus, all nonaspirin NSAIDs were associated with a significantly increased risk for spontaneous abortion, the highest being with diclofenac (odds ratio, 3.09). No dose-response effect was found.
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Rosuvastatin Fails to Outperform Atorvastatin in High-Risk Patients
Rosuvastatin (Crestor) is not significantly better than atorvastatin (Lipitor) in slowing the progression of atherosclerosis, according to results from the SATURN trial.
     The 2-year trial, conducted by rosuvastatin's manufacturer, included some 1300 patients with coronary artery disease randomized to daily rosuvastatin (40 mg) or atorvastatin (80 mg). The study's primary endpoint — change in atheroma volume on intravascular ultrasound — did not differ significantly between the groups, the manufacturer said in a press release, although the absolute numbers favored rosuvastatin.
     The findings come in anticipation of generic atorvastatin hitting the market in November, the Wall Street Journal reports.
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MM: Its just as important to know what does not work as it is to know what does. Whether the option is nutritional, homeopathic or allopathic, the most expensive treatment is the one that does not work. Many people get caught up in wanting only the “natural approach”. This is a great idea if it works. This is why we review all available literature before we create a Synergy Blends product. We want the consumer to pay for results, not conjecture.
Arch Intern Med 2011 Aug 8/22; 171:1363
Again, Soy Didn't Prevent Menopausal Bone Loss or Vasomotor Symptoms
Two-year placebo-controlled trial failed to find benefit.
     Most studies of soy have not demonstrated clinically important efficacy in menopausal women; nonetheless, women remain interested in whether soy-derived supplements alleviate menopausal symptoms. Investigators in south Florida randomized nonosteoporotic women with onset of menopause ≤5 years before enrollment to receive daily soy isoflavones (200 mg) or placebo for 2 years. Outcomes assessed at baseline and at 12 and 24 months included spine and hip bone-mineral density (BMD), menopausal symptoms, and vaginal epithelial maturation. In all, 248 women (mean age, 52; two thirds white Latina, one quarter white non-Latina, and 10% black) were enrolled.
     At baseline, more than two thirds of participants reported ≥1 menopausal symptom; vaginal maturation was consistent with hypoestrogenism in both groups. At 2 years, BMD had declined at all sites by about 2% in both groups; in addition, 48% of women in the soy group and 32% in the placebo group reported experiencing hot flashes (P=0.02). Vaginal epithelial maturation did not change significantly from baseline in either group. In general, adverse event rates were similar in both groups; however, constipation was reported by 31% and 21% of women in the soy and placebo groups, respectively (a marginally significant difference).
     Comment: The isoflavone in this trial — similar to that contained in many soy products marketed in the U.S. — provides a dose about twice the amount ingested in the typical Asian diet. Other trials of soy isoflavones generally have not shown that supplementation prevents loss of BMD. An exception is an Italian trial in which the isoflavone genistein had positive effects on BMD (JW Womens Health Jul 19 2007). As editorialists note, current alternative treatments for menopausal symptoms (with the possible exception of off-label use of certain antidepressants and gabapentin, which are modestly effective) do not approach estrogen therapy in efficacy.
Andrew M. Kaunitz, MD Published in Journal Watch Women's Health August 25, 2011
     Citation(s):Levis S et al. Soy isoflavones in the prevention of menopausal bone loss and menopausal symptoms: A randomized, double-blind trial. Arch Intern Med 2011 Aug 8/22; 171:1363.
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Par Pharmaceutical Engaged in Illegal Drug-Switching Scheme, U.S. Says
     Par Pharmaceutical Cos. has engaged in an illegal drug-switching scheme to increase sales, the U.S. said in a lawsuit in which two Mylan Inc. units are also accused by a whistleblower of wrongdoing. The lawsuit claims that Woodcliff, New Jersey-based Par conspired with its pharmacy customers to switch prescriptions of generic Zantac from tablets to higher-priced capsules to skirt Medicaid price limits. To increase sales, defendants marketed their higher-priced dosage forms to pharmacies by falsely portraying their drugs as equivalent to popular, lower-priced generics, allowing the drugstores to get higher reimbursements from Medicaid programs and "evade the government's price limits," according to the complaint.
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MM: We brought this off-label use of Avastin® to the attention of patients, listeners and clinicians in the Chicagoland area in June of 2005 when the literature was first published. We continue to provide over 6,000 doses of this medication annually to local physicians thereby saving Medicare and the American people over $11,500,000 annually! Mark Drugs and other compounding pharmacies are doing our part to help the deficit. Isn’t it about time that other areas of medicine and healthcare commerce start contributing as well? We need to look at cost –effective options of treatment that are safe and effective and to limit litigation with tort reform so that physicians are willing to look at effective options without fear of reprisal.
Avastin for Age Related Macular Degeneration Could Save More than $1B
     Genentech's Avastin off-label use for macular degeneration, rather than the company's similar eye drug Lucentis, could have saved Medicare more than $1 billion over two years, an HHS inspector general found in an audit. Also, Medicare beneficiaries would have saved $275 million. Currently, Lucentis is the single-biggest expense in the pharma budget of Medicare Part B, which covers injectables and biologics, the Wall Street Journal reports.
     The price difference between the two drugs—$2,000 versus about $50—prompted a call on Medicare to ask Congress for more power over pricing, at least with expensive biologics like Lucentis. A potential complication is that for this use, Avastin must be repackaged into small doses; a manipulation that opens Avastin to contamination.
     Editor's Note: Pharmacies involved in this activity must be USP Chapter <797> compliant.

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MM: There are presently 180+ injectible drugs for hospital use that are unavailable and are predominantly, if not all produced offshore. There are many more products for the general population that are unavailable and also produced offshore. This has become a massive and untenable problem. We need to bring more pharmaceutical and raw chemical manufacturing back home or this will only be the tip of the iceberg. No matter how much money is given to the FDA for foreign plant inspection, there will continue to be violations and shortages of life saving and life changing product for American patients.
Quality Problems More Likely in Offshore Drug Plants
     Drugs produced in offshore manufacturing plants—even those run by U.S. manufacturers—pose a greater quality risk than those prepared in the mainland U.S., a new study suggests. The results show how difficult it is to transfer world-class quality control to an offshore plant, even under the best of conditions.
     The study utilized inspection data that the U.S. FDA compiled on Puerto Rican and mainland U.S. pharmaceutical manufacturing plants. These plants produced both over-the-counter and prescription drugs. Facilities in more distant, less developed countries may face even greater obstacles to quality control. The results should serve as a caution to pharmaceutical executives who want to cut costs by producing drugs offshore.
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Meta-Analysis: Chocolate Appears to Be Heart-Healthy
     Higher levels of chocolate intake "seem to be associated with a substantial reduction in the risk of cardiometabolic disorders," a BMJ meta-analysis reports.
     Researchers examined seven observational studies, encompassing nearly 115,000 adult participants, that measured chocolate intake and cardiometabolic outcomes. Compared with the lowest level of chocolate consumption, the highest intake was associated with a roughly one third decrease in the risk for any cardiovascular disease or stroke. There was no benefit, however, with regard to heart failure.
     The authors offer several cautions with their findings, including the fact that high levels of fat and sugar are found in most commercial preparations of chocolate. They also note that the present evidence only points to an association between chocolate and heart health.
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Lancet 2011 Aug 24
Ambulatory BP Monitoring Appears to Be Cost-Effective for
Diagnosing Hypertension

In a hypothetical cohort, ambulatory blood pressure monitoring was better than office- or home-based monitoring.
     In some studies, ambulatory blood pressure (ABP) correlates more strongly with adverse cardiovascular outcomes than does either office-based BP (OBP) or home-based BP (HBP). Hypertension usually is diagnosed with OBP monitoring, with ABP monitoring used mainly to resolve diagnostic uncertainty or to confirm antihypertensive treatment effectiveness. ABP monitoring could serve as a diagnostic standard for hypertension that requires treatment, but would it be cost-effective?
     British researchers modeled a hypothetical population (age, ≥40) with screening BP measurements >140/90 mm Hg, risk profile equivalent to the general population, and diagnoses of hypertension by OBP, HBP, or ABP monitoring. The researchers used evidence-based assumptions for prevalence of hypertension, sensitivity and specificity of OBP and HBP monitoring relative to ABP monitoring, and probabilities of adverse cardiovascular events. The simulation ran for the equivalent of 60 years; assumptions were that blood pressure checks occurred every 5 years for healthy patients and that generic medications were prescribed as needed.
     ABP monitoring was the most cost-effective diagnostic strategy for men and women of any age and maintained its advantage when underlying assumptions were varied. The higher cost of diagnosis using ABP monitoring was more than offset by eliminating the costs of unnecessary treatment. In older cohorts, ABP monitoring also produced better health outcomes.
     Comment: This study is directly relevant for the U.K.'s unified health service, but whether payers in the fragmented U.S. healthcare system would voluntarily pay the higher cost for more accurate diagnosis is unclear, especially if they perceived that some other payer might reap the downstream benefit.
Bruce Soloway, MD Published in Journal Watch General Medicine September 8, 2011
     Citation(s):Lovibond K et al. Cost-effectiveness of options for the diagnosis of high blood pressure in primary care: A modelling study. Lancet 2011 Aug 24; [e-pub ahead of print]. (http://dx.doi.org/10.1016/S0140-6736(11)61184-7)
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Lancet 2011 Aug 16
Minimal Physical Activity Confers Mortality Benefit
Just 15 minutes of exercise daily lowered 8-year mortality and cancer incidence.
     Current guidelines recommend 150 minutes weekly of leisure-time physical activity (LTPA) to achieve a variety of health benefits, but the benefits of less exercise are uncertain. Investigators in Taiwan studied a cohort of more than 400,000 healthy people who participated in a privately operated medical screening program during 13 years. At enrollment, patients described and quantified their LTPA levels and were grouped into five activity levels (from "inactive" to "very high volume").
     Fifty-four percent of patients were "inactive" (<60 minutes of LTPA weekly), and another 22% were "low volume" (average, 92 minutes weekly). After a mean follow-up of 8 years, compared with inactive individuals, those with low-volume activity had significantly lower mortality from all causes (hazard ratio, 0.86), all cancers (HR, 0.90), cardiovascular disease (HR, 0.81), and ischemic heart disease (HR, 0.75), and a significantly lower incidence of all cancers (HR, 0.94). Most of these health benefits increased in dose-related fashion as activity level rose.
     Comment: This cohort study cannot establish causation, but an average of 15 minutes of daily exercise — half the recommended amount — was associated with significantly lower 8-year mortality and cancer incidence. Many people might find this modest level of exercise more achievable than the recommended level; its potential benefit could encourage inactive individuals to introduce some level of exercise into their daily routines.
Bruce Soloway, MD Published in Journal Watch General Medicine September 6, 2011
MM: These are very impressive weight loss numbers for both gastric bypass and duodenal switch procedures but the adverse effects are huge. We have seen similar weight loss with HCG without similar adverse effects. Plus HCG weight loss is a fraction of the price. Please go to our website for more information on the HCG protocol. http://www.markdrugs.com/weightloss.html
      Citation(s):Wen CP et al. Minimum amount of physical activity for reduced mortality and extended life expectancy: A prospective cohort study. Lancet 2011 Aug 16; [e-pub ahead of print]. (http://dx.doi.org/10.1016/S0140-6736(11)60749-6)
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MM: These are very impressive weight loss numbers for both gastric bypass and duodenal switch procedures but the adverse effects are huge. We have seen similar weight loss with HCG without similar adverse effects. Plus HCG weight loss is a fraction of the price. Please go to our website for more information on the HCG protocol. http://www.markdrugs.com/weightloss.html
Duodenal Switch Surgery Riskier Than Gastric Bypass
     The first randomized comparison of gastric bypass and duodenal switch surgery, published in the Annals of Internal Medicine, shows greater weight loss and improvements in cardiovascular risk factors with duodenal switch, but at the expense of more adverse events.
     Two years after gastric bypass or duodenal switch was performed on some 60 patients with superobesity (BMI, 50 to 60), most cardiovascular risk factors improved in both groups. Duodenal switch patients had greater weight loss than bypass patients (mean loss, 74 vs. 51 kg), as well as greater reductions in total and LDL cholesterol. However, they also had more adverse events (62% vs. 32%); in particular, malnutrition-related events such as night blindness, severe iron deficiency, and protein calorie deficiency occurred only after duodenal switch.
     An editorialist notes that few patients had adverse cardiovascular profiles to begin with and concludes: "We should seriously question whether there is any role for the duodenal switch operation ... its complications are very real and very severe."
MM: I agree with the research that Gabapentin may not prevent PHN but in combination with other drugs in an appropriate Enhanced Absorption Vehicle (EAV), it has the potential to effectively provide relief from PHN. Please contact Mark Drugs for more information about the options for treating PHN as well as other peripheral neuropathies.
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MM: I agree with the research that Gabapentin may not prevent PHN but in combination with other drugs in an appropriate Enhanced Absorption Vehicle (EAV), it has the potential to effectively provide relief from PHN. Please contact Mark Drugs for more information about the options for treating PHN as well as other peripheral neuropathies.
Arch Dermatol
2011 Aug; 147:901
Does Gabapentin Prevent Postherpetic Neuralgia?
Researchers believe so, but their uncontrolled trial doesn't prove it.
     Gabapentin is approved for treating postherpetic neuralgia (PHN) after shingles, based on clinical trials in which it was started only when pain had persisted for at least 3 months. In this new uncontrolled study, researchers sought to determine whether early gabapentin therapy prevents PHN.
     The study involved 133 immunocompetent patients (age, ≥50) with acute herpes zoster and pain scores >3 (on a 10-point scale). All patients received 1-week courses of valacyclovir, and all received gabapentin for at least 4 weeks (starting at 300 mg daily and titrating to 1200 mg 3 times daily, if tolerated). If patients' pain scores remained >3 at 4 weeks, gabapentin was continued for 4 additional weeks.
     The proportion of patients with any pain (score, >0) was 20% at 3 months and 10% at 6 months. The authors compare this result to findings from eight previous natural history studies, in which PHN incidence at 6 months ranged from about 15% to 40%.
     Comment: The researchers conclude that early gabapentin therapy prevents PHN. However, their conclusion is purely speculative, given the absence of contemporaneous controls. Interestingly, in the largest shingles study ever conducted — the randomized trial of the vaccine (Zostavax; JW Gen Med Jun 14 2005) — the incidence of PHN among unvaccinated patients who developed shingles was only 12%, which was similar to the incidence in the current study. The authors acknowledge that a randomized controlled trial should be performed.
Allan S. Brett, MD Published in Journal Watch General Medicine August 25, 2011
     Citation(s): Lapolla W et al. Incidence of postherpetic neuralgia after combination treatment with gabapentin and valacyclovir in patients with acute herpes zoster: Open-label study. Arch Dermatol 2011 Aug; 147:901. (http://dx.doi.org/10.1001/archdermatol.2011.81)
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BMJ 2011 Jul 28; 343:d4044
An Ounce of Prevention . . . Is Money in the Bank
An economic modeling analysis based on U.K. data adds to the growing evidence base supporting population-wide initiatives to reduce cardiovascular risk factors.
     According to some analyses, population-wide prevention strategies could save billions of dollars annually; however, the comparative cost-effectiveness of general and specific interventions is difficult to determine. Therefore, investigators built an economic model designed to assess the potential cost-effectiveness of a population-wide program in England and Wales that would reduce risk factors in order to prevent cardiovascular disease (CVD). Primary outcomes were cardiovascular events avoided, quality-adjusted life years (QALYs) gained, and cost savings from cases prevented or postponed, making possible the estimation of amounts worth spending to accomplish specific goals.
     The researchers estimated that compared with no intervention, a program that reduces cardiovascular risk in about 50 million people by 1% would prevent about 25,000 new cases of CVD, add about 98,000 QALYs, and result in savings of at least $48 million per year. Reducing mean cholesterol by 5% would result in annual savings of at least $130 million. Reducing individuals' salt intake by 3 g per day would prevent approximately 30,000 cases of CVD and save at least $65 million per year. Legislation to reduce intake of trans fats by approximately 0.5% would gain about 750,000 QALYs and generate net savings of at least $380 million per year.
     Comment: Based on this analysis, even small reductions in cardiovascular risk factors can result in big savings in healthcare costs. The findings are consistent with those of models based on data from other countries, including the U.S. These analyses provide strong support for large-scale, population-wide interventions to reduce cardiovascular risk.
JoAnne M. Foody, MD Published in Journal Watch Cardiology August 31, 2011
     Citation(s):Barton P et al. Effectiveness and cost effectiveness of cardiovascular disease prevention in whole populations: Modelling study. BMJ 2011 Jul 28; 343:d4044. http://www.ncbi.nlm.nih.gov/pubmed/21798967?dopt=Abstract
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Arch Gen Psychiatry 2011 Aug; 68:853.
Valproate Does Not Prevent Agitation in Alzheimer Disease Patients
On several measures, the drug performs worse than placebo.
     Divalproex (valproate) is frequently used to treat agitation in demented patients despite the absence of sufficient supportive data. In an NIH- and manufacturer-funded, 2-year, prospective study, researchers aimed to determine whether valproate would prevent or slow the onset of agitation or psychosis in 313 patients with mild-to-moderate Alzheimer disease who had not yet experienced these common and disabling complications.
     Patients were randomized to valproate (12-month mean modal dose, 250 mg/day; mean serum level, 42.7 µg/mL) or placebo. Ninety-four patients underwent magnetic resonance imaging (MRI) at baseline and after 12 months; 88 of these had valid data on brain volumes.
     The valproate and placebo groups did not differ in dropouts, agitation, psychosis, cognition, functioning, nursing-home placement, or global outcomes. However, at 12 and 18 months, measures of cognition and activities of daily living were significantly better with placebo than with valproate. Valproate was associated with sedation, along with other typical adverse effects, such as gait disturbance, weakness, and gastrointestinal distress. In the MRI subgroup, valproate was associated with greater loss of bilateral hippocampal and whole brain volume, faster ventricular enlargement, and a more rapid decrease in Mini-Mental State Examination scores.
     Comment: Some might argue that valproate could improve existing agitation and psychosis, even though it did not prevent them. However, both treated and untreated patients developed agitation and psychosis; it is unlikely that valproate would treat agitation, because it occurred while patients were taking the drug. Achieving higher drug serum levels might have led to greater effectiveness, but even these relatively healthy patients would not have tolerated higher doses. Particularly worrisome are the apparently valproate-associated accelerated rate of volume loss and adverse effects that could increase the risk for falls. Currently, in the absence of a specific indication like epilepsy or bipolar disorder, the justification for using valproate in Alzheimer patients is weak.
Steven Dubovsky, MD Published in Journal Watch Psychiatry August 29, 2011
     Citation(s):Tariot PN et al. for the Alzheimer's Disease Cooperative Study Group. Chronic divalproex sodium to attenuate agitation and clinical progression of Alzheimer disease. Arch Gen Psychiatry 2011 Aug; 68:853. http://www.ncbi.nlm.nih.gov/pubmed/21810649?dopt=Abstract
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JAMA 2011 Aug 10; 306:627
"It's a _____!": A Noninvasive Method for Determining Fetal Sex
Analysis of circulating cell-free fetal DNA in maternal blood: Current technology performs best after 20 weeks' gestation.
     Pregnant women with fetuses at risk for X-linked or other sex-dependent genetic disorders must undergo invasive procedures (e.g., chorionic villus sampling) to learn the fetal sex or wait until the second trimester when ultrasound is sufficiently reliable. Researchers have made use of circulating cell-free fetal DNA in maternal blood to determine fetal sex, thereby making this information available earlier than is possible with ultrasound. Now, investigators have performed a systematic review and meta-analysis of 57 studies to assess the analytical value of this technology.
     Real-time quantitative polymerase chain reaction (RTQ-PCR) for amplification of fetal DNA was most commonly used and was superior to conventional amplification techniques. Testing after 20 weeks' gestation (sensitivity, 99.0%; specificity, 99.6%) was most accurate; however, testing at 7 to 12 weeks (sensitivity, 94.8%; specificity, 98.9%) and at 13 to 20 weeks (sensitivity, 95.5%; specificity, 99.1%) was reasonably accurate. Testing before 7 weeks had poor sensitivity (74.5%).
    Comment: This evolving technology is a rational option for predicting fetal sex, although currently, it performs less well during early pregnancy, when such testing would be most useful. Nonetheless, its marketability as a tool for parents who wish to know the sex of their unborn child as soon as possible is clear (many commercial ventures already offer such testing). I anticipate the refinement and broader applications of noninvasive prenatal diagnostic techniques. However, the potential use of such technology to facilitate sex selection is concerning given that, in a number of communities, sex ratios already have shifted, secondary to selective abortion of female fetuses (e.g., Lancet 2011; 377:1921).
Allison Bryant, MD, MPH Published in Journal Watch Women's Health September 1, 2011
     Citation(s):Devaney SA et al. Noninvasive fetal sex determination using cell-free fetal DNA: A systematic review and meta-analysis. JAMA 2011 Aug 10; 306:627.
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BMJ 2011 Jul 28; 343:d4411
Sorting Out the Value of Mammography
Analysis of paired European countries suggests screening has little effect on breast cancer mortality.
     Mortality from invasive breast cancer continues to fall in North America, Australia, and most western European countries. To assess the relative effects on breast cancer mortality of mammographic screening and improved treatment, investigators paired selected European countries based on geographic contiguity, socioeconomic status, and quality of and access to healthcare services. For each of three pairs (Sweden and Norway; the Netherlands and Belgium; Northern Ireland [U.K.] and the Republic of Ireland), nationwide mammographic screening had been implemented by 1990 in the first country and substantially later in the second. Breast cancer mortality was compared for each pair.
     For example, national screening mammography was initiated in the mid-1980s in Sweden (countrywide coverage achieved by 1997) and the mid-1990s in Norway (countrywide coverage achieved by 2005). Despite the later introduction of screening in Norway, breast cancer mortality between 1989 and 2006 declined by 16% in Sweden and by 24% in Norway. Similar trends were observed in the other paired countries.
     Comment: This analysis of breast cancer mortality contrasts with a similar study of cervical cancer in Scandinavia: Although access to surgery and radiation therapy was comparable among all Nordic countries from 1965 through 1980, large reductions in cervical cancer mortality during this period were observed in countries with nationwide cytology screening but not in countries with delayed implementation of such screening. Authors of another recent study (JW Womens Health Sep 22 2010) have also made a credible argument that screening mammography plays a limited role in lowering breast cancer mortality. Improvements in breast cancer management (and access to treatment) seem to be more important. Overall, these observations should help clinicians to be comfortable adopting a flexible approach to when and how often women choose to be screened (JW Womens Health Jul 28 2011).
Andrew M. Kaunitz, MD Published in Journal Watch Women's Health August 11, 2011
     Citation(s):Autier P et al. Breast cancer mortality in neighbouring European countries with different levels of screening but similar access to treatment: Trend analysis of WHO mortality database. BMJ 2011 Jul 28; 343:d4411. (http://dx.doi.org/10.1136/bmj.d4411) http://www.ncbi.nlm.nih.gov/pubmed/21798968?dopt=Abstract
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FDA Wants To Make It Safer To Split Tablets
     Splitting tablets is not new. Many people do so every day to save money or adjust dosages. But how does one know that each half—or portion—contains the needed amount of medication? Just because a tablet is scored is no guarantee that patients will get the exact dose they need.
     The agency conducted internal research on tablet splitting and found, in some cases, possible safety issues, especially when tablets are not scored or evaluated for splitting. These include variations in tablet content, weight, disintegration, dissolution, and stability. The FDA has now issued a guidance for drug companies on data that is needed for applications to support scored tablets, including:

  1. The dosage amount meant to be achieved after splitting the tablet should not be below the minimum therapeutic dose indicated on approved labeling.
  2. Modified release tablets in which the control of drug release can be compromised by splitting should not be scored.

     Also, generic manufacturers must ensure that the tablets follow the same scoring as reference-listed drugs, or brand-name meds. For a copy of the new guidance, go to:
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Florida Shutting Down 'Pill Mill' Clinics
     For a long time, Florida has been the nation's center for the illegal sale of prescription drugs: Doctors in the state purchased 89 percent of all the Oxycodone sold in the country last year. Now, the governor has signed a law that makes it harder for pain clinics and pharmacies to engage in the illegal distribution of prescription drugs. With the help of these tougher laws, officials have moved aggressively this year to shut down so-called pill mills and disrupt the pipeline that moves the drugs north. In the past year, more than 400 clinics were either shut down or closed their doors.
     New laws also affect distribution because as of July, Florida doctors are barred, with a few exceptions, from dispensing narcotics and addictive medications in their offices or clinics. As a result, doctors' purchases of Oxycodone, which reached 32.2 million doses in the first six months of 2010, fell by 97 percent in the same period this year.
     Pharmacies are also being scrutinized closer. The number of applications to open new pharmacies in Florida has nearly doubled in the past two years, possibly the result of doctors' facing tougher rules. Florida now makes up half of all the requests for new pharmacies in the entire country. Now, background checks are required for owners, employees, and violators. Whether they are pharmacists, doctors, or clinic owners, they face stiffer, swifter penalties.
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FDA Chemist Reaping $3.77 Million in Profits Nearing Plea Over
Insider Trading Charges

     An FDA chemist and his son accused of making millions of dollars with inside information about drug approvals are close to reaching plea agreements. Cheng Yi Liang and his son Andrew were charged in March with conspiracy, securities fraud, and wire fraud for making $2.27 million in trades involving five pharmaceutical companies between November 2007 and March 2011. Securities regulators reported additional trades and that the father reaped more than $3.77 million in profits and avoided losses.
     Even though insider trading cases are relatively common, the Liang case was unusual because it involved a federal government employee using sensitive information from the job to reap a windfall. Critical information about prescription drug approvals or denials can prompt big stock swings. Liang worked at the FDA beginning in 1996 in the Office of New Drug Quality Assessment and had access to the agency's internal tracking system for new drug applications. His salary was $122,744 a year, according to a court document.
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BJOG 2011 Aug 3
Long-Term Effects of Eating Disorders on Fertility and Pregnancy
Fertility was modestly affected by lifetime eating disorders.
     Eating disorders commonly disrupt menstrual cycles, but information is sparse about long-term effects of these disorders on fertility and attitudes toward pregnancy. Investigators examined these issues in a cohort of 14,600 women that included 171 with lifetime anorexia nervosa, 199 with lifetime bulimia nervosa, and 82 with lifetime anorexia+bulimia.
     Twenty-one percent of women with anorexia and 20% of those with anorexia+bulimia — but only 12% of those in the general population — had been seen by a physician for lifetime fertility problems. Compared with women in the general population, those with eating disorders were equally likely to require >12 months to conceive; however, women with anorexia+bulimia were more likely than those in the general population (6.2% vs. 2.7%) to have received medical assistance in conceiving their current pregnancies and were more likely to take >6 months to conceive. Rates of intentional pregnancy were 58% in women with anorexia and 72% in the general population. Women with eating disorders were more likely to have negative reactions when they first discovered they were pregnant, although these feelings tended to abate by 18 weeks' gestation. Women with lifetime anorexia or anorexia+bulimia were more likely than those in the general population to view motherhood as a personal sacrifice.
    Comment: These data show that fertility is only modestly affected in women with lifetime eating disorders. Thus, healthcare providers should counsel women with histories of eating disorders that they probably can have children, even when menstrual patterns are disturbed. Contraceptive counseling should be provided as appropriate. Because of their attitudes toward pregnancy, these women might require additional psychological support, especially during early pregnancy.
Robert W. Rebar, MD Published in Journal Watch Women's Health September 8, 2011
     Citation(s):Easter A et al. Fertility and prenatal attitudes towards pregnancy in women with eating disorders: Results from the Avon Longitudinal Study of Parents and Children. BJOG 2011 Aug 3; [e-pub ahead of print].
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BMJ 2011 Jul 26; 343:d4464
Consumer Behavior Tracked After Mandated Calorie Labeling of Fast Foods
The minority of customers who read the labels ordered lower-calorie lunches.
     To help consumers make better food choices, New York City implemented a regulation in 2008 that required major fast-food chain restaurants to post the calorie content of all food items on menus, menu boards, and item tags. To assess the effect of this regulation, researchers surveyed lunchtime customers at 168 fast-food restaurants from the city's top 11 fast-food chains in 2007 and 2009. The customers — 7309 in 2007 and 8489 in 2009 — provided sales receipts, demographic information, and opinions about the use of calorie labels.
     Overall mean calorie count per purchase did not change from 2007 to 2009 (828 and 846 kcal). Mean calories per purchase declined significantly at three chains (McDonald's, 829 vs. 786 kcal; Au Bon Pain, 555 vs. 475 kcal; KFC, 927 vs. 868 kcal) and rose significantly at one (Subway, 749 vs. 882 kcal). In 2009, 15% of customers said they used the calorie label information; these customers consumed significantly fewer calories than those who did not use the information (757 vs. 863 kcal).
     Comment: One interpretation of these findings is that some fast-food customers were influenced by calorie information; however, another interpretation is that calorie-conscious customers were already predisposed both to read labels and to order lower-calorie foods and weren't actually influenced by calorie information at the point of sale. More detailed longitudinal studies in other communities are required to enlighten policymaking.
Thomas L. Schwenk, MD Published in Journal Watch General Medicine August 11, 2011
     Citation(s):Dumanovsky T et al. Changes in energy content of lunchtime purchases from fast food restaurants after introduction of calorie labelling: Cross sectional customer surveys. BMJ 2011 Jul 26; 343:d4464. (http://dx.doi.org/10.1136/bmj.d4464 http://www.ncbi.nlm.nih.gov/pubmed/21791497?dopt=Abstract
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MM: Band-aid medicine really bothers me. This is an interesting article but unfortunately we ignore the elephant in the room. There is growing obesity, food choice additive problems and a lack of repairing the problem at its starting point. No matter how much medication and HCP contact time is provided; if people are not educated and take the initiative to eat and exercise properly, the problems will continue to grow.
2011 Aug 30; 124:1046
Fewer Visits, Fewer Meds, More Risk Factors Hamper Hypertension Control
Two decades of U.S. population-based data increase our understanding of uncontrolled or treatment-resistant hypertension and point toward improvement in healthcare strategies.
     Hypertension control in the U.S. has improved over time, but high rates of uncontrolled hypertension persist (JW Cardiol Jun 9 2010). To identify clinical characteristics associated with hypertension that is untreated, uncontrolled on one to two antihypertensive medications, or resistant to appropriate treatment, investigators assessed National Health and Nutrition Examination Surveys data from 1988–1994, 1999–2004, and 2005–2008, involving 13,375 adults with hypertension. Hypertension was defined as blood pressure (BP) of ≥140/≥90 mm Hg, and apparent treatment-resistant hypertension (aTRH) was defined as hypertension that persisted despite the use of three or more antihypertensive medications.
     In all three surveys, more than half of patients with uncontrolled hypertension were untreated. Independent predictors of untreated hypertension included male sex, infrequent healthcare visits (0 to 1 per year), body mass index <25 kg/m2, absence of chronic kidney disease, and Framingham 10-year coronary risk <10%.
     In 2005–2008, 72.0% of patients with treated uncontrolled hypertension (34.4% of all patients with uncontrolled hypertension) reported taking only one or two BP medications, suggesting therapeutic inertia. This group was older and had significantly higher Framingham 10-year coronary risk than patients controlled on one or two medications. The rate of treated patients with aTRH increased from 15.9% in 1998–2004 to 28.0% in 2005–2008 (P<0.001). Factors independently associated with aTRH included obesity, chronic kidney disease, and Framingham 10-year coronary risk >20%.
     Comment: This large, longitudinal study reveals consistent characteristics of untreated, undertreated, and apparently treatment-resistant hypertension that can inform efforts to improve blood pressure control, such as increasing frequency of healthcare visits and intensifying ineffective treatments. Patients with obesity, kidney dysfunction, or high Framingham 10-year coronary risk are at particular risk for resistant hypertension and might benefit from treatment that is aggressive, tailored, or both.
JoAnne M. Foody, MD Published in Journal Watch Cardiology September 7, 2011
     Citation(s): Egan BM et al. Uncontrolled and apparent treatment resistant hypertension in the United States, 1988 to 2008. Circulation 2011 Aug 30; 124:1046.
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MM: We’ve seen this data before. The only difference is that it’s a 5 year study. Once again, start with lifestyle modification and changes to the food chain such as the massive amount of hi fructose corn syrup that is being used as an additive in so many products.
2011 Jul 26; 343:d4169
Intensive Glucose-Lowering Treatment Does Not Lower 5-Year Mortality
In this meta-analysis, treatment did not lower risks for other adverse outcomes associated with type 2 diabetes.
     Recent trials cast doubt on the assumption that intensive glucose-lowering treatment in patients with type 2 diabetes lowers short- or long-term mortality and adverse cardiovascular (CV) events. In this meta-analysis of 13 randomized controlled trials, researchers addressed outcomes with intensive glucose-lowering.
     Overall, 35,000 patients (mean age, 62) received either intensive or standard glucose-lowering treatment. After a mean follow-up of 5 years, intensive glucose lowering was not associated with lower risks for all-cause mortality and CV death; in fact, these adverse outcomes were slightly — although nonsignificantly — more common with intensive treatment (risk ratios, 1.04 and 1.11, respectively). Patients randomized to intensive glucose-lowering treatment had significantly lower risks for nonfatal myocardial infarction (MI; RR, 0.85) and microalbuminuria (RR, 0.90), but significantly elevated risk for severe hypoglycemia (RR, 2.3). Risks for any stroke, nonfatal stroke, congestive heart failure (CHF), eye events, and peripheral vascular disease events did not differ between groups. When the analyses were restricted to high-quality studies, the lower risk for nonfatal MI associated with intensive glucose lowering disappeared and excess risk for CHF emerged.
     Comment: In this study, compared with standard treatment, intensive glucose-lowering treatment in patients with type 2 diabetes did not lower risks for all-cause or CV death or, for that matter, most other adverse outcomes associated with diabetes. Patients and clinicians should aim for reasonable glucose control that minimizes hypoglycemia and should focus on CV risk factor modification through diet, exercise, weight loss, smoking cessation, blood pressure control, and lipid lowering.
Paul S. Mueller, MD, MPH, FACP Published in Journal Watch General Medicine September 6, 2011
     Citation(s): Boussageon R et al. Effect of intensive glucose lowering treatment on all cause mortality, cardiovascular death, and microvascular events in type 2 diabetes: Meta-analysis of randomised controlled trials. BMJ 2011 Jul 26; 343:d4169.
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BMJ 2011 Jul 19; 343:d4094
Stopping Aspirin Raises Risk for Nonfatal Myocardial Infarction in Patients with Cardiovascular Disease
However, risk for coronary heart disease death did not increase.
     Daily low-dose aspirin (75–300 mg) prevents adverse cardiovascular (CV) events in patients with established CV disease. However, patients sometimes stop taking aspirin, either for no good reason or because of side effects. In an industry-funded, nested, case-control study, investigators determined risk for myocardial infarction (MI) and death from coronary heart disease (CHD) after discontinuation of low-dose aspirin in patients with histories of adverse CV or cerebrovascular events.
     A large U.K. primary care database was used to identify 39,500 patients (age range, 50–84) with first-ever prescriptions for low-dose aspirin for secondary prevention of adverse CV events. During a mean follow-up of 3.2 years, 876 patients experienced nonfatal MIs, and 346 died from CHD. After adjustment for multiple potential confounders, patients who had recently stopped taking aspirin (31–180 days before the index date) had significant excess risk for nonfatal MI compared with current aspirin users (risk was 63% higher after stopping). In contrast, risk for CHD death was not higher. The authors estimate that stopping aspirin was associated with four additional nonfatal MIs per 1000 person-years.
     Comment: These results highlight the importance of low-dose aspirin therapy for secondary prevention of CV disease. In the absence of a compelling clinical reason, patients with established CV disease should not stop taking low-dose aspirin. Notably, nonadherence was the most common reason for discontinuation. Given that most U.S. patients use over-the-counter aspirin, clinicians should ascertain whether their patients are actually buying and using it.
Paul S. Mueller, MD, MPH, FACP Published in Journal Watch General Medicine August 9, 2011
     Citation(s):García Rodríguez LA et al. Discontinuation of low dose aspirin and risk of myocardial infarction: Case-control study in UK primary care. BMJ 2011 Jul 19; 343:d4094. (http://dx.doi.org/10.1136/bmj.d4094)
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JAMA 2011 Aug 24/31; 306:856
Worsening Diastolic Function Predicts Heart Failure
Progression of diastolic dysfunction is an independent risk factor that warrants vigilance but not — at this point — screening or intervention.
     Left ventricular (LV) diastolic dysfunction is an important precursor of heart failure (HF). However, change in diastolic function over time has not been correlated with the development of overt HF. This study involved 1402 participants in the Olmsted County Heart Function Study (mean age, 61; 90% white; 49% men) who underwent two clinical and echocardiographic evaluations 4 years apart. At the first examination, 2.3% of the population had abnormal systolic function. Diastolic function, assessed at both examinations in 75.5% of participants, was characterized as normal, mild (abnormal relaxation without increased LV end-diastolic pressure [LVEDP]), moderate (abnormal relaxation with increased LVEDP), or severe (reduced LV compliance with restrictive filling).
     The prevalence of any diastolic dysfunction increased from 23.8% at the first evaluation to 39.2% at the second. Diastolic function worsened in 23.4% of participants, more frequently in older than in younger individuals, and improved in only 8.8%. During a mean follow-up of 6.3 years after the second examination, 81 participants developed new clinical HF. Any diastolic dysfunction at the second examination was associated with nearly a doubling of the risk for HF (hazard ratio, 1.81), even after accounting for age, hypertension, diabetes, and coronary artery disease. The cumulative rate of incident HF rose with increasing severity of diastolic dysfunction at the second examination from 2.6% in participants with sustained normal diastolic function to 12.2% in those with moderate or severe diastolic dysfunction.
     Comment: These findings suggest that progression of diastolic dysfunction is common and is an important precursor of incident heart failure. However, the results are limited by the possibility of participation and survival biases and require replication in more-diverse populations. Furthermore, they do not support screening for diastolic dysfunction or interventions aimed at preventing its progression, which have not been shown to improve meaningful patient outcomes such as HF and its associated symptoms.
Frederick A. Masoudi, MD, MSPH, FACC, FAHA Published in Journal Watch Cardiology
August 31, 2011
     Citation(s): Kane GC et al. Progression of left ventricular diastolic dysfunction and risk of heart failure. JAMA 2011 Aug 24/31; 306:856.
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Ann Intern Med Ann Intern Med 2011 Jul 19; 155:87
Patients Comprehend Clinical Data Best When Expressed as Percentages
Nevertheless, most people had difficulty understanding the benefits and harms of treatments.
     To determine how best to present data to patients on the benefits and harms of treatments, researchers randomly assigned nearly 3000 U.S. adults from a nationally representative cohort to receive drug information in one of five numeric formats. Data were presented in tables as natural frequencies (x in 1000); variable frequencies (x in 100, x in 1000, etc., as needed to maintain the numerator >1); percentages; percentages and natural frequencies; or percentages and variable frequencies. Participants were asked 18 questions that assessed their interpretation of the data, which outlined the expected benefits and adverse effects associated with treatment. The study was conducted online.
     The mean number of correct responses was between 13 and 14 in all five groups. However, the proportion of participants who correctly answered at least 16 of the 18 questions was greatest for those receiving data as percentages and variable frequencies (35%) or percentages only (34%); it was lowest for data presented only as frequencies (26%).
     Comment: In this randomized study, participants appeared to best understand potential benefits and harms of treatment when information was displayed as percentages. However, in this relatively educated population (38% had at least a college degree), only about a third of participants fully understood the data — a finding that points to the limitations of leaving treatment decisions solely to patients.
Jamaluddin Moloo, MD, MPH Published in Journal Watch General Medicine August 23, 2011
     Citation(s): Woloshin S and Schwartz LM. Communicating data about the benefits and harms of treatment: A randomized trial. Ann Intern Med 2011 Jul 19; 155:87. (http://www.annals.org/content/155/2/87.long)
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Article from Vital Choices Newsletter
September 8, 2011
Red Wine May Aid Weight Control
Review of relevant studies sees mixed findings on drinking and weight, depending on gender, amount, and drink type; moderate red wine seems to help
by Craig Weatherby
     A daily glass of red wine may help keep weight and belly fat in check, according to a new evidence review by researchers at Spain’s University of Navarra. The authors analyzed data from 31 epidemiological studies, which reveal associations between foods in people’s diets and their health, without proving a cause-effect relationship (Sayon-Orea C et al. 2011). 
In all of the studies, researchers had collected information on people’s alcohol consumption and body mass index.

The review paper’s authors noted that people tend to underestimate their weight and overestimate their height, which downplays their body mass index (BMI) … the measure used to gauge whether participants are at a healthy weight, overweight, or obese. However, one suspects that this underestimation of BMI would be more common among overweight people than among leaner participants, who would have less to “hide”.

Red wine (in moderation) shines in evidence review
As the authors wrote, “… light-to-moderate alcohol intake, especially wine intake, may be more likely to protect against weight gain, whereas consumption of spirits [is linked to] weight gain.” (Sayon-Orea C et al. 2011) Many of the studies linked greater body weight or abdominal adiposity (belly fat) among heavy or binge drinkers. But most found no links between obesity and moderate drinking, with some studies finding lower body weight in moderate drinkers

In general, links between weight and alcohol were stronger in men, possibly due to their choices of alcoholic drink and higher average daily alcohol intake.

Some studies found difference between genders, while others found that both male and female heavy drinkers showed the greatest weight gain or had the highest rates of obesity. Importantly, in the studies where researchers analyzed each type of alcoholic beverage separately, they found that, compared with non-drinkers, wine drinkers were at lower risk of obesity or excess belly fat. In contrast, people who drank hard liquors were at higher risk of being overweight or obese.

For example, data from the most recent US National Health and Nutrition Examination Survey (NHANES) showed that, compared to non-drinkers “heavy” drinkers – defined as four or more drinks a day – had higher odds of being obese and overweight. However, compared to non-drinkers, “light to moderate” drinking (one to two per day) came with significantly lower odds of being overweight and obesity. And a Danish study among 42,696 adults found no serious weight problems in men or women who consumed one glass of wine a week to one glass per day, with the smallest waist circumference gain for those who drank slightly less than one glass of wine per day.

Red wine antioxidants may help keep bellies in check
The Spanish reviewers offered a plausible explanation why, in addition to healthier overall lifestyles, people who drink red wine seem at lower risk of weight problems. As they said, the polyphenols in red wine – and related ones in cocoa, green tea and many fruits and vegetables – appear to inhibit creation of body fat (Ohyama K et al. 2011). Polyphenols – especially the catechins and procyanidins that abound mostly in red grapes, red wine, cocoa, and green tea – do this in various ways:

*The enterotype shifts wrought by consuming probiotic dairy products like yogurt tend to promote body fat. However, these changes also exert positive effects … see “Live Cultures May Lift Mood”. And resveratrol – a polyphenol compound found in red wine – reportedly reduces formation of new body fat, and inhibits expression of genes that help produce body fat (Beaudeux JL ET AL. 2010).

Sources; Ahn J, Lee H, Kim S, Ha T. Resveratrol inhibits TNF-alpha-induced changes of adipokines in 3T3-L1 adipocytes. Biochem Biophys Res Commun. 2007 Dec 28;364(4):972-7. Epub 2007 Oct 29. Beaudeux JL, Nivet-Antoine V, Giral P. Resveratrol: a relevant pharmacological approach for the treatment of metabolic syndrome? Curr Opin Clin Nutr Metab Care. 2010 Nov;13(6):729-36. Review. Chuang CC, McIntosh MK. Potential mechanisms by which polyphenol-rich grapes prevent obesity-mediated inflammation and metabolic diseases. Annu Rev Nutr. 2011 Aug 21;31:155-76. Ejaz A, Wu D, Kwan P, Meydani M. Curcumin inhibits adipogenesis in 3T3-L1 adipocytes and angiogenesis and obesity in C57/BL mice. J Nutr. 2009 May;139(5):919-25. Epub 2009 Mar 18. Hursting SD. Inflammatory talk: linking obesity, NF-κB, and Aromatase. Cancer Prev Res (Phila). 2011 Mar;4(3):285-7. Kang L, Heng W, Yuan A, Baolin L, Fang H. Resveratrol modulates adipokine expression and improves insulin sensitivity in adipocytes: Relative to inhibition of inflammatory responses. Biochimie. 2010 Jul;92(7):789-96. Epub 2010 Feb 25. Klaus S, Pültz S, Thöne-Reineke C, Wolfram S. Epigallocatechin gallate attenuates diet-induced obesity in mice by decreasing energy absorption and increasing fat oxidation. Int J Obes (Lond). 2005 Jun;29(6):615-23. Lin J, Della-Fera MA, Baile CA. Green tea polyphenol epigallocatechin gallate inhibits adipogenesis and induces apoptosis in 3T3-L1 adipocytes. Obes Res. 2005 Jun;13(6):982-90. Ohyama K, Furuta C, Nogusa Y, Nomura K, Miwa T, Suzuki K. Catechin-Rich Grape Seed Extract Supplementation Attenuates Diet-Induced Obesity in C57BL/6J Mice. Ann Nutr Metab. 2011;58(3):250-8. Epub 2011 Aug 9. Rastmanesh R. High polyphenol, low probiotic diet for weight loss because of intestinal microbiota interaction. Chem Biol Interact. 2011 Jan 15;189(1-2):1-8. Epub 2010 Oct 15. Review. Sayon-Orea C, Martinez-Gonzalez MA, Bes-Rastrollo M. Alcohol consumption and body weight: a systematic review. Nutr Rev. 2011 Aug;69(8):419-31. doi: 10.1111/j.1753-4887.2011.00403.x. Subbaramaiah K, Howe LR, Bhardwaj P, Du B, Gravaghi C, Yantiss RK, Zhou XK, Blaho VA, Hla T, Yang P, Kopelovich L, Hudis CA, Dannenberg AJ. Obesity is associated with inflammation and elevated aromatase expression in the mouse mammary gland. Cancer Prev Res (Phila). 2011 Mar;4(3):329-46. Wang Y, Lee KW, Chan FL, Chen S, Leung LK. The red wine polyphenol resveratrol displays bilevel inhibition on aromatase in breast cancer cells. Toxicol Sci. 2006 Jul;92(1):71-7. Epub 2006 Apr 11.
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Arch Gen Psychiatry 2011 Jul; 68:724
Fatal Outcomes of Eating Disorders
In a meta-analysis of studies with an average of 13 years of follow-up, anorexia nervosa was associated with a standardized mortality ratio of 5.86.
     Despite advances in treatment, eating disorders remain a clinical challenge. These researchers examined mortality rates in a meta-analysis of 36 longitudinal studies (mean follow-up, 13 years) involving 12,808 patients with anorexia nervosa (AN), bulimia nervosa (BN), or eating disorders not otherwise specified (EDNOS, a heterogeneous group of patients with eating disorders that do not meet full criteria for AN or BN).
     Mortality was greater in patients with all eating disorders compared with the reference populations (standardized mortality ratios: AN, 5.86; BN, 1.93; EDNOS, 1.92), although the calculation for EDNOS was based on only four studies. In the 35 studies with data on AN, older age at first presentation was the only predictor of mortality that could be derived from the limited information available; 20% of AN deaths were by suicide.
     Comment: Patients receiving the diagnosis of EDNOS vary considerably in different centers, and other researchers have reported that more than 80% of patients with an EDNOS diagnosis either had a previous AN or BN diagnosis or later go on to develop one of these disorders. Therefore, the increased mortality in patients with unspecified eating disorders may really be attributable to AN. In addition, a considerable amount of the heightened mortality rate in eating disorders might be attributable to comorbid psychiatric (especially mood) or medical disorders. Nevertheless, it is disturbing that mortality remains high in AN, which has recently been noted to be chronic and to begin later in life more frequently than was previously appreciated. Clinicians should be aware of the significant risk for death in all patients with eating disorders, especially AN.
Steven Dubovsky, MD Published in Journal Watch Psychiatry August 8, 2011
     Citation(s):Arcelus J et al. Mortality rates in patients with anorexia nervosa and other eating disorders: A meta-analysis of 36 studies. Arch Gen Psychiatry 2011 Jul; 68:724.

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