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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
May 13, 2013

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Respiratory Viruses and Otitis Media
Sweetening the Brain: Higher Fasting Glucose Levels and Alzheimer-Like Abnormalities
Memory Loss, Confusion Noted by Many Older Adults
Could Vitamin D Supplementation Lower Blood Pressure in Blacks?
Pfizer to Sell Viagra Directly from Its Website
Pfizer to Sell Viagra Direct to Patients
Economists Wonder Why Health Costs Continue to Stabilize
Salutary Effects of Lower Energy Intake, Higher Physical Activity, and Weight Loss in Cuba
Is Infantile Colic an Early Form of Migraine?
Reclassifying Endometrial Carcinoma
Mastectomy Is More Common in Medicaid Patients
Urological Group's Guidelines Recommend Against PSA Screening in Most Men
FDA Approves New Cholesterol-Cutting Combination Drug
Weight Loss with Lifestyle Interventions in the Seriously Mentally Ill
Pets — Especially Dogs — Are Good for the Heart
Your New Gym: A Kitchen Chair
Omega-3 Fatty Acids and Later-Life Mortality
Omega-3 Fatty Acid Supplementation in Patients with Risk Factors: A Randomized Trial

MM: Several weeks ago I reported an article on how few new antibiotics have been developed in the past decade and that the recommendation of prevention of infection and proper stewardship of antibiotic use would be necessary to maintain the value of antibiotic therapy. This article reminds us that most middle ear infections may be prevented before it becomes necessary for antibiotic use. Xylitol chewing gum, nasal sprays/drops and other products may be paired with oral doses of Vitamin D3 for this purpose. Please contact Mark Drugs for more details or to purchase these products. This is where an ounce of prevention is truly worth a pound of cure.
Pediatr Infect Dis J 2013 Apr; 32:314
Respiratory Viruses and Otitis Media
Seasonal activity of respiratory syncytial virus and human metapneumovirus was strongly correlated with seasonal diagnosis of acute otitis media.
Acute otitis media (AOM) is one of the most common pediatric infections. Bacteria have been thought to cause the majority of cases, but with use of more-sensitive molecular methods, respiratory viruses are being detected with increasing frequency in the middle-ear fluid of children with AOM. Now, using medical records from a large healthcare system in Utah, researchers have analyzed the temporal relationship between circulating respiratory viruses and pediatric ambulatory care visits for AOM.
From 2002 through 2010, 46,460 (48%) of 94,418 nasopharyngeal specimens submitted for viral testing were positive. Also during this period, AOM was diagnosed in 271,268 children who were living in Utah and treated at an Intermountain healthcare facility (average, 30,141 cases per year). Respiratory syncytial virus (RSV), human metapneumovirus, and — to a lesser extent — influenza viruses showed winter peaks, between November and April; adenovirus, rhinovirus, and parainfluenza virus had less-pronounced seasonality. AOM cases showed moderate seasonality, with 66% occurring between November and April. Significant correlations were seen between AOM visits and the activity of individual circulating respiratory viruses. Correlations were strongest for RSV and metapneumovirus (P<0.001) and remained significant for these viruses with lag times of 2, 4, and 8 weeks between virus detection and AOM diagnosis. Adenovirus, rhinovirus, and parainfluenza virus were not associated with AOM visits.
Comment: The retrospective nature of this study does not allow conclusions about whether virus activity is truly predictive of acute otitis media visits. Because there were no cultures of middle ear fluid specimens, it is unclear whether the viruses caused AOM directly or fit the assumed pathogenesis by causing Eustachian tube dysfunction — a set-up for AOM. In either case, prevention of these viral infections might lead to a reduction in AOM incidence.
Robert S. Baltimore, MD  Published in Journal Watch Infectious Diseases April 24, 2013
Citation(s): Stockmann C et al. Seasonality of otitis media and the role of respiratory viral activity in children. Pediatr Infect Dis J 2013 Apr; 32:314.
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Neurology 2013 Apr 23; 80:1557
Sweetening the Brain: Higher Fasting Glucose Levels and Alzheimer-Like Abnormalities
A study in cognitively healthy, nondiabetic individuals with family histories of dementia
Diabetes and problems with elevated glucose appear to be risk factors for Alzheimer disease (AD) and cognitive dysfunction. These researchers examined whether higher fasting serum glucose levels affect the same brain regions associated with lower regional cerebral metabolic rates for glucose (rCMRgl) in AD.
The participants were 124 cognitively healthy individuals (mean age, 64) who did not have a diabetes history and who had a first-degree relative diagnosed with probable AD. Magnetic resonance imaging, positron emission tomography (PET), and cognitive tests were administered, with fasting serum glucose levels obtained during PET.
Higher fasting serum glucose levels were significantly associated with lower rCMRgl in several brain regions implicated in AD (precuneus/posterior cingulate and the parietal, prefrontal, and occipital areas). The strongest association with low rCMRgl was found in the right parietal area. The findings were not associated with APOE status.
Comment: Abnormal glucose regulation increases the risk for cognitive decline and may have a role in the pathophysiology of Alzheimer disease, possibly by affecting metabolism in the same brain regions. This study finding gives us an additional reason to educate our patients about factors that affect insulin and glucose sensitivity, such as carbohydrate intake and sleep–wake disruption (JW Psychiatry Apr 6 2009), as well as interventions that can improve control (exercise, avoidance of certain carbohydrates). These factors can be targets for future prevention studies in presymptomatic individuals.
Jonathan Silver, MD  Published in Journal Watch Psychiatry May 6, 2013
Citation(s): Burns CM et al. Higher serum glucose levels are associated with cerebral hypometabolism in Alzheimer regions. Neurology 2013 Apr 23; 80:1557.
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Memory Loss, Confusion Noted by Many Older Adults
By Cara Adler
One in eight noninstitutionalized adults aged 60 and older reported an increase in memory problems during the preceding year, according to a CDC analysis of 2011 data from the Behavioral Risk Factor Surveillance System survey published in MMWR.
Of 60,000 respondents, 13% reported having confusion or memory loss that had gotten worse or more frequent during the past year; of those with memory problems, 35% reported interference with work, social, volunteer, or household activities. People with these functional difficulties were more likely to report needing or getting help from family or friends. Only about one in three people with memory problems reported discussing them with a healthcare provider.
MMWR's editors say these findings provide baseline estimates of the scope of the problem and "underscore the need to facilitate timely discussions with healthcare and service providers so that linkages can be made to accurate information and needed services."
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MM: This information is not a complete surprise but can certainly be used clinically and immediately in most medical practices. When it is considered that the greatest effects on blood pressure in blacks occurs when vitamin D levels start below 20ng/ml and that so many blacks, in particular, fall within this range, idiopathic hypertension may find a pathway to oblivion. We can only hope that this information will not be lost on the medical community and that public health officials will find this information demonstrative and will put it into immediate use. This is another way to inexpensively reduce the risk of stroke and other cardiovascular disease in the general population.
Hypertension 2013 Apr; 61:779
Could Vitamin D Supplementation Lower Blood Pressure in Blacks?
In a small randomized trial, supplementation had a small but significant dose-related effect on systolic blood pressure.
Compared with whites, blacks have significantly higher rates of hypertension and significantly lower levels of 25-hydroxyvitamin D (25[OH]D). To assess the effects on blood pressure (BP) of treating the relative vitamin D deficiency in blacks, investigators conducted a randomized, double-blind, placebo-controlled trial of cholecalciferol (vitamin D3) supplementation (1000, 2000, or 4000 IU/day) for 3 months during the winter in 250 black adults (93% non-Hispanic; median age, 51; median body-mass index, 31 kg/m2). Baseline patient characteristics did not differ significantly among the four treatment arms (median 25[OH]D level, 15.7 ng/mL; median BP, 122/78 mm Hg; antihypertensive medication use, 42%).
Cholecalciferol use was associated with marked increases in median 25(OH)D levels at 3 months (45.9, 34.8, and 29.7 ng/mL in participants assigned to 4000, 2000, and 1000 IU/day of cholecalciferol, respectively); 3 months after treatment cessation, the increases were attenuated but still substantial (31.2, 27.0, and 21.2 ng/mL, respectively). Systolic — but not diastolic — BP fell significantly with both increasing cholecalciferol dose (1.4 mm Hg per 1000 IU/day) and increasing plasma 25(OH)D level (0.2 mm Hg per 1 ng/mL). The treatment effect was similar in an analysis restricted to patients who were not taking antihypertensive medications and in subgroups with baseline systolic BP levels <120 and ≥120 mm Hg, but was greater in patients with baseline plasma 25(OH)D levels <20 ng/mL than in those with levels ≥20 ng/mL.
Comment: In contrast to findings in other populations (JW Gen Med Oct 16 2012), these results show significant reductions in systolic blood pressure with vitamin D supplementation in blacks. The study was conducted during the winter to minimize seasonal variation in vitamin D levels, but it was small and short in duration. Larger-scale trials are needed to assess the efficacy and role of vitamin D supplements in the treatment of hypertension in blacks.
Joel M. Gore, MD  Published in Journal Watch Cardiology May 8, 2013
Citation(s): Forman JP et al. Effect of vitamin D supplementation on blood pressure in blacks. Hypertension 2013 Apr; 61:779.
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MM: When we let greed take over there will undoubtedly be problems that result and I feel that this move by Pfizer is laden with greed. Viagra is not a product free of side effects or danger and the dispensing of it without direct pharmacist consultation is a disaster waiting to happen.
Pfizer to Sell Viagra Directly from Its Website
By Joe Elia
Pfizer says it will make its most-counterfeited product, the erectile dysfunction drug Viagra (sildenafil), directly available on its website, making it the first major drugmaker to try this approach.
A prescription is still required, and the pills will sell for $25 each, according to the Associated Press. Three pills in the first order are free.
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MM: Another commentary...
Pfizer to Sell Viagra Direct to Patients
For the first time in the drug industry, Pfizer Inc. will begin selling Viagra directly to patients on its website. It will still require a prescription, but they no longer have to face a pharmacist to get it filled. If the price of $25 per tablet seems excessive, Pfizer is offering three free tablets with the first order and 30% off the second one. Other pharmaceutical manufacturers will probably watch Pfizer's move closely and, if it works, could begin selling other medicines that are rampantly counterfeited and sold online, particularly treatments for non-urgent conditions seen as embarrassing, including examples such as diet medications, medicines for baldness, and birth control pills.
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Economists Wonder Why Health Costs Continue to Stabilize
 By Joe Elia
Policy wonks are scratching their heads over continued good news about U.S. health costs. National health spending increased at a stable rate from 2009 to 2011, at about 4% per year. That's in contrast to increases of 6% to almost 10% between 2000 and 2007.
What has them most puzzled, according to a report in the New York Times and blogs in Health Affairs, is that the spending slowdown doesn't seem to be entirely attributable to the last recession.
Commentators point to "fundamental structural changes in the health system" as playing a role. Among those changes is the increasing likelihood that physicians are salaried and not practicing under fee-for-service incentives. Also at play is the fact that patients' out-of-pocket costs have increased substantially, by some 140% over the past 10 years, according to the New York Times
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BMJ 2013 Apr 9; 346:f1515
Salutary Effects of Lower Energy Intake, Higher Physical Activity, and Weight Loss in Cuba
Weight changes related to economic hardship and recovery were associated with changes in diabetes incidence and cardiovascular-related mortality.
During the economic crisis in Cuba (1991–1995), food and gas shortages resulted in lower food intake, greater energy expenditure (e.g., through walking and bicycling as alternatives to motorized transport), and weight loss across the population. Since then, the Cuban economy has recovered, and Cubans are less active and have gained weight. In this study, investigators assessed the associations between population-wide weight changes and health outcomes in Cuba between 1980 and 2010.
During the economic crisis, daily per capita energy intake was 2400 kcal, and 80% of adults were physically active; average weight loss during 5 years was 5.5 kg. During the economic recovery period (1996–2010), daily energy intake rose to 3200 kcal, the proportion of overweight and obese adults increased 20%, and the proportion of physically active adults fell to 55%. Between 1997 and 2009, diabetes incidence and prevalence doubled. During the "weight rebound phase" (2002–2009), diabetes-related mortality increased, and previously declining cardiovascular and overall mortality returned to pre-1991 rates.
Comment: In this fascinating, albeit unfortunate, "natural experiment," population-wide weight loss was associated with better health and lower mortality, and population-wide weight gain was associated with the opposite. Obviously, one cannot implement population-wide food and fuel rationing to compel weight loss in adults. However, these results remind us of the salutary effects of lower energy intake and more physical activity.
Paul S. Mueller, MD, MPH, FACP  Published in Journal Watch General Medicine May 7, 2013
Citation(s): Franco M et al. Population-wide weight loss and regain in relation to diabetes burden and cardiovascular mortality in Cuba 1980-2010: Repeated cross sectional surveys and ecological comparison of secular trends. BMJ 2013 Apr 9; 346:f1515.
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JAMA 2013 Apr 17; 309:1607
Is Infantile Colic an Early Form of Migraine?
In a case-control study, migraine was significantly associated with a history of infantile colic.
The etiology of infantile colic is uncertain. An association between colic and migraine has been proposed but not well studied. Investigators examined this association in a multicenter European case-control study of 208 consecutive children (age range, 6–18 years) diagnosed with migraine headache (66 with aura), 120 children with tension headache, and 471 controls from the same hospitals.
Infantile colic was ascertained on the basis of parent responses to a criteria-based structured interview and physician-recorded diagnosis in the child's mandatory health booklet. The prevalence of colic was 72% in children with migraine (70% with aura and 74% without aura), 33% in those with tension headaches, and 27% in controls. Odds ratios for infantile colic with migraine were 6.61 on the basis of parental reports and 6.68 on the basis of health booklet documentation. Tension headache was not associated with infantile colic. Among children with migraine, a pulsating quality of headache pain was significantly more common in those with colic than in those without.
Comment: This well-designed study adds to the growing body of research suggesting infant colic may be an early-life manifestation of genes that later in childhood are expressed as migraine headache. One possible explanation for the association is that infants with migrainous genetics may be sensitive to the new stimuli they encounter in early infancy and may express this sensitivity through excessive crying. Prospective longitudinal cohort studies are needed to further elucidate the relation between infant colic and pediatric migraine, as well as the relation between infant colic and other childhood periodic syndromes such as abdominal migraine. As the basic pathophysiology is unraveled, the promise of new interventions for both disorders beckons. Treatment of colic with current migraine medications is not recommended at this time.
F. Bruder Stapleton, MD  Published in Journal Watch Pediatrics and Adolescent Medicine May 8, 2013
Citation(s): Romanello S et al. Association between childhood migraine and history of infantile colic. JAMA 2013 Apr 17; 309:1607.
Epstein LG and Zee PC. Infantile colic and migraine. JAMA 2013 Apr 17; 309:1636. (http://dx.doi.org/10.1001/jama.2013.3873)
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Nature 2013 May 2; 497:67
Reclassifying Endometrial Carcinoma
The identification of new genomic subtypes might lead to more targeted approaches.
Endometrial cancers have been broadly classified into two groups: type 1, which are linked to obesity and estrogen excess and have a favorable prognosis, and type 2, which are mostly serous carcinomas and have an unfavorable prognosis. Based on these clinical subtypes, physicians make treatment decisions about chemotherapy and radiation therapy.
Now, investigators have conducted genomic and proteomic analyses of 373 endometrial tumors to further classify endometrial cancer into four groups: POLE ultramutated, microsatellite instability hypermutated, copy-number low, and copy-number high. They discovered that ERBB2 (the gene encoding for HER2) was focally amplified in 25% of serous and serous-like tumors, suggesting that the use of anti-HER2 therapy may be beneficial in this patient subpopulation. They also found that a subtype of endometrial cancer shares features with high-grade ovarian cancers and basal-like breast cancer, suggesting potential similarities in treatment response. The investigators concluded that these genomic subtypes will help clinicians determine optimal therapies for patients and may help in the selection of targeted approaches.
Comment: It has long been recognized that cancers have distinct molecular characteristics that may not be well depicted in pathology reports but that can serve as both prognostic and predictive markers. In fact, breast cancer was the first solid tumor in which molecular subtypes were found to have a huge impact on prognosis and treatment (Nature 2000; 406:747). Now, genomic assays are routinely used in breast cancer to aid clinicians in making treatment decisions (e.g., JW Oncol Hematol Nov 15 2011). The current study is a huge step toward applying this technique in other malignancies. In the era of targeted therapies, identifying pathways that drive tumor growth will be essential for developing successful approaches.
— Virginia Kaklamani, MD, DSc  Dr. Kaklamani is an Assistant Professor in the Division of Hematology/Oncology at the Northwestern University Feinberg School of Medicine in Chicago.
Published in Journal Watch Oncology and Hematology May 1, 2013
Citation(s): The Cancer Genome Atlas Research Network. Integrated genomic characterization of endometrial carcinoma. Nature 2013 May 2; 497:67.
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JAMA Surg 2013 Apr 24
Mastectomy Is More Common in Medicaid Patients
However, women with private insurance were more likely to undergo mastectomy for small tumors.
Disparity in breast cancer treatment among certain patient subgroups is well known. But little has been documented regarding surgical management based on patient financial status. Now, investigators have conducted a retrospective study in a single healthcare system in the Midwest to examine the effect of insurance payer type on mastectomy rates in 1539 women with stage I–III breast cancer.
Women on Medicaid were more likely than those with private insurance to undergo mastectomy (60% vs. 39%; P<0.05) and to have larger tumors at diagnosis (3.3 cm vs. 2.1 cm; P<0.05). Increasing tumor size and stage were independent predictors of mastectomy (P<0 .05). Of note, women with private insurance were more likely than those with Medicaid to have mastectomy for smaller (<2 cm) tumors (47% vs.11%; P<0.05).
Comment: Larger tumor size in patients with Medicaid in this study suggests that these women were less likely to receive screening mammography. One important consideration in patients with large primary breast cancer is the use of preoperative systemic therapy to downsize tumors and increase the likelihood of breast-conserving surgery. However, in this healthcare system, the extent of preoperative systemic therapy and its use according to insurance payer are unclear. The finding that women with small breast cancers who had private health insurance were significantly more likely than those with Medicaid to undergo mastectomy is a bit surprising since anecdotal experience in many centers across the U.S. has suggested that an increasing number of women, regardless of insurance status, have been requesting mastectomy and immediate breast reconstruction for small cancers. Therefore, it would be of interest to see what time trends reveal about this issue. Also worth considering is whether treatment of women with Medicaid versus other payers differs by surgeon in this healthcare system. Establishment of system-wide cancer diagnostic and treatment pathways for multidisciplinary practice might also minimize differences in care based on type of insurance.
Henry Mark Kuerer, MD, PhD, FACS  Published in Journal Watch Oncology and Hematology May 7, 2013
Citation(s):Adepoju L et al. Effect of insurance payer status on the surgical treatment of early stage breast cancer: Data analysis from a single health system. JAMA Surg 2013 Apr 24 : [e-pub ahead of print].
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Urological Group's Guidelines Recommend Against PSA Screening in Most Men
By Kelly Young
The American Urological Association's new guidelines recommend prostate cancer screening only in men aged 55 to 69 and based on shared decision-making and the patient's preferences. The guidelines put AUA's position more in line with other medical organizations.
In the 55-to-69 age group, one prostate-cancer death is prevented for every 1000 men screened over a decade. For men who decide to undergo prostate-specific antigen screening, AUA recommends testing every two years or more, rather than annual testing.
The group now recommends against routine PSA screening for men younger than 55 who are at average risk, those older than 69, and those with less than 10 to 15 years of expected life remaining.
The recommendations come less than a year after the U.S. Preventive Services Task Force recommended against routine PSA screening in all men.
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MM: Did I miss something here? Wasn't it determined the last time that a statin was combined with ezetimibe (aka Zetia) that there was no clinical benefit to this combination? In fact there were no longitudinal benefits at all! Is the FDA or the American public the one who Merck is hoping to dupe this time?
FDA Approves New Cholesterol-Cutting Combination Drug
By Kristin J. Kelley
The FDA has approved a new ezetimibe-atorvastatin tablet (brand name, Liptruzet) for lowering cholesterol in patients with primary or mixed hyperlipidemia, and in those with homozygous familial hypercholesterolemia.
In a trial of some 620 patients, the once-daily tablet reduced LDL cholesterol by 53% at the lowest dose (10/10 mg) and 61% at the highest dose (10/80 mg). Common side effects include changes in liver function tests, muscle pain, memory loss, and tendon problems.
The combination treatment has not been shown to improve cardiovascular outcomes better than atorvastatin, which has some cardiologists questioning the FDA's decision. Steven Nissen, chairman of cardiology at the Cleveland Clinic, says in Forbes that the agency seems to be "tone deaf" to concerns "about approving drugs with surrogate endpoints like cholesterol without evidence of a benefit for the disease [cardiologists] are truly trying to treat — cardiovascular disease."
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N Engl J Med 2013 Mar 21
Weight Loss with Lifestyle Interventions in the Seriously Mentally Ill
An 18-month intervention using exercise and weight management shows modest promise.
In patients with serious mental illness, little physical activity, poor diet, and adverse metabolic consequences of many atypical antipsychotic and other psychiatric medications contribute to high rates of obesity and mortality — patients' obesity rates are nearly twice as high and mortality rates are two to more than three times as high as in the general population. These investigators randomized 291 patients with schizophrenia-related conditions, bipolar disorder, or major depression (but no active alcohol or other substance abuse) from 10 psychiatric rehabilitation centers to a lifestyle intervention group or to a control group (mean age, 45; 50% male; 38% black; mean baseline weight, 226 lb.; mean body-mass index, 36.3).
The rehabilitation programs typically provided breakfasts and lunches. The 18-month intervention included group and individual weight management to reduce junk beverages and foods, increase intake of fruits and vegetables, and reduce portion size. Group exercise sessions emphasized graded increases of moderately intensive aerobics.
Program participation was strongest in the first 6 months and tailed off thereafter. Overall, 93% of enrollees were weighed at the follow-ups. Average weight loss was significant for intervention patients (–7.5 lb. at 18 months) but not for controls (–0.5 lb.). About 38% of those in the program vs. 23% of controls lost 5% or more of their starting weight.
Comment: At entry, controls took a higher average number of psychiatric medications than intervention patients, which might have affected weight. Furthermore, the study did not track medication switches, which might have affected weight loss. Nevertheless, these encouraging — although modest — results represent large lifestyle changes for many patients. Would sustained application of such interventions produce long-term effects on weight, overall health, and mortality?
Joel Yager, MD  Published in Journal Watch Psychiatry April 8, 2013
Citation(s): Daumit GL et al. A behavioral weight-loss intervention in persons with serious mental illness. N Engl J Med 2013 Mar 21; [e-pub ahead of print].
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Pets — Especially Dogs — Are Good for the Heart
By Kelly Young
The American Heart Association (AHA) recommends pet ownership as a reasonable option for reducing cardiovascular risk. Dog ownership in particular seems to improve cardiovascular fitness, possibly because of the need to regularly walk a dog.
In a scientific statement published in Circulation, the AHA notes that people should not get a pet solely to improve their cardiovascular health.
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Your New Gym: A Kitchen Chair
By Joe Elia
High-intensity interval training (periods of intense exercise near one's peak capacity followed by brief recovery periods) could allow shortening of exercise regimens, according to a Health and Fitness Journal study.
The New York Times' Well blog calls it "the scientific 7-minute workout," and the only equipment that one apparently needs is a simple chair and a wall to lean (not slouch) against. Twelve exercises are performed in strict order using 15 repetitions each, allowing opposing muscle groups to alternate between work and rest.
Caution: the authors say the regimen is not for the overweight, detrained, injured, or elderly.

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Ann Intern Med 2013 Apr 2; 158:515.
Omega-3 Fatty Acids and Later-Life Mortality
In older adults, higher circulating {omega}-3 fatty acid levels were associated with lower cardiovascular-related mortality.
Trials of {omega}-3 polyunsaturated fatty acid ({omega}3-PUFA) supplementation for preventing cardiovascular (CV) morbidity and mortality — most of which have involved patients with or at high risk for CV disease — generally have failed to show that supplementation improves outcomes. Results from the latest negative randomized trial have just been published (JW Gen Med May 8 2013).
In this observational study, researchers took a different approach: They evaluated the association between plasma levels of {omega}3-PUFAs and mortality in 2692 older people (mean age, 74) without coronary heart disease, stroke, or heart failure who were not taking {omega}3-PUFA supplements when they underwent baseline testing in 1992 or 1993.
During 16 years of follow-up, 1625 deaths occurred; 570 were CV-related. After adjustment for potential confounders, CV-related mortality was 35% lower among participants in the highest versus the lowest quintile of total {omega}3-PUFA levels. Plasma {omega}3-PUFA levels generally were unassociated with non–CV-related mortality.
Comment: In this study, higher plasma {omega}-3 polyunsaturated fatty acid levels were associated with significantly lower cardiovascular-related mortality at 16 years. As the authors note, this was the first study in which the association between plasma {omega}3-PUFA levels and mortality was evaluated in an otherwise healthy population. Because of the possibility of residual confounding, and because of the nonlinear relation between dietary intake of {omega}3-PUFAs and plasma levels, the implications of this study for practice are unclear.
Jamaluddin Moloo, MD, MPH  Published in Journal Watch General Medicine May 8, 2013
Citation(s): Mozaffarian D et al. Plasma phospholipid long-chain {omega}-3 fatty acids and total and cause-specific mortality in older adults: A cohort study. Ann Intern Med 2013 Apr 2; 158:515.
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N Engl J Med 2013 May 9; 368:1800
Omega-3 Fatty Acid Supplementation in Patients with Risk Factors: A Randomized Trial
Supplementation failed to improve any outcome.
In several recent randomized trials of secondary prevention after myocardial infarction, {omega}-3 fatty acid supplementation conferred no benefit. Now, Italian researchers have conducted an industry-supported trial that is a hybrid of primary and secondary prevention. The 12,500 participants qualified in three different ways: diabetes plus one other risk factor (48%); four nondiabetes cardiovascular risk factors that included age >65 and male sex (21%); or clinical evidence of atherosclerosis, such as angina, previous stroke, or peripheral vascular disease (30%). Previous myocardial infarction was an exclusion criterion.
Patients received either daily {omega}-3 fatty acids (1 g) or placebo. During average follow-up of 5 years, the incidence of the primary endpoint — cardiovascular-related death or hospital admission related to cardiovascular causes — was 12% in both groups, and {omega}-3 fatty acid supplementation did not lower the incidence of any secondary endpoints. None of the subgroups based on enrollment criteria (i.e., diabetes, multiple nondiabetes risk factors, or clinical atherosclerosis) benefited from supplementation. One prespecified subgroup interaction was barely statistically significant: In women (but not men), the primary event rate was slightly lower with supplementation than with placebo.
How does this latest result fit with the totality of the previously published data? A recent meta-analysis included 20 randomized trials (69,000 patients) in which researchers compared {omega}-3 fatty acid administration to controls (usually placebo). Two trials involved dietary intervention, and 18 involved supplements. Sixteen trials were purely secondary prevention studies, and 4 were mixed primary/secondary prevention studies. The bottom line: {omega}-3 fatty acid supplementation did not lower risk for death, myocardial infarction, or stroke during follow-ups ranging from 1 to 6 years (JAMA 2012; 308:1024).
Comment: This latest randomized trial falls in line with other recent studies: {omega}-3 fatty acid supplementation failed to improve clinical outcomes in patients with multiple cardiovascular risk factors or known atherosclerosis. Appropriately, the authors acknowledge that the slight difference in outcomes by sex could have been a chance finding. We have no reason to prescribe {omega}-3 fatty acids for primary or secondary prevention or to encourage patients to buy them on their own.
Allan S. Brett, MD  Published in Journal Watch General Medicine May 8, 2013
Citation(s): The Risk and Prevention Study Collaborative Group. n-3 fatty acids in patients with multiple cardiovascular risk factors. N Engl J Med 2013 May 9; 368:1800.

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