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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
February 25, 2012

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Do Antibiotics Help Uncomplicated Sinusitis?
Analysis Confirms Role of Endometriosis in Heightened Risk for Ovarian Cancer
What's Really Important in a Woman's Lipid Profile?
Is Obstructive Sleep Apnea Associated with Cardiovascular Mortality in Women?
BRCA1 and BRCA2 Mutations and Prognosis in Ovarian Cancer
Infants' Tylenol Recalled Over New Dosing System
Hepatitis C Overtakes HIV as Cause of Death in U.S.
IM Administration of Benzodiazepines as Good as IV for Epileptic Seizures
  En Route to Hospital
Helicobacter pylori and Inflammatory Bowel Disease
PPIs Don't Ease Asthma Symptoms in Children with Severe Asthma and Asymptomatic GERD
Chipping Away at Bone: Proton-Pump Inhibitors and Smoking
PPI-Associated Clostridium difficile Infection
Community-Acquired C. difficile Infection Different from Hospital Acquired
FDA Advisers Recommend Approval of New Diet Pill
Benefits of Physical Activity After Cancer Treatment
Another Molecular Clue About Exercise's Power to Combat Obesity and Type 2 Diabetes
Antibiotics and Severe Bleeding Among Older Adults on Warfarin
Safety of Chemotherapy During Pregnancy
Fried-Food Consumption Not Linked to Heart Disease or Death
Omega-3s Curbed Heart Risk in Small Babies
Lactose Malabsorption in Children Is Not Associated with Lower Calcium Intake
  or Bone Mass)
Stem Cells on the Clock: Circadian Rhythm Proteins Regulate Epidermal Stem Cells

MM: Its true that antibiotics are over prescribed but its not enough to simply say no. Alternatives will be demanded because the public and parents are not willing to accept a simple “wait and watch” response from their Health Care Provider (HCP). People want answers and wealternatives and we have them if we are willing to get out of the box to do so. I have recommended Vitamin D-3 on many occasions for viral infection-like symptoms with great success. My typical recommendation is approximately 1000IU of vitamin D3 per pound of body weight for 2-5 days. This dose and schedule has never shown any adverse reactions in my practice and almost universally has demonstrated almost immediate positive responses. High dose Vitamin D3 has become a staple in my medicine cabinet and that of many of my family members, patients and colleagues. We have it available in both 5000 and 50,000IU capsules combined with probiotics that enhance the effect and absorbtion of the vitamin D3.
JAMA 2012 Feb 15; 307:685
Do Antibiotics Help Uncomplicated Sinusitis?
A placebo-controlled study says no.
Many studies have indicated that antibiotics are wildly overprescribed for sinusitis (JW Gen Med Jan 31 2012). However, randomized trials on the utility of these medications have had conflicting results, with statistical interpretation complicated by different enrollment criteria and high rates of spontaneous improvement.
In a double-blinded study, researchers randomized 166 adults reporting 1 to 4 weeks of standard sinusitis symptoms (including maxillary pain or tenderness in the face or teeth, and purulent nasal secretions) to receive 10 days of amoxicillin or placebo, along with a range of as-needed symptom-relief medications (acetaminophen, guaifenesin, dextromethorphan, pseudoephedrine, and nasal saline spray). Imaging studies were not performed.
Symptom improvement — evaluated on a standardized questionnaire called the "SNOT-16" — was indistinguishable between the groups at day 3, slightly favored amoxicillin at day 7, and was then indistinguishable again at day 10. Reported adverse effects of treatment and overall satisfaction with treatment did not differ between groups; recurrence rates were similar.
Comment: These data again support the decision to withhold antibiotics in patients with standard-issue sinus complaints. Unfortunately, clinicians must then do repeated battle with patients who are convinced that only an antibiotic will help them. For these patients, watchful waiting, with the promise of reevaluation should symptoms fail to improve, may be a realistic if not always achievable approach to treatment.
— Abigail Zuger, MD Published in Journal Watch General Medicine February 21, 2012
Citation(s):Garbutt JM et al. Amoxicillin for acute rhinosinusitis: A randomized controlled trial. JAMA 2012 Feb 15; 307:685. (http://dx.doi.org/10.1001/jama.2012.138)
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MM: Endometriosis can be a very painful condition for many women. Unfortunately, the typical first line treatment seems to be administration of birth control pills. In my opinion, this is a band-aid or cover-up approach. All is does is delay the symptome to a later time. It fails to address any of the underlying issues. We have worked with patients and their doctors and have recommended the use of Bio-Identical Progesterone Cream and/or capsules for this condition. The majority of patients seem to respond well and show long term benefits with this approach. They typically see rapid symptom relief and are able to frequently become pregnant if so desired. Please contact Mark Drugs for more information.
Analysis Confirms Role of Endometriosis in Heightened Risk for Ovarian Cancer
Endometriosis increases risk for invasive ovarian cancer, an analysis of several international studies confirms, but the risk does not extend to all tumor subtypes. The results appear in the Lancet Oncology.
Researchers pooled data from 13 case-control studies performed within the Ovarian Cancer Association Consortium. In those studies, which included some 8000 women with invasive ovarian cancer and 13,000 controls, women self-reported whether they had a history of endometriosis.
Roughly 9% of women with invasive cancer reported a history of endometriosis, compared with 6% of controls. Women with a positive history were more likely to have clear-cell, endometrioid, and low-grade serous tumors, but the other two tumor subtypes (mucinous and high-grade serous) were not associated with endometriosis.
A commentator writes that because some of the tumor subtypes associated with endometriosis present at an early stage and thus could be resected, targeted screening could be considered for some women.
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Ann Intern Med 2011 Dec 6; 155:742.
What's Really Important in a Woman's Lipid Profile?
Prospective data from the Women's Health Initiative suggest that HDL level is a significant inverse predictor of coronary events, regardless of LDL level.
An inverse association exists between HDL level and cardiovascular disease. In men, this association has been found to be independent of LDL level. To find out if the association is consistent across the spectrum of LDL or apolipoprotein (apoA-I and apoB100) levels in women, researchers conducted an industry-sponsored analysis of data involving 26,861 participants in the Women's Health Study. All were aged ≥45 and healthy at baseline.
During approximately 11 years of follow-up, 929 cardiovascular events occurred, including 602 coronary events and 319 strokes. In multivariate analysis, HDL and apoA-I levels were inversely associated with risk for coronary events (but not for stroke). This association was consistent in subgroups stratified by age, race, hypertension, smoking status, diabetes, hormone therapy, and body-mass index. After risk-factor adjustment, the inverse association of HDL level with coronary events remained statistically significant across the range of LDL levels. In women with low apoB100 levels, however, neither HDL nor apoA-I level was associated with coronary risk.
Comment: These observational data suggest that in healthy women, HDL level is the most useful lipid-panel predictor of incident coronary events, and that the association holds for a broad range of LDL levels. When assessing global coronary risk in women, clinicians should focus especially on HDL level. However, no outcomes studies have demonstrated an association of targeted HDL-raising therapy with improved outcomes. For now, LDL remains the prime target of lipid modification in women with hypercholesterolemia.
Joel M. Gore, MD Published in Journal Watch Cardiology February 1, 2012
Citation(s):Mora S et al. Association of high-density lipoprotein cholesterol with incident cardiovascular events in women, by low-density lipoprotein cholesterol and apolipoprotein B100 levels: A cohort study. Ann Intern Med 2011 Dec 6; 155:742.
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Ann Intern Med 2012 Jan 17; 156:115
Is Obstructive Sleep Apnea Associated with Cardiovascular Mortality in Women?
Like men, women with severe OSA are at increased cardiovascular risk and should receive appropriate treatment.
Obstructive sleep apnea (OSA) is a recognized risk factor for cardiovascular death in men but hasn't been well studied in women. To find out more, investigators at two sleep clinics in Spain prospectively followed 1116 women who underwent either polysomnography or respiratory polygraphy.
During a median follow-up of 72 months, 41 patients (3.6%) died of cardiovascular disease and 37 (3.3%) died of noncardiovascular disease. In untreated patients, cardiovascular mortality rates were as follows:

Patients treated with continuous positive airway pressure (CPAP; median adherence, 6 hours per day) had cardiovascular mortality rates similar to those of control patients, regardless of OSA severity. In multivariate analysis, untreated severe OSA was an independent predictor of cardiovascular mortality; no significant difference in cardiovascular mortality risk was found among control patients, those with CPAP-treated severe OSA, those with CPAP-treated mild-to-moderate OSA, and those with untreated mild-to-moderate OSA. Sensitivity analysis by type of diagnostic sleep study did not affect the results.
Comment: In this observational study of obstructive sleep apnea in women, untreated severe OSA was associated with increased cardiovascular mortality, whereas treatment of severe OSA with continuous positive airway pressure reduced the mortality risk to that of women without OSA. All women with suggestive symptoms should be evaluated for OSA, and those with OSA should receive appropriate treatment.
— Joel M. Gore, MD Published in Journal Watch Cardiology February 22, 2012
Citation(s): Campos-Rodriguez F et al. Cardiovascular mortality in women with obstructive sleep apnea with or without continuous positive airway pressure treatment. Ann Intern Med 2012 Jan 17; 156:115.
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JAMA 2012 Jan 25; 307:382
BRCA1 and BRCA2 Mutations and Prognosis in Ovarian Cancer
Five-year overall survival rate was higher in carriers than noncarriers.
Some studies have shown that women with ovarian cancer who carry BRCA1 or BRCA2 mutations have a better prognosis than noncarriers, whereas other studies found no such differences. To examine this issue further, investigators conducted a pooled analysis of 26 observational studies involving 3879 women with ovarian cancer: 909 carried BRCA1 mutations, 304 carried BRCA2 mutations, and 2666 were noncarriers.
Rates of 5-year overall survival were significantly higher in BRCA1 mutation carriers (44%; 95% confidence interval, 40%–48%) and BRCA2 mutation carriers (52%; 95% CI, 46%–58%) than noncarriers (36%; 95% CI, 34%–38%). These differences remained significant after adjustments for age, time of diagnosis, and stage and grade of ovarian cancer.
Comment: This large study provides conclusive evidence that prognosis in ovarian cancer is better among BRCA 1 or BRCA 2 mutation carriers than noncarriers. The improved survival might be the result of improved sensitivity to platinum agents, although more data is needed to confirm this hypothesis. Going forward, it will be important to use BRCA mutation status to stratify patients in clinical trials of ovarian cancer.
— Virginia Kaklamani, MD, DSc Dr. Kaklamani is an Assistant Professor in the Division of Hematology/Oncology at Northwestern University Feinberg School of Medicine in Chicago.
Published in Journal Watch Oncology and Hematology February 21, 2012
Citation(s): Bolton KL et al. Association between BRCA1 and BRCA2 mutations and survival in women with invasive epithelial ovarian cancer. JAMA 2012 Jan 25; 307:382.
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Infants' Tylenol Recalled Over New Dosing System
The entire U.S. supply of Infants' Tylenol has been recalled because of consumer complaints about the new SimpleMeasure dosing system, the manufacturer announced late last week.
The new system includes a dosing syringe and a flow restrictor at the top of the bottle. Seventeen customers have complained that when they inserted the syringe into the flow restrictor, the restrictor was pushed into the bottle, according to Reuters. No adverse events have been reported, and the company says the risk for serious events is "remote." As such, consumers may continue using the product if the flow restrictor stays in place.
The recall affects seven lots (574,000 bottles) of grape-flavored 1-oz Tylenol oral suspension for children younger than 2 years of age.

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Hepatitis C Overtakes HIV as Cause of Death in U.S.
The hepatitis C virus (HCV) has rapidly surpassed HIV as a cause of death in the U.S., according to an Annals of Internal Medicine study.
CDC researchers examined nearly 22 million death records over 9 years. By 2007, the age-adjusted mortality rate for HIV dropped to 4.16 deaths per 100,000 people per year, while the HCV mortality rate climbed to 4.58 deaths per 100,000. The hepatitis B virus (HBV) mortality rate remained relatively flat.
Roughly three quarters of HCV-related deaths occurred in people between the ages of 45 and 64. The authors say this relatively young age of people dying from HCV "portends a large and ever-increasing health care burden."
They conclude: "The experience with HIV mortality reduction suggests that a similar approach to HBV and HCV prevention might lead to similar reductions in mortality from viral hepatitis over time."
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IM Administration of Benzodiazepines as Good as IV for Epileptic Seizures En Route to Hospital
Paramedics caring for patients with prolonged epileptic seizures have as much success ending the seizures with intramuscular midazolam as they do with intravenous lorazepam.
In a noninferiority study, some 900 patients in status epilepticus who had been convulsing for longer than 5 minutes received either intramuscular midazolam or intravenous lorazepam. The primary outcome, the termination of seizures before arrival in the emergency department, was 73% with the intramuscular benzodiazepine and 63% with the intravenous one.
Writing in the New England Journal of Medicine, the authors point out that their study showed not only that intramuscular midazolam was equal to intravenous lorazepam, but that the differences clearly favored the superiority of intramuscular midazolam.
Dr. J. Stephen Bohan concludes in Journal Watch Emergency Medicine: "Prehospital protocols should instruct use of intramuscular midazolam as the primary treatment for prolonged seizure activity not caused by a correctable condition, such as hypoglycemia."
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Aliment Pharmacol Ther 2012 Feb; 35:469
Helicobacter pylori and Inflammatory Bowel Disease
Investigators conclude that H. pylori infection is inversely associated with IBD, whereas non–H. pylori chronic gastritis is positively associated with it.
Some preliminary studies have suggested that patients with Helicobacter pylori infection are less likely to have inflammatory bowel disease (IBD) than the general population.
To investigate this possibility further, investigators used a large national database of surgical pathology reports to examine biopsy results for patients who underwent both upper endoscopy and colonoscopy on the same day. The results from gastroscopy specimens were reviewed for the presence of esophagitis, gastritis, and H. pylori infection; those from colonoscopy specimens were evaluated for the presence of ulcerative colitis (UC), Crohn disease (CD), and indeterminate colitis.
IBD was identified in 1061 (1.6%) of 65,515 patients; the remaining patients were used as controls. The associations between H. pylori infection and IBD as well as between non–H. pylori gastritis and IBD were evaluated using multivariate logistic regression, with adjustment for potential confounders.
The presence of H. pylori infection was inversely associated with diagnosis of any IBD (adjusted odds ratio, 0.53; 95% confidence interval, 0.39–0.70), CD (AOR, 0.48; 95% CI, 0.27–0.79), UC (AOR, 0.59; 95% CI, 0.39–0.84), and indeterminate colitis (AOR, 0.43; 95% CI, 0.15–0.95). Conversely, the presence of non–H. pylori chronic gastritis was positively associated with these diagnoses: any IBD (AOR, 5.61; 95% CI, 4.35–7.14), CD (AOR, 11.06; 95% CI, 7.98–15.02, UC (AOR, 2.25; 95% CI, 1.31–3.60), and indeterminate colitis (AOR, 6.91; 95% CI, 3.50–12.30).
Comment: This well-designed study confirms suggestions that patients with H. pylori infection are at decreased risk for IBD. This finding, along with the positive association between non–H. pylori gastritis and IBD, raises questions about the mechanism underlying these associations. It should be noted that the prevalence of H. pylori infection was only 9% in the cohort overall, and even lower in the younger age groups. This might reflect the decreasing prevalence of the infection in the U.S. population or a potential selection bias. Less than 1% of the patients had no insurance, 3% were covered by Medicaid, and 69% had private insurance. Underrepresentation of patients from lower economic groups might have reduced the prevalence of H. pylori infection and introduced the possibility that the findings are due to factors associated with higher economic status.
— David J. Bjorkman, MD, MSPH (HSA), SM (Epid.) Published in Journal Watch Gastroenterology February 24, 2012
Citation(s):Sonnenberg A and Genta RM. Low prevalence of Helicobacter pylori infection among patients with inflammatory bowel disease. Aliment Pharmacol Ther 2012 Feb; 35:469.
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JAMA 2012 Jan 25; 307:373
PPIs Don't Ease Asthma Symptoms in Children with Severe Asthma and Asymptomatic GERD
In addition, lansoprazole raised the incidence of adverse events.
Gastroesophageal reflux disease (GERD) is more common in children with asthma than in children without asthma, but whether the association is causal is uncertain. Nonetheless, patients with uncontrolled asthma and no reflux symptoms are often given proton-pump inhibitors (PPIs) despite unproven benefit. To examine the effect of PPIs on asthma control in children, researchers randomized 306 children (age range, 6–17 years) with poorly controlled asthma and no reflux symptoms to receive lansoprazole or placebo in addition to inhaled corticosteroid treatment for 24 weeks; of 115 children who underwent esophageal pH monitoring, 43% had asymptomatic GERD.
The mean change in Asthma Control Questionnaire score (the primary outcome) and secondary measures of asthma control did not differ significantly between the lansoprazole and placebo groups in the entire sample or in the subgroup of patients who had reflux on pH monitoring. Patients treated with lansoprazole were 1.3 times more likely than placebo recipients to experience upper respiratory infections (a significant difference) and had 6 times more fractures (6 vs. 1 fracture, a nonsignificant difference; P=0.06).
Comment: These results are consistent with those of a similar study in adults (JW Gen Med Apr 16 2009). Unnecessary PPI use raises asthma-related healthcare costs and risk for upper respiratory infection and possibly fracture in children. An editorialist notes that although PPIs have little or no proven benefit in children with reflux, PPIs continue to be prescribed on the basis of experience in adults and because they are perceived as safe. The available studies indicate there is no role for empirical treatment of asymptomatic GERD in patients of any age with asthma.
— David J. Amrol, MDDr. Amrol is an Associate Professor of Clinical Internal Medicine and Director of the Division of Allergy and Immunology at the University of South Carolina School of Medicine in Columbia.
Published in Journal Watch General Medicine February 2, 2012
Citation(s):Holbrook JT et al. Lansoprazole for children with poorly controlled asthma: A randomized controlled trial. JAMA 2012 Jan 25; 307:373.
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BMJ 2012 Jan 31; 344:e372
Chipping Away at Bone: Proton-Pump Inhibitors and Smoking
Long-term PPI use was associated with excess risk for postmenopausal hip fractures, especially in smokers.
Proton-pump inhibitors (PPIs) suppress gastric acid production and, consequently, calcium absorption. Thus, long-term PPI use may reduce bone density and raise fracture risk. Using data from the Nurses' Health Study (NHS) and prior studies, investigators assessed the association between long-term PPI use and risk for hip fracture in postmenopausal women.
Among 80,000 women in the NHS (age range at entry, 30–55), PPI use rose from 7% in 2000 to 19% in 2008. Absolute risk for hip fracture was 2.0 events per 1000 person-years among regular PPI users and 1.5 events per 1000 person-years among nonusers. Adjusted for multiple factors (e.g., body-mass index, calcium intake, osteoporosis history, use of hormone therapy), risk for hip fracture among women who used PPIs regularly for ≥2 years was 40% higher than among nonusers and rose with duration of PPI use. Among previous or current smokers, PPI use was associated with a 50% increased risk for hip fracture, whereas among never-smokers, PPI use was not associated with excess risk. In a meta-analysis involving 11 studies and 1.5 million participants, PPI use was associated with a 30% increased risk for hip fracture.
Comment: Notably, proton-pump inhibitor use also has been associated with excess risks for vertebral, forearm, and wrist fractures (JW Gen Med Jun 8 2010). The finding that chronic PPI use is associated with excess risk for hip fracture, especially in women with histories of smoking, suggests that long-term PPI use in women should be critically evaluated.
— Paul S. Mueller, MD, MPH, FACP Published in Journal Watch General Medicine February 14, 2012
Citation(s): Khalili H et al. Use of proton pump inhibitors and risk of hip fracture in relation to dietary and lifestyle factors: A prospective cohort study. BMJ 2012 Jan 31; 344:e372.
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Rockville, MD: Food and Drug Administration; Feb 8 2012
PPI-Associated Clostridium difficile Infection
The FDA recently alerted healthcare professionals and patients that use of proton-pump inhibitors may increase the risk for Clostridium difficile–associated diarrhea.
On reviewing published studies and information from the FDA's Adverse Event Reporting System, the FDA warned the public that use of proton-pump inhibitors (PPIs) may increase the risk for Clostridium difficile–associated diarrhea (CDAD). Although the strength of the association varied widely among studies, most studies found risk for C. difficile infection or disease to be 1.4 to 2.75 times higher in patients with PPI exposure than in those without. Many of the patients affected also had other risk factors, such as antibiotic use, older age, or certain comorbid conditions.
PPIs (and possibly histamine-2 antagonists) alter the gastric pH and can allow overgrowth of C. difficile. Several of these agents are now sold over the counter, without need for a prescription.
Patients taking PPIs should be advised to seek medical care promptly if they experience watery diarrhea that does not improve, abdominal pain, and fever. Those found to have C. difficile infection may require replacement of fluid and electrolytes and may need to discontinue or change a prescribed antimicrobial therapy. Uncommon but serious complications include kidney failure, toxic megacolon, bowel perforation, and even death.
Comment: The literature suggests that PPI use increases risk for several problems in addition to C. difficile infection — for example, nosocomial pneumonia, drug–drug interactions (because PPIs decrease absorption of several antimicrobial and antiretroviral agents), and electrolyte imbalances. The effects of dose and duration are not entirely clear, but using the lowest dose for the prescribed indication — and for no longer than necessary — makes sense.
Unfortunately, PPIs are often prescribed without good reason, such as for stress-ulcer prophylaxis in patients who don't qualify for this therapy. Furthermore, once started, these medications are often continued indefinitely. Over-the-counter availability of PPIs compounds the risk for adverse events by decreasing clinician oversight and, potentially, patient awareness of such risk.
Lynn L. Estes, PharmD Published in Journal Watch Infectious Diseases February 22, 2012
Citation(s):FDA Drug Safety Communication. Clostridium difficile-associated diarrhea can be associated with stomach acid drugs known as proton pump inhibitors (PPIs). Rockville, MD: Food and Drug Administration; Feb 8 2012.
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Am J Gastroenterol 2012 Jan; 107:89
Community-Acquired C. difficile Infection Different from Hospital Acquired
Community-acquired cases tended to occur in younger, healthier patients — mostly women — and were often not associated with antibiotic use.
Clostridium difficile infection (CDI) is increasing in both frequency and severity in the U.S., but little is known about the breakdown of community-acquired versus hospital-acquired cases. To address this gap, researchers reviewed data from all confirmed cases of CDI in a Minnesota county from 1991 through 2005.
The incidence of both community-acquired and hospital-acquired CDI increased dramatically during the study period. Of all 385 cases, 41% were community acquired. Compared with patients with hospital-acquired CDI, those with community-acquired disease were younger (median age, 50 vs. 72), healthier, and more likely to be female (76% vs. 60%). They were also less likely to have antibiotic exposure (78% vs. 94%), to be on acid suppressants (22% vs. 47%), to have cancer (17% vs. 32%), or to have severe infection (20% vs. 31%). Risk for recurrence did not differ between the two groups (28% and 30%).
Comment: These data are useful for clinicians trying to treat patients with diarrhea. Community-acquired cases are often not associated with antibiotic use, tend to be mild, and, for unclear reasons, occur mostly in females.
Douglas K. Rex, MD Published in Journal Watch Gastroenterology February 24, 2012
Citation(s): Khanna S et al. The epidemiology of community-acquired Clostridium difficile infection: A population-based study. Am J Gastroenterol 2012 Jan; 107:89.
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FDA Advisers Recommend Approval of New Diet Pill
FDA advisers have voted 20 to 2 to approve the diet pill Qnexa, a combination of phentermine and topiramate, Reuters reports. If approved, Qnexa will be the first new prescription weight-loss pill to hit the market in 13 years.
In 2010, the FDA rejected the pill's approval over concerns that it could raise the risk for heart problems and birth defects. During this week's meeting, advisers said the manufacturer should conduct a study on the potential for heart problems, while supporting the company's intent to restrict its use to nonpregnant women. The advisers were split on whether the heart study should be performed before or after the pill's approval.
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BMJ 2012 Jan 31; 344:e70
Benefits of Physical Activity After Cancer Treatment
Exercise improved physical function, psychological outcomes, and quality of life in cancer survivors.
Can physical activity mitigate some of the debilitating effects of cancer treatment? To find out, investigators conducted a meta-analysis of 34 randomized, controlled trials in which patients were assigned to physical-activity interventions after their cancer treatment or did not engage in posttreatment exercise regimens. Twenty-two of the trials (65%) included only breast cancer patients; most of the others included patients with various types of cancer. Physical-activity interventions (median duration, 13 weeks) included aerobic exercise and resistance strength training. Exercise intensity, specified in only 13 trials, was usually moderate.
Compared with physical inactivity, exercise interventions were associated with significant improvements in body weight, body-mass index, peak oxygen consumption, peak power output, 6-minute walking distance, bench- and leg-press weight capacity, handgrip strength, fatigue, depression, and some quality-of-life measures.
Comment: This meta-analysis showed that exercise improved the physical function, psychological outcomes, and quality of life in patients who had been treated for cancer. Although most of the trials involved only breast cancer patients and none assessed the effects of physical activity on cancer recurrence or mortality, the findings nevertheless make a compelling case for advising cancer survivors to be physically active.
Paul S. Mueller, MD, MPH, FACP Published in Journal Watch General Medicine February 23, 2012
Citation(s): Fong DYT et al. Physical activity for cancer survivors: Meta-analysis of randomised controlled trials. BMJ 2012 Jan 31; 344:e70.
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Nature 2012 Jan 26; 481:463
Another Molecular Clue About Exercise's Power to Combat Obesity and Type 2 Diabetes
Exercising muscle produces irisin, which converts calorie-storing white fat cells into calorie-burning brown fat cells.
During the past 14 years, researchers have identified an important biochemical pathway in energy metabolism. At the center of this pathway is a molecule called PGC1-α, a transcription factor that stimulates the coordinated activation of many other genes. Exercise triggers muscle cells to produce PGC1-α; as a result, white fat cells develop into brown fat cells (which burn rather than store calories; JW Gen Med Sep 30 2008), and insulin resistance is reduced. But how does muscle-derived PGC1-α elicit its effects in distant tissues?
These investigators now report that PGC1-α stimulates muscle cells to produce and secrete a hormone, which they call irisin. This hormone transforms subcutaneous white fat cells into brown fat cells. Even without exercise or decreases in caloric intake, irisin causes weight loss and reduced insulin resistance in mice. Human muscle also produces irisin in response to exercise; indeed, human and mouse irisin are identical.
Comment: These results demonstrate that exercise not only burns calories directly, but also causes the body to burn additional calories through activation of the PGC1-α pathway and subsequent production of irisin. Besides being an important discovery in the molecular physiology of exercise, irisin might one day constitute a treatment for obesity and insulin resistance. Many "silver bullets" for obesity have come and gone; still, I'd bet on this newly discovered molecule.
Anthony L. Komaroff, MD Published in Journal Watch General Medicine February 23, 2012
Citation(s): Boström P et al. A PGC1-α-dependent myokine that drives brown-fat-like development of white fat and thermogenesis. Nature 2012 Jan 26; 481:463.
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Am J Med 2012 Feb; 125:183.
Antibiotics and Severe Bleeding Among Older Adults on Warfarin
In a case-control study, all concomitant antibiotics were associated with increased risk for bleeding; risk was highest with azole antifungals.
Warfarin — the most commonly prescribed oral anticoagulant worldwide — has a narrow therapeutic range. Many drugs, including antibiotics, have been linked to bleeding in warfarin users. Patients receiving anticoagulants generally are older and have more comorbidities than the general population and may be at increased risk for this complication.
To assess the bleeding risk associated with concomitant warfarin and antibiotic use in older patients, researchers performed a case-control study involving a cohort of Medicare beneficiaries who were using warfarin continuously in 2007–2008. Within this group of 38,762 patients, 798 (2.1%) were hospitalized in 2008 for bleeding and met the study criteria. Each case patient was matched with three control patients from the cohort, based on age, sex, race/ethnicity, and indication for warfarin use. Controls were assigned an index month corresponding to the event date of the matched case.
Concomitant exposure to any antibiotic doubled the risk for a bleeding episode, compared with no such exposure (adjusted odds ratio, 2.0; 95% confidence interval, 1.6–2.5). The risk was further increased among individuals whose antibiotic prescriptions began ≤15 days before the index event (AOR, 2.4; 95% CI, 1.8–3.2). The six antibiotic categories examined were all associated with a significant risk for bleeding, but azole antifungals were associated with the greatest risk (AOR, 4.6; 95% CI, 1.9–11.0).
Comment: This important study reminds us of the potentially grave effects of drug–drug interactions. The finding of a major interaction between azole antifungals and warfarin is not surprising, given that azoles inhibit CYP2C9, the enzyme responsible for metabolizing warfarin.
Neil M. Ampel, MD Published in Journal Watch Infectious Diseases February 22, 2012
Citation(s):Baillargeon J et al. Concurrent use of warfarin and antibiotics and the risk of bleeding in older adults. Am J Med 2012 Feb; 125:183.
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Lancet Oncol 2012 Feb 10
Safety of Chemotherapy During Pregnancy
In a long-term European study, health outcomes were similar between children exposed in utero to chemotherapy and the general population.
When cancer is diagnosed during pregnancy, women, obstetricians, and oncologists must make difficult therapeutic decisions based on limited data. To determine long-term outcomes after prenatal exposure to chemotherapy, investigators assessed neurologic, cardiac, and behavioral outcomes in 70 children in three European countries who were exposed in utero to cytotoxic drugs for cancer treatment. Children were assessed periodically between age 18 months and 18 years.
During pregnancy, half of the women received chemotherapy only and half also underwent surgery, radiation therapy, or all three treatment modalities. Breast cancer was the most common type of malignancy, and anthracyclines were the most commonly used chemotherapeutic agents. Median gestational age at diagnosis and gestational age at birth were 18 and 36 weeks, respectively. Incidence and types of congenital malformations were similar to those in the general population. During follow-up, most children demonstrated normal cognitive development; of those with below-normal cognitive development, most had been delivered preterm, and mean IQ scores rose by 11 points for each additional month in utero. Measures of behavior, overall health, hearing, and growth also tended to be similar to those in the general population, as were electrocardiography and echocardiography results.
Comment: As an editorialist points out, clinicians can use these findings to reassure pregnant women who need chemotherapy that treatment seems safe for their offspring — and that iatrogenic preterm delivery should be avoided whenever possible. If chemotherapy is initiated at ≥14 weeks' gestational age (after organogenesis) and delivery is planned to occur ≥3 weeks after the last treatment cycle (thereby allowing fetal drug excretion via the placenta), children exposed prenatally to chemotherapy can, as the authors state, "do as well as other children."
Andrew M. Kaunitz, MD Published in Journal Watch Women's Health February 23, 2012
Citation(s): Amant F et al. Long-term cognitive and cardiac outcomes after prenatal exposure to chemotherapy in children aged 18 months or older: An observational study. Lancet Oncol 2012 Feb 10; [e-pub ahead of print]. (http://dx.doi.org/10.1016/S1470-2045(11)70363-1)
Cardonick E. Treatment of maternal cancer and fetal development. Lancet Oncol 2012 Feb 10; [e-pub ahead of print]. (http://dx.doi.org/10.1016/S1470-2045(11)70408-9)
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BMJ 2012 Jan 24; 344:e363
Fried-Food Consumption Not Linked to Heart Disease or Death
The type of oil used for frying (olive versus sunflower) did not influence the findings.
Consumption of fried foods is thought to be unhealthy, but few data are available to support this assertion. Researchers recently conducted a prospective study of fried-food consumption and risk for coronary heart disease (CHD) among 41,000 Spanish adults aged 29 to 69 who were free of CHD at baseline. Typical daily fried-food consumption was assessed at study entry using a validated tool and ranged from 0 to 817 grams.
During a median follow-up of 11 years, 606 CHD events occurred, and 1135 study participants died. No links were seen between baseline fried-food consumption and either CHD or all-cause mortality. The type of oil used for frying (olive versus sunflower) did not influence the findings.
Comment: In this study, consumption of foods fried with olive or sunflower oil was not associated with CHD or all-cause mortality. As noted by editorialists, a limitation of the study was that fried-food consumption was assessed only at baseline; participants may have altered their intake later. Furthermore, the results cannot be generalized to consumption of foods fried with other types of oils.
Paul S. Mueller, MD, MPH, FACP Published in Journal Watch General Medicine February 21, 2012
Citation(s): Guallar-Castillón P et al. Consumption of fried foods and risk of coronary heart disease: Spanish cohort of the European Prospective Investigation into Cancer and Nutrition study. BMJ 2012 Jan 24; 344:e363. (http://dx.doi.org/10.1136/bmj.e363)
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Omega-3s Curbed Heart Risk in Small Babies
Fish oil plus canola oil prevented the artery-wall thickening and higher lifelong stroke and heart attack risks linked to low birth weights; omega-6 fats did no good
by Craig Weatherby

Being born smaller than most babies comes with a host of heightened health risks throughout life, including heart risks.  
Low birth weight is a serious problem in the developing world … and it’s become more common in America. (See our sidebar, “Small babies: A big and growing problem”.) So it’s encouraging to hear that smaller babies given omega-3s did not develop one of the particular cardiovascular risk factors found in their petite peers. Unfortunately, babies fed omega-6 fats in the new trial did develop thick artery walls … providing even more evidence that the average American’s excessive omega-6 fat intake (from vegetable oils) can exert adverse effects. The new findings carry substantial weight, as they come from a relatively large, controlled clinical trial.
Smaller babies develop thicker arteries
Babies whose birth weights fall in the bottom 10 percent are more likely to develop abnormally thick artery walls. Low birth weight is also associated with other cardiovascular risk factors, including high blood levels of triglycerides and LDL (“bad”) cholesterol and higher blood pressure. (Omega-3s are known to lower blood levels of triglycerides and LDL (“bad”) cholesterol and help control blood pressure.) As a consequence, small babies tend to suffer early onset of atherosclerosis and higher risks of related heart attack or stroke.

Atherosclerosis is a leading heart-risk factor, defined by build-up of fatty, inflamed plaque in arteries. Arterial plaque can rupture, yielding clots that can cause heart attack, stroke, or sudden cardiac death … and plaque constricts blood flow to the heart, leading to congestive heart failure. As a consequence of their tendency to develop atherosclerosis early, people born small have a higher lifelong risk of suffering heart attacks or stroke. For every kilogram by which a baby is deemed underweight at birth, their risk for coronary artery disease later in life rises by 10 to 20 percent (Phend C 2012).

Clinical trial finds omega-3s curb a key heart risk factor in small babies
The trial involved 616 children born at term ... that is, neither early nor late (Skilton MR et al. 2012). Researchers from Australia’s University of Sydney randomly assigned children to one of two groups placed on different regimens from the start of bottle-feeding or six months of age, until five years of age:

The scientists gave the control group omega-6-rich sunflower oil supplements, margarines, and cooking oil because this delivered the high-omega-6/low-omega-3 intake typical of western (e.g., American and Australian) diets. Western diets are awash in the omega-6-rich vegetable oils most commonly used in home cooking and in packaged and prepared foods: namely, corn, soy, sunflower, safflower, and cottonseed. The only common exceptions are canola, olive, and “hi-oleic” sunflower oils. (Macadamia nut and coconut oils are also low in omega-6s.)

At eight-years of age, the researchers tested the thickness of the children’s artery walls, using a standard measure called carotid intima-media thickness:

Specifically, the carotid intima-media thickness in the omega-3 group was 0.041mm less per kilogram of birth weight. It’s estimated that this difference would decrease future risk of attack by 5 to 7 percent, and reduce future stroke risk by 6 to 8 percent, per kilogram of lower birth weight (Phend C 2012). Thus, the smallest babies should see the biggest benefits from consuming ample omega-3s.

If the new findings are confirmed by future trials, efforts to ensure adequate pre- and post-natal omega-3 intakes could benefit one out of 10 people throughout their lives. Maternal and childhood diets rich in omega-3s would spare these people and their families much suffering … and possibly save billions of health care dollars annually.
Sources: Cosmi E, Visentin S, Fanelli T, Mautone AJ, Zanardo V. Aortic intima media thickness in fetuses and children with intrauterine growth restriction. Obstet Gynecol. 2009 Nov;114(5):1109-14. Hovi P, Turanlahti M, Strang-Karlsson S, Wehkalampi K, Järvenpää AL, Eriksson JG, Kajantie E, Andersson S. Intima-media thickness and flow-mediated dilatation in the Helsinki study of very low birth weight adults. Pediatrics. 2011 Feb;127(2):e304-11. Epub 2011 Jan 24. Lo Vasco VR, Salmaso R, Zanardo V, Businaro R, Visentin S, Trevisanuto D, Cosmi E. Fetal aorta wall inflammation in ultrasound-detected aortic intima/media thickness and growth retardation. J Reprod Immunol. 2011 Sep;91(1-2):103-7. Epub 2011 Jul 13. Norman M. Low birth weight and the developing vascular tree: a systematic review. Acta Paediatr. 2008 Sep;97(9):1165-72. Epub 2008 Jun 12. Review. Phend C. Fish Oil May Fix Heart Risk Tiny Babies Face. MedPage Today. February 20, 2012. Accessed at:
http://www.medpagetoday.com/OBGYN/Pregnancy/31260. Skilton MR, Ayer JG, Harmer JA, Webb K, Leeder SR, Marks GB, Celermajer DS. Impaired Fetal Growth and Arterial Wall Thickening: A Randomized Trial of Omega-3 Supplementation. Pediatrics. 2012 Feb 20. [Epub ahead of print] Skilton MR, Viikari JS, Juonala M, Laitinen T, Lehtimäki T, Taittonen L, Kähönen M, Celermajer DS, Raitakari OT. Fetal growth and preterm birth influence cardiovascular risk factors and arterial health in young adults: the Cardiovascular Risk in Young Finns Study. Arterioscler Thromb Vasc Biol. 2011 Dec;31(12):2975-81. Epub 2011 Sep 22. Tilling K, Smith GD, Chambless L, Rose K, Stevens J, Lawlor D, Szklo M. The relation between birth weight and intima-media thickness in middle-aged adults. Epidemiology. 2004 Sep;15(5):557-64. Trevisanuto D, Avezzù F, Cavallin F, Doglioni N, Marzolo M, Verlato F, Zanardo V. Arterial wall thickness and blood pressure in children who were born small for gestational age: correlation with umbilical cord high-sensitivity C-reactive protein. Arch Dis Child. 2010 Jan;95(1):31-4. Epub 2009 Sep 21. University of Sydney. Omega-3 linked with reduced risk for smallest babies. February 21, 2012. Accessed at:
U.S. Centers for Disease Control and Prevention (CDC). Is low birthweight a health problem? Accessed at:
http://www.cdc.gov/pednss/how_to/interpret_data/case_studies/low_birthweight/what.htm. U.S. Department of Health and Human Services, Health Resources and Services Administration, Maternal and Child Health Bureau. Child Health USA 2008-2009. Accessed at http://mchb.hrsa.gov/chusa08/hstat/hsi/pages/202lbw.html. Yang XZ, Liu Y, Mi J, Tang CS, DU JB. Pre-clinical atherosclerosis evaluated by carotid artery intima-media thickness and the risk factors in children. Chin Med J (Engl). 2007 Mar 5;120(5):359-62.
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J Pediatr Gastroenterol Nutr 2012 Feb; 54:204
Lactose Malabsorption in Children Is Not Associated with Lower Calcium Intake or Bone Mass
Lactose absorbers and malabsorbers have the same calcium intake and bone density.
Results from adult studies of the effects of lactose malabsorption on calcium intake and bone mass have been conflicting. To examine these effects in children, researchers performed hydrogen breath testing after a lactose challenge in 76 children in Brazil (age range, 5–12 years). Forty-seven children (62%) had lactose malabsorption; half had at least one gastrointestinal symptom of lactose intolerance following the test. Only three children reported previous history of milk intolerance.
Data from two 24-hour dietary recalls showed no significant differences between lactose absorbers and malabsorbers in daily median intake of calories, milk, other dairy products, calcium from milk, or total calcium. None of the children drank soy milk or Lactaid, and none took calcium supplements. Dual-energy x-ray absorptiometry of the lumbar spine showed similar bone-mineral content and density and bone-mineral density z-scores in lactose absorbers and malabsorbers. Dietary calcium and bone mass were also similar among lactose malabsorbers who had symptoms of intolerance after the lactose challenge, lactose malabsorbers who were lactose tolerant, and lactose absorbers.
Comment: These findings suggest that although lactose malabsorption is more common than we might think, based on reports from children of milk-related symptoms, it might not lead to lower calcium intake or bone mass. These Brazilian children consumed less than the recommended 1000–1300 mg of calcium per day, and milk intake averaged only about 6 ounces per day. Also, the study included few children with histories of symptomatic milk intolerance. A 2007 study in girls aged 10 to 13 years had similar results (Pediatrics 2007; 120:e669): Calcium intake and bone mass were similar in lactose absorbers and malabsorbers but were significantly lower in girls with reported milk intolerance than in those with no intolerance. Milk-intolerant children might still require close monitoring of calcium intake as well as vitamin D status.
Cornelius W. Van Niel, MD Published in Journal Watch Pediatrics and Adolescent Medicine February 22, 2012
Citation(s): da Silva Medeiros LC et al. Lactose malabsorption, calcium intake, and bone mass in children and adolescents. J Pediatr Gastroenterol Nutr 2012 Feb; 54:204.
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Nature 2011 Dec 8; 480:209
Stem Cells on the Clock: Circadian Rhythm Proteins Regulate Epidermal Stem Cells
Investigators found an association between expression of genes associated with stem cell function and expression of circadian rhythm genes.
Circadian rhythm in mammals is regulated by complex interactions between many proteins. In mice, it is well known that hair follicle cycles advance synchronously in early adulthood.
By following the level of Per1, a protein that regulates the circadian cycle, these investigators realized that within mouse skin, different populations of dormant follicular stem cells exist at different states (analogous to 12 midnight and 12 noon on a molecular clock). As the hair cycle progressed through anagen, bulge cells became "synchronized," and all expressed high levels of Per1. When they probed the differences between the two initially divergent cell populations, the authors found an association between expression of genes associated with stem cell function and expression of circadian rhythm genes. The clock protein Bmal1 modulates the expression of stem cell regulatory genes to create populations that are either predisposed or less prone to activation. Deleting Bmal1 from skin reduced cell cycling in basal cells and reduced epidermal differentiation, perhaps reflective of premature aging. Mice with deleted Bmal1 were resistant to tumor formation and had a smaller proportion of tumor-initiating cells when treated with chemical carcinogens.
Comment: The genes that regulate circadian rhythms can directly affect cell cycle regulation and are required for proper epidermal morphogenesis. The conserved use of an intrinsic timing mechanism to regulate the potential of hair follicle stem cells is as much a surprise as it is beautiful. These findings also suggest that it may be possible to regulate stem cell capacity through the manipulation of circadian rhythm proteins.
Kenneth Y. Tsai, MD, PhD
Published in Journal Watch Dermatology January 20, 2012
Citation(s): Janich P et al. The circadian molecular clock creates epidermal stem cell heterogeneity. Nature 2011 Dec 8; 480:209

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