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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
November 5, 2011

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Many Teens with Polycystic Ovarian Syndrome Screen Positive for Sleep Problems
Can Celecoxib or Helicobacter pylori Eradication Reduce Gastric Lesions?
$10 Million Lawsuit Against Wyeth Filed Over Hormone Replacement Drug
Lipitor "Deals" and "OTC" Plans
For Vitamin and Mineral Supplementation, Less Is More
Prenatal Folic Acid Lowers Risk for Language Delay
Bilingualism Shapes Early Brain Development
Caffeinated Coffee and Late-Life Depression in Women
Depression Is Less Common in Women Who Drink Coffee
Is a Cure at Hand for Cystic Fibrosis in Some Children?

MM: The exciting aspect of this study is the correlation with ghrelin-leptin balance and sleep and the overlapping evidence that shows a benefit of the HCG weight loss protocol and PCOS.
J Pediatr 2011 Oct; 159:591
Many Teens with Polycystic Ovarian Syndrome Screen Positive for
Sleep Problems

About half of adolescents with PCOS screened positive for sleep-disordered breathing or excessive daytime sleepiness.
     Adult women with polycystic ovarian syndrome (PCOS) have high rates of sleep-disordered breathing (SDB), but whether adolescents do too is unclear. Investigators compared the prevalence of SDB and excessive daytime sleepiness (EDS) in 103 girls with PCOS (age range, 13–18 years; 56% Hispanic and 29% black) and 90 girls without PCOS matched for age, race, and body-mass index (BMI)-z scores from adolescent and obesity clinics at the same hospital. SDB was assessed with the Pediatric Sleep Questionnaire-Sleep-Related Disordered Breathing scale, which has been previously validated in this age group. EDS was assessed with a modified version of the Epworth Sleepiness Scale, which has not been validated in teens.
     Significantly more girls with PCOS than controls screened positive for SDB (46% vs. 28%) and EDS (54% vs. 36%). Among girls with PCOS, those who screened positive for SDB and EDS had significantly higher fasting insulin levels and insulin resistance (but not fasting glucose or free and total testosterone levels) than those without evidence of sleep-related problems. In regression analysis, BMI-z score was not associated with SDB or EDS.
     Comment: PCOS is a complex endocrine disorder, and treatment has focused on correcting or ameliorating the androgen excess, insulin resistance, and obesity that characterize it. Although the scale used to screen girls for EDS has not been validated in teens, the findings suggest that we should add careful screening and judicious referral for SDB to our management of girls with PCOS. The finding that BMI-z score was not related to risk for SDB indicates that we cannot use BMI alone to identify which girls with PCOS are at risk for SDB.
Alain Joffe, MD, MPH, FAAP Published in Journal Watch Pediatrics and Adolescent Medicine November 2, 2011
     Citation(s):Nandalike K et al. Screening for sleep-disordered breathing and excessive daytime sleepiness in adolescent girls with polycystic ovarian syndrome.
J Pediatr 2011 Oct; 159:591
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MM: What makes this such an interesting article is that it supports the theory of why ulcers and GI distress are alleviated and ameliorated by the anti-inflammatory actions of both probiotics and digestive enzymes that we incorporate into the BettenAid & HeartBurn Away products that we have developed at the Mark Drugs and Homefirst Labs.
Gut 2011 Sep 13
Can Celecoxib or Helicobacter pylori Eradication Reduce Gastric Lesions?
Regression of precancerous lesions was better with either treatment than with placebo.
     Both Helicobacter pylori infection and high levels of cyclooxygenase (COX)-2 have been associated with gastric cancer. To explore whether H. pylori eradication and a selective COX-2 inhibitor can reduce gastric lesions, investigators in China conducted a prospective, randomized, double-blind study involving patients with documented H. pylori infection and histologic evidence of chronic atrophic gastritis, intestinal metaplasia, dysplasia, or indefinite dysplasia.
     A total of 1024 patients were randomized to one of four treatments: placebo alone, placebo with 7 days of H. pylori therapy, placebo with 24 months of celecoxib, or 7 days of H. pylori therapy and 24 months of celecoxib. Patients underwent endoscopic biopsies at baseline and after 24 months.
     Among the 919 patients who completed treatment and underwent final endoscopic biopsies, regression of gastric lesions occurred in more patients who received celecoxib than placebo (52.8% vs. 41.2%; odds ratio, 1.72; 95% confidence interval, 1.07–2.76) and in more who received H. pylori treatment than placebo (59.3% vs. 41.2%; OR, 2.19; 95% CI, 1.32–3.64). However, combination H. pylori and celecoxib therapy was not superior to placebo. Gastric cancers occurred in nine patients.
     Comment: The authors conclude that either celecoxib or H. pylori therapy alone improves regression of precancerous gastric lesions. However, a high rate of spontaneous lesion regression occurred in the placebo group (41.2%), which suggests considerable variability in the natural history of these lesions and the possibility of sampling error when random biopsies are taken. It is intriguing to speculate why either treatment alone increases regression but the combination does not. Might H. pylori infection stimulate the COX-2 expression that plays a role in carcinogenesis? Additional studies are needed to validate these findings in other populations and to clarify the mechanisms of action.
David J. Bjorkman, MD, MSPH (HSA), SM (Epid.) Published in Journal Watch Gastroenterology November 4, 2011
     Citation(s): Wong BCY et al. Effects of selective COX-2 inhibitor and Helicobacter pylori eradication on precancerous gastric lesions. Gut 2011 Sep 13; [e-pub ahead of print]. (http://dx.doi.org/10.1136/gutjnl-2011-300154)
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$10 Million Lawsuit Against Wyeth Filed Over Hormone Replacement Drug
     An Orleans Parish woman diagnosed with breast cancer has filed a lawsuit against the manufacturer of her hormone replacement therapy drugs. The suit was filed against Wyeth, Wyeth Pharmaceuticals Inc., Pfizer Inc., Pharmacia Corp., and Pharmacia & Upjohn Company on October 21 in federal court in New Orleans.
     The defendants have been accused of manufacturing and selling hormone therapy drugs that dramatically increase the risk of breast cancer, ovarian cancer, strokes, blood clots, and cardiovascular disease; the drugs involved include Prempro, Premarin, and Provera.
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Lipitor "Deals" and "OTC" Plans
     Pfizer is striking deals with drug-benefit plans and providing discounts to patients to encourage continued use of branded Lipitor, and to preserve a big chunk of its nearly $11 billion in annual sales as soon as it loses U.S. market exclusivity on November 30. Over the long term, Pfizer will seek to sell an over-the-counter version of Lipitor, which, if successful, would counter the generic market.
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MM: There is no question that iron and copper have their own set of dangers in excess but let’s nit throw out the baby with the bath water. I can see the media sinking their teeth in this headline and ignoring the benefits that truly are available with appropriate nutritional supplementation guided by a legitimate and knowledgeable dietitian, pharmacist or other clinician.
Arch Intern Med 2011 Oct 10; 171:1625
For Vitamin and Mineral Supplementation, Less Is More
Multivitamins, particularly those containing iron or copper, might raise risk for death.
     In the U.S., few individuals face nutritional deficiencies, yet dietary supplements are a multibillion-dollar industry. To explore the relation between older women's use of dietary supplements and mortality, researchers analyzed data on supplement use collected between 1986 and 2008 from 38,772 participants in the Iowa Women's Health Study (mean age at baseline, 62). Deaths were ascertained annually using state and national death registries. Analyses were adjusted for more than 10 potential confounders including age and alcohol intake.
     Self-reported use of at least one dietary supplement daily rose from 63% in 1986 to 85% in 2004 (mean follow-up, 19 years). However, with the exception of calcium, supplement use was not associated with lower risk for cancer-related, cardiovascular, or all-cause death. Rather, several supplements were associated with significantly higher risk for death — most notably, iron (with a strong, dose-dependent association) and copper.
     Comment: The authors' finding about calcium must be taken in context: Other studies have shown that use of calcium supplements can raise risk for cardiovascular disease — but, unlike those studies, this one did not include adjustment for use of low-dose aspirin (JW Gen Med Aug 31 2010 and JW Gen Med May 12 2011). Reverse causation must be considered as a possible explanation for the findings that show potential harms of multivitamins and supplements, as people with failing health might be more likely to use dietary supplements. Nonetheless, caution regarding use of dietary supplements by well-nourished individuals seems warranted and makes biological sense. Unintentional ingestion of multivitamins is a common cause of poisoning (particularly in children). The body has no way to excrete iron or copper, which are both hepatotoxic at high levels. Thus, clinicians should advise most Americans to focus on eating healthy diets and reserving use of dietary supplements for symptomatic nutrient deficiency.
Eleanor Bimla Schwarz, MD, MS Published in Journal Watch Women's Health
November 3, 2011
     Citation(s):Mursu J et al. Dietary supplements and mortality rate in older women: The Iowa Women's Health Study. Arch Intern Med 2011 Oct 10; 171:1625
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JAMA 2011 Oct 12; 306:1566.
Prenatal Folic Acid Lowers Risk for Language Delay
The benefits of folic acid supplementation extend to language development during early childhood.
     Knowledge of the protective effect of folic acid against neural tube defects has led to concerted public health campaigns to promote folic acid supplementation. Despite these efforts, periconceptional supplementation rates remain suboptimal in the U.S. To examine whether folic acid has other benefits in neurodevelopment, investigators in Norway — a country that does not fortify foods with folic acid — prospectively evaluated the association between maternal report of folic acid supplementation early in pregnancy and language delay in nearly 39,000 offspring. Severe language delay (defined as limitation to 1-word or unintelligible utterances at age 3 years) was measured by maternal report on a validated language grammar rating scale.
     After adjustment for confounding factors including maternal education, parity, and marital status, children of women who reported supplemental folic acid use from 4 weeks before conception to 8 weeks after conception had significantly lower odds of having severe language delay, compared with children of mothers who reported no supplement use (adjusted odds ratio, 0.82; 95% confidence interval, 0.69–0.97). This association was not seen in women who took supplements containing no folic acid during the same period, reducing the likelihood that the results are merely explained by benefits afforded to health-conscious patients. In addition, folic acid did not affect risk for severe gross motor delay. Both of these findings support the likelihood that folic acid deficiency plays a causal role in language delay.
     Comment: That folic acid supplementation might have advantages beyond protection against neural tube defects is not surprising; what is surprising is that high-quality study results supporting this notion have been so long in coming. Because of the association between periconceptional folic acid and anomalies of the central nervous system, a randomized controlled trial in which this micronutrient is withheld would be unethical. Thus, large prospective observational studies such as this one are as close as we will likely come to proving folic acid's other reproductive benefits. The association between maternal folic acid intake during early gestation and developmental outcomes will be strengthened in future studies that use standardized tests of neurodevelopment. In the meantime, these data provide even more compelling reasons to improve efforts to ensure periconception folic acid repletion among all women, especially very young women and racial and ethnic minorities who historically have had woefully low rates of adequate folic acid intake.
Allison Bryant, MD, MPH Published in Journal Watch Women's Health October 27, 2011
     Citation(s): Roth C et al. Folic acid supplements in pregnancy and severe language delay in children. JAMA 2011 Oct 12; 306:1566.
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New York Times Oct 10 , 2011; D5
Bilingualism Shapes Early Brain Development
Bilingual exposure facilitates early language development by wiring the brain to enhance learning in both languages.
     Pediatricians recognize the myth that early exposure to two languages results in language confusion and delayed speech. Recently, pediatrician Perri Klass wrote in the New York Times about studies on early brain development in infants exposed to one or two languages in which early perception of sounds and words were measured by analyzing where babies turn their gaze and the duration of their attention in response to hearing sounds. Her observations include the following:

     Comment: Children raised in bilingual homes might have a slight delay in expressive language until age 2 years; they mix syntax and vocabulary of both languages. After 2 years, they can switch from one language to another, and their combined vocabulary meets expected milestones. Bilingual exposure facilitates early language development by wiring the brain to enhance learning in both languages.
Martin T. Stein, MD Published in Journal Watch Pediatrics and Adolescent Medicine
November 2, 2011
     Citation(s): Klass P. Hearing bilingual: How babies sort out language.
New York Times Oct 10 , 2011; D5.
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Arch Intern Med 2011 Sep 26; 171:1571
Caffeinated Coffee and Late-Life Depression in Women
Study raises the possibility that coffee provides protection.
     Coffee is one of the most common dietary sources of caffeine. To explore whether caffeinated coffee protects women against late-life depression, researchers analyzed Nurses' Health Study data from 50,739 U.S. women (mean age, 63) who were depression-free in 1996. Participants reported caffeine consumption at regular intervals between 1980 and 2002 and reported diagnoses of depression and use of antidepressants between 1996 and 2006.
      Analysis adjusted for potential confounders (e.g., use of hormone therapy, smoking, body-mass index, physical activity, marital and employment status, comorbidities) showed that greater consumption of caffeinated coffee was associated with lower risk for developing depression. This relation was not seen for caffeinated tea, soda, or chocolate or for decaffeinated coffee. Current (but not former) smoking showed a marginally significant positive interaction with caffeinated coffee consumption on risk for depression.
     Comment: Although the half-life of caffeine is 3 to 6 hours, the authors evaluated the relation between coffee consumption and incident depression 2 years later. This makes sense if one assumes that coffee consumption remained stable, but the authors did not provide any data to support this assumption. In addition, although most late-life depression occurs among women who have experienced previous episodes of depression (Arch Gen Psychiatry 2005; 62:593), the investigators were unable to adjust for histories of depression. This is particularly relevant if women who had been previously depressed tended to drink more coffee, raising the possibility of reverse causation. Alcohol consumption also affects risk for depression; however, the current analyses were not adjusted for alcohol intake. The authors state that "further adjustment for alcohol intake did not materially affect the results," yet those are the very results I would want to see, especially given the unexpected interaction between smoking, caffeinated coffee consumption, and rates of depression. Although recommending coffee consumption for its health benefits seems premature, women who enjoy drinking caffeinated coffee can at least be reassured that consumption of this beverage does not seem to be associated with excess risk for depression.
Eleanor Bimla Schwarz, MD, MS Published in Journal Watch Women's Health October 20, 2011
     Citation(s): Lucas M et al. Coffee, caffeine, and risk of depression among women. Arch Intern Med 2011 Sep 26; 171:1571.
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Arch Intern Med 2011 Sep 26; 171:1571.
Depression Is Less Common in Women Who Drink Coffee
Four or more cups daily seemed to protect against developing depression.
     One prospective study involving men showed a reduced risk for depression with increased coffee consumption (Public Health Nutr 2010; 13:1215), and several studies have shown an association between increased coffee consumption and decreased risk for suicide. Using data from the Nurses' Health Study, investigators studied about 50,000 women who were free of depression at baseline; coffee consumption and new diagnoses of depression were documented during 10 years of follow-up.
     In analyses adjusted for numerous clinical and demographic variables, risk for depression in women who drank four or more cups of coffee daily was 20% lower than in women who drank one cup or less weekly. No association was observed between risk for depression and consumption of either decaffeinated coffee or caffeine from other sources (e.g., tea, chocolate); however, noncoffee sources probably contributed too little caffeine for meaningful assessment.
     Comment: These results are biologically plausible, because caffeine affects dopaminergic transmission as an adenosine-receptor antagonist. The finding that decaffeinated coffee doesn't lower risk for depression suggests that caffeine is the active component. However, confirmatory data from randomized trials would be preferable before we use these findings to make clinical recommendations.
Thomas L. Schwenk, MD Published in Journal Watch General Medicine October 6, 2011
     Citation(s):Lucas M et al. Coffee, caffeine, and risk of depression among women. Arch Intern Med 2011 Sep 26; 171:1571. (http://dx.doi.org/10.1001/archinternmed.2011.393)
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N Engl J Med 2011 Nov 3; 365:1663
Is a Cure at Hand for Cystic Fibrosis in Some Children?
Oral ivacaftor is associated with early and sustained improvement in pulmonary function in CF patients with the G551D-CFTR mutation.
     About 4% to 5% of patients with cystic fibrosis (CF) have a defect in the CF transmembrane conductance regulator (CFTR) protein. In an industry-sponsored, double-blind, randomized, placebo-controlled trial, investigators evaluated the efficacy of oral ivacaftor — a CFTR potentiator — in 161 CF patients older than 12 years with at least one G551D-CFTR mutation.
     After 24 weeks of daily treatment (150 mg every 12 hours), the increase in forced expiratory volume at 1 second (FEV1) from baseline was significantly greater in the ivacaftor group (mean increase, 0.367 liters) than in the placebo group (17.2% vs. 0.1%). A significant treatment effect was noted by day 15 and continued throughout 48 weeks of treatment. At 48 weeks, 67% of ivacaftor-treated patients were free of pulmonary exacerbations versus 41% of placebo recipients (hazard ratio, 0.455). The decline in sweat chloride levels from baseline was significantly greater in the ivacaftor group than in the placebo group (–48.7 mmol/L vs. –0.8 mmol/L). Ivacaftor-treated patients gained significantly more weight than placebo recipients (mean, 3.1 kg vs. 0.4 kg). The incidence of adverse events was similar in the two groups.
     Comment: This exciting clinical trial demonstrates that daily oral ivacaftor therapy is associated with early and sustained improvement in pulmonary function in CF patients with the G551D-CFTR mutation and offers promise for a cure. Whether ivacaftor will be equally effective in young CF patients and if the benefit will be sustained beyond 48 weeks remain to be seen.
F. Bruder Stapleton, MD Published in Journal Watch Pediatrics and Adolescent Medicine November 2, 2011
     Citation(s):Ramsey BW et al. A CFTR potentiator in patients with cystic fibrosis and the G551D mutation. N Engl J Med 2011 Nov 3; 365:1663.
Davis PB. Therapy for cystic fibrosis — The end of the beginning? N Engl J Med 2011 Nov 3; 365:1734.

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