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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
June 4, 2011

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Kids Who Sleep More Are Less Likely to Become Overweight
High-Selenium Yeast Supplements Improve Plasma Lipid Levels
FDA Warns That Breast Thermography Shouldn't Replace Mammography
Aspirin and NSAIDs Might Raise Risk for Diverticulitis and Diverticular Bleeding
Avastin vs. Lucentis for Neovascular Macular Degeneration
FDA Weighs in on Possible Increased Risk for VTE with Drospirenone Birth Control
North America's PHARMA Driving Up Costs
Is the High Price of Drugs Justifiable?
France to Stop Paying for Pfizer's Champix
Dinner Plate Replaces Food Pyramid
Griseofulvin vs. Terbinafine for Tinea Capitis: Which Is Ahead?
Exercise the Arms, Benefit the Legs
WHO Group Says Cell Phones 'Possibly' Carcinogenic

Kids Who Sleep More Are Less Likely to Become Overweight
     The more sleep that young children get, the less likely they are to become overweight, according to a longitudinal study in BMJ.
     Researchers in New Zealand followed some 240 children from ages 3 to 7. Sleep was measured with accelerometers at ages 3, 4, and 5, while body mass index and body composition were measured yearly.
     After multivariable adjustment, each additional hour of sleep from ages 3 to 5 was associated with a reduction in BMI of 0.49 at age 7 — corresponding to a reduction in body weight of 0.7 kg in a child of median height. Differences in fat mass index, rather than fat-free mass index, accounted for the reduced BMI. In addition, each extra hour of sleep was associated with a 61% reduction in the risk for being overweight at age 7.
     The authors speculate that both behavioral and hormonal factors may play a role in the sleep-weight connection.
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Ann Intern Med 2011 May 17; 154:656.
High-Selenium Yeast Supplements Improve Plasma Lipid Levels
But the effects of this treatment in individuals with normal or high baseline selenium concentrations remain unproven, as do clinical outcomes.
     Low selenium concentrations have been linked to increased cardiovascular mortality and morbidity. However, evidence supporting an association between selenium concentration and coronary heart disease risk is ambiguous. To find out more, investigators in the U.K. conducted a randomized, double-blind, parallel-group study involving 501 volunteers, aged 60 to 74, stratified by age and sex. Participants received high-selenium yeast at one of three doses (100, 200, or 300 µg/day) or placebo. At least one lipid measurement was available for 95% of participants at baseline, 6 months, or both.
     At baseline, mean plasma selenium concentration was 91.2 µg/L, and higher selenium concentrations were correlated with higher total cholesterol and HDL levels and with lower total cholesterol-to-HDL ratios. During 6-month follow-up, plasma selenium increased significantly in all three selenium groups but remained unchanged in the placebo group. Selenium supplementation at both 100 µg/day and 200 µg/day significantly reduced mean total cholesterol and non-HDL levels. The 300 µg/day dose had no significant effect on total cholesterol or non-HDL levels but significantly increased mean HDL levels. No major adverse events were reported.
     Comment: Selenium supplementation produced modest improvements in plasma lipids in this cohort; however, the mean baseline selenium concentration was low compared with the mean selenium concentration in the U.S., recently reported to be 136.7 µg/L. Although the findings are statistically significant, their clinical significance is unclear. Selenium supplementation as adjunct or alternative therapy for hyperlipidemia is therefore unjustified in the absence of low serum selenium levels, which is rare in the U.S.
Joel M. Gore, MD Published in Journal Watch Cardiology June 1, 2011
     Citation(s):Rayman MP et al. Effect of supplementation with high-selenium yeast on plasma lipids: A randomized trial. Ann Intern Med 2011 May 17; 154:656.
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FDA Warns That Breast Thermography Shouldn't Replace Mammography
     Breast thermography should not be used instead of mammography, the FDA stated on Thursday, noting that thermography has not been approved as a stand-alone tool for breast cancer screening or diagnosis.
     Telethermographic devices produce infrared images and do not require exposure to radiation or breast compression, which some healthcare providers claim make them superior to mammographic devices. However, says the FDA, "there is simply no evidence" that breast thermography can take the place of mammography.
     The agency has sent warning letters to manufacturers and practitioners who have made misleading claims about breast thermography use.
MM: We tend to forget how detrimental certain common products may be to our health. All Flex Pro may be an exceptional alternative to Aspirin or NSAID’s for arthritis or virtually any other muscle or joint pain without many of  the  side effects seen with these other products.
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MM: We tend to forget how detrimental certain common products may be to our health. All Flex Pro may be an exceptional alternative to Aspirin or NSAID’s for arthritis or virtually any other muscle or joint pain without many of  the  side effects seen with these other products.

Gastroenterology 2011 May; 140:1427
Aspirin and NSAIDs Might Raise Risk for Diverticulitis and Diverticular Bleeding
Moderately elevated risk was noted in an observational study.
     Observational studies (with various limitations) have suggested that regular use of aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs) raises risk for complications of colonic diverticulosis. This association is explored in an analysis from the observational Health Professionals Follow-Up Study.
     Among 47,000 male participants, 14,000 used aspirin regularly, and 2500 used nonaspirin NSAIDs regularly (i.e., at least twice weekly). During 22 years of follow-up, 939 men reported diverticulitis, and 256 reported diverticular bleeding. In a multivariate analysis, regular aspirin use was associated with significantly elevated risks for diverticulitis (hazard ratio, 1.25) and diverticular bleeding (HR, 1.70); the same was true for regular NSAID use (HRs, 1.72 and 1.74, respectively). For both aspirin and NSAID use, these findings represent roughly one additional case of diverticular complications per 1000 person-years.
     Comment: Because aspirin and NSAIDs inhibit mucosal protective mechanisms and promote bleeding, these findings are physiologically plausible. Even if the findings do reflect cause and effect, benefits of aspirin (e.g., secondary prevention of cardiovascular events) or NSAIDs (e.g., pain relief) will outweigh a small increase in absolute risk for diverticular complications in many patients. But, for some patients (e.g., those with histories of diverticulitis or diverticular bleeding who have marginal indications for aspirin or NSAIDs), this study provides reasons to avoid those drugs.
Allan S. Brett, MD Published in Journal Watch General Medicine June 2, 2011
     Citation(s):Strate LL et al. Use of aspirin or nonsteroidal anti-inflammatory drugs increases risk for diverticulitis and diverticular bleeding. Gastroenterology 2011 May; 140:1427. (http://dx.doi.org/10.1053/j.gastro.2011.02.004)
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N Engl J Med 2011 May 19; 364:1897
Avastin vs. Lucentis for Neovascular Macular Degeneration
This head-to-head trial is a great example of comparative effectiveness research on a costly treatment.
     Inhibitors of vascular endothelial growth factor — bevacizumab (Avastin) and ranibizumab (Lucentis) — are used to treat patients with neovascular age-related macular degeneration. Bevacizumab is FDA-approved for cancer treatment and is prescribed off-label for neovascular age-related macular degeneration, whereas ranibizumab was specifically developed and approved for this indication. Because the drugs differ dramatically in cost per dose — about US$50 for bevacizumab versus $2000 for ranibizumab, usually given monthly — the need for a head-to-head comparison has been obvious.
     NIH-sponsored investigators randomized patients to intravitreal injections of bevacizumab or ranibizumab, each administered monthly or as needed. Visual acuity outcomes with the four regimens were roughly similar at 1 year. Serious systemic adverse events occurred slightly more frequently with bevacizumab (24% vs. 19%; P=0.04). Annual drug costs per patient were $595 and $385 for monthly and as-needed bevacizumab versus $23,400 and $13,800 for monthly and as-needed ranibizumab.
     Comment: This trial merits the attention of primary care physicians, but not because they must choose between these two drugs (that's the ophthalmologists' call). Rather, the trial is a good example of NIH-sponsored comparative effectiveness research to address an important clinical question — involving brand-name drugs — with major cost implications. The authors wonder whether the small difference in adverse event rates was a chance occurrence, because the pattern of events did not conform to any particular organ system. This trial and the politics of comparative effectiveness research were recently addressed in a New York Times editorial.
Allan S. Brett, MD Published in Journal Watch General Medicine May 31, 2011
     Citation(s):The CATT Research Group. Ranibizumab and bevacizumab for neovascular age-related macular degeneration. N Engl J Med 2011 May 19; 364:1897. (http://dx.doi.org/10.1056/NEJMoa1102673)
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FDA Weighs in on Possible Increased Risk for VTE with Drospirenone
Birth Control

     The FDA is investigating a possible link between venous thromboembolism and drospirenone-containing contraceptives. This follows the recent publication of two BMJ studies that found a two- to threefold higher VTE risk with drospirenone, compared with contraceptives containing levonorgestrel. (Both studies were summarized in Physician's First Watch in April.)
     The agency says it is looking into conflicting findings on this issue. It recommends that clinicians discuss the warning signs of thromboembolism with their patients and report any adverse effects to the MedWatch database.
     The following products contain drospirenone: Yaz (generics: Gianvi and Loryna), Yasmin (generics: Ocella, Syeda, and Zarah), Beyaz, and Safyral.

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North America's PHARMA Driving Up Costs
     North America's (NA) PHARMA companies are turning to international markets for growth; they're scouting Central Europe, Eastern Europe, Turkey, and the Middle East for potential generics deals. This is likely to push prices upward on the world market.
     It has been that most Central European PHARMA deals went to a European drugmaker or an Indian company; now, NA PHARMA is swooping in. As an example, Canadian drugmaker Valeant Pharmaceuticals bought out Lithuania's AB Sanitas, and U.S.-based Watson Pharmaceuticals purchased Greece's Specifar.
     In these deals, the entire bidding pool was dominated by North American companies. The problem is there aren't that many midsized generics firms to go around in those regions. There's now a "scarcity premium," which will increase as consolidation continues.
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Is the High Price of Drugs Justifiable?
PHARMA companies are excited to tout the benefits of their newest drugs but seem far less willing to let the public know the price of the product.

  1. Optimer Pharmaceuticals announced that its new drug to treat diarrhea caused by the bacterium Clostridium difficile would cost $2,800, about twice as much as the existing approved drug.
  2. Vertex Pharmaceuticals provided a lot of information about how generous the company was going to be in helping customers with their insurance copayments but was silent about how much the drug would actually cost-$49,000.
  3. Merck's $1,100-a-week price of its new hepatitis C drug, Victrelis, is another example.

Some physicians are becoming frustrated trying to find documented information, outside of news reports, on the price of the new hepatitis C drugs. It is really remarkable that patients and physicians often don't know how much treatments or tests cost.
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France to Stop Paying for Pfizer's Champix (Chantix-USA)
     France will no longer pay for Pfizer's stop-smoking drug Champix. The treatment will be pulled from the government formulary of medications eligible for reimbursement because of ongoing controversy about its potential side effects, Health Minister Xavier Bertrand said. "Questions have been raised about Champix, so I've decided it will no longer be covered by (state) health insurance," said Bertrand.
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Dinner Plate Replaces Food Pyramid
     A dinner plate, called MyPlate, has replaced the food pyramid as a reminder to help Americans make healthful food choices, the U.S. Department of Agriculture announced on Thursday.
     The new icon reflects the 2010 Dietary Guidelines for Americans, emphasizing that half of one's meal should come from fruits and vegetables, one quarter from grains, and another quarter from protein (the protein should be lean, and at least half the grains should be whole grains). Next to the plate is a glass representing low-fat dairy products.
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J Am Acad Dermatol 2011 Apr; 64:663
Griseofulvin vs. Terbinafine for Tinea Capitis: Which Is Ahead?
Each agent has its uses in this common fungal infection in children.
     Since the late 1950s, griseofulvin has been the treatment of choice for tinea capitis; it is very safe and inexpensive and is available in tablet or liquid forms. The main disadvantages are long treatment duration (6–8 weeks) and erratic absorption. Shorter treatment and longer tissue retention of drug have increased use of newer antifungal agents (terbinafine, itraconazole, and fluconazole) for adult fungal skin infections. These agents, however, are much more expensive, dosage forms are limited, and data regarding pediatric use are few.
     Investigators performed a meta-analysis of randomized, controlled trials to compare griseofulvin with terbinafine for tinea capitis treatment in children and adults. Seven studies involving 2163 subjects were included, and clinical and mycological cure rates and adverse effects were compared. No significant differences in efficacy were found between griseofulvin (mean duration, 8 weeks; range, 6–12 weeks) and terbinafine (mean duration, 4 weeks; range, 2–6 weeks). Terbinafine was more efficacious for Trichophyton species and griseofulvin for Microsporum species. Both agents had good safety profiles. The authors recommend that pretreatment and intermittent laboratory investigations are unnecessary in terbinafine treatment of healthy children because adverse side effects are rare, and the tests do not effectively predict these rare reactions.
     Comment: Head-to-head studies of tinea capitis treatment in the U.S. are limited by FDA-required dosing of griseofulvin at 10 mg/kg/day, an outdated and inadequate dosage for Trichophyton tonsurans. Current U.S. practice for the microsize griseofulvin suspension is to use 20–25 mg/kg/day (the dose would need to be converted if ultramicrosize tablets are prescribed). In this meta-analysis of studies from around the world, griseofulvin dosing ranged from 6 to 20 mg/kg/day. Despite suboptimal dosing in many, griseofulvin beat terbinafine for Microsporum canis infections. Ideally, pretreatment fungal cultures can guide our choice of agent. Terbinafine works well against T. tonsurans when treatment duration is adequate, but terbinafine oral granules are prohibitively expensive; therefore, I prescribe tablets for children (cut in half, if needed). Itraconazole is another alternative to griseofulvin for M. canis infection in children. For T. tonsurans, I still prescribe a lot of griseofulvin: It's safe, it's cheap, and it works well when given correctly.
Mary Wu Chang, MD Published in Journal Watch Dermatology May 20, 2011
     Citation(s):Tey HL et al. Meta-analysis of randomized, controlled trials comparing griseofulvin and terbinafine in the treatment of tinea capitis. J Am Acad Dermatol 2011 Apr; 64:663.
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J Vasc Surg 2011 May; 53:1265
Exercise the Arms, Benefit the Legs
Supervised arm exercises improved walking distance in patients with vascular claudication.
     Graded walking exercises improve maximum walking distance in patients with peripheral arterial disease and claudication. However, some patients find it difficult to push themselves to the point of pain, and others have impediments such as lower-extremity arthritis. Previous research has demonstrated that upper-extremity exercise can improve lower-extremity performance in patients with claudication, presumably through systemic and central cardiovascular adaptations.
     In new research from the U.K., 104 patients with lower-extremity vascular claudication were randomized to an upper-limb exercise training group, a lower-limb exercise training group, or a nontreated control group. Intervention patients participated in twice-weekly supervised sessions involving either arm-cranking or leg-cycling equipment. At 24 weeks, maximum walking distance was lengthened by about 100 meters in both intervention groups, compared with the control group. Both intervention groups improved on various standardized assessments of quality-of-life and functional status, with some trends toward better outcomes in the upper-extremity group. Benefits were generally sustained at 48 and 72 weeks.
   Comment: In this trial (and in several earlier ones), supervised upper-extremity exercise compared favorably with lower-extremity exercise in patients with vascular claudication. Because this intervention is not widely prescribed, clinicians who order it should discuss the rationale and treatment goals with the physical therapists to whom they refer patients.
Allan S. Brett, MD Published in Journal Watch General Medicine May 31, 2011
     Citation(s):Saxton JM et al. Upper- versus lower-limb aerobic exercise training on health-related quality of life in patients with symptomatic peripheral arterial disease. J Vasc Surg 2011 May; 53:1265. (http://dx.doi.org/10.1016/j.jvs.2010.10.125)
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WHO Group Says Cell Phones 'Possibly' Carcinogenic
     Electromagnetic radiation generated by cell phones is "possibly carcinogenic" to humans, the WHO's International Agency for Research on Cancer concludes.
     According to a WHO press release, an international working group of 31 scientists analyzed hundreds of studies and found — on the basis of "limited" evidence — a positive association between wireless telephone use and glioma. The group cited one study that showed a 40% increased risk for glioma among the heaviest users (people who reported using their cell phones 30 minutes daily over 10 years). However, chance, bias, or confounding could not yet be ruled out, so electromagnetic radiation was given the "2B" classification as being possibly carcinogenic.
     IARC director Christopher Wild said that further research needs to be done on heavy, long-term use of cell phones. Until those results are published, he added, "it is important to take pragmatic measures to reduce exposure such as hands-free devices or texting."

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