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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
February 21, 2015

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Metformin for Diabetes Prevention? Only in the Highest Risk Patients
Participating in Walking Groups Is Associated with Wide-Ranging Health Benefits
Multi-drug Cancer Cocktail Adds to Life
Pricey Ophthalmics are Found to be Equally Effective
FDA Warns People with Peanut Allergies to Consider Avoiding Ground Cumin
A Healthful Diet Is Associated with Lower Risk for COPD
Do Nasal Steroids Stunt Growth?

MM: Here is a report that will fizzle and die. The reason? Because it discourages blanket use of a drug to treat what has become a worldwide problem. This is an unpopular approach because it limits drug manufacturer revenues. The fact that the data only supports the preventative use of metformin in the highest risk cases and that it is essentially ineffective in the lower quartiles does not mean that there will be a more judicious use of metformin. Also, the data that states that lifestyle changes are of benefit to all groups is likely to be stifled as well. My pessimistic side attributes this to the inability of drug companies to make money by telling people to change their habits and that medication is not the best answer.
Metformin for Diabetes Prevention? Only in the Highest Risk Patients
By Amy Orciari Herman, Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS
Metformin's benefits for diabetes prevention appear limited to the highest-risk patients, according to an analysis of data from the Diabetes Prevention Program trial, published in the BMJ.
Researchers studied over 3000 patients at high risk for type 2 diabetes who had been randomized to metformin therapy, a lifestyle intervention, or placebo. Participants were divided into quartiles of baseline risk according to factors such as fasting plasma glucose and hemoglobin A1c levels.
During roughly 3 years' follow-up, metformin therapy was associated with a 21% absolute risk reduction for diabetes among patients in the highest quartile of baseline risk (number needed to treat to prevent one case, 4.6); patients in the lower quartiles experienced little benefit. The lifestyle intervention also benefited the highest-risk group the most, but benefits were seen in the lower quartiles as well.
The researchers say their findings "could decrease overtreatment and make prevention of diabetes far more efficient, effective, and patient centered."
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MM: I like the premise of brisk group walking. It is a non-competitive means of getting a relatively mild aerobic exercise that encourages socialization. This combats depression and increases social interactions that may diminish some of the risks of developing Alzheimer's Disease (AD). The most difficult component of this approach is establishing a time to perform this activity. Once again, we see a low risk, low cost, easy method of improving overall health that the majority of us seem to be missing.
Br J Sports Med 2015 Jan 19
Participating in Walking Groups Is Associated with Wide-Ranging Health Benefits
Benefits include improvements in blood pressure, lung function, body-mass index, and risk for depression.
Regular brisk walking (i.e., walking at a pace of 3–5 miles per hour) is a convenient form of exercise. Evidence suggests that joining a walking group not only is a cost-effective way to increase physical activity but that it also improves adherence to walking. To assess the health benefits of outdoor group walking, researchers conducted a meta-analysis of 42 studies from 14 countries involving 1843 participants (mean age, 54; 74% women) and 74,000 hours of participant walking time. Time spent walking ranged from 20 to 460 minutes weekly, and studies ranged in duration from 3 weeks to 1 year. Mean adherence was 75%.
During the intervention, participants in walking groups showed significant improvements in systolic blood pressure, diastolic blood pressure, resting heart rate, percent body fat, body-mass index, total cholesterol, depression scores, maximum volume of oxygen consumption (VO2max), 6-minute walk time, and quality of life for physical functioning. No adverse effects were reported.
Comment: This meta-analysis indicates that participating in outdoor walking groups has many physiological and psychological health benefits. A vexing challenge for patients is how to initiate and sustain an exercise program. Joining a walking group is easy, convenient, and safe, and it's associated with high participant adherence (presumably because of the social and supportive aspects of group walking).
Citation(s): Hanson S and Jones A.Is there evidence that walking groups have health benefits? A systematic review and meta-analysis. Br J Sports Med 2015 Jan 19; [e-pub ahead of print].
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MM: This is exciting news as it shows an definitive improved duration of survival. The problem that I see is that adjunctive treatments that will diminish the adverse effects of these drugs are being ignored. One of these is IV glutathione. Oncologists are typically very fearful of anything that doesn't strictly attack cancer cells. They are afraid of strengthening any part of the body in their efforts to destroy an injurious body component. Antioxidants such as glutathione and IV vitamin C may improve results by decreasing adverse effects of the drugs and simply strengthening the patient. Oncologists need to recognize these potential benefits and not be completely fearful of them. Those practitioners who are incorporating some of these approaches are rewarded by seeing an improved Quality of Life (QOL) of their patients along with better medication tolerance and a subsequent greater opportunity for a successful treatment..
Multi-drug Cancer Cocktail Adds to Life
A three-drug cocktail of breast cancer drugs buys patients an extra 16 months of life and physicians have rushed to make it standard therapy. This combination includes two "magic bullet" drugs combined with standard chemotherapy and is used in patients with advanced HER-2 positive breast cancer. Debates are often held over changing practice for something that extends survival by a few months; so, 15.7 months is quite impressive. The cocktail includes Perjeta (pertuzumab), Herceptin, and docetaxel.
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MM: We've had this discussion regarding treatment of Age Related Macular Degeneration before and yet there is aggressive continuing resistance from the FDA and various members of the Senate who push to prohibit repackaging of Avastin into unit of use syringes for physician offices to administer. Clinical experiences have demonstrated the effectiveness and low relative risk of this practice when it is performed by competent compounding pharmacists in a <797> compliant facility. The fact that the cost to the consumer, Medicare and the American public is substantially reduced is a very good reason to utilize this practice. The only legitimate argument against it is not clinically based. That argument is that the drug manufacturers make MUCH LESS from Avastin sales than from Eylea or Lucentis.
Pricey Ophthalmics are Found to be Equally Effective
A government-funded study has found that three drugs, ranging in price from $50 to $1,950 a dose, are equally effective in treating many cases of vision loss caused by diabetes. However, the most expensive drug, Eylea (Regeneron Pharmaceuticals) was more effective for patients who had poorer vision before starting treatment. Lucentis, costing $1,200 a dose, and Avastin, at $50 a dose, were found to be essentially equivalent.
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FDA Warns People with Peanut Allergies to Consider Avoiding Ground Cumin
By Kristin J. Kelley, Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS
People with severe allergies to peanuts should be extra cautious not to consume food with cumin powder or ground cumin (e.g., as a spice or as an ingredient in seasoning mixes), the FDA warned on Thursday. Some products containing cumin have tested positive for undeclared peanut protein.
The FDA recommends that consumers with peanut allergies and their caregivers read ingredient panels when shopping, and call manufacturers to see if products that contain unnamed "spices" have any cumin powder in them.
A list of affected products is available in the FDA safety alert.
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BMJ 2015 Feb 3; 350:h286
A Healthful Diet Is Associated with Lower Risk for COPD
Even among smokers, those with the healthiest eating patterns were less likely to develop chronic obstructive pulmonary disease.
Smoking is the main cause of chronic obstructive pulmonary disease (COPD), but as many as one third of COPD patients have never smoked. Might other modifiable behaviors, such as diet, affect risk for COPD? To explore this issue, researchers examined the association between diet quality and risk for COPD in >120,000 health professionals (73,000 women and 47,000 men) who completed food frequency questionnaires between 1984 and 2000. Participants' diets were scored using the Alternate Healthy Eating Index 2010 (AHEI-2010): The healthier the diet (i.e., the higher the intakes of whole grains, polyunsaturated fats, nuts, and long-chain ω-3 fats and the lower the intakes of red or processed meats, refined grains, and sugar-sweetened drinks), the higher the score.
During the study, 723 women and 167 men received diagnoses of COPD. Incidence of newly diagnosed COPD was associated inversely with AHEI-2010 score. Adjusted for multiple variables, including smoking, risk for developing COPD was one third lower among participants in the highest quintile versus the lowest quintile of AHEI-2010 scores (hazard ratio, 0.7). Results were similar in subanalyses of ex-smokers (HR, 0.5) and current smokers (HR, 0.7).
Comment: In this study, a healthful diet was associated with lower risk for COPD. These results are consistent with those of previous studies in which diets rich in antioxidants were associated with better lung function and lower COPD-related mortality. Although this association between diet and lung function isn't necessarily intuitive, it is biologically plausible. The authors note that the lungs exist in a high-oxygen environment and might be exquisitely susceptible to dietary exposures, both toxic and protective.
Citation(s): Varraso R et al. Alternate Healthy Eating Index 2010 and risk of chronic obstructive pulmonary disease among US women and men: Prospective study. BMJ 2015 Feb 3; 350:h286.

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MM: I frequently get this question about steroids in general and nasal steroids specifically with regards to stunting the growth of young people. My position is that if we see even nominal impedance of growth, we are likely to observe other systems that are being put at risk. The risks may be small but there are risks that are unknown as well. The use of these products can effect a short term easing of symptoms but can result in unknown dangers down the road. Since these are inflammatory and sensitivity conditions, we should first consider approaches such as substantial doses of probiotics, vitamin D3that achieves a consistent blood level of 60-80ng/ml and other approaches that support the immune system rather than suppressing it.
Pediatrics 2015 Feb; 135:e348
Do Nasal Steroids Stunt Growth?
Nasacort was associated with a small but statistically significant decrease in growth velocity compared with placebo.
A new practice guideline (Physician's First Watch Feb 3 2015) advocates the empiric use of nasal steroids as first-line therapy for allergic rhinitis in children aged 2 years and older. Inhaled corticosteroids have been associated with decreases in linear growth, but conflicting results and study design weaknesses led the FDA to publish guidelines for pediatric clinical trials evaluating inhaled corticosteroids and growth. In an industry-supported study conforming to these FDA guidelines, researchers randomized 299 normally growing children (age range, 3 to 9 years) with skin test–positive perennial allergic rhinitis and active symptoms to receive triamcinolone acetonide aqueous nasal spray (Nasacort; one 55-µg spray in each nostril daily) or placebo.
About 75% of children took the nasal spray 75% of the time. Mean growth velocity during the 12-month treatment phase was significantly lower in the Nasacort group than the placebo group (5.7 vs. 6.1 cm/year). The difference appeared within the first 2 months of treatment, and this gap did not widen significantly from months 4 to 12. During 2 months of follow-up, growth velocity decreased slightly in the placebo group and increased slightly in the Nasacort group. No differences in bone age or urinary free cortisol appeared between groups.
Comment: This study was rigorous, but it looked at only one type of nasal steroid. Also, the follow-up period was short, so the possibility of catch-up growth was not assessed. Nasacort's effect on growth was statistically significant but small. Given that the slowing effect occurred in the first few months, my usual advice to use nasal steroids for 2 or 3 months and then take a break out of concern for side effects now seems pointless, at least for Nasacort. I will continue to prescribe nasal steroids judiciously, and include this information in decision-making discussions.
Citation(s): Skoner DP et al. Intranasal triamcinolone and growth velocity. Pediatrics 2015 Feb; 135:e348.

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