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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
July 26, 2014

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Muscle Mass Predicts Longevity in Older Adults
Organic Foods Contain More Antioxidants, Fewer Pesticides
Over 99% of Alzheimer's Drugs Not Effective in Tests
For Patients at Risk for Alzheimer's, Multidisciplinary Intervention May Slow Decline
Again, Niacin Proves Ineffective in Statin-Treated Patients with Vascular Disease
Exogenous Testosterone's Effects in Menopausal Women: A Matter of Dosage?
"Assistant Physicians" Allowed to Treat Patients in Rural Missouri
Antibiotics Frequently Used in Flu
Tamoxifen May Produce Fewer Side Effects in Gel Form
Compounding Pharmacists Have a Solution to Painkiller Overuse
A New Target for Neuropathic Pain?

MM: We have heard the expression, "thin on the outside, fat on the inside". Assessing health by only measuring weight on the scale is short-sighted and wrong. A much more meaningful measurement is Body Impedance Analysis (BIA).This measures the percentage of fat, muscle, and water and differentiates whether the water is within the cells or surrounding them. By having this data a clinician can recommend appropriate lifestyle activities and people can actually measure their progress for attaining these goals. Let the scale be one of several tools and not the only one.
Am J Med 2014 Jun; 127:547
Muscle Mass Predicts Longevity in Older Adults
No significant correlations were found between mortality and body-mass index.
The association of obesity (as defined by high body-mass index [BMI]) with risk for premature death in older adults has been inconsistent, and some studies suggest that mortality might be lower in those who are obese than in those who are not. Notably, BMI incorporates both fat and muscle mass, which have different metabolic effects. To determine whether greater muscle mass is associated with lower all-cause mortality, researchers examined data collected between 1988 and 1994 on 3659 U.S. adults (age, ≥55 in men and ≥65 in women) who were not underweight and who were alive ≥2 years after the start of the study. Muscle mass was measured using bioelectrical impedance.
During median follow-up of 13.2 person-years, 2012 participants died. After adjusting for confounders, all-cause mortality was significantly lower among people in the highest quartile of muscle mass relative to those in the lowest quartile (relative risk, 0.81). In contrast, BMI was not associated significantly with all-cause mortality.
Comment: This study showed a strong correlation between higher muscle mass and longevity among older adults. It also suggests that BMI (which doesn't distinguish between fat and muscle mass) is an inadequate predictor of early mortality. However, this study does not tell us whether interventions that increase muscle mass will lengthen survival in older adults.
Citation(s): Srikanthan P and Karlamangla AS.Muscle mass index as a predictor of longevity in older adults. Am J Med 2014 Jun; 127:547.

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MM: The debate of organic vs. nonorganic continues to rage. Consumers who can afford to eat organically will often do so. I know that given the choice, I will choose the organic option more often than not but not everyone has the financial ability nor the opportunity to do so. I think that we have to be judicious in choosing when an organic option has benefits that outweigh the upfront monetary cost. The important thing is to determine when it makes a difference in your health to eat an organic product and when it makes little to no difference.
Organic Foods Contain More Antioxidants, Fewer Pesticides
By Amy Orciari Herman
Edited by Susan Sadoughi, MD, and André Sofair, MD, MPH
Organically grown crops contain more antioxidants and fewer pesticides than nonorganic foods, according to a meta-analysis of over 340 studies in the British Journal of Nutrition. The findings run counter to previous research suggesting few differences between organic and conventional foods.
Among the findings:

The lead author emphasized caution in interpreting the findings: "We are not making health claims based on this study, because we can't," he told the New York Times. He added that the study is insufficient "to say organic food is definitely healthier for you, and it doesn't tell you anything about how much of a health impact switching to organic food could have."
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MM: Many of us "boomers" are looking for the development of effective treatments for Alzheimer's Disease (AD). We have seen our parents, grandparents and other loved ones deteriorate before our eyes. We have to wonder at the almost total failure to come up with effective treatments for AD. Is it possibly because we lack a true understanding of the nature and/or cause of this disease? In my opinion, we need to focus more on the prevention of this disease than we have in the past. We need to discover therapies and actions that will prevent rather than reactively treat the disorder. It is obvious that the treatment route has failed.
Over 99% of Alzheimer's Drugs Not Effective in Tests
Between the years of 2002-2012, the failure rate for drugs developed to treat Alzheimer's disease was an astonishing 99.6%, according to a study released by the Cleveland Clinic Lou Ruvo Center for Brain Health. The analysis showed 244 drugs failed and only one was effective; this in the first-ever study of conducted clinical trials for a disease that is expected to leave millions of baby boomers with dementia in the next few decades. According to the study author, there are now only about 80 drugs being tested. Drugs which have previously been approved include Aricept, Exelon, Razadyne, and Cognex.
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MM: It makes sense that by utilizing as many different pathways as possible a patient will increase their cognitive potential or retard its decline. It appears to be sort of like cross training for the brain. Complementary areas seem to strengthen the entire organism.
For Patients at Risk for Alzheimer's, Multidisciplinary Intervention May Slow Decline
By Kelly Young
Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM
A multipronged intervention is associated with better cognitive performance than usual health advice in older adults at risk for Alzheimer's disease, according to the results of a randomized trial presented at the Alzheimer's Association International Conference.
In the FINGER study (Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability), nearly 1300 adults aged 60 to 77 with modifiable risk factors for Alzheimer's were randomized to either usual medical advice or to an intervention that included modification of cardiovascular risk factors, nutritional advice, physical activity, cognitive training, and social activities. After 2 years, patients in the intervention group performed better on a cognitive exam, including tests of memory, executive function, and cognitive processing speed.
The Alzheimer's Association's director of scientific programs and outreach called the results "very encouraging," but said they require confirmation.
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MM: Ineffective? Any simple change that has a beneficial net effect and demonstrates little to any negative effect is an effective treatment in my book. this study was looking at the wrong patient groups in its test subjects and that is a more significant criticism. Niacin alone is not terribly effective but when it is accompanied by a combination of other natural lipid modulating products such as probiotics, guggullipids, phytosterols, phytostanols and policosanol along with red yeast rice, patients will frequently see meaningful results in their lipid profiles with rare reports of adverse reactions that are quite common with statins. Mark Drugs offers a product that combines these ingredients in a capsule that is taken twice daily. Please contact us or go to www.MarkDrugs.com for more information.
N Engl J Med 2014 Jul 17; 371:288
Again, Niacin Proves Ineffective in Statin-Treated Patients with Vascular Disease
In a large randomized trial, niacin was associated with serious adverse effects but no cardiovascular benefit
In the 2011 AIM-HIGH trial, niacin (added to a statin) failed to improve outcomes in patients with cardiovascular disease (NEJM JW Gen Med Nov 15 2011). We now have results from another randomized niacin trial — the industry-sponsored HPS2-THRIVE study. The study involved nearly 26,000 patients with known vascular disease whose mean LDL and HDL cholesterol levels were 64 mg/dL and 44 mg/dL, respectively, while taking simvastatin (40 mg daily; with ezetimibe in some cases). Patients received either 2 g of extended-release niacin daily or placebo; niacin was combined with laropiprant, a drug that lessens niacin-related flushing.
During median follow-up of 4 years, niacin lowered LDL cholesterol levels by a mean of 10 mg/dL and raised HDL cholesterol levels by a mean of 6 mg/dL, compared with placebo. However, there was no significant difference between groups in incidence of major adverse cardiovascular events (13.2% vs. 13.7%; P=0.29), and even the subgroup with the lowest HDL cholesterol levels and highest triglyceride levels at baseline showed no benefit from niacin. Niacin was associated with a slight excess in overall mortality (6.2% vs. 5.7%; P=0.08). Niacin recipients had significant excess risk for serious adverse events traditionally associated with this drug (e.g., gastrointestinal, musculoskeletal, and diabetes-related), as well as for infection and bleeding.
Comment: Why the investigators expected benefit from niacin therapy in this population is unclear: LDL cholesterol levels in this group of statin users were extremely low, and HDL cholesterol levels — although low — were not rock-bottom low, so substantial additional benefit from niacin would almost have to be mediated through some putative non–lipid-related effect. In any case, if AIM-HIGH didn't put niacin out of business as add-on therapy for statin-treated patients, HPS2-THRIVE should. The results also raise the possibility that medications might push total and LDL cholesterol levels too low, perhaps creating harms that would offset potential benefits (average LDL cholesterol level in this trial's niacin recipients was 54 mg/dL).
Final note: Combination niacin-laropiprant was approved by the European Medicines Agency in 2008 and withdrawn several years later; the combination has never been approved in the U.S.Comment — Cardiology Harlan M. Krumholz, MD, SM In a letter published in the same issue as this report, the AIM-HIGH investigators provide data on serious side effects of niacin in their study. Especially in this context, HPS2-THRIVE represents an astonishing reversal for niacin. We are now learning that in the statin era, niacin — for years, a billion-dollar drug — has no demonstrated ability to lower risk and is associated with serious side effects. It's true that niacin's effects have not been evaluated in every patient population, but the evidence supporting this drug is from the 1960s and is not that strong. I don't see any indication for niacin at this point. (To join a discussion of these findings, read Harlan Krumholz and Nicholas Downing's blog on CardioExchange, an online community hosted by the New England Journal of Medicine and NEJM Journal Watch and dedicated to improving cardiac patient care. Membership is free for Engl J Med 2014 Jul 17; 371:203medical professionals.)
Citation(s): The HPS2-THRIVE Collaborative Group.Effects of extended-release niacin with laropiprant in high-risk patients. N. (http://dx.doi.org/10.1056/NEJMoa1300955)
Anderson TJ et al. Safety profile of extended-release niacin in the AIM-HIGH trial. N Engl J Med 2014 Jul 17; 371:288.
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MM:I am not an advocate of supraphysiologic doses of Testosterone for men or for women. I believe that many of the adverse effects of hormone therapy have been due to the attitude that, " if a little bit works ok then a bit more will work that much better". This is a flawed approach and a complete mis-understanding of hormone physiology. men have what is called a "negative feedback loop" that kicks in if testosterone levels get too high. This is part of several protective mechanisms that the body has in order to protect itself from overexposure or over-production of hormone. A similar system is present for thyroid hormones and physiological protection.
Since 1992 we have been treating perimenopausal and menopausal female patients with success for diminished libido by using these lower and more appropriate doses of testosterone in transdermal creams and gels. The protocols are simple and easy to both administer and monitor. The success rate is as high as 75% with no significant history of adverse reactions. Please contact Mark Drugs for more information about these prescription products.

Menopause 2014 Jun; 21:612
Exogenous Testosterone's Effects in Menopausal Women: A Matter of Dosage?
In a short-term trial, only markedly supraphysiologic testosterone levels enhanced sexuality, lean body mass, and muscle strength.
Although androgen administration can augment sexuality as well as musculoskeletal parameters in menopausal women, data are insufficient to address the dosages and serum levels of testosterone needed to achieve these benefits. Investigators randomized post-hysterectomy menopausal women (mean total and free testosterone levels, 13.0 ng/dL and 2.2 pg/mL, respectively [below the range for healthy premenopausal women]) to 12 weeks of transdermal estradiol (0.05 mg daily) followed by 24 weekly intramuscular injections of placebo or testosterone enanthate at doses of 3.0 mg, 6.0mg, 12.5mg, or 25.0 mg while continuing transdermal estrogen.
In 62 evaluable women who received testosterone, total and free serum testosterone levels increased in a dose-dependent fashion. Among women randomized to the 25-mg (highest) dose, mean total testosterone serum level at 24 weeks was 210 ng/dL (5–6 times higher than values in healthy premenopausal women). Compared with women who received placebo, those who received the highest testosterone dose had better measures of sexual desire, arousal, frequency of sexual activity, lean body mass, and physical strength. Frequency of adverse effects was generally similar among groups; however, excess hair growth was significantly more common in women who received the two highest doses of testosterone.
Comment: This well-executed study confirms that, while testosterone can enhance sexuality and musculoskeletal parameters in menopausal women receiving estrogen, the levels needed to achieve these benefits are markedly supraphysiologic. The authors note that they did not recruit participants with low sexual desire; thus, it remains unknown whether lower doses of testosterone might provide benefits in women with baseline sexual dysfunction. In addition, this short-duration trial did not permit determination of cardiovascular risks or benefits associated with prolonged testosterone supplementation, underscoring the need for long-term randomized trials addressing safety concerns
Citation(s): Huang G et al. Testosterone dose-response relationships in hysterectomized women with or without oophorectomy: Effects on sexual function, body composition, muscle performance and physical function in a randomized trial. Menopause 2014 Jun; 21:612.

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MM: I don't really see a big problem with this approach. It potentially gives a new grad the opportunity to gain real life experience in a relatively low risk environment while providing care to under-served areas. Emergency and well care are the areas that are most often utilized and with the advent of video-conferencing, these Assistant Physicians have many of the tools available to them that residents have in other family practice or internal medicine teaching environments.
"Assistant Physicians" Allowed to Treat Patients in Rural Missouri
By Kelly Young
Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS
Missouri has passed a law that will enable medical school grads to treat patients in underserved, rural areas without completing a year of residency, the Wall Street Journal reports.
The so-called "assistant physicians" will be supervised in person by a physician for 30 days before being able to treat patients on their own and prescribe most drugs. The law requires the graduates to pass the first two parts of the national licensing exam and get approval from the state's Board of Healing Arts, which grants medical licenses.
Several medical groups opposed the move, but proponents say the measure is needed because one in five Missouri residents doesn't have sufficient access to physicians.
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MM: It is ridiculous that almost 1/2 of those who received treatment received an antibiotic for a confirmed viral infection. I find it abhorrent that clinicians will ignore proven, evidence based medicine to treat patients with a demonstrably detrimental approach. It is bad enough that many of the antivirals demonstrate little to no benefit for the flu and they are still prescribed as expensive placebos that will likely demonstrate increased resistance over time as their use continues. In my opinion, a superior approach is the use or nutraceuticals to support, modulate and enhance the immune system. Products such as Vitamin D3, Vitamin C and zinc have demonstrated these benefits. Contact Mark Drugs for more information and guidance to how these products may offer benefits to immune support.
Antibiotics Frequently Used in Flu
By Kelly Young
Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS
Patients with laboratory-confirmed influenza in 2012-2013 commonly received antibiotic treatment, according to a study in Clinical Infectious Diseases.
Roughly 6800 patients aged 6 months and older presenting with acute respiratory infection at five U.S. clinics were tested for influenza with real-time reverse transcription polymerase chain reaction (PCR). Of patients most likely to benefit from antivirals (e.g., presenting within 2 days of symptom onset and having PCR-confirmed influenza), 28% received an antiviral and 24% received an antibiotic.
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MM: Transdermal application of a variety of drugs has gained increased acceptance in a number of therapeutic areas. Whereas hormone therapy previously dominated the transdermal options, pain management and scar therapy have taken a prominent role as effective and frequently superior treatment options. I have uses bisphosphonates in a transdermal form for osteoporotic patients and they have had no gastric issues and have seen increases in their bone density. Therefore, it is not a surprise that tamoxifen should show transdermal benefits.
Tamoxifen May Produce Fewer Side Effects in Gel Form
Tamoxifen may be more efficacious for women if applied in gel form to their breast. In a small study, the blood levels were much lower when it was administered as a gel, reports a study in the journal Clinical Cancer Research. Dr. Seema Khan, a professor of surgery at the Northwestern University Feinberg School of Medicine, and her team found that applying the gel form directly to the breast caused lower levels of the drug to show up in blood tests, suggesting that side effects could be avoidable.
Editor's Note: It is not unusual to have lower blood levels with some transdermally administered drugs but still have effectiveness. We should review the therapeutic window concept as it may not apply in all cases.
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MM: I find it frustrating when managed care companies place their own profits well ahead of patient care. If a doctor, nurse or pharmacist did this then they would be subject to possible criminal charges. Yet, insurance companies perform these heinous acts with little to no retribution.
Compounding Pharmacists Have a Solution to Painkiller Overuse
Compounding pharmacists may offer a possible answer to the continuing overuse of opioid painkillers across the country; however, decisions from PBMs to limit coverage of some individually prepared medications could eliminate the solution before it is extensively tried.
Earlier this month Express Scripts announced that it was dropping coverage for 1,000 drug ingredients found in many compounded medications, beginning September 15. David Whitrap announced that the move would lower treatment costs for employers on those medications by 95% while affecting just 0.6% of their patient consumer base.
Proponents say the idea of compounding for pain management has garnered increased interest from health practitioners in recent years. For example, while a powerful oral pain medication has the potential of being abused by a patient to use for non-medical reasons, converting a painkiller into a topical skin cream lowers the risk of abuse.
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MM: It slays me that results of pain relief is considered successful when the results show less than a 10% improvement over the base rate. Compounding pharmacists have been making transdermal compounded neuropathic pain creams that have demonstrated a minimal number of adverse reactions and have brought significant relief, when used appropriately by patients. The key to proper use is proper education on how to use these products. All too often people are told to schmeer the creams over areas of their body as if they were covering a bagel and then hope that they get relief. Although this may provide temporary relief to a given area, longitudinal relief is limited. Applying these creams in much smaller amounts to specific trigger points and dermatomal sites tends to provide much greater relief for longer periods of time when compared to "shotgun" application styles. The less is more approach may serve to be the most beneficial one.
Lancet 2014 May 10; 383:1637
A New Target for Neuropathic Pain?
A phase 2 trial demonstrates the potential of angiotensin II type 2 antagonists, a new treatment target, to relieve the chronic neuropathic pain of postherpetic neuralgia.
Because existing treatments for postherpetic neuralgia are often insufficient or ineffective, researchers have been investigating EMA401, an oral angiotensin II type 2 (AT2R) antagonist. For the current multicenter, placebo-controlled, double-blind, randomized, phase 2, manufacturer-sponsored clinical trial, 183 participants with established postherpetic neuralgia received either EMA401 (100 mg twice daily) or placebo for 28 days. Trial sites were in eastern Europe, Ukraine, and South Africa. The primary outcome was the change in mean pain intensity, according to a 0–10 scale, as recorded in weekly patient-completed diaries.
During the last week of treatment, patients given EMA401 had significantly less pain compared with baseline than did those given placebo (mean reductions in pain scores, −2·29 vs. −1·60; difference of least square means, −0·69, a significant difference). No serious adverse events attributable to EMA401 were reported.
Comment: In this well-designed and well-analyzed phase 2 clinical trial, the AT2R antagonist EMA401 has analgesic efficacy in postherpetic neuralgia. Although a net reduction of less than 1 point on an 11-point scale might seem small, it is in fact comparable to the best available orally administered treatments. No biomarkers were included, as none is validated for chronic pain. The treatment period was short; subsequent studies will need to demonstrate that the compound maintains efficacy relative to placebo for 12 weeks. No other trials of this medication category have been reported. The adverse event profile was encouraging, especially the lack of sedation or other effects that are drawbacks to existing approved therapies for pain. Despite the small market potential of PHN, analysis of numerous clinical trials has shown that PHN is a better model than painful diabetic neuropathy for evaluating new neuropathic pain therapies. The biggest obstacle to eventual approval of EMA401 will be the requirement to replicate the results in larger studies of much longer duration and in a larger range of study sites.
Citation(s): Rice ASC et al. EMA401, an orally administered highly selective angiotensin II type 2 receptor antagonist, as a novel treatment for postherpetic neuralgia: A randomised, double-blind, placebo-controlled phase 2 clinical trial. Lancet 2014 May 10; 383:1637.

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