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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
November 23, 2013

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The Burden of Uterine Fibroids
Alkermes to Produce Both Addictive Drug and Treatment!
Three Metabolic Risk Factors Could Account for Half of Coronary Heart Disease
   Risk in Overweight Patients
Vitamin D Supplements Don't Prevent Respiratory Infections
Vitamin D–Binding Protein Levels Are Lower in Blacks Than in Whites
Three Principles for Prescribing Antibiotics to Children With Upper Respiratory Tract Infections
American Headache Society: Five Tests. Treatments that 'Physicians and
   Patients Should Question'
Bariatric Surgery Is Superior to Medical Management for Weight Loss
Nut Consumption Tied to Reduced Mortality Risk
Does Glucose Regulation Matter If You're Not Diabetic?
Fuzzy Math: New calculator Seen as Overestimating cardiovascular Risk

MM: Although more than half of women under 40 who experience uterine fibroids request non-invasive options for treatment, many of the drug treatments that are typically provided do little to shrink the fibroids or have very nasty adverse effects. Fortunately, there is a simple treatment that we have had tremendous success with for many of these patients. That is Bio-Identical Progesterone Cream. It is an inexpensive treatment and has a very low incidence of adverse reactions in most patients. This product is available without a prescription but should have the guidance of a health professional such as the pharmacists at Mark Drugs in Roselle and Deerfield.
Am J Obstet Gynecol 2013 Oct; 209:e1
The Burden of Uterine Fibroids
National survey gauges symptoms and concerns associated with this common condition.
Uterine leiomyomas (fibroids) are the principal cause of hysterectomy in the U.S., and prevalence of this common condition is three times higher among black women than white women. In two related studies funded by Fibroid Relief (a program of the Focused Ultrasound Foundation) and supported by the NIH, investigators invited >140,000 U.S. women (age range, 29–59) to participate in a Harris Interactive online survey. A total of 968 eligible respondents (i.e., those with self-reported symptomatic fibroids) completed the survey; of these, 573 were white and 268 were black. Data were weighted using an algorithm reflecting a nationally representative sample.
Symptoms most commonly reported as severe or very severe were menstrual pain or cramps (29%), heavy or prolonged bleeding (29%), passage of clots during menses (26%), fatigue (25%), and abdominal discomfort (24%). Women younger than 40 were more likely than older women to indicate that their fibroids interfered with their quality of life, making them feel “not in control.” Black women were significantly more likely than whites to report severe or very severe symptoms that interfered with physical activities, relationships, and work. Overall, 51% of respondents expressed a preference for uterine-sparing treatments, and more than three quarters considered it important to have noninvasive options. These concerns were significantly more prevalent among the youngest group of women. Black women were more likely than whites to express concerns about the effects of fibroids and associated treatment on future fertility and pregnancy.
Comment: Although uterine fibroids are common among women of all races, this condition disproportionately affects black women, who appear more likely to have severe symptoms and greater concerns about effects on physical activity, social relationships, and future fertility. Many women are interested in noninvasive treatment options. These findings should assist clinicians as they help symptomatic women choose appropriate treatment.
Citation(s): Borah BJ et al. The impact of uterine leiomyomas: A national survey of affected women. Am J Obstet Gynecol 2013 Oct; 209:e1. (http://dx.doi.org/10.1016/j.ajog.2013.07.017) Stewart EA et al. The burden of uterine fibroids for African-American women: Results of a national survey. J Womens Health (Larchmt) 2013 Oct; 22:807.

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MM: I have to question whether it is ethical to provide to the market both a drug with known addictive properties while also providing the treatment for the addiction. This is an example of life imitating art. A recent episode of the TV adapted graphic novel "Arrow" had this precise plot. The hero shot and killed the perpetrator of the addictive crime. I don't think that anyone in the audience had a problem with the hero's action. I wonder what would happen if a similar action (economic or violent - take your pick) was taken against Alkermes?
Alkermes to Produce Both Addictive Drug and Treatment!
Critics of the pharmaceutical industry have been known to accuse the industry of making drugs that cause side effects and then making more drugs to treat those side effects. A new example is the drug Zohydro, a new analgesic approved by the FDA last month. Concerned that the drug will result in more addicts, doctors point out that the company will also market Vivitrol, a medication designed to treat those very addicts.
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MM: Are we closing the barn door after the livestock has escaped? The authors of this study ultimately make the proper conclusion; i.e. Address the underlying problem of increasing obesity and the metabolic issues will also be addressed and it will be for the long term rather than merely giving drugs to treat the symptoms. Hopefully this data will not be twisted to justify increased metabolic drug treatments.
Three Metabolic Risk Factors Could Account for Half of Coronary Heart Disease Risk in Overweight Patients
By Kelly Young
Successfully controlling high blood pressure, lipids, and glucose levels could potentially reduce coronary heart disease risk by half and stroke risk by three fourths in overweight patients, according to a Lancet study.
Researchers analyzed the results of nearly 100 prospective cohort studies of adults with BMIs over 20.
Over a median follow-up of 13 years, the hazard ratio for coronary heart disease was 1.27 for each 5-unit increase in BMI, and the HR for stroke was 1.18. However, after adjustment for high blood pressure, cholesterol, and glucose, the respective HRs fell to 1.15 and 1.04. The authors calculate that 46% of BMI's excess risk for coronary heart disease and 76% of the excess risk for stroke is mediated by these three metabolic risk factors. Blood pressure was the most significant mediator of the three.
They conclude: "Reliance on control of the metabolic mediators might be only a partial and temporary response to the obesity epidemic. Rather, creative and bold strategies are needed that can curb and reverse rising adiposity."
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MM: Based on this study I have to wonder why it is that we have had hundreds of patients who have increased their Vitamin D blood level to 60-80 ng/ml and who no longer have their annual episodes of colds, flu or other upper respiratory illnesses or if they do get a cold or flu, the duration is briefer and less intense that their episodes in the past. In this study the participants took only 1000IU of vitamin D on a daily basis. It is my opinion that they took an inadequate dose to improve their overall health and failed to get to that critical blood level of 60-80ng/ml where it truly seems to make a difference.
Clin Infect Dis 2013 Nov 15; 57:1384
Vitamin D Supplements Don't Prevent Respiratory Infections
Vitamin D deficiency has been associated with many medical problems, but whether repletion improves clinical outcomes is still largely unclear. U.S. researchers who were conducting a large blinded trial of vitamin D3 and calcium supplementation for preventing large bowel adenomas included a substudy to look at rates of upper respiratory tract infection among participants.
Participants were healthy adults (age range, 45–75) whose initial vitamin D levels exceeded 12 ng/mL. During a period that spanned two winter “flu seasons,” 399 participants who were receiving daily vitamin D (1000 mg) and 360 participants who were receiving placebo reported identical rates of both serious and trivial upper respiratory infections. These results were unaffected by adjustment for receipt of supplemental calcium, receipt of flu vaccine, or body-mass index. Rates were similar during the first winter of the study, which overlapped the H1N1 flu pandemic (2009–2010), and during the subsequent one without pandemic influenza. Mean serum vitamin D levels did not differ among participants who did and did not report respiratory illnesses.
Comment: This study joins others in suggesting that supplemental vitamin D doesn't prevent respiratory infections — at least in people without severe vitamin D deficiencies.
Citation(s): Rees JR et al. Vitamin D3 supplementation and upper respiratory tract infections in a randomized, controlled trial. Clin Infect Dis 2013 Nov 15; 57:1384.

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MM: It is interesting that nature has provided this protective adaptation for blacks. It is also not surprising as people, in general, - as we have known for a long time - have similar mechanisms to protect themselves from exposure to environmental toxins that mimic the negative effects of estrogens.
N Engl J Med 2013 Nov 21; 369:1991
Vitamin D–Binding Protein Levels Are Lower in Blacks Than in Whites
Black patients with low levels of total 25-hydroxyvitamin D might have normal bioavailable levels.
Compared with whites, blacks have lower 25-hydroxyvitamin D levels but higher bone- mineral density and lower risk for fragility fractures. How can we explain this apparent paradox? A new study of about 2000 middle-aged adults in Baltimore suggests that the answer might lie in vitamin D–binding protein. Black and white participants (about 1000 each) were closely matched for age, sex, and body-mass index.
Mean total 25-hydroxyvitamin D levels were substantially lower in blacks than in whites (16 vs. 26 ng/mL). However, the mean level of vitamin D–binding protein in blacks was half that in whites, resulting in similar levels of bioavailable, or free, 25-hydroxyvitamin D in blacks and whites. Polymorphisms in the vitamin D–binding protein gene differed in frequency among blacks and whites; these polymorphisms explained most of the variation in vitamin D–binding protein levels.
Comment: The clinical implication of this study is that 25-hydroxyvitamin D levels might not accurately reflect the bioavailable component. Blacks in particular are more likely to be predisposed genetically to low levels of binding protein, resulting in low total — but sufficient bioavailable — 25-hydroxyvitamin D levels. This observation might be why we often see bone-density preservation in blacks with low levels of total 25-hydroxyvitamin D.
Citation(s): Powe CE et al. Vitamin D–binding protein and vitamin D status of black Americans and white Americans. N Engl J Med 2013 Nov 21; 369:1991.
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Three Principles for Prescribing Antibiotics to Children With Upper Respiratory Tract Infections
By Kelly Young
The American Academy of Pediatrics has laid out three simple principles for prescribing antibiotics to children with upper respiratory tract infections. The recommendations, published in Pediatrics, are intended to address the growing threat of antibiotic resistance.
The principles include determining the likelihood that the infection is caused by bacteria, weighing the benefits of prescribing versus the risks, and prescribing antibiotics judiciously. In particular:

Deborah Lehman, a pediatric infectious diseases specialist with NEJM Journal Watch, comments: "For some infections — severe otitis media, worsening or severe sinusitis, and strep pharyngitis — antibiotics are indicated, but physicians should apply stringent criteria when making these diagnoses, and the prescribing of broad-spectrum antibiotics for these conditions is discouraged."
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American Headache Society: Five Tests. Treatments that 'Physicians and Patients Should Question'
By Amy Orciari Herman
The American Headache Society has released a list of five things in headache medicine that "physicians and patients should question." The list, published as part of the American Board of Internal Medicine's "Choosing Wisely" campaign, advises the following:

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BMJ 2013 Oct 22; 347:f5934
Bariatric Surgery Is Superior to Medical Management for Weight Loss
Surgical patients were more likely to experience remission of type 2 diabetes and improved quality of life.
Recent randomized trials have shown that bariatric surgery is more effective than nonsurgical therapy for various outcomes (e.g., weight loss, resolution of diabetes) in obese patients. In a meta-analysis of 11 randomized trials (nearly 800 obese participants; baseline body-mass index [BMI] range, 30–52 kg/m2), investigators summarized and quantified the effects of bariatric surgery compared with nonsurgical treatment. Follow-up ranged from 40 weeks to 2 years.
Compared with individuals randomized to nonsurgical treatment (i.e., diet, exercise, behavioral modification, medications), those randomized to bariatric surgery lost significantly more weight (mean difference, −26 kg) and were significantly more likely to experience remission of type 2 diabetes (relative risk, 22.1), remission of metabolic syndrome (RR, 2.4), improved quality of life, and reduction in medication use. Those randomized to bariatric surgery also exhibited lower triglyceride and higher HDL cholesterol levels; changes in LDL cholesterol level and blood pressure did not differ between groups. No adverse cardiovascular events or deaths occurred after bariatric surgery. The most common adverse events after bariatric surgery were iron-deficiency anemia (15% after malabsorptive surgery) and reoperations (8%).
Comment: In this meta-analysis, bariatric surgery was superior to nonsurgical management for multiple outcomes, including weight loss, resolution of diabetes, and quality of life. However, several limitations must be noted: Included trials were relatively small with short follow-up (2-year maximum) and were conducted at centers of excellence for bariatric surgery. Current guidelines recommend bariatric surgery evaluation for patients with BMIs >40 kg/m2 or with BMIs >35 kg/m2 plus obesity-related comorbidities such as diabetes, arthritis, or obstructive sleep apnea (Endocr Pract 2013; 19:337).
Citation(s): Gloy VL et al. Bariatric surgery versus non-surgical treatment for obesity: A systematic review and meta-analysis of randomised controlled trials. BMJ 2013 Oct 22; 347:f5934.
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MM: This is a study to be careful of. Nuts may be high in fats, may be salted or otherwise treated with sugar or high fructose corn syrup. None of which are particularly good for you. If you plan on eating more nuts, then use them as a substitute for chips or sweets and try to eat raw nuts as these are the most potentially beneficial.
Nut Consumption Tied to Reduced Mortality Risk
By Kelly Young
People who regularly eat nuts have a lower mortality risk than people who don't eat nuts, according to an industry-funded, observational study in the New England Journal of Medicine.
Researchers assessed the nut consumption of some 75,000 women in the Nurses' Health Study and over 40,000 men in the Health Professionals Follow-up Study via regular food-frequency questionnaires. Participants were followed for up to 30 years.
People who ate nuts once a week had a lower risk for dying during follow-up than people who abstained from nuts (hazard ratio, 0.89). Risks decreased even more as nut consumption increased. In addition, more nut consumption translated to lower risk for dying from cancer and heart disease. The benefits were similar for tree nuts and peanuts.
The authors caution: "Epidemiologic observations establish associations, not causality, and not all findings from observational studies have been confirmed in controlled, randomized clinical trials."
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Neurology 2013 Oct 23
Does Glucose Regulation Matter If You're Not Diabetic?
 Better control is beneficial cognitively, even for individuals within the normal range.
Many studies have associated cognitive problems with high glucose levels in patients with diabetes. Using magnetic resonance imaging (MRI), researchers have now examined the relationship of glucose to memory (on a verbal learning task) and brain structure in 141 individuals whose glucose and glycosylated hemoglobin (HbA1c) levels were within the normal range (72 women; mean age, 63).
Participants had a normal body-mass index and minimally used alcohol, cigarettes, and caffeine. Higher levels of HbA1c and fasting glucose were associated with lower performance on all three memory subtasks, smaller hippocampal volume (on 3-Tesla MRI), and worse hippocampal density (measured via diffusion tensor imaging). Further analysis suggested that the effects of HbA1c on memory are mediated partly by hippocampal volume and density.
Comment: According to this study, glucose regulation even within the normal range is correlated with memory and hippocampal structure. Although the study population is small, these results should make us consider lifestyle and dietary changes that may optimize glucose control. These can include exercise, avoidance of sleep deprivation, and a diet that is not only lower in calories, but also, possibly, in simple carbohydrates.
Citation(s): Kerti L et al. Higher glucose levels associated with lower memory and reduced hippocampal microstructure. Neurology 2013 Oct 23; [e-pub ahead of print].
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Fuzzy Math: New calculator Seen as Overestimating cardiovascular Risk
By Joe Elia
The calculator that accompanies new guidelines on lowering cardiovascular risk could mistakenly make "millions more people" candidates for statins, according to a New York Times story.
The root of the problem may be that the numbers used to calculate patients' risks come from studies done in the 1990s when, for instance, more people smoked. Researchers using data from other cohorts found that the calculator overestimated risk by between 75% and 150%. Those results are due to appear in the Lancet on Tuesday, according to the Times report.
Whatever the cause, cardiologist Steven Nissen told the Times: "We need a pause to further evaluate this approach before it is implemented on a widespread basis."

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