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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
October 11, 2014

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Childhood Obesity an Important Predictor of Left Ventricular Hypertrophy
Questioning Beta-Blockers in Patients with Heart Failure and AF
AAP Policy Statement on Late School Start for Adolescent Sleep Deprivation
Is There a Preferred Time to Introduce Gluten in Infants at Risk for Celiac Disease?
Susceptibility-Based Therapy for Helicobacter pylori
Life Expectancy in U.S. Reaches All-Time High
ACC/AHA Cardiovascular Risk Calculator Again Questioned
Overuse of Opioids for Headache Treatment in U.S. EDs
Testosterone Therapy in Patients with Type 2 Diabetes
Medication Adherence Is Higher with Generic Statins Than with Brand-Name Statins

MM: We readily refer to our children as our future and we encourage them to study and work hard but we must also encourage them to eat and live a healthy lifestyle. One of the most effective ways to accomplish this is by demonstrating and teaching better habits from a very early age. It is never too late to start . Improvements to physical activity, lifestyle, diet and even smoking will show benefits to the person who adopts such strategies and these same habits and activities, both good and bad, will likely communicate to our children.
J Am Coll Cardiol 2014 Oct 6
Childhood Obesity an Important Predictor of Left Ventricular Hypertrophy
LVH and cardiac remodeling were associated with greater body-mass index and, to a lesser extent, higher blood pressure in both childhood and adulthood in a decades-long study.
Several cardiovascular risk factors are associated with left ventricular hypertrophy (LVH), but little is known about the association of childhood adiposity and adulthood LV parameters. Therefore, investigators examined the effects of adiposity and elevated blood pressure (BP) during childhood on adulthood LV remodeling patterns in 1061 adults aged 24 to 46 years enrolled in the Bogalusa Heart Study. The authors characterized four LV remodeling patterns, indexed to body height (LV mass index): normal, concentric remodeling, eccentric hypertrophy, and concentric hypertrophy. Mean follow-up was 28 years.
Higher values of body-mass index (BMI) and BP in childhood, adulthood, or both were significantly associated with higher LV mass index and LVH after adjustment for race, sex, and age at measurement. Higher values of BMI and BP in childhood and adulthood were significantly associated with eccentric hypertrophy and concentric hypertrophy but not with concentric remodeling. BMI had a consistently and significantly greater influence on eccentric hypertrophy than did BP.
Comment: This large cohort study demonstrates the important consequences of childhood obesity and hypertension on long-term cardiovascular parameters, including LVH and cardiac remodeling. These data, although limited, support continued efforts to control and prevent cardiac risk factors early in childhood.
Citation(s): Lai CC et al. Impact of long-term burden of excessive adiposity and elevated blood pressure from childhood on adulthood left ventricular remodeling patterns: The Bogalusa Heart Study. J Am Coll Cardiol 2014 Oct 6; [e-pub ahead of print].
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MM: In spite of there being little benefit in mortality with these medications, there are not a lot of debilitating adverse effects and in general they are very inexpensive. as sad as these criteria are for endorsement, many practitioners use them for these reasons and basic practitioner familiarity with these drugs. For these reasons, doctors and other prescribers are unlikely to change their prescribing habits.
Lancet 2014 Sep 2
Questioning Beta-Blockers in Patients with Heart Failure and AF
These medications may do no harm, but neither do they seem to improve mortality and hospitalization rates.
Atrial fibrillation (AF) and chronic systolic heart failure commonly coexist. Because beta-blockers are considered foundational evidence-based therapy for left ventricular systolic dysfunction (LVSD), many clinicians have presumably assumed that beta-blockers should be used as first-line agents to achieve rate control and reduce mortality in patients with both LVSD and AF. These researchers compared the relationship between beta-blocker therapy and outcomes in patients with heart failure and with or without AF in a manufacturer-sponsored meta-analysis (NCT00832442) that used patient-level data from 10 randomized, controlled trials of beta-blockers in 18,254 heart-failure patients.
Overall, 3066 patients (17%) had AF; they were older by 5 years and more often male than those in sinus rhythm. Left ventricular ejection fraction was similar (median, 0.27) in the AF and sinus-rhythm groups. Crude rates of death, the primary endpoint, were higher in AF patients (21%) than in those with sinus rhythm (16%). Compared with placebo, beta-blockers were associated with significantly lower mortality in those with sinus rhythm (hazard ratio, 0.73) but not in those with AF (HR, 0.97; for the interaction, P=0.002, indicating meaningful heterogeneity based upon baseline rhythm). Several other endpoints showed similar patterns, including cardiovascular death, hospitalizations, and combinations of these events.
Comment: This study calls into question the mortality benefits of beta-blockers in patients with heart failure and concomitant AF and the broad guideline recommendation for beta-blockers to prevent mortality in systolic heart failure. One can only speculate about why baseline rhythm would influence treatment efficacy. Still, the results do not suggest that beta-blockers are harmful. For the many patients with AF requiring an agent to control heart rate or moderate blood pressure, beta-blockers remain a reasonable approach. My guess for now: Most practitioners will continue to use beta-blockers in their patients with LVSD and AF.
Citation(s): Kotecha D et al. Efficacy of β blockers in patients with heart failure plus atrial fibrillation: An individual-patient data meta-analysis. Lancet 2014 Sep 2; [e-pub ahead of print].
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MM: Although I applaud the AAP on making a statement and taking a stand regarding sleep, I sincerely doubt that anything in schools will occur to establish a later start time. Kids are over scheduled and expectations are increasing regularly. In many cases, homework levels are almost equal to time spent in the classroom and if after school activities such as sports and clubs are added to the mix, there is little enough time to satisfy all these time demands without establishing a later start time. I also fear that if a later start time is introduced, coaches will simply take advantage of this by having morning practices that are more aggressive than those already being demanded. On the other hand, knowledge is power and perhaps this knowledge will have a lifelong positive effect on sleep habits and on future generations.
Pediatrics 2014 Sep; 134:642
AAP Policy Statement on Late School Start for Adolescent Sleep Deprivation
Recommendations to pediatric clinicians focus on educating patients, parents, and educators to support policy change in school start times.
Sponsoring Organization: American Academy of Pediatrics
Target Population: Pediatric healthcare providers
Background and Objective: The average amount of nightly sleep of high school seniors is <7 hours, and most teenagers have difficulty falling asleep before 11:00 pm. Insufficient sleep in adolescence begins at puberty with the onset of a sleep-wake “phase delay” and delayed nocturnal melatonin secretion. Lifestyle choices and academic challenges are additional factors.
Research studies of sleep patterns in adolescents demonstrate that delaying school start times is an effective strategy to reverse chronic sleep loss, which can impair mental health, physical health, safety, and academic achievement. A new policy statement from the American Academy of Pediatrics Committee on Adolescence and Council on School Heath provides the following specific recommendations for pediatric healthcare providers to address the adverse effects of insufficient sleep in adolescents.
Key Recommendations:

Comment: A medical home is enhanced when pediatricians actively support collaborations of patients and families with those who direct school policies. Evidence-based studies that support the effectiveness of a late school start time provide a foundation for pediatric advocacy in the community. Pediatricians are well positioned to educate and motivate parents, teachers, and school administrators in initiating a developmentally sound school start time. A few committed parents who bring these ideas to a school can make a difference.
Citation(s): Adolescent Sleep Working Group, Committee on Adolescence and Council on School Health.School start times for adolescents. Pediatrics 2014 Sep; 134:642. (http://dx.doi.org/10.1542/peds.2014-1697)

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MM: There is a great deal of concern regarding gluten sensitivity and celiac disease that previously went unnoticed by most Americans. One of the possible reasons for this greater presence of the problem isthe much higher presence of gluten in our food chain resulted from the increased presence of GMO foods that have incorporated it into their genetic make-up. One of the difficulties in going "back in time" is that it has cost seed manufacturers hundreds of millions of dollars to develop these seed products and many farmers are under contract with these seed companies to use their products. Although many of these products are herbicide and pest resistant resulting in higher yields they may also carry the genes that produce increased gluten and simply taste better. This is a problem that will not go away in a hurry and may never disappear completely. Unfortunately big business is probably going to win this battle and consumers will be the losers.
N Engl J Med 2014 Oct 2; 371:1304
Is There a Preferred Time to Introduce Gluten in Infants at Risk for Celiac Disease?
Two studies find that timing of postnatal introduction of gluten did not alter the risk for developing celiac disease.
Controversy exists concerning when to introduce gluten-containing foods in infants at risk for celiac disease, although a preferred time of between 4 and 6 months of age has been proposed. In two multicenter, randomized studies of children with a first-degree relative with celiac disease, investigators assessed the association between timing of gluten feeds and risk for celiac disease.
In the first study, Vriezinga and colleagues introduced gluten to 944 infants between ages 16 and 24 weeks who were positive for HLA-DQ2 or HLA-DQ8 and assessed biopsy-proven celiac disease at age 3 years. Development of celiac disease was similar in children given gluten and in those given placebo (5.9% and 4.5%). Development of antitransglutaminase and antigliadin antibodies was also similar in the two groups.
In the second study, Lionetti and colleagues introduced gluten to 707 infants at either 6 or 12 months of age. At age 5 years, neither clinical celiac disease nor autoimmunity development differed between children given gluten at age 6 versus 12 months. At age 10 years, 16.5% of children had developed autoimmunity and 13.2% had developed clinical celiac disease. Compared with children with standard-risk HLA genotypes, children with high-risk HLA genotypes had higher rates of both celiac disease autoimmunity (37.9% vs. 19.2%; P=0.001) and clinical celiac disease (25.8% vs. 15.8%; P=0.05). Breast-feeding did not alter the clinical or serological development of celiac disease in either study.
Comment: These studies show that in children at high risk for celiac disease, the timing of gluten introduction and breast-feeding do not alter the development of either autoimmunity or clinical celiac disease. These data highlight the importance of watching for celiac disease in children with a first-degree relative who has the condition.
Citation(s): Vriezinga SL et al. Randomized feeding intervention in infants at high risk for celiac disease. N Engl J Med 2014 Oct 2; 371:1304. (http://dx.doi.org/10.1056/NEJMoa1404172)

Lionetti E et al. Introduction of gluten, HLA status, and the risk of celiac disease in children. N Engl J Med 2014 Oct 2; 371:1295.
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MM: I think that the reviewer of this article sort of missed the boat on this one. The real point of the study is that antibiotic resistance is a real and continuously growing problem and that we must seek other alternatives to treating problems such as GI issues with an approach that is not self defeating. Probiotics and digestive enzymes may not solve 100% of the challenges that arise but combining them with additional approaches to acid balance such as Betaine HCl or mild products such as apple cider vinegar will use a more natural approach to restoring the appropriate environmental balance of the GI tract and will discourage pathogenic microorganism growth. without causing stronger opponents to the human condition or putting our population at increased risk.
Am J Gastroenterol 2014 Aug 5
Susceptibility-Based Therapy for Helicobacter pylori
In Korea, where drug-resistance rates are high, susceptibility-guided therapy was more efficacious than clarithromycin-based standard triple therapy.
Helicobacter pylori eradication rates are decreasing as antibiotic resistance increases throughout the world. In a randomized, open-label study involving 114 H. pylori–infected patients in Korea with gastric epithelial neoplasms, investigators compared the efficacy of susceptibility-guided therapy with that of clarithromycin-based triple therapy.
Gastric mucosal biopsy samples were obtained to confirm infection and determine antibiotic-resistance patterns. Half the participants received a proton pump inhibitor (PPI; either 40 mg of lansoprazole or 30 mg of pantoprazole), 1 g of amoxicillin, and 500 mg of clarithromycin, all twice daily for 7 days. The other half received the same PPI and amoxicillin therapy, plus a third drug selected based on resistance patterns (for clarithromycin-sensitive H. pylori strains, the same regimen as the other group; for clarithromycin-resistant strains, 500 mg of metronidazole twice daily; for metronidazole- and clarithromycin-resistant strains, 400 mg of levofloxacin once daily).
Intention-to-treat analysis showed eradication rates of 94.7% (95% confidence interval, 88.8%–100%) for susceptibility-based therapy and 71.9% (95% CI, 60.2%–83.5%) for standard therapy. Participants with treatment failure received second-line therapy using the susceptibility-based approach; only one individual again experienced treatment failure.
Comment: Clearly, the major determinant in H. pylori treatment failures is underlying drug resistance. When drug susceptibility data are available, as in this study, treatment can be designed based upon that information. Unfortunately, sensitivity testing is both logistically and economically impractical in most settings. Having an understanding of the underlying sensitivity patterns in the local population may be the best way to select the optimal treatment regimen.
Citation(s): Park C-S et al. Pretreatment antimicrobial susceptibility-guided vs. clarithromycin-based triple therapy for Helicobacter pylori eradication in a region with high rates of multiple drug resistance. Am J Gastroenterol 2014 Aug 5; [e-pub ahead of print]. (http://dx.doi.org/10.1038/ajg.2014.222)
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MM: It is certainly good to see that we are living longer and that we have a record low infant mortality rate but the real question must be, "Are we living better?" I contend that we may not be. We are at record high levels of diabetes and asthma in North America. Obesity, heart disease and chronic pain of many types are resulting in debilitated and miserable Americans. We are using more prescription medications than we have ever used. All this leads to a conclusion that we may be living longer due to advances in life preserving techniques but we may not be living better. Perhaps the approach of quality over quantity is one that should be examined here.
Life Expectancy in U.S. Reaches All-Time High
Life expectancy at birth reached a record high of 78.8 years in 2012, according to data released on Wednesday from the CDC's National Center for Health Statistics. (Granted, it's only an increase of 0.1 year from 2011, but still, it's the highest it's ever been.)
Broken down by sex, life expectancy was 81.2 years for females and 76.4 for males. The 10 leading causes of death in 2012 were the same as in 2011.
At the same time, the infant mortality rate reached a record low, at 597.8 infant deaths per 100,000 live births.
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MM: For decades it was wrongly thought that women had a much lower risk of heart disease and consequent death than men so it is completely appropriate to play catch-up to give women equal care to men. Where the program changes is when there is inaccurate data going in the other direction that causes women, or any group, to take more medication or actions than are necessary thereby putting them at risk for other adverse drug reactions and a net decreased quality of life. That appears to be the case with the CV Risk Calculator in its present form.
ACC/AHA Cardiovascular Risk Calculator Again Questioned
By Larry Husten, Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM
A new study in JAMA Internal Medicine finds serious flaws in the cardiovascular risk calculator at the heart of the American College of Cardiology/American Heart Association 2013 cardiovascular guidelines.
Analyzing data from the Women's Health Study, researchers found that the predicted rate of cardiovascular disease using the guideline calculator was significantly higher than the actual observed rate in the trial. They considered and ruled out several "alternative explanations" for the discrepancy, including under-ascertainment of events and increased use of statins and revascularization procedures in their population.
The authors note that there have been at least seven studies now finding similar flaws in the risk calculator.
In an invited commentary, cardiologist Steve Nissen calculates that overestimation of cardiovascular risk would lead to millions of additional U.S. patients receiving statins. He concludes, "the ACC and AHA should promptly revise the guidelines to address the criticisms offered by independent authorities."
AHA President Elliott Antman had the following response: "These comments are the same that we heard and addressed when we published the guidelines last year. Multiple publications since that time have validated the concepts and the utility of the risk assessment tool and cholesterol guidelines. In addition, we continue to receive positive feedback from healthcare providers who use the guidelines as a tool to drive discussions with their patients about appropriate care."
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Am J Emerg Med 2014 Sep; 32:1068
Overuse of Opioids for Headache Treatment in U.S. EDs
Nationwide, opioids were administered at 35% of ED visits for headache in 2010.
Treatment of primary headache disorders (migraine, tension headache) with opioids is not recommended and is more likely to do harm than good. Researchers reviewed data from the National Hospital Ambulatory Medical Care Survey from 2001 to 2010 to assess trends in opioid use at emergency department (ED) visits with headache listed as a reason for the visit.
The percentage of ED visits for headache during which opioids were administered increased from 21% in 2001 to 35% in 2010.
Comment: Using an opioid to treat tension or migraine headache is not good medicine. Opioids are not recommended, because primary headaches are recurrent, and these agents cause rebound symptoms and are associated with addictions that can be very difficult to manage. Avoid opioids and butalbital (a barbiturate in the Fiorinal family of drugs) when treating primary headache disorders. Treatment guidelines clearly establish the primacy of other medications (sumatriptan, caffeine, nonsteroidal anti-inflammatory drugs, antiemetics) over opioids.
Citation(s): Mazer-Amirshahi M et al. Trends in opioid analgesic use for headaches in US emergency departments. Am J Emerg Med 2014 Sep; 32:1068. (http://dx.doi.org/10.1016/j.ajem.2014.07.001

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MM: I truly believe that Testosterone Replacement Therapy(TRT) has a place in therapy for men who demonstrate low systemic Testosterone. However, it is my belief that the majority of men who visit TRT clinics do not qualify for the treatment. Men with definitively low T suffer from a multitude of potentially debilitating symptoms but the number of men who are truly hypogonadal and who would truly benefit from this treatment is far less than the number who are seeking it. One of the problems with the exogenous provision of testosterone is that the human body protects itself from large doses of Testosterone or Estrogen by making a protein called Sex Hormone Binding Globulin (SHBG) that binds up excess hormone when exposed to it, and over time, if the exposure is repeated, those defenses remain present. The other problem is that many clinicians are not aware that Testosterone is converted in part to estradiol and that is through a process called aromatase. To get the greatest benefit from testosterone, a man should also receive a concomitant dose of an aromatase inhibitor. In obese males, and especially when the testosterone is applied to the skin, the amount of estradiol (estrogen) that is produced may lead to added problems with erectile dysfunction.
J Clin Endocrinol Metab 2014 Oct; 99:3821
Testosterone Therapy in Patients with Type 2 Diabetes
In a randomized trial, treatment did not improve somatic, psychological, or sexual symptoms.
Some clinicians prescribe testosterone for middle-aged and older men who have vague symptoms and low-normal total blood testosterone levels. In this placebo-controlled, randomized trial from Australia, researchers examined the effect of treatment with long-acting intramuscular testosterone undecanoate (Aveed) in 88 men with type 2 diabetes and total testosterone levels between 144 and 346 ng/dL. The primary outcome was the score on a standardized 17-item questionnaire (Aging Male Symptoms [AMS] scale), which includes somatic, psychological, and sexual items. Most patients' baseline scores were in the mild-to-moderate range of severity.
Testosterone supplementation increased mean blood testosterone by about 170 ng/dL. However, at 18 and 40 weeks, the testosterone group experienced no improvement in mean total AMS score (or somatic, psychological, or sexual subscores) compared with the placebo group. On a secondary outcome (an erectile function scale), scores actually were worse in the treatment group than in the placebo group (P<0.02).
Comment: In this study, which was supported by a manufacturer of testosterone undecanoate, testosterone supplementation did not improve the AMS score (a composite measure of somatic, psychological, and sexual symptoms). The authors note that three other randomized trials have been performed to examine whether testosterone therapy improves AMS scores in men with type 2 diabetes and mildly low testosterone levels. Two of them (one from the U.K., the other from several western European countries) showed no effect; the other (from Russia) showed a positive effect. In those studies, outcomes for specific sexual endpoints were mixed. Bottom line: testosterone supplementation does not improve general quality-of-life endpoints in this population. Whether this conclusion applies to nondiabetic men, or to men with markedly low testosterone levels and profound constitutional symptoms, is unclear.
Citation(s): Gianatti EJ et al. Effect of testosterone treatment on constitutional and sexual symptoms in men with type 2 diabetes in a randomized, placebo-controlled clinical trial. J Clin Endocrinol Metab 2014 Oct; 99:3821.

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MM: There is no big surprise that people will tend to use a product more regularly that is supposed to help them .If it costs them less, and they are convinced that it is beneficial they will be more diligent about compliance. The problem is that the actual benefits of statin use is questionable relative to the benefits that they allegedly provide. When all the numbers come in, statins provide much less benefit to both mortality and morbidity than one might suspect and the potential adverse reactions of muscular pain, increased risk of diabetes and kidney dysfunction make the purported benefits even less poignant.
Ann Intern Med 2014 Sep 16; 161:400
Medication Adherence Is Higher with Generic Statins Than with Brand-Name Statins
Cardiovascular outcomes also were better.
Many factors affect medication adherence, including out-of-pocket costs. In a study funded by a large generic-drug manufacturer, researchers evaluated adherence and clinical outcomes among Medicare beneficiaries in whom generic statins (lovastatin, pravastatin, or simvastatin) or their brand-name equivalents were initiated between 2006 and 2008. Adherence and outcomes were calculated using linked medical and pharmacy claims data.
Analysis involved about 90,000 patients, 93% of whom had initiated generic statins. Mean copayments were US$10 for generic statins and $48 for the brand-name versions. Adherence was higher among generic statin users (77% vs. 71%), and, after adjustment for potentially confounding variables, the rate of the composite outcome (i.e., hospitalization for acute coronary syndrome or stroke and all-cause mortality) was 8% lower in the generic group (absolute difference, −1.53 events per 100 person-years).
Comment: This research group might be the first to compare the effects of initiating generic and brand-name medications on both adherence and clinical outcomes. The finding that medication adherence was higher among generic statin users than among those who took brand-name statins was not surprising. However, the finding that generic statin initiation also was associated with better clinical outcomes is new and highlights the importance of considering cost when prescribing medications.
Citation(s): Gagne JJ et al. Comparative effectiveness of generic and brand-name statins on patient outcomes: A cohort study. Ann Intern Med 2014 Sep 16; 161:400. (http://dx.doi.org/10.7326/M13-2942

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