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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
March 18, 2017

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Vitamin D Supplementation Lowers Risk for Acute Respiratory Tract Infections
Menopausal Hormone Therapy and Alzheimer Disease: Protective or Not?
For Combatting Menopausal Symptoms, Low-Dose Oral Conjugated Estrogens
    and Transdermal Estradiol Work Well
Celiac Disease Prevalence Is Higher in Northern U.S. Latitudes
Gallstones Are Associated with Right-Sided Colon Cancer
Suboptimal Diet Is Associated with Excess Mortality from Cardiometabolic Diseases
Indian Active Pharmaceutical Ingredient Maker Scolded for Not Ensuring River Water It
    Uses is Safe
Second Banned Manufacturer Still Shipping Active Pharmaceutical Ingredients
Using Alcohol and Marijuana Influences College Performance
Gene Replacement for Sickle Cell Disease: A Case Report
Does High-Flow Warm Humidified Oxygen Benefit Children with Moderate Bronchiolitis?
Variability of Fasting Glucose and Risk for Diabetic Polyneuropathy

BMJ 2017 Feb 15; 356:i6583
Vitamin D Supplementation Lowers Risk for Acute Respiratory Tract Infections
Participants with severe vitamin D deficiency benefitted most.
Observational evidence suggests that low blood concentrations of 25-hydroxyvitamin D are associated with susceptibility for acute respiratory tract infections. In this meta-analysis of 25 randomized, double-blind, placebo-controlled trials, researchers used individual participant data on about 11,000 children and adults to examine whether vitamin D supplementation lowered risk for acute respiratory tract infections (upper, lower, and unclassified location).
In all studies, vitamin D was administered orally: bolus doses every 1 to 3 months, weekly doses, daily doses, or a combination of bolus and daily doses. Vitamin D supplementation significantly lowered risk for acute respiratory tract infections (by 12%;adjusted odds ratio, 0.88). This protective effect was observed only in participants who received daily or weekly vitamin D and was stronger in participants whose baseline 25-hydroxyvitamin D levels were <10 ng/mL (<25 nmol/L; adjusted OR, 0.3) than in those whose baseline levels were higher (AOR, 0.75). In addition, the protective effect appeared to be limited to upper respiratory infections. Vitamin D supplementation was not associated with serious adverse events.
COMMENT:  In this study, vitamin D supplementation lowered risk for acute respiratory tract infections, especially among participants with severe vitamin D deficiency (baseline 25-hydroxyvitamin D level, <10 ng/mL). Notably, the prevalence of severe vitamin D deficiency among U.S. adults has been estimated to be 6% or ≈20 million people (Arch Intern Med 2009; 169:626). These results are biologically plausible — as noted by the authors, in vitro studies have shown that vitamin D and its metabolites induce antimicrobial effects.
CITATION(S): Martineau AR et al. Vitamin D supplementation to prevent acute respiratory tract infections: Systematic review and meta-analysis of individual participant data. BMJ 2017 Feb 15; 356:i6583.

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Neurology 2017 Feb 15
Menopausal Hormone Therapy and Alzheimer Disease: Protective or Not?
In a Finnish cohort study, AD risk was only lowered by HT after >10 years of self-reported use.
Evidence indicates that women are more likely than men to develop Alzheimer disease (AD) due to their longer lifespan and hormonal attenuation at menopause. In this longitudinal cohort study, researchers assessed the effect of postmenopausal hormonal therapy (HT) on risk for AD in 8195 Finnish women (baseline age range, 47–56) who completed questionnaires every 5 years from study entry in 1989 until 2009. Use of HT was determined by self-report and registry data, which were available 7 years after baseline and included information on HT preparation (i.e., estrogen-only or combined estrogen and progesterone). AD diagnoses were defined based on published criteria; incident cases were verified with a prescription reimbursement register. Women who were >12 months from their last menstrual cycle or who had undergone bilateral oophorectomy with or without hysterectomy were considered postmenopausal. More than 90% of participants were postmenopausal by the 10-year follow-up.
During the 20-year follow-up, 227 cases of incident AD (mean age at diagnosis, 72) occurred. Women with AD were more likely to be menopausal at baseline, older, less physically active, and unemployed. HT use, whether self-reported or register-based, did not affect risk for developing AD; in addition, the HT preparation was not associated with AD risk. After adjustment for age, body-mass index, socioeconomic status, and conditions such as cancer and surgery, AD risk was lower in those women with self-reported HT use for >10 years (hazard ratio, 0.53; 95% confidence interval, 0.31–0.91).
COMMENT: The results of this prospective study are mixed and limited by the lack of registry-based data on HT use at baseline. Although the overall effect of HT on AD risk needs further study, early initiation and longer duration of postmenopausal HT may be important considerations for decreasing AD risk.
CITATION(S): Imtiaz B et al. Postmenopausal hormone therapy and Alzheimer disease: A prospective cohort study.Neurology 2017 Feb 15; [e-pub]. (http://dx.doi.org/10.1212/WNL.0000000000003696)
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Menopause 2017 Mar; 24:238
For Combatting Menopausal Symptoms, Low-Dose Oral Conjugated Estrogens and Transdermal Estradiol Work Well
Both estrogen preparations were highly effective against hot flashes and night sweats over a 4-year timeframe.
Menopausal symptoms, experienced by most perimenopausal women and continuing for years in many, are a recognized indication for menopausal hormone therapy (HT). To compare the efficacy of two forms of HT, 727 women (baseline age range, 42–58; within 3 years of menopause onset) were randomized to receive daily oral conjugated estrogens (o-CEE; 0.45 mg) or transdermal estradiol (t-E2; 50 µg) with micronized oral progesterone (200 mg for 12 days each month) or placebo for 48 months. Menopausal symptoms were self-assessed at regular intervals.
By 6 months, incidence of moderate-to-severe hot flashes decreased more with either HT (from 44% to 4% [o-CEE] or 7% [t-E2]) than with placebo (from 44% to 28%; P<0.001), and efficacy of the two formulations was similar. Symptom relief was maintained until the end of the 4-year trial for both forms of HT and, to a lesser extent, placebo. Insomnia was intermittently reduced by either HT, but irritability was not affected. Degree of symptom relief was not affected by body-mass index or race/ethnicity.
COMMENT: As the investigators note, this is the first study to compare two HT regimens having distinct routes of administration. The findings document highly effective symptomatic relief with lower oral doses of estrogen than are typically administered, while also confirming the expected attenuation in menopausal symptoms without treatment over time. This study provides reassurance that low-dose oral or standard-dose transdermal estrogen can provide appropriate longterm relief for women with moderate-to-severe vasomotor symptoms.
CITATION(S): Santoro N et al. Longitudinal changes in menopausal symptoms comparing women randomized to low-dose oral conjugated estrogens or transdermal estradiol plus micronized progesterone versus placebo: The Kronos Early Estrogen Prevention Study. Menopause 2017 Mar; 24:238.
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Gastroenterology 2017 Feb 23
Celiac Disease Prevalence Is Higher in Northern U.S. Latitudes
This association has been found in other parts of the world but remains biologically unexplained.
The prevalence of some autoimmune disorders varies with geographic latitude. To investigate whether celiac disease is among those disorders, investigators analyzed data from a large U.S. cross-sectional interview-based survey. They also examined adherence to a gluten-free diet (GFD) at different latitudes.
Data from 22,277 interviewees aged ≥6 years surveyed during 2009 to 2014 were included. Participants were asked if they had ever received a diagnosis of CD and if they adhered to a GFD. They also underwent blood testing. Celiac disease was defined as meeting at least one of the following criteria: 1) positive serology (tissue transglutaminase immunoglobulin A test confirmed by endomysial antibody test) or 2) both a self-reported healthcare provider diagnosis of celiac disease and adherence to a GFD.
The prevalence of CD was 0.7% overall and increased with increasing latitude (0.2% in latitudes <35º north, 0.6% in latitudes 35–<40º [adjusted odds ratio, 3.18], and 1.2% in latitudes ≥40º [aOR, 5.45]). Other factors associated with a higher prevalence of CD were having ≥12 years of education and being overweight or obese. Gluten avoidance without celiac disease was present in 1.1% of the sample and was twice as common in latitudes ≥40º north (1.6%) as in latitudes <35º (0.8%) or 35–<40º (0.7%).
COMMENT: As with some other autoimmune disorders, the prevalence of CD appears to be greater in northern versus southern latitudes in the U.S. The environmental factors that impact the genetic predisposition to CD to create this effect are unclear.
Note to readers: At the time NEJM Journal Watch reviewed this paper, its publisher noted that it was not in final form and that subsequent changes might be made.
CITATION(S): Unalp-Arida A et al. Lower prevalence of celiac disease and gluten-related disorders in persons living in southern vs northern latitudes of the United States. Gastroenterology 2017 Feb 23; [e-pub]. (http://dx.doi.org/10.1053/j.gastro.2017.02.012)
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Gastroenterology 2017 Feb 23
Gallstones Are Associated with Right-Sided Colon Cancer
Routine screening seems reasonable in patients with gallstones or prior cholecystectomy.
Cholecystectomy has been associated with an increased risk for right-sided colon cancer. This link is often attributed to increased exposure of proximal colon mucosa to secondary bile acids after cholecystectomy.
In a prospective study from Copenhagen, residents aged 30 to 70 years were invited to undergo abdominal ultrasound between 1982 and 1992 and then followed for a median of 25 years. Of 5928 participants, 7% had gallstones and 3% had cholecystectomy at baseline. Of those with gallstones, 15% had awareness of gallstones, and the remainder were not notified of the results. During follow-up, 7% developed at least one gastrointestinal (GI) cancer, 23% developed a non-GI cancer, 45% were alive without cancer, and 25% died of other causes. Only 1% were lost to follow-up.
Overall risk for GI cancers was elevated in persons with gallstone disease (defined as either gallstones or cholecystectomy; hazard ratio, 1.5) and in patients with cholecystectomy alone (HR, 1.7). In subgroups of colorectal cancers, right-sided cancer was associated with gallstone disease and gallstones, but not with cholecystectomy alone. Rates of other specific GI cancers were not elevated in patients with gallstone disease.
COMMENT Given this result and previous trial findings, it is likely that both asymptomatic gallstones and prior cholecystectomy are associated with increased risk for right-sided colon cancer. None of our guidelines currently recommend more-intensive screening for these patients. It seems reasonable to notify affected patients of this risk and to encourage routine screening based on this risk. Informed and concerned patients and their physicians might consider some screening intensification.
Note to readers: At the time NEJM Journal Watch reviewed this paper, its publisher noted that it was not in final form and that subsequent changes might be made.
CITATION(S): Shabanzadeh DM et al. Association between screen-detected gallstone disease and cancer in a cohort study. Gastroenterology 2017 Feb 23; [e-pub].
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JAMA 2017 Mar 7; 317:912
Suboptimal Diet Is Associated with Excess Mortality from Cardiometabolic Diseases
Nearly half the deaths were related to poor nutrient consumption, including high sodium intake and low intake of nuts and seeds.
Dietary factors affect risk for cardiometabolic diseases (e.g., heart disease, stroke, and type 2 diabetes), but the specific factors involved and their individual effects on risk are unclear. In this study, investigators used various sources of data to quantify the effect of suboptimal diet on cardiometabolic disease–related mortality in the U.S. in 2012. They identified 10 specific dietary factors (e.g., fruits, vegetables, whole grains, sodium, nuts and seeds, processed meats) that were associated strongly with cardiometabolic disease and estimated the absolute number and proportion of cardiometabolic disease–related deaths associated with suboptimal intake of each food.
On multivariate analysis, overall suboptimal intake of the 10 dietary factors accounted for 45.4% of 702,308 cardiometabolic disease–related deaths in 2012; the largest contributors to these deaths were high sodium intake (9.5%), low consumption of nuts and seeds (8.5%), and high intake of processed meats (8.2%). Between 2002 and 2012, cardiometabolic disease–related mortality fell by 25%, with the greatest effects coming from improved intakes of polyunsaturated fats and nuts and seeds and lower intake of sugar-sweetened beverages.
COMMENT: These data — which provide guidance on dietary modifications that are likely to have the largest effects — have value for public health professionals who plan population-based initiatives and for clinicians who advise individual patients.
CITATION(S): Micha R et al. Association between dietary factors and mortality from heart disease, stroke, and type 2 diabetes in the United States. JAMA 2017 Mar 7; 317:912.
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Indian Active Pharmaceutical Ingredient Maker Scolded for Not Ensuring
River Water It Uses is Safe

The FDA warned an Indian active pharmaceutical ingredient (API) maker that it had not ensured the water it gets from a nearby river is sanitary before using it to make its products. In the warning letter to Badrivishal Chemicals & Pharmaceuticals, the FDA said its plant in Maharashtra has been using the river water since 2014 despite the fact that the water passes through farmland where it is subject to agricultural runoff and animal waste, and is stored in a tank with a hole in it that does not protect it from dirt and debris. 
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Second Banned Manufacturer Still Shipping Active Pharmaceutical Ingredients
China's Lumis Global Pharmaceuticals has been sent a warning letter for selling active pharmaceutical ingredients (APIs) it got from a supplier on the FDA import alert list, then faking Certificates of Analysis (COA). When the FDA has serious concerns about the APIs or drugs made at a facility outside the U.S., it often will place it on its import alert list to prevent the products from entering the U.S. However, that is not a guarantee they won't get in.
This is the second time in recent months that the FDA has slapped a Chinese company with a warning letter after finding that it was buying products from a banned supplier, faking COA and then shipping the APIs as their own. 
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PLoS One 2017 Mar 8; 12:e0172213
Using Alcohol and Marijuana Influences College Performance
Students who use higher amounts of alcohol and marijuana have lower grade point averages, but grades improved after substance use lessened.
The academic impacts of alcohol and marijuana, the two most commonly abused substances on college campuses, have not been studied in depth. These researchers recruited freshmen from two colleges and examined academic performance and monthly patterns of alcohol and marijuana use for 2 years (4 semesters).
Based on consumption patterns, 1138 students were categorized into three clusters:
Cluster 1: no or low users of both substances (43%; men, 38%)
Cluster 2: moderate-to-high alcohol plus no-or-low marijuana users (41%; men, 37%)
Cluster 3: moderate-to-high users of both (16%; men, 54%)
Extremely few students had heavy marijuana use combined with minimal alcohol use. Group membership remained relatively stable across all semesters. Cigarette smoking was reported by 4% of cluster 1 and 9% of cluster 2 but 20% of cluster 3.
During the four semesters, grade point averages (GPAs) were highest in cluster 1, intermediate in cluster 2, and lowest in cluster 3. Baseline depression scores were highest in cluster 3. GPAs were positively associated with SAT scores and negatively associated with baseline depression scores. Over time, among the 142 students whose substance use improved, GPAs increased.
COMMENT: Although these results are not surprising, they confirm the impacts of heavier alcohol and marijuana use on academic achievement, their association with higher depression scores, and the observation that reducing substance use correlates with improving academic improvements. This is important information for people designing prevention and early intervention programs on college campuses. Clinicians can use these findings to buttress psychoeducation and motivational interviewing.
CITATION(S): Meda SA et al. Longitudinal influence of alcohol and marijuana use on academic performance in college students. PLoS One 2017 Mar 8; 12:e0172213.
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N Engl J Med 2017 Mar 2; 376:848
Gene Replacement for Sickle Cell Disease: A Case Report
This dramatic outcome provides proof of concept for a potentially curative treatment.
The substitution of valine for glutamic acid in the β-chain of hemoglobin S (HbS) is associated with the formation of hemoglobin polymers that promote vaso-occlusion, organ infarcts, and sickle cell crises. Polymer formation is retarded by hydroxyurea, which increases fetal hemoglobin, or by replacement of hematopoietic stem cells via allogeneic transplantation. But these measures are occasionally ineffective or infeasible in many patients with sickle cell disease (SCD). Replacement of the gene for βS-globin might cure this disorder.
To examine the safety and effectiveness of gene therapy for SCD, investigators prepared a modified βA-globin gene encoding an antisickling variant (βA-T87Q) incorporated into a self-inactivating lentiviral vector. The final product, LentiGlobin BB305, was transduced into bone marrow-enriched CD34+ cells obtained from a 13-year-old boy with severe homozygous SCD refractory to hydroxyurea. Following marrow ablation with busulfan, the patient was infused with the transduced stem cells.
Engraftment of neutrophils was achieved on day 38 after transplantation, and platelet engraftment was achieved on day 91. Various cell lines displayed progressive increases in gene marking, and hemoglobin rose to 12 g/dL, enabling red cell transfusions to be discontinued by day 88. By month 15 after transplantation, HbT87Q constituted 48% of hemoglobin, and HbS constituted 49%. Previous signs of hemolysis had disappeared, and no new SCD-related clinical events occurred. In addition, no evidence of lentivirus replication or insertional mutagenesis was observed.
COMMENT: This dramatic outcome supports further study of gene therapy for SCD, and the investigators have embarked on a multicenter, phase I/II clinical study that, to date, has recruited seven patients with SCD and four patients with β-thalassemia. Whether this potentially curative treatment will play a role in the management of the many patients with severe hemoglobinopathies will become clearer as clinical experience increases and longer-term data on safety and efficacy accumulate.
CITATION(S): Ribeil JA et al. Gene therapy in a patient with sickle cell disease. N Engl J Med 2017 Mar 2; 376:848.
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Lancet 2017 Feb 1
Does High-Flow Warm Humidified Oxygen Benefit Children with Moderate Bronchiolitis?
Randomized trial data suggest that high-flow oxygen is effective as rescue therapy after standard oxygen therapy fails.
The use of high-flow warm humidified oxygen (HFWHO) in children with bronchiolitis is becoming more frequent despite an absence of supporting data from randomized trials.
In a three-year, single-center trial, investigators compared the time to weaning off oxygen among 202 children aged <24 months with moderate symptoms of bronchiolitis who were randomized to HFWHO or standard nasal cannula oxygen therapy upon admission to the hospital or presentation to the emergency department.
Time to weaning off oxygen was similar between groups. Significantly more children in the standard therapy group than in the HFWHO group failed treatment (33 vs. 14). Of the 33 children who failed standard therapy, 20 responded to HFWHO and did not require treatment escalation (continuous positive airway pressure or intermittent positive pressure ventilation in the intensive care unit); all 14 of those who failed HFWHO therapy required treatment escalation.
COMMENT: These data suggest that oxygen delivery is only one aspect of the benefit of HFWHO in treating children with bronchiolitis. The primary benefit may be the high flow and resultant positive airway pressure, not the oxygen concentration delivered. HFWHO should be considered after standard nasal cannula therapy fails as it might prevent the need for further escalation in respiratory support.
CITATION(S): Kepreotes E et al. High-flow warm humidified oxygen versus standard low-flow nasal cannula oxygen for moderate bronchiolitis (HFWHO RCT): An open, phase 4, randomised controlled trial. Lancet 2017 Feb1; [e-pub].
Cunningham S and Fernandes RM.High-flow oxygen therapy in acute bronchiolitis. Lancet 2017 Feb 1; [e-pub].
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Neurology 2017 Mar 7; 88:944
Variability of Fasting Glucose and Risk for Diabetic Polyneuropathy
Variability of fasting glucose is independently associated with risk for diabetic polyneuropathy.
Diabetic polyneuropathy (DPN) is one of the most common complications in patients with type 2 diabetes mellitus, affecting about 30% of patients admitted to hospitals and 20% to 30% of community-based patients. Risk factors include diabetes duration, hyperglycemia, and age, as well as hypertension, dyslipidemia, and obesity (Rev Diabetic Stud 2015; 12:48). The role of glycemic variability in DPN has been unclear. To see if the variations in fasting plasma glucose (FPG), measured by the coefficient of variation (CV), could predict DPN risk independently of glycated hemoglobin (HbA1c) and other risk factors, researchers enrolled 36,152 patients ≥30 years old with type 2 diabetes in the Diabetes Care Management program of Taiwan.
During an average 7.23 years of follow-up, 7219 incident cases of DPN occurred (crude incidence, 27.62 per 1000 person-years; 25.83 for men, 29.31 for women). After adjustment for known risk factors, the incidence of DPN in the first, second, third, fourth, and fifth quintiles of FPG-CV were 24.97, 26.23, 26.23, 29.43 and 31.55 per 1000 person-years. FPG-CV was a significant predictor of DPN, with hazard ratios (after multivariate adjustment) of 1.14 and 1.15 for the fourth and fifth FPG-CV quintiles, respectively.
COMMENT: This interesting study shows that glycemic variability can be an independent risk factor for diabetic polyneuropathy. Nevertheless, the role of glucose variability in the pathophysiology of DPN remains a subject of debate. Treatment of other risk factors for DPN may help delay or prevent this complication.
CITATION(S): Yang C-P et al. Variability of fasting plasma glucose increased risks of diabetic polyneuropathy in T2DM.Neurology 2017 Mar 7; 88:944.

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