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Content 7


The Doctor and the Pharmacist

Radio Show Articles:
November 12, 2016

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Topical Analgesics Decreases Use of Other Pain Medications
Breast-Feeding Deters Diabetes
Multidrug-Resistant Yeast Identified in U.S.
Does Aerobic Exercise Improve Cognitive Performance in Vascular Cognitive Impairment?
Obesity Screening and Brief Physician Intervention Can Lead to Weight Loss
A Low-Carbohydrate/High-Fat Diet for GERD?
Monitoring Disease Activity in Inflammatory Bowel Disease
Stapled or Excisional Hemorrhoidectomy for Severe Hemorrhoids?
A Single-Pill Regimen for Chronic HCV Infection in Treatment-Experienced Patients
Do PPIs Protect Against Upper GI Bleeding in Patients Taking Warfarin?
Proton Pump Inhibitors Linked to Fundic Gland Polyps

Topical Analgesics Decreases Use of Other Pain Medications
Patients treated for at least five months with topical analgesics used less oral medication, including opioids, nonsteroidal anti-inflammatory drugs (NSAIDs), and over-the-counter (OTC) agents. (PAINWeek 2016 , Abstract 47). The OPERA (Optimizing Patient Experience and Response to Topical Analgesics) study wanted to determine whether there were any differences between topical analgesics and other types of available treatments.
A brief summary of the study shows that after three months on topical therapy, patients experienced reduced use of opioids (27.5%), NSAIDs (64.1%), and OTC analgesics (51.4%). After at least five months with the topical therapy, the reductions were more pronounced: 41.5% for opioids, 70.9% in those taking NSAIDs (70.9%), and 51.6% for OTC analgesics. 
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Obstet Gynecol 2016 Nov; 128:1095
Breast-Feeding Deters Diabetes
In a Canadian study, incident diabetes was less common among both mothers who had breast-fed and their offspring.
Prevalence of diabetes mellitus (DM) has been rising rapidly in North America, particularly among indigenous (First Nations) people, pointing to the importance of identifying modifiable risk factors. To assess the extent to which breast-feeding affects DM risk, researchers in Canada conducted a retrospective cohort study using administrative data from 334,553 live births in Manitoba between 1987 and 2011.
Overall, 56% of First Nations mothers and 83% of non–First Nations mothers initiated breast-feeding before hospital discharge. Information about maternal body-mass index was unavailable; however, after adjusting for multiple other potential confounders, risk for incident diabetes was lower among both First Nations mothers and non–First Nations mothers who began breast-feeding before hospital discharge than among those who did not breast-feed, regardless of histories of gestational diabetes (3.5% vs. 7.6%; P<0.001). Similarly, infants whose mothers initiated breast-feeding prior to hospital discharge were less likely to develop DM.
COMMENT: These findings highlight the importance of ensuring that maternity facilities follow “Baby-Friendly” best practices for supporting mothers who wish to breast-feed (“Ten Steps to Successful Breastfeeding,” available at http://www.unicef.org/newsline/tenstps.htm). Unfortunately, minority communities in the U.S. (which face the highest risk for diabetes) are least likely to have access to Baby-Friendly birthing facilities.
CITATION(S): Martens PJ et al. Breastfeeding initiation associated with reduced incidence of diabetes in mothers and offspring. Obstet Gynecol 2016 Nov; 128:1095. (http://dx.doi.org/10.1097/AOG.0000000000001689)
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Multidrug-Resistant Yeast Identified in U.S.
By Kelly Young, Edited by Susan Sadoughi, MD, and André Sofair, MD, MPH
Cases of multidrug-resistant Candida auris infection have been identified for the first time in the U.S., the CDC reports in MMWR. This follows a CDC alert this summer requesting that clinicians report any cases to their health departments. The invasive yeast has been reported on four other continents.
Based in part on a retrospective review of microbiology records, seven cases in four states from 2013 to 2016 were found. All of the affected patients had preexisting medical conditions, such as blood malignancies or brain tumor. Four patients died soon after C. auris was identified. Many of the isolates were resistant to multiple antifungals.
The agency cautions that the infections may have been transmitted in healthcare settings and that the pathogen may initially be misidentified as other Candida species.
The CDC advises healthcare workers to use standard and contact precautions in patients colonized or infected with C. auris.
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Neurology 2016 Oct 19
Does Aerobic Exercise Improve Cognitive Performance in Vascular Cognitive Impairment?
A preliminary study suggests that an aerobic exercise intervention may produce short-term improvement.
In this single-blind, randomized, controlled trial, the authors investigated whether aerobic exercise improved cognitive performance and activities of daily living in older adults with vascular cognitive impairment (VCI). VCI was clinically defined by the presence of small-vessel ischemic disease on neuroimaging and cognitive impairment. The intervention group underwent aerobic training in three 1-hour sessions a week for 6 months. The control group received usual care plus education about VCI and about a healthy diet. Primary outcomes were general cognitive performance based on the Alzheimer's Disease Assessment Scale–Cognitive subscale (ADAS-Cog), executive function, and activities of daily living. Secondary outcomes included general cardiovascular capacity, physical activity level, and physiologic markers. Outcomes were determined at baseline, post-intervention, and 12-months (i.e., 6 months post-intervention).
Seventy participants (mean age, 74) were randomized. The intervention group had a small, statistically significant improvement in ADAS-Cog scores after the intervention but not at the 12-month follow-up assessment. The intervention and control groups did not differ significantly in executive function or activities of daily living. General cardiovascular capacity measured by the 6-Minute Walk Test and resting diastolic blood pressure improved in the aerobic exercise group post-intervention, but results were not sustained at the 12-month assessment. Adverse effects included non-syncopal falls in three participants, two of these during aerobic training.
COMMENT; This study provides preliminary data that aerobic exercise may lead to short-term improvements in general cognitive performance, general cardiovascular capacity, and resting diastolic blood pressure in patients with vascular cognitive impairment. Ensuring compliance and maintenance of a thrice-weekly aerobic exercise program may lead to more long-term benefits.
CITATION(S): Liu-Ambrose T et al. Aerobic exercise and vascular cognitive impairment: A randomized controlled trial.Neurology 2016 Oct 19; [e-pub]. (http://dx.doi.org/10.1212/WNL.0000000000003332)
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Lancet 2016 Oct 24
Obesity Screening and Brief Physician Intervention Can Lead to Weight Loss
Referral to group support was somewhat effective and took about 30 seconds of physicians' time.
Guidelines recommend that physicians screen for obesity and refer patients to effective weight-loss programs. Researchers in England screened adults in 57 primary care practices for obesity (body-mass index, ≥30 kg/m2) and enrolled 1882 obese patients seeking care for other problems; participants were randomized to receive physician advice to lose weight (the “advice” group) or to receive a referral to a free weight-loss program consisting of 12 weekly 1-hour group sessions (the “support” group). Such programs are available throughout the U.K. but are underutilized. Physicians were trained to take no more than 30 seconds to deliver advice or offer group support; initial appointments were arranged immediately for patients who accepted group support.
Forty percent of patients in the “support” group attended at least one group-support session, compared with 9% of those in the “advice” group (who presumably referred themselves). At 1 year, mean weight loss was 2.4 kg among support patients and 1.0 kg among advice patients; 25% of support patients and 14% of advice patients lost ≥5% of baseline weight, and 12% and 6%, respectively, lost ≥10% of baseline weight. All between-group differences were statistically significant. Most patients thought the screening and interventions were appropriate and helpful.
COMMENT: The authors suggest that an annual brief intervention like that studied here could substantially lower the population prevalence of diabetes, hypertension, and heart disease. Such an intervention is far less costly than pharmaceutical management, and the brief physician role clearly is feasible. Public and private payers in the U.S. should take heed.
CITATION(S): Aveyard P et al. Screening and brief intervention for obesity in primary care: A parallel, two-arm, randomised trial. Lancet 2016 Oct 24; [e-pub]. (http://dx.doi.org/10.1016/S0140-6736(16)31893-1)
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Aliment Pharmacol Ther 2016 Nov; 44:976
A Low-Carbohydrate/High-Fat Diet for GERD?
Obese women following an individualized diet had complete resolution of gastroesophageal reflux disease symptoms and discontinuation of GERD medications after 10 weeks.
Although dietary management of gastroesophageal reflux disease (GERD) is not supported in current guidelines, some data suggest that consumption of a low-carbohydrate/high-fat diet can resolve or significantly reduce GERD symptoms.
To examine that hypothesis, researchers examined carbohydrate intake and insulin resistance in 144 obese women who underwent a 16-week low-carbohydrate/high-fat diet, including 42 women with GERD at baseline. Participants received instructions and a 14-day menu plan individualized to calculated resting energy expenditure. Carbohydrates (total and simple) were balanced by menu planning, as were fats (saturated, monounsaturated, polyunsaturated), which were provided in preportioned containers at weekly clinic visits.
Women with GERD experienced significantly greater decreases in dietary intake of total sugars, available carbohydrate, sucrose, glycemic load, and insulin resistance compared with the non-GERD group. These reductions were significantly greater in European-American versus African-American women, particularly the decline in insulin resistance, which was three times greater in European-Americans. All women had lasting resolution of GERD symptoms and discontinuation of GERD medication by week 10.
COMMENT: These provocative findings support a balanced high-fat/low-carbohydrate diet in patients with GERD. Notable outcomes include the universal discontinuation of GERD medications and impressive improvement in glycemic control. However, the substantial weight loss achieved (averaging about 6 kg [13 pounds] during 16 weeks) makes it difficult to be certain that the outcomes were due to diet alone. Also, as the intervention involved carefully balanced dietary calculations and menus, the results may not be easily replicable. Further research is needed, but it seems reasonable to recommend at least limiting dietary simple carbohydrates in patients with GERD.
CITATION(S): Pointer SD et al. Dietary carbohydrate intake, insulin resistance and gastro-oesophageal reflux disease: A pilot study in European- and African-American obese women. Aliment Pharmacol Ther 2016 Nov; 44:976.

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Gastroenterology 2016 Oct 14
Monitoring Disease Activity in Inflammatory Bowel Disease
Clinicians should be aware of intense monitoring protocols being recommended by thought leaders in IBD.
In a review on monitoring disease activity in inflammatory bowel disease (IBD), the following are some key clinical points:

COMMENT: This level of monitoring is considerably more intense than I and most of my stable patients with IBD are used to, and possibly more than many stable patients would accept. The approach of treat to target is based on sound observation, as so-called deep remission (endoscopic healing) predicts a lower risk for clinical relapse. This observation has been extended to the concept that asymptomatic patients with active endoscopic disease should have treatment intensified until endoscopic healing occurs. Though logical, that has not yet been proven to be the most effective, cost-effective, and patient-accepted approach. In my view, all clinicians managing patients with IBD should be aware of these intense monitoring protocols that are being recommended by thought leaders so that we can discuss these protocols with patients, particularly at the time of new diagnosis and surgical resection in CD.
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):Panes J et al. Advances in use of endoscopy, radiology, and biomarkers to monitor inflammatory bowel diseases. Gastroenterology 2016 Oct 14; [e-pub].
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Lancet 2016 Oct 7
Stapled or Excisional Hemorrhoidectomy for Severe Hemorrhoids?
Use excisional hemorrhoidectomy for disease too advanced for rubber band ligation therapy.
Excisional hemorrhoidectomy for advanced hemorrhoids is considered a painful procedure, which has led to development of alternative approaches. One of these is stapled hemorrhoidopexy, which involves excision of a rim of tissue above the internal hemorrhoids with re-anastomosis of the mucosa using staples. This operation is sometimes endorsed for being less painful than excisional hemorrhoidectomy.
In a randomized, controlled trial in the U.K., researchers compared outcomes with excisional hemorrhoidectomy versus stapled hemorrhoidopexy in 777 patients with grade 2, 3, or 4 hemorrhoids (22%, 63%, and 15%, respectively).
In the first few weeks after hemorrhoidectomy, quality of life was better in patients with the stapling procedure, but after 6 weeks it was better with excisional hemorrhoidectomy. Symptoms returned in 32% in the stapling group versus 14% in the excisional group. Continence scores and tenesmus were both worse in the stapling group. Serious adverse events occurred in 9% in the excisional group versus 7% with the stapled hemorrhoidopexy.
COMMENT:This study indicates that excisional therapy is dominant over stapled hemorrhoidopexy for treatment of grades 2–4 hemorrhoids. Patients with grades 2–3 hemorrhoids are often treated with rubber banding, and in a parallel study involving patients with grades 1–3 hemorrhoids, rubber banding was superior to hemorrhoidal artery ligation. Considering all available data, it seems reasonable to still consider thermal treatments such as infrared coagulation or bipolar treatment for very early grade hemorrhoids, but otherwise treatment should be dominated by rubber band ligation and excisional hemorrhoidectomy for disease too advanced for rubber band ligation.
CITATION(S): Watson AJM et al. Comparison of stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease (eTHoS): A pragmatic, multicentre, randomised controlled trial. Lancet 2016 Oct7; [e-pub].
Bach SP and Fearnhead NS.eTHoS piles pressure on haemorrhoidopexy. Lancet 2016 Oct 7; [e-pub].
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Gastroenterology 2016 Oct 5
A Single-Pill Regimen for Chronic HCV Infection in Treatment-Experienced Patients
Elbasvir/grazoprevir was effective, with or without ribavirin, in patients with chronic hepatitis C virus infection who had previously received interferon-based therapy.
In January 2016, the FDA approved a single-pill regimen — elbasvir/grazoprevir (EBR/GZR; Zepatier) — to treat adults with chronic hepatitis C virus (HCV) genotypes 1 and 4 infection. In an industry-funded, multinational, open-label phase III trial, researchers randomized 420 HCV-infected patients (genotypes 1, 4, and 6) who had previously been treated with peginterferon/ribavirin (PEG/RBV) to receive daily elbasvir (50 mg)/grazoprevir (100 mg), with or without twice-daily RBV, for 12 or 16 weeks. Of the cohort, 35% had cirrhosis and 64% were previous null or partial responders to PEG/RBV.
Rates of sustained virologic response (SVR) at 12 weeks posttreatment (the primary endpoint) ranged from 92% for 12 weeks of EBR/GZR without RBV to 98% for 16 weeks of EBR/GZR with RBV. Adding ribavirin to 12 weeks of therapy did not significantly improve the primary endpoint, nor did extending therapy to 16 weeks (except possibly in genotype 1a patients who had an NS5A resistance-associated variant). In subgroup analyses, SVR rates were 100% at 12 weeks for all patients who had genotype 1b HCV infection and for all patients with prior PEG/RBV relapse.
COMMENT: This trial documents the high overall efficacy of elbasvir/grazoprevir, with or without ribavirin, in patients with chronic HCV genotypes 1, 4, and 6 infection who had previously received interferon-based therapy. Extending treatment from 12 to 16 weeks, adding ribavirin, or both appear to add little to the benefit (with a possible exception in a subset of genotype 1a patients). Overall, these findings are similar to previous results in treatment-naive patients, suggesting that previous failure of interferon-based treatment generally does not mean that a newer HCV therapy will be ineffective.
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): Kwo P et al. Effectiveness of elbasvir and grazoprevir combination, with or without ribavirin, for treatment-experienced patients with chronic hepatitis C infection. Gastroenterology 2016 Oct 5; [e-pub]. (http://dx.doi.org/10.1053/j.gastro.2016.09.045)
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Gastroenterology 2016 Sep 14
Do PPIs Protect Against Upper GI Bleeding in Patients Taking Warfarin?
Proton-pump inhibitors reduced upper gastrointestinal bleeding, but by a significant amount only in patients also taking NSAIDs or antiplatelet agents.
Proton-pump inhibitors (PPIs) reduce the risk for upper gastrointestinal bleeding (UGIB) in patients taking nonsteroidal anti-inflammatory drugs (NSAIDs) and antiplatelet agents (APAs). To assess the impact of PPIs on bleeding in patients taking warfarin, investigators performed a retrospective cohort study involving 97,430 patients in the Tennessee Medicaid database and the 5% National Medicare sample who were newly prescribed warfarin.
Analysis of 75,720 patient-years of follow-up data showed the following:

The authors conclude that PPIs reduce hospitalizations for UGIB by 24% overall in patients taking warfarin, but significantly reduce this rate only in patients also taking NSAIDs or APAs.
COMMENT: This large study combining data from two databases emphasizes the impact of PPI use in patients taking NSAIDs and APAs while also taking warfarin. PPIs are indicated in this setting to reduce bleeding and hospitalization. The nonsignificant trend toward reduced UGIB in the absence of NSAIDs or APAs suggests a possible effect of smaller magnitude, but requires additional study.
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): Ray WA et al. Association of proton pump inhibitors with reduced risk of warfarin-related serious upper gastrointestinal bleeding. Gastroenterology 2016 Sep 14; [e-pub].
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Pharmacol Ther 2016 Sep 15
Proton Pump Inhibitors Linked to Fundic Gland Polyps
PPI use has an association with FGPs that increases with the duration of therapy.
Fundic gland polyps (FGPs) are a common incidental finding at upper endoscopy. An association between FGPs and the use of proton pump inhibitors (PPIs) has long been suggested, but good data have been lacking.
To further explore the potential link between FGPs and PPIs, investigators in Australia conducted a meta-analysis of 12 studies (involving 39,671 participants) that included data on the prevalence of FGPs in PPI users versus nonusers.
The number of FGPs was significantly greater in PPI users than in nonusers (odds ratio, 2.46; 95% confidence interval, 1.42–4.27). The association increased with duration of PPI use (OR, 4.71; 95% CI, 2.22–9.99 for ≥6 months of therapy, and OR, 5.32; 95% CI, 2.58–10.99 for ≥12 months of therapy). The authors conclude that PPI use is associated with an increased prevalence of FGPs and that this association increases with the duration of PPI therapy.
COMMENT: The authors note that the quality of the studies available for analysis was variable and heterogeneous. Nonetheless, the findings support the general assumption that there is a link between PPI use and FGPs, although this association does not prove causation, nor does it address possible underlying mechanisms. A more important question is whether or not the association has any clinical significance or caries any risk for patients taking PPIs. In the absence of a genetic predisposition (e.g., APC gene mutation), the risk for dysplastic transformation in FGPs is very low. Because years of experience suggest that the relationship between PPIs and FGPs is benign, formal studies with long-term follow-up to verify this assumption have not been performed.
CITATION(S): Martin FC et al. Systematic review with meta-analysis: Fundic gland polyps and proton pump inhibitors.Aliment Pharmacol Ther 2016 Sep 15; [e-pub].

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