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Physicians: .25 AMA PRA Category I CreditsTM
Family Physicians: .25 Prescribed credits
Nurse Practitioners: .25 Contact hours

Release Date: August 6, 2014
Expiration Date: August 6, 2015

Estimated Completion Time: 15 minutes

There is no fee for this activity.

To Receive Credit

In order to receive your certificate of participation, you should read the information about this activity, including the disclosure statements, review the entire activity, take the post-test, and complete the evaluation form. You may then follow the directions to print your certificate of participation. To begin, click the CME icon above.

Program Overview

Learning Objectives

Upon successful completion of this educational program, the reader should be able to:

1. Discuss the significance of this article as it relates to your clinical practice.
2. Be able to apply this knowledge to your patient's diagnosis, treatment and management.

Faculty Information

Alan Ehrlich, MD
Assistant Clinical Professor in Family Medicine, University of Massachusetts Medical School, Worcester, Massachusetts, USA; Senior Deputy Editor, DynaMed, Ipswich, Massachusetts, USA

Michael Fleming, MD, FAAFP
Assistant Clinical Professor of Family Medicine and Comprehensive Care, LSU Health Science Center School of Medicine, Shreveport, Louisiana, USA; Assistant Clinical Professor of Family Medicine, Department of Family and Community Medicine, Tulane University Medical School, New Orleans, Louisiana, USA; Chief Medical Officer, Amedisys, Inc. & Antidote Education Company


Dr. Ehrlich, Dr. Fleming, DynaMed Editorial Team members, and the staff of Antidote Education Company have disclosed that they have no relevant financial relationships or conflicts of interest with commercial interests related directly or indirectly to this educational activity.

No commercial support has been received for this activity.

Accreditation Statements

ACCME: This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of Antidote Education Company and EBSCO Publishing. Antidote is accredited by the ACCME to provide continuing medical education for physicians. Antidote Education Company designates this enduring activity for a maximum of 0.25 AMA PRA Category 1 CreditsTM. Physicians should only claim credit commensurate with the extent of their participation in the activity.

AAFP: This enduring material activity, DynaMed EBM Focus Volume 9, has been reviewed and is acceptable for up to 15.25 Prescribed credits by the American Academy of Family Physicians. AAFP certification begins March 5, 2014. Term of approval is for one year from this date. Each EBM Focus is approved for .25 Prescribed credits. Credit may be claimed for one year from the date of each update. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

AANP: This program is approved for 0.25 contact hour(s) of continuing education by the American Association of Nurse Practitioners. This program was planned in accordance with AANP CE Standards and Policies and AANP Commercial Support Standards.

Program ID: 1405237L

DynaMed Careers

Looking for a change? The DynaMed editorial team is expanding and looking for talented and driven individuals. Visit the links below to learn about these exciting opportunities.

Section Editor of Specialty Content

Last week 793 journal articles were evaluated via DynaMed's Systematic Literature Surveillance and summaries of 181 articles were added to DynaMed content.

Based on criteria for selecting "articles most likely to change clinical practice," one article was selected by the DynaMed Editorial Team.

Addition of Extended-Release Niacin/Laropiprant to Statin-Based Therapy Increases Risk of Serious Adverse Events and Does Not Decrease Risk of Major Vascular Events in Patients With Vascular Disease
Reference: N Engl J Med 2014 Jul 17;371(3):203 (level 1 [likely reliable] evidence)

For several decades, observational studies have shown correlations between certain lipid markers and risk of major vascular events. Several of these markers have been evaluated as potential targets for the prevention or management of vascular disease. Niacin (also called nicotinic acid or vitamin B3) is an essential human nutrient that increases high density lipoprotein (HDL) cholesterol concentrations through several different mechanisms. Improvements in clinical outcomes in patients at risk of cardiovascular disease have been demonstrated with reduction in low density lipoprotein (LDL) cholesterol concentration. However, although increased HDL cholesterol concentrations are correlated with lower risk of vascular events in observational studies, it has remained unclear whether the addition of niacin to statin-based therapy actually helps decrease the risk of major vascular events. A recent large randomized trial evaluated the addition of a combination of niacin and laropiprant (a prostaglandin inhibitor used to prevent flushing) in patients with vascular disease receiving statin-based therapy.

A total of 42,424 patients aged 50-80 years with a history of myocardial infarction, cerebrovascular disease, peripheral arterial disease, or diabetes entered an unblinded run-in period with simvastatin followed by added ezetimibe if necessary until LDL cholesterol-lowering therapy was standardized, plus extended-release niacin/laropiprant. Afterwards, 25,673 patients without clinically significant adverse events during run-in continued statin therapy and were randomized to extended-release niacin/laropiprant 2 g/40 mg per day orally vs. placebo. The primary outcome was major vascular events, defined as a composite of nonfatal myocardial infarction, coronary-related death, stroke, and arterial revascularization. During median 3.9 years follow-up, the rate of major vascular events was 13.2% with extended-release niacin-laropiprant vs. 13.7% with placebo (not significant). In addition, extended-release niacin-laropiprant was associated with an increased rate of fatal or nonfatal serious adverse events compared to placebo (55.6% vs. 52.7%, p < 0.001, NNH 34). The increased serious adverse events with niacin/laropiprant included infections, gastrointestinal bleeding, disorders of glucose metabolism, and other events associated with gastrointestinal, respiratory, or musculoskeletal systems. Extended-release niacin-laropiprant was also associated with a nonsignificant increase in all-cause mortality compared to placebo (6.2% vs. 5.7%, p = 0.08).

The findings from this new trial are also consistent with those of the AIM-HIGH trial, which also found no reduction in vascular events with extended-release niacin compared to placebo in patients receiving statin therapy (N Engl J Med 2011 Dec 15;365(24):2255). Furthermore, this new trial showed that the use of combination niacin/laropiprant increases the rate of adverse events. In addition, the adverse event rate observed in this trial underestimates the true adverse event rate associated with treatment, since patients experiencing adverse events during the unblinded run-in period were excluded from the trial. It is noteworthy that many adverse events observed in the new trial, including infection and gastrointestinal bleeding, were not expected based on previous studies evaluating niacin such as AIM-HIGH, and may be associated with laropiprant as opposed to niacin itself. As well, it is noteworthy that in this trial, although niacin/laripoprant was associated with substantially increased HDL cholesterol concentrations, the baseline HDL cholesterol levels were not substantially below the normal threshold (about 44 mg/dL in each group). Thus the interpretation of these findings is less clear for patients with low or very low HDL cholesterol levels the population towards which niacin treatment is primarily targeted.

Collectively, the current evidence shows no evidence of benefit (through effects on HDL concentrations or otherwise) and an increased rate of adverse events with extended-release niacin in this patient population. Combination niacin/laropiprant has not been approved by the U.S. Food and Drug Administration, and has had its marketing authorization withdrawn by the European Medicines Agency based on the results of this new trial (EMA press release).

For more information see the Niacin topic in DynaMed.

Earn CME Credit for reading this e-Newsletter. For more information on this educational activity, see the CME sidebar.

EBSCO Health Launches Pediatric Clinical Information Mobile App

PEMSoft Now Available For iPhone, iPad, and Android Devices

A mobile app designed specifically for pediatricians, emergency department physicians, physicians-in-training and other medical providers caring for children with acute illnesses and injury, is now available from EBSCO Health, the leading provider of clinical decision support solutions for the healthcare industry.

Designed by pediatricians, emergency physicians and other medical specialists, PEMSoft is a pediatric evidence-based point-of-care medical reference tool for hospitals, emergency departments, clinics, pediatric group practices, transport services, and medical schools. The vast content in PEMSoft addresses the entire spectrum of neonatal, infant, child, adolescent and young adult health. PEMSoft authors adhere to a strict evidence-based editorial policy focused on systematic identification, evaluation and consolidation of practice-changing clinical literature.

The PEMSoft Mobile app includes explicit step-by-step emergency critical care procedures, information about common pediatric signs and symptoms and content covering pediatric injuries and management approaches. More than 3,000 evidence-based pediatric topics and a similar number of medical illustrations, clinical images and videos are also available via the mobile app.

The PEMSoft Mobile App is accessible from both Apple and Android devices.

For more information and technical support, visit the PEMSoft Mobile Access page.

Call for Peer Reviews

We are currently seeking subspecialty reviewers for our Patient Education Resource Center (PERC). PERC provides fact sheets and discharge instructions for patients leaving the hospital or emergency room. These hand-outs fulfill the meaningful use requirements for the Medicare & Medicare Services Incentive Programs.

Click here to speak with us about becoming a peer reviewer.

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