April 19, 2016, Vol 315, No. 15, Pages 1539-1672

In This Issue of JAMA

Highlights

Abstract Full Text

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JAMA. 2016;315(15):1539-1541. doi:10.1001/jama.2015.14214

Audio Editors' Summary: PCSK9 inhibitors and statin intolerance, pembrolizumab for melanoma, CDC opioid prescribing guideline, and more

Original Investigation

Efficacy and Tolerability of Evolocumab vs Ezetimibe in Patients With Muscle-Related Statin Intolerance: The GAUSS-3 Randomized Clinical Trial

Steven E. Nissen, MD; Erik Stroes, MD, PhD; Ricardo E. Dent-Acosta, MD; et al.

Abstract Full Text

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JAMA. 2016;315(15):1580-1590. doi:10.1001/jama.2016.3608

This 2-stage randomized clinical trial compared lipid-lowering efficacy of 2 nonstatin therapies, ezetimibe and evolocumab, among patients with uncontrolled low-density lipoprotein cholesterol levels and intolerance to 2 or more statins.

Editorial
PCSK9 Inhibitors for Statin Intolerance?
David D. Waters, MD; Priscilla Y. Hsue, MD; Sripal Bangalore, MD, MHA

Effect of Losmapimod on Cardiovascular Outcomes in Patients Hospitalized With Acute Myocardial Infarction: A Randomized Clinical Trial

Michelle L. O’Donoghue, MD, MPH; Ruchira Glaser, MD, MSCE; Matthew A. Cavender, MD; et al.

Abstract Full Text

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JAMA. 2016;315(15):1591-1599. doi:10.1001/jama.2016.3609

This randomized trial evaluates the efficacy and safety of losmapimod vs placebo on cardiovascular outcomes in patients hospitalized with an acute myocardial infarction (MI).

Association of Pembrolizumab With Tumor Response and Survival Among Patients With Advanced Melanoma

Antoni Ribas, MD, PhD; Omid Hamid, MD; Adil Daud, MD; et al.

Abstract Full Text

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JAMA. 2016;315(15):1600-1609. doi:10.1001/jama.2016.4059

This study pools patient cohorts from randomized and nonrandomized studies to investigate associations between pembrolizumab therapy and tumor response among patients with advanced melanoma with and without prior ipilimumab therapy.

Audio Author Interview: Pembrolizumab, Tumor Response, and Survival in Advanced Melanoma

Editorial
PD-1 Blockade in Melanoma: A Promising Start, but a Long Way to Go
Shailender Bhatia, MD; John A. Thompson, MD

Preliminary Communication

Safety and Immunogenicity of Novel Adenovirus Type 26– and Modified Vaccinia Ankara–Vectored Ebola Vaccines: A Randomized Clinical Trial

Iain D. Milligan, MRCP; Malick M. Gibani, MRCP; Richard Sewell, BA; et al.

Abstract Full Text

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JAMA. 2016;315(15):1610-1623. doi:10.1001/jama.2016.4218

This phase 1 randomized clinical trial investigated the safety and tolerability of 2 vaccines against Ebola virus: an adenovirus type 26 vector vaccine encoding Ebola glycoprotein (Ad26.ZEBOV) and a modified vaccinia Ankara vector vaccine encoding glycoproteins from Ebola virus, Sudan virus, Marburg virus, and Tai Forest virus nucleoprotein (MVA-BN-Filo).

Research Letter

Opioid Prescribing After Surgical Extraction of Teeth in Medicaid Patients, 2000-2010

James A. Baker, BS; Jerry Avorn, MD; Raisa Levin, MS; et al.

Abstract Full Text

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JAMA. 2016;315(15):1653-1654. doi:10.1001/jama.2015.19058

This study examines the frequency of opioid prescriptions filled within 7 days of extraction among Medicaid patients.

Editorial
The CDC Guideline on Opioid Prescribing: Rising to the Challenge
Yngvild Olsen, MD, MPH

Opioids Prescribed After Low-Risk Surgical Procedures in the United States, 2004-2012

Hannah Wunsch, MD, MSc; Duminda N. Wijeysundera, MD, PhD; Molly A. Passarella, MS; et al.

Abstract Full Text

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JAMA. 2016;315(15):1654-1657. doi:10.1001/jama.2016.0130

This study assesses trends in the amount of hydrocodone/acetaminophen and oxycodone/acetaminophen prescribed for postoperative pain management.

Editorial
The CDC Guideline on Opioid Prescribing: Rising to the Challenge
Yngvild Olsen, MD, MPH

Special Communication

CDC Guideline for Prescribing Opioids for Chronic Pain—United States, 2016

Deborah Dowell, MD, MPH; Tamara M. Haegerich, PhD; Roger Chou, MD

Abstract Full Text

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JAMA. 2016;315(15):1624-1645. doi:10.1001/jama.2016.1464

This guideline from the Centers for Disease Control and Prevention makes 12 recommendations to improve communication about opioids for chronic pain, to improve the safety and effectiveness of pain treatment, and to reduce risks associated with long-term opioid therapy.

Audio: Opioid Prescribing: Rising to the Challenge

Editorial
The CDC Guideline on Opioid Prescribing: Rising to the Challenge
Yngvild Olsen, MD, MPH
Zero Pain Is Not the Goal
Thomas H. Lee, MD, MSc
The Potential Impact on Children of the CDC Guideline for Prescribing Opioids for Chronic Pain: Above All, Do No Harm
Neil L. Schechter, MD; Gary A. Walco, PhD
Seeking Balance Between Pain Relief and Safety: CDC Issues New Opioid-Prescribing Guidelines
William Renthal, MD, PhD
Opioid Prescribing for Chronic Pain: Not for the Faint of Heart
Mitchell H. Katz, MD
Striving for Safe, Effective, Affordable Care for Cancer Survivors With Chronic Pain: Another Kind of Moonshot
Michael J. Fisch, MD, MPH; Victor T. Chang, MD

Viewpoint

Managing the Risks of Concurrent Surgeries

Michelle M. Mello, JD, PhD; Edward H. Livingston, MD

Abstract Full Text

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JAMA. 2016;315(15):1563-1564. doi:10.1001/jama.2016.2305

This View Point presents the practice of concurrent surgeries, calls for 3 steps to regulate the practice, and advocates more direct communication with patients about the practice.

Audio Clinical Review: Is It Safe? What Happens When Your Surgeon Is Not Actually Doing Some of Your Operation?

Updating the Toxic Substances Control Act to Protect Human Health

Leonardo Trasande, MD, MPP

Abstract Full Text

JAMA. 2016;315(15):1565-1566. doi:10.1001/jama.2016.2037

This Viewpoint attempts to explain flaws in bills from both houses of Congress to update the Toxic Substances Control Act for the first time in 40 years.

Pharmacist-Prescribed Birth Control in Oregon and Other States

Y. Tony Yang, ScD, LLM, MPH; Katy B. Kozhimannil, PhD, MPA; Jonathan M. Snowden, PhD

Abstract Full Text

JAMA. 2016;315(15):1567-1568. doi:10.1001/jama.2016.2327

This Viewpoint discusses new laws that improve women’s access to contraceptives and the ways that critics say the laws fall short.

A Piece of My Mind

Sins of the Fathers

Jeffrey Walden, MD

Abstract Full Text

JAMA. 2016;315(15):1569-1570. doi:10.1001/jama.2016.0024

Editorial

PCSK9 Inhibitors for Statin Intolerance?

David D. Waters, MD; Priscilla Y. Hsue, MD; Sripal Bangalore, MD, MHA

Abstract Full Text

JAMA. 2016;315(15):1571-1572. doi:10.1001/jama.2016.3670

PD-1 Blockade in Melanoma: A Promising Start, but a Long Way to Go

Shailender Bhatia, MD; John A. Thompson, MD

Abstract Full Text

JAMA. 2016;315(15):1573-1575. doi:10.1001/jama.2016.4012

This Editorial discusses the use of PD-1 blockade in treating patients with metastatic melanoma in the KEYNOTE-1 trial.

Zero Pain Is Not the Goal

Thomas H. Lee, MD, MSc

Abstract Full Text

JAMA. 2016;315(15):1575-1577. doi:10.1001/jama.2016.1912

The CDC Guideline on Opioid Prescribing: Rising to the Challenge

Yngvild Olsen, MD, MPH

Abstract Full Text

JAMA. 2016;315(15):1577-1579. doi:10.1001/jama.2016.1910

JAMA Guide to Statistics and Methods

Interpretation of Clinical Trials That Stopped Early

Kert Viele, PhD; Anna McGlothlin, PhD; Kristine Broglio, MS

Abstract Full Text

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JAMA. 2016;315(15):1646-1647. doi:10.1001/jama.2016.2628

This JAMA Guide to Statistics and Methods discusses how to interpret the results of clinical trials that are stopped early based on formal, prespecified stopping rules.

Audio: JAMA Guide to Statistics and Methods

JAMA Clinical Challenge

Pancytopenia in a Patient With Hypothyroidism

Brandon McMahon, MD; Suneel Kamath, MD

Abstract Full Text

JAMA. 2016;315(15):1648-1649. doi:10.1001/jama.2016.2155

A 25-year-old woman with hypothyroidism presented with recent fatigue and weight loss. A peripheral blood smear and bone marrow biopsy showed megaloblastic changes; laboratory analysis showed pancytopenia and elevated levels of lactate dehydrogenase and vitamin B₁₂. What would you do next?

Medical News & Perspectives

Researchers Turn to Canine Clinical Trials to Advance Cancer Therapies

Julie A. Jacob, MA

Abstract Full Text

JAMA. 2016;315(15):1550-1552. doi:10.1001/jama.2016.0082

This Medical News & Perspectives article explores how the study of naturally occurring cancers in pet dogs is helping advance cancer research for humans.

News From the Food and Drug Administration