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Muscle-related statin intolerance is reported by 5% to 20% of patients taking statins. In a randomized trial that enrolled 511 adults with uncontrolled low-density lipoprotein cholesterol (LDL-C) levels and a history of muscle-related intolerance to statins, Nissen and colleagues compared the lipid-lowering efficacy of 2 nonstatin therapies—evolocumab (a protein convertase subtilisin/kexin type 9 inhibitor; PCSK9) and ezetimibe. The authors report that compared with ezetimibe treatment, evolocumab use resulted in greater reduction in LDL-C levels after 24 weeks. In an Editorial, Waters and colleagues discuss use of PCSK9 inhibitors in patients with statin intolerance.
Continuing Medical Education
Activation of p38 mitogen-activated protein kinase (MAPK) is implicated in inflammation and cell death. O’Donoghue and colleagues assessed the efficacy of losmapimod—a p38 MAPK inhibitor—in a multicenter randomized placebo-controlled trial involving 3503 patients hospitalized with acute myocardial infarction (MI). The authors report that use of losmapimod compared with placebo did not reduce the risk of major ischemic cardiovascular events—a composite of cardiovascular death, MI, or severe recurrent ischemia leading to urgent coronary revascularization.
Pembrolizumab—a monoclonal antibody against programmed cell death protein 1 (PD-1)—is an approved treatment for unresectable or metastatic melanoma. In an analysis of pooled data from 655 patients with advanced melanoma enrolled in clinical trials of pembrolizumab, Ribas and colleagues found that pembrolizumab administration was associated with an overall objective response rate of 33%, a 12-month progression-free survival rate of 35%, and a median overall survival of 23 months. In an Editorial, Bhatia and Thompson discuss PD-1 blockade in melanoma.
Author Video Interview
Clinical development of candidate Ebola vaccines has focused on a strategy of vector vaccine technology. Milligan and colleagues evaluated 2 candidate Ebola vaccines—an adenovirus-type 26 vector vaccine (Ad26.ZEBOV) and a modified Ankara vector vaccine (MVA-BN-Filo)—in a phase 1 clinical study involving 87 healthy adult volunteers. The authors report that vaccine recipients did not experience any vaccine-related serious adverse events. An immune response was observed following primary immunization with Ad26.ZEBOV, with sustained elevation of specific immunity following an MVA-BN-Filo booster.
The “CDC Guideline for Prescribing Opioids for Chronic Pain—United States, 2016” provides guidance for primary care clinicians treating adults with chronic pain—outside of active cancer treatment, palliative care, or end-of-life care. Dowell and colleagues summarize findings from the guideline evidence review and detail 12 key recommendations—intended to improve the safety and effectiveness of pain treatment and reduce the risks associated with long-term opioid therapy. Two editorials discuss challenges in the treatment of pain.
Editorials 1 and 2, Research Letter 1 and 2, and JAMA Patient Page
Author Audio Interviews and Continuing Medical Education
This JAMA Guide to Statistics and Methods article by Viele and colleagues discusses the interpretation of clinical trials terminated early—for success or futility—based on formal, prespecified stopping rules. Important considerations when interpreting results of trials stopped early include the trial design and quality of trial conduct, treatment safety, and results of secondary trial end points.
A 25-year-old woman who had recently initiated levothyroxine supplementation for hypothyroidism presented with fatigue and weight loss. Results of a complete blood cell count and findings on a peripheral blood smear and bone marrow biopsy were consistent with pancytopenia. Laboratory values included elevated vitamin B12 and low haptoglobin levels. What would you do next?
Highlights. JAMA. 2016;315(15):1539–1541. doi:10.1001/jama.2015.14214
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