CardioExchange Archive

December 20th, 2012

HPS2-THRIVE: No Benefit, Signal of Harm for Niacin Therapy

Larry Husten, PHD

The largest-ever study of niacin has failed to show a clinical benefit of niacin and even found a strong signal of harm. Merck announced today that the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study did not meet its primary endpoint. In that study, the combination of a statin and Merck’s niacin compound, Tredaptive, a combination of extended-release niacin and […]

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December 19th, 2012

Pradaxa To Be Contraindicated in Patients with Mechanical Heart Valves

Larry Husten, PHD

Boehringer Ingelheim is starting to inform physicians about a new contraindication for its oral anticoagulant drug Pradaxa (dabigatran). The company has told investigators in trials utilizing dabigatran that it will shortly be sending a “Dear Doctor Letter,” also known as a Direct Healthcare Professional Communication (DHPC), to healthcare professionals. The letter will inform physicians that, […]

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December 18th, 2012

Promising One-Year Results for Renal Denervation in Resistant Hypertension

Larry Husten, PHD

Denervation of the renal sympathetic nerve may become an important new tool in the fight against resistant hypertension.  Previously, the main results of the Symplicity HTN-2 trial demonstrated that in selected patients renal denervation resulted in a large and highly significant reduction in systolic blood pressure (BP) at six months. Now, longer followup from the trial, published in Circulation, […]

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December 18th, 2012

Amgen Pleads Guilty to Misbranding Anemia Drug Aranesp

Larry Husten, PHD

Biotechnology giant Amgen today pleaded guilty in federal court to a misdemeanor charge of misbranding Aranesp (darbepoetin alfa), its highly successful anemia drug. The government accused Amgen of marketing Aranesp for indications not approved by the FDA and other illegal marketing practices. The judge deferred a decision on the plea until Wednesday. When the final settlement is announced further details about […]

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December 17th, 2012

New Guidelines Define State-of-the-Art STEMI Care

Larry Husten, PHD

New guidelines published online today in Circulation and the Journal of the American College of Cardiology provide an efficient overview of the best treatments for STEMI patients. (Available for download are PDFs of the full version [64 pages] or the executive summary  [27 pages] of the 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction.) “We’re looking to a future where more patients […]

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December 14th, 2012

CHMP Recommends Against Approval for Mipomersen in Europe

Larry Husten, PHD

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency today recommended that mipomersen (Kynamro; Isis and Genzyme) not be approved for use in Europe. The novel antisense oligonucleotide works by inhibiting the synthesis of apolipoprotein-B and is under development in the United States and Europe for the treatment of familial hypercholesterolemia. CHMP […]

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December 13th, 2012

Hypertension And Smoking Top List Of Global Risk Factors

Larry Husten, PHD

Worldwide, hypertension and tobacco smoking are the single largest causes of death and disability, according to findings from the Global Burden of Disease Study 2010 (GBD 2010), the largest ever assessment and analysis of global health and disease. In an unprecedented move, the Lancet devoted an entire issue to the study, including seven separate articles and eight comments. GBD 2010 […]

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December 12th, 2012

FDA: Small, Nonsignificant Risk from Chantix

Larry Husten, PHD

The FDA today updated its safety review of the smoking cessation drug varenicline (Chantix, Pfizer). A large meta-analysis, which the FDA had required Pfizer to perform, found a higher rate of major adverse cardiovascular events (MACE) in patients taking varenicline than in patients taking placebo. However, the increase in risk was very small and did not achieve statistical significance. […]

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December 12th, 2012

State of the Heart: AHA Publishes Year-End Statistical Update

Larry Husten, PHD

Although deaths from cardiovascular disease have been declining for many years, continued progress is threatened by disturbing trends in U.S. lifestyles. That’s the clear message from the American Heart Association’s year-end report, “Heart Disease and Stroke Statistical Update 2013,” published in Circulation. “Americans need to move a lot more, eat healthier and less, and manage risk […]

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December 12th, 2012

Boehringer Ends Phase 2 Trial of Dabigatran in Mechanical Valve Patients

Larry Husten, PHD

Boehringer Ingelheim today announced that it had discontinued a phase 2 trial of its anticoagulant drug dabigatran (Pradaxa) in patients with mechanical heart valves. As reported here in October, the company had previously terminated one arm of the study after an interim review of the data by the trial’s Data Safety Monitoring Board. The RE-ALIGN trial was an open-label, 12-week randomized comparison of […]

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