January 9th, 2013
Niacin Therapy in the Crossfire
William Edward Boden, MD and Harlan M. Krumholz, MD, SM
William E. Boden, lead investigator of the AIM-HIGH trial, and CardioExchange’s Harlan M. Krumholz debate the current state of research on niacin therapy.
January 8th, 2013
Two Retractions for Embattled Chief Investigator of KYOTO HEART Study
Larry Husten, PHD
The editor of Circulation Journal, the official journal of the Japanese Circulation Society (and not to be confused with the American Heart Association’s [AHA’s] better known Circulation) has announced the retraction of two substudies from the KYOTO HEART Study. The papers, according to the editor, “contain a number of serious errors in data analysis.” The announcement contained no additional information about […]
January 4th, 2013
Why Has Niacin Therapy Failed to THRIVE?
William Edward Boden, MD and John Ryan, MD
In the wake of HPS2-THRIVE, John Ryan asks William E. Boden, lead investigator of the AIM-HIGH trial, for his perspective on niacin and other HDL-modifying therapies.
January 3rd, 2013
Combination of Ezetimibe and Atorvastatin Back on FDA Approval Path
Larry Husten, PHD
A combination tablet containing the cholesterol-lowering drugs ezetimibe and atorvastatin is back on the path to possible FDA approval, according to Merck, which already markets Zetia (ezetimibe) and Vytorin, the combination of ezetimibe and simvastatin. Merck has repeatedly stumbled in its efforts to gain FDA approval of the proposed new drug, which has been dubbed “Son […]
December 26th, 2012
FDA Approves Lomitapide for Homozygous Familial Hypercholesterolemia
Larry Husten, PHD
Aegerion Pharmaceuticals said today that the FDA had approved lomitapide (Juxtapid) to help further lower cholesterol in patients with homozygous familial hypercholesterolemia. The approval comes with a box warning about the risk of hepatotoxicity and a Risk Evaluation and Mitigation Strategy (REMS) Program which will require certification of health care providers and pharmacies before the drug can be […]
December 25th, 2012
Autopsy Studies Find Dramatic Drop in Early Atherosclerosis Over the Past 60 Years
Larry Husten, PHD
Military service members who died during the past decade were far less likely to have atherosclerosis than service members who died in Korea or Vietnam, according to a new study published in JAMA. Although it is impossible to fully understand the causes and implications of the finding, the results provide powerful new evidence of a very […]
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 […]
December 20th, 2012
Is “Zapping the Kidneys” Miraculous?
Richard A. Lange, MD, MBA and L. David Hillis, MD
Renal denervation for resistant hypertension is generating a lot of excitement. In this blog, Rick Lange and David Hillis take stock of the evidence and the efforts underway to explore the potential scope of indications for the procedure.
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, […]
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 […]