It hasn’t received a lot of media attention but on Tuesday the FDA approved an expansion of the canagliflozin (Invokana, Janssen) label to include a reduction in the risk of heart attack, stroke, or CV death in adults with type 2 diabetes and established CV disease. Canagliflozin, an oral SGLT2 inhibitor, thus becomes the third…
Moment Of Truth For Struggling And Expensive Cholesterol Drugs
February 15, 2018 by 7 Comments
It will be the moment of truth for the expensive new cholesterol drugs known as PCSK9 inhibitors. Next month we will learn much more about the PCSK9 inhibitor class of cholesterol drugs. A lot of the remaining uncertainty about the efficacy— or lack of efficacy— of these drugs will be resolved when a large cardiovascular…
27,000 Patient PCSK9 Inhibitor Trial Meets Main Endpoints
February 2, 2017 by 3 Comments
(Updated) –Cardiovascular outcomes finally available for PCSK9 inhibitors. Amgen announced on Thursday afternoon that the FOURIER trial had met both its primary composite endpoint (cardiovascular death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina or coronary revascularization) and the even more rigorous key secondary composite endpoint (cardiovascular death, non-fatal MI or non-fatal stroke). The company…
Pfizer Ends Development Of Its PCSK9 Inhibitor
November 1, 2016 by 1 Comment
–Immune issues and diminishing efficacy doomed the new drug. Pfizer announced on Tuesday that it was discontinuing development of bococizumab, its cholesterol-lowering PCSK9 inhibitor under development. “The totality of clinical information now available for bococizumab, taken together with the evolving treatment and market landscape for lipid-lowering agents, indicates that bococizumab is not likely to provide…
Prominent Cardiologists Decry Tepid Support For Empagliflozin By Endocrinologists
July 5, 2016 by 1 Comment
At the FDA advisory panel empagliflozin enjoyed strong support from the cardiologists and statisticians but not from the endocrinologists. An FDA advisory panel last week turned out to be a much more contentious and divided than many had expected. Based on the FDA’s own analysis of last year’s Empa-Reg Outcome trial I had predicted that the…
Empagliflozin May Be Poised To Gain CV Indication
June 24, 2016 by Leave a Comment
–FDA reviewers have raised no major questions ahead of Tuesday’s advisory panel meeting. The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will likely lend its support to an important new expanded indication for empagliflozin (Jardiance, Boehringer Ingelheim). The new indication is to reduce the risk of all-cause mortality by reducing the incidence of cardiovascular death,…
Clinical Trial Expert’s Deep Dive Into The Important New Liraglutide Trial
June 13, 2016 by Leave a Comment
–Sanjay Kaul plunges into the LEADER data pool There will be a lot of discussion in the near future about the LEADER trial, the large new trial assessing cardiovascular outcomes with liraglutide (Victoza, Novo Nordisk). The trial is the latest in a series of large CVOTs with new diabetes drugs showing benefit— or at least…
First PCSK9 Outcome Trial Results Pushed Back To 2017
June 8, 2016 by Leave a Comment
Uptake of the new drugs likely to lag without strong outcomes data. Uptake of the new drugs likely to lag without strong outcomes data.Uptake of the new drugs likely to lag without strong outcomes data. (Updated) –Uptake of the new drugs likely to lag without strong outcomes data. There’s probably nothing more eagerly awaited in…
Orexigen Terminates Another Cardiovascular Outcomes Trial
April 13, 2016 by Leave a Comment
Updated–In a further sign of the chaos surrounding its weight loss drug Contrave, Orexigen has again terminated an FDA-mandated cardiovascular outcomes trial with the drug. Following a year of controversy (see below) Orexigen last month assumed sole control of Contrave (the combination of naltrexone and bupropion) from its former partner, Takeda. The company has now terminated enrollment…
Controversial, Ill-Fated Obesity Drug Trial Published In JAMA
March 8, 2016 by Leave a Comment
The final– but now largely useless– results of the cardiovascular safety trial of the obesity drug Contrave have now been published in JAMA, one year after the trial’s dramatic and scandalous crash and burn. By way of background: Contrave is a combination of naltrexone and bupropion marketed as a weight loss drug by Orexigen and…
Top Line Results Favor Victoza In Large Cardiovascular Outcomes Trial
March 4, 2016 by Leave a Comment
Novo Nordisk today announced top-line positive results of the LEADERS trial, the cardiovascular outcomes trial testing its diabetes drug Victoza (liraglutide). Liraglutide is a GLP-1 inhibitor used to help achieve glucose control in patients with type 2 diabetes. 9,340 people with type 2 diabetes were randomized to liraglutide or placebo in LEADERS for 3.5 –…
Sanjay Kaul On The Empa-Reg Outcome Study
September 17, 2015 by 1 Comment
The really big medical news today is the publication of the highly anticipated Empa-Reg Outcome study in the New England Journal of Medicine. It is the first large clinical trial with a diabetes drug (empagliflozin, Jardiance) to demonstrate a significant reduction in cardiovascular outcomes. The trial even resulted in a surprising, statistically significant reduction in mortality. I asked Sanjay Kaul for…
Recent Comments