Follow me on twitter @drportnay for daily thoughts, comments on recent news items and retweets

Tuesday, October 27, 2015

Anti-Inflammatory Flops in Acute MI

Anti-Inflammatory Flops in Acute MI | Medpage Today
Not all new medicines work out. Even though the science behind them may be sound and preliminary studies may show safety. When put to the test, they sometimes fail to show a benefit. 

Patients routinely talk to me about the price of medications. The development and testing of medications is staggering. When I see a negative study such as this, I am reminded about just how much money GlaxoKlineSmith has already placed in this drug's development - only to have it be shown not to work. 

I hope you find this interesting

Anti-Inflammatory Flops in Acute MI

The novel anti-inflammatory agent losmapimod failed to improve heart attack outcomes, GlaxoSmithKline announced in top-line results for the LATITUDE-TIMI 60 trial.

The p38 MAP kinase inhibitor did not reduce the primary composite endpoint of cardiovascular death, myocardial infarction, or severe recurrent ischemia requiring urgent coronary artery revascularization at an interim analysis.

The findings came from part A of the phase III trial, with 3,503 ST-segment or non-ST-segment elevation myocardial infarction (STEMI or NSTEMI) patients, designed to support a larger part B with more than 20,000 additional patients.

While the part A results will be presented in full at an upcoming scientific meeting, the second portion of the trial will be scrapped, GlaxoSmithKline said.

The subset of STEMI patients did show reductions of 30% to 50% in prespecified endpoints of cardiovascular death, heart failure hospitalization, and the composite of the two, but these did not reach statistical significance because of small numbers of events. GSK said it would consider that option for future development, although some industry observers such as FierceBiotech were skeptical.

Losmapimod's p38 MAP kinase target is "associated with the acute inflammation and cellular injury that occurs in the blood vessels and in the heart during and immediately after an acute coronary syndrome," the company noted in a press release.

No comments:

Post a Comment