Hopes that losmapimod would benefit patients after a STEMI heart attack were not borne out by a study reported today at the American College of Cardiology's meeting in Chicago, IL.
Investigators have recommended that a large efficacy trial of losmapimod to reduce major cardiovascular events in patients hospitalized after myocardial infarction would be a waste of time--at least in patients like the ones they have studied.
The drug, an anti-inflammatory that inhibits p38 mitogen-activated protein kinase, was hoped to reduce the rate of cardiovascular death, subsequent heart attack or the need for coronary revascularization. But but in a trial reported today at the American College of Cardiology's 65th Scientific Session & Expo in Chicago, IL, it did not meet its primary endpoint.
That substance is an enzyme present in heart muscle cells and other cell types. It is activated by stressors including a heart attack, but also by high blood pressure.
"Overall the results were neutral, showing no evidence of efficacy in our primary analysis," said Michelle O'Donoghue, MD, a cardiologist and investigator in the study, known as LATITUDE-TIMI 60.
O'Donoghue is a cardiologist at Brigham and Women's Hospital in Boston, MA.
However, she added "We did see intriguing signals toward there potentially being some efficacy in STEMI patients."
That would require a different study she said.
The trial, the largest losmapimod study to date, was a randomized double-blind study involving 3,500 patients at 322 hospital in 34 countries. Those who got the drug received 7.5 mg twice daily.and the others got a placebo.
After 12 weeks there was no difference in the rate of cardiovascular death, subsequent heart attack or urgent coronary revascularization in the treatment group vs. those on a placebo.
O'Donoghue said further study might show if there are other patients who might be helped by the drug. Taking the drug for more than 12 weeks might have had a different outcome she said.
The concept of targeting pathways related to inflammation remains valid, she noted.
The trial was funded by GlaxoSmithKline and the study was published in JAMA at the same time it was presented.