New drug nets positive results
Treatment lowers heart risks
ORLANDO, Fla. — A newer cholesterol drug, used with older statin medicines, modestly lowered heart risks and deaths in a big study of heart attack survivors that might persuade insurers to cover the pricey treatment more often.
Results on the drug, Praluent, were announced yesterday at an American College of Cardiology conference in Florida. It’s the first time a cholesterol-lowering drug has reduced deaths since statins such as Lipitor and Crestor came out decades ago.
“It’s the ultimate outcome; it’s what matters to patients,” said study leader Dr. Philippe Gabriel Steg of Hospital Bichat in Paris.
But the benefit was small — 167 people would need to use Praluent for nearly three years to prevent a single death.
“That’s a high cost” that may still hinder its use, said one independent expert, Dr. Amit Khera, a preventive cardiologist at UT Southwestern Medical Center in Dallas and a spokesman for the American Heart Association.
The drug’s makers, Sanofi and Regeneron Pharmaceuticals, sponsored the study and said they would work with insurers on pricing to get the medicine to those who need it the most.
Doctors focus on lowering LDL, or bad cholesterol, to prevent heart problems. Statins are the main class of medicines for this, but some people can’t tolerate or get enough help from them.
Praluent and a similar drug, Amgen’s Repatha, work in a different way and lower cholesterol much more. Patients give themselves shots of the medicine once or twice a month.
Last year, a study showed Repatha cut heart problems but did not improve survival. The new study tested the rival drug, Praluent, for a longer time and in patients at higher risk — nearly 19,000 people who in the previous year had a heart attack or chest pain serious enough to put them in the hospital.
All had LDL over 70 despite maximum statin use. Half were given Praluent and the rest, dummy shots.
After nearly three years, 9.5 percent of those on Praluent and 11.1 percent of those on dummy medicine had suffered a heart attack, stroke, heart-related death or serious chest pain; 3.5 percent on Praluent and 4.1 percent on dummy medicine died.
That worked out to a 15 percent lower risk with Praluent. Benefits were greater for those whose LDL was 100 or more at the start of the study. The drug had no major safety issues.