A Genzyme and Isis Pharmaceuticals Inc. study suggests that mipomersen sodium injections reduce the odds of major adverse cardiovascular events in patients with familial hypercholesterolemia, compared with the 2 years prior to therapy.
A Genzyme and Isis Pharmaceuticals Inc. study suggests that mipomersen sodium (Kynamro) injections reduce the odds of major adverse cardiovascular events (MACE) in patients with familial hypercholesterolemia (FH), compared with the 2 years prior to therapy.
The retroactive analysis involved patients with homozygous and herterozygous FH who participated in the long-term study of Kynamro after having completed 1 of the drug’s phase 3 placebo-controlled, 6-month trials, according to a company press release. Data was also derived from patients who had completed at least 2 years of Kynamro treatment.
In the study, MACE were defined as myocardial infarction, stroke, unstable angina, and revascularization procedures.
For the 2 years prior to treatment, 62% of patients experienced MACE, but after an average of 24.4 months after the start of Kynamro therapy, only 9% of patients experienced MACE, according to the press release.
"Patients with homozygous FH have extreme cholesterol levels and are at significant risk for cardiovascular events,” said Sotirios Tsimikas, MD, professor of medicine and director of vascular medicine at the University of California and vice president of clinical development and leader of the cardiovascular franchise at Isis, in a press release. “…The data presented is encouraging and adds to the broad-lipid lowering profile observed in these patients.”
Kynamro may cause hepatic toxicity, according to the manufacturers.