Known as Cordaptive, the drug raised HDL cholesterol and caused less facial flushing in a study than Niaspan, an existing med sold by Abbott Labs, but the Merck pill also caused an increase in liver enzymes and had an impact blood sugar for diabetics. The results were described at the American College of Cardiology in Chicago and here isthe Merck statement.
Separately, Merck halted enrollment in a different, late-stage study of Cordaptive to consider recent results from similar clinical trials, including a failed study of the cholesterol drug Vytorin. The study, which uses ultrasound imaging as a measure, is testing Cordaptive as a treatment for familial hypercholesterolemia, a rare genetic disorder. The study will continue, but with about 300 people instead of the planned 900 participants. Just the same, Merck still expects an FDA decision on Cordaptive this spring.
The pill contains an extended-release form of niacin, which is a vitamin, and a chemical called laropiprant to stop flushing, a dilation of blood vessels that causes redness and an unpleasant burning sensation on the neck and face. Flushing is a common side effect of niacin-based drugs, and the biggest reason many patients stop taking current products, including Niaspan, Reuters reminds us. Merck contends the problem was largely averted and could boost interest in HDL-raising therapy.
Michael Koren, a Jacksonville, Florida, cardiologist who led the study, maintains the side effects are not worrisome, although patients were taken out of the study if they developed elevated liver enzymes, a potential sign of toxicity. The study involved 1,455 patients, aged 18 to 80, with either high levels of LDL and triglycerides, or low HDL levels.
One group received Cordaptive, beginning with 1-gram doses of the niacin component for the first month, and taking the full recommended 2-gram dose of niacin for the remaining 12 weeks of the study. Another group took Niaspan, starting with 500 milligram doses of the extended release form of niacin and graduating to the recommended 2-gram dose by week twelve. They continued to take that dose for the remaining four weeks.