Merck's Long-Acting Niacin Drug Has Serious Side Effects

Editor's Choice Main Category: Cardiovascular / Cardiology Also Included In: Cholesterol;Vascular Article Date: 11 Mar 2013 - 0:00 PDT

Current ratings for: Merck's Long-Acting Niacin Drug Has Serious Side Effects

A major study (HPS2-THRIVE) found that Tredaptive, which consist of the vitamin niacin combined with anti-flushing agent laropiprant, provides no benefit and may even be hazardous for patients with vascular disease.

The HPS2-THRIVE study involving 25,673 patients, which lasted four years, tested a combination of ER (extended-release) niacin with laropiprant on patients with heart disease, stroke and other cardiovascular problems - 14,741 patients were from Europe (United Kingdom and Scandinavia) and 10,932 were from China. They were randomly selected to receive either ER niacin/laropiprant 2g/40mg or a placebo. They were all on simvastatin (with or without ezetimibe) - simvastatin is a widely prescribed cholesterol-lowering drug.

HPS2-THRIVE did not meet the primary endpoint of reducing the risk of a major vascular event, defined as the composite of nonfatal heart attack or heart-related death, a need for angioplasty or bypass surgery, or stroke.

Those in the ER niacin/laropiprant group had approximately the same rates of major vascular events as participants in the placebo group (13.2% vs. 13.7%).

Tredaptive combines extended-release niacin with laropiprant, an experimental medication designed to prevent facial flushing (linked to niacin).

When Merck announced that Tredaptive did not prevent strokes, heart attacks, death and other complications in heart patients, it abandoned any thoughts of seeking approval from the US FDA (Food and Drug Administration). The company added that sales in several countries where it was available would stop. The company had hoped to market this combination under the trade names Tredaptive in Europe and Cordaptive in the USA.

The researchers in the HPS2-THRIVE study found that patients in the Tredaptive group, compared to those in the placebo group:

Niacin, also called nicotinic acid, vitamin PP or Vitamin B3, has drawn significant attention from patients and doctors because it is said to raise HDL cholesterol (high-density lipoprotein "good" cholesterol), while at the same time reducing "bad" LDL cholesterol (LDL=low-density lipoprotein). Niacin blocks the availability of LDL building blocks by preventing the breakdown of fat.

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Merck's Long-Acting Niacin Drug Has Serious Side Effects