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Niacin Extended-Release/ Lovastatin Combination Effective in Patients with Multiple Lipid Disorders

Patients with multiple lipid disorders can be effectively treated with a combination of niacin extended-release (niacin ER) and lovastatin, say researchers in the United States.

For such patients, particularly those at high risk, combination therapy for dyslipidaemia showed promise as an effective treatment, the researchers point out.

Dose-response relationships and safety of a new dual-component drug product containing niacin ER/lovastatin were evaluated in this double-blind, multi-centre trial, by D. B. Hunninghake and clinicians at The Heart Disease Prevention Clinic, University of Minnesota, Minneapolis.

The 28 week study randomly assigned 237 patients with type IIA or IIB hyperlipidemia to one of four escalating-dose treatment groups. Each group received either niacin ER/lovastatin 1,000/20 mg, niacin ER/lovastatin 2,000/40 mg, niacin ER 2,000 mg or lovastatin 40 mg.

Treatment by niacin ER/lovastatin was found to be more effective than each of its components, showing improved levels of low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C) and triglycerides (TG). This therapy also showed a clear dose-response effect and additivity across the dosage range.

Greater mean reductions in LDL-C (-42%) were attained by the 2,000/40 dose compared with 1,000/20 (-28%, p < 0.001), lovastatin 40 mg (-32%, p < 0.05) or niacin ER 2,000 mg (-14%, p < 0.05).

This higher dose was also significantly more effective in increasing HDL-C levels (+30%) compared with the 1,000/20 dose (+21%, p = 0.016). Moreover the 2,000/40 dose showed a greater decrease in TG (-43%) than with 1,000/20 (-26%, p = 0.009).

Lovastatin monotherapy was found to be less effective in reducing lipoprotein (a) levels than the three niacin-containing treatments.

Twelve subjects in the niacin ER/lovastatin groups, 11%, and one on lovastatin alone withdraw from the study because of flushing.

Reversible elevations in liver transaminases were found in one subject in the 2,000/40 group and one in the lovastatin 40-mg group.

The researchers report there was no drug-related myopathy.
Clin Cardiol 2003 Mar;26:3:112-8. "A dose-ranging study of a new, once-daily, dual-component drug product containing niacin extended-release and lovastatin"

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