A dose‐ranging study of a new, once‐daily, dual‐component drug product containing niacin extended‐release and lovastatin

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Abstract
Background: Combination therapy for dyslipidemia holds promise as effective treatment for patients with multiple lipid disorders, especially those at high risk. Hypothesis: This study evaluated dose‐response relationships and safety of a new dual‐component drug product containing niacin extended‐release (niacin ER) and lovastatin. Methods: The 28‐week double‐blind multicenter trial randomized 237 patients with type IIA or IIB hyperlipidemia to one of four escalating‐dose treatment groups: niacin ER/lovastatin 1,000/20 mg, niacin ER/lovastatin 2,000/40 mg, niacin ER 2,000 mg, or lovastatin 40 mg. Results: Niacin ER/lovastatin was more effective than each of its components for improving levels of low‐density lipoprotein cholesterol (LDL‐C), high‐density lipoprotein cholesterol (HDL‐C), and triglycerides (TG), and exhibited a clear dose‐response effect and additivity across the dosage range. The 2,000/40 dose achieved greater mean reductions in LDL‐C (‐42%) than 1,000/20 (‐28%, pConclusions: Niacin ER/lovastatin is well tolerated and effective for patients with multiple lipid disorders.