Niacin/lovastatin clinical studies
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
Clinical Studies
In a multi-center, randomized, double-blind, parallel, 28-week, active-comparator study in patients with Type IIa and IIb hyperlipidemia, ADVICOR was compared to each of its components (NIASPAN and lovastatin). Using a forced dose-escalation study design, patients received each dose for at least 4 weeks. Patients randomized to treatment with ADVICOR initially received 500 mg/20 mg. The dose was increased at 4-week intervals to a maximum of 1000 mg/20 mg in one-half of the patients and 2000 mg/40 mg in the other half. The NIASPAN monotherapy group underwent a similar titration from 500 mg to 2000 mg. The patients randomized to lovastatin monotherapy received 20 mg for 12 weeks titrated to 40 mg for up to 16 weeks. Up to a third of the patients randomized to ADVICOR or NIASPAN discontinued prior to Week 28. In this study, ADVICOR decreased LDL-C, TG and Lp(a), and increased HDL-C in a dose-dependent fashion (Tables 3, 4, 5 and 6 below). Results from this study for LDL-C mean percent change from baseline (the primary efficacy variable) showed that:
LDL-lowering with ADVICOR was significantly greater than that achieved with lovastatin 40 mg only after 28 weeks of titration to a dose of 2000 mg/40 mg (p<.0001) ADVICOR at doses of 1000 mg/20 mg or higher achieved greater LDL-lowering than NIASPAN (p<.0001) The LDL-C results are summarized in Table 3.
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ADVICOR achieved significantly greater HDL-raising compared to lovastatin and NIASPAN monotherapy at all doses (Table 4).
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In addition, ADVICOR achieved significantly greater TG-lowering at doses of 1000 mg/20 mg or greater compared to lovastatin and NIASPAN monotherapy (Table 5).
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The Lp(a) lowering effects of ADVICOR and NIASPAN were similar, and both were superior to lovastatin (Table 6). The independent effect of lowering Lp(a) with NIASPAN or ADVICOR on the risk of coronary and cardiovascular morbidity and mortality has not been determined.
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ADVICOR Long-Term Study
A total of 814 patients were enrolled in a long-term (52-week), open-label, single-arm study of ADVICOR. Patients were force dose-titrated to 2000 mg/40 mg over 16 weeks. After titration, patients were maintained on the maximum tolerated dose of ADVICOR for a total of 52 weeks. Five hundred-fifty (550) patients (68%) completed the study, and fifty-six percent (56%) of all patients were able to maintain a dose of 2000 mg/40 mg for the 52 weeks of treatment. The lipid-altering effects of ADVICOR peaked after 4 weeks on the maximum tolerated dose, and were maintained for the duration of treatment. These effects were comparable to what was observed in the double-blind study of ADVICOR (Tables 3-5).[1]
References
- ↑ "ADVICOR (NIACIN AND LOVASTATIN) TABLET, EXTENDED RELEASE [ABBVIE INC.]". Retrieved 18 February 2014.