A Long-term Study of ERN/LRPT (Extended Release Niacin/Laropiprant [MK0524A]) in Patients With Dyslipidemia (0524A-102)

Summary

This study will evaluate the efficacy of laropiprant (LRPT) to reduce flushing symptoms beyond 6 months and will measure the impact of withdrawal of laropiprant in patients following 20 weeks of stable maintenance therapy.

Timeline

Start

2009-10

Primary completion

2011-01

Completion

2011-01

Outcome

Met primary endpoint

registry analysis (superiority or other test); ERN/LRPT vs ERN/LRPT Then ERN; p <0.001; Cochran-Mantel-Haenszel; NCT00961636 ↗

paper ERN/LRPT produced significantly less NIF than ERN alone during the postwithdrawal period, as measured by the number of days each week PMID 22683042 ↗

paper with a GFSS of ≥4 (p <0.001) PMID 22683042 ↗

Publications

• Results Maccubbin DL, Chen F, Anderson JW, Sirah W, McCrary Sisk C, Kher U, Olsson AG, Bays HE, Mitchel YB. Effectiveness and safety of laropiprant on niacin-induced flushing. Am J Cardiol. 2012 Sep 15;110(6):817-22. doi: 10.1016/j.amjcard.2012.05.009. Epub 2012 Jun 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Niacin	Small molecule	2 g	—
Subject	laropiprant	Small molecule	40 mg	—

Indications