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Combination Niacin-Laropiprant Plus Simvastatin Reduces Cholesterol by Almost 50%: Presented at AHA

By Ed Susman

ORLANDO, FL -- November 6,, 2007 -- When patients with dyslipidemia added simvastatin to their experimental combination of extended-release niacin and laropiprant -- a novel anti-flushing agent -- they reported reductions in low density lipoprotein cholesterol (LDL-C) of as much as 48% from baseline.

These findings were presented here on November 5 at the American Heart Association (AHA) 2007 Scientific Sessions.

The study also showed that high density liopoprotein cholesterol (HDL-C) was increased by 28% and triglycerides decreased by 33% among the 590 participants who took the three agents, said Gilbert Gleim, PhD, Director of Clinical Research in Atherosclerosis and Cardiovascular Disease, Merck & Co., Inc., Whitehouse Station, New Jersey, United States.

"We saw reductions in all cholesterol parameters, including a 17% drop in apolipoprotein B," Dr. Gleim said to a packed audience that included more than 250 people who stood or sat in hallways outside the meeting room at the Orange County C Convention Center.

Following a 6 to 8-week washout period, the 1,398 participants entered a 4-week diet and placebo run-in phase. They were then randomized equally to 1 g of extended release niacin coupled with one of the following: 20 mg of laropiprant; simvastatin 10 mg, 20 mg or 40 mg; or the combination of simvastatin and the experimental compound in the same doses. They stayed on that regimen for 4 weeks.

The participants then had their dose escalated to 2 g of extended release niacin/40 mg laropiprant. The simvastatin dose was also doubled, except for the patients already taking simvastatin 40 mg, who remained on that dosing schedule through another 8 weeks.

The 192 patients taking the combination of extended-release niacin plus laropiprant achieved a 17% reduction in LDL-C, a 23% increase in HDL-C, and a 22% decrease in triglycerides.

The 585 patients assigned to simvastatin alone in various doses had a pooled average reduction of 37% in LDL-C; a 6% increase in HDL-C, and a 15% reduction in triglycerides.

Discontinuations due to flushing occurred in 4.8% of the patients receiving the experimental combination alone; 8.7% in those where simvastatin was added to the regimen.

"Extended-release niacin/laropiprant plus simvastatin significantly improved the overall lipid profile and was generally well tolerated in patients with dyslipidemia," Dr. Gleim said.

"These data support the use of laropiprant to improve the tolerability and therapeutic dosing of niacin, alone and with a statin -- therapies proven to reduce cardiovascular risk," he concluded.

Funding for this study was provided by Merck & Co.


[Presentation title: Lipid-Altering Efficacy and Safety Profile of Co-Administered Extended Release Niacin/Laropiprant and Simvastatin in Patients With Dyslipidemia. Abstract 683]

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