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Articles by Eseng Lai
Total Records ( 1 ) for Eseng Lai
  Eseng Lai , M. Gerard Waters , James R. Tata , Waldemar Radziszewski , Inna Perevozskaya , Wei Zheng , Larissa Wenning , Daniel T. Connolly , Graeme Semple , Amy O. Johnson-Levonas , John A. Wagner , Yale Mitchel and John F. Paolini
 

Background

Development of niacin-like agents that favorably affect lipids with an improved flushing profile would be beneficial.

Objective

To evaluate a niacin receptor partial agonist, MK-0354, in Phase I and II studies.

Methods

The pharmacokinetic/pharmacodynamic effects of single and multiple doses (7 days) of MK-0354 (300-4000 mg) were evaluated in two Phase I studies conducted in healthy men. A Phase II study assessed the effects of MK-0354 2.5 g once daily on lipids during 4 weeks in 66 dyslipidemic patients.

Results

MK-0354 single doses up to 4000 mg and multiple doses (7 days) up to 3600 mg produced robust dose-related reductions in free fatty acid (FFA) over 5 hours. Single doses of MK-0354 300 mg and extended release-niacin (Niaspan) 1 g produced comparable reductions in FFA. Suppression of FFA following 7 daily doses of MK-0354 was similar to that after a single dose. In the Phase II study, MK-0354 2.5 g produced little flushing but no clinically meaningful effects on lipids (placebo-adjusted percent change: high-density lipoprotein cholesterol, 0.4%, 95% confidence interval −5.2 to 6.0; low-density lipoprotein cholesterol, −9.8%, 95% confidence interval −16.8 to −2.7; triglyceride, −5.8%, 95% confidence interval −22.6 to 11.9).

Conclusion

Treatment with MK-0354 for 7 days resulted in plasma FFA suppression with minimal cutaneous flushing. However, 4 weeks of treatment with MK-0354 failed to produce changes in high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, or triglycerides.

 
 
 
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