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Articles by Amy O. Johnson-Levonas
Total Records ( 3 ) for Amy O. Johnson-Levonas
  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.

  Harold E. Bays , Eliot A. Brinton , Joseph Triscari , Erluo Chen , Darbie Maccubbin , Alexandra MacLean , Kendra Gibson , Amy O. Johnson-Levonas and Yale B. Mitchel
  The degree of glycemic control may alter lipid levels, which might also alter treatment efficacy of lipid agents.
  Christie Ballantyne , Gilbert Gleim , Nancy Liu , Christine McCrary Sisk , Amy O. Johnson-Levonas and Yale Mitchel
 

Background

The use of extended-release niacin and the prostaglandin D2 receptor antagonist laropiprant (ERN/LRPT) reduces niacin-induced flushing in patients while preserving its lipid-modifying effects.

Objective

This predefined exploratory analysis examined the individual and combined effects of ERN/LRPT and simvastatin (SIM) on lipoprotein subclasses.

Methods

This double-blind study randomized 1398 dyslipidemic patients equally to ERN/LRPT 1 g/20 mg, SIM (10, 20, or 40 mg), or ERN/LRPT 1 g/20 mg + SIM (10, 20, or 40 mg) once daily for 4 weeks. At week 5, doses were doubled, except SIM 40 mg (unchanged) and ERN/LRPT 1 g/20 mg + SIM 40 mg (switched to ERN/LRPT 2g/40 mg + SIM 40 mg). Cholesterol associated with lipoprotein subclasses was quantified by vertical auto profile II (VAP II).

Results

ERN/LRPT + SIM and SIM alone lowered LDL-C 1 and 3, whereas the effects were variable for ERN/LRPT; all three treatments increased LDL-C 4. ERN/LRPT + SIM and ERN/LRPT raised HDL-C 2 and 3, with greater relative percent changes in HDL 2 than HDL 3. ERN/LRPT + SIM for 12 weeks produced substantial reductions in IDL-C, which was additive compared with each monotherapy.

Conclusion

Coadministered ERN/LRPT + SIM produced marked reductions in atherogenic lipoproteins, with the greatest effect on IDL-C, and increases in protective HDL subclasses.

 
 
 
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