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Articles by Christine McCrary Sisk
Total Records ( 3 ) for Christine McCrary Sisk
  Harold E. Bays , Arvind Shah , Jianxin Lin , Christine McCrary Sisk , John F. Paolini and Darbie Maccubbin
 

Objective

Patients with metabolic syndrome (MetS) are at increased risk for cardiovascular disease. Niacin improves lipid abnormalities associated with MetS, but is underused, mainly because of flushing. Laropiprant (LRPT) reduces niacin-induced flushing and, in combination with extended-release niacin (ERN/LRPT), improves lipid levels.

Methods

In this post-hoc subgroup analysis of a phase 3 randomized, double-blind, placebo-controlled, 24-week study (n = 1613), we evaluated the efficacy and safety of ERN/LRPT in dyslipidemic patients with MetS. Dyslipidemic patients were randomized 3:2:1 to ERN/LRPT 1 g, ERN 1 g, or placebo. After 4 weeks, active treatment doses were doubled (2 tablets) for 20 weeks.

Results

Relative to placebo, ERN/LRPT significantly lowered low-density lipoprotein cholesterol and increased high-density lipoprotein cholesterol levels to a similar degree in MetS and non-MetS cohorts. ERN/LRPT significantly (P < .001) lowered triglyceride levels versus placebo in patients with MetS and without MetS (−30.2% vs −22.2%, respectively). The between subgroup difference in triglyceride lowering was not significant. For all lipid parameters, ERN/LRPT and ERN produced similar magnitude changes. ERN/LRPT and ERN produced similar increases in median fasting blood glucose levels versus placebo in patients with MetS (2.0 and 4.0 mg/dL, respectively) and without MetS (4.0 mg/dL for both groups), consistent with a known effect of niacin.

Conclusion

In patients with MetS, ERN/LRPT improves multiple lipid parameters associated with increased cardiovascular disease risk. ERN/LRPT numerically improved triglyceride levels more in patients with versus without MetS, which is likely related to greater baseline triglycerides in MetS patients.

  James McKenney , Harold Bays , Michael Koren , Christie M. Ballantyne , John F. Paolini , Yale Mitchel , Abigaile Betteridge , Olga Kuznetsova , Aditi Sapre , Christine McCrary Sisk and Darbie Maccubbin
 

Objective

To evaluate the safety profile of extended-release niacin/laropiprant (ERN/LRPT), pooling data from studies in the clinical development program.

Methods

Data were pooled from three active- or placebo-controlled phase 3 studies and three 1-year extensions of phase 2 studies that ranged from 12 to 52 weeks (N = 4747): ERN/LRPT = 2548; ERN or Niaspan® (ERN-NSP = 1268); or simvastatin or placebo (SIMVA-PBO = 931).

Results

The safety and tolerability profile for ERN/LRPT was similar to that of ERN-NSP, except for fewer flushing-related adverse experiences and discontinuations with ERN/LRPT than ERN-NSP. The incidence of consecutive ≥3x the upper limit of normal increases in alanine aminotransferase and/or aspartate aminotransferase was numerically (but not statistically) greater with ERN/LRPT (1.0%) than ERN-NSP (0.5%) and similar to SIMVA-PBO (0.9%). Elevations were reversible with therapy discontinuation and not associated with clinical hepatotoxicity. There was no evidence that ERN/LRPT administered alone or concurrently with a statin had adverse effects on muscle. ERN/LRPT and ERN-NSP produced small median increases in fasting blood glucose levels (∼4 mg/dL) after 24 weeks of treatment, consistent with known effects of niacin.

Conclusion

The favorable safety and tolerability profile of ERN/LRPT for up to 1 year supports the use of LRPT to achieve improved therapeutic dosing of niacin, an agent with comprehensive lipid-modifying efficacy and shown to reduce cardiovascular risk.

  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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