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Articles by Aditi Sapre
Total Records ( 2 ) for Aditi Sapre
  Debra Kush , Hyo-Soo Kim , Da Yi Hu , Ji Liu , Waheeda Sirah , Aditi Sapre , Christine McCrary , John F. Paolini and Darbie Maccubbin
 

Background
Niacin has proven lipid-modifying efficacy and cardiovascular benefit; however, it is underused because of skin flushing, a process mediated primarily by prostaglandin D2 (PGD2). Laropiprant (LRPT), a PGD2 receptor (DP1) antagonist that mitigates niacin-induced flushing, has been combined with extended-release niacin (ERN) into a fixed-dose tablet containing 1 g of ERN and 20 mg of LRPT (ERN/LRPT 1 g). In a large-scale (n = not, vert, similar1600), multinational, 6-month study in dyslipidemic patients, ERN/LRPT 2 g produced superior lipid-modifying efficacy vs placebo, whether administered alone or with concomitant statins.

Objective
This Phase III, randomized, double-blind study evaluated the lipid-modifying efficacy of ERN/LRPT alone or added to ongoing statins in Asian patients with primary hypercholesterolemia or mixed hyperlipidemia.

Methods
After a 4-week placebo run-in, patients were randomized to ERN/LRPT 1 g (n = 322) or placebo (PBO; n = 324). After 4 weeks, the dose was advanced to 2 tablets/d (ERN/LRPT 2 g or PBO) for 8 additional weeks. End points included effects of ERN/LRPT 2 g vs PBO on low-density lipoprotein cholesterol (LDL-C; primary), high-density lipoprotein cholesterol (HDL-C), triglyceride (TG), and other lipids/lipoproteins.

Results
Relative to PBO, ERN/LRPT 2 g produced significant (P < .001) changes in LDL-C (−14.7%), HDL-C (15.9%), TG (−23.4%), LDL-C:HDL-C (−25.5%), non-HDL-C (−16.4%), apolipoprotein (Apo) B (−15.4%), and Apo A-I (5.3%) from baseline to week 12 in the total population. Similar results were observed in patients treated with ERN/LRPT alone or added to ongoing statin.

Conclusion
ERN/LRPT 2 g, administered alone or with a statin, produced significant improvements in multiple lipid/lipoprotein parameters in dyslipidemic Asian 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.

 
 
 
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