Asian Science Citation Index is committed to provide an authoritative, trusted and significant information by the coverage of the most important and influential journals to meet the needs of the global scientific community.  
ASCI Database
308-Lasani Town,
Sargodha Road,
Faisalabad, Pakistan
Fax: +92-41-8815544
Contact Via Web
Suggest a Journal
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

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.

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.

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.

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.

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


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


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).


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.


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.

Copyright   |   Desclaimer   |    Privacy Policy   |   Browsers   |   Accessibility