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Lipid-modifying efficacy and tolerability of extended-release niacin/laropiprant in patients with primary hypercholesterolaemia or mixed dyslipidaemia.
Int J Clin Pract. 2008 Dec; 62(12):1959-70.IJ

Abstract

BACKGROUND

Improving lipids beyond low-density lipoprotein cholesterol (LDL-C) lowering with statin monotherapy may further reduce cardiovascular risk. Niacin has complementary lipid-modifying efficacy to statins and cardiovascular benefit, but is underutilised because of flushing, mediated primarily by prostaglandin D(2) (PGD(2)). Laropiprant (LRPT), a PGD(2) receptor (DP1) antagonist that reduces niacin-induced flushing has been combined with extended-release niacin (ERN) into a fixed-dose tablet.

METHODS AND RESULTS

Dyslipidaemic patients were randomised to ERN/LRPT 1 g (n = 800), ERN 1 g (n = 543) or placebo (n = 270) for 4 weeks. Doses were doubled (2 tablets/day; i.e. 2 g for active treatments) for 20 weeks. ERN/LRPT 2 g produced significant changes vs. placebo in LDL-C (-18.4%), high-density lipoprotein cholesterol (HDL-C; 20.0%), LDL-C:HDL-C (-31.2%), non-HDL-C (-19.8%), triglycerides (TG; -25.8%), apolipoprotein (Apo) B (-18.8%), Apo A-I (6.9%), total cholesterol (TC; -8.5%), TC:HDL-C (-23.1%) and lipoprotein(a) (-20.8%) across weeks 12-24. ERN/LRPT produced significantly less flushing than ERN during initiation (week 1) and maintenance (weeks 2-24) for all prespecified flushing end-points (incidence, intensity and discontinuation because of flushing). Except for flushing, ERN/LRPT had a safety/tolerability profile comparable with ERN.

CONCLUSION

Extended-release niacin/LRPT 2 g produced significant, durable improvements in multiple lipid/lipoprotein parameters. The improved tolerability of ERN/LRPT supports a simplified 1 g-->2 g dosing regimen of niacin, a therapy proven to reduce cardiovascular risk.

Authors+Show Affiliations

Merck Research Laboratories, Rahway, NJ 07065, USA. darbie_maccubbin@merck.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19166443

Citation

Maccubbin, D, et al. "Lipid-modifying Efficacy and Tolerability of Extended-release Niacin/laropiprant in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia." International Journal of Clinical Practice, vol. 62, no. 12, 2008, pp. 1959-70.
Maccubbin D, Bays HE, Olsson AG, et al. Lipid-modifying efficacy and tolerability of extended-release niacin/laropiprant in patients with primary hypercholesterolaemia or mixed dyslipidaemia. Int J Clin Pract. 2008;62(12):1959-70.
Maccubbin, D., Bays, H. E., Olsson, A. G., Elinoff, V., Elis, A., Mitchel, Y., Sirah, W., Betteridge, A., Reyes, R., Yu, Q., Kuznetsova, O., Sisk, C. M., Pasternak, R. C., & Paolini, J. F. (2008). Lipid-modifying efficacy and tolerability of extended-release niacin/laropiprant in patients with primary hypercholesterolaemia or mixed dyslipidaemia. International Journal of Clinical Practice, 62(12), 1959-70. https://doi.org/10.1111/j.1742-1241.2008.01938.x
Maccubbin D, et al. Lipid-modifying Efficacy and Tolerability of Extended-release Niacin/laropiprant in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia. Int J Clin Pract. 2008;62(12):1959-70. PubMed PMID: 19166443.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Lipid-modifying efficacy and tolerability of extended-release niacin/laropiprant in patients with primary hypercholesterolaemia or mixed dyslipidaemia. AU - Maccubbin,D, AU - Bays,H E, AU - Olsson,A G, AU - Elinoff,V, AU - Elis,A, AU - Mitchel,Y, AU - Sirah,W, AU - Betteridge,A, AU - Reyes,R, AU - Yu,Q, AU - Kuznetsova,O, AU - Sisk,C McCrary, AU - Pasternak,R C, AU - Paolini,J F, PY - 2009/1/27/entrez PY - 2009/1/27/pubmed PY - 2009/4/18/medline SP - 1959 EP - 70 JF - International journal of clinical practice JO - Int J Clin Pract VL - 62 IS - 12 N2 - BACKGROUND: Improving lipids beyond low-density lipoprotein cholesterol (LDL-C) lowering with statin monotherapy may further reduce cardiovascular risk. Niacin has complementary lipid-modifying efficacy to statins and cardiovascular benefit, but is underutilised because of flushing, mediated primarily by prostaglandin D(2) (PGD(2)). Laropiprant (LRPT), a PGD(2) receptor (DP1) antagonist that reduces niacin-induced flushing has been combined with extended-release niacin (ERN) into a fixed-dose tablet. METHODS AND RESULTS: Dyslipidaemic patients were randomised to ERN/LRPT 1 g (n = 800), ERN 1 g (n = 543) or placebo (n = 270) for 4 weeks. Doses were doubled (2 tablets/day; i.e. 2 g for active treatments) for 20 weeks. ERN/LRPT 2 g produced significant changes vs. placebo in LDL-C (-18.4%), high-density lipoprotein cholesterol (HDL-C; 20.0%), LDL-C:HDL-C (-31.2%), non-HDL-C (-19.8%), triglycerides (TG; -25.8%), apolipoprotein (Apo) B (-18.8%), Apo A-I (6.9%), total cholesterol (TC; -8.5%), TC:HDL-C (-23.1%) and lipoprotein(a) (-20.8%) across weeks 12-24. ERN/LRPT produced significantly less flushing than ERN during initiation (week 1) and maintenance (weeks 2-24) for all prespecified flushing end-points (incidence, intensity and discontinuation because of flushing). Except for flushing, ERN/LRPT had a safety/tolerability profile comparable with ERN. CONCLUSION: Extended-release niacin/LRPT 2 g produced significant, durable improvements in multiple lipid/lipoprotein parameters. The improved tolerability of ERN/LRPT supports a simplified 1 g-->2 g dosing regimen of niacin, a therapy proven to reduce cardiovascular risk. SN - 1742-1241 UR - https://www.unboundmedicine.com/medline/citation/19166443/Lipid_modifying_efficacy_and_tolerability_of_extended_release_niacin/laropiprant_in_patients_with_primary_hypercholesterolaemia_or_mixed_dyslipidaemia_ L2 - https://doi.org/10.1111/j.1742-1241.2008.01938.x DB - PRIME DP - Unbound Medicine ER -