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Consistency of extended-release niacin/laropiprant effects on Lp(a), ApoB, non-HDL-C, Apo A1, and ApoB/ApoA1 ratio across patient subgroups.
Bays, Harold E; Shah, Arvind; Lin, Jianxin; Sisk, Christine McCrary; Dong, Qian; Maccubbin, Darbie.
Afiliação
  • Bays HE; L-MARC Research Center, Louisville, KY 40213, USA. hbaysmd@aol.com
Am J Cardiovasc Drugs ; 12(3): 197-206, 2012 Jun 01.
Article em En | MEDLINE | ID: mdl-22500948
BACKGROUND: According to prior analyses, extended-release niacin/laropiprant (ERN/LRPT) consistently reduces low-density lipoprotein cholesterol (LDL-C) and triglycerides (TG) and increases high-density lipoprotein cholesterol (HDL-C) levels across a wide range of dyslipidemic patient subgroups. OBJECTIVES: This analysis examined ERN/LRPT's consistency across four phase III, randomized, double-blind trials in improving other lipid/lipoprotein parameters associated with cardiovascular risk, across several key dyslipidemic patient subgroups. METHODS: In three of the studies, the randomized population included patients with primary hypercholesterolemia or mixed hyperlipidemia; in the remaining study, the population included patients with type 2 diabetes mellitus. The lipid-altering consistency of ERN/LRPT's efficacy was evaluated versus the pre-defined comparator (placebo or active control) among key subgroups of sex, race (White, non-White), region (US, ex-US), baseline age (<65 years, ≥65 years), use of statin therapy (yes, no), coronary heart disease (yes, no), risk status (low, multiple, high), and type of hyperlipidemia (primary hypercholesterolemia, mixed dyslipidemia), as well as across baseline LDL-C, HDL-C, and TG levels. The consistency of the treatment effects on lipoprotein(a).[Lp(a)], apolipoprotein B (ApoB), non-HDL-C, ApoA1, and ApoB/ApoA1 ratio was evaluated by examining treatment difference estimates of the percentage change from baseline with 95% confidence intervals. RESULTS: Treatment with ERN/LRPT produced significantly greater improvements in Lp(a), ApoB, non-HDL-C, ApoA1, and ApoB/ApoA1 ratio compared with placebo/active comparator in each study. These effects were generally consistent across key subgroups within each study. CONCLUSION: ERN/LRPT produced lipid-altering efficacy on the parameters evaluated in four controlled studies; these effects were generally consistent across all examined subgroups. ERN/LRPT represents an effective and reliable therapeutic option for the treatment of dyslipidemia in a wide range of patient types. CLINICAL TRIAL REGISTRATION: Registered as Clinicaltrials.gov NCT00269204, NCT00269217, NCT00479388, and NCT00485758.
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Dislipidemias / Indóis / Niacina Tipo de estudo: Clinical_trials / Etiology_studies Limite: Aged / Female / Humans / Male Idioma: En Ano de publicação: 2012 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Dislipidemias / Indóis / Niacina Tipo de estudo: Clinical_trials / Etiology_studies Limite: Aged / Female / Humans / Male Idioma: En Ano de publicação: 2012 Tipo de documento: Article