SIMCOR® (niacin extended-release/simvastatin tablets)

Guidelines & HDL-C

Low HDL-C & Simvastatin Data

Low HDL-C: Prevalent and moderately affected by simvastatin


Low HDL-C was prevalent in nearly half of high-risk* simvastatin monotherapy patients not at LDL-C goal


A large-scale national EMR database of high-risk simvastatin monotherapy patients with dyslipidemia (n=116,795)1

Data Analysis: A retrospective, observational, cross-sectional analysis conducted using electronic medical records (EMR) data provided by GE Healthcare's Medical Quality Improvement Consortium database of patient records (age ≥18 years) collected from January 2003 to September 2010. As of September 2010, this database captured approximately 700,000 dyslipidemia patients (defined as those who were prescribed cholesterol medication and had all 3 lipid values recorded: LDL-C, HDL-C, and TG.) Of those, 37,486 were high-risk patients on simvastatin monotherapy (treated for ≥90 days) not at LDL-C goal of <100 mg/dL. Optimal HDL-C levels were ≥40 mg/dL if male and ≥50 mg/dL if female.


Limitations: sociodemographic, cultural, and other factors beyond the scope of this study; use of lipid data from a single visit; EMR data captured prescribed therapy, not necessarily what was dispensed.


*CHD or CHD-risk equivalent.


Simvastatin monotherapy significantly affected LDL-C, and moderately affected HDL-C


Simvastatin 40 mg lipid results in the Upper Dose Comparative Study at Weeks 18 and 24 (n=433)1,a

Study Design: Pooled data from two 6-month, multicenter, double-blind, randomized, and active-controlled studies to evaluate efficacy and safety of simvastatin 80 mg (n=664) compared with simvastatin 40 mg (n=433).

Simvastatin 80 mg results (n=664): HDL-C, 8%; LDL-C,*-47%.

aMean % change averaged.
bn=432.
*n=663.

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Upper Dose Comparative Study Design1
Data from two 6-month studies were pooled—a US study with 521 patients and an international study with 584 patients. Both studies were multicenter, double-blind, randomized, and active-controlled to evaluate efficacy and safety of simvastatin 80 mg (n=664) compared with simvastatin 40 mg (n=433).

Reference

  1. Data on file, Abbott Laboratories.