Effectiveness of simvastatin therapy in raising HDL-C in patients with type 2 diabetes and low HDL-C

Michael Miller, Adrian S Dobs, Zhong Yuan, Wendy P. Battisti, Hannah Borisute, Joanne Palmisano

Research output: Contribution to journalArticle

Abstract

Objective: To evaluate the efficacy of high and moderate doses of simvastatin (80 and 40 mg), for raising high density lipoprotein-cholesterol (HDL-C), improving HDL sub-fractions, and affecting other parameters, including high sensitivity C-reactive protein (hs-CRP), in patients with type 2 diabetes mellitus (DM) and low HDL-C. Research design and methods: This double-blind, placebo-controlled, randomized, 3-period, complete block, 6-week crossover study examined the efficacy of simvastatin in adult men and women (N = 151) with stable type 2 DM (HbA1C <9%), low density lipoprotein-cholesterol (LDL-C) > 100 mg/dL (2.6 mmol/L), HDL-C <40 mg/dL (<1 mmol/L), and fasting triglyceride level > 150 (> 1.7 mmol/L) and <700 mg/dL (<7.9 mmol/L). This study included adult men (71%) and women (29%) of various races (89% white, 6% black, 1% Asian, 3% other) enrolled from 29 practice-based sites in the United States. Main outcome measures: Percentage change in HDL-C from baseline at the end of each 6-week treatment interval. Results: Both simvastatin 80 and 40 mg significantly increased total HDL-C from baseline (mean increases of 8% ± 1 [SE] and 5% ± 1, respectively; p <0.001) compared with placebo, and significantly reduced plasma concentrations of LDL-C (p <0.001), triglycerides (p <0.001), apolipoprotein B (p <0.001), and hs-CRP (p ≤ 0.012). Compared with simvastatin 40 mg, the 80 mg dose provided additional efficacy. Simvastatin 80 mg also significantly (p <0.001) increased HDL2 from baseline (14% ± 3[SE]) and placebo phases (10 ± 3). An exploratory analysis showed 87% (simvastatin 80 mg) and 82% (simvastatin 40 mg) of patients reached the NCEP ATP III treatment goals for LDL-C compared with 14% on placebo. Conclusions: Both simvastatin 80 and 40 mg raise HDL-C and improve other measures associated with elevated coronary risk in patients with type 2 DM and low HDL-C.

Original languageEnglish (US)
Pages (from-to)1087-1094
Number of pages8
JournalCurrent Medical Research and Opinion
Volume20
Issue number7
DOIs
StatePublished - Jul 2004

Fingerprint

Simvastatin
LDL Cholesterol
Type 2 Diabetes Mellitus
HDL Cholesterol
Placebos
Therapeutics
C-Reactive Protein
Apolipoproteins B
Double-Blind Method
Cross-Over Studies
Triglycerides
Research Design
Adenosine Triphosphate
Outcome Assessment (Health Care)

Keywords

  • Diabetes Mellitus, type 2
  • Efficacy
  • HDL-C
  • Simvastatin

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Effectiveness of simvastatin therapy in raising HDL-C in patients with type 2 diabetes and low HDL-C. / Miller, Michael; Dobs, Adrian S; Yuan, Zhong; Battisti, Wendy P.; Borisute, Hannah; Palmisano, Joanne.

In: Current Medical Research and Opinion, Vol. 20, No. 7, 07.2004, p. 1087-1094.

Research output: Contribution to journalArticle

Miller, Michael ; Dobs, Adrian S ; Yuan, Zhong ; Battisti, Wendy P. ; Borisute, Hannah ; Palmisano, Joanne. / Effectiveness of simvastatin therapy in raising HDL-C in patients with type 2 diabetes and low HDL-C. In: Current Medical Research and Opinion. 2004 ; Vol. 20, No. 7. pp. 1087-1094.
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T1 - Effectiveness of simvastatin therapy in raising HDL-C in patients with type 2 diabetes and low HDL-C

AU - Miller, Michael

AU - Dobs, Adrian S

AU - Yuan, Zhong

AU - Battisti, Wendy P.

AU - Borisute, Hannah

AU - Palmisano, Joanne

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N2 - Objective: To evaluate the efficacy of high and moderate doses of simvastatin (80 and 40 mg), for raising high density lipoprotein-cholesterol (HDL-C), improving HDL sub-fractions, and affecting other parameters, including high sensitivity C-reactive protein (hs-CRP), in patients with type 2 diabetes mellitus (DM) and low HDL-C. Research design and methods: This double-blind, placebo-controlled, randomized, 3-period, complete block, 6-week crossover study examined the efficacy of simvastatin in adult men and women (N = 151) with stable type 2 DM (HbA1C <9%), low density lipoprotein-cholesterol (LDL-C) > 100 mg/dL (2.6 mmol/L), HDL-C <40 mg/dL (<1 mmol/L), and fasting triglyceride level > 150 (> 1.7 mmol/L) and <700 mg/dL (<7.9 mmol/L). This study included adult men (71%) and women (29%) of various races (89% white, 6% black, 1% Asian, 3% other) enrolled from 29 practice-based sites in the United States. Main outcome measures: Percentage change in HDL-C from baseline at the end of each 6-week treatment interval. Results: Both simvastatin 80 and 40 mg significantly increased total HDL-C from baseline (mean increases of 8% ± 1 [SE] and 5% ± 1, respectively; p <0.001) compared with placebo, and significantly reduced plasma concentrations of LDL-C (p <0.001), triglycerides (p <0.001), apolipoprotein B (p <0.001), and hs-CRP (p ≤ 0.012). Compared with simvastatin 40 mg, the 80 mg dose provided additional efficacy. Simvastatin 80 mg also significantly (p <0.001) increased HDL2 from baseline (14% ± 3[SE]) and placebo phases (10 ± 3). An exploratory analysis showed 87% (simvastatin 80 mg) and 82% (simvastatin 40 mg) of patients reached the NCEP ATP III treatment goals for LDL-C compared with 14% on placebo. Conclusions: Both simvastatin 80 and 40 mg raise HDL-C and improve other measures associated with elevated coronary risk in patients with type 2 DM and low HDL-C.

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