The effect of simvastatin on triglyceride-rich lipoproteins in patients with type 2 diabetic dyslipidemia: A SILHOUETTE Trial Sub-study

Michael Miller, Adrian S Dobs, Z. Yuan, W. P. Battisti, J. Palmisano

Research output: Contribution to journalArticle

Abstract

Objective: To determine if simvastatin effectively decreases the elevated levels of triglyceride (TG), TG-rich lipoproteins, and small, dense LDL particles, which are characteristic of diabetic dyslipidemia. Research design and methods: We conducted a prespecified analysis from a double-blind, placebo-controlled, randomized, 6-week crossover trial in patients with type 2 diabetes and low HDL-C (<40 mg/dL). Each patient was randomized to 1 of 6 possible treatment arms; each patient received simvastatin 80 mg, simvastatin 40 mg, and placebo over 3 periods. We used the validated vertical auto profile (VAP) method to directly assess TG-rich lipoproteins and LDL subclasses. We assessed the efficacy of simvastatin to improve the lipoprotein profile in adult men (71%) and women (29%) (n = 151) with stable type 2 diabetes (HbA 1c <9%), LDL-C > 100 mg/dL, HDL-C <40 mg/dL, and fasting TG level > 150 and <700 mg/dL (median = 273 mg/dL). Main outcome measures: Percentage change from baseline in IDL and VLDL (TG-rich lipoproteins), LDL subclasses, and additional lipoproteins at the end of each 6-week treatment interval; percentage of patients who reached NCEP ATP III non-HDL goal of <130 mg/dL by the end of each 6-week period. Results: Both simvastatin 80 mg and 40 mg significantly reduced VLDL-C, VLDL3, and IDL, as well as the four LDL subclasses measured with VAP, compared with placebo. Simvastatin 80 mg, compared with simvastatin 40 mg, provided additional efficacy. With simvastatin 80 mg, 77.2% of patients not at their non-HDL-C goal of <130 mg/dL at study baseline reached goal, compared with 65.7% following simvastatin 40 mg treatment, and 2.2% following placebo. Conclusions: Treatment with simvastatin effectively reduced the elevated levels of TG-rich lipoproteins and improved LDL composition in patients with type 2 diabetes. A large percentage of these patients attained the NCEP ATP III non-HDL-C goal of <130 mg/dL, which demonstrates the improvement of the atherogenic profile in these patients.

Original languageEnglish (US)
Pages (from-to)343-350
Number of pages8
JournalCurrent Medical Research and Opinion
Volume22
Issue number2
DOIs
StatePublished - Feb 2006

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Simvastatin
Dyslipidemias
Lipoproteins
Triglycerides
Placebos
Type 2 Diabetes Mellitus
Adenosine Triphosphate
Cross-Over Studies
Research Design
Therapeutics
Outcome Assessment (Health Care)
oxidized low density lipoprotein

Keywords

  • Diabetes mellitus
  • Efficacy
  • Simvastatin
  • Triglycerides

ASJC Scopus subject areas

  • Medicine(all)

Cite this

The effect of simvastatin on triglyceride-rich lipoproteins in patients with type 2 diabetic dyslipidemia : A SILHOUETTE Trial Sub-study. / Miller, Michael; Dobs, Adrian S; Yuan, Z.; Battisti, W. P.; Palmisano, J.

In: Current Medical Research and Opinion, Vol. 22, No. 2, 02.2006, p. 343-350.

Research output: Contribution to journalArticle

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abstract = "Objective: To determine if simvastatin effectively decreases the elevated levels of triglyceride (TG), TG-rich lipoproteins, and small, dense LDL particles, which are characteristic of diabetic dyslipidemia. Research design and methods: We conducted a prespecified analysis from a double-blind, placebo-controlled, randomized, 6-week crossover trial in patients with type 2 diabetes and low HDL-C (<40 mg/dL). Each patient was randomized to 1 of 6 possible treatment arms; each patient received simvastatin 80 mg, simvastatin 40 mg, and placebo over 3 periods. We used the validated vertical auto profile (VAP) method to directly assess TG-rich lipoproteins and LDL subclasses. We assessed the efficacy of simvastatin to improve the lipoprotein profile in adult men (71{\%}) and women (29{\%}) (n = 151) with stable type 2 diabetes (HbA 1c <9{\%}), LDL-C > 100 mg/dL, HDL-C <40 mg/dL, and fasting TG level > 150 and <700 mg/dL (median = 273 mg/dL). Main outcome measures: Percentage change from baseline in IDL and VLDL (TG-rich lipoproteins), LDL subclasses, and additional lipoproteins at the end of each 6-week treatment interval; percentage of patients who reached NCEP ATP III non-HDL goal of <130 mg/dL by the end of each 6-week period. Results: Both simvastatin 80 mg and 40 mg significantly reduced VLDL-C, VLDL3, and IDL, as well as the four LDL subclasses measured with VAP, compared with placebo. Simvastatin 80 mg, compared with simvastatin 40 mg, provided additional efficacy. With simvastatin 80 mg, 77.2{\%} of patients not at their non-HDL-C goal of <130 mg/dL at study baseline reached goal, compared with 65.7{\%} following simvastatin 40 mg treatment, and 2.2{\%} following placebo. Conclusions: Treatment with simvastatin effectively reduced the elevated levels of TG-rich lipoproteins and improved LDL composition in patients with type 2 diabetes. A large percentage of these patients attained the NCEP ATP III non-HDL-C goal of <130 mg/dL, which demonstrates the improvement of the atherogenic profile in these patients.",
keywords = "Diabetes mellitus, Efficacy, Simvastatin, Triglycerides",
author = "Michael Miller and Dobs, {Adrian S} and Z. Yuan and Battisti, {W. P.} and J. Palmisano",
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T1 - The effect of simvastatin on triglyceride-rich lipoproteins in patients with type 2 diabetic dyslipidemia

T2 - A SILHOUETTE Trial Sub-study

AU - Miller, Michael

AU - Dobs, Adrian S

AU - Yuan, Z.

AU - Battisti, W. P.

AU - Palmisano, J.

PY - 2006/2

Y1 - 2006/2

N2 - Objective: To determine if simvastatin effectively decreases the elevated levels of triglyceride (TG), TG-rich lipoproteins, and small, dense LDL particles, which are characteristic of diabetic dyslipidemia. Research design and methods: We conducted a prespecified analysis from a double-blind, placebo-controlled, randomized, 6-week crossover trial in patients with type 2 diabetes and low HDL-C (<40 mg/dL). Each patient was randomized to 1 of 6 possible treatment arms; each patient received simvastatin 80 mg, simvastatin 40 mg, and placebo over 3 periods. We used the validated vertical auto profile (VAP) method to directly assess TG-rich lipoproteins and LDL subclasses. We assessed the efficacy of simvastatin to improve the lipoprotein profile in adult men (71%) and women (29%) (n = 151) with stable type 2 diabetes (HbA 1c <9%), LDL-C > 100 mg/dL, HDL-C <40 mg/dL, and fasting TG level > 150 and <700 mg/dL (median = 273 mg/dL). Main outcome measures: Percentage change from baseline in IDL and VLDL (TG-rich lipoproteins), LDL subclasses, and additional lipoproteins at the end of each 6-week treatment interval; percentage of patients who reached NCEP ATP III non-HDL goal of <130 mg/dL by the end of each 6-week period. Results: Both simvastatin 80 mg and 40 mg significantly reduced VLDL-C, VLDL3, and IDL, as well as the four LDL subclasses measured with VAP, compared with placebo. Simvastatin 80 mg, compared with simvastatin 40 mg, provided additional efficacy. With simvastatin 80 mg, 77.2% of patients not at their non-HDL-C goal of <130 mg/dL at study baseline reached goal, compared with 65.7% following simvastatin 40 mg treatment, and 2.2% following placebo. Conclusions: Treatment with simvastatin effectively reduced the elevated levels of TG-rich lipoproteins and improved LDL composition in patients with type 2 diabetes. A large percentage of these patients attained the NCEP ATP III non-HDL-C goal of <130 mg/dL, which demonstrates the improvement of the atherogenic profile in these patients.

AB - Objective: To determine if simvastatin effectively decreases the elevated levels of triglyceride (TG), TG-rich lipoproteins, and small, dense LDL particles, which are characteristic of diabetic dyslipidemia. Research design and methods: We conducted a prespecified analysis from a double-blind, placebo-controlled, randomized, 6-week crossover trial in patients with type 2 diabetes and low HDL-C (<40 mg/dL). Each patient was randomized to 1 of 6 possible treatment arms; each patient received simvastatin 80 mg, simvastatin 40 mg, and placebo over 3 periods. We used the validated vertical auto profile (VAP) method to directly assess TG-rich lipoproteins and LDL subclasses. We assessed the efficacy of simvastatin to improve the lipoprotein profile in adult men (71%) and women (29%) (n = 151) with stable type 2 diabetes (HbA 1c <9%), LDL-C > 100 mg/dL, HDL-C <40 mg/dL, and fasting TG level > 150 and <700 mg/dL (median = 273 mg/dL). Main outcome measures: Percentage change from baseline in IDL and VLDL (TG-rich lipoproteins), LDL subclasses, and additional lipoproteins at the end of each 6-week treatment interval; percentage of patients who reached NCEP ATP III non-HDL goal of <130 mg/dL by the end of each 6-week period. Results: Both simvastatin 80 mg and 40 mg significantly reduced VLDL-C, VLDL3, and IDL, as well as the four LDL subclasses measured with VAP, compared with placebo. Simvastatin 80 mg, compared with simvastatin 40 mg, provided additional efficacy. With simvastatin 80 mg, 77.2% of patients not at their non-HDL-C goal of <130 mg/dL at study baseline reached goal, compared with 65.7% following simvastatin 40 mg treatment, and 2.2% following placebo. Conclusions: Treatment with simvastatin effectively reduced the elevated levels of TG-rich lipoproteins and improved LDL composition in patients with type 2 diabetes. A large percentage of these patients attained the NCEP ATP III non-HDL-C goal of <130 mg/dL, which demonstrates the improvement of the atherogenic profile in these patients.

KW - Diabetes mellitus

KW - Efficacy

KW - Simvastatin

KW - Triglycerides

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