Diabetes Metab J.  2014 Feb;38(1):64-73. 10.4093/dmj.2014.38.1.64.

Statin Discontinuation after Achieving a Target Low Density Lipoprotein Cholesterol Level in Type 2 Diabetic Patients without Cardiovascular Disease: A Randomized Controlled Study

• Lee SH
• Kwon HS
• Park YM
• Ko SH
• Choi YH
• Yoon KH
• Ahn YB

• KMID: 2174187
• DOI: http://doi.org/10.4093/dmj.2014.38.1.64

Abstract

BACKGROUND
This study investigated the rate of relapse of dyslipidemia and the factors which could predict relapse following a short-term statin discontinuation after achieving a target low density lipoprotein cholesterol (LDL-C) level in type 2 diabetic patients without cardiovascular disease (CVD).
METHODS
Ninety-nine subjects on rosuvastatin treatment and whose LDL-C level was lower than 100 mg/dL were randomly assigned to discontinue or maintain statin treatment at a 2:1 ratio. The subjects were followed-up after 10 weeks. A relapse of dyslipidemia was defined as a reascent of LDL-C level to greater than 100 mg/dL.
RESULTS
The statin discontinuation group had a significant rate of relapse compared to the maintenance group (79% vs. 3%, respectively). Pretreatment and baseline lipid levels, their ratios, and hemoglobin A1c level were significantly different between the relapse and nonrelapse groups. The pretreatment and baseline lipid profiles and their ratios were independently associated with relapse. The pretreatment LDL-C level was the most useful parameter for predicting a relapse, with a cutoff of 123 mg/dL. During the follow-up period, no CVD event was noted.
CONCLUSION
The relapse rate of dyslipidemia was high when statins were discontinued in type 2 diabetic patients without CVD. Statin discontinuation should be considered carefully based on the pretreatment lipid profiles of patients.

Keyword

Cardiovascular diseases; Cholesterol, LDL; Diabetes mellitus, type 2; Dyslipidemia; Statin

MeSH Terms

Cardiovascular Diseases*
Cholesterol, LDL*
Diabetes Mellitus, Type 2
Dyslipidemias
Follow-Up Studies
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors*
Recurrence
Rosuvastatin Calcium
Cholesterol, LDL

Figure

• 

  Fig. 1 A flow diagram of the study.

• 

  Fig. 2 Changes in lipid profiles. (A) Total cholesterol, (B) triglycerides, (C) HDL-C, and (D) LDL-C. The maintenance group is represented by triangles; the discontinuation, nonrelapse group is represented by black circles; and the discontinuation, relapse group is represented by white circles. Values are presented as mean±standard error. HDL-C, high density lipoprotein cholesterol; LDL-C, low density lipoprotein cholesterol. aP<0.05 vs. the maintenance group, bP<0.05 vs. the discontinuation, nonrelapse group.

• 

  Fig. 3 Comparison of lipid profiles between the relapse and the nonrelapse groups after statin discontinuation. (A) Pretreatment LDL/HDL-C ratio, (B) baseline LDL/HDL-C ratio, (C) baseline ApoB/ApoA1 ratio, (D) pretreatment TC/HDL-C ratio, and (E) baseline TC/HDL-C ratio. Values are presented as scatter dot plots and mean±standard error. LDL-C, low density lipoprotein cholesterol; HDL-C, high density lipoprotein cholesterol; ApoB, apolipoprotein B; ApoA1, apolipoprotein A1; TC, total cholesterol.

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