Simvastatin-ezetimibe combination therapy is associated with a lower rate of major adverse cardiac events in type 2 diabetics than high potency statins alone: A population-based dynamic cohort study.
BACKGROUND
Recent trials have shown a reduction in the risk of major adverse cardiac events (MACE) with simvastatin-ezetimibe therapy in patients with acute coronary syndrome. The potential benefits of simvastatin-ezetimibe for patients at a lower risk of MACE are unclear. This study aimed to investigate the differences of MACE risk between patients with type 2 diabetes mellitus (DM) using simvastatin-ezetimibe or high potency statins.


METHODS
This population-based dynamic cohort study used data from the Taiwan National Health Insurance Database. The study subjects were patients with type 2 DM, aged between 40 and 75 years. The simvastatin-ezetimibe group took simvastatin-ezetimibe only, and the statin group took atorvastatin or rosuvastatin but not simvastatin or ezetimibe. The two groups were matched for age, gender, medication date, DM diagnosis date, hypertension, and cardiovascular complications. The outcome variable was new-onset MACE. Univariate and multivariate survival analyses were performed.


RESULTS
A total of 20,485 patients (53% male; 4099 in the simvastatin-ezetimibe group and 16,396 in the statin group) were included, with a mean age of 59.1 years. In a total of 37,388 person-years, 1100 patients developed new-onset MACE. The annual incidence rate of new-onset MACE was lower in the simvastatin-ezetimibe group (2.61%) than that in the statin group (3.02%) (p=0.0476). After Cox regression analysis, simvastatin-ezetimibe use was independently associated with a lower risk of MACE (HR, 0.77; 95% confidence interval 0.66-0.90).


CONCLUSIONS
Compared to high potency statins alone, simvastatin-ezetimibe therapy was associated with a lower incidence of MACE in patients with type 2 DM.
Chang Gung University and Department of Cardiology, Chang Gung Memorial Hospital, Taipei, Taiwan.
Shang-Hung
SH
Chang
Chang Gung University and Department of Cardiology, Chang Gung Memorial Hospital, Taipei, Taiwan.
Lung-Sheng
LS
Wu
Chang Gung University and Department of Cardiology, Chang Gung Memorial Hospital, Taipei, Taiwan.
Cheng-Hung
CH
Lee
Chang Gung University and Department of Cardiology, Chang Gung Memorial Hospital, Taipei, Taiwan.
Chi-Tai
CT
Kuo
Department of Public Health, College of Medicine, Chang Gung University, Taiwan.
Jia-Rou
JR
Liu
Chang Gung University and Department of Cardiology, Chang Gung Memorial Hospital, Taipei, Taiwan.
Ming-Shien
MS
Wen
Chang Gung University and Department of Cardiology, Chang Gung Memorial Hospital, Taipei, Taiwan.
Wei-Jan
WJ
Chen
Department of Public Health, College of Medicine, Chang Gung University, Taiwan; Biostatistics Core Laboratory, Molecular Medicine Research Center, Chang Gung University, Taiwan. Electronic address: lichu@mail.cgu.edu.tw.
Lai-Chu
LC
See
Chang Gung University and Department of Cardiology, Chang Gung Memorial Hospital, Taipei, Taiwan. Electronic address: yeongshinn@cgmh.org.tw.
Yung-Hsin
YH
Yeh
D000328:Adult; D000368:Aged; D000924:Anticholesteremic Agents / Q000008:administration & dosage*; D015331:Cohort Studies; D003924:Diabetes Mellitus, Type 2 / Q000175:diagnosis* / Q000188:drug therapy* / Q000453:epidemiology; D004338:Drug Combinations; D000069499:Ezetimibe, Simvastatin Drug Combination / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage*; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D011159:Population Surveillance; D013624:Taiwan / Q000453:epidemiology; D016896:Treatment Outcome
D000924:Anticholesteremic Agents; D004338:Drug Combinations; D000069499:Ezetimibe, Simvastatin Drug Combination; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors
Major adverse cardiac events; Simvastatin–ezetimibe; Statins; Type 2 diabetes