Statins and risk for new-onset diabetes mellitus: A real-world cohort study using a clinical research database

Medicine (Baltimore). 2016 Nov;95(46):e5429. doi: 10.1097/MD.0000000000005429.

Abstract

Although concern regarding the increased risk for new-onset diabetes mellitus (NODM) after statin treatment has been raised, there has been a lack of evidence in real-world clinical practice, particularly in East Asians. We investigated whether statin use is associated with risk for NODM in Koreans. We conducted a retrospective cohort study using the clinical research database from electronic health records. The study cohort consisted of 8265 statin-exposed and 33,060 matched nonexposed patients between January 1996 and August 2013. Matching at a 1:4 ratio was performed using a propensity score based on age, gender, baseline glucose levels (mg/dL), and hypertension. The comparative risks for NODM with various statins (atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin, and simvastatin) were estimated by both statin exposure versus matched nonexposed and within-class comparisons. The incidence of NODM among the statin-exposed group (6.000 per 1000 patient-years [PY]) was higher than that of the nonexposed group (3.244 per 1000 PY). The hazard ratio (HR) of NODM after statin exposure was 1.872 (95% confidence interval [CI], 1.432-2.445). Male gender (HR, 1.944; 95% CI, 1.497-2.523), baseline glucose per mg/dL (HR, 1.014; 95% CI, 1.013-1.016), hypertension (HR, 2.232; 95% CI, 1.515-3.288), and thiazide use (HR, 1.337; 95% CI, 1.081-1.655) showed an increased risk for NODM, while angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker showed a decreased risk (HR, 0.774; 95% CI, 0.668-0.897). Atorvastatin-exposed patients showed a higher risk for NODM than their matched nonexposed counterparts (HR, 1.939; 95% CI, 1.278-2.943). However, the risk for NODM was not significantly different among statins in within-class comparisons. In conclusion, an increased risk for NODM was observed among statin users in a practical healthcare setting in Korea.

Publication types

  • Observational Study

MeSH terms

  • Adult
  • Age Factors
  • Aged
  • Blood Glucose / analysis
  • Diabetes Mellitus / epidemiology*
  • Dyslipidemias / drug therapy
  • Electronic Health Records / statistics & numerical data
  • Female
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors* / administration & dosage
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors* / adverse effects
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors* / classification
  • Hypertension* / drug therapy
  • Hypertension* / epidemiology
  • Male
  • Middle Aged
  • Republic of Korea / epidemiology
  • Research Design
  • Retrospective Studies
  • Risk Factors

Substances

  • Blood Glucose
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors