title: Nicorandil and diabetes: a nested case-control study to examine a signal generated by prescription-event monitoring.
abstract: OBJECTIVE
  To investigate a signal generated by an observational cohort study that treatment with the potassium channel opener drug, nicorandil, is associated with an increased incidence of diabetes mellitus (DM).
  
  
  METHODS
  Nested case-control study within cohorts used for prescription-event monitoring.
  
  
  RESULTS
  The cohort study of nicorandil showed that there was a significant difference between the event rate for DM in the first month after starting nicorandil, compared to months 2-6 (difference in rates 1.93, 99% CI 0.7-3.1, per 1000 patient months of treatment). However, the adjusted odds ratio from the case-control study was 1.42 (95% CI 0.66-3.07) for incidence of newly diagnosed DM in nicorandil versus four comparator drugs.
  
  
  CONCLUSIONS
  The nested case-control study was used as a hypothesis-testing instrument for following up a signal of a possible drug reaction to nicorandil. It showed no evidence that nicorandil is associated with increased incidence of newly diagnosed DM.
authors.affiliation: N.DUNN@DSRU.U-NET.COM
authors.forename: N
authors.initials: N
authors.lastname: Dunn
authors.forename: S
authors.initials: S
authors.lastname: Freemantle
authors.forename: R
authors.initials: R
authors.lastname: Mann
mesh_terms: D000368:Aged; D000889:Anti-Arrhythmia Agents / Q000009:adverse effects*; D016022:Case-Control Studies; D003920:Diabetes Mellitus / Q000453:epidemiology*; D005260:Female; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D020108:Nicorandil / Q000009:adverse effects*; D012306:Risk; D014665:Vasodilator Agents / Q000009:adverse effects*
chemical_list: D000889:Anti-Arrhythmia Agents; D014665:Vasodilator Agents; D020108:Nicorandil