Nicorandil and diabetes: a nested case-control study to examine a signal generated by prescription-event monitoring.
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.
Dunn
N
N
N.DUNN@DSRU.U-NET.COM
Freemantle
S
S
Mann
R
R
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*
D000889:Anti-Arrhythmia Agents; D014665:Vasodilator Agents; D020108:Nicorandil