Table 3.
Headache incidences registered during randomized controlled trials (RCT) and open label clinical trials with nicorandil
| Paper | Study design | Dose (daily) | Indication | No. of patients | Headache No. |
|---|---|---|---|---|---|
| Camm & Maltz, 1989, Am. J. Cardiol [92]. | RCT | 20–60 mg | Angina pectoris | 8 | 20 mg 50% 40 mg 88% 60 mg 67% |
| Raftery et al. 1993, Eur. Heart Journal [93]. | RCT | 20 mg and 40 mg | Angina pectoris | 18 | 11 (61%) |
| Roland 1993, Eur. Heart Journal [94]. | Review | 10–80 mg | Angina pectoris | 1680 | 36% |
| Wolf et al. 1993, Eur.J.Clin.Pharmacol [95]. | RCT | 20–200 μg i.v. | Healthy volunteers | 48 | 19 (40%) |
| Witchitz & Darmaon, 1995, Cardiovasc. Drugs& Therap [96]. | Open label | 20–40 mg | Angina pectoris | 197 | 45 (23%) |
| Dunn et al. 1999, Pharmacoepidemiology and Drug safety [97]. | Prescription-event monitoring (PEM) study | Varying | Angina pectoris & ischemic heart disease | 13,260 | 477 (4%) |