[Actions of pentaerithritol tetranitrate, isosorbide mononitrate and placebo on headache and ability to work of healthy subjects].
In a randomised, double-blind, four-way crossover study, 24 healthy volunteers received 240 mg/d pentaerithritol tetranitrate (PETN, CAS 78-11-5), 150 mg/d PETN, 60 mg/d isosorbide mononitrate slow release (ISMN, CAS 16051-77-7) or placebo in each study period for two days. Headache and disability to work were self-rated six times per day; individual measurements were combined to total scores. ISMN caused headaches more frequently (in approx. 90% of volunteers) and more severe (average total score 15.2) and a greater disability (average total score 6.0) than the high or low PETN-dosage (both in approx. 50%, headache score 4.9 or 6.4, disability score 1.1 or 2.1, resp.) and placebo (in approx. 10%, headache 0.8, disability 0), all these differences were statistically significant (p < 0.01, Wilcoxon). The high PETN-dosage showed a non-significant trend to produce fewer systemic side effects than the low PETN-dosage (not vice versa). With ISMN six volunteers prematurely terminated the study period and one volunteer who was replaced withdrew from the entire study due to side effects; all volunteers completed the study periods with the other medications.
Pfaffenrath
V
V
Neurologische Praxis, München.
de la Motte
S
S
Harrison
F
F
Rüthning
C
C
D000328:Adult; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006261:Headache / Q000139:chemically induced*; D006801:Humans; D007548:Isosorbide Dinitrate / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics; D008297:Male; D010417:Pentaerythritol Tetranitrate / Q000008:administration & dosage / Q000009:adverse effects* / Q000493:pharmacokinetics; D014665:Vasodilator Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000493:pharmacokinetics; D014937:Work / Q000523:psychology*
D014665:Vasodilator Agents; D010417:Pentaerythritol Tetranitrate; D007548:Isosorbide Dinitrate; C030397:isosorbide-5-mononitrate