[Evaluation of clinical effectiveness and adverse effects of Polnitrin].
In a double-blind, randomized, placebo cross-controlled trial the effectiveness and the adverse effects of two types of buccal tablets containing 5 mg nitroglycerin: Polnitrin produced by Warsaw Pharmaceutical Works POLFA and its analogue of foreign origin, were assessed. The third compared preparation was sublingual nitroglycerin in 0.5 mg tablets. The longest dissolution in the buccal cavity showed Polnitrin (mean 6.6 hours). Polnitrin significantly increased the resting heart rate during 3 hours, and during 6 hours at maximal effort. The foreign analogue decreased significantly the systolic pressure during 3 hours after application. No significant differences were noted in the effects on the basic haemodynamic parameters between the compared buccal tablets. Exercise tolerance and coronary reserve were assessed with repeated exercise tests on moving track (Marquette Case-12). Immediately after being stuck to the gum Polnitrin, its analogue and sublingual nitroglycerin significantly prolonged the marching time: total, till pain, and till ischaemia. After 6 hours the marching time till pain appearance was significantly longer after Polnitrin than after placebo or its analogue. Local adverse effects connected with the presence of the tablet in the oral vestibule may hamper the treatment with Polnitrin in some cases. The most frequent side effect were headaches which are known to occur usually after all nitrates.
Kośmicki
M
M
Kliniki Choroby Wieńcowej Instytutu Kardiologii, Warszawie.
Sadowski
Z
Z
D000278:Administration, Buccal; D000286:Administration, Sublingual; D000328:Adult; D001682:Biological Availability; D003327:Coronary Disease / Q000188:drug therapy* / Q000503:physiopathology; D004311:Double-Blind Method; D004341:Drug Evaluation; D005080:Exercise Test; D017079:Exercise Tolerance / Q000187:drug effects / Q000502:physiology; D006261:Headache / Q000139:chemically induced*; D006801:Humans; D007024:Hypotension, Orthostatic / Q000139:chemically induced*; D008875:Middle Aged; D005996:Nitroglycerin / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D011044:Poland
D005996:Nitroglycerin
Ocena skuteczności klinicznej i działań niepozadanych preparatu Polnitrin.