[Evaluation of the efficacy and tolerability of protirelin. Results of a multicenter study in Italy].

Controlled clinical trials demonstrated protireline tartrate (TRH-T) efficacy, with its analeptic, analgesic and arousing effects, in the treatment of neurological and functional impairment due to cerebrovascular accidents and head injuries. While the efficacy profile has been extensively studied, there isn't yet a completely satisfactory evaluation on TRH-T tolerability profile. We decided to perform, in Italy, a phase IV clinical trial on the efficacy-safety ratio of TRH-T, involving more than 170 centers spread in the whole country. The trial was an open study, with no control group, enrolling 2359 patients (M = 1405; F = 930; n.d. = 24), most aged between 50 and 80 years. About 52% of them had stroke sequelae, about 15% head injury, 11% a TIA and another 11% cerebral hemorrhage. The patients received TRH-T (4 mg/die) for a cycle of 14 days, by either intramuscular or intravenous routes (slow infusion). Drug efficacy was declared good in about 45% and excellent in about 18% of the patients with stroke. Two hundred twenty eight adverse events were found in 153 patients (M = 92; F = 61), namely with an incidence of 6.49%; they were more frequently detected in elderly patients and in those affected by cerebral hemorrhage or TIA. The most frequent adverse events concerned mucocutaneous, gastrointestinal, cardiovascular and central nervous systems; they were mostly considered light or moderate, and only one third of them required suspension of treatment. Drug-event causal relationship was judged, referring to the "Lasagna algorithm", as definite in 23.7% of the adverse events.(ABSTRACT TRUNCATED AT 250 WORDS)