RESUMO
A multi-centre, double-blind trial was carried out in general practice to compare the effectiveness and tolerability of clomipramine and diazepam in patients with agoraphobia or social phobia. Patients were allocated at random to receive one or other of the trial drugs over a period of 12 weeks and dosage was adjusted to need. During the last 4 weeks daily dosage ranged from 25 to 150 mg clomipramine and from 10 to 30 mg diazepam. Analysis of results from 33 patients (15 clomipramine, 18 diazepam) showed that clomipramine was significantly superior to diazepam in improving and maintaining improvement in situational anxiety, interference in lifestyle, accompanied travel distance and total score on an agoraphobia inventory. Tolerability of clomipramine was comparable to that of diazepam.
Assuntos
Agorafobia/tratamento farmacológico , Clomipramina/uso terapêutico , Diazepam/uso terapêutico , Transtornos Fóbicos/tratamento farmacológico , Adolescente , Adulto , Idoso , Agorafobia/psicologia , Ensaios Clínicos como Assunto , Clomipramina/efeitos adversos , Diazepam/efeitos adversos , Método Duplo-Cego , Medicina de Família e Comunidade , Humanos , Pessoa de Meia-Idade , Transtornos Fóbicos/psicologia , Distribuição AleatóriaRESUMO
The efficacy of eltoprazine, a mixed 5-HT1 agonist, in treating aggressive behaviour in mentally handicapped patients was evaluated in a double-blind, placebo- and baseline-controlled study. In the total sample of 160 patients who entered the 8 week double-blind treatment phase, efficacy was not demonstrated. Also in a 28 week double-blind follow-up study, efficacy could not be demonstrated. Post-hoc exploratory analyses suggested eltoprazine was significantly better than placebo in reducing aggression scores of a subgroup of severely aggressive patients. There was no evident relationship between the plasma level of eltoprazine and therapeutic effect or safety and tolerance. The overall safety and tolerance of chronic eltoprazine treatment was good. In the discussion, several issues and pitfalls of aggression research are dealt with.
Assuntos
Agressão/efeitos dos fármacos , Deficiência Intelectual/tratamento farmacológico , Piperazinas/uso terapêutico , Agonistas do Receptor de Serotonina/uso terapêutico , Adolescente , Adulto , Idoso , Relação Dose-Resposta a Droga , Método Duplo-Cego , Feminino , Seguimentos , Humanos , Deficiência Intelectual/psicologia , Masculino , Pessoa de Meia-Idade , Determinação da Personalidade , Piperazinas/efeitos adversos , Agonistas do Receptor de Serotonina/efeitos adversos , Comportamento Social , Resultado do TratamentoRESUMO
This multicentre double-blind trial in general practice compared the efficacy and tolerability of the sustained-release formulation of clomipramine (Anafranil SR) with its conventional formulation (Anafranil) in the treatment of phobias. Patients were allocated at random to receive clomipramine 75 mg once daily as either the sustained-release or conventional formulation for 11 weeks following a 1-week dosage build-up period. Analysis of results from forty-six patients showed that the sustained release formulation of clomipramine 75 mg was as effective as the conventional formulation of clomipramine 75 mg in improving symptoms of phobia as assessed by a phobia inventory and global evaluation. Unwanted effects attributable to therapy were similar in both treatment groups but there were fewer withdrawals due to unwanted effects of the sustained release formulation of clomipramine 75 mg. It was concluded that the sustained-release formulation of clomipramine does offer advantages for patients requiring 75 mg clomipramine daily.
Assuntos
Clomipramina/uso terapêutico , Transtornos Fóbicos/tratamento farmacológico , Adolescente , Adulto , Idoso , Ensaios Clínicos como Assunto , Clomipramina/efeitos adversos , Preparações de Ação Retardada/efeitos adversos , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-IdadeRESUMO
Nineteen patients receiving oxprenolol slow-release (SR) 160 mg (three patients) or 320 mg (16 patients) once daily for mild to moderate hypertension were treated with oxprenolol Oros 16/260 once daily for 3 weeks following a 2 week placebo wash-out period. Repeated dosing with both Oros and SR oxprenolol preparations, in comparison with placebo, significantly reduced supine systolic and diastolic blood pressures, and pulse rate at 24 h after dosing. Single Oros doses also significantly reduced pulse rate and diastolic, but not systolic, blood pressure at 24 h. The reduction in supine systolic blood pressure was greater during repeated dosing with oxprenolol SR than after a single dose of the Oros preparation. Control of supine diastolic blood pressure (less than or equal to 90 mm Hg) at 24 h after dosing was achieved in 13 out of 18 patients with oxprenolol SR (two out of three patients given 160 mg, and 11 out of 15 given 320 mg). Similar control was achieved in 11 out of 18 patients after a single dose of oxprenolol Oros, and in 13 out of 17 patients treated for 3 weeks. The mean percentage reduction in exercise heart rate (EHR) compared to placebo, at 24 h after dosing, was 16% following Oros treatment for 3 weeks, and 12% following SR administration. After a single dose of oxprenolol Oros EHR, was reduced by 9% at 24 h compared to placebo. At 3 weeks the Oros formulation was significantly better than the SR tablet at reducing EHR. Oxprenolol Oros 16/260 was effective over 24 h and well tolerated.(ABSTRACT TRUNCATED AT 250 WORDS)