RESUMO
Suloctidil is a new drug that is currently being evaluated in many clinical trials for use in dementia and thrombotic disorders. Hepatotoxicity has to date been reported exclusively in the European literature, and the few available histologic descriptions have been reported in the French language. We report a case of suloctidil-induced hepatotoxicity documented by serum liver biochemical tests and liver biopsy. Histologic features included focal necrosis of hepatocytes, mild hyperplasia of Kupffer cells, and other features suggestive of mild acute hepatitis.
Assuntos
Doença Hepática Induzida por Substâncias e Drogas/etiologia , Propanolaminas/efeitos adversos , Suloctidil/efeitos adversos , Idoso , Doença de Alzheimer/tratamento farmacológico , Biópsia , Doença Hepática Induzida por Substâncias e Drogas/diagnóstico , Humanos , Fígado/patologia , Testes de Função Hepática , Masculino , Suloctidil/uso terapêuticoAssuntos
Doença Hepática Induzida por Substâncias e Drogas/etiologia , Propanolaminas/efeitos adversos , Suloctidil/efeitos adversos , Vasodilatadores/efeitos adversos , Doença Hepática Induzida por Substâncias e Drogas/diagnóstico , Humanos , Testes de Função Hepática , Masculino , Pessoa de Meia-IdadeRESUMO
Four hundred and thirty-eight patients who had suffered a thromboembolic stroke not less than two weeks or more than four months previously, were entered into a placebo-controlled randomized clinical trial to determine whether suloctidil (200 mg t.i.d.) would influence the subsequent recurrence of stroke, the occurrence of myocardial infarction, or cardiovascular death. The two treatment groups were comparable at baseline with respect to important prognostic variables and there was good adherence to the study protocol during an average follow-up of 20 months. Significantly more patients complained of side-effects in the suloctidil group and more hepatotoxicity was also reported in the suloctidil group. Four cases of clinical hepatitis were suspected to be due to suloctidil, each of which was reversible on termination of study treatment; relative increases in SGOT and SGPT at three months in the suloctidil group were found to be mild and transient. The primary analysis of efficacy was based on the incidence of the first event of stroke, myocardial infarction or cardiovascular death, but excluding events that occurred more than 28 days after complete withdrawal from study medication for whatever reason. Thus, the primary analysis included 38 events in the suloctidil group and 47 in the placebo group (p = 0.17) representing a risk reduction of 24%. If total mortality is substituted for cardiovascular death, the corresponding figures are 47 in the suloctidil group and 58 in the placebo group (p = 0.08).(ABSTRACT TRUNCATED AT 250 WORDS)
Assuntos
Transtornos Cerebrovasculares/prevenção & controle , Propanolaminas/uso terapêutico , Suloctidil/uso terapêutico , Tromboembolia/prevenção & controle , Ensaios Clínicos como Assunto , Feminino , Humanos , Masculino , Infarto do Miocárdio/prevenção & controle , Cooperação do Paciente , Distribuição Aleatória , Fumar , Suloctidil/efeitos adversosRESUMO
15 aged patients with clinical and laboratory evidence of cerebrovascular insufficiency and/or myocardial sclerosis were given suloctidil (Locton) at the daily dose of 200 mg X 3, for 180 days, under the conditions of an open trial. Blood and plasma viscosity, red cell deformability, total lipids, cholesterol, triglycerides, fibrinolysis (plasminogen, antiplasmin, euglobulins with and without activator, fibrinogen), and capillaroscopic parameters in the small conjunctival vessels (artery, vein, and capillary diameter, appearance of collaterals, red cell aggregation and flow homogeneity) were evaluated. After 30 days of treatment and particularly at the end of the trial a significant improvement of almost all these parameters was observed. Tolerance was always excellent.
