RESUMEN
The effects of zolpidem, an imidazopyridine derivative, were studied in 107 patients suffering from insomnia, 60.9% of whom were over 60 years of age, in a 6-month, single-blind, flexible dose, general practitioner study. Comparison was made between baseline, last day of treatment and 10 days after the end of treatment to assess efficacy and rebound insomnia. An improvement in all efficacy parameters--time taken to fall asleep, total amount of nocturnal sleep and number of nocturnal awakenings--was reported by the investigator and the patients; the improvement was evident from the first evaluation day and was maintained throughout the trial. Improvement was also maintained during the washout period with a lack of rebound insomnia. There was no sign of withdrawal symptoms and tolerance to zolpidem did not develop over the 6-month treatment period. Adverse events were mild and infrequent, and tended to resolve with a dose reduction. It is concluded that 10 mg/day zolpidem is an appropriate starting dose and is effective and safe for the treatment of sleep disturbances of different origins.
Asunto(s)
Hipnóticos y Sedantes/uso terapéutico , Piridinas/uso terapéutico , Trastornos del Inicio y del Mantenimiento del Sueño/tratamiento farmacológico , Adulto , Anciano , Anciano de 80 o más Años , Medicina Familiar y Comunitaria , Femenino , Humanos , Masculino , Persona de Mediana Edad , Placebos , ZolpidemRESUMEN
In a double-blind, randomized, multicenter, two-way crossover study, efficacy and tolerability of two glibenclamide (CAS 1028-21-8) preparations with different rates of release were compared during a 28 day long-term treatment period for each preparation. It involved 80 patients with diabetes mellitus type II difficult to stabilize orally, who had received preliminary glibenclamide treatment. The switching from one treatment to the other in particular was strictly controlled: day profiles on glucose and insulin were prepared on the last day of the long-term therapy period and again on the first two days of the next long-term therapy period. Halfway through each treatment period and on the last day of each therapy period, the glucose content of the 24 h urine was determined in order to assess diabetes stabilization. The quality of diabetes stabilization and tolerability being comparable for both treatments, there were no statistically significant differences determined for AUC, Cmin, Cmax, tmin and tmax in the insulin day profile and glucose day profile on switching from treatment A (Glibenclamid-ratiopharm) to B (reference preparation) nor from B to A. The tolerability of both preparations was very good.
Asunto(s)
Diabetes Mellitus Tipo 2/tratamiento farmacológico , Gliburida/uso terapéutico , Anciano , Glucemia/metabolismo , Método Doble Ciego , Femenino , Gliburida/administración & dosificación , Gliburida/efectos adversos , Hemoglobina A2/metabolismo , Humanos , Insulina/sangre , Masculino , Persona de Mediana EdadRESUMEN
A doubld-blind crossover study of oral domperidone (10 mg t.d.s.) involving 48 patients suffering from chronic postprandial dyspepsia, showed a significant relief of symptoms on active treatment compared to placebo. The trial lasted eight weeks, the crossover in medication taking place at four weeks. Side effects were rare and mild and it is concluded that domperidone could be a very useful drug for the symptomatic treatment of upper gastrointestinal distress.
Asunto(s)
Antieméticos/uso terapéutico , Bencimidazoles/uso terapéutico , Dispepsia/tratamiento farmacológico , Piperidinas/uso terapéutico , Adolescente , Adulto , Antieméticos/efectos adversos , Enfermedad Crónica , Ensayos Clínicos como Asunto , Método Doble Ciego , Femenino , Alimentos , Humanos , Masculino , Persona de Mediana EdadRESUMEN
In a double-blind cross-over study over eight weeks two groups of 24 patients each with symptoms of chronic postprandial dyspepsia received during the first four-week period either 10 mg domperidon t.i.d. or placebo. After four weeks the medication was exchanged. Despite some improvement of symptoms under placebo, statistical analysis revealed a significantly higher improvement rate after domperidon.
Asunto(s)
Dispepsia/tratamiento farmacológico , Hormonas Gastrointestinales/uso terapéutico , Motilina/uso terapéutico , Adolescente , Adulto , Método Doble Ciego , Evaluación de Medicamentos , Femenino , Humanos , Masculino , Persona de Mediana EdadRESUMEN
The relevance, to general practice, of the various views on the idiopathic tetany syndrome is discussed. The effect of a drug (Frubiase Calcium forte), which largely metts the requirements stemming from the above, on all important symptome and diagnostic signs was found to be statistically superior to placebo on the basis of a randomised double blind trial in 80 patients.