RESUMEN
BACKGROUND: Relapse is frequent after initial treatment for gastro-oesophageal reflux. An alternative strategy to intermittent or continuous therapy may be on-demand treatment. AIM: To compare the efficacy and safety of on-demand lansoprazole 15 mg and placebo treatment in patients with gastro-oesophageal reflux. METHODS: This was a multicentre, randomized, double-blind study in two parallel groups of patients. In the acute study phase, all included patients (n = 203) were treated with lansoprazole 15 mg (once per day) for 4 weeks. At week 4, asymptomatic patients entered the 6-month, on-demand, follow-up phase and were randomized to receive either lansoprazole 15 mg (once per day) or placebo. RESULTS: A higher percentage of patients in the lansoprazole group completed the 6-month follow-up than in the placebo group [81% vs. 61% (P = 0.003)]. Only 16% of patients in the lansoprazole group discontinued the study for insufficient control of heartburn vs. 28% in the placebo group (P = 0.046). The mean daily intake in patients who completed the study was 1-5 capsules/day in the lansoprazole 15 mg group. CONCLUSIONS: On-demand treatment with lansoprazole 15 mg in symptomatic patients after short-term, continuous treatment is a promising therapeutic alternative to intermittent and continuous treatment to maintain heartburn control in patients with gastro-oesophageal reflux.
Asunto(s)
Antiulcerosos/administración & dosificación , Reflujo Gastroesofágico/tratamiento farmacológico , Pirosis/tratamiento farmacológico , Omeprazol/análogos & derivados , 2-Piridinilmetilsulfinilbencimidazoles , Adulto , Anciano , Método Doble Ciego , Femenino , Pirosis/etiología , Humanos , Lansoprazol , Masculino , Persona de Mediana Edad , Omeprazol/administración & dosificación , Satisfacción del Paciente , Resultado del TratamientoRESUMEN
OBJECTIVE: Somatostatin analogs are the first-line drugs for controlling hormone-mediated symptoms of carcinoid tumors. Prospective and retrospective studies have suggested that somatostatin analogs also have antiproliferative activity. The octapeptide lanreotide is available in sustained-release form, obviating the need for daily injections. METHODS: A total of 46 patients were enrolled in this open, prospective, phase II trial. They received lanreotide 30 mg i.m. every 14 days for 6 months when they had symptomatic carcinoid tumors, and lanreotide 30 mg i.m. every 10 days if they had nonsymptomatic tumors. Nonsymptomatic tumors were progressive before the start of the study. Tumor size was assessed every 3 months by means of computed tomography. The assessment was centralized and was made by an external panel. RESULTS: In all, 30 patients had symptomatic neuroendocrine tumors and 16 had asymptomatic neuroendocrine tumors. Five patients in the group with symptomatic tumors and two in the group with nonsymptomatic tumors were considered not to be evaluable. The mean duration of treatment was 12 months in the group with symptomatic tumors and 13 months in the other group. Among the 39 evaluable patients, two objective responses were obtained, giving an objective response rate of 5% (one in the group with symptomatic tumors and one in the other group). Nineteen patients had no significant increase in their tumor size for a mean of 9.5 months. CONCLUSIONS: Lanreotide is safe and well tolerated in patients with carcinoid tumors. It seems to have both symptomatic and antitumoral effects in this setting.
Asunto(s)
Antineoplásicos/uso terapéutico , Neoplasias del Sistema Digestivo/tratamiento farmacológico , Síndrome Carcinoide Maligno/tratamiento farmacológico , Tumores Neuroendocrinos/tratamiento farmacológico , Péptidos Cíclicos/uso terapéutico , Somatostatina/análogos & derivados , Antineoplásicos/administración & dosificación , Estudios de Casos y Controles , Esquema de Medicación , Femenino , Neoplasias Gastrointestinales/tratamiento farmacológico , Humanos , Inyecciones Intramusculares , Masculino , Persona de Mediana Edad , Péptidos Cíclicos/administración & dosificación , Estudios Prospectivos , Somatostatina/administración & dosificación , Somatostatina/uso terapéutico , Factores de TiempoRESUMEN
BACKGROUND: Somatostatin analogues effectively control flushing and diarrhoea in patients with the carcinoid syndrome. The octapeptide lanreotide is available in slow release form, which could eliminate the necessity of twice a day injections as with octreotide. PATIENTS AND METHODS: 39 patients with carcinoid syndrome were included in a prospective multicentre study. Patients received lanreotide 30 mg intramuscularly every 14 days for six months. The number and intensity of flushing episodes and bowel movements, urinary 5 hydroxy-indolacetic acid (5 HIAA) concentrations, and variations of tumour mass were recorded. RESULTS: After one month of treatment, flushing episodes (median (range)) decreased significantly (3 (0.3-24) episodes per day v 1 (0-15), p = 0.04) and completely resolved in 39% of the patients. A significant decrease was seen in the number of bowel movements and discomfort related to diarrhoea. Urinary 5 HIAA concentrations were unchanged in 57% of the patients and decreased in 18%. After six months of treatment, the actuarial proportions of patients with at least a 50% decrease in the number of flushing episodes and bowel movements were 54% and 56%, respectively. Forty two per cent of the patients who were treated for six months had at least a 50% reduction in 5 HIAA values. No clear signs of regression of tumours were seen in any of the patients. Lanreotide was well tolerated despite transient mild pain or erythema at the injection site in 25% of the patients. Biliary lithiasis appeared in two patients after six months of lanreotide. CONCLUSION: Lanreotide, 30 mg intramuscularly every other week, is an effective and convenient treatment in patients with the carcinoid syndrome.