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1.
Cephalalgia ; 30(12): 1458-67, 2010 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-20974604

RESUMEN

INTRODUCTION: This study investigated the efficacy and tolerability of the highly selective iNOS inhibitor GW274150 in prophylaxis of migraine headache. SUBJECTS AND METHODS: The study was conducted in two parts, each comprising a 4-week baseline period, a 12-week, double-blind, parallel-group treatment period, and a 4-week follow-up period. The study had an adaptive design in that findings of Part 1 of the study were used to inform the conduct of Part 2. Following an interim analysis at the end of Part 1, the trial could be stopped for futility or continued in Part 2 to study the full-dose response or to increase sample size in case initial assumptions had been violated. The primary end-point in both parts of the study was the probability of the occurrence of a migraine headache day during the baseline period and the treatment period. RESULTS: In Part 1, adult male and female patients with migraine received GW274150 60 mg (n = 37), 120 mg (n = 37), or placebo (n = 38) once daily for 12 weeks. In Part 2, female patients with migraine received GW274150 60 mg (n= 160) or placebo (n = 154) once daily for 12 weeks. GW274150 was no more effective than placebo for the primary efficacy end-point or any secondary efficacy end-point in Part 1 or Part 2. GW274150 was generally well tolerated. CONCLUSIONS: GW274150 at doses predicted to inhibit iNOS >80% did not differ from placebo in the prophylaxis of migraine. The results do not support a role of iNOS inhibition in migraine prevention.


Asunto(s)
Inhibidores Enzimáticos/uso terapéutico , Trastornos Migrañosos/prevención & control , Óxido Nítrico Sintasa de Tipo II/antagonistas & inhibidores , Sulfuros/uso terapéutico , Adulto , Método Doble Ciego , Femenino , Humanos , Masculino
2.
Br J Nutr ; 97(3): 550-60, 2007 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-17313718

RESUMEN

Long-term supplementation with conjugated linoleic acid (CLA) reduces body fat mass (BFM) and increases or maintains lean body mass (LBM). However, the regional effect of CLA was not studied. The study aimed to evaluate the effect of CLA per region and safety in healthy, overweight and obese adults. A total of 118 subjects (BMI: 28-32 kg/m2) were included in a double blind, placebo-controlled trial. Subjects were randomised into two groups supplemented with either 3 x 4 g/d CLA or placebo for 6 months. CLA significantly decreased BFM at month 3 (Delta=- 0 x 9 %, P=0 x 016) and at month 6 (Delta=- 3 x 4 %, P=0 x 043) compared with placebo. The reduction in fat mass was located mostly in the legs (Delta=- 0 x 8 kg, P<0 x 001), and in women (Delta=-1 x 3 kg, P=0 x 046) with BMI >30 kg/m2 (Delta=-1 x 9 kg, P=0 x 011), compared with placebo. The waist-hip ratio decreased significantly (P=0 x 043) compared with placebo. LBM increased (Delta=+0 x 5 kg, P=0 x 049) within the CLA group. Bone mineral content was not affected (P=0 x 70). All changes were independent of diet and physical exercise. Safety parameters including blood lipids, inflammatory and diabetogenic markers remained within the normal range. Adverse events did not differ between the groups. It is concluded that supplementation with CLA in healthy, overweight and obese adults decreases BFM in specific regions and is well tolerated.


Asunto(s)
Tejido Adiposo/efectos de los fármacos , Suplementos Dietéticos , Ácidos Linoleicos Conjugados/uso terapéutico , Obesidad/tratamiento farmacológico , Sobrepeso/efectos de los fármacos , Tejido Adiposo/patología , Adolescente , Adulto , Anciano , Antropometría/métodos , Composición Corporal/efectos de los fármacos , Índice de Masa Corporal , Peso Corporal/efectos de los fármacos , Método Doble Ciego , Ingestión de Energía/efectos de los fármacos , Ejercicio Físico , Femenino , Humanos , Ácidos Linoleicos Conjugados/efectos adversos , Lípidos/sangre , Masculino , Persona de Mediana Edad , Obesidad/patología , Relación Cintura-Cadera , Pérdida de Peso/efectos de los fármacos
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