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Titolo:
Second phase of a double-blind study clinical trial on Sibutramine for thetreatment of patients suffering essential obesity: 6 months after treatment cross-over
Autore:
Fanghanel, G; Cortinas, L; Sanchez-Reyes, L; Berber, A;
Indirizzi:
Arzneimittelforsch BASF Pharma, Mexico City 04370, DF, Mexico Arzneimittelforsch BASF Pharma Mexico City DF Mexico 04370 70, DF, Mexico Hosp Gen Mexico, Dept Endocrinol, Obes Res Clin, Mexico City, DF, Mexico Hosp Gen Mexico Mexico City DF Mexico Res Clin, Mexico City, DF, Mexico
Titolo Testata:
INTERNATIONAL JOURNAL OF OBESITY
fascicolo: 5, volume: 25, anno: 2001,
pagine: 741 - 747
SICI:
0307-0565(200105)25:5<741:SPOADS>2.0.ZU;2-U
Fonte:
ISI
Lingua:
ENG
Soggetto:
RESTING METABOLIC-RATE; WEIGHT-LOSS; LONG-TERM; DIETARY RESTRICTION; ENERGY-EXPENDITURE; EFFICACY; TOLERABILITY; AGENT;
Keywords:
obesity treatment; Sibutramine; double blind; placebo controlled; cross-over clinical trial;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
22
Recensione:
Indirizzi per estratti:
Indirizzo: Berber, A Arzneimittelforsch BASF Pharma, La Candelaria 186,Colonia Atlantida,CP 04370, Mexico City 04370, DF, Mexico Arzneimittelforsch BASF Pharma La Candelaria 186,Colonia Atlantida,CP 04370 Mexico City DF Mexico 04370
Citazione:
G. Fanghanel et al., "Second phase of a double-blind study clinical trial on Sibutramine for thetreatment of patients suffering essential obesity: 6 months after treatment cross-over", INT J OBES, 25(5), 2001, pp. 741-747

Abstract

OBJECTIVE: To evaluate the weight gain after Sibutramine 10 mg daily discontinuation. To evaluate the effect of Sibutramine 10 mg daily in patients who were on a diet for 6 months. DESIGN: After a double-blind, placebo-controlled, parallel, prospective phase for 6 months, the treatments were crossed over and the patients continued in double-blind observation for another 6-month period. SUBJECTS: Forty out of 44 patients who were on Sibutramine and 42/44 who were on placebo switched the trial medication. All the patients were obese at the beginning of the trial (body mass index, BMI > 30 kg /m(2)). During the first phase, the weight loss in the Sibutramine group was 7.52 kg (95% confidence intervals (95% CI) 6.15; 8.9) and that in the placebo group 3.56 kg (95% CI 2.41; 4.7) (using last observation carried forward (LOCF)). MEASUREMENTS: Body weight, BMI, waist, medical history, assessment of hunger, satiety and diet compliance, standard laboratory assessments, blood pressure, heart rate and ECC. RESULTS: Thirty out 40 patients in the Sibutramine/placebo (S/P) group and32 out of 42 in the placebo/Sibutramine (P/S) group completed the second phase of the trial. During the second part of the trial the S/P gained 3.21 (95% CI 2.15; 4.26) kg, 1.21 (0.82; 1.59) kg/m(2), and 2.83 (1.55; 4.12) waist cm. The P/S group lost 1.62 (2.62; 0.61), 0.67 (1.09; -0.25) kg/m(2), and 1.85 (3.18; 0.53) waist cm. Eleven patients in the S:P group suffered 14adverse events, mainly blood pressure increase (n = 4); 19 patients in theP/S group had 29 adverse events, mainly dry mouth (n = 8), constipation (n= 5) and blood pressure increase (n = 4). Only one PIS patient withdrew because of an adverse event. CONCLUSIONS: After Sibutramine discontinuation patients had weight gain but they did not reach the baseline body weight. No significant adverse events presented after Sibutramine discontinuation. When Sibutramine was administrated to patients after 6 months of diet, the weight plateau was broken. Early Sibutramine administration had better effects than late post-diet administration. Sibutramine was well tolerated by the patients.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 30/11/20 alle ore 12:12:01