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Titolo:
A clinical trial of the use of Sibutramine for the treatment of patients suffering essential obesity
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 Gen Hosp, Serv Endocrinol, Mexico City, DF, Mexico Gen Hosp Mexico City DF Mexico Serv Endocrinol, Mexico City, DF, Mexico
Titolo Testata:
INTERNATIONAL JOURNAL OF OBESITY
fascicolo: 2, volume: 24, anno: 2000,
pagine: 144 - 150
SICI:
0307-0565(200002)24:2<144:ACTOTU>2.0.ZU;2-0
Fonte:
ISI
Lingua:
ENG
Soggetto:
BODY-MASS INDEX; WEIGHT-LOSS; RISK FACTOR; EFFICACY; OVERWEIGHT; ADULTS; WOMEN;
Keywords:
obesity treatment; Sibutramine; double blind; placebo controlled; 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, Candelaria 186, Mexico City 04370, DF, Mexico Arzneimittelforsch BASF Pharma Candelaria 186 Mexico City DF Mexico 04370
Citazione:
G. Fanghanel et al., "A clinical trial of the use of Sibutramine for the treatment of patients suffering essential obesity", INT J OBES, 24(2), 2000, pp. 144-150

Abstract

OBJECTIVE: To evaluate the safety and efficacy of Sibutramine 10 mg per os, once a day in obese patients over a period of 6 months. DESIGN: A monocenter, double-blind, placebo-controlled, parallel, prospective clinical trial. SUBJECTS: 109 male and female obese patients (BMI > 30 kg/m(2)) from 16 to65 y entered the trial. MEASUREMENTS: Body weight, body mass index (BMI), waist and waist/hip ratio, medical history, assessment of hunger, satiety and diet compliance, standard laboratory assessments, blood pressure, heart rate and EGG. RESULTS: 40 out of 55 patients in the Sibutramine group and 44 out of 54 patients in the placebo group completed the trial. Using the method of last observation carried forward (LOCF), the weight loss in the Sibutramine group was 7.52 kg (95% confidence intervals (95% CI) 6.15; 8.9) and that in theplacebo group was 3.56 kg (95% CI 2.41; 4.7). The BMI loss was 3.14 kg/m(2) (95% CI 2.58; 3.69) in the Sibutramine group and 1.46 kg/m2 (95% CI 0.99;1.93) in the placebo group. The waist reduction was 12.51 cm (95% CI 9.25;15.77) in the Sibutramine group and 3.26 cm (95% CI 1.38; 5.14) in the placebo group (P < 0.05 by paired Student's t-test for all the intragroup comparisons). 32 Sibutramine patients had 45 adverse events, the most frequent adverse events in the Sibutramine group being dry mouth (n=19), increase inblood pressure (n=5), constipation (n=5) and tachycardia (n=5); 23 placebopatients had 29 adverse events, mainly increase in blood pressure (n=11) and dry mouth (n=10). Two Sibutramine patients withdrew from the trial due to adverse events. CONCLUSION: Sibutramine induces significant loss of body weight, BMI and waist, but does not significantly affect cardiovascular function. Sibutramine was well tolerated by most of the patients.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 25/11/20 alle ore 01:14:32