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Titolo:
Six-month treatment of obesity with sibutramine 15 mg; A double-blind, placebo-controlled monocenter clinical trial in a Hispanic population
Autore:
Cuellar, GEM; Ruiz, AM; Monsalve, MCR; Berber, A;
Indirizzi:
Arzneimittelforsch BASF Pharma, Mexico City, DF, Mexico ArzneimittelforschBASF Pharma Mexico City DF Mexico co City, DF, Mexico IMSS Delegac 04, Modulo Diabet, Hosp Psiquiatrico, Unidad Med Familiar, Mexico City, DF, Mexico IMSS Delegac 04 Mexico City DF Mexico Familiar, Mexico City, DF, Mexico IMSS Delegac 04, Comite Local Invest, Hosp Psiquiatrico, Unidad Med Familiar, Mexico City, DF, Mexico IMSS Delegac 04 Mexico City DF Mexico Familiar, Mexico City, DF, Mexico IMSS, Unidad Invest Med Enfermed Metab, Ctr Med Nacl Siglo 21, Mexico City, DF, Mexico IMSS Mexico City DF Mexico tr Med Nacl Siglo 21, Mexico City, DF, Mexico
Titolo Testata:
OBESITY RESEARCH
fascicolo: 1, volume: 8, anno: 2000,
pagine: 71 - 82
SICI:
1071-7323(200001)8:1<71:STOOWS>2.0.ZU;2-6
Fonte:
ISI
Lingua:
ENG
Soggetto:
MEXICAN-AMERICANS; NATIONAL-HEALTH; SAN-ANTONIO; WEIGHT-LOSS; US ADULTS; PREVALENCE; OVERWEIGHT; EFFICACY; WOMEN; CITY;
Keywords:
obesity treatment; sibutramine; placebo-controlled; clinical trial; Hispanic population;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Life Sciences
Citazioni:
32
Recensione:
Indirizzi per estratti:
Indirizzo: Berber, A Arzneimittelforsch BASF Pharma, Candelaria 186,Colonia Atlantida,CP 04370,Mexico City, DF, Mexico Arzneimittelforsch BASF Pharma Candelaria186,Colonia Atlantida,CP 04370 Mexico City DF Mexico
Citazione:
G.E.M. Cuellar et al., "Six-month treatment of obesity with sibutramine 15 mg; A double-blind, placebo-controlled monocenter clinical trial in a Hispanic population", OBES RES, 8(1), 2000, pp. 71-82

Abstract

Objective: To evaluate the safety and efficacy of sibutramine 15 mg by mouth once per day in obese patients over a period of 6 months. Research Methods and Procedures: A monocenter, double-blind, placebo controlled, parallel, prospective clinical trial was carried out. Sixty-nine male and female obese patients (body mass index [BMI] > 30 kg/m(2)) aged 16 to65 years entered the trial. Results: 22 of 35 patients in the sibutramine group and 9 of 34 patients in the placebo group completed the trial. The high dropout rate in the sibutramine group was due to adverse events in 3 cases, lack of efficacy (as judged by patients) in 7, loss to follow-up in 2, and an orthopedic device being worn in 1; in the placebo group the dropouts were ascribed to lack of efficacy (as judged by patients) in 17 cases and to loss to follow-up in 8 cases. Using the method of last observation carried forward, the weight loss in the sibutramine group was 10.27 kg (95% confidence intervals [95% CI] 7.66; 13.07) and 1.26 kg (95% CI 0.3; 2.23) in the placebo group. The BMI loss was 4.17 kg/m(2) (95% CI 3.11; 5.22) in the sibutramine group and 0.53 kg/m(2) (95% CI 0.13; 0.92) in the placebo group. The waist circumference 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 control group (p < 0.05 by paired Student's ttest for all the intragroup comparisons). Twenty-three sibutramine patients had 34 adverse events, the most frequent adverse events in the sibutramine group were upper respiratory tract infections (n = 6) and constipation (n= 6); 16 placebo patients had 21 adverse events. Three sibutramine patients withdrew their informed consent when they had adverse events,Discussion: The results show that sibutramine induces significant loss of body weight and waist circumference. Cardiovascular function was not significantly affected by sibutramine. Sibutramine was well tolerated by most of the patients.

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Documento generato il 25/11/20 alle ore 01:03:07