PMID- 16861099
OWN - NLM
STAT- MEDLINE
DCOM- 20060929
LR  - 20220408
IS  - 0149-2918 (Print)
IS  - 0149-2918 (Linking)
VI  - 28
IP  - 5
DP  - 2006 May
TI  - Use of sibutramine in obese mexican adolescents: a 6-month, randomized, 
      double-blind, placebo-controlled, parallel-group trial.
PG  - 770-82
AB  - BACKGROUND: The prevalence of overweight and obesity in children and adolescents 
      is increasing in both the United States and Mexico. OBJECTIVE: The goal of this 
      article was to assess the efficacy and safety of sibutramine in obese Mexican 
      adolescents. METHODS: This was a 6-month, randomized, double-blind, 
      placebo-controlled, prospective clinical trial of sibutramine QD. Male and female 
      patients aged 14 to 18 years with sex-specific body mass index (BMI) for age and 
      sex >85th percentile were eligible. The primary end points for the trial were the 
      baseline versus end point absolute values for body weight, BMI, and percentage of 
      the initial BMI (%BMI); secondary end points were waist circumference and 
      percentage of the initial waist circumference (%waist). These were measured at 
      days -15, 0, 30, 60, 90, 120, 150, and 180 of the study. Quality of life was 
      assessed at the study start and end using the 36-Item Short-Form Health Survey 
      (SF-36) questionnaire. Blood pressure and heart rate were assessed, and adverse 
      events (AEs) were recorded. Both groups received individually tailored diet and 
      exercise programs. RESULTS: Forty-six patients (age range, 14-18 years) with a 
      BMI >95th percentile for age were included (sibutramine group, n = 23 [14 
      females, 9 males]; placebo group, n = 23 [12 females, 11 males]). Twenty-one 
      patients in the sibutramine group and 19 patients in the placebo group completed 
      the 6-month trial. Using the intent-to-treat data, weight (mean [SD]) in the 
      sibutramine group changed from 92.5 (14.6) kg to 85.7 (14.4) kg, for a net weight 
      loss of 7.3 kg (95% CI 4.6-9.9), a waist circumference loss of 8.0 cm (95% CI, 
      4.7-11.3), and a % BMI loss of 9.2% (95% CI, 6.9-11.6). In the placebo group, 
      weight changed from 98.9 (22.7) kg to 94.6 (22.5) kg, a weight loss of 4.3 kg 
      (95% CI, 1.7-6.9), a waist circumference loss of 3.8 cm (95% CI, 0.7-7.0), and a 
      %BMI loss of 5.2% (95% CI, 2.4-7.9) (P < 0.05 for all intragroup comparisons; P > 
      0.05 for the intergroup comparisons). Mean (SD) scores on the SF-36 scale in the 
      sibutramine group changed from 78.0 (13.3) at baseline to 84.8 (7.4) at study end 
      (P < 0.05); the respective values in the placebo group were 82.8 (10.3) and 87.3 
      (7.6) (P < 0.05). At base-line, systolic blood pressure (SBP) was 116.7 (5.9) mm 
      Hg in the sibutramine group and 118.3 (7.6) mm Hg in the placebo group; at end 
      point, the respective SBPs were 112.4 (9.6) mm Hg and 112.6 (6.5) mm Hg. At 
      baseline, diastolic blood pressure (DBP) was 78.9 (4.5) mm Hg in the sibutramine 
      group and 79.5 (5.2) mm Hg in the placebo group; at end point, the respective 
      DBPs were 73.5 (6.3) mm Hg and 76.6 (6.2) mm Hg. At baseline, heart rate was 76.3 
      (6.4) beats/min in the sibutramine group and 81.1 (9.5) beats/min in the placebo 
      group; at end point, the respective findings were 79.8 (8.8) beats/min and 77.6 
      (8.6) beats/min (P > 0.05 for all preceding intergroup comparisons). One patient 
      in the sibutramine group had increased blood pressure (at month 3) and 3 had 
      increased heart rate (at months 1, 2, and 4); 2 patients receiving placebo had 
      increased blood pressure (month 3) and 2 had increased heart rate (at months 1 
      and 3). These changes disappeared in 1 week and did not require treatment or 
      trial suspension. Additionally, in the sibutramine group, 3 patients experienced 
      4 mild AEs: headache, dry mouth, headache with nausea, and headache with weakness 
      and paleness (P > 0.05). In the placebo group, 3 patients experienced 4 mild AEs: 
      2 cases of headache, as well as 1 case of headache with somnolence and 1 case of 
      headache with dry mouth (P > 0.05). CONCLUSION: Sibutramine 10 mg QD in addition 
      to diet and exercise was effective and generally well tolerated in this 
      population of obese Mexican adolescents.
FAU - Garcia-Morales, Leticia M
AU  - Garcia-Morales LM
AD  - Endocrinology Department, Hospital Infantil de Mexico Federico Gomez, Mexico 
      City, Mexico.
FAU - Berber, Arturo
AU  - Berber A
FAU - Macias-Lara, Cecilia C
AU  - Macias-Lara CC
FAU - Lucio-Ortiz, Claudia
AU  - Lucio-Ortiz C
FAU - Del-Rio-Navarro, Blanca E
AU  - Del-Rio-Navarro BE
FAU - Dorantes-Alvarez, Luis M
AU  - Dorantes-Alvarez LM
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Appetite Depressants)
RN  - 0 (Cyclobutanes)
RN  - WV5EC51866 (sibutramine)
SB  - IM
MH  - Adolescent
MH  - Appetite Depressants/*therapeutic use
MH  - Cyclobutanes/*therapeutic use
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Mexico
MH  - Obesity/*drug therapy
MH  - Prospective Studies
MH  - Time Factors
MH  - Weight Loss/*drug effects
EDAT- 2006/07/25 09:00
MHDA- 2006/09/30 09:00
CRDT- 2006/07/25 09:00
PHST- 2006/07/25 09:00 [pubmed]
PHST- 2006/09/30 09:00 [medline]
PHST- 2006/07/25 09:00 [entrez]
AID - S0149-2918(06)00119-6 [pii]
AID - 10.1016/j.clinthera.2006.05.008 [doi]
PST - ppublish
SO  - Clin Ther. 2006 May;28(5):770-82. doi: 10.1016/j.clinthera.2006.05.008.