OBJECTIVE:To determine values of simple anthropometric measurements which are associated with the presence of type 2 diabetes mellitus, hypertension and dyslipidaemia and to assess anthropometric cut-off values for predicting the likelihood of these chronic conditions in a Mexican population. DESIGN AND SETTING: The data were obtained from PRIT (Prevalence of Cardiovascular Risk Factors in General Hospital Workers) surveys from 1994 to 2000 adjusted to the structure of the overall Mexican population. SUBJECTS: A total of 2426 men and 5939 women aged 38.99 AE 7.11 and 39.11 AE 14.25 y, respectively. MEASUREMENTS: The optimal sensitivity and specificity of using various cut-off values of BMI (body mass index), WHR (waistto-hip ratio), WC (waist circumference) and WTH (waist-to-height ratio) to predict type 2 diabetes mellitus (DM), hypertension (HT), or dyslipidaemia were examined by receiver operating characteristic curve (ROC) analysis. The likelihood ratios for having diabetes, hypertension and dyslipidaemia in subjects with various cut-off values of BMI, WHR, WC and WTH were calculated. Multiple step-wise logistic regression analysis was used to examine the independent relationship between the anthropometric indexes, age and smoking, and the odds ratio of having chronic conditions. RESULTS: The BMI cut-off to predict DM, HT, or dyslipidaemia varied from 25.2 to 26.6 kg=m 2 in both men and women. The optimal WC cut-offs were 90 cm in men and 85 cm in women. The WHR cut-off was about 0.90 in men and 0.85 in women, and the optimal WTH cut-off was 52.5 in men and varied from 53 to 53.5 in women. The cut-off levels for WC, WHR and WTH corresponded to the inflexion points in the likelihood ratio graphs. In the case of BMI likelihood ratio graphs, we found a significant increase in the risk for chronic conditions from 22 to 23 BMI levels in both genders. Logistic regression analyses disclosed that only BMI and age were included in all the models as well as the influence of smoking in DM and dyslipidaemia in men. CONCLUSION: Although these results may not be readily applied to the rest of the Mexican population or to other Hispanic populations, they point to the necessity of similar studies with large randomized samples to find the cut-off levels for chronic conditions in different populations.
OBJECTIVE: To evaluate the safety and ef®cacy 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 b b 30 kgam 2 ) from 16 to 65 y entered the trial. MEASUREMENTS: Body weight, body mass index (BMI), waist and waistahip ratio, medical history, assessment of hunger, satiety and diet compliance, standard laboratory assessments, blood pressure, heart rate and ECG. 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% con®dence intervals (95% CI) 6.15; 8.9) and that in the placebo group was 3.56 kg (95% CI 2.41; 4.7). The BMI loss was 3.14 kgam 2 (95% CI 2.58; 3.69) in the Sibutramine group and 1.46 kgam 2 (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 in blood pressure (n 5), constipation (n 5) and tachycardia (n 5); 23 placebo patients 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 signi®cant loss of body weight, BMI and waist, but does not signi®cantly affect cardiovascular function. Sibutramine was well tolerated by most of the patients.
Metformin is an effective, safe, and well-tolerated treatment that improves metabolic control and favorably modifies secondary clinical alterations due to insulin resistance, such as arterial hypertension, overweight, and hyperlipidemia, in obese patients with NIDDM suffering from secondary failure to sulfonylureas.
This 6-month randomized study evaluated the safety and efficacy of sibutramine in 57 overweight Hispanic patients with hypertension. Following a 2-week washout to confirm the diagnosis of hypertension, antihypertensive medication was adjusted to achieve a blood pressure less than 140/90 mm Hg before institution of either sibutramine 10 mg or placebo once a day. A body mass index in excess of 27 kg/m2 was required for entry. At study end, weight had changed from 75.4+/-9.6 to 70.0+/-9.5 kg in the sibutramine group and from 77.9+/-9.0 to 74.5+/-9.4 kg in the placebo group. In the sibutramine group, systolic blood pressure was 127.8+/-5.8 mm Hg after stabilization and 125.2+/-8.5 mm Hg after completion of the trial; respective values for diastolic blood pressure were 82.4+/-3.7 and 81.5+/-4.6 mm Hg. With placebo, blood pressure dropped from 129.0+/-7.1/80.9+/-4.9 mm Hg to 122.8+/-9.7/80.3+/-5.4 mm Hg at the same timepoints. In the sibutramine group, 14 patients reported 21 adverse events, most frequently headache (n=5), constipation (n=4), and dry mouth (n=4). In the placebo group, 13 patients had 20 adverse events. Sibutramine is safe and effective in overweight Hispanic patients with hypertension, but monitoring of blood pressure and titration of antihypertensive medication are necessary.
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