A randomized double-blind placebo-controlled study of the long-term efficacy and safety of diethylpropion in the treatment of obese subjects.

OBJECTIVE: To evaluate the efficacy of diethylpropion on a long-term basis, with emphasis in cardiovascular and psychiatric safety aspects. DESIGN: Randomized, double-blind, placebo-controlled trial. MEASUREMENTS: Following a 2-week screening period, 69 obese healthy adults received a hypocaloric diet and were randomized to diethylpropion 50 mg BID (n=37) or placebo (n=32) for 6 months. After this period, all participants received diethylpropion in an open-label extension for an additional 6 months. The primary outcome was percentage change in body weight. Electrocardiogram (ECG), echocardiography and clinical chemistry were performed at baseline and every 6 months. Psychiatric evaluation and application of Hamilton rating scales for depression and anxiety were also performed by experienced psychiatrists at baseline and every 3 months. RESULTS: After 6 months, the diethylpropion group lost an average of 9.8% (s.d. 6.9%) of initial body weight vs 3.2% (3.7%) in the placebo group (P<0.0001). From baseline to month 12, the mean weight loss produced by diethylpropion was 10.6% (8.3%). Participants in the placebo group who were switched to diethylpropion after 6 months lost an average of 7.0% (7.7%) of initial body weight. The difference between groups at month 12 was not significant (P=0.07). No differences in blood pressure, pulse rate, ECG and psychiatric evaluation were observed. Dry mouth and insomnia were the most frequent adverse events. CONCLUSION: Diethylpropion plus diet produced sustained and clinically significant weight loss over 1 year. It seems to be safe in relation to cardiovascular and psychiatric aspects in a well-selected population.

Cardiovascular risk and obesity.

BACKGROUND: This is an overview of the mechanisms of obesity and its relation to cardiovascular risks, describing the available treatment options to manage this condition. MAIN BODY: The pathogenesis of obesity includes the balance between calories consumed and energy expenditure followed by the maintenance of body weight. Diet, physical activity, environmental, behavioral and physiological factors are part of the complex process of weight loss, since there are several hormones and peptides involved in regulation of appetite, eating behavior and energy expenditure. The cardiovascular complications associated to obesity are also driven by processes involving hormones and peptides and which include inflammation, insulin resistance, endothelial dysfunction, coronary calcification, activation of coagulation, renin angiotensin or the sympathetic nervous systems. Pharmacological treatments are often needed to insure weight loss and weight maintenance as adjuncts to diet and physical activity in people with obesity and overweight patients. CONCLUSION: To accomplish satisfactory goals, patients and physicians seek for weight loss, weight maintenance and improvement of the risk factors associated to this condition, especially cardiovascular risk.

Effects of two diet techniques and delivery mode on weight loss, metabolic profile and food intake of obese adolescents: a fixed diet plan and a calorie-counting diet.

The aim of this study is to compare the weight loss of obese adolescents on two different low-calorie diets: fixed diet plan and calorie-counting diet. This is a randomized clinical study with 66 obese adolescents (body mass index Z score (ZBMI)>+3, 13.7±0.7 years, 60.6% male) with anthropometric, food intake, physical activity, laboratory, body composition and stage of pubertal development data evaluated. There was a reduction in the ZBMI in both groups (P<0.0001), without significant difference between them (P=0.87). There was a significant reduction in insulin, and homeostasis model assessment insulin resistance (HOMA-IR), with no difference between groups. A reduction in total energy intake of the groups was found, with an increase in the proportion of protein and reduction in carbohydrates. In this cohort of severely obese adolescents, fixed diet plan and calorie-counting diet led to a similar reduction of ZBMI, metabolic markers and total energy intake.

[Frequency of utilization and reasons for exclusion from thrombolytic therapy in patients with acute myocardial infarction in Salvador-Bahia]. / Freqüência de utilização e razões de exclusão da terapia trombolítica no infarto agudo do miocárdio em Salvador-Bahia.

PURPOSE: To determine the rate of utilization and reasons for exclusion from thrombolytic therapy in acute myocardial infarction (AMI) in the setting of Intensive Care Unit (ICU) Salvador-BA. METHODS: Retrospective cohort study recording patients admitted with suspected AMI in six ICU in Salvador-BA between January/93 and December/94 were reviewed. RESULTS: Three hundred and eighty-eight of confirmed cases of AMI were analysed, 165 (42.0%) were admitted at public hospitals and 225 (58.0%) at private hospitals. Thrombolytic therapy was indicated in 143 (36.8%) patients. The thrombolysis was more frequently performed in men (PR = 1.96 IC 95% 1.39-2.77), in patients less than 60 years of age (PR = 4.46 CI 95% 2.17-9.19) and in those with Killip class I (PR = 2.62 CI 95% 1.60-4.31). The major reasons for excluding from thrombolytic therapy were late arrival, old age and lack of ST elevation. Thirty three percent of patients were excluded for more than one reasons. Multivariate analysis showed that female gender was associated with a reduced indication for thrombolytic therapy, independent of the clinical findings on admission. CONCLUSION: The frequency of the use and reasons for excluding patients from thrombolytic therapy in AMI in Salvador-BA were similar to those of other clinical studies. The recent recommendations of the Thrombolysis Brazilian Consensus will enhance the utilization of this therapy, as it expands its utilization to elderly patients and to those who arrive late to the hospital.

Obesity and obstructive sleep apnea-hypopnea syndrome.

Obstructive sleep apnea-hypopnea syndrome involves recurring episodes of total obstruction (apnea) or partial obstruction (hypopnea) of airways during sleep. Obstructive sleep apnea-hypopnea syndrome affects mainly obese individuals and it is defined by an apnea-hypopnea index of five or more episodes per hour associated with daytime somnolence. In addition to anatomical factors and neuromuscular and genetic factors, sleep disorders are also involved in the pathogenesis of sleep apnea. Obesity affects upper airway anatomy because of fat deposition and metabolic activity of adipose tissue. Obstructive sleep apnea-hypopnea syndrome and metabolic syndrome have several characteristics such as visceral obesity, hypertension and insulin resistance. Inflammatory cytokines might be related to the pathogenesis of sleep apnea and metabolic syndrome. Sleep apnea treatment includes obesity treatment, use of equipment such as continuous positive airway pressure, drug therapy and surgical procedures in selected patients. Currently, there is no specific drug therapy available with proven efficacy for the treatment of obstructive sleep apnea-hypopnea syndrome. Body-weight reduction results in improvement of sleep apnea, and obesity treatment must be emphasized, including lifestyle changes, anti-obesity drugs and bariatric surgery.