Weight reduction by sibutramine in obese subjects in primary care medicine: the SAT Study.

BACKGROUND: Sibutramine is a selective serotonin and noradrenaline reuptake inhibitor that is known to reduce body weight. The efficacy of this drug in primary care medicine is currently unknown. OBJECTIVE: To study, in a primary healthcare setting, the effect of a standardized non-pharmacological treatment program and 15 mg sibutramine or placebo on long-term weight reduction in obese subjects with a body mass index >or= 30 and < 40 kg/m(2). DESIGN: A multicentre, double-blind, placebo-controlled, randomized, parallel group comparison over 54 weeks of continuous therapy. SETTING: 33 general practitioners in Germany. SUBJECTS: 389 obese patients were recruited of whom 362 were randomized. MEASUREMENTS: Primary measure was weight reduction at week 54; others included reduction in BMI, waist circumference, waist-hip ratio, blood pressure and blood lipids. RESULTS: 348 obese subjects were analyzed using an intention-to-treat analysis. Mean weight loss in the sibutramine (S) group was 8.1 +/- 8.2 kg vs. 5.1 +/- 6.5 kg in the placebo (P) group (p < 0.001; Intent-to-treat analysis). More subjects lost more than 5 % and 10 % of initial weight with sibutramine than with placebo (5 %, S: 62.6 %, P: 41.4 %, p < 0.001; 10 %, S: 40.8, P: 19.0 %, p < 0.001). Weight loss was accompanied by an improvement in the lipid profile, in particular, an increase in HDL-cholesterol and a decrease in fasting triglycerides. In both groups, systolic and diastolic blood pressure decreased in those with moderate hypertension and remained unchanged in those with normal blood pressure at baseline. There was a modest increase in heart rate in S (1.9 beats/min) vs. P (- 0.9 beats/min) (p < 0.05). CONCLUSIONS: Under primary care conditions, sibutramine 15 mg daily proved to be a safe and effective drug for additional weight loss in obese subjects undergoing a comprehensive weight reduction program.

The cost implications of obesity for health care and society.

The prevalence of obesity (body mass index (BMI) > 30 kg/m2) has been rising consistently in recent decades. Obesity is among the key promoters of a number of other highly prevalent and often fatal diseases. These characteristics make obesity one of the major cost drivers in Western health-care systems. For Germany, the direct costs of obesity itself are estimated to be about 850 million DM. Taking into account all attributable co-morbidities, the direct costs are estimated to be between 8.6-11.5 billion DM. If the indirect costs are also included in the calculations, these costs will multiply still further. There is a need for clinical trials in a primary care setting, in order to determine the impact of drug treatment (for example, sibutramine) on the treatment of obesity, the quality of life and the benefits of this treatment by means of a cost-benefit analysis (CBA) and cost-utility analysis (CUA).

[Conception and conversion of medical technology assessment--an international comparison]. / Konzeption und Umsetzung des Medical Technology Assessment--ein internationaler Vergleich.

The outcome of adjusting health care spending to the overall economic performance of the country has become a major issue of health care policy of the industrialized nations. How can progress in medicine be consistently financed under the restriction of fixed contributions to mandatory sickness funds? Medical Technology Assessment is an interdisciplinary concept that proposes solutions to this issue. This article discusses the concept of Medical Technology Assessment and shows how Medical Technology Assessment should be implemented into the health care system. This article depicts how Medical Technology Assessment is implemented in the United States of America, in the United Kingdom and in the Netherlands. It also discusses which institutions take steps towards Medical Technology Assessment in Germany. The second article examines how to implement Medical Technology Assessment into the German health care system.

Necrotizing enterocolitis (NEC)--mortality and long-term results.

From 1974-88 73 patients were treated for necrotizing enterocolitis (NEC) in the surgical department at the Children's Hospital of Cologne. 70% of these had other complaints and 77% were premature babies, of which 30% were small-for-dates. A greater than expected proportion of deaths occurred in babies not of low birth-weight: Of those above 2500 g 35% died and of those under 1500 g 20%. Initial signs and symptoms became apparent in 80% within the first two weeks. The most frequent signs were distended abdomen (81%), diffuse tenderness (46%), bloody stools (39%) and absent peristalsis (39%). Radiology showed edema of the bowel wall in 49%, free air in the abdomen in 38% and intestinal pneumatosis in 34%. It remains questionable whether peritoneal lavage could lead to earlier diagnosis and referral of the sick children to the hospital. The course of the disease was less severe when babies had received breast milk. Colon and distal ileum were involved most frequently. Laparotomy showed perforations of the bowel in 39 patients (64%), inflammatory alterations in 18 and necroses in 12. The survival rates improved within the period of 1974-88 from 64 to 79%. Thirty-two of the 51 survivors were available for follow-up: 9 patients (28%) had more than 4 stools/day, 8 (25%) were underweight, 8 (25%) suffered from food intolerance, 5 (16%) from diarrhoea, 4 (13%) from limited exercise tolerance. Physical retardation could only be seen in 3 children under the age of 2.