Weight loss and quality of life improvement in obese subjects treated with sibutramine: a double-blind randomized multicenter study.

BACKGROUND AND AIM: Obesity affects cardiovascular risk and also quality of life (QoL). The aim of this study was to test weight loss and impact on QoL after sibutramine treatment in obese subjects. METHODS: Double-blind randomized trial on 309 outpatients (51 males, 258 females; age 41.8 +/- 10.9 years, BMI 35.0 +/- 3.1 kg/m(2)) randomized to sibutramine (n = 154) or to placebo (n = 155) treatment. A combination of sibutramine 10 mg or matching placebo and a balanced hypocaloric diet was given for 6 months with monthly evaluations. The main outcome measures were weight loss, the impact of weight on QoL, BMI, and waist circumference. RESULTS: The mean weight reduction was 8.2 kg in the sibutramine group and 3.9 in the placebo group at 6 months (p < 0.01). 40% of the sibutramine subjects and 14% of the control subjects lost > or =10% of their body weight (p < 0.01). The improvement in the impact of weight on QoL was statistically significant only in the sibutramine group at 6 months (mean -12.5 vs. -4.5 points; p < 0.01). In the sibutramine group the reduction in BMI (-3.1 vs. -1.4 kg/m(2)) and waist circumference (7.7 vs. 3.5 cm) was significantly greater (p < 0.001). The incidence of adverse events was low and similar to the placebo. CONCLUSIONS: This study confirmed that sibutramine significantly enhances the effect of diet on weight loss, BMI and waist circumference reduction, and showed a significant improvement of QoL.

[Biliary surgery in the aged]. / La chirurgia biliare nell'anziano.

Between 1980 and 1995 in the Section of General and Oncological Surgery of the Department of Surgery of the University of Catania, on a total of 1715 biliary surgical procedures, 926 were performed on the elderly patients, 287 of which in emergency. Cholelithiasis (469 cases) morbidity 4.5%, mortality 0.4%; acute colecystitis, (247 cases) morbidity 21%, mortality 12%. Choledocholithiasis (122 cases) surgical treatment (51 cases) morbidity 21.6%, mortality 3.9%; endoscopic treatment (71 cases) morbidity 9.4%, mortality 0%. Neoplasms of the biliary tract (48 cases) diagnostic laparotomises 9, surgery (27 cases) morbidity 37%, mortality 11%; endoscopy (12 cases) morbidity 33%, mortality 0%. Acute obstructive cholangitis (34 cases), surgical drainage (9 cases) morbidity 55%, mortality 33%; endoscopic drainage (22 cases) morbidity 14%, mortality 4.8%; transhepatic drainage (3 cases) morbidity 66%, mortality 33%. Acute biliary pancreatitis (6 cases) surgery (2 cases) morbidity 100%, mortality 50%; endoscopy (4 cases) morbidity 25%, mortality 0%. This experience confirms that in elderly patients the treatment of choice for cholelithiasis is cholecystectomy and for acute colecystitis is early cholecistectomy. The preferred treatment of choledocholithiasis and severe acute biliary pancreatitis is endoscopic sphincterectomy. Endoscopic or radiologic drainages are the choice for acute biliary pancreatitis. In conclusion elderly patients with surgical biliary problems should be treated by a surgical, endoscopic and radiological team, taking in account all the available procedures.

[Treatment of the residual pancreatic stump after pancreatoduodenectomy: pancreatogastrostomy]. / Trattamento del moncone pancreatico residuo dopo duodenocefalopancreatectomia: la pancreatogastrostomia.

In the last few years more and more often the use of pancreaticogastrostomy (PG) for reconstruction after pancreatoduodenectomy (PD) has been reported. Aim of this paper is to review pertinent Literature and to try to define, on the basis of Authors' experience, the role this technique may have in reducing morbidity and mortality of PD. From January 1993 to June 1995 nine pancreaticogastrostomies were performed. Five patients had an adenocarcinoma of the papilla, two had a carcinoma of the distal choledochus and two had a carcinoma of the head of the pancreas. Major complications in this series were one operative death unrelated to PG and a massive bleeding from the gastric site of the anastomosis occurred 3 days after the operation, associated to a partial dehiscence of the anastomosis, treated surgically. Reported results after pancreaticogastrostomy seem to demonstrate a dramatic decrease in morbidity and mortality after PD, however, the real value of this technique will be established only after a greater clinical experience and, when possible, wider randomized prospective studies.

[Prophylaxis of postoperative infections: immunoglobulins or antibiotics?]. / Profilassi delle infezioni postoperatorie: immunoglobuline o antibiotici?

Authors report the preliminary results of their experience in the infections prophylaxis treatment on the operated oncologic patient, with a particular care for immunoprophylaxis aiming to improve the immune defenses. 89 patients have been considered, dividing them into three groups according to the therapy carried out: e.v. immunoglobulins (300 mg/kg per day, for three days), e.v. immunoglobulins associated with routine antibiotic prophylaxis, routine antibiotic prophylaxis. The results show a remarkable reduction both of the period of postoperative bedridding in the group treated with e.v. immunoglobulins only, and of the infective complications in the patients treated with e.v. immunoglobulins (alone or in association with antibiotic prophylaxis), compared with the check group (antibiotic prophylaxis only).

Pharmacological treatment of intermittent claudication: double blind controlled study of Sulodexide vs placebo.

A double blind placebo controlled randomized study was used to assess the clinical variations caused by Sulodexide treatment (100 mg/die) vs placebo in 30 patients with a mean age of 50.3 years suffering from peripheral arterial obstructive disease of the lower limbs (II stage). The general tolerance of the therapy was monitored over the medium-term. There were marked changes in the clinical signs and symptoms in the Sulodexide group, which showed a gradual constant improvement, while they were stationary in the placebo group. Confirmation of the marked improvement in the Sulodexide group was provided by the Winsor index which showed a significant increase in these patients while only a minimum variation was observed in the placebo group. The positive antithrombotic action of the active treatment led to an increase in the blood supply in previously ischemic regions, without creating haemorrhagic risks or disturbing the haemostatic balance. The absence of adverse reactions and good systemic tolerance is also noteworthy.

Lowering of plasma viscosity by the oral administration of the glycosaminoglycan sulodexide in patients with peripheral vascular disease.

The aim of the double-blind, crossover, placebo-controlled study was to evaluate whether oral administration of sulodexide, a medium molecular weight glycosaminoglycan, had an effect on whole blood, plasma and serum viscosity, and/or plasma fibrinogen concentrations. The drug was administered orally at a dose of 500 lipoproteinlipase releasing units twice daily for 1 month to two groups of 20 patients with peripheral vascular disease; one group was administered a placebo--drug sequence and the other a drug--placebo sequence. Orally administered sulodexide had a marked effect on plasma viscosity and on plasma fibrinogen concentrations, whereas there were no effects on whole blood viscosity. No significant side-effects were observed. The fact that sulodexide was highly effective, even after oral administration, suggests it may be useful for the treatment of patients with atheromatous vascular diseases of the lower limbs requiring chronic therapy.