The experience of sibutramine administration in patients with obesity and controlled arterial hypertension

BACKGROUND: Obesity is a metabolic disorder that becomes epidemic. Visceral adiposity increases the risk of arterial hypertension, diabetes mellitus and other comorbidities. According to this, the main aim of obesity treatment is not only a weight loss but also a decrease of the risk of comorbidities. AIMS: to assess the efficiency and safety of sibutramine in patients with obesity and arterial hypertension, to evaluate the drug influence on epicardial fat thickness. MATERIALS AND METHODS: 57 patients aged 35-60 with obesity and arterial hypertension were included in the study. All patients at the beginning and after 7 months of follow-up underwent complex examination including anthropometric measurement, ECG, office and ambulatory blood pressure measurement, echocardiography. Patients with controlled arterial hypertension were included. During the first month of follow-up patients were given general weight loss recommendations. Then sibutramine was added. Control visits to assess efficiency and safety of drug treatment were held after 1 and 6 months of follow-up. RESULTS: Women predominated among the study participants. Visceral adiposity was approved by anthropometric measurements among all patients. Most patients had impaired left ventricle geometry: concentric remodeling or hypertrophy. During the first month of follow-up the weight loss was mild: 2 kg (less than 2%) in average. Sibutramine for 1 month the weight loss increased: 3.7 kg (more than 2%) in average. After 6 months of drug administration the weight loss of patients consisted 8.6 kg (6.2%) in average. According to echocardiography results indexed mass of LV myocardium decreased in all patients more significantly in women. Also in this group of patients significant decrease of epicardial fat thickness was revealed. Adverse events of sibutramine were revealed in 26.3% of patients. The most frequent were constipation (12.3%) and dry mouth (10.6%). The severity of symptoms persisted for 1 month and then decreased, additional therapy was not required. CONCLUSIONS: Sibutramine treatment of obesity promotes effective weight loss, influences the adipose tissue distribution, decreases the progress of associated comorbidities. Sibutramine is an effective and safe drug that can be used in patients with visceral adiposity and controlled arterial hypertension

A Survey of Empirical Results on Program Slicing

International audienceBACKGROUND:Patients with peripheral artery disease have an increased risk of cardiovascular morbidity and mortality. Antiplatelet agents are widely used to reduce these complications.METHODS:This was a multicentre, double-blind, randomised placebo-controlled trial for which patients were recruited at 602 hospitals, clinics, or community practices from 33 countries across six continents. Eligible patients had a history of peripheral artery disease of the lower extremities (previous peripheral bypass surgery or angioplasty, limb or foot amputation, intermittent claudication with objective evidence of peripheral artery disease), of the carotid arteries (previous carotid artery revascularisation or asymptomatic carotid artery stenosis of at least 50%), or coronary artery disease with an ankle-brachial index of less than 0·90. After a 30-day run-in period, patients were randomly assigned (1:1:1) to receive oral rivaroxaban (2·5 mg twice a day) plus aspirin (100 mg once a day), rivaroxaban twice a day (5 mg with aspirin placebo once a day), or to aspirin once a day (100 mg and rivaroxaban placebo twice a day). Randomisation was computer generated. Each treatment group was double dummy, and the patient, investigators, and central study staff were masked to treatment allocation. The primary outcome was cardiovascular death, myocardial infarction or stroke; the primary peripheral artery disease outcome was major adverse limb events including major amputation. This trial is registered with ClinicalTrials.gov, number NCT01776424, and is closed to new participants.FINDINGS:Between March 12, 2013, and May 10, 2016, we enrolled 7470 patients with peripheral artery disease from 558 centres. The combination of rivaroxaban plus aspirin compared with aspirin alone reduced the composite endpoint of cardiovascular death, myocardial infarction, or stroke (126 [5%] of 2492 vs 174 [7%] of 2504; hazard ratio [HR] 0·72, 95% CI 0·57-0·90, p=0·0047), and major adverse limb events including major amputation (32 [1%] vs 60 [2%]; HR 0·54 95% CI 0·35-0·82, p=0·0037). Rivaroxaban 5 mg twice a day compared with aspirin alone did not significantly reduce the composite endpoint (149 [6%] of 2474 vs 174 [7%] of 2504; HR 0·86, 95% CI 0·69-1·08, p=0·19), but reduced major adverse limb events including major amputation (40 [2%] vs 60 [2%]; HR 0·67, 95% CI 0·45-1·00, p=0·05). The median duration of treatment was 21 months. The use of the rivaroxaban plus aspirin combination increased major bleeding compared with the aspirin alone group (77 [3%] of 2492 vs 48 [2%] of 2504; HR 1·61, 95% CI 1·12-2·31, p=0·0089), which was mainly gastrointestinal. Similarly, major bleeding occurred in 79 (3%) of 2474 patients with rivaroxaban 5 mg, and in 48 (2%) of 2504 in the aspirin alone group (HR 1·68, 95% CI 1·17-2·40; p=0·0043).INTERPRETATION:Low-dose rivaroxaban taken twice a day plus aspirin once a day reduced major adverse cardiovascular and limb events when compared with aspirin alone. Although major bleeding was increased, fatal or critical organ bleeding was not. This combination therapy represents an important advance in the management of patients with peripheral artery disease. Rivaroxaban alone did not significantly reduce major adverse cardiovascular events compared with asprin alone, but reduced major adverse limb events and increased major bleeding