Searchable abstracts of presentations at key conferences in endocrinology
Endocrine Abstracts (2015) 37 OC11.5 | DOI: 10.1530/endoabs.37.OC11.5

ECE2015 Oral Communications Obesity (5 abstracts)

Preliminary analysis of the PRIMAVERA Study: reduxine safety monitoring in patients with alimentary obesity

Ivan Dedov 1, , Galina Melnichenko 1, , Tatiana Romantsova 2 & Marina Zhuravleva 2


1Endocrinology Research Center, Moscow, Russia; 2I.M. Sechenov Moscow State Medical University, Moscow, Russia.


Background: The SCOUT trial showed that sibutramine produced weight loss with some increased cardiovascular morbidity but not mortality. But these results should not be extrapolated to a routine practice as a lot of the SCOUT participants had contraindications for sibutramine. In order to summarise data on efficacy and safety of sibutramine administration in routine clinical practice according to approved indications and to implement risks monitoring system in Russia, PRIMAVERA non-interventional study has been initiated (NCT01773733, clinicaltrial.gov).

Methods: 98.774 obese patients from 142 Russian cities, treated with sibutramine 10–15 mg/day. Preliminary results were analyzed for 16 515 patients (82% – women, 18% – men). Patients were treated under control of body weight, blood pressure and pulse rate.

Results: 2.5% of patients dropped out during screening phase due to contraindications to sibutamine use. 3% of patients stayed on treatment for 3 month, 65% – for 6 month and 29.5% – for 12 month. Mean weight loss was significant: 7.5±2.8 kg by month 3, 14.3±5.9 kg by month 6 and 18.8±8.2 kg by month 12 (P<0.01). Mean waist circumference decreased significant: 5.85±3.31 cm, 10.71±6.48 cm and 15.15±8.91 cm by month 3, 6 and 12 respectively (P<0.01). According to the Well-Being Questionnaire, body weight loss was accompanied by general increase in quality of life. Treatment with sibutramine was not associated with significant increase of blood pressure and pulse rate. Adverse events were reported for 2.8% patients. There were no reports of The Serious Adverse Events related to sibutramine use.

Conclusion: Based on preliminary analysis, sibutramine use according to approved indications is safe and effective for long-term treatment of obesity. Due to PRIMAVERA program the principles of sibutramine efficacy and safety monitoring are being implemented into routine clinical practice.

Disclosure: The research was supported by ‘Promomed RUS’ pharmaceutical company.

Article tools

My recent searches

No recent searches.