RIMONABANT IN CLINICAL PRACTICE (RICP). A SWEDISH MULTICENTER SURVEY IN PRIMARY CARE

Author(s)

Linder R1, Olsson Birgersson M2, de Faire U3, Ridderstråle M4, Rössner S3, Sjöström L5, Rydén L31Pygargus AB, Stockholm, Sweden, 2sanofi aventis AB, Stockholm, Sweden, 3Karolinska Institutet, Stockholm, Sweden, 4University Hospital MAS, Malmö, Sweden, 5Sahlgrenska University Hospital, Gothenburg, Sweden

OBJECTIVES: To describe the prescription pattern of rimonabant in relation to the approved indications and the stated limitations of reimbursement. Secondly to compare the efficiency and adverse effects in rimonabant treated patients with the impact of conventional care in matched controls without rimonabant treatment during a follow up period of up to 12 months. METHODS: The survey was based on retrospective collection of data through a specified extraction and data management method, Pygargus Customized eXtraction Program (CXP) developed to extract patient data from an Electronic Health Record (EHR) system (Profdoc Journal III). Centers were selected with a wide socio-economic and geographical spread. RESULTS: Body mass index (BMI) was available in 922 patients out of 1477 (62%). Of those patients, 93% were prescribed rimonabant according to the indication and 79% within the reimbursement criteria. In reality, 97% of the total cohort obtained reimbursement. Patients prescribed rimonabant for at least 6 months showed a mean weight reduction of 6.0 kg after 12 months compared to 0.4 kg in controls. The mean decrease in HbA1c was 0.3% in patients with type-2 diabetes versus 0.0% in controls. More than half of patients and controls (54.4 vs. 54.3 %) had a documented psychiatric illness such as anxiety, depressive disorders or sleep disturbances at baseline. There was no increase in the co-prescription of anxiolytics /sedatives /anti-depressant over time comparing rimonabant treated patients with controls. CONCLUSIONS: The majority of patients were prescribed rimonabant according to the given rules for indication and reimbursement. Weight reduction in the total cohort and reduction of HbA1c in patients with type 2 diabetes during the follow up year, were of similar magnitude as reported in various clinical trials. The safety analysis did not signal any increase in adverse events including psychiatric illness in patients treated with rimonabant more than six months.

Conference/Value in Health Info

2009-10, ISPOR Europe 2009, Paris, France

Value in Health, Vol. 12, No. 7 (October 2009)

Code

PSY58

Topic

Health Policy & Regulatory, Study Approaches

Topic Subcategory

Post Marketing Studies, Reimbursement & Access Policy

Disease

Diabetes/Endocrine/Metabolic Disorders

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