Efficacy and tolerability of rimonabant in overweight or obese patients with type 2 diabetes: a randomised controlled study  

Oleh:

Scheen, Andre J. ; Finer, Nick ; Hollander, Priscilla ; Jensen, Michael D ; Gaal, Luc F Van

Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: The Lancet (keterangan: ada di Proquest) vol. 368 no. 9548 (Nov. 2006), page 1660.

Ketersediaan

Perpustakaan FK Nomor Panggil: L01.K.2006.06 Non-tandon: 1 (dapat dipinjam: 0) Tandon: tidak ada

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Isi artikel

Background Rimonabant, a selective cannabinoid type 1 receptor blocker, reduces bodyweight and improves cardiovascular and metabolic risk factors in non-diabetic overweight or obese patients. The aim of the RIO-Diabetes trial was to assess the efficacy and safety of rimonabant in overweight or obese patients with type 2 diabetes that was inadequately controlled by metformin or sulphonylureas. Methods 1047 overweight or obese type 2 diabetes patients (body-mass index 27—40 kg/m2) with a haemoglobin A1c (HbA1c) concentration of 6·5—10·0% (mean 7·3% [SD 0·9] at baseline) already on metformin or sulphonylurea monotherapy were given a mild hypocaloric diet and advice for increased physical activity, and randomly assigned placebo (n=348), 5 mg/day rimonabant (360) or 20 mg/day rimonabant (339) for 1 year. Two individuals in the 5 mg/day group did not receive double-blind treatment and were thus not included in the final analysis. The primary endpoint was weight change from baseline after 1 year of treatment. Analyses were done on an intention-to-treat basis. This trial is registered at ClinicalTrials.gov, number NCT00029848. Findings 692 patients completed the 1 year follow-up; numbers in each group after 1 year were much the same. Weight loss was significantly greater after 1 year in both rimonabant groups than in the placebo group (placebo: -1·4 kg [SD 3·6]; 5 mg/day: -2·3 kg [4·2], p=0·01 vs placebo; 20 mg/day: -5·3 kg [5·2], p<0·0001 vs placebo). Rimonabant was generally well tolerated. The incidence of adverse events that led to discontinuation was slightly greater in the 20 mg/day rimonabant group, mainly due to depressed mood disorders, nausea, and dizziness. Interpretation These data indicate that 20 mg/day rimonabant, in combination with diet and exercise, can produce a clinically meaningful reduction in bodyweight and improve HbA1c and a number of cardiovascular and metabolic risk factors in overweight or obese patients with type 2 diabetes inadequately controlled by metformin or sulphonylureas.

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