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SERENADE: the Study Evaluating Rimonabant Efficacy in Drug-naive Diabetic Patients: effects of monotherapy with rimonabant, the first selective CB1 receptor antagonist, on glycemic control, body weight, and lipid profile in drug-naive type 2 diabetes.
Diabetes Care. 2008 Nov; 31(11):2169-76.DC

Abstract

OBJECTIVE

The purpose of this study was to assess the glucose-lowering efficacy and safety of rimonabant monotherapy in drug-naive type 2 diabetic patients.

RESEARCH DESIGN AND METHODS

The Study Evaluating Rimonabant Efficacy in Drug-Naive Diabetic Patients (SERENADE) was a 6-month, randomized, double-blind, placebo-controlled trial of 20 mg/day rimonabant in drug-naive patients with type 2 diabetes (A1C 7-10%). The primary end point was A1C change from baseline; secondary end points included body weight, waist circumference, and lipid profile changes.

RESULTS

A total of 281 patients were randomly assigned; 278 were exposed to treatment, and 236 (84.9%) completed the study. Baseline A1C (7.9%) was reduced by -0.8% with rimonabant versus -0.3% with placebo (Delta A1C -0.51%; P = 0.0002), with a larger rimonabant effect in patients with baseline A1C >or=8.5% (Delta A1C -1.25%; P = 0.0009). Weight loss from baseline was -6.7 kg with rimonabant versus -2.8 kg with placebo (Delta weight -3.8 kg; P < 0.0001). Rimonabant induced improvements from baseline in waist circumference (-6 vs. -2 cm; P < 0.0001), fasting plasma glucose (-0.9 vs. -0.1 mmol/l; P = 0.0012), triglycerides (-16.3 vs. +4.4%; P = 0.0031), and HDL cholesterol (+10.1 vs. +3.2%; P < 0.0001). Adverse events of interest that occurred more frequently with rimonabant versus placebo were dizziness (10.9 vs. 2.1%), nausea (8.7 vs. 3.6%), anxiety (5.8 vs. 3.6%), depressed mood (5.8 vs. 0.7%), and paresthesia (2.9 vs. 1.4%).

CONCLUSIONS

Rimonabant monotherapy resulted in meaningful improvements in glycemic control, body weight, and lipid profile in drug-naive type 2 diabetic patients. Further ongoing studies will better establish the benefit-to-risk profile of rimonabant and define its place in type 2 diabetes management.

Authors+Show Affiliations

Dallas Diabetes and Endocrine Center, Dallas, Texas, USA. juliorosenstock@dallasdiabetes.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18678611

Citation

Rosenstock, Julio, et al. "SERENADE: the Study Evaluating Rimonabant Efficacy in Drug-naive Diabetic Patients: Effects of Monotherapy With Rimonabant, the First Selective CB1 Receptor Antagonist, On Glycemic Control, Body Weight, and Lipid Profile in Drug-naive Type 2 Diabetes." Diabetes Care, vol. 31, no. 11, 2008, pp. 2169-76.
Rosenstock J, Hollander P, Chevalier S, et al. SERENADE: the Study Evaluating Rimonabant Efficacy in Drug-naive Diabetic Patients: effects of monotherapy with rimonabant, the first selective CB1 receptor antagonist, on glycemic control, body weight, and lipid profile in drug-naive type 2 diabetes. Diabetes Care. 2008;31(11):2169-76.
Rosenstock, J., Hollander, P., Chevalier, S., & Iranmanesh, A. (2008). SERENADE: the Study Evaluating Rimonabant Efficacy in Drug-naive Diabetic Patients: effects of monotherapy with rimonabant, the first selective CB1 receptor antagonist, on glycemic control, body weight, and lipid profile in drug-naive type 2 diabetes. Diabetes Care, 31(11), 2169-76. https://doi.org/10.2337/dc08-0386
Rosenstock J, et al. SERENADE: the Study Evaluating Rimonabant Efficacy in Drug-naive Diabetic Patients: Effects of Monotherapy With Rimonabant, the First Selective CB1 Receptor Antagonist, On Glycemic Control, Body Weight, and Lipid Profile in Drug-naive Type 2 Diabetes. Diabetes Care. 2008;31(11):2169-76. PubMed PMID: 18678611.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - SERENADE: the Study Evaluating Rimonabant Efficacy in Drug-naive Diabetic Patients: effects of monotherapy with rimonabant, the first selective CB1 receptor antagonist, on glycemic control, body weight, and lipid profile in drug-naive type 2 diabetes. AU - Rosenstock,Julio, AU - Hollander,Priscilla, AU - Chevalier,Soazig, AU - Iranmanesh,Ali, AU - ,, Y1 - 2008/08/04/ PY - 2008/8/6/pubmed PY - 2009/2/5/medline PY - 2008/8/6/entrez SP - 2169 EP - 76 JF - Diabetes care JO - Diabetes Care VL - 31 IS - 11 N2 - OBJECTIVE: The purpose of this study was to assess the glucose-lowering efficacy and safety of rimonabant monotherapy in drug-naive type 2 diabetic patients. RESEARCH DESIGN AND METHODS: The Study Evaluating Rimonabant Efficacy in Drug-Naive Diabetic Patients (SERENADE) was a 6-month, randomized, double-blind, placebo-controlled trial of 20 mg/day rimonabant in drug-naive patients with type 2 diabetes (A1C 7-10%). The primary end point was A1C change from baseline; secondary end points included body weight, waist circumference, and lipid profile changes. RESULTS: A total of 281 patients were randomly assigned; 278 were exposed to treatment, and 236 (84.9%) completed the study. Baseline A1C (7.9%) was reduced by -0.8% with rimonabant versus -0.3% with placebo (Delta A1C -0.51%; P = 0.0002), with a larger rimonabant effect in patients with baseline A1C >or=8.5% (Delta A1C -1.25%; P = 0.0009). Weight loss from baseline was -6.7 kg with rimonabant versus -2.8 kg with placebo (Delta weight -3.8 kg; P < 0.0001). Rimonabant induced improvements from baseline in waist circumference (-6 vs. -2 cm; P < 0.0001), fasting plasma glucose (-0.9 vs. -0.1 mmol/l; P = 0.0012), triglycerides (-16.3 vs. +4.4%; P = 0.0031), and HDL cholesterol (+10.1 vs. +3.2%; P < 0.0001). Adverse events of interest that occurred more frequently with rimonabant versus placebo were dizziness (10.9 vs. 2.1%), nausea (8.7 vs. 3.6%), anxiety (5.8 vs. 3.6%), depressed mood (5.8 vs. 0.7%), and paresthesia (2.9 vs. 1.4%). CONCLUSIONS: Rimonabant monotherapy resulted in meaningful improvements in glycemic control, body weight, and lipid profile in drug-naive type 2 diabetic patients. Further ongoing studies will better establish the benefit-to-risk profile of rimonabant and define its place in type 2 diabetes management. SN - 1935-5548 UR - https://www.unboundmedicine.com/medline/citation/18678611/SERENADE:_the_Study_Evaluating_Rimonabant_Efficacy_in_Drug_naive_Diabetic_Patients:_effects_of_monotherapy_with_rimonabant_the_first_selective_CB1_receptor_antagonist_on_glycemic_control_body_weight_and_lipid_profile_in_drug_naive_type_2_diabetes_ L2 - http://care.diabetesjournals.org/cgi/pmidlookup?view=long&amp;pmid=18678611 DB - PRIME DP - Unbound Medicine ER -