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Variation of inflammatory parameters after sibutramine treatment compared to placebo in type 2 diabetic patients.
J Clin Pharm Ther. 2011 Oct; 36(5):592-601.JC

Abstract

WHAT IS KNOWN AND OBJECTIVE

The efficacy of sibutramine has been demonstrated in randomized trials in obese/overweight patients including those with type 2 diabetes mellitus (T2DM). Our objective was to evaluate the effects of 1-year treatment with sibutramine compared to placebo on body weight, glycaemic control, lipid profile, and inflammatory parameters in type 2 diabetic patients.

METHODS

Two hundred and forty-six patients with uncontrolled T2DM [glycated haemoglobin (HbA(1c)) > 8·0%] in therapy with different oral hypoglycaemic agents or insulin were randomized to take 10 mg of sibutramine or placebo for 12 months. We evaluated at baseline, and after 3, 6, 9, and 12 months these parameters: body weight, body mass index (BMI), HbA(1c) , fasting plasma glucose (FPG), post-prandial plasma glucose (PPG), fasting plasma insulin (FPI), homeostasis model assessment insulin resistance index (HOMA-IR), total cholesterol (TC), low density lipoprotein-cholesterol (LDL-C), high density lipoprotein-cholesterol (HDL-C), triglycerides (Tg), leptin, tumour necrosis factor-α (TNF-α), adiponectin (ADN), vaspin, high sensitivity C-reactive protein (Hs-CRP).

RESULTS AND DISCUSSION

We observed a decrease of body weight after 9 and 12 months in the group treated with sibutramine, but not in the control group. Regarding glycaemic and lipid profile, although there are differences seen over time within each of the groups, we did not obtain any significant differences between the two groups. Both placebo and sibutramine gave a similar improvement of HOMA-IR, leptin, TNF-α, ADN, and Hs-CRP. No vaspin variations were observed in either group.

WHAT IS NEW AND CONCLUSION

Sibutramine resulted in a decrease in body weight at 9 months and at 12 months that was not observed with placebo. Although there were differences seen over time within each of the groups, there were no significant differences between groups for any other parameter that we measured.

Authors+Show Affiliations

Department of Internal Medicine and Therapeutics, University of Pavia, Pavia "G. Descovich"Atherosclerosis Study Center, Department of Internal Medicine, Aging and Kidney Diseases, University of Bologna, Bologna, Italy. giuseppe.derosa@unipv.itNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

21070297

Citation

Derosa, G, et al. "Variation of Inflammatory Parameters After Sibutramine Treatment Compared to Placebo in Type 2 Diabetic Patients." Journal of Clinical Pharmacy and Therapeutics, vol. 36, no. 5, 2011, pp. 592-601.
Derosa G, Maffioli P, Ferrari I, et al. Variation of inflammatory parameters after sibutramine treatment compared to placebo in type 2 diabetic patients. J Clin Pharm Ther. 2011;36(5):592-601.
Derosa, G., Maffioli, P., Ferrari, I., Palumbo, I., Randazzo, S., D'Angelo, A., & Cicero, A. F. (2011). Variation of inflammatory parameters after sibutramine treatment compared to placebo in type 2 diabetic patients. Journal of Clinical Pharmacy and Therapeutics, 36(5), 592-601. https://doi.org/10.1111/j.1365-2710.2010.01217.x
Derosa G, et al. Variation of Inflammatory Parameters After Sibutramine Treatment Compared to Placebo in Type 2 Diabetic Patients. J Clin Pharm Ther. 2011;36(5):592-601. PubMed PMID: 21070297.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Variation of inflammatory parameters after sibutramine treatment compared to placebo in type 2 diabetic patients. AU - Derosa,G, AU - Maffioli,P, AU - Ferrari,I, AU - Palumbo,I, AU - Randazzo,S, AU - D'Angelo,A, AU - Cicero,A F G, Y1 - 2010/11/12/ PY - 2010/11/13/entrez PY - 2010/11/13/pubmed PY - 2012/3/9/medline SP - 592 EP - 601 JF - Journal of clinical pharmacy and therapeutics JO - J Clin Pharm Ther VL - 36 IS - 5 N2 - WHAT IS KNOWN AND OBJECTIVE: The efficacy of sibutramine has been demonstrated in randomized trials in obese/overweight patients including those with type 2 diabetes mellitus (T2DM). Our objective was to evaluate the effects of 1-year treatment with sibutramine compared to placebo on body weight, glycaemic control, lipid profile, and inflammatory parameters in type 2 diabetic patients. METHODS: Two hundred and forty-six patients with uncontrolled T2DM [glycated haemoglobin (HbA(1c)) > 8·0%] in therapy with different oral hypoglycaemic agents or insulin were randomized to take 10 mg of sibutramine or placebo for 12 months. We evaluated at baseline, and after 3, 6, 9, and 12 months these parameters: body weight, body mass index (BMI), HbA(1c) , fasting plasma glucose (FPG), post-prandial plasma glucose (PPG), fasting plasma insulin (FPI), homeostasis model assessment insulin resistance index (HOMA-IR), total cholesterol (TC), low density lipoprotein-cholesterol (LDL-C), high density lipoprotein-cholesterol (HDL-C), triglycerides (Tg), leptin, tumour necrosis factor-α (TNF-α), adiponectin (ADN), vaspin, high sensitivity C-reactive protein (Hs-CRP). RESULTS AND DISCUSSION: We observed a decrease of body weight after 9 and 12 months in the group treated with sibutramine, but not in the control group. Regarding glycaemic and lipid profile, although there are differences seen over time within each of the groups, we did not obtain any significant differences between the two groups. Both placebo and sibutramine gave a similar improvement of HOMA-IR, leptin, TNF-α, ADN, and Hs-CRP. No vaspin variations were observed in either group. WHAT IS NEW AND CONCLUSION: Sibutramine resulted in a decrease in body weight at 9 months and at 12 months that was not observed with placebo. Although there were differences seen over time within each of the groups, there were no significant differences between groups for any other parameter that we measured. SN - 1365-2710 UR - https://www.unboundmedicine.com/medline/citation/21070297/Variation_of_inflammatory_parameters_after_sibutramine_treatment_compared_to_placebo_in_type_2_diabetic_patients_ L2 - https://doi.org/10.1111/j.1365-2710.2010.01217.x DB - PRIME DP - Unbound Medicine ER -