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The endothelin receptor antagonist bosentan improves peripheral endothelial function in patients with type 2 diabetes mellitus and microalbuminuria: a randomised trial.
Diabetologia. 2012 Mar; 55(3):600-7.D

Abstract

AIMS/HYPOTHESIS

Endothelial dysfunction is important in the development of vascular complications in diabetes. Patients with type 2 diabetes have increased production of the vasoconstrictor and pro-inflammatory peptide, endothelin-1. Short-term intra-arterial administration of endothelin antagonists improves endothelium-dependent vasodilatation in patients with type 2 diabetes. We tested the hypothesis that oral administration of the dual endothelin receptor antagonist, bosentan, improves peripheral endothelial function in patients with type 2 diabetes and microalbuminuria.

METHODS

This placebo-controlled and double-blind study was performed on 46 patients with type 2 diabetes and microalbuminuria (urine albumin/creatinine ratio >3 mg/mmol) at a medical university department. Patients were randomised to bosentan, 125 mg two times per day (n = 28), or placebo (n = 28) for 4 weeks. The computer-generated randomisation code was kept in sealed envelopes. Patients and people doing examinations or assessing outcomes were blinded. The primary endpoint was change in microvascular endothelium-dependent vasodilatation, based on change in digital reactive hyperaemia index. The secondary endpoint was change in brachial artery flow-mediated vasodilatation.

RESULTS

Reactive hyperaemia index increased from 1.73 ± 0.43 (mean ± SD) at baseline to 2.08 ± 0.59 at follow-up (p < 0.05) in the bosentan group (n = 22), but did not change in the placebo group (1.84 ± 0.49 to 1.87 ± 0.47; n = 24). The change in reactive hyperaemia index from baseline was greater in the bosentan group than in the placebo group (p < 0.05). Nitroglycerine-induced digital hyperaemia was not affected. Brachial artery flow-mediated vasodilatation and blood pressure did not change during treatment.

CONCLUSIONS/INTERPRETATION

Oral treatment of 4 weeks duration with the dual endothelin receptor antagonist, bosentan, improves peripheral endothelial function in patients with type 2 diabetes and microalbuminuria.

Authors+Show Affiliations

Karolinska Institutet, Department of Medicine, Cardiology Unit, Karolinska University Hospital, Solna, 171 76 Stockholm, Sweden. arnar.rafnsson@karolinska.seNo affiliation info availableNo 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

22200728

Citation

Rafnsson, A, et al. "The Endothelin Receptor Antagonist Bosentan Improves Peripheral Endothelial Function in Patients With Type 2 Diabetes Mellitus and Microalbuminuria: a Randomised Trial." Diabetologia, vol. 55, no. 3, 2012, pp. 600-7.
Rafnsson A, Böhm F, Settergren M, et al. The endothelin receptor antagonist bosentan improves peripheral endothelial function in patients with type 2 diabetes mellitus and microalbuminuria: a randomised trial. Diabetologia. 2012;55(3):600-7.
Rafnsson, A., Böhm, F., Settergren, M., Gonon, A., Brismar, K., & Pernow, J. (2012). The endothelin receptor antagonist bosentan improves peripheral endothelial function in patients with type 2 diabetes mellitus and microalbuminuria: a randomised trial. Diabetologia, 55(3), 600-7. https://doi.org/10.1007/s00125-011-2415-y
Rafnsson A, et al. The Endothelin Receptor Antagonist Bosentan Improves Peripheral Endothelial Function in Patients With Type 2 Diabetes Mellitus and Microalbuminuria: a Randomised Trial. Diabetologia. 2012;55(3):600-7. PubMed PMID: 22200728.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The endothelin receptor antagonist bosentan improves peripheral endothelial function in patients with type 2 diabetes mellitus and microalbuminuria: a randomised trial. AU - Rafnsson,A, AU - Böhm,F, AU - Settergren,M, AU - Gonon,A, AU - Brismar,K, AU - Pernow,J, Y1 - 2011/12/27/ PY - 2011/09/02/received PY - 2011/11/21/accepted PY - 2011/12/28/entrez PY - 2011/12/28/pubmed PY - 2012/7/20/medline SP - 600 EP - 7 JF - Diabetologia JO - Diabetologia VL - 55 IS - 3 N2 - AIMS/HYPOTHESIS: Endothelial dysfunction is important in the development of vascular complications in diabetes. Patients with type 2 diabetes have increased production of the vasoconstrictor and pro-inflammatory peptide, endothelin-1. Short-term intra-arterial administration of endothelin antagonists improves endothelium-dependent vasodilatation in patients with type 2 diabetes. We tested the hypothesis that oral administration of the dual endothelin receptor antagonist, bosentan, improves peripheral endothelial function in patients with type 2 diabetes and microalbuminuria. METHODS: This placebo-controlled and double-blind study was performed on 46 patients with type 2 diabetes and microalbuminuria (urine albumin/creatinine ratio >3 mg/mmol) at a medical university department. Patients were randomised to bosentan, 125 mg two times per day (n = 28), or placebo (n = 28) for 4 weeks. The computer-generated randomisation code was kept in sealed envelopes. Patients and people doing examinations or assessing outcomes were blinded. The primary endpoint was change in microvascular endothelium-dependent vasodilatation, based on change in digital reactive hyperaemia index. The secondary endpoint was change in brachial artery flow-mediated vasodilatation. RESULTS: Reactive hyperaemia index increased from 1.73 ± 0.43 (mean ± SD) at baseline to 2.08 ± 0.59 at follow-up (p < 0.05) in the bosentan group (n = 22), but did not change in the placebo group (1.84 ± 0.49 to 1.87 ± 0.47; n = 24). The change in reactive hyperaemia index from baseline was greater in the bosentan group than in the placebo group (p < 0.05). Nitroglycerine-induced digital hyperaemia was not affected. Brachial artery flow-mediated vasodilatation and blood pressure did not change during treatment. CONCLUSIONS/INTERPRETATION: Oral treatment of 4 weeks duration with the dual endothelin receptor antagonist, bosentan, improves peripheral endothelial function in patients with type 2 diabetes and microalbuminuria. SN - 1432-0428 UR - https://www.unboundmedicine.com/medline/citation/22200728/The_endothelin_receptor_antagonist_bosentan_improves_peripheral_endothelial_function_in_patients_with_type_2_diabetes_mellitus_and_microalbuminuria:_a_randomised_trial_ L2 - https://doi.org/10.1007/s00125-011-2415-y DB - PRIME DP - Unbound Medicine ER -