Medizinische Universität Graz - Research portal
Selected Publication:
SHR Neuro Cancer Cardio Lipid Metab Microb
Balletshofer, BM; Goebbel, S; Rittig, K; Enderle, M; Schmölzer, I; Wascher, TC; Ferenc Pap, A; Westermeier, T; Petzinna, D; Matthaei, S; Häring, HU.
Intense cholesterol lowering therapy with a HMG-CoA reductase inhibitor does not improve nitric oxide dependent endothelial function in type-2-diabetes--a multicenter, randomised, double-blind, three-arm placebo-controlled clinical trial.
EXP CLIN ENDOCRINOL DIABETES 2005 113: 324-330.
Doi: 10.1055/s-2005-865642
Web of Science
PubMed
FullText
FullText_MUG
Google Scholar
- Co-authors Med Uni Graz
- Wascher Thomas
- Altmetrics:
- Dimensions Citations:
- Plum Analytics:
- Scite (citation analytics):
- Abstract:
- Disturbances in nitric oxide (NO) metabolism resulting in endothelial dysfunction play a central role in the pathogenesis of atherosclerosis in hypercholesterolemia and in individuals with type 2 diabetes. It is unclear whether lipid lowering therapy with HMG-CoA-reductase inhibitors might improve endothelial function in subjects with type 2 diabetes as it is demonstrated in non-diabetic subjects with hypercholesterolemia. We examined the influence of 0.2 mg and 0.8 mg cerivastatin on endothelial function in a multicenter, randomised, double-blind, and three-arm placebo-controlled clinical trial. Endothelial function was assessed by nitric oxide-dependent flow mediated vasodilatation (FMD) of the brachial artery. A total of 103 patients with type 2 diabetes were enrolled in the study. Bayer Company undertook a voluntary action to withdraw cerivastatin from market, therefore the study was terminated earlier. At this point 77 patients were randomised, of which 58 completed the study (mean age 60 +/- 8 years, HbA1c 7.4 +/- 0.9 %). At baseline mean FMD was disturbed in all three therapy arms (5.18 +/- 2.31 % in the placebo group, 3.88 +/- 1.68 in the 0.2-mg cerivastation group, and 4.86 +/- 2.25 in the 0.8-mg cerivastatin group). Despite a significant reduction in cholesterol and LDL-cholesterol-levels after 12 weeks of treatment (decrease in LDL-cholesterol - 26.8 +/- 13.9 % in the 0.2-mg group and - 40.3 +/- 16.0 % in the 0.8-mg group, p = 0.0001, ANCOVA) there was no difference in flow mediated vasodilatation (p = 0.52 and p = 0.56 vs. placebo, respectively, ANCOVA). HbA1c, CRP, and HDL-cholesterol did not change during the study. Furthermore no difference in safety profile between cerivastatin and placebo was found. Despite a significant improvement in lipid profile under statin therapy, no improvement of endothelial dysfunction in terms of nitric oxide bioavailability could be detected.
- Find related publications in this database (using NLM MeSH Indexing)
- Blood Glucose - metabolism
- Blood Pressure - drug effects
- Brachial Artery - drug effects
- C-Reactive Protein - metabolism
- Cholesterol - blood
- Diabetes Mellitus, Type 2 - complications
- Double-Blind Method - complications
- Endothelium, Vascular - drug effects
- Female - drug effects
- Fibrinogen - metabolism
- Humans - metabolism
- Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use
- Hypercholesterolemia - complications
- Male - complications
- Middle Aged - complications
- Nitric Oxide - physiology
- Pyridines - therapeutic use
- Triglycerides - blood
- Vasodilation - drug effects
- Find related publications in this database (Keywords)
- endothelium
- nitric oxide
- brachial artery
- atherosclerosis
- diabetes
- endothelial dysfunction
- flow-mediated vasodilation
- statin
- ultrasound
- vascular
- vasodilation
- placebo controlled
- randomized clinical study
- double-blind