PMID- 16634837 OWN - NLM STAT- MEDLINE DCOM- 20060915 LR - 20151119 IS - 0014-2972 (Print) IS - 0014-2972 (Linking) VI - 36 IP - 5 DP - 2006 May TI - No effect of homocysteine-lowering therapy on vascular inflammation and haemostasis in peripheral arterial occlusive disease. PG - 333-9 AB - BACKGROUND: Although peripheral arterial occlusive disease (PAOD) is significantly associated with elevated homocysteine levels, the clinical relevance of hyperhomocysteinaemia for the prevention and progression of PAOD is still unknown. MATERIALS AND METHODS: A total of 65 patients suffering from symptomatic PAOD with elevated homocysteine levels were randomized onto placebo or B-vitamins (50 mg thiaminhydrochlorid, 50 mg pyridoxine, and 0.05 mg cyanocobalamin), plus 5 mg folic acid daily for 6 weeks. Serum levels of folic acid, vitamin B12, creatinine, ultra-sensitive C-reactive protein (usCRP), interleukin (IL)-6, IL-8, IL-18, monocyte-chemo-attractant-protein-1 (MCP-1) and plasma levels of homocysteine, tissue factor (TF) and tissue factor pathway inhibitor (TFPI) were determined on the 1st day and 42nd day. Primary outcome was reduction of homocysteine, secondary outcomes were reduction of usCRP, IL-6, IL-8, Il-18, MCP-1, TF and TFPI. RESULTS: The mean reduction of homocysteine concentration was 33% (95%CI 33.36-55.76, or 18.9+/-5.4 micromol L-1-12.6+/-2.8 micromol L-1, P=0) in the B-vitamin group compared with 1% in the placebo group. Folic acid (P=0) and vitamin B12 (P=0) increased significantly in the verum group, but both remained unchanged in the control group. No treatment effect of lowering of homocysteine on any markers of haemostasis (TF, TFPI) or inflammation (usCRP, IL-6, IL-8, IL-18 and MCP-1) was observed. CONCLUSION: Although homocysteine is associated with vascular disease risk in the general population and in particular with PAOD, marked lowering of homocysteine concentrations by folic acid and B-vitamin supplementation does not influence inflammatory responses involving usCRP, IL-6, IL-8, IL-18 and MCP-1, nor tissue factor. These results provide evidence against a major effect of hyperhomocysteinaemia on vascular chronic inflammation or coagulation in patients with symptomatic peripheral arterial occlusive disease. FAU - Schernthaner, G-H AU - Schernthaner GH AD - Department of Internal Medicine II, Medical University of Vienna, and Department of Internal Medicine I, Rudolfstiftung Hospital, Vienna, Austria. gerit.schernthaner@meduniwien.ac.at FAU - Plank, C AU - Plank C FAU - Minar, E AU - Minar E FAU - Bieglmayer, C AU - Bieglmayer C FAU - Koppensteiner, R AU - Koppensteiner R FAU - Schernthaner, G AU - Schernthaner G LA - eng PT - Journal Article PT - Randomized Controlled Trial PL - England TA - Eur J Clin Invest JT - European journal of clinical investigation JID - 0245331 RN - 0 (Biomarkers) RN - 0 (Inflammation Mediators) RN - 0LVT1QZ0BA (Homocysteine) RN - 12001-76-2 (Vitamin B Complex) RN - 935E97BOY8 (Folic Acid) SB - IM MH - Aged MH - Arterial Occlusive Diseases/blood/*etiology MH - Biomarkers/blood MH - Chronic Disease MH - Drug Therapy, Combination MH - Female MH - Folic Acid/therapeutic use MH - Hemostasis/drug effects MH - Homocysteine/blood MH - Humans MH - Hyperhomocysteinemia/complications/*drug therapy MH - Inflammation Mediators/blood MH - Male MH - Middle Aged MH - Patient Compliance MH - Peripheral Vascular Diseases/blood/*etiology MH - Vasculitis/blood/*drug therapy/etiology MH - Vitamin B Complex/therapeutic use EDAT- 2006/04/26 09:00 MHDA- 2006/09/16 09:00 CRDT- 2006/04/26 09:00 PHST- 2006/04/26 09:00 [pubmed] PHST- 2006/09/16 09:00 [medline] PHST- 2006/04/26 09:00 [entrez] AID - ECI1639 [pii] AID - 10.1111/j.1365-2362.2006.01639.x [doi] PST - ppublish SO - Eur J Clin Invest. 2006 May;36(5):333-9. doi: 10.1111/j.1365-2362.2006.01639.x.