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A pilot study with simvastatin and folic acid/vitamin B12 in preparation for the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH).
Nutr Metab Cardiovasc Dis. 2000 Aug; 10(4):195-203.NM

Abstract

BACKGROUND AND AIM

This study was conducted in preparation for the Study Evaluating Additional Reduction in Cholesterol and Homocysteine (SEARCH). SEARCH is a 12,000 patient 2X2 factorial study in post-myocardial infarction patients that will compare simvastatin 20 mg with simvastatin 80 mg to evaluate whether greater LDL-C reductions with simvastatin provide greater coronary event reductions. SEARCH will also test the hypothesis that lowering plasma homocysteine with folic acid and vitamin B12 will reduce coronary events. This pilot study was performed to determine whether any clinically meaningful interaction between simvastatin and folic acid/vitamin B12 exists.

METHODS AND RESULTS

Following a 2-week diet/placebo run-in period, 141 patients with primary hypercholesterolaemia were randomised to one of three treatments for 6 weeks: 80 mg/day simvastatin and 2 mg folic acid/0.8 mg vitamin B12 daily (combination group); or 80 mg/day simvastatin and placebo vitamins (simvastatin alone group); or 2 mg folic acid/0.8 mg vitamin B12 daily and placebo simvastatin (vitamins alone group). The combination group and simvastatin alone group experienced similar serum lipid changes with reductions in LDL-cholesterol of 55.2% and 51.5% respectively. The combination group and vitamins alone group experienced similar homocysteine lowering with reductions in homocysteine of 25.3% and 23.1% respectively. All therapies were well tolerated.

CONCLUSIONS

There was no detectable antagonistic effect when simvastatin and folic acid/vitamin B12 were administered concomitantly.

Authors+Show Affiliations

Chiltern International Ltd., Slough, UK.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

11079257

Citation

MacMahon, M, et al. "A Pilot Study With Simvastatin and Folic Acid/vitamin B12 in Preparation for the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH)." Nutrition, Metabolism, and Cardiovascular Diseases : NMCD, vol. 10, no. 4, 2000, pp. 195-203.
MacMahon M, Kirkpatrick C, Cummings CE, et al. A pilot study with simvastatin and folic acid/vitamin B12 in preparation for the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH). Nutr Metab Cardiovasc Dis. 2000;10(4):195-203.
MacMahon, M., Kirkpatrick, C., Cummings, C. E., Clayton, A., Robinson, P. J., Tomiak, R. H., Liu, M., Kush, D., & Tobert, J. (2000). A pilot study with simvastatin and folic acid/vitamin B12 in preparation for the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH). Nutrition, Metabolism, and Cardiovascular Diseases : NMCD, 10(4), 195-203.
MacMahon M, et al. A Pilot Study With Simvastatin and Folic Acid/vitamin B12 in Preparation for the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH). Nutr Metab Cardiovasc Dis. 2000;10(4):195-203. PubMed PMID: 11079257.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A pilot study with simvastatin and folic acid/vitamin B12 in preparation for the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH). AU - MacMahon,M, AU - Kirkpatrick,C, AU - Cummings,C E, AU - Clayton,A, AU - Robinson,P J, AU - Tomiak,R H, AU - Liu,M, AU - Kush,D, AU - Tobert,J, PY - 2000/11/18/pubmed PY - 2001/3/3/medline PY - 2000/11/18/entrez SP - 195 EP - 203 JF - Nutrition, metabolism, and cardiovascular diseases : NMCD JO - Nutr Metab Cardiovasc Dis VL - 10 IS - 4 N2 - BACKGROUND AND AIM: This study was conducted in preparation for the Study Evaluating Additional Reduction in Cholesterol and Homocysteine (SEARCH). SEARCH is a 12,000 patient 2X2 factorial study in post-myocardial infarction patients that will compare simvastatin 20 mg with simvastatin 80 mg to evaluate whether greater LDL-C reductions with simvastatin provide greater coronary event reductions. SEARCH will also test the hypothesis that lowering plasma homocysteine with folic acid and vitamin B12 will reduce coronary events. This pilot study was performed to determine whether any clinically meaningful interaction between simvastatin and folic acid/vitamin B12 exists. METHODS AND RESULTS: Following a 2-week diet/placebo run-in period, 141 patients with primary hypercholesterolaemia were randomised to one of three treatments for 6 weeks: 80 mg/day simvastatin and 2 mg folic acid/0.8 mg vitamin B12 daily (combination group); or 80 mg/day simvastatin and placebo vitamins (simvastatin alone group); or 2 mg folic acid/0.8 mg vitamin B12 daily and placebo simvastatin (vitamins alone group). The combination group and simvastatin alone group experienced similar serum lipid changes with reductions in LDL-cholesterol of 55.2% and 51.5% respectively. The combination group and vitamins alone group experienced similar homocysteine lowering with reductions in homocysteine of 25.3% and 23.1% respectively. All therapies were well tolerated. CONCLUSIONS: There was no detectable antagonistic effect when simvastatin and folic acid/vitamin B12 were administered concomitantly. SN - 0939-4753 UR - https://www.unboundmedicine.com/medline/citation/11079257/A_pilot_study_with_simvastatin_and_folic_acid/vitamin_B12_in_preparation_for_the_Study_of_the_Effectiveness_of_Additional_Reductions_in_Cholesterol_and_Homocysteine__SEARCH__ L2 - https://medlineplus.gov/heartattack.html DB - PRIME DP - Unbound Medicine ER -