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FIELDS of dreams, fields of tears: a perspective on the fibrate trials.
Int J Clin Pract 2006; 60(4):442-9IJ

Abstract

Endpoint studies have been performed with fibrates in coronary heart disease since 1971. The results have been confusing - starting with initial benefits in small studies, but contradicted by either minimal benefits in the Coronary Drug Project or adverse noncardiovascular (non-CV) effects in the World Health Organization Clofibrate Study. Fibrates returned for patients with low HDL-C and low LDL-C after a 25% event reduction were seen in the Veterans Affairs HDL Intervention Trial. The greater prominence ascribed to the lipid triad of the metabolic syndrome and the increasing prevalence of diabetes increased the topicality of fibrates given their main action of converting small dense to light buoyant LDL. The Fenofibrate Intervention in Event Lowering in Diabetes (FIELD) Study has carried on the tradition. Fenofibrate therapy in 9795 patients comprising a mixed low-risk primary and a medium-risk secondary prevention cohort resulted in an 11% reduction in coronary events (p = 0.16), a similar but significant reduction in CV events (p = 0.04; number needed to treat = 70). The benefits were concentrated in primary prevention and on nonfatal myocardial events, but the study was confounded by asymmetrical statin drop-in due to the LDL-C-lowering effect of fenofibrate. Safety was generally good, including in combination with statins, but old concerns about sudden death, pancreatitis and venous thrombosis returned. Unexpected benefits were seen with fenofibrate on microvascular endpoints including microalbuminuria and retinopathy. Fenofibrate is a reasonable second-line therapy for dyslipidaemia in diabetes and safe in combination therapy. Its benefits on microvascular disease and in combination therapy require further confirmation.

Authors+Show Affiliations

Department of Chemical Pathology, St Thomas' Hospital, London, UK. anthony.wierzbicki@kcl.ac.uk

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

16620358

Citation

Wierzbicki, A S.. "FIELDS of Dreams, Fields of Tears: a Perspective On the Fibrate Trials." International Journal of Clinical Practice, vol. 60, no. 4, 2006, pp. 442-9.
Wierzbicki AS. FIELDS of dreams, fields of tears: a perspective on the fibrate trials. Int J Clin Pract. 2006;60(4):442-9.
Wierzbicki, A. S. (2006). FIELDS of dreams, fields of tears: a perspective on the fibrate trials. International Journal of Clinical Practice, 60(4), pp. 442-9.
Wierzbicki AS. FIELDS of Dreams, Fields of Tears: a Perspective On the Fibrate Trials. Int J Clin Pract. 2006;60(4):442-9. PubMed PMID: 16620358.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - FIELDS of dreams, fields of tears: a perspective on the fibrate trials. A1 - Wierzbicki,A S, PY - 2006/4/20/pubmed PY - 2006/12/9/medline PY - 2006/4/20/entrez SP - 442 EP - 9 JF - International journal of clinical practice JO - Int. J. Clin. Pract. VL - 60 IS - 4 N2 - Endpoint studies have been performed with fibrates in coronary heart disease since 1971. The results have been confusing - starting with initial benefits in small studies, but contradicted by either minimal benefits in the Coronary Drug Project or adverse noncardiovascular (non-CV) effects in the World Health Organization Clofibrate Study. Fibrates returned for patients with low HDL-C and low LDL-C after a 25% event reduction were seen in the Veterans Affairs HDL Intervention Trial. The greater prominence ascribed to the lipid triad of the metabolic syndrome and the increasing prevalence of diabetes increased the topicality of fibrates given their main action of converting small dense to light buoyant LDL. The Fenofibrate Intervention in Event Lowering in Diabetes (FIELD) Study has carried on the tradition. Fenofibrate therapy in 9795 patients comprising a mixed low-risk primary and a medium-risk secondary prevention cohort resulted in an 11% reduction in coronary events (p = 0.16), a similar but significant reduction in CV events (p = 0.04; number needed to treat = 70). The benefits were concentrated in primary prevention and on nonfatal myocardial events, but the study was confounded by asymmetrical statin drop-in due to the LDL-C-lowering effect of fenofibrate. Safety was generally good, including in combination with statins, but old concerns about sudden death, pancreatitis and venous thrombosis returned. Unexpected benefits were seen with fenofibrate on microvascular endpoints including microalbuminuria and retinopathy. Fenofibrate is a reasonable second-line therapy for dyslipidaemia in diabetes and safe in combination therapy. Its benefits on microvascular disease and in combination therapy require further confirmation. SN - 1368-5031 UR - https://www.unboundmedicine.com/medline/citation/16620358/FIELDS_of_dreams_fields_of_tears:_a_perspective_on_the_fibrate_trials_ L2 - https://doi.org/10.1111/j.1368-5031.2006.00882.x DB - PRIME DP - Unbound Medicine ER -