[The FIELD study presented and published. Unconvincing results of fenofibrates in diabetic patients].
The prognosis of the patients with the Type II diabetes mellitus without myocardial infarction is as serious as the prognosis of the patients who had experienced myocardial infarction without diabetes mellitus. Consequently there is a big interest of IHD prevention options in diabetic patients, not only by hypertension therapy, but also by hypolipidemic treatment. That is why the results of FIELD study were expected with a great interest. FIELD study randomized 9 795 patients with the Type II diabetes mellitus and initial values of total cholesterol 3.0 to 6.5 mmol/l and in addition with total cholesterol/HDL-cholesterol rate > or = 4.0 or with the values of plasmatic triglycerides between 1.0 and 5.0 mmol/l for treatment with 200 mg of micronized phenophibrate or placebo. As phenophibrate positively influences the typical lipid disorder at diabetic patients, the throughout positive results of phenophibrate had been expected. Study did not fulfil the primary objective of the study of coronary deaths/ non fatal myocardial infarctions (insignificant decrease by 11%). Although phenophibrate significantly decreased non fatal myocardial infarctions and myocardial revascularizations, total mortality and cardiovascular mortality were not positively influenced and they even show non significant aggravating trend. Moreover, the positive effect of phenophibrate on non fatal myocardial infarctions and revascularizations was present only at the persons who had not experienced a cardiovascular disease and only at the persons under 65 years. Phenophibrate positively influenced some diabetic micro vascular complications (nephropathy and retinopathy). Thus, the results of FIELD study present a disappointment and that is why the recommendations of the statin therapy as a priority therapy of dislipidemia stay unchanged also for the patients with Type II diabetes mellitus.
Widimský
J
J
Klinika kardiologie IKEM, Praha. widimsky@post.cz
D002318:Cardiovascular Diseases / Q000150:complications / Q000517:prevention & control; D003924:Diabetes Mellitus, Type 2 / Q000150:complications*; D005260:Female; D011345:Fenofibrate / Q000627:therapeutic use*; D006801:Humans; D000960:Hypolipidemic Agents / Q000627:therapeutic use*; D008297:Male; D017202:Myocardial Ischemia / Q000150:complications / Q000517:prevention & control*; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome
D000960:Hypolipidemic Agents; D011345:Fenofibrate