PILOT-STUDY OF THE EFFECT OF THE SIMVASTATIN-CIPROFIBRATE COMBINATIONON MYOCARDIAL-INFARCTION RISK PROFILE IN PATIENTS WITH REFRACTORY FAMILIAL COMBINED HYPERLIPIDEMIA

The effect on the risk profile for myocardial infarction (MI) and the efficacy of combined therapy with simvastatin and ciprofibrate in pati ents with refractory familial combined hyperlipidaemia (FCHL) were inv estigated. 13 patients (9 males and 4 females) with a mean age of 40 y ears (range 26 to 52 years) who did not have coronary heart disease at baseline were studied. All patients followed a hypolipidaemic diet pl us placebo fur 1 month. Beginning at month 0, the patients received co mbined treatment with simvastatin 20 mg/day and ciprofibrate 100 mg/da y for 6 months. At months -1, 0, 1, 3 and 6, plasma concentrations of the following parameters were measured: total cholesterol, low-density lipoprotein cholesterol (LDLC), very low-density lipoprotein choleste rol (VLDLC), high-density lipoprotein cholesterol (HDLC), triglyceride s, apoproteins B and Al (ape B and Al), and fibrinogen, The effect of combined treatment on the 10-year probability of developing MI was cal culated. At the sixth month of combined therapy, the calculated MI ris k was reduced by 66% and the following modifications, compared with pl acebo, were recorded: total cholesterol -30%, LDLC -41%, VLDC -56%, HD LC +16%, triglycerides -56%, apo B -32%, apo Al +20%, LDC to HDLC rati o -49%, apo B to Al ratio -47%, and plasma fibrinogen -29%, All change s were significant (ANOVA p < 0.01). One patient was withdrawn from th e study because of a sustained increase in serum transaminase values. Myopathy or other major adverse effects of the drug combination were n ot recorded in any patient. It was concluded that combined treatment w ith simvastatin and ciprofibrate is efficient and has a beneficial eff ect on MI risk profile in patients with FCHL, but it should be adminis tered only in selected patients with severe combined hyperlipidaemia. Close monitoring of patients for adverse effects of the drug combinati on is imperative.