ABSTRACT
OBJECTIVE: Combined hyperlipidaemia is a common and highly atherogenic lipid phenotype with multiple lipoprotein abnormalities that are difficult to normalise with single-drug therapy. The ATOMIX multicentre, controlled clinical trial compared the efficacy and safety of atorvastatin and bezafibrate in patients with diet-resistant combined hyperlipidaemia. PATIENTS AND STUDY DESIGN: Following a 6-week placebo run-in period, 138 patients received atorvastatin 10mg or bezafibrate 400mg once daily in a randomised, double-blind, placebo-controlled trial. To meet predefined low-density lipoprotein-cholesterol (LDL-C) target levels, atorvastatin dosages were increased to 20mg or 40mg once daily after 8 and 16 weeks, respectively. RESULTS: After 52 weeks, atorvastatin achieved greater reductions in LDL-C than bezafibrate (percentage decrease 35 vs 5; p < 0.0001), while bezafibrate achieved greater reductions in triglyceride than atorvastatin (percentage decrease 33 vs 21; p < 0.05) and greater increases in high-density lipoprotein-cholesterol (HDL-C) [percentage increase 28 vs 17; p < 0.01 ]. Target LDL-C levels (according to global risk) were attained in 62% of atorvastatin recipients and 6% of bezafibrate recipients, and triglyceride levels <200 mg/dL were achieved in 52% and 60% of patients, respectively. In patients with normal baseline HDL-C, bezafibrate was superior to atorvastatin for raising HDL-C, while in those with baseline HDL-C <35 mg/dL, the two drugs raised HDL-C to a similar extent after adjustment for baseline values. Both drugs were well tolerated. CONCLUSION: The results show that atorvastatin has an overall better efficacy than bezafibrate in concomitantly reaching LDL-C and triglyceride target levels in combined hyperlipidaemia, thus supporting its use as monotherapy in patients with this lipid phenotype.
ABSTRACT
Forty outpatients (11 men and 29 women) aged between 65 and 85 years (mean age of 68 years) with mild to moderate hypertension [mean systolic/diastolic blood pressure (SBP/DBP) after 2 weeks on placebo of 175/102 mm Hg] were included in a randomized, double-blind, parallel-group study to compare the efficacy and tolerance of 10 mg of bisoprolol once daily (o.d., n = 20) and 20 mg of nifedipine sustained release (SR) b.i.d. (n = 20) during 4 weeks of treatment. SBP and DBP were significantly reduced compared to baseline with both treatments. There was no significant difference in efficacy between the two treatments after 2 and 4 weeks. After 2 weeks, the number of patients with normalized DBP (< or =90 mm Hg) was higher with bisoprolol than with nifedipine, this difference no longer being present after 4 weeks. Resting heart rate was significantly reduced with bisoprolol from 78+/-8 to 68+/-9 beats/min after 4 weeks, but there was no change in heart rate with nifedipine. Adverse events were reported by 6 patients on bisoprolol (20 events) and 12 patients on nifedipine (51 events) and the overall tolerance of bisoprolol was considered to be significantly better than that of nifedipine. Because bisoprolol is equally effective when administered once daily in comparison with nifedipine SR, which has to be given twice daily, and since bisoprolol exhibits a better tolerance, this beta-blocker appears to be a useful drug of first choice for the treatment of elderly hypertensive patients.
