M. Lye et al., Elderly patients with hypercholesterolaemia: a double-blind study of the efficacy, safety and tolerability of fluvastatin, CORON ART D, 9(9), 1998, pp. 583-590
Background Coronary heart disease is a major cause of morbidity and mortali
ty in the elderly, a rapidly growing section of the population. Elderly pat
ients have been excluded from most preventative risk factor trials.
Methods We evaluated fluvastatin, a fully synthetic hydroxymethyl glutaryl
coenzyme A reductase inhibitor, in white patients older than 60 years, in s
even hospital centres, After an 8-week cholesterol-decreasing diet phase, p
atients were allocated to groups to receive fluvastatin 40 mg daily (n = 33
) or placebo (n = 36) given for 12 weeks. All patients had low-density lipo
protein cholesterol concentrations greater than or equal to 4.1 mmol/l 1 we
ek before they were allocated to a treatment at random. After receiving ran
domised treatment for 12 weeks, 50 patients then received fluvastatin 40 mg
daily on an open basis for a further 12 weeks.
Results Mean +/- SD age was 70.7 +/- 5.2 years for fluvastatin patients and
68.3 +/- 5.6 years for placebo. Mean +/- SD percentage changes in lipid co
ncentrations from randomisation to the end of 12 weeks were calculated (n =
63) by intent-to-treat analysis. Total cholesterol decreased by 21.64 +/-
8.7% in the fluvastatin group and by 2.91 +/- 7.25% in the placebo group (P
< 0.01); high-density lipoprotein cholesterol increased by 4.98 +/- 10.84%
in the fluvastatin group and decreased by 0.05 +/- 8.68% in the placebo gr
oup (P = 0.05); low-density lipoprotein cholesterol decreased by 27.14 +/-
8.45% in the fluvastatin group and by 2.1.6 +/- 9.68% in the placebo group
(P < 0.01); very-low-density lipoprotein cholesterol decreased by 30.70 +/-
30.65% in the fluvastatin group and by 9.80 +/- 28.6% in the placebo group
(P < 0.01); triglyceride decreased by 18.13 +/- 17.35% in the fluvastatin
group and by 2.97 +/- 21.85% in the placebo group (P < 0.01). There were no
statistically significant differences between treatment groups for any oth
er biochemical or haematological parameters. Adverse events were mainly mil
d, diminishing with continued treatment, and no event was serious by standa
rd criteria. Patient-assessed tolerability after randomised treatment was '
very good' for 18 fluvastatin patients and for 26 placebo patients (P = 0.7
9), Seven patients withdrew from the 12-week follow-up (four from the fluva
statin group and three from the placebo group).
Conclusions We conclude that fluvastatin decreases lipid concentrations eff
ectively and safely in elderly patients, producing clinically significant d
ecreases in total cholesterol, low-density lipoprotein cholesterol, triglyc
eride and, especially, very-low-density lipoprotein cholesterol, while incr
easing high-density lipoprotein cholesterol moderately. Coronary Artery Dis
9:583-590 (C) 1998 Lippincott Williams & Wilkins.