Key result
Pitavastatin did not significantly reduce the composite of cardiac death and hospitalization for worsening heart failure compared to control in Japanese patients with chronic heart failure (aHR 0.922).
Why the study?
Does pitavastatin reduce cardiac death or hospitalization for worsening HF in Japanese patients with chronic heart failure?
RCT (n=574)
Open-label, blinded-endpoint (PROBE)
Minimization method with biased-coin assignment
Yes
Does pitavastatin reduce cardiac death or hospitalization for worsening HF in Japanese patients with chronic heart failure?
Effect estimate: aHR 0.922 (95% CI 0.632-1.345)
Absolute Event Rate: 18% vs 19.9%
p-value: p=0.672
Pitavastatin did not improve clinical outcomes in patients with chronic heart failure, consistent with prior trials of other statins in this population, though subgroup analysis suggested potential benefit in those with LVEF ≥30%.
Neutral primary endpoint for pitavastatin in chronic HF; reinforces neutral findings across prior statin RCTs.
BACKGROUND: Recent clinical trials using rosuvastatin, a hydrophilic statin, did not show beneficial effects on cardiovascular events in patients with heart failure. We examined the cardioprotective effects of pitavastatin, a lipophilic statin, on Japanese patients with chronic heart failure (CHF). METHODS AND RESULTS: A total of 574 Japanese patients with CHF were randomly assigned to the pitavastatin group (n=288) or the control group (n=286). There was no significant difference between the 2 groups for the primary outcome, which was a composite of cardiac death and hospitalization for worsening HF (adjusted hazard ratio (aHR): 0.922, 95% confidence interval (CI): 0.632-1.345, P=0.672). A strongly significant statistical interaction between the effect of pitavastatin and left ventricular ejection fraction (LVEF) was found (P=0.004). In patients with LVEF ≥30%, a significant reduction in the primary outcome (aHR: 0.525, 95% CI: 0.308-0.896, P=0.018) was observed in the pitavastatin group. Pitavastatin did not show any effects on the primary outcome (aHR: 1.582, 95% CI: 0.890-2.813, P=0.118) in the subgroup of patients with LVEF <30%. CONCLUSIONS: Pitavastatin did not reduce cardiac death or hospitalization for worsening HF in Japanese patients with CHF. (UMIN-ID: UMINC000000428).
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Takano et al. (2013) conducted an RCT in Chronic heart failure (n=574). Pitavastatin vs. Control (no statin) was evaluated on Composite of cardiac death and hospitalization for worsening HF (aHR 0.922, 95% CI 0.632-1.345, p=0.672). Pitavastatin did not significantly reduce the composite of cardiac death and hospitalization for worsening heart failure compared to control in Japanese patients with chronic heart failure (aHR 0.922).
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