Four RCTs were included in the review (n=27,548); sample sizes ranged from 4,162 to 10,001.
There was a significant increase in risk in the intensive-dose versus moderate-dose statin group for the following outcomes: drug-induced adverse event (OR 1.44, 95% CI: 1.33, 1.55, p<0.001; NNH 30, 95% CI: 24, 37), drug-induced adverse event requiring discontinuation of therapy (OR 1.28, 95% CI: 1.18, 1.39, p≤0.001; NNH 47, 95% CI: 35, 69), AST or ALT elevation ≥3 times ULN (OR 4.84, 95% CI: 3.27, 6.16, p≤0.001; NNH 86, 95% CI: 72, 106), and CK elevation ≥10 times ULN (OR 9.97, 95% CI: 1.28, 77.92, p=0.028; NNH 1,532, 95% CI: 890, 5,528).
There was no significant difference between the groups in risk of rhabdomyolysis or ACM.
There was a decreased risk in the intensive-dose versus moderate-dose statin group for the following: CV death (OR 0.86, 95% CI: 0.75, 0.99, p=0.031; NNT 229, 95% CI: 119, 2844), MI (OR=0.84, 95% CI: 0.76, 0.93, p<0.001; NNT 99, 95% CI: 63, 224) and stroke (OR 0.82, 95% CI: 0.72, 0.94, p=0.004; NNT 166, 95% CI: 98, 526).
The findings suggested that treating 1000 patients with intensive-dose rather than moderate-dose therapy would prevent 4 additional CV deaths, 10 MIs and 6 strokes, while causing 33 additional adverse events (21 requiring drug discontinuation). For every CV event prevented by intensive-dose compared to moderate-dose therapy, eight patients could be expected to have an adverse event of any type, five a potentially serious adverse event and three an AST or ALT elevation ≥3 times ULN.
Other results were reported in the review.