Table 3

Secondary safety endpoints

 Combination lipid-lowering therapy (N = 6215)High-intensity atorvastatin monotherapy (N = 25 778)Risk difference
(95% CI)a
Hazard ratio (95% CI)bP-value
Discontinuation of statin519 (8.4)2571 (10.0)−1.6 (−2.5 to −0.8)0.81 (0.73−0.90)<0.001
New-onset diabetes requiring medicationc237/3370 (7.0)1253/14 244 (8.8)−1.7 (−2.9 to −0.6)0.80 (0.70−0.92)0.002
Rhabdomyolysis14 (0.2)90 (0.3)−0.1 (−0.3 to 0.1)0.80 (0.47−1.34)0.390
Cholecystectomy71 (1.1)236 (0.9)0.2 (0.0 to 0.5)1.27 (0.96−1.70)0.098
Cancer diagnosis246 (4.0)1037 (4.0)0.0 (−0.6 to 0.5)0.98 (0.84−1.14)0.799
 Combination lipid-lowering therapy (N = 6215)High-intensity atorvastatin monotherapy (N = 25 778)Risk difference
(95% CI)a
Hazard ratio (95% CI)bP-value
Discontinuation of statin519 (8.4)2571 (10.0)−1.6 (−2.5 to −0.8)0.81 (0.73−0.90)<0.001
New-onset diabetes requiring medicationc237/3370 (7.0)1253/14 244 (8.8)−1.7 (−2.9 to −0.6)0.80 (0.70−0.92)0.002
Rhabdomyolysis14 (0.2)90 (0.3)−0.1 (−0.3 to 0.1)0.80 (0.47−1.34)0.390
Cholecystectomy71 (1.1)236 (0.9)0.2 (0.0 to 0.5)1.27 (0.96−1.70)0.098
Cancer diagnosis246 (4.0)1037 (4.0)0.0 (−0.6 to 0.5)0.98 (0.84−1.14)0.799
a

A 95% confidence interval (CI) for absolute risk reduction attributed to each treatment was calculated.

b

Cox proportional hazard models were used to obtain adjusted hazard ratio, 95% CI, and P-values by defining high-intensity atorvastatin monotherapy as the reference arm.

c

Incidence of new-onset diabetes requiring medication was assessed for participants without prior diabetes history at enrolment.

Table 3

Secondary safety endpoints

 Combination lipid-lowering therapy (N = 6215)High-intensity atorvastatin monotherapy (N = 25 778)Risk difference
(95% CI)a
Hazard ratio (95% CI)bP-value
Discontinuation of statin519 (8.4)2571 (10.0)−1.6 (−2.5 to −0.8)0.81 (0.73−0.90)<0.001
New-onset diabetes requiring medicationc237/3370 (7.0)1253/14 244 (8.8)−1.7 (−2.9 to −0.6)0.80 (0.70−0.92)0.002
Rhabdomyolysis14 (0.2)90 (0.3)−0.1 (−0.3 to 0.1)0.80 (0.47−1.34)0.390
Cholecystectomy71 (1.1)236 (0.9)0.2 (0.0 to 0.5)1.27 (0.96−1.70)0.098
Cancer diagnosis246 (4.0)1037 (4.0)0.0 (−0.6 to 0.5)0.98 (0.84−1.14)0.799
 Combination lipid-lowering therapy (N = 6215)High-intensity atorvastatin monotherapy (N = 25 778)Risk difference
(95% CI)a
Hazard ratio (95% CI)bP-value
Discontinuation of statin519 (8.4)2571 (10.0)−1.6 (−2.5 to −0.8)0.81 (0.73−0.90)<0.001
New-onset diabetes requiring medicationc237/3370 (7.0)1253/14 244 (8.8)−1.7 (−2.9 to −0.6)0.80 (0.70−0.92)0.002
Rhabdomyolysis14 (0.2)90 (0.3)−0.1 (−0.3 to 0.1)0.80 (0.47−1.34)0.390
Cholecystectomy71 (1.1)236 (0.9)0.2 (0.0 to 0.5)1.27 (0.96−1.70)0.098
Cancer diagnosis246 (4.0)1037 (4.0)0.0 (−0.6 to 0.5)0.98 (0.84−1.14)0.799
a

A 95% confidence interval (CI) for absolute risk reduction attributed to each treatment was calculated.

b

Cox proportional hazard models were used to obtain adjusted hazard ratio, 95% CI, and P-values by defining high-intensity atorvastatin monotherapy as the reference arm.

c

Incidence of new-onset diabetes requiring medication was assessed for participants without prior diabetes history at enrolment.

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