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. 2020 Mar 15;8(1):e000943. doi: 10.1136/bmjdrc-2019-000943

Table 2.

Primary and secondary efficacy clinical events in patients with and without diabetes mellitus



Endpoint
Diabetes Non-diabetes Interaction
P value*
Evacetrapib n/N (KM estimate) Placebo n/N (KM estimate) HR (95% CI) P value Evacetrapib n/N (KM estimate) Placebo n/N (KM estimate) HR (95% CI) P value
Primary composite† 564/4127 (14.5) 589/4109 (16.0) 0.95 (0.85 to 1.07) 0.38 201/1911 (11.5) 175/1945 (9.7) 1.17 (0.96 to 1.44) 0.12 0.075
 Cardiovascular death 116/4127 (3.1) 134/4109 (3.7) 0.86 (0.67 to 1.10) 0.23 20/1911 (1.2) 26/1945 (1.5) 0.78 (0.43 to 1.39) 0.40 0.76
 Myocardial infarction 189/4126 (4.9) 186/4108 (4.9) 1.01 (0.83 to 1.24) 0.92 62/1910 (3.7) 69/1944 (3.8) 0.91 (0.65 to 1.29) 0.60 0.61
 Stroke 64/4127 (1.7) 77/4109 (2.2) 0.83 (0.59 to 1.15) 0.25 27/1911 (1.6) 19/1945 (1.0) 1.45 (0.80 to 2.60) 0.22 0.10
 Hospitalization for unstable angina 113/4127 (3.0) 106/4109 (2.9) 1.06 (0.81 to 1.38) 0.67 40/1911 (2.2) 37/1945 (2.1) 1.10 (0.70 to 1.72) 0.68 0.90
 Coronary revascularization 351/4127 (9.2) 360/4109 (9.9) 0.97 (0.84 to 1.12) 0.67 132/1911 (7.4) 118/1945 (6.5) 1.14 (0.89 to 1.46) 0.31 0.28
Triple composite‡ 319/4127 (8.2) 346/4109 (9.4) 0.91 (0.79 to 1.06) 0.25 105/1911 (6.3) 98/1945 (5.5) 1.09 (0.83 to 1.44) 0.54 0.27
All-cause mortality 176/4127 (4.6) 206/4109 (5.7) 0.85 (0.69 to 1.04) 0.11 43/1911 (2.6) 58/1945 (3.4) 0.75 (0.51 to 1.11) 0.15 0.58

*For interaction between status of diabetes and treatment assigned.

†The primary composite endpoint was the time to first occurrence of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina or coronary revascularization.

‡The triple composite endpoint was the time to first occurrence of cardiovascular death, myocardial infarction or stroke.

KM, Kaplan-Meier.