Table 2.
Transition to diabetes based on treatment-emergent adverse event data alone by treatment group
| Placebo-controlled pool |
Ezetimibe-controlled pool |
|||
|---|---|---|---|---|
| Placebo (n = 818) | Alirocumab (n = 1620) | Ezetimibe (n = 428) | Alirocumab (n = 582) | |
| Incident diabetes mellitus or diabetic complications TEAE | ||||
| n (%,95% mid-P CI) | 21 (2.6, 1.6–3.8) | 27 (1.7, 1.1–2.4) | 9 (2.1, 1.0–3.8) | 9 (1.5, 0.8–2.8) |
| Number of patients with an event per 100 patient-yeara (95% CI) | 1.8 (1.1–2.8) | 1.2 (0.8–1.7) | 2.8 (1.3–5.4) | 1.8 (0.8–3.4) |
| HR vs. control (95% CI)b | 0.64 (0.36–1.14) | 0.55 (0.22–1.41) | ||
| Diabetes mellitus or diabetic complications TEAE, n (%) | ||||
| Diabetes mellitus or diabetic complications (CMQ) | 21 (2.6) | 27 (1.7) | 9 (2.1) | 9 (1.5) |
| Type 2 diabetes mellitus | 13 (1.6) | 21 (1.3) | 2 (0.5) | 5 (0.9) |
| Diabetes mellitus | 4 (0.5) | 4 (0.2) | 2 (0.5) | 2 (0.3) |
| Diabetic neuropathy | 0 | 1 (<0.1) | 0 | 0 |
| Diabetic retinopathy | 0 | 1 (<0.1) | 0 | 0 |
| Glucose tolerance decreased | 0 | 1 (<0.1) | 0 | 0 |
| Blood glucose increased | 1 (0.1) | 0 | 3 (0.7) | 1 (0.2) |
| Hyperglycaemia | 3 (0.4) | 0 | 2 (0.5) | 1 (0.2) |
MedDRA 17.1. The selection of preferred terms (PTs) is based on the CMQ ‘diabetes mellitus or diabetic complications’.
n (%) = number and percentage of individuals with at least one event. Table sorted by decreasing incidence of PT in the alirocumab group of placebo-controlled pool. Individuals without diabetes at baseline defined as those not assigned CMQ code ‘diabetes’ recorded in medical history.
aCalculated as number of individuals with an event divided by total patient years.
bCalculated using a Cox model stratified on the study.
CI, confidence interval; CMQ, Custom Medical Query; HR, hazards ratio; MedDRA, Medical Dictionary for Regulatory Activities; TEAE, treatment-emergent adverse event.