Table 1.
Reasons for withdrawal from pre-randomization run-in
| LDL-lowering therapy alone | LDL-lowering therapy plus active ERN/LRPT | |
|---|---|---|
| Number entering phase | 36 059 | 38 369 |
| Mean duration of phase (weeks) | 4.6 | 7.4 |
| Medical reasons | ||
| Skin | ||
| Pruritis | 80 (0.2%) | 2536 (6.6%) |
| Rash | 65 (0.2%) | 1416 (3.7%) |
| Flushing | 20 (<0.1%) | 646 (1.7%) |
| Other skin | 13 (<0.1%) | 192 (0.5%) |
| Any skin reason | 170 (0.5%) | 4326 (11.3%) |
| Gastrointestinal (GI) | ||
| Any upper GIa | 208 (0.6%) | 1108 (2.9%) |
| Any lower GI | 170 (0.5%) | 883 (2.3%) |
| Other GI | 98 (0.3%) | 278 (0.7%) |
| Any gastrointestinal reason | 454 (1.3%) | 2117 (5.5%) |
| Hepatobiliary | ||
| Abnormal alanine transaminaseb | 223 (0.6%) | 472 (1.2%) |
| Other hepatobiliary | 2 (<0.1%) | 9 (<0.1%) |
| Any hepatobiliary reason | 225 (0.6%) | 481 (1.3%) |
| Musculoskeletal | ||
| Muscle symptomsa | 268 (0.7%) | 498 (1.3%) |
| Rheumatological | 65 (0.2%) | 196 (0.5%) |
| Gout | 5 (<0.1%) | 60 (0.2%) |
| Abnormal creatine kinase | 12 (<0.1%) | 33 (<0.1%) |
| Other musculoskeletal | 397 (1.1%) | 381 (1.0%) |
| Any musculoskeletal reason | 704 (2.0%) | 1096 (2.9%) |
| Diabetes | ||
| New-onset diabetes mellitus | 0 (0.0%) | 3 (<0.1%) |
| Major diabetes complication | 0 (0.0%) | 5 (<0.1%) |
| Other diabetes-related reason | 26 (<0.1%) | 656 (1.7%) |
| Any diabetes-related reason | 26 (<0.1%) | 664 (1.7%) |
| Other medical | ||
| Pre-syncope/syncope | 55 (0.2%) | 261 (0.7%) |
| Palpitations | 36 (<0.1%) | 123 (0.3%) |
| Other cardiovascular | 186 (0.5%) | 436 (1.1%) |
| Respiratory | 25 (<0.1%) | 118 (0.3%) |
| Cancer | 12 (<0.1%) | 45 (0.1%) |
| Other | 380 (1.1%) | 1277 (3.3%) |
| Contraindicated medication | 25 (<0.1%) | 49 (0.1%) |
| Medical advice | 90 (0.2%) | 157 (0.4%) |
| Planned revascularization | 8 (<0.1%) | 45 (0.1%) |
| Any other medical reason | 802 (2.2%) | 2354 (6.1%) |
| Any medical reason | 2211 (6.1%) | 9798 (25.5%) |
| Non-medical reasons | ||
| Patient wishes/did not attend | 1502 (4.2%) | 2403 (6.3%) |
| Difficulty swallowing tablets | 68 (0.2%) | 746 (1.9%) |
| Other | 639 (1.8%) | 1317 (3.4%) |
| Any non-medical reason | 1988 (5.5%) | 3804 (9.9%) |
| Any reason | 4055 (11.2%) | 12 696 (33.1%) |
Participants may report more than one reason for withdrawal. Percentages are shown relative to the number of participants entering the phase. LDL-lowering therapy alone: LDL stabilization on simvastatin 40 mg or ezetimibe/simvastatin 10/40 mg daily. LDL-lowering therapy plus active ERN/L: LDL-lowering treatment plus ER niacin/laropiprant (1 g daily for 4 weeks increasing to 2 g daily for 4 weeks).
aIncludes routinely sought symptoms at run-in and randomization visits.
bMeasured at run-in and randomization visits: participants were excluded if >2× upper limit of normal.