Table 1.
Demographics and baseline characteristics of patients included in the meta-analysis according to study and treatment group
| Study (trial number) | Study design | Treatment arms | Treatment period (follow-up period) | Randomized patients, n | Age, years | Female sex | Caucasian | Japanese ethnicity | LDL-C, (mg/Dl) |
|---|---|---|---|---|---|---|---|---|---|
| Brohet et al. (2005) [26] | Randomized, double-blind, placebo-controlled, multi-arm | EZE 10 mg QD + SIM 10/20 mg QD | 6 weeks (no additional follow-up) | 208 | 63.6 ± 11.1 | 63 (30.3) | 121.8 ± 16.2 | ||
| SIM 10/20 mg QD | 210 | 62.7 ± 9.6 | 52 (24.8) | 123.0 ± 13.9 | |||||
| EZE 10 mg QD + SIM 10 mg QD | 65 | 117.9 | |||||||
| EZE 10 mg QD + SIM 20 mg QD | 143 | 123.7 | |||||||
| SIM 10 mg QD | 72 | 121.8 | |||||||
| SIM 20 mg QD | 138 | 123.4 | |||||||
| Cannon et al. (2015) [12] IMPROVE-IT (NCT00202878)a | Randomized, double-blind, controlled, two-arm | EZE 10 mg QD + SIM 40–80 mg QD | Median 6 years (no additional follow-up) | 9067 | 63.6 ± 9.7 | 2225 (24.5) | 7578 (83.6) | 93.8 | |
| SIM 40–80 mg QD | 9077 | 63.6 ± 9.8 | 2191 (24.1) | 7624 (84.0) | 93.8 | ||||
| Hibi et al. (2018) [27] (NCT00549926)a, b | Randomized, open-label, controlled, two-arm | EZE 10 mg QD + PITA 2 mg QD | 10 months (no additional follow-up) | 50c | 63 ± 10.0 | 9 (18.0) | 123 ± 32.0 | ||
| PITA 2 mg QD | 53c | 63 ± 12.0 | 12 (22.6) | 126 ± 33.0 | |||||
| Joshi et al. (2017) [28]b | Randomized, controlled, two-arm | EZE 10 mg QD + ROSU 10 mg QD | 24 weeks (no additional follow-up) | 40 | 60.3 ± 9.8 | 18 (45.0) | 162.7 ± 23.1 | ||
| ROSU 10 mg QD | 40 | 59.8 ± 11.1 | 15 (37.5) | 153.4 ± 24.8 | |||||
| Masuda et al. (2015) [29] (UMIN000010323) | Randomized, open-label, controlled, two-arm | EZE 10 mg QD + ROSU 5 mg QD | 6 months (no additional follow-up) | 21c | 64.0 ± 7.9 | 2 (9.5) | 0 | 21 (100) | 131.8 ± 25.6 |
| ROSU 5 mg QD | 19c | 70.2 ± 7.6 | 3 (15.8) | 0 | 19 (100) | 123.0 ± 27.0 | |||
| Ran et al. (2017) [30]a, b | Randomized, controlled, multi-arm | EZE 10 mg QD + ROSU 10 mg QD | 12 weeks (no additional follow-up) | 42 | 60.4 ± 8.2 | 10 (23.8) | 141 ± 27.0 | ||
| ROSU 10 mg QD | 42 | 60.6 ± 6.7 | 11 (26.2) | 141 ± 33.0 | |||||
| ROSU 20 mg QD | 41 | 60.5 ± 10.0 | 11 (26.8) | 141 ± 35.0 | |||||
| Ren et al. (2017) [31]a | Randomized, controlled, two-arm | EZE 10 mg QD + ROSU 10 mg QD | 12 months (no additional follow-up) | 55 | 57.3 ± 1.5 | 7 (12.7) | 116.0 ± 37.1 | ||
| ROSU 10 mg QD | 58 | 60.7 ± 1.3 | 12 (20.7) | 113.3 ± 39.4 | |||||
| Ueda et al. (2017) [32] ZIPANGU (UMIN000006971) | Randomized, open-label, controlled, two-arm | EZE 10 mg QD + ATOR 10–20 mg QD | 9 months (no additional follow-up) | 54c | 71 ± 8.0 | 13 (24.1) | 101 ± 27.0 | ||
| ATOR 10–20 mg QD | 54c | 68 ± 11.0 | 10 (18.5) | 100 ± 27.0 | |||||
| Wang et al. (2017) [33] | Randomized, controlled, two-arm | EZE 10 mg QD + ATOR 20 mg QD | 12 months (no additional follow-up) | 51 | 58 ± 10.0 | 20 (39.2) | 136.5 ± 33.6 | ||
| ATOR 20 mg QD | 49 | 58 ± 9.0 | 19 (38.8) | 133.4 ± 29.0 | |||||
| Wang et al. (2016) [34]b | Randomized, controlled, two-arm | EZE 10 mg QD + ROSU 10 mg QD | 12 months (no additional follow-up) | 50c | 63 ± 10.0 | 14 (28.0) | 140.0 ± 45.6 | ||
| ROSU 10 mg QD | 48c | 65 ± 12.0 | 13 (27.1) | 134.6 ± 48.7 | |||||
| West et al. (2011) [35] (NCT00587678)b | Randomized, double-blind;b open-label | EZE 10 mg QD + SIM 40 mg QD | 2 years (no additional follow-up) | 18c | 62 ± 8.0 | 8 (44.4) | 14 (78.0) | 118 ± 38.1 | |
| SIM 40 mg QD | 16c | 59 ± 10.0 | 5 (31.3) | 13 (81.0) | 118 ± 40.0 | ||||
| EZE 10 mg QD | 33c | 65 ± 10.0 | 17 (51.5) | 24 (73.0) | 100 ± 23.0 | ||||
| Zou et al. (2016) [36]b | Randomized, controlled, two-arm | EZE 10 mg QD + ATOR 10 mg QD | 12 months (no additional follow-up) | 40 | 69.3 ± 5.8 | ||||
| ATOR 10 mg QD | 40 | 70.3 ± 7.2 |
Data are presented as mean ± standard deviation or N (%) unless otherwise indicated
ATOR atorvastatin, EZE ezetimibe, LDL-C low-density lipoprotein cholesterol, NR not reported, PITA pitavastatin, QD daily, ROSU rosuvastatin, SIM simvastatin
aTrials included in sensitivity analysis of patients with recent acute coronary syndrome (< 1 year)
bStudies including statin-naïve patients at enrolment
cPatient population defined as follows: Hibi et al. [27], randomized patients included in the full analysis set; Masuda et al. [29], randomized patients included in the primary analysis; Ueda et al. [32], randomized patients who were included in the analysis; Wang et al. [34], randomized patients included in the analysis; West et al. [35], randomized patients included in the analysis