Table 1.
Participants with outcomes during active, passive, and entire follow-up
Active intervention period (5.6 years) |
Passive follow-up (additional 3.1 years) |
Total follow-up (8.7 years) |
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Rosuvastatin vs. placebo |
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Rosuva (n = 6361) | Plac (n = 6344) | HR (95% CI) | P-value | Rosuva (n = 4696) | Plac (n = 4630) | HR (95% CI) | P-value | Rosuva (n = 6361) | Rate per 100 py | Plac (n = 6344) | Rate per 100 py | HR (95% CI) | P-value | |
MACE-1 | 235 (3.7%) | 304 (4.8%) | 0.76 (0.64–0.91) | 0.002 | 146 (3.1%) | 181 (3.9%) | 0.80 (0.64–0.99) | 0.042 | 378 (5.9%) | 0.77 | 472 (7.4%) | 0.98 | 0.79 (0.69–0.90) | 0.0005 |
MACE-2 | 277 (4.4%) | 363 (5.7%) | 0.75 (0.64–0.88) | 0.0004 | 173 (3.7%) | 207 (4.5%) | 0.83 (0.68–1.01) | 0.065 | 440 (6.9%) | 0.90 | 550 (8.7%) | 1.15 | 0.79 (0.69–0.89) | 0.0002 |
MACE-2 + angina | 306 (4.8%) | 393 (6.2%) | 0.77 (0.66–0.89) | 0.0006 | 177 (3.8%) | 215 (4.6%) | 0.81 (0.67–0.99) | 0.043 | 471 (7.4%) | 0.97 | 584 (9.2%) | 1.22 | 0.79 (0.70–0.89) | 0.0002 |
Coronary ischaemic eventsa ,b | 113 (1.8%) | 148 (2.3%) | 0.76 (0.59–0.97) | 0.025 | 28 (0.6%) | 51 (1.1%) | 0.54 (0.34–0.86) | 0.01 | 139 (2.2%) | 0.28 | 191 (3.0%) | 0.40 | 0.72 (0.58–0.90) | 0.003 |
CV death | 154 (2.4%) | 171 (2.7%) | 0.89 (0.72–1.11) | 0.306 | 115 (2.5%) | 128 (2.8%) | 0.89 (0.69–1.15) | 0.377 | 269 (4.7%) | 0.54 | 299 (4.7%) | 0.61 | 0.89 (0.76–1.05) | 0.171 |
BP-lowering therapyc vs. placebo
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BP (n = 6356) | Plac (n = 6349) | HR (95% CI) | P-value | BP (n = 4677) | Plac (n = 4649) | HR (95% CI) | P-value | BP (n = 6356) | Rate per 100 py | Plac (n = 6349) | Rate per 100 py | HR (95% CI) | P-value | |
MACE-1 | 260 (4.1%) | 279 (4.4%) | 0.93 (0.79–1.10) | 0.40 | 169 (3.6%) | 158 (3.4%) | 1.07 (0.86–1.33) | 0.52 | 419 (6.6%) | 0.86 | 431 (6.8%) | 0.89 | 0.97 (0.85–1.11) | 0.67 |
MACE-2 | 312 (4.9%) | 328 (5.2%) | 0.95 (0.81–1.11) | 0.51 | 196 (4.2%) | 184 (4.0%) | 1.07 (0.88–1.31) | 0.51 | 492 (7.7%) | 1.02 | 498 (7.8%) | 1.03 | 0.99 (0.87–1.12) | 0.84 |
MACE-2 + angina | 335 (5.3%) | 364 (5.7%) | 0.92 (0.79–1.06) | 0.26 | 203 (4.3%) | 189 (4.1%) | 1.08 (0.89–1.32) | 0.45 | 522 (8.2%) | 1.08 | 533 (8.4%) | 1.11 | 0.98 (0.87–1.10) | 0.72 |
Stroke | 75 (1.2%) | 94 (1.5%) | 0.80 (0.59–1.08) | 0.14 | 44 (0.9%) | 34 (0.7%) | 1.30 (0.83–2.03) | 0.26 | 116 (1.8%) | 0.24 | 128 (2.0%) | 0.91 | 0.91 (0.70–1.16) | 0.44 |
Coronary ischaemic eventsa , b | 120 (1.9%) | 141 (2.2%) | 0.85 (0.67–1.08) | 0.19 | 36 (0.8%) | 43 (0.9%) | 0.84 (0.54–1.31) | 0.43 | 154 (2.4%) | 0.32 | 176 (2.8%) | 0.36 | 0.87 (0.70–1.09) | 0.23 |
Combination therapyc vs. double placebo
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Combo (n = 3180) | Dbl Plac (n = 3168) | HR (95% CI) | P-value | Combo (n = 2539) | Dbl Plac (n = 2312) | HR (95% CI) | P-value | Combo (n = 3180) | Rate per 100 py | Dbl Plac (n = 3168) | Rate per 100 py | HR (95% CI) | P-value | |
MACE-1 | 113 (3.6%) | 157 (5.0%) | 0.71 (0.56–0.90) | 0.005 | 70 (3.0%) | 82 (3.5%) | 0.85 (0.62–1.17) | 0.32 | 181 (5.7%) | 0.74 | 234 (7.4%) | 0.97 | 0.76 (0.63–0.92) | 0.006 |
MACE-2 | 136 (4.3%) | 187 (5.9%) | 0.72 (0.57–0.89) | 0.003 | 83 (3.5%) | 94 (4.0%) | 0.88 (0.65–1.18) | 0.39 | 214 (6.7%) | 0.88 | 272 (8.6%) | 1.13 | 0.77 (0.65–0.92 | 0.005 |
MACE-2 + angina | 147 (4.6%) | 205 (6.5%) | 0.71 (0.57–0.87) | 0.001 | 86 (3.6%) | 98 (4.2%) | 0.87 (0.65–1.17) | 0.36 | 228 (7.2%) | 0.94 | 290 (9.2%) | 1.21 | 0.77 (0.65–0.92 | 0.003 |
Coronary ischaemic eventsa ,b | 52 (1.6%) | 80 (2.5%) | 0.64 (0.45–0.91) | 0.013 | 13 (0.6%) | 28 (1.2%) | 0.46 (0.24–0.89) | 0.02 | 65 (2.0%) | 0.27 | 102 (3.2%) | 0.42 | 0.63 (0.46–0.86) | 0.004 |
BP, blood pressure; CI, confidence interval; CV, cardiovascular; Dbl Plac, double placebo; HR, hazard ratio; MACE-1, myocardial infarction, stroke or cardiovascular death; MACE-2, myocardial infarction, stroke, cardiovascular death, revascularization, resuscitated cardiac arrest or heart failure; Plac, placebo; py, person-years; Rosuva, rosuvastatin.
Coronary ischaemic events: fatal or non-fatal myocardial infarction, resuscitated cardiac arrest, angina, and revascularization.
Post hoc outcome.
BP-lowering therapy: candesartan + hydrochlorothiazide.
Combintion therapy: candesartan/hydrochlorothiazide + rosuvastatin.