Methods |
Type of RCT: 1:3 parallel‐group, double‐blind dose‐ranging RCT Settings: outpatient care Duration: 24 weeks Start and stop dates: NA |
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Participants |
Number of participants: 248 (247 with baseline data) Number lost to follow‐up: 20 Women: 107 (43%) Age (SD), years: 64 (8) History of CVD: 129 (52%) Participants with FH: NA Participants with established CHD or CHD equivalent risk (not defined further) |
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Interventions |
Background therapy: standard of care, potentially including statin therapy Randomised therapy: 24 weeks of RG7652 (MPSK3169A) every 4, 8, or 12 weeks vs placebo RUG7652 dose: 5 dosage regimens were administered: 200 mg every 8 weeks, 400 mg every 8 weeks, 800 mg every 12 weeks, 400 mg every 4 weeks, 800 mg every 8 weeks, resulting in a 2‐week equivalent dose of 50 mg to 200 mg |
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Outcomes | Lipids, any adverse events, CVD, all‐cause mortality | |
Notes |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Only an abstract/poster was available |
Allocation concealment (selection bias) | Unclear risk | Only an abstract/poster was available |
Blinding of participants and personnel (performance bias) LDL‐C | Unclear risk | Only an abstract/poster was available |
Blinding of outcome assessment (detection bias) LDL‐C | Unclear risk | Only an abstract/poster was available. Unknown if a central laboratory was used |
Incomplete outcome data (attrition bias) All outcomes | High risk | 1 participant was excluded from modified ITT population, and 19 participants (7.66%) did not complete the study |
Selective reporting (reporting bias) | Unclear risk | Full paper has not yet been published |
Other bias | High risk | Funded by F. Hoffman‐La Roche Ltd |