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. 2017 Apr 28;2017(4):CD011748. doi: 10.1002/14651858.CD011748.pub2
Methods Type of RCT: 1:3 parallel‐group, double‐blind dose‐ranging RCT
Settings: outpatient care
Duration: 24 weeks
Start and stop dates: NA
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)
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
Outcomes Lipids, any adverse events, CVD, all‐cause mortality
Notes
  • Reduction in lipids was given as an overall P value and as a range of effects. Effect was averaged and standard error was calculated assuming a standard normal distribution. This results in a very conservative estimate of precision

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