Willich 2009.

Study characteristics
Methods	Parallel randomised controlled clinical trial Randomisation ratio: 1:1 Equivalence design: (2‐sided confidence interval) Open‐label
Participants	N recruited = 8108 N randomised= 8108 (4044 control, 4064 intervention) N reported outcomes = 6872 Mean age 60.8 yrs (SD 10.41), 56.1% men INCLUSION CRITERIA Low density lipoprotein cholesterol (LDL‐C) > 115 mg/dl if statin‐naïve or else > 125 mg/dl Participants were also required to have at least one of the following risk factors: history of CHD, other atherosclerotic disease, 10‐year CHD risk Z20%, or diabetes EXCLUSION CRITERIA Fasting triglycerides > 400 mg/dl (4.5 mmol/l); familial or secondary hypercholesterolaemia; active liver disease, defined as elevations of aspartate aminotransferase or alanine aminotransferase (ALT) Z1.5 upper limit of normal (ULN); creatine kinase greater than 3ULN; or unstable angina COUNTRY/SETTING: Germany STUDY PERIOD: Enrolment between April 2002 and February 2004
Interventions	INTERVENTION GROUP Participants in the intervention group received 10/20 mg rosuvastatin in addition to a starter pack containing a videotape, an educational leaflet, details of the free phone patient helpline and website, and labels with a reminder to take study medication. Participants also received regular personalised letters and phone calls throughout the study. CONTROL GROUP The control group received 10/m20 rosuvastatin alone
Outcomes	PRIMARY OUTCOMES: Long‐term cumulative direct and indirect disease related costs associated with rosuvastatin treatment either with or without additional compliance programme at 12 and 36 months SECONDARY OUTCOMES: Number (%) of participants achieving 1998 European LDL‐C and total cholesterol goals after 3, 6, and 12 months of therapy; number (%) of participants increasing their dose of rosuvastatin at month 3; percentage change from baseline in lipids and lipoproteins; compliance with drug therapy (assessed by counting the number of pills returned by the patient at 6 and 12 months); and safety.
Notes	Aim: "To determine whether a compliance‐enhancing program could increase the level of lipid control patients treated with rosuvastatin" Funding: "This study was supported by a grant from AstraZeneca." Conflicts: None reported Language: English
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"For the 12‐month intervention phase, consecutive patients were randomized 1: 1, using a computer‐generated randomization list, to receive rosuvastatin 10 mg daily (manufacturer AstraZeneca GmbH, D‐22876 Wedel, Germany) either with or without a compliance program"
Allocation concealment (selection bias)	Low risk	See above
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Unblinded open‐label study
Incomplete outcome data (attrition bias) All outcomes	Low risk	"Assuming a 20% dropout rate, at least 6608 patients were required to be recruited for 90% power"
Selective reporting (reporting bias)	Low risk	All outcomes reported

BAS bile acid sequestrants

BMI body mass index

BP blood pressure

CHD coronary heart disease

COI conflict of interest

FDC fixed‐dose combination

FMD flow mediated dilatation

GEE generalised estimated equations

HDL‐C high density lipoprotein cholesterol

IMT intima media thickness

ITT intention to treat

LDL‐C low density lipoprotein cholesterol

MEMS Medication Event Monitoring System

MI myocardial infarction

RCT randomised controlled trial

SD standard deviation

SE standard error

TC total cholesterol

TRG triglycerides