Table 1. Baseline Characteristics and Study Quality of included Randomised Controlled Trials.

IncludedStudy	Study population characteristics	Mean age (SD); female gender (%)	Mean SBP(SD)/DBP (SD) mmHg	Mean total cholesterol (SD); LDL (SD) mmol/L	‘Polypill’ contents (dose); n	Comparison; n	Duration of follow-up;	Outcomes assessed;	Study quality (Jadad score [25])
Grimm et al.2010 [31] *	Primary prevention (no previousCVD) Inclusion criteria: Any CVDrisk factor but no diabetes	56 (range 24–84); 50%	132.6 (11.8)/81.5 (8.9)	5.48 (0.78); 3.35 (0.60)	Amlodipine (5–10 mg) Atorvastatin (20 mg); n = 122	Amlodipine (5–10 mg); n = 122	6 weeks	SBP, DBP*, Total cholesterol, LDL, AEs;	Jadad 5/5; 89% follow-up
Malekzadeh et al.2010 [34] *	Primary prevention (no previousCVD) Inclusion criteria: >50/55 yrs,no previous CVD; not on active BPor lipid lowering medications. No exclusionfor diabetes	59.1 (6.9); 33%	127.5 (17.3)/79.8 (10.1)	5.26 (1.01); 2.99 (0.68)	Aspirin (81 mg), Enalapril (2.5 mg), Atorvastatin (20 mg) and Hydrochloro-thiazide (12.5 mg); n = 241	Placebo; n = 234	12 months	SBP, DBP, Total cholesterol, LDL, AEs;	Jadad 4/5; Imbalance in baseline chchs suggests inadequacy of randomisation; Low follow-up rate: 68% in intervention, 78% in control
Neutel et al.2009 [32] *	Primary prevention (no previousCVD) Inclusion criteria: Hypertensionor dyslipidaemia but no diabetesand not on any treatment	52.9 (10.7);54%	146.5 (10.0)/91.1 (6.8)	5.65 (0.72); 3.46 (0.60)	Amlodipine (5 mg) Atorvastatin (20 mg)(plus TLC);n = 66	Placebo (plus TLC); n = 64	8 weeks	SBP, DBP. Total cholesterol, LDL, AEs;	Jadad 4/5; 90% follow-up
Pill Collaborative2011 [33]	Primary prevention (no previousCVD) Inclusion criteria: 5-yr CVD risk>7.5% (based on Framinghamrisk score) or 5%–7.5% and 2 CVDrisk factors. No exclusionfor diabetes	61.4 (7.2); 19%	134.0 (13.5)/80.5 (9.0)	5.50 (1.05); 3.65 (0.90)	Aspirin (75 mg), Lisinopril (10 mg) Hydrochlorothiazide (12.5 mg) and Simvastatin (20 mg); n = 189	Placebo; n = 189	12 weeks	SBP, DBP, Total cholesterol, LDL, AEs;	Jadad 5/5; 99% follow-up and some imbalance in baseline SBP
Wald2012 [36]	Primary prevention (no previousCVD) Inclusion criteria: over50 years of age	59 (range 51–77); 26%	143.0 (16)/86.0 (10)**	5.9 (1.0); 3.7 (0.9)**	Amlodipine (2.5 mg) Losartan (25 mg), Hydrochlorothiazide (12.5 mg) and Simvastatin (40 mg); n = 86	Placebo; n = 86	12 weeks (cross-over RCT)	SBP, DBP, Total cholesterol, LDL, AEs	Jadad 5/5; 98% follow-up
The IndianPolycap Study ‘TIPS’2009 [35] #	Primary prevention (no previous CVD) Inclusion criteria: at least one CV risk factor (including diabetes)	53.6 (7.7); 44%	134.3 (12.3)/85.2 (8.1)	4.7 (0.9); 3.0 (0.8)	Hydrochlorothiazide (12·5 mg), Atenolol (50 mg), Ramipril (5 mg), Simvastatin (20 mg), Aspirin (100 mg); n = 412	Aspirin (100 mg); n = 205 (Simvastatin 20 mg group added for BP comparison n = 202)	12 weeks (some 8–12 weeks);	SBP, DBP, Total cholesterol, LDL, AEs;	Jadad 5/5; 85% follow-up in these three arms

^*BP not assessed in meta-analysis as both arms contained an anti-hypertensive;

^**Following placebo 12 weeks of cross-over RCT;

^#Double-blind 9-arm with varying medication components and number of components. Only three arms were used in this meta-analysis: the polycap, aspirin and simvastatin arms;

BP = blood pressure and measured in mmHg; SBP = systolic blood pressure; DBP = Diastolic blood pressure; Total chol. = total cholesterol in mmol/L; LDL = LDL cholesterol in mmol/L; AE = adverse events; TLC = therapeutic lifestyle changes; SD = standard deviation; CVD = cardiovascular disease.