Table 2:
Primary and secondary end points, by study arm
| Polypill | Usual Care | Difference (95%, CI)* | P | |||
|---|---|---|---|---|---|---|
| Baseline | 12 months | Baseline | 12 months | |||
| Primary End Points | ||||||
| Systolic BP, mmHg | 140 (19) | 131 (21) | 140 (17) | 138 (23) | −7 (−12, −2) | 0.003 |
| LDL cholesterol, mg/dl | 113 (33) | 98 (35) | 113 (37) | 109 (32) | −11 (−18, −5) | 0.0003 |
| Secondary End Points | ||||||
| Diastolic BP, mmHg | 83 (8) | 78 (9) | 83 (8) | 81 (10) | −3 (−5, −1) | - |
| TC, mg/dl | 198 (37) | 183 (47) | 199 (42) | 194 (37) | −11 (−19, −3) | - |
| HDL cholesterol, mg/dl | 62 (21) | 60 (21) | 64 (23) | 63 (21) | −1 (−4, 2) | - |
| TG, mg/dl | 116 (88) | 118 (104) | 110 (76) | 115 (71) | −2 (−20, 15) | - |
| CVD risk estimate | 12.0 (8.8) | 9.4 (8.0) | 12.8 (9.9) | 13.3 (11.5) | −3.1 (−4.6, −1.6) | - |
Values shown are mean (SD). BP, blood pressure; TC, total cholesterol; TG, triglycerides; CVD, cardiovascular disease. Sample size for systolic blood pressure (at both baseline and 12 months): polypill arm (n=128), usual care (n=147). Sample size for LDL cholesterol (at both baseline and 12 months): polypill arm (n=126), usual care (n=147). Twenty participants in the polypill arm and 8 participants in the usual care arm discontinued trial participation and did not have data at 12 months. In addition, two participants in the polypill arm had missing LDL data, due to insufficient blood sample (n=1) or missing baseline direct LDL cholesterol measurement (n=1). One TG observation was censored due to value > 1000.
95% confidence intervals presented in this report have not been adjusted for multiplicity, and therefore inferences drawn from these intervals may not be reproducible.