Table 2.
Summary of primary and secondary outcomesa.
| Outcome | Baseline | Differenceb | Difference adjusted by baseline | |||||||
|
|
Control | Intervention | Control (n=468) | Intervention (n=462) | Coefficient (95% CI) | Odds ratio (95% CI) | Risk ratio (95% CI) | P value | ||
| Primary outcome, mean (SD) | ||||||||||
|
|
LDLc (mg/dl) | 88.0 (36.9) | 88.0 (37.5) | 5.1 (31.8) | 7.0 (33.8) | 1.85 (−2.5 to 6.2) | N/Ad | N/A | .42 | |
| Secondary outcome | ||||||||||
|
|
Thromboxane B2 (ng/ml)e, mean (SD) | 61.2 (133.2) | 58.8 (138.1) | −19.6 (131.0) | −18.6 (94.0) | −0.28 (−10.54 to 10.0) | N/A | N/A | .96 | |
|
|
Heart rate (bpm), mean (SD) | 68.6 (11.6) | 68.5 (10.5) | −0.1 (13.9) | 0.6 (10.5) | 0.54 (−1.0 to 2.1) | N/A | N/A | .48 | |
|
|
SBPf (mmHg), mean (SD) | 128.0 (21.2) | 129.3 (20.6) | 1.3 (19.4) | 0.8 (20.7) | 0.14 (−2.3 to 2.6) | N/A | N/A | .91 | |
|
|
DBPg (mmHg), mean (SD) | 71.5 (11.9) | 71.7 (11.3) | 0.7 (11.7) | −0.1 (10.7) | −0.70 (−2.0 to 0.6) | N/A | N/A | .30 | |
|
|
MARS-5h (score), mean (SD) | 22.8 (3. 8) | 23.1 (3.1) | 0.2 (3.7) | −0.02 (3.4) | −0.01 (−0.4 to 0.4) | N/A | N/A | .96 | |
|
|
Self-reported adherence (7 days), mean (SD) | 9.1 (2.1) | 9.2 (2.0) | 0.1 (2.0) | 0.2 (2.0) | 0.05 (−0.2 to 0.3) | N/A | N/A | .69 | |
|
|
Self-reported adherence (30 days), mean (SD) | 9.1 (2.0) | 9.2 (1.9) | 0.1 (1.9) | 0.1 (2.0) | 0.02 (−0.2 to 0.2) | N/A | N/A | .83 | |
|
|
Change in adherencei, mean (SD) | N/A | N/A | 1.2 (0.2) | 1.1 (0.20) | N/A | 0.94 (0.6 to 1.5) | N/A | .81 | |
|
|
Hospitalization for cardiovascular eventsj, n (%) | N/A | N/A | 32 (6.8) | 27 (5.8) | N/A | N/A | 0.85 (0.5 to 1.4) | .54 | |
|
|
Hospitalization for any causek, n (%) | N/A | N/A | 49 (10.5) | 50 (10.8) | N/A | N/A | 1.03 (0.71 to 1.5) | .92 | |
|
|
Death from cardiovascular eventsl, n (%) | N/A | N/A | 3 (0.6) | 2 (0.4) | N/A | N/A | 0.68 (0.1 to 4.0) | .99 | |
|
|
Death from any causej, n (%) | N/A | N/A | 8 (1.7) | 14 (3) | N/A | N/A | 1.80 (0.8 to 4.3) | .20 | |
aSample sizes may vary slightly because some individuals have missing values.
bCalculated as the difference between final and baseline measurements.
cLDL: low-density lipoprotein.
dN/A: not applicable.
eCreatinine adjusted (mg/dl)
fSBP: systolic blood pressure.
gDBP: diastolic blood pressure.
hMARS-5: Medication Adherence Report Scale-5.
iWithin each group is the number of patients that lose adherence over those that became adherent.
jWithin each group is the proportion of patients who experienced the event.