Appendix Table 2.
Changes in Other Measures From Baseline to the 3-Year Visit
| Measure | Isradipine |
Placebo |
LSM Adjusted Difference (95% CI) | P Value* | ||||
|---|---|---|---|---|---|---|---|---|
| Patients, n | Mean Observed Change (SD) | LSM Adjusted Change (95% CI) | Patients, n | Mean Observed Change (SD) | LSM Adjusted Change (95% CI) | |||
| Total UPDRS score to 1 y† | 169 | 4.75 (6.80) | 4.65 (3.59 to 5.70) | 165 | 5.42 (7.28) | 5.30 (4.25 to 6.35) | −0.66 (−2.09 to 0.77) | 0.37 |
| UPDRS PIGD score | 162 | 0.12 (0.33) | 0.12 (0.07 to 0.17) | 158 | 0.10 (0.33) | 0.10 (0.05 to 0.15) | 0.02 (−0.05 to 0.09) | 0.60 |
| UPDRS tremor score | 162 | 0.01 (0.34) | 0.00 (−0.05 to 0.05) | 158 | 0.02 (0.34) | 0.01 (−0.03 to 0.06) | −0.01 (−0.08 to 0.05) | 0.74 |
| Hoehn and Yahr stage | 162 | 0.11 (0.47) | 0.15 (0.09 to 0.22) | 159 | 0.24 (0.55) | 0.21 (0.15 to 0.28) | −0.06 (−0.15 to 0.03) | 0.195 |
| Beck Depression Inventory total score | 161 | 0.85 (3.91) | 0.77 (0.05 to 1.49) | 159 | 1.26 (5.09) | 1.34 (0.63 to 2.04) | −0.57 (−1.54 to 0.40) | 0.25 |
| Levodopa‡ | 162 | 298 (347) | 307 (257 to 356) | 159 | 296 (272) | 307 (259 to 355) | −0.20 (−66 to 66) | 0.99 |
| Cumulative levodopa‡ | 162 | 461 (542) | 471 (388 to 555) | 159 | 489 (510) | 508 (426 to 590) | −37 (−149 to 75) | 0.52 |
| Systolic blood pressure (SD), mm Hg§ | 162 | −6.01 (15.70) | −6.11 (−8.28 to −3.95) | 159 | 1.66 (15.33) | 1.03 (−1.10 to 3.15) | −7.14 (−10.05 to −4.23) | <0.001 |
| Diastolic blood pressure (SD), mm Hg§ | 162 | −4.04 (9.23) | −4.64 (−5.93 to −3.36) | 159 | −0.50 (9.30) | −0.71 (−1.96 to 0.55) | −3.94 (−5.66 to −2.22) | <0.001 |
LSM = least-squares mean; PIGD = postural instability and gait disorder; UPDRS = Unified Parkinson’s Disease Rating Scale.
*
For comparisons of LSMs (not adjusted for multiple comparisons).
†
Changes from baseline to the earlier of the 1-y visit or the determination of need for antiparkinson therapy.
‡
Levodopa dose in milligrams at the 3-y visit. Cumulative levodopa dose in milligram-years through the 3-y visit.
§
Measured while patient was seated.