Table 3.
Changes in clinical and laboratory data among 41 participants who completed the study
| Secondary Outcomes | Pasireotide Long-Acting Release, n=29 | Placebo, n=12 | P Value for Percent Change between Groups | ||||
|---|---|---|---|---|---|---|---|
| Baseline | 12 mo | Percent Changea | Baseline | 12 mo | Percent Changea | ||
| Blood glucose, mg/dlb | 93±12 | 127±27 | 39±30 | 91±13 | 92±11 | 2±15 | <0.001d |
| Hemoglobin A1C, %b | 5.5±0.5 | 6.4±0.6 | 18±11 | 5.29±0.28 | 5.4±0.3 | 2±3 | <0.001d |
| Serum creatinine, mg/dlb | 1.0±0.3 | 1.0±0.3 | 2±12 | 1.00±0.28 | 1.1±0.5 | 3±16 | 0.79 |
| eGFR (CKD-EPI), ml/min per 1.73 m2b | 74±24 | 73±22 | −0.3±14 | 74±18 | 73±22 | −2±18 | 0.79 |
| Albumin-creatinine ratio, mg/gb | 4.4±0.2 | 4.3±0.3 | −1±6 | 4.34±0.21 | 4.4±0.2 | 1±3 | 0.23 |
| Heart rate, BPMc | 65±13 | 61±16 | −0.2±0.2 | 62.8±11.1 | 58±11 | −0.1±0.1 | 0.73 |
| QT calculated, msc | 416±18 | 417±24 | 0.0±0.1 | 416±17 | 418±19 | 0.0±0 | 0.97 |
Unless indicated otherwise, data are mean ± SD or n (%). P values were calculated using the equal variance t test for continuous measures and the chi-squared or Fisher exact test for categorical measures. CKD-EPI, Chronic Kidney Disease Epidemiology Collaboration; BPM, beats per minute; QT, time from the beginning of the QRS complex, representing ventricular depolarization, to the end of the T wave.
Percent change was calculated for clinical and laboratory parameters using the equation =[(X month value – baseline value)/baseline value] ×100.
Laboratory measurements: one patient was missing laboratory measurements at 12 mo and so, was not included in the analysis. Fourteen patients had their serum creatinine and eGFR measures excluded due to autosomal dominant polycystic liver disease genotype, ESKD, or kidney transplant.
EKG measurements: QT calculated (Fridericia).
Denotes significance at the 0.05 α-level.