Table 4.
Exploratory pharmacodynamic and efficacy outcome analysis results
| Change from baseline |
Difference, AZD8601 versus placebo (p) | ||
|---|---|---|---|
| AZD8601 3 mg (n = 7) | Placebo (n = 4) | ||
| Pharmacodynamics at 3 months | |||
| 15O-water PETa | |||
| Treated area stress myocardial blood flow, mL/g/min | 0.4342 | 0.4070 | 0.0272 (0.462) |
| Treated area myocardial flow reserve, ratio | 0.3729 | 0.3862 | −0.0133 (0.513) |
| Efficacy at 6 months | |||
| Echocardiographya | |||
| Left ventricular end-diastolic volume, mL | −12.329 | 0.853 | −13.182 (0.698) |
| Left ventricular end-systolic volume, mL | −11.919 | 9.099 | −21.018 (0.852) |
| Left ventricular ejection fraction, % | 4.072 | −5.296 | 9.367 (0.054) |
| Global longitudinal strain, % | 2.914 | 3.070 | −0.156 (0.539) |
| Patient-reported outcomesa | |||
| KCCQ overall summary score | 17.04 | −5.55 | 22.59 (0.044) |
| SAQ physical limitation score | 18.39 | 10.18 | 8.21 (0.247) |
| SAQ angina stability score | 6.91 | 6.66 | 0.26 (0.492) |
| SAQ angina frequency score | 26.73 | 18.22 | 8.52 (0.225) |
| SAQ treatment satisfaction score | 7.47 | −4.21 | 11.68 (0.092) |
| SAQ quality of life score | 31.11 | 14.31 | 16.79 (0.145) |
| Cardiac biomarkerb | |||
| N-terminal pro-B-type natriuretic peptide, pmol/L | 0.990 | 1.735 | 0.57 (0.108) |
Data are from mixed-model repeated measures with treatment, visit, and visit-by-treatment interaction as fixed factors, subject as random factor, and baseline value as covariate. One-sided nominal p values are presented. KCCQ, Kansas City Cardiomyopathy Questionnaire; PET, positron emission tomography; SAQ, Seattle Angina Questionnaire.
a
Least-squares mean change from baseline and least-squares mean difference versus placebo.
b
Ratio versus baseline and ratio versus placebo.