crossover randomized trial
LIONESS
The Physiological Effects of GLP-1 on Haemodynamics During Exercise in Patients With Ischaemic Heart Disease
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Liraglutide 1.8 mg subcutaneous once daily Liraglutide escalated to 1.8 mg daily | rate limiting drugs, long acting nitrates and nicorandil withdrawn before study; lifestyle: not reported | 24 | 22 | 22 |
| A2 | Placebo Saline placebo | rate limiting drugs, long acting nitrates and nicorandil withdrawn before study; lifestyle: not reported | 24 | 22 | 22 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Liraglutide 1.8 mg subcutaneous once daily A1 | Placebo A2 | Whole trial ALL |
|---|---|---|---|---|
| age sequence:liraglutide_first | mean (years) | 59.2 | ||
| age sequence:liraglutide_first | sd (years) | 9.1 | ||
| age sequence:placebo_first | mean (years) | 65.3 | ||
| age sequence:placebo_first | sd (years) | 7.3 | ||
| age | mean (years) | 62.5 | ||
| age | sd (years) | 8.6 | ||
| bmi sequence:liraglutide_first | mean (kg/m2) | 29.6 | ||
| bmi sequence:liraglutide_first | sd (kg/m2) | 4.8 | ||
| bmi sequence:placebo_first | mean (kg/m2) | 30.1 | ||
| bmi sequence:placebo_first | sd (kg/m2) | 3.4 | ||
| bmi | mean (kg/m2) | 29.8 | ||
| bmi | sd (kg/m2) | 4.0 | ||
| egfr | mean (mL/min/1.73 m2) | 76.2 | ||
| egfr | sd (mL/min/1.73 m2) | 21.1 | ||
| other male sequence:liraglutide_first | n | 9 | ||
| other male sequence:liraglutide_first | percent | 90 | ||
| other male sequence:placebo_first | n | 11 | ||
| other male sequence:placebo_first | percent | 91.7 | ||
| other male | n | 20 | ||
| other male | percent | 90.9 | ||
| sbp | mean (mmHg) | 134.4 | ||
| sbp | sd (mmHg) | 18.3 | ||
| weight | mean (kg) | 88.75 | ||
| weight | sd (kg) | 16.5 | ||
| white | n | 20 | ||
| white | percent | 90.9 |
Results
6 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
Discontinuation due to adverse events (2 lines; O26)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 22 | not stated; per protocol; R0018990:Results | ||||
| A2 | events | 0 / 22 | not stated; per protocol; R0018990:Results |
Discontinuation due to gastrointestinal adverse events (2 lines; O27E)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 22 | not stated; per protocol; R0018990:Results | ||||
| A2 | events | 0 / 22 | not stated; per protocol; R0018990:Results |
Acute pancreatitis (2 lines; O29)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 22 | not stated; per protocol; R0018990:Results | ||||
| A2 | events | 0 / 22 | not stated; per protocol; R0018990:Results |