Table 3. Adherence to Medication Protocol and Adverse Events in a Study of the Effect of High-Dose Baclofen on Agitation-Related Events Among Patients With Unhealthy Alcohol Use Receiving Mechanical Ventilation.
| Outcome | Baclofen (n = 159) | Placebo (n = 155) |
|---|---|---|
| Total protocolized doses given, mean (SD), % | 91 (13) | 92 (14) |
| Patients with 100% adherence to treatment protocol, No. (%)a | 49/146 (33.6) | 66/149 (44.3) |
| Treatment duration, median (IQR), d | 7.0 (5.0-13.0) | 8.0 (5.0-11.0) |
| Events requiring temporary stoppage of treatment drug, No. (%) | n = 158 | |
| eGFR<15 mL/min/1.73m2 without indication for RRTb | 15 (9.5) | 9 (5.8) |
| Enteral route unavailable | 7 (4.4) | 9 (5.8) |
| Dispensing error | 3 (1.9) | 4 (2.6) |
| Heart rate <50/min | 1 (0.6) | 0 |
| Patient oppositionc | 0 (0.0) | 2 (1.3) |
| Adverse events requiring drug discontinuation, No. (%)d | n = 158 | |
| Total | 23 (14.6) | 7 (4.5)e |
| Delayed awakeningf | 14 (8.9) | 3 (1.9) |
| Stroke | 4 (2.5) | 1 (0.6) |
| Seizure | 2 (1.3) | 4 (2.6) |
| Heart rate <35/min | 2 (1.3) | 0 |
| Reactive unilateral or bilateral mydriasis | 1 (0.6) | 0 |
Abbreviations: eGFR, estimated glomerular filtration rate; IQR, interquartile range; RRT, renal replacement therapy.
Adherence to the protocol was noted from 0% to 100% from day 1 until the definitive discontinuation of the treatment. It was defined each day by the ratio of the actual dose administered to the protocol-specified dose. Adherence is unknown for patients with missing data.
The equation in the Modification of Diet in Renal Disease study17 was used to determine the eGFR.
Patient refusing to take the study drug on 1 or more occasions.
Prespecified adverse events requiring premature definitive discontinuation of the study drug. Full description of adverse events is available in eTable 7 in Supplement 2.
One patient presented 2 reasons for premature discontinuation.
Defined as eyes not open 72 hours after sedation interruption.