Added Levodopa Does Not Significantly Benefit Stroke Recovery
Levodopa added to standardized stroke rehabilitation did not significantly improve motor function at 3 months, according to results from a randomized clinical trial published in JAMA.
“These results do not support the use of levodopa as an adjunct to rehabilitation therapy for enhancing motor recovery after acute stroke,” wrote first author Stefan T. Engelter, MD, of the University of Basel, Basel, Switzerland, and study coauthors.
Despite mixed evidence on its effectiveness, levodopa is used in stroke rehabilitation to potentially boost motor recovery. Researchers conducted the double-blind ESTREL trial (NCT03735901) to investigate whether adding levodopa therapy to standardized rehabilitation therapy based on active task-oriented training improved recovery.
>>QUIZ: Early DOAC Initiation in AF-Related Ischemic Stroke
The study involved 610 patients with acute stroke from 13 stroke units and centers and 11 collaborating rehabilitation centers in Switzerland. All patients had clinically meaningful hemiparesis, defined as a total National Institutes of Health Stroke Scale score of ≥3 points for motor arm, motor leg, and limb ataxia. At baseline, the median total score on the Fugl-Meyer Assessment (FMA), for which lower scores indicate worse motor function, was 34 out of a possible 100. The median age of patients was 73 years.
Researchers randomized 307 patients to levodopa/carbidopa (100 mg/25 mg) and 303 patients to placebo 3 times daily for 39 days. Patients in both groups also received standardized rehabilitation therapy. The primary outcome was the adjusted mean between-group difference in FMA total score at 3 months. A 6-point difference was considered relevant to the patient.
By 3 months, 28 patients had died. The primary analysis included the 582 remaining patients.
Median FMA scores were 68 in the levodopa group and 64 in the placebo group at 3 months, according to the study. The adjusted mean between-group difference in FMA scores was −0.90 points.
The most common serious adverse event was infection, with 55 reports in the levodopa group and 44 reports in the placebo group, researchers reported. In all, 126 serious adverse events occurred in the levodopa group and 129 in the placebo group.
Reference
