Prescription and acceptance of durable medical equipment in FORTITUDE-ALS, a study of in ALS: post hoc analyses of a randomized, double-blind, placebo-controlled clinical trial.

: To evaluate the possible effect of , a fast skeletal muscle troponin activator, on prescription and acceptance of durable medical equipment (DME) in the FORTITUDE-ALS trial. Health economic outcome information was collected in FORTITUDE-ALS (NCT03160898); sites recorded if and when DME, specifically manual or power wheelchairs, gastrostomy tubes, noninvasive ventilators, or augmentative language devices, was prescribed by a physician and accepted by the patient (DME-PAP) during the trial. Acceptance was defined as the patient agreeing the item was needed. Cox regression analysis compared time to DME-PAP for each dose with placebo. Post hoc analyses evaluated all doses compared with placebo. At least one DME item was prescribed and accepted by 33/114 (28.9%) of placebo patients, 19/112 (17.0%) of patients receiving 150 mg bid, 24/113 (21.2%) receiving 300 mg bid, and 29/117 (24.8%) receiving 450 mg bid. The proportion of new DME-PAP was significantly lower in patients receiving 150 mg bid vs placebo (17.0% vs 28.9%,  = 0.032). The hazard ratio versus placebo for accepting at least one DME item for all doses combined was 0.61 (confidence interval: 0.39, 0.96,  = 0.032). 25% of placebo patients were prescribed and agreed to obtain a DME item by 84 days; this threshold was met for -treated patients at 120 days. Results suggest ALS patients receiving may have lower risk of and delayed need for DME related to impaired mobility, breathing, swallowing, or speaking; this delay is consistent with other measures indicating delay in disease progression.