Does Low Dose Angiotensin Converting Enzyme Inhibitor Prevent Pneumonia in Older People With Neurologic Dysphagia–A Randomized Placebo-Controlled Trial

Abstract Objective To examine if angiotensin converting enzyme inhibitor reduces the risk of pneumonia in older patients on tube-feeding because of dysphagia from cerebrovascular diseases. Design Randomized placebo-controlled trial. Setting Acute and subacute geriatrics units, speech therapists' clinic, and nursing home. Participants Older patients on tube-feeding for >2 weeks because of dysphagia secondary to cerebrovascular diseases. Intervention Participants were randomized to lisinopril 2.5 mg or placebo once daily for 26 weeks. Measurements Participants were followed up at weeks 12 and 26. The primary outcome was the incidence rate of pneumonia as determined by pneumonic changes on x-ray and clinical criteria. The secondary outcomes were mortality rate and swallowing ability as defined by the Royal Brisbane Hospital Outcome Measure for Swallowing at week 12. Results A total of 93 older patients were randomized. In interim analysis, 71 completed the trial, whereas 15 had dropped out. Among those who had completed the trial, odds ratio (OR) for death was significantly higher in the intervention group (unadjusted OR 2.94, P  = .030; fully adjusted OR 7.79, P  = .018). There was no difference in the incidence of pneumonia or fatal pneumonia in the 2 groups. The intervention group had a marginally better swallowing function at week 12 (Royal Brisbane Hospital Outcome Measure for Swallowing score: 4.2 ± 1.5 in intervention group, 3.5 ± 1.5 in placebo group, P  = .053). As a result of the interim finding on mortality, the trial was prematurely terminated with 7 participants still in the trial. Conclusions Low dose lisinopril given to older tube-fed patients with neurologic dysphagia resulted in increased mortality, although swallowing function showed marginal improvement. ACE inhibitors did not prevent pneumonia in older patients with neurologic dysphagia and might increase mortality.