Cerebrolysin appears ischemic stroke treatment potential but prion diseases risk

Stroke Rounds: Post-Acute Peptide Tx Reduces Disabilityby Crystal PhendSenior Staff Writer, MedPage Today This article is a collaboration between MedPage Today® and: Medpage Today Neuropeptide injections improved arm function and global function when given in the month after ischemic stroke, a phase II trial showed. Injections of the product sold as Cerebrolysin in Russia, China, and surrounding countries had a "large" effect size on the Action Research Arm Test (ARAT) score on day 90 compared with placebo (Mann-Whitney estimator 0.71, P<0.0001). "The multivariate effect size on global status, as assessed using 12 different outcome scales, indicated a small-to-medium superiority of Cerebrolysin, (Mann-Whitney estimator 0.62; 95% CI 0.58-0.65; P<0.0001)," Dafin F. Muresanu, PhD, of "Iuliu Hatieganu" University of Medicine and Pharmacy in Napoca, Romania, and colleagues found. The proportion of patients with minimal disability at 90 days, marked by a modified Rankin Scale (mRS) score of 0 to 1, was 42.3% with the injections compared with 14.9% on placebo, the researchers reported online in Stroke. The intervention likewise up-shifted the proportion of patients with a "good" functional outcome marked by mRS scores of 2 or less. Cerebrolysin is a mixture of low molecular weight neuropeptides and free amino acids derived from pig brain tissue through a standardized manufacturing process. "No one knows exactly what's in there, nevertheless it has a very strong track record in animal models," commented Costantino Iadecola, MD, director of Cornell's Brain and Mind Research Institute in New York City. The findings were promising as there's little other than rehabilitation to offer patients in the post-acute phase, he said. "Many of the drugs we have were originally developed from biological material and we had to use molecular biology to develop recombinant forms and control adverse effects." But he warned against trying to import the substance, as one Alzheimer's group has noted can be done. "Before the I's are dotted and the T's are crossed, don't rush into treatment," Iadecola cautioned, noting that the small studies done so far are not enough to establish safety in terms of antibody development and even possibly prion diseases, which could take years to show up. The CARS trial randomized 208 moderate-to-severe stroke patients to double-blind treatment with Cerebrolysin (once-daily 30 mL injections) or saline placebo for 21 days, starting 24 to 72 hours after onset, along with a standardized rehabilitation program for all patients. Baseline stroke severity, disability, and other characteristics were similar between groups. "Cerebrolysin was safe and well tolerated," the researchers noted, pointing to a 3.8% rate of premature discontinuation. "This study was planned as an exploratory phase II trial," Muresanu's group wrote. "This design limits the degree of evidence obtained; thus, the results should be confirmed in a large-scale phase III trial. In addition, the generalizability of our results to other regions and stroke populations should be evaluated in future research."