The majority of patients with Alzheimer’s disease would not have been eligible to take part in the clinical trials of the new controversial Alzheimer’s drug aducanumab (Aduhelm), according to physicians at Beth Israel Deaconess Medical Center.
They examined medical claims from 2018 for Medicare enrollees with a diagnosis of either cognitive impairment, Alzheimer’s disease or Alzheimer’s disease-related disorders and found that the vast majority of these patients had one or more conditions that would have excluded them from the aducanumab clinical trials, including cardiovascular disease, prior stroke, use of blood thinners, and age over 85 years.
The Food and Drug administration approved aducanumab in July, despite criticism from many physicians that there was not enough persuasive evidence to support its approval without more clinical trials.
“Our findings are concerning given the broad FDA labelling for aducanumab,” said corresponding author Timothy S. Anderson, MD, MAS, a clinician investigator and assistant professor medicine in the Division of General Medicine at BIDMC. “The public conversation on aducanumab has focused on limited benefit and high costs, it is equally important to consider that the majority of patients with Alzheimer’s disease are likely to face higher risks of adverse events than the patients studied in the trials.”
The research letter was published Thursday in JAMA.