What don’t we know about an Alzheimer’s drug side effect? - STAT
https://www.statnews.com/2023/11/28/lecanemab-leqembi-aducanumab-donanemab-side-effects-aria-brain/
Since the FDA’s approval of lecanemab (marketed as Leqembi) and Medicare’s recent decision to cover the drug, I have met with Alzheimer’s patients and their loved ones who are anxious to know whether they may benefit from this new treatment. They come in hope that this new medication may slow the progression of a cruel memory-robbing and personality-eroding disease.
As a practicing physician who has cared for patients with Alzheimer’s disease and other dementias for more than two decades, it is important for me to present all the benefits and risks associated with any new medication fully and without bias. I want to empower my patients and their families to make the most appropriate and evidence-based decisions about their care. It is therefore concerning to me that while the modest benefit of Leqembi in slowing the progression of Alzheimer’s has been highlighted both in medical journals and the media, relatively less attention has been paid to common side effects of the drug: brain swelling and bleeding that are together called amyloid-related imaging abnormalities, or ARIA, which have been found in all three drugs designated as “breakthrough treatments” by the Food and Drug Administration: lecanemab, aducanumab, and donanemab. I am especially worried about drugmakers’ lack of transparency in fully reporting all details of clinical outcomes related to ARIA.
ARIA have been consistently observed with most drugs like Leqembi that successfully remove sticky fragments of a protein called beta-amyloid from the brain. Recognizing the potential for rare but “serious and life-threatening” complications due to ARIA, the FDA has determined that these drugs should carry a black box warning, the highest level of precaution reserved for medicines associated with major risks of harm to patients. The rates of brain swelling and/or bleeding due to ARIA in clinical trials of lecanemab, aducanumab, and donanemab ranged from 12%-35% in treated patients, compared with 3%-13% in those receiving a placebo.
https://www.statnews.com/2023/11/28/lecanemab-leqembi-aducanumab-donanemab-side-effects-aria-brain/
Since the FDA’s approval of lecanemab (marketed as Leqembi) and Medicare’s recent decision to cover the drug, I have met with Alzheimer’s patients and their loved ones who are anxious to know whether they may benefit from this new treatment. They come in hope that this new medication may slow the progression of a cruel memory-robbing and personality-eroding disease.
As a practicing physician who has cared for patients with Alzheimer’s disease and other dementias for more than two decades, it is important for me to present all the benefits and risks associated with any new medication fully and without bias. I want to empower my patients and their families to make the most appropriate and evidence-based decisions about their care. It is therefore concerning to me that while the modest benefit of Leqembi in slowing the progression of Alzheimer’s has been highlighted both in medical journals and the media, relatively less attention has been paid to common side effects of the drug: brain swelling and bleeding that are together called amyloid-related imaging abnormalities, or ARIA, which have been found in all three drugs designated as “breakthrough treatments” by the Food and Drug Administration: lecanemab, aducanumab, and donanemab. I am especially worried about drugmakers’ lack of transparency in fully reporting all details of clinical outcomes related to ARIA.
ARIA have been consistently observed with most drugs like Leqembi that successfully remove sticky fragments of a protein called beta-amyloid from the brain. Recognizing the potential for rare but “serious and life-threatening” complications due to ARIA, the FDA has determined that these drugs should carry a black box warning, the highest level of precaution reserved for medicines associated with major risks of harm to patients. The rates of brain swelling and/or bleeding due to ARIA in clinical trials of lecanemab, aducanumab, and donanemab ranged from 12%-35% in treated patients, compared with 3%-13% in those receiving a placebo.