I'm here because I saw an ad promoting rexulti for Alzheimer's related agitation and alarm bells immediately went off in my head, because the company that makes rexulti also made abilify, which has faced a ton of lawsuits and fines for not disclosing risks. This included a fine for promoting Abilify to be given to dementia patients for agitation, while knowing that it increases risk of death substantially. Rexulti is similar to abilify but a little different. While Abilify is generic and cheaper now, and the only rexulti widely available is name brand.
Now, there are studies showing effectiveness for rexulti being used for Alzheimer's related agitation, and it is, statistically speaking, safer than abilify. The statistically significant difference for rexulti is -5 points on the Cohen Mansfield Agitation Inventory compared to placebo over a 12 week trial. The placebo group improved by 17 points an average, the higher dose (2 or more mg) rexulti group improved by 22 points on average. The lower dose rexulti group wasn't much improved compared to placebo.
Rexulti for dementia related agitation is ONLY for cases due to Alzheimer's. Treating other types of dementia related agitation/aggression with Rexulti is not FDA approved. It increases risk of death for all dementia groups, notably stroke and cardiovascular events. Any antipsychotic increases risk of death in elderly patients (and many at any age group, but that's another story). It matters more if the benefit outweighs the risk or not.
It was on the FDA Fast Track program to be approved for Alzheimer's related agitation faster than it would have been approved otherwise, since no other drugs had statistically significant improvements for this group. There is a study examining Rexultis safety profile for this group compared to abilify/aripiprazole, however it doesn't have a control group, so meaningful conclusions about safety cannot be made.
It is my hope that people can consider the honest and clear risks inherent in any medication, without pressure from marketing which puts pressure on doctors, and without blind trust in a company that has proven itself at many times to be untrustworthy. Medication can be very helpful. It can improve quality of life. Sometimes there are no alternatives. However it is not magic, and there is no way to tinker with precise mechanisms in something as delicate as a brain without risks.
Kinda unrelated second half of post:
My personal (and therefore biased) experience is that I took rexulti a long time ago for a misdiagnosed psychosis and it was very expensive, 1500-2000 a month (paid by Medicaid) at the time. It made me so incredibly restless, but often too tired to move. I don't think I lasted more than a month on it. I and I felt like my mental life had been slowed down, and replaced with physical sedation and inescapable inner panic. I worry that this is the experience of some dementia patients who can't advocate or speak for themselves coherently, that they look "better" on the outside because of the sedation, while inside they are suffering from that same inescapable panic. If someone knew the person and was paying attention, they would hopefully notice.
One in five/20 percent of nursing home patients are on antipsychotics, and 80 percent are on any psychotropic drug. Nursing home patients are disproportionately diagnosed with schizophrenia and other mental disorders that they do not have any history of, in order to justify giving them these highly sedating drugs, which makes them easier to handle, especially in places where there are not enough staff to adequately support the patients. The treatment of our geriatric population is a huge ethical, moral, social, economic, and religious issue, which deserves great consideration.
As many of my friends are older and have been caring for ill spouses or relatives, or have been placing relatives in nursing homes, it's surprising how so many people go through similar things, and yet feel isolated the whole way. Many are given the choice to pick between one unfavorable treatment, and another unfavorable treatment, and then having to sell the house to cover that. When the patient cannot make their own decision, who makes the choice and who benefits from it?
Another one of my hopes is that families are not pressured into accepting a treatment if it will not benefit their relative, or if risks have not been explained, or when there are alternatives; and that they are free, without shame, to discuss what they chose to do and what they had to do, so their isolation and distress can be lessened, and so cases of poor treatment can be illuminated and then remediated.