Antipsychotics Flop in ICU Delirium Trial

The use of antipsychotics was also standard in past decades for ER visits involving deliriants like PCP and STP.  It had very negative cognitive effects as it does when used with ICU delirium, but the medical staff persist in thinking that shutting someone up is the same thing as treating them….

Certain antipsychotics in critically ill patients weren’t effective treatments for delirium, results from a major randomized trial showed.

For patients in the phase III MIND-USA (Modifying the Incidence of Delirium) trial, neither haloperidol (Haldol) nor ziprasidone (Geodon) extended the number of days alive without delirium or coma — the trial’s primary endpoint — reported E. Wesley Ely, MD, MPH, of Vanderbilt University Medical Center in Nashville, and colleagues (P=0.26 for overall effect):

  • Haloperidol: 7.9 days (95% CI 4.4-9.6)
  • Ziprasidone: 8.7 days (95% CI 5.9-10.0)
  • Placebo: 8.5 days (95% CI 5.6-9.9)

“This study uproots 40 years of clinical practice and took over 15 years from the time we started this line of inquiry to get to this point in discovery,” Ely told MedPage Today. “It is one of the most negative trials I’ve ever seen, which translates into something very positive for patient care.”

“It was nutty that for 40 years we were treating patients with an entire class of drugs, antipsychotics, without any proof they worked for delirium,” Ely continued. “The practice is very widespread to use antipsychotics for delirium. It is happening right now in many tens of thousands of patients, and over the year probably millions of patients in many settings receive antipsychotics for delirium — nursing homes, hospitals, ICUs.”

“We undertook the study with equipoise. Not knowing but feeling confident that either answer, whatever is truth, would change medicine,” said Ely.

None of the secondary efficacy endpoints were significantly different between groups, either. These included time to ICU and hospital discharge, days to freedom from mechanical ventilation, as well as mortality at 30 and 90 days.

Similarly, safety endpoints also didn’t significantly differ between treatments, which included frequency of excessive sedation as well as frequency of extrapyramidal symptoms, although prolongation of the correct QT interval was slightly more common with ziprasidone.

“The study is good news for patients, but it still needs more data going forward,” said Ely. “It is wonderful news for patients because it will help their physicians to avoid giving them drugs for delirium when that is not going to help them, and also the ICU teams will be able to direct their care for the delirium in more established and successful directions, such as the ABCDEF bundle.”

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