Barriers to Prescribing LAIs for Schizophrenia

Transcript: John M. Kane, MD: There are 3 different trial designs that study the efficacy of oral vs injectable antipsychotics, in terms of efficacy and relapse.

In a randomized, double-blind, controlled trial participants are randomly assigned to either oral or long-acting injectable [LAI] medicine and have to sign consent forms. These studies are inconsistent. The last meta-analysis did not show a significant advantage for the long-acting injectable medicine.

I would argue those studies change the ecology of care. When someone enters a trial it's a very different situation. Oftentimes, they are getting more attention and they select people who are more likely to be adherent. The other 2 types of trials can be very informative.

In the mirror-image study, patients are switched from an oral medicine to a long-acting injectable medicine, and they are followed for a comparable interval, both before and after. We compare their relapses and hospitalizations in the 2 years before and the 2 years after the switch to an LAI. Looking at those studies and the meta-analyses, we see a very significant advantage for the long-acting injectable drugs.

The third type of study is the naturalistic or cohort study. This study follows a large population of patients, some are taking oral medicine and some are on long-acting injectable medicine. The goal is to determine which group has the lowest rate of hospitalization or relapse. Some of the best studies of that type have come out of Scandinavia, where they have patient registries and studies involving thousands of patients. The evidence is compelling in demonstrating the potential value of long-acting drugs.

One of the most striking studies was in first episode schizophrenia that Jari Tiihonen, [MD, PhD,] published in The American Journal of Psychiatry, where 2500 patients who had been hospitalized for their first episode, within 60 days of leaving the hospital, half of them weren't taking their medicine.

Looking at the difference between oral medication and long-acting injectables, there was a significantly lower rate of hospitalization among the patients taking long-acting injectables. We have significant evidence from many sources that can answer the question about reducing the risk of relapse with long-acting injectable medicines.

We've heard strong arguments for this strategy, and the use of long-acting injectable medicines. Henry, do you want to comment on the American Psychiatric Association guidelines for the treatment of schizophrenia that were published in 2004?

Henry A. Nasrallah, MD: The guidelines are outdated. It's inexcusable for a major organization to wait 16 years to update the guidelines for such a disabling, devastating brain disorder. Also, the 2004 guidelines are nonsensical. They recommend long-acting injectables for patients who have shown evidence of nonadherence. In other words, they've already had 1, 2, or 3 relapses; they've already become disabled. They've already lost massive amounts of brain tissue, and they’ve developed treatment resistance. And now you consider long-acting [medication]?

Transcript Edited for Clarity