Efficacy and Safety of Antipsychotics

Peter Salgo, MD: Efficacy, safety, once every 2 months, aripiprazole lauroxil [ARISTADA], and extended release: Where are we in this, just pharmacologically and clinically?

Mauricio Tohen, MD, DPH, MBA: I can’t say whether the 1-, 2-, or 3-month injection is the best; it really depends on the patient.

Peter Salgo, MD: If you want to go once every 2 months, what are the most common side effects that you see?

Mauricio Tohen, MD, DPH, MBA: There wouldn’t be any different side effects if it’s once a month or every 2 months. I would say the major risk is that, with 2-month treatments, you have the advantage duration. In terms of side effects, they would be the same.

Peter Salgo, MD: What about injection-site issues and injections altogether?

Richard Jackson, MD: The injection-site issue is usually not a problem. The advancement is that these solutions, from water based to oil based, provide much better toleration. Patients, once they’re on them, typically want to maintain treatment because they aren’t experiencing the typical paranoia or anxiety. Over time, they significantly improve their level of function; their insight is poor early on, but many patients on long-acting injections have a wider window of proper community transition.

Nneka Jones Tapia, PsyD: The long-acting injections work better for individuals leaving correctional institutions because we know that there is sometimes a delay in care in the community.

Mauricio Tohen, MD, DPH, MBA: There’s another advantage of the long-lasting injectables, which is that medication discontinuation carries a high risk of relapse. That risk is higher in the oral medications as opposed to the injectables, which is certainly an additional benefit.

Peter Salgo, MD: There’s an injectable and an oral formulation of extended-release aripiprazole lauroxil, correct? Are these agents interchangeable, in terms of clinical effectiveness, regardless of the iteration?

Richard Jackson, MD: If you’re taking the oral every day, it’s interchangeable. The problem is in maintaining the same active ingredient when metabolized differently. Patients who take their medicine every day, unfortunately, are a rarity.

Steven Leifman: Or they don’t take it at the same time; they skip a day.

Richard Jackson, MD: Absolutely.

Mauricio Tohen, MD, DPH, MBA: When you look at clinical trials in which they compare oral and injectable, and you know that the patient is taking his or her medication regularly, the efficacy is exactly the same.

Peter Salgo, MD: Study patients are notoriously reliable because they are monitored frequently.

Mauricio Tohen, MD, DPH, MBA: Absolutely.

Peter Salgo, MD: In the real world, nobody is.

Richard Jackson, MD: You have to do a real-world study. You can look at patients before and after a newer, long-acting injectable, see that there’s ample data suggesting they perform better once they’re on the long-acting injectable versus when they’re prescribed orally.

Peter Salgo, MD: Are there some patients with schizophrenia who are clear candidates for injectables, whatever the cost?

Richard Jackson, MD: The patient with schizophrenia, in general, is the prime candidate because the majority of these patients are nonadherent to their medication. It’s pretty rare to find someone who’s not an ideal candidate.

Mauricio Tohen, MD, DPH, MBA: Patients with bipolar disorder are ideal candidates since they are also nonadherent. In the past we used to think the best patients or candidates were those who had multiple episodes—patients who had chronic illness for a long time. That, however, is not the case: Frequently, a patients are nonadherent when they first become ill; this is the time they are the most nonadherent.

Richard Jackson, MD: Especially if they’re better tolerated.

Nneka Jones Tapia, PsyD: They’re at increased risk of suicide as well.

Mauricio Tohen, MD, DPH, MBA: And violence.

Nneka Jones Tapia, PsyD: Yes.

Mauricio Tohen, MD, DPH, MBA: Most patients, while they are in the developmental stage of mental illness, do not commit substance abuse; this is the time to administer preventive medicine.

Peter Salgo, MD: It’s a window.

Mauricio Tohen, MD, DPH, MBA: A window because they’re at risk. If we do a preventive during this period, the deterioration will be prevented with long-acting injections.

Steven Leifman: We have a program—the only one in the country—that takes people who otherwise would have gone to a competency restoration facility and instead are placed in a reintegration program with long-acting injectables. We’re finding that the patients prefer it—that their compliance with their program is much improved and their rearrest rate is significantly reduced. For us, we have found it to be rather beneficial. I do concern myself with some of the side effects, and it’s something that certainly has to be monitored. At the same time, in terms of helping keep people out of our system, it has been very effective.

Peter Salgo, MD: Can you adjust this stuff? Is it a one-size-fits-all dose and dosing frequency, or can you tailor it?

Richard Jackson, MD: There’s a difference among the medications. You mentioned that aripiprazole lauroxil has a variety of dosing options. It actually has a variety of dosing intervals: For some patients you’d administer once a month, while others, every 6 weeks. Maybe some patients want it every 2 months. You have that ability with that medication.

Transcript edited for clarity.