AT THE ASCP ANNUAL MEETING
MIAMI (FRONTLINE MEDICAL NEWS) – Expert clinicians endorsed long-acting injectables as a preferred treatment for bipolar I disorder on the basis of patient characteristics and treatment history, rather than on an assumed level of treatment adherence, according to a small survey.
“Just over three-quarters of the experts we surveyed said they were ‘somewhat’ or ‘not very’ confident about their ability to assess their patients’ adherence,” said Martha Sajatovic, MD , who presented the data during a poster session at a meeting of the American Society of Clinical Psychopharmacology, formerly the New Clinical Drug Evaluation Unit meeting.
The finding reflects a shift, according to Dr. Sajatovic, professor of psychiatry and neurology, and the Willard Brown Chair in Neurological Outcomes Research, at Case Western University in Cleveland.
“It shows that long-acting injectables are increasingly considered appropriate for prevention in high-risk patients such as those who have poor social support, previous serious relapse, or who have had risk of harm to self or others. Experts also endorsed consideration of long-acting injectables earlier in the illness. Patients in the early phase of illness have the most to lose if they relapse and the most to gain from effective maintenance treatment,” she said in an interview.
The traditional view of using long-acting injectable antipsychotics (LAIs) for patients with bipolar I disorder is that they are appropriate only in certain cohorts, such as patients with very severe illness or at the more extreme spectrum in terms of risk, and those who are homeless or pose a risk to themselves or others, Dr. Sajatovic said. Also, when it comes to the use of LAIs, there is a lack of guidance – which might contribute to clinicians’ reluctance to prescribe or recommend them, she said.
In the survey, of the 42 experts contacted by Dr. Sajatovic and her colleagues, 34 responded. According to those respondents, 11% of their patients with bipolar disorder were being treated with LAIs, compared with one-third of all patients with schizophrenia/schizoaffective disorder.
Using a scale of 1-9, with 1 being “extremely inappropriate,” 2-3 being “usually inappropriate,” 4-6 being “sometimes appropriate,” 7-8 being “usually appropriate,” and 9 being “extremely appropriate,” all tended to favor patient characteristics and treatment history over adherence when rating criteria for treatment selection. This was true regardless of whether patients were newly diagnosed with bipolar disorder, or whether their diagnosis was established and treated with an antipsychotic for 2 or more years.
For comparison, Dr. Sajatovic and her colleagues also surveyed the expert panel members on their use of LAIs in established schizophrenia and schizoaffective disorder.
Patients with a history of two or more hospitalizations for bipolar relapses and those who were either homeless or had unstable housing were rated by most respondents as usually appropriate for LAIs as first-line treatment. For those with dubious treatment adherence, the profile was similar: LAIs were considered by a majority of respondents as usually appropriate if there was a history of two or more hospitalizations for bipolar relapses, as well as homelessness or an unstable housing situation. LAIs also were considered by a majority as usually appropriate in this cohort if there was a history of violence to others, and if patients had poor insight into their illness.
Spotty treatment adherence to medications was the most common treatment history characteristic cited for first-line prescription of LAIs in patients with an established bipolar disorder diagnosis. Other first-line LAI criteria cited by most respondents for this cohort were if they previously had done well on an LAI, and if they frequently missed clinic appointments.
Virtually all the criteria above applied to patients with established illness and questionable adherence, although the expert clinicians also largely cited a failure to respond to lithium or an anticonvulsant mood stabilizer, a predominant history of manic relapse, and a strong therapeutic alliance as additional reasons to view LAIs as usually appropriate.
Regardless of the assumption of adherence or nonadherence, in most cases in which patients had an established bipolar diagnosis, more than half of the expert panel said use of an LAI was extremely appropriate.
In patients with an established diagnosis of bipolar disorder with questionable treatment adherence, respondents strongly endorsed the idea that it was usually appropriate to use LAIs as first-line treatment if the patients had a history of two or more hospitalizations for bipolar relapses, homelessness or an otherwise unstable living arrangement, violence toward others, and poor insight into their illness.
The panel members were blinded to the study’s sponsor, which was Otsuka. All respondents had an average of 25 years of clinical experience and an average of 22 years of research experience, and all had extensive expertise in the use of two or more LAIs, although no specific antipsychotic brand names were included in the survey.
Just more than one-third of respondents reported spending all or most of their professional time seeing patients, and one-fifth reported that they saw patients half of the time. The average age of patients seen by the respondents was 35-65 years.
Dr. Sajatovic disclosed receiving research grants from the National Institutes of Health, Alkermes, Janssen, Merck, and several other pharmaceutical companies and foundations; serving as a consultant for numerous entities, including Otsuka; and receiving royalties from UpToDate, and several publishing companies.
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