H Lynn Starr1, Jason Bermak2, Lian Mao3, Steve Rodriguez4, Larry Alphs5. 1. Janssen Scientific Affairs, LLC, 1125 Trenton Harbourton Rd, Titusville, NJ 08560, USA. Electronic address: HStarr@its.jnj.com. 2. SF-CARE, Inc., 369 Pine Street #218, San Francisco, CA 94104, USA. Electronic address: jbermak@comcast.net. 3. Janssen Research and Development, LLC, 1125 Trenton-Harbourton Rd, Titusville, NJ 08560, USA. Electronic address: LMao@its.jnj.com. 4. Janssen Scientific Affairs, LLC, 1125 Trenton Harbourton Rd, Titusville, NJ 08560, USA. Electronic address: SRodrig6@its.jnj.com. 5. Janssen Scientific Affairs, LLC, 1125 Trenton Harbourton Rd, Titusville, NJ 08560, USA. Electronic address: lalphs@its.jnj.com.
Abstract
INTRODUCTION: Comorbid substance abuse is known to blunt response to treatment for underlying psychiatric disorders, but it has not been investigated in schizophrenia when comparing the effects of long-acting injectable antipsychotics with those of oral antipsychotics. METHODS: This exploratory analysis compared once-monthly paliperidone palmitate (PP1M) with daily oral antipsychotics on time to treatment failure in patients with schizophrenia and a history of incarceration. Subjects were stratified into substance abuse (reported substance or alcohol misuse in the past 30days on the baseline Addiction Severity Index-Lite Version and/or met criteria for a current MINI diagnosis of a substance abuse disorder) and nonabuse cohorts. RESULTS: In the substance abuse cohort, treatment failure was observed in 56.2% (73/130) and 64.2% (86/134) of subjects in the PP1M and oral antipsychotic groups, respectively. For the nonabuse cohort, treatment failure was observed in 36.5% (35/96) and 53.6% (45/84) of subjects in the PP1M and oral antipsychotic groups, respectively. Median (95% confidence interval [CI]) time to first treatment failure was 291 (179-428) days and 186 (94-296) days in the PP1M and oral antipsychotic groups, respectively. Median (95% CI) time to first treatment failure was >450 and 284 (147 to >450) days in the respective treatment groups. CONCLUSION: Greater treatment effects were evident with PP1M compared with oral antipsychotics in both cohorts. The observed beneficial effect of PP1M was attenuated in the substance-abuse cohort, further reinforcing both the need for and value of continued research to optimize patient care in these complex patient populations.
RCT Entities:
INTRODUCTION: Comorbid substance abuse is known to blunt response to treatment for underlying psychiatric disorders, but it has not been investigated in schizophrenia when comparing the effects of long-acting injectable antipsychotics with those of oral antipsychotics. METHODS: This exploratory analysis compared once-monthly paliperidone palmitate (PP1M) with daily oral antipsychotics on time to treatment failure in patients with schizophrenia and a history of incarceration. Subjects were stratified into substance abuse (reported substance or alcohol misuse in the past 30days on the baseline Addiction Severity Index-Lite Version and/or met criteria for a current MINI diagnosis of a substance abuse disorder) and nonabuse cohorts. RESULTS: In the substance abuse cohort, treatment failure was observed in 56.2% (73/130) and 64.2% (86/134) of subjects in the PP1M and oral antipsychotic groups, respectively. For the nonabuse cohort, treatment failure was observed in 36.5% (35/96) and 53.6% (45/84) of subjects in the PP1M and oral antipsychotic groups, respectively. Median (95% confidence interval [CI]) time to first treatment failure was 291 (179-428) days and 186 (94-296) days in the PP1M and oral antipsychotic groups, respectively. Median (95% CI) time to first treatment failure was >450 and 284 (147 to >450) days in the respective treatment groups. CONCLUSION: Greater treatment effects were evident with PP1M compared with oral antipsychotics in both cohorts. The observed beneficial effect of PP1M was attenuated in the substance-abuse cohort, further reinforcing both the need for and value of continued research to optimize patient care in these complex patient populations.
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