Effectiveness of long-term aripiprazole therapy in patients with acutely relapsing or chronic, stable schizophrenia: a 52-week, open-label comparison with olanzapine
To compare the long-term efficacy and safety of aripiprazole with olanzapine in patients with either acute relapsing or chronic, stable schizophrenia.
Materials and methods
A 52-week, open-label extension to a 26-week, multicenter, randomized, double-blind, placebo-controlled trial in patients with chronic schizophrenia. Patients who completed the initial treatment or who met the protocol definition of relapse after ≥2 weeks of double-blind treatment were randomized to aripiprazole (15–30 mg/day, n = 104) or olanzapine (10–20 mg/day, n = 110) for 52 weeks.
Sixty-nine percent of patients completed the study. Efficacy improvements were similar between groups at endpoint, mean reductions in Positive and Negative Syndrome Scale (PANSS) Total scores from baseline for patients completing the study (observed cases) were similar in chronic stable patients (aripiprazole, −7.94; olanzapine, −7.36) and in patients with acute relapse (aripiprazole, −31.19; olanzapine, −29.55). Olanzapine-treated patients reported more extrapyramidal symptoms (EPS)-related adverse events (18%) than aripiprazole-treated patients (10%). No significant differences in EPS were seen between treatments at endpoint. Olanzapine was associated with significantly greater weight gain than aripiprazole at all time points (week 52 [LOCF]: +2.54 vs +0.04 kg; p < 0.001). Changes in fasting glucose and lipid levels at endpoint favored aripiprazole over olanzapine, with significant differences observed for total cholesterol, low- and high-density lipoprotein. While differences observed for changes in fasting glucose and triglycerides favored aripiprazole, they were not statistically significant.
Aripiprazole showed similar efficacy to olanzapine for long-term treatment of acutely psychotic and chronic, stable schizophrenia patients, with a lower liability for weight gain or increased lipid levels.
KeywordsAripiprazole Olanzapine Schizophrenia Efficacy Safety
The principal investigators of this study were as follows: Uryi Alexandrovsky, MD, Serbsky National Research Centre for Social and Forensic Psychiatry, Moscow, Russia; Mohammed Bari, MD, Synergy Clinical Research Center, California, USA; Valeriy Bitensky, MD, Department of Psychiatry, Ukraine; David W. Brown, MD, Community Clinical Research Inc., Texas, USA; Michail Burducovsky, MD, 4th Psychiatric Hospital, St Petersburg, Russia; Wlodzimierz Chrzanowski, MD, Psychiatric Clinic of Medical Academy in Bialystok, Poland; Vladislav Demchenko, MD, Ukraine Psychiatric Association, Ukraine; Ivan Drabek, MD, Psychiatricka Lecebna, Czech Republic; Carlos Figueroa, MD, Research Strategies Inc., California, USA; Janusz Janczewski, MD, Regional Mental Hospital, Poland; Mieczyslaw Janiszewski, MD, Regional Psychiatric Center, Poland; Svetlana E. Kazakova, MD, Department of Psychiatry Lugansk State Medical University, Ukraine; Zurab Kekelidze, MD, Serbsky National Research Centre for Social and Forensic Psychiarty, Russia; Mary Ann Knesevich, MD, St Paul Medical Center, Texas, USA; Alexander Kociubynsky, MD, Bekhterev Research Institute, Russia; Mark Lerman, MD, Alexian Brothers Behavioral Health Hospital, Illinois, USA; Adam F. Lowy, MD, Psychiatric Institute of Washington, Washington, USA; Vladimir Muchl, MD, Psychiatricka Lecebna Lnare, Czech Republic; Alexander Mouzitchenko, MD, State Medical Academy, Russia; Galina Panteleeva, MD, Clinical Department of Endogenous Mental Disorders and Affective States, Russia; David A. Sack, MD, Institute for Psychopharmacology Research, California, USA; Yuri L. Nuller, MD, Psychoneurological Research Institute, Russia; Viktor Samokhvalov, MD, Department of Psychiatry, Crimea State Medical University, Ukraine; Vladimir Tochilov, MD, Mechniokv Medical Academy, Russia; Tram K. Tran-Johnson, PharmD, PsyD, California Neuropsychopharmacology Clinical Research Institute, LLC, California, USA; Boris Tsygankov, MD, Moscow State University of Medicine and Stomatology, Russia; Rouslan Vovin, MD, PhD, Psychoneurological Research Institute, Russia. This study was sponsored by Bristol-Myers Squibb Company and Otsuka Pharmaceutical Company, Ltd.
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