05 Apr 2009 05:00 AM
Long-Term Tolerability And Safety Data Of Abilify(R) In Combination Treatment For Patients With Bipolar I Disorder
ABILIFY® (aripiprazole), when used in combination with lithium or valproate, is a generally well-tolerated long-term treatment for patients with Bipolar I Disorder, who are partially non-responsive to lithium or valproate monotherapy.1 The data presented today at the annual congress for the World Psychiatric Association (WPA) report a favourable long-term safety profile for ABILIFY in combination with lithium or valproate.1
Professor Eduard Vieta, lead study investigator and Professor of Psychiatry and Director of the Bipolar Disorders Programme of the Hospital Clinic at the University of Barcelona, Spain, said "As a doctor, I value data on safety, tolerability and efficacy as extremely important. Clinicians look for treatments that are efficacious and tolerable in the long term. This study reports that aripiprazole can provide Bipolar I Disorder patients with a combination treatment option with the benefits of good long-term safety and tolerability."
The efficacy and safety of ABILIFY, used in combination with lithium or valproate for the treatment of patients with Bipolar I Disorder, were investigated during a 6-week multicentre, double-blind, randomized, placebo-controlled study involving 348 patients, followed by a 46-week open-label extension phase.
In total, 283 patients entered the extension phase of the study, (prior placebo n=104 vs prior ABILIFY n=179).
The primary objective of the extension phase was to assess the long-term safety and tolerability of ABILIFY in combination with lithium or valproate. Patients in the study were followed up for an additional 46 weeks.
The open-label extension data, presented at the WPA congress, showed that ABILIFY, in combination with lithium or valproate, continued to be well-tolerated with no new or unexpected adverse side effects.
Evaluation of long-term efficacy was a secondary objective due to the open-label nature of the extension phase. Since there was no double-blind control, definitive statements regarding efficacy can not be made, but results support that improvements in bipolar symptoms were maintained through 52 weeks.1
The Young Mania Rating Scale (YMRS) Total Score and the Clinical Global Impressions-Bipolar-Severity of illness (CGI-BP-S) (Mania) Score continued to improve from the end of the double-blind phase to week 52…
Professor Eduard Vieta, lead study investigator and Professor of Psychiatry and Director of the Bipolar Disorders Programme of the Hospital Clinic at the University of Barcelona, Spain, said "As a doctor, I value data on safety, tolerability and efficacy as extremely important. Clinicians look for treatments that are efficacious and tolerable in the long term. This study reports that aripiprazole can provide Bipolar I Disorder patients with a combination treatment option with the benefits of good long-term safety and tolerability."
The efficacy and safety of ABILIFY, used in combination with lithium or valproate for the treatment of patients with Bipolar I Disorder, were investigated during a 6-week multicentre, double-blind, randomized, placebo-controlled study involving 348 patients, followed by a 46-week open-label extension phase.
In total, 283 patients entered the extension phase of the study, (prior placebo n=104 vs prior ABILIFY n=179).
The primary objective of the extension phase was to assess the long-term safety and tolerability of ABILIFY in combination with lithium or valproate. Patients in the study were followed up for an additional 46 weeks.
The open-label extension data, presented at the WPA congress, showed that ABILIFY, in combination with lithium or valproate, continued to be well-tolerated with no new or unexpected adverse side effects.
Evaluation of long-term efficacy was a secondary objective due to the open-label nature of the extension phase. Since there was no double-blind control, definitive statements regarding efficacy can not be made, but results support that improvements in bipolar symptoms were maintained through 52 weeks.1
The Young Mania Rating Scale (YMRS) Total Score and the Clinical Global Impressions-Bipolar-Severity of illness (CGI-BP-S) (Mania) Score continued to improve from the end of the double-blind phase to week 52…
