Clinical use of aripiprazole in patients with schizophrenia: a real-life setting results from the German Postmarketing Surveillance Study.
When aripiprazole (ABILIFY) received its approval in Germany for the treatment of schizophrenia, a hospital-based postmarketing surveillance study was initiated in order to gain further insights concerning safety and efficacy of the antipsychotic under real-life conditions. Efficacy was rated by using standard CGI, GAF, and SF-12 instruments, whereas safety was evaluated according to the reports on adverse effects. Data from 799 patients with schizophrenia from 122 psychiatric hospitals returned for evaluation. Eighty percent of the patients were treated for 4 weeks with 10-30 mg/day aripiprazole (mean modal dose 15 mg/day). Within the observation period significant improvements of CGI, GAF, and SF-12 ratings was observed. Aripiprazole was tolerated well by the patients. Most frequent adverse effects were insomnia, irritability, restlessness, nausea and vomiting, in general being moderate to mild and corresponding to the known tolerability profile of aripiprazole. The results demonstrate that the administration of aripiprazole can result in an improvement of the symptoms of schizophrenia within 4 weeks in a real-life hospital-based in- and outpatient setting.
Messer
Thomas
T
District Hospital, Augsburg, Germany.
Schmauss
Max
M
Spevakne-Goeroecs
Terez
T
Kungel
Martin
M
Ebrecht
Marcel
M
Werner
Christian
C
Modell
Sieglinde
S
D000328:Adult; D017109:Akathisia, Drug-Induced / Q000209:etiology; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000068180:Aripiprazole; D005260:Female; D005858:Germany; D006801:Humans; D008297:Male; D009325:Nausea / Q000139:chemically induced; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D011569:Psychiatric Status Rating Scales; D015363:Quinolones / Q000009:adverse effects / Q000627:therapeutic use*; D012559:Schizophrenia / Q000188:drug therapy*; D007319:Sleep Initiation and Maintenance Disorders / Q000139:chemically induced; D014839:Vomiting / Q000139:chemically induced
D014150:Antipsychotic Agents; D010879:Piperazines; D015363:Quinolones; D000068180:Aripiprazole