Background: The lack of compliance of many patients suffering from schizophrenia, usually a result of the strong side effects of their medication, motivates both physicians and patients to search for other effective antipsychotic therapies. Although several second-generation antipsychotic drugs are currently available, relatively
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Background: The lack of compliance of many patients suffering from schizophrenia, usually a result of the strong side effects of their medication, motivates both physicians and patients to search for other effective antipsychotic therapies. Although several second-generation antipsychotic drugs are currently available, relatively few studies exist in Switzerland that consider the expectations of patients upon changing their therapy, apart from the efficacy and tolerability of the medication. Objective: The aim of the present survey TRACE (Treatment with Aripiprazole based on Case Experience) was to scientifically monitor the effects of a switch from the patient’s current therapy to Aripiprazole, a new antipsychotic drug, and to gain more information about everyday practices in the Swiss medical system. Methods: This 12-week open-label prospective survey was carried out between June 2004 and February 2005 in Switzerland, in cooperation with 112 psychiatrists. The investigation comprised of 303 patients with schizophrenia and schizo-affective disorders in 89% (n = 270) of the cases and other psychiatric disorders in 11% (n = 33). After having added Aripiprazole to their current therapy, the downtitration of their current neuroleptic drug took place during the follow-up of this survey. Approximately 80% of the patients received a dose of 15 mg/day Aripiprazole and the remaining 20% between 10 and 30 mg/day. During the first visit (V1) both the physicians and the patients filled out a questionnaire with the following items: diagnosis, pretreatment, BPRS Extended, BMI, therapy goal and quality of life (SF-12), this information being collected on a non-standardised interview. During a second, not obligatory visit (V2), after 4 to 8 weeks, and during the final visit (V3), after 12 weeks, the following data were recorded during a non-standardised interview: efficacy,BPRS-Extended,tolerability,BMI,quality of life (SF-12) and reasons for possible therapy withdrawals. Results: From the initial group of 303 patients, 78.2% (n = 238) were observed over the entire follow-up period of 12 weeks and 21.8% (n = 66) withdrew from it. During the first visit, 80.5% (n = 244) of the patients recorded that they expected an improved tolerability with the new antipsychotic after therapy change. From these patients most expectations (59.7%, n = 181) focused on a lower body weight. Others reasons for a switch were expectations for: fewer negative symptoms (45.5%) and fewer positive symptoms (40.3%). The average overall BPRS-Extended score was reduced significantly (p <0.001) from 61.5 (± 18.6) to 47.6 (± 17.8) at the final observation. The percentage of obese patients (BMI >30) was reduced from 26.9% (n = 78) at the beginning of the investigation to 24.1% (n = 70).The overall BMI could also be lowered significantly (mean Δ = –0.5, p <0.001). In 79.9% (n = 242) of the patients no suspected adverse reactions arose. 20.1% (n = 61) registered side effects including restlessness, sleeping disorders or nausea. The value of the ShortForm SF-12 for the determination of the quality of life showed that there was a significant improvement in both the physical and the psychological sum scale (mean Δ = +3.3 and Δ = +7.9, p <0.001, respectively). Conclusion: The results of this investigation show that the switch to Aripiprazole provides a clear improvement for many patients with schizophrenia or schizo-affective disorders included in this survey with regard to efficacy and tolerability. Expectations and hopes of Swiss patients, and their physicians, from a change in therapy were fulfilled, in most cases, by the end of the observation period.
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