No abstract

Ciclesonide 320 μg b.i.d. sustained lung function and asthma symptoms in patients with severe asthma over 12 weeks' treatment, and maintained lung function during a 40-week EP; ciclesonide 640 μg b.i.d. did not provide additional benefits. Long-term use of ciclesonide was not associated with increased local AEs or negative effects on cortisol levels.

This study presents a methodological approach to an expost facto investigation of sample bias in drug utilization observation (DUO) studies using the example of a DUO with the nontricyclic antidepressant fluoxetine. A total of 479 psychiatrists and neurologists and 2,401 patients were investigated. The purpose of the study was to judge the representativeness of our DUO sample for two populations: first, for all psychiatrics and neurologists prescribing fluoxetine or all patients being treated with fluoxetine in Germany and, second, for all psychiatrists and neurologists prescribing antidepressants or all patients being treated with antidepressants in Germany. Criteria for the representativeness test were physician variables (gender, size of community where practicing, federal state, age, volume of prescriptions) and patient variables (gender, age, prescription-related diagnosis, concurrent illnesses, concomitant medications). The study shows that the DUO sample can rightfully claim representativeness in the majority of parameters for the psychiatrists and neurologists prescribing fluoxetine and for the patients being treated with fluoxetine. There are more noticeable discrepancies with regard to the psychiatrists and neurologists in general and to the patients being treated with antidepressants in general. The methodological problems of pharmacoepidemiological investigation of representativeness are discussed.

The task-force on Phase-IV-Research of the Association for Neuropharmacology and Pharmacopsychiatry (AGNP) has developed guidelines for the implementation of scientifically sound drug utilisation observation studies (DUO studies). These guidelines have been adopted by the executive committee as the position of the association. DUO studies are prospective pharmacoepidemiological studies, by which prescription, illness, and patient data of individual patients are collected without interference with the routine course of treatment. They can answer questions on the interaction of treatment modalities with positive and negative treatment outcome. Scientific standards require that there is a study protocol which describes the epidemiological, statistical, procedural, and quality assurance methodology and states who is responsible for what. As such studies can violate data protection regulations or can be used for sales instead of scientific purposes, consultation of an ethics committee is recommended.

Between 1990 and 1993, a series of drug utilization observation studies with fluoxetine (Flx) were conducted in Germany in several waves. 3,158 patients treated by psychiatrists/neurologists (PN) and 15,601 patients treated by general practitioners/internists (GPI) were included; data collection at start and end of treatment focussed on diagnoses, symptoms, prescription, comedication, efficacy (CGI, Zung scale), and adverse events. Differences between PN and GPI patients were of major interest. For more than 90% of both the PN and the GPI cases. Fix was used for the indication of "depression", with a dosis of 20 mg/day. More PN patients (47%) than GPI patients (28%) were diagnosed as "endogenous"; GPI patients more often presented with first episodes (36 vs. 24%). "suicidal ideation" was less prominent compared to PN subjects (17 vs. 28%). Psychotropic comedication was regarded as necessary in 39% (PN) and 10% (GPI) of the cases. Early treatment termination because of "remission/major improvement" was observed in 13% (PN) vs. 21% (GPI) and because of "adverse events" in 11% (PN) vs. 3% (GPI) of the patients. At observation end, 53% (PN) vs. 74% (GPI) were rated as "symptom-free/markedly improved" (CGI); self-ratings reflected comparable results, marked improvements over time, but still PN/GPI differences at the end. "Suicidality" related to depression was more pronounced in the PN group at both points in time. 24% (PN) vs. 6% (GPI) of the cases reported "routine" adverse events, while in 2% (PN) and 1% (GPI) "serious" adverse events were observed. (For all the above comparisons p < 0.001 to < 0.0001.) These findings reveal that-under routine conditions handled by PNs and GPIs-Fix shows an efficacy and safety consistent with clinical trial data. The body of data suggests that PN patients present with more severe depression and more suicidality, require more comedication, and end up with a poorer outcome. Differences in the physicians' perception of psychiatric and somatic symptomatology and their treatment routines may also have something to do with the PN/GPI group differences observed.