Adherence to Long-Term Interferon Beta-1b Injection Therapy in Patients with Multiple Sclerosis Using an Electronic Diary.

INTRODUCTION: Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system requiring long-term treatment, which is often hampered by non-adherence to self-applicable therapies, provoking continued disease activity and health care system burdens. This study assessed the influence of a personal digital assistant (PDA) with diary function (n = 339 patients) on persistence and adherence to an interferon beta treatment regimen in comparison to a paper patient diary (n = 330 patients). METHODS: Patients who recently started with subcutaneous injections of interferon beta-1b were recruited in this prospective, non-interventional, national cohort study for an observational period of 2 years after successful completion of the initial dose escalation. RESULTS: Therapy persistence as assessed by the drop-out rate within 104 weeks was about 50% in both study cohorts. In male patients, the drop-out rate was 10% lower when using a PDA compared to the non-PDA group. Use of a PDA with an injection reminder function increased adherence to the injection schedule (every other day) by a mean of 24.5 injections over 24 months in comparison to use of a PDA without injection reminder function. CONCLUSION: Persistence in this study was in the published range of observational MS studies. Furthermore, in male patients continuation of therapy might be positively influenced by use of a PDA, and both female and male patients might benefit from an integrated reminder function. In conclusion, electronic diaries reminding patients of upcoming injections can promote an improved adherence to MS therapy. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00902135. FUNDING: Bayer Vital GmbH.

Effectiveness and medication acceptance of olanzapine disintegrating tablets compared to standard olanzapine tablets in acutely treated psychiatric patients.

BACKGROUND: This study compared effectiveness and acceptance of orally disintegrating olanzapine tablets (ODT) with standard-coated tablets (SOT) in acutely ill psychiatric patients admitted to psychiatric hospitals for emergency treatment. METHODS: Large, prospective, observational study at hospital emergency units across Germany in patients with a diagnosis or tentative diagnosis of acute schizophrenia treated with ODT or SOT. Clinical (CGI-S and CGI-I) outcomes, attitudes towards medication (Nursing Assessment of Medication Acceptance, NAMA) scale, suicidal ideation, and adverse events were assessed at start of treatment and after 2 weeks. RESULTS: Both olanzapine formulations, ODT (N = 247) and SOT (N = 207), showed similar effectiveness after 2 weeks. CGI-I improved in 92.1% of patients (ODT: 91.8%, SOT: 92.3%). In patients receiving both formulations suicidal ideations were reduced (ODT from 53.9% to 20.6%, SOT from 51.2% to 22.7%). ODT was preferably given to severely ill (SOT: 49.8%, ODT: 64.4%) and aggressive patients. Adverse events were reported for 6.5% of ODT- and 2.9% of SOT-patients. This difference was possibly caused by the characteristics of patients receiving ODT. CONCLUSIONS: This non-randomized, observational study shows comparable outcomes and tolerability in patients treated with both olanzapine formulations. In an acute treatment setting, orally disintegrating tablets were preferably used for more severely ill and aggressive patients with low medication acceptance.

Effects of olanzapine and clozapine upon pulse rate variability.

Based upon their in vitro receptor binding profiles, the atypical antipsychotics clozapine and olanzapine exhibit cholinergic receptor binding of similar potency. Data comparing the in vivo anticholinergic effects, however, of these neuroleptics upon neurocardiac control are sparse. The goal of this study was to compare the in vivo effects of clozapine and olanzapine upon neurocardiac control by assessment of the pulse rate variability (PRV) in schizophrenic patients and healthy controls. Twenty patients with schizophrenia (according to DSM-III-R criteria) treated with either clozapine (100-600 mg/day) or olanzapine (10-20 mg/day), and ten healthy controls, were recruited into the study. PRV was assessed by continuously recording the skin blood volume in the fingertip of the second digit under resting conditions and PRV parameters were calculated. When significant differences in PRV parameters between the patients and controls were detected by Kruskal-Wallis tests, Mann-Whitney tests were used to test for group differences between the olanzapine- and clozapine-treated patients. In comparison to the healthy controls, the PRV parameters of the clozapine- and olanzapine-treated schizophrenic patients were significantly reduced. Indeed the reduction of PRV was significantly greater in the clozapine-treated group compared to the olanzapine-treated group (P<0.05). Compared to the controls, only the clozapine-treated patients showed a significantly diminished low-frequency (LF)/high frequency (HF)-ratio, a PRV parameter reflecting sympatho-vagal balance. The significantly greater reductions in PRV parameters of the clozapine-treated compared to olanzapine-treated patients may be caused by clozapine's higher affinity for alpha(1)-adrenergic receptors in vivo compared with olanzapine. The similar LF/HF ratios of the healthy controls and olanzapine-treated patients suggests that the sympathetic-parasympathetic modulation of PRV remains relatively unchanged even during olanzapine treatment.