Assessment of new application system in Portuguese patients with relapsing-remitting multiple sclerosis.

OBJECTIVE: To evaluate the satisfaction level of multiple sclerosis (MS) patients treated with interferon beta-1b (IFNbeta-1b, Betaferon*) using a newly developed application system compared to their currently used application system. METHODS: A survey was conducted in Portugal in patients treated with IFNbeta-1b for relapsing-remitting MS with the Betaject or Betaject Lite autoinjector. Nurses demonstrated the new application system and supervised the first injection. Patients rated their overall satisfaction retrospectively with their current application system and prospectively after the first, the seventh and the 15th injection with the newly developed application system. Additionally, the ease of use was evaluated for both application systems using a questionnaire consisting of 13 questions. Responses were compiled and descriptive analyses performed. RESULTS: A total of 249 patients evaluated the current and the new system after the first, 235 after the seventh and 174 after the 15th injection. The satisfaction level was high with the current system (70.3%, 'satisfied' or 'very satisfied'). However, compared with the current system, more patients were either 'satisfied' or 'very satisfied' (98%) with the new system after first injection. Only a minority of patients rated 'somewhat satisfied': 2.0% after the first, 8.6% after the seventh, and 4.4% after the 15th injection. Increased overall satisfaction level ('satisfied' or 'very satisfied') with the newly developed system was maintained over time (98% - first, 90.5% - seventh, 93.8% - 15th injection). The thinner, pre-attached 30-gauge needle and the visual signalling of injection completion were among the changes considered as strong improvements to the new system by up to 80.3% of patients. LIMITATION: Retrospective analysis of current system. CONCLUSIONS: This survey documented patient satisfaction with different application systems of IFNbeta-1b. The increased satisfaction with the new application system indicates an improvement to the currently used injection system, which may contribute to further advancement in adherence and consequently higher clinical efficacy of treatment.

Different acute tolerance development to EEG, psychomotor performance and subjective assessment effects after two intermittent oral doses of alprazolam in healthy volunteers.

BACKGROUND/AIMS: Benzodiazepines (BZDs) are the most effective of the psychotropic drugs in the treatment of anxiety disorders. Tolerance has been reported for the majority of BZDs after chronic administration. However, little attention has been paid to the possibility that tolerance might be present after the intermittent oral administration of BZDs. The objectives of the present study were to assess tolerance development after the administration of two intermittent single oral doses of alprazolam given 15 days apart in healthy volunteers, and to compare the results obtained using measures from different domains: neurophysiological, psychomotor and subjective. METHODS: Twenty-four healthy volunteers received 2 mg of alprazolam orally on two experimental days, 15 days apart. Plasma concentrations and pharmacodynamics (PD) were assessed before drug intake and at different times in the following 24 h. PD was assessed through EEG (relative alpha and relative beta-1 activities), cancellation task (total and correct number of responses) and visual analogue scales (activity and drowsiness). RESULTS: No differences were observed in the PKs of alprazolam between occasions. A proteresis was present in both administrations for impairments of psychomotor performance and relative beta-1 activity, whereas it was present only after the second administration for subjective assessments and relative alpha activity. The proteresis on the second occasion was higher than on the first one. CONCLUSIONS: The administration of two single oral doses of alprazolam, 2 weeks apart in healthy volunteers, yielded the same PKs on both occasions, but significant changes were observed in the PD profile. Acute tolerance was observed after the second administration. Two patterns of acute tolerance development were obtained: (1) impairments of psychomotor performance and relative beta-1 activity, and (2) subjective assessments and relative alpha activity.