[Efficacy of tiotropium bromide (Spiriva) in patients with chronic-obstructive pulmonary disease (COPD) of different severities]. / Wirksamkeit von Tiotropiumbromid (Spiriva) bei verschiedenen Schweregraden der chronisch-obstruktiven Lungenerkrankung (COPD).

BACKGROUND: Aim of this study was to evaluate the efficacy of inhaled Tiotropium bromide in COPD patients of different severities in pneumological practices during a three months clinical trial. METHODS: A randomized, double blind, placebo controlled study including COPD-patients (FEV1/FVC < 70 %, FEV1 < or = 70 % predicted; age > or = 40 years; > or = 10 pack years) of different severities was performed. The efficacy of 18 microg Tiotropium bromide once daily on lung function and exacerbations over 12 weeks was evaluated by respective pulmonary function tests (spirometry) before (trough value) and 2 hours after inhalation of study medication. RESULTS: 1639 patients (1236 Tiotropium bromide, 403 placebo; FEV1 reversibility after 200 microg Ipratropium bromide + 200 microg Fenoterol: 7.9 +/- 7.5 % predicted [mean +/- sd]) were randomized. After 12 weeks of treatment Tiotropium bromide led to significant increases of trough FEV1 (23 - 24 h after last inhalation; + 79 +/- 17 ml), and 2 h after Tiotropium bromide inhalation (+ 128 +/- 19 ml) (all values vs. placebo, adjusted mean +/- se, p < 0.0001). FVC and IVC were also improved significantly. In mild COPD (FEV1 > or = 50 - 70 %) improvements were most pronounced (trough FEV1 + 113 +/- 29 ml, 2 h post-inhalation + 181 +/- 33 ml; all values vs. placebo., p < 0.0001). 14.6 % of patients treated with Tiotropium bromide had a COPD exacerbation vs. 19.9 % of patients treated with placebo (p = 0.0151). The time to first exacerbation was prolonged (p = 0.0092 vs. placebo). CONCLUSION: Tiotropium bromide 18 microg once daily led to a persistent improvement of lung function and a reduction of exacerbations in patients with COPD of different severities.

[Efficacy of a disease management programme in asthma]. / Effizienz eines Disease Management Programmes bei Asthma.

BACKGROUND: Disease Management Programmes (DMP) are intended to improve the quality of the medical care of chronically sick patients and at the same time to keep stable or to reduce the costs to the healthcare system. The effectiveness of a DMP was evaluated by means of an accompanying study. METHOD: Within the framework of the DMP, the patients were managed by case managers who carried out patient instructions, evaluated the symptoms and lung function values (FEV (1)) on a daily basis and supervised treatment goals with the aid of predetermined algorithms. Initially, in collaboration with the family doctor, a treatment schedule was drawn up continuously monitored and adapted. In a 12-month multicentre evaluation study, the quality of life of the patients was determined using the FLA and Euroquol questionnaires. Furthermore, symptoms, lung function (FEV (1)) and the total costs of the treatment were measured. RESULTS: The quality of life (FLA, EuroQuol) of the patients in the Disease Management group was statistically significantly improved compared with the start of the study and with the control group. Inpatient respiratory-related costs were only incurred in the control group ( 320). No significant differences were found in the case of the other direct cost parameters (costs for asthma-related drugs 716 and 720 in the control group and DMP group respectively). The indirect costs were higher in the DMP group due to more frequent disability. With regard to overall symptoms, a pronounced reduction was only achieved in the DMP group. The mean FEV (1) measured in the physicians practice rose in the DMP group from 1.82 l to 1.89 l, whereas in the control group it fell slightly from 1.84 l to 1.78 l. The daily FEV (1) measurements at patient's home showed an increase of about 10 % in the values after 12 months. CONCLUSIONS: The tested DMP for asthmatics brought about a significant improvement in the state of health, asthmatic symptoms and lung function of asthmatics. The direct costs of treatment were also found to be lower.