Aktuelle Abstracts 30.08.2001

Lancet 2001 Jul 28;358(9278):265-70

Cilomilast, a selective phosphodiesterase-4 inhibitor for treatment of patients with chronic obstructive pulmonary disease: a randomised, dose-ranging study.

Compton CH, Gubb J, Nieman R, Edelson J, Amit O, Bakst A, Ayres JG, Creemers JP, Schultze-Werninghaus G, Brambilla C, Barnes NC
Department of SmithKline Beecham Pharmaceuticals, Harlow, UK.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a common, progressive respiratory disease that causes great morbidity and mortality despite treatment. There is evidence for airway inflammation in COPD. Cilomilast is an orally active, potent, selective phosphodiesterase type 4 inhibitor, which in vitro can affect cells thought to be of clinical importance in COPD. Our aim was to assess the safety, efficacy, and dose response of cilomilast in the treatment of patients with this disease. METHODS: We did a 6-week, randomised, dose-ranging study in 424 patients with COPD (forced expiratory volume in 1 s [FEV(1)] 46.8% of predicted, FEV(1)/forced vital capacity [FVC] 54.6%, and postsalbutamol reversibility 5.4%). We randomly assigned individuals at 60 European centres to receive cilomilast 5 (n=109), 10 (n=102), or 15 (n=107) mg twice daily, or placebo (n=106). The main outcome measure was trough FEV(1) before and after use of a bronchodilator. Analyses were by intention to treat. FINDINGS: Cilomilast 15 mg twice daily significantly improved FEV(1) compared with placebo (mean 130 mL vs -30 mL [95% CI 90-240] at week 6, p<0.0001). FVC and peak expiratory flow were also improved (p=0.001 and p<0.0001, respectively). Quality of life measures did not differ significantly between the groups. There were no significant differences in serious adverse events between the groups. INTERPRETATION: Cilomilast 15 mg twice daily might be an effective maintenance treatment for COPD. Further clinical studies are underway.

Publication Types:
Clinical trial
Randomized controlled trial
PMID: 11498212, UI: 21389464

Lancet 2001 Jul 28;358(9278):256-7

A role for phosphodiesterase type-4 inhibitors in COPD?

Johnson DC
Pulmonary and Critical Care Unit, Massachusetts General Hospital, Boston, MA 02114, USA.

Publication Types:
PMID: 11498207, UI: 21389459

Pneumologie 2001 Jun;55(6):306-10

[Efficacy of demand oxygen delivery systems in patients with chronic obstructive lung disease].

[Article in German] Johann U, Fichter J, Sybrecht GW
Universitatskliniken des Saarlandes, Innere Medizin V, Homburg/Saar.

To maintain mobility in patients with chronic hypoxemia who are under long-term oxygen therapy, portable oxygen systems are available. They have the disadvantage of a short range. To prolong the range and to reduce the cost of oxygen treatment, demand oxygen delivery systems (DODS) are used. Aim of the study was to compare three DODS (DOC-2000 [D], TransTracheal Inc.; Oxytron [O], Weinmann; Pulsair [P], DeVilbiss, Sunrise Medical) with continuous oxygen delivery. 17 patients (age 67.82 +/- 9.46 years; FEV1 1.23 +/- 0.69 l; PaO2 48.8 +/- 6.7 mm Hg) were studied. The continuous flow oxygen (CONT) and the DODS were applied to the patients for 30 minutes each in random sequence with an airflow of 2 l/min. After 15 and 30 minutes arterial blood gas analysis was done. Oxygen saturation was recorded continuously by pulseoximetry. After 15 minutes no significant differences in PaO2 were found between CONT and DODS. After 30 minutes no significant difference in PaO2 was found in CONT as compared to P. Significant lower PaO2 values were found for O and D as compared to CONT (p < 0.01). With P the range of a portable oxygen source was increased by 161.5 percent, with O by 172 percent, with D the range was increased by only 17.2 percent. Prolongation of range of a portable oxygen source can be achieved by means of DODS without a decrease of PaO2 and thus without loss of quality of the oxygen treatment. However, there are differences in efficacy between the DODS.

Publication Types:
Clinical trial
Randomized controlled trial
PMID: 11458439, UI: 21352076

Pneumologie 2001 Jun;55(6):289-94

[The impact of different definitions of hypoxemia on the relation between awake pulmonary pressure and hypoxemia during sleep in patients with COPD].

[Article in German] Rasche K, Duchna HW, Orth M, Walther J, de Zeeuw J, Bauer TT, Jager D, Schultze-Werninghaus G
Berufsgenossenschaftliche Kliniken Bergmannsheil, Klinikum der Ruhr-Universitat Bochum, Medizinische Klinik und Poliklinik, Abteilung fur Pneumologie, Allergologie und Schlafmedizin.

BACKGROUND: Sleep related hypoxemia (SRH) in chronic obstructive pulmonary disease (COPD) can be easily detected by pulse-oximetry and may contribute to the development of pulmonary hypertension (PH). Since several parameters for the quantification of SRH are in use, we investigated which of these parameters has the strongest relation to the awake pulmonary arterial pressure (PAP) and is able to distinguish between patients without and with PH. PATIENTS AND METHODS: 44 COPD-patients (awake PaO2 > or = 60 mm Hg) were investigated. PAP at rest (PAP; pathological threshold > 20 mm Hg) and under physical exercise (PAPB; p.t. > 28 mm Hg) were determined during daytime by Swan-Ganz-catheter. To quantify the degree of SRH the following parameters of nocturnal pulse-oximetry were used: mean nocturnal oxygen saturation (SaO2 m; p.t. < 90%), nadir SaO2 (SaO2 min; p.t. < 85%), and mean time of SaO2 < or = 90% in relation to total time of registration (t90; p.t. > 30%). Linear correlations and regressions as Chi 2-respectively Fisher-test were used for statistical analysis (p < 0.05). RESULTS: Generally there was only a weak relation between PAP and SRH. The best linear correlation at rest respectively under physical exercise was found between PAP and SaO2 min (r = -0.529 resp. -0.541, p < 0.001). Using the above defined thresholds for PAP and SaO2 patients could be most precisely separated into those without and with PH using SaO2 min with a threshold for the pathological range of < 85% (p = 0.030 resp. 0.002). t90 with a threshold > 30%, however, had a much worse selectivity (p = 0.487 resp. 0.057). CONCLUSIONS: In COPD-patients with SRH the closest relation can be found between nadir SaO2 and PAP resp. PAPB. Furthermore nadir SaO2 (< 85%) could more precisely separate patients into those without and with pulmonary hypertension than t90. The overall weak relation between nocturnal oxygenation and pulmonary hypertension shows, however, that other factors such as daytime PaO2, hypercapnia or emphysema are involved in the development of pulmonary hypertension in COPD.

PMID: 11458436, UI: 21352073

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