Absence of adverse effects of tiotropium/ olodaterol compared with the monocomponents on long-term heart rate and blood pressure in patients with moderate-to-very-severe COPD

Stefan Andreas (Avtor), Lorcan Mcgarvey (Avtor), Ulrich Bothner (Avtor), Matthias Trampisch (Avtor), Alberto De La Hoz (Avtor), Matjaž Fležar (Avtor), Roland Buhl (Avtor), Peter Alter (Avtor)

Povzetek

Introduction: Long-acting [beta]2-agonists (LABAs) and long-acting muscarinic antagonists (LAMAs) are established maintenance bronchodilator treatments for chronic obstructive pulmonary disease (COPD) with the potential to increase heart rate (HR) and impact blood pressure (BP). While previous studies indicate that HR and BP are not negatively influenced by tiotropium or olodaterol monotherapy, the effect of tiotropium/olodaterol has not been evaluated. We report a post hoc analysis of the effect of dual bronchodilation with tiotropium/olodaterol versus monocomponents on HR and BP in patients with moderate-to-very-severe COPD included in the large TONADO© study. Methods: The TONADO© trials (1237.5 [NCT01431274] and 1237.6 [NCT01431287]) were two replicate, randomized, double-blind, parallel-group, 52-week, Phase III trials that compared tiotropium/olodaterol (5/5 [micro]g and 2.5/5 [micro]g) with tiotropium (5 [micro]g and 2.5 [micro]g) and olodaterol (5 [micro]g) in patients with moderate-to-very-severe COPD. Patients with cardiovascular comorbidities were included. Changes in HR and systolic/diastolic BP were measured before and after dosing with the study medication at each visit (baseline, Week 12, Week 24 and Week 52). Results: Overall, 3,100 patients were included in this analysis. Over 52 weeks, small changes from baseline in mean HR (<2 beats per minute [bpm]) and small changes from pre- to post-dose (<1 bpm) were evident at different time points. There was a non-significant increase from baseline in mean diastolic and systolic BP (<2 mmHg) observed over 52 weeks of treatment. The short-term (1 hour pre- to 1 hour post-dose) mean changes in systolic and diastolic BP over 52 weeks in the tiotropium/olodaterol 5/5 [micro]g group were comparable with those observed for the monocomponents at all time points. Conclusion: There were no differences in HR or BP among patients on tiotropium/olodaterol when compared with monocomponents. This supports the already demonstrated cardiovascular safety profile of tiotropium/olodaterol as long-acting maintenance bronchodilator treatment for COPD, including patients with cardiovascular comorbidities.

Ključne besede

tiotropij;olodaterol;tiotropium;

Podatki

Jezik:	Angleški jezik
Leto izida:	2020
Tipologija:	1.01 - Izvirni znanstveni članek
Organizacija:	GeoZS - Geološki zavod Slovenije
Založnik:	Dove Medical Press
UDK:	616.2
COBISS:	28042755
ISSN:	1178-2005
Matična publikacija:	International journal of COPD
Št. ogledov:	839
Št. prenosov:	529
Ocena:	0 (0 glasov)
Metapodatki:

Ostali podatki

Sekundarne ključne besede:	Pulmonary disease, chronic obstructive;Drug therapy;Heart rate;Blood pressure;Kronična obstruktivna pljučna bolezen;Terapija z zdravili;Srčna frekvenca;Krvni tlak;
Komentar vira:	Nasl. z nasl. zaslona; Soavtor iz Slovenije: Matjaž Fležar; Opis vira z dne 11. 9. 2020;
Strani:	str. 1935-1944
Zvezek:	ǂVol. ǂ15
Čas izdaje:	2020
DOI:	10.2147/COPD.S246348
ID:	12035040