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Once-Daily Nebivolol 5mg Does Not Reduce Airway Patency in Patients with Chronic Obstructive Pulmonary Disease and Arterial Hypertension

A Placebo-Controlled Crossover Study

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Abstract

Objective: To evaluate the 24-hour time-course of the effects of a single dose of nebivolol 5mg on airway patency in patients with chronic obstructive pulmonary disease (COPD).

Design: Short-term, randomised, double-blind, placebo-controlled, crossover study.

Patients: 12 ex-smokers (five males; mean age 63.8 ± 9.8 years, range 46 to 75 years) with stable COPD [mean baseline forced expiratory volume in 1 second (FEV1) 54.9 ± 11.9%; change in FEV1 after salbutamol 200μg = +6.0 ± 3.8% of baseline value] and WHO stage 1–2 mild to moderate arterial hypertension [mean baseline systolic (SBP) and diastolic (DBP) blood pressure, 150.0 ± 12.1 and 97.9 ± 8.4mm Hg, respectively].

Main outcome measures and results: The measured variables were lung function [vital capacity (VC), FEV1, forced vital capacity (FVC), peak expiratory flow (PEF), maximum mid-expiratory flow (MMEF) and specific airway resistance (SRaw)], SBP/DBP and heart rate at baseline (t0), and at 1 (t1), 3 (t3), 6 (t6), 12 (t12) and 24 (t24) hours after the administration of nebivolol or placebo. Exhaled nitric oxide (e-NO) was also assayed at t0, t6 and t24. ANOVA showed that none of the changes from baseline during either 24-hour monitoring period was significant. In terms of the non-respiratory variables, nebivolol did not significantly improve SBP or DBP, although there was a trend towards a reduction in both: the difference in the change in DBP over time between the two treatments was of borderline significance (ANOVA, p < 0.06). Heart rate remained unchanged during both treatments. No significant changes in e-NO were observed throughout the study between placebo and nebivolol treatment.

Conclusions: Our results suggest that a single efficacious dose of nebivolol does not affect airway patency in hypertensive patients with COPD, and seem to confirm the broad tolerability margin of this drug in patients with COPD.

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Acknowledgements

This study was partially funded by A. Menarini, Italy.

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Correspondence to R. W. Dal Negro.

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Dal Negro, R.W., Tognella, S. & Pomari, C. Once-Daily Nebivolol 5mg Does Not Reduce Airway Patency in Patients with Chronic Obstructive Pulmonary Disease and Arterial Hypertension. Clin. Drug Investig. 22, 361–367 (2002). https://doi.org/10.2165/00044011-200222060-00003

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