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Efficacy and safety of combining olodaterol Respimat(®) and tiotropium HandiHaler(®) in patients with COPD: results of two randomized, double-blind, active-controlled studies.

Abstract

BACKGROUND

Combining bronchodilators with different mechanisms of action may improve efficacy and reduce risk of side effects compared to increasing the dose of a single agent in chronic obstructive pulmonary disease (COPD). We investigated this by combining two long-acting bronchodilators: once-daily muscarinic antagonist tiotropium and once-daily β2-agonist olodaterol.

METHODS

Two replicate, double-blind, randomized, 12-week studies (ANHELTO 1 [NCT01694771] and ANHELTO 2 [NCT01696058]) evaluated the efficacy and safety of olodaterol 5 μg once daily (via Respimat(®)) combined with tiotropium 18 μg once daily (via HandiHaler(®)) versus tiotropium 18 μg once daily (via HandiHaler(®)) combined with placebo (via Respimat(®)) in patients with moderate to severe COPD. Primary efficacy end points were area under the curve from 0-3 hours of forced expiratory volume in 1 second (FEV1 AUC0-3) and trough FEV1 after 12 weeks (for the individual trials). A key secondary end point was health status by St George's Respiratory Questionnaire (SGRQ) total score (combined data set).

RESULTS

Olodaterol + tiotropium resulted in significant improvements over tiotropium + placebo in FEV1 AUC0-3 (treatment differences: 0.117 L [P<0.001], ANHELTO 1; 0.106 L [P<0.001], ANHELTO 2) and trough FEV1 (treatment differences: 0.062 L [P<0.001], ANHELTO 1; 0.040 L [P=0.0029], ANHELTO 2); these were supported by secondary end points. These effects translated to improvements in SGRQ total scores (treatment difference -1.85; P<0.0001). The tolerability profile of olodaterol + tiotropium was similar to tiotropium monotherapy.

CONCLUSION

These studies demonstrated that olodaterol (Respimat(®)) and tiotropium (HandiHaler(®)) provided bronchodilatory effects above tiotropium alone in patients with COPD. In general, both treatments were well tolerated.

Authors+Show Affiliations

Saint Francis Hospital and Medical Center, Hartford, CT, USA.Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.Morgantown Pulmonary Associates, Morgantown, WV, USA.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25342898

Citation

ZuWallack, Richard, et al. "Efficacy and Safety of Combining Olodaterol Respimat(®) and Tiotropium HandiHaler(®) in Patients With COPD: Results of Two Randomized, Double-blind, Active-controlled Studies." International Journal of Chronic Obstructive Pulmonary Disease, vol. 9, 2014, pp. 1133-44.
ZuWallack R, Allen L, Hernandez G, et al. Efficacy and safety of combining olodaterol Respimat(®) and tiotropium HandiHaler(®) in patients with COPD: results of two randomized, double-blind, active-controlled studies. Int J Chron Obstruct Pulmon Dis. 2014;9:1133-44.
ZuWallack, R., Allen, L., Hernandez, G., Ting, N., & Abrahams, R. (2014). Efficacy and safety of combining olodaterol Respimat(®) and tiotropium HandiHaler(®) in patients with COPD: results of two randomized, double-blind, active-controlled studies. International Journal of Chronic Obstructive Pulmonary Disease, 9, 1133-44. https://doi.org/10.2147/COPD.S72482
ZuWallack R, et al. Efficacy and Safety of Combining Olodaterol Respimat(®) and Tiotropium HandiHaler(®) in Patients With COPD: Results of Two Randomized, Double-blind, Active-controlled Studies. Int J Chron Obstruct Pulmon Dis. 2014;9:1133-44. PubMed PMID: 25342898.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of combining olodaterol Respimat(®) and tiotropium HandiHaler(®) in patients with COPD: results of two randomized, double-blind, active-controlled studies. AU - ZuWallack,Richard, AU - Allen,Lisa, AU - Hernandez,Gemzel, AU - Ting,Naitee, AU - Abrahams,Roger, Y1 - 2014/10/14/ PY - 2014/10/25/entrez PY - 2014/10/25/pubmed PY - 2015/2/25/medline KW - bronchodilator KW - long-acting beta2-agonist KW - long-acting muscarinic antagonist KW - olodaterol Respimat® KW - tiotropium HandiHaler® SP - 1133 EP - 44 JF - International journal of chronic obstructive pulmonary disease JO - Int J Chron Obstruct Pulmon Dis VL - 9 N2 - BACKGROUND: Combining bronchodilators with different mechanisms of action may improve efficacy and reduce risk of side effects compared to increasing the dose of a single agent in chronic obstructive pulmonary disease (COPD). We investigated this by combining two long-acting bronchodilators: once-daily muscarinic antagonist tiotropium and once-daily β2-agonist olodaterol. METHODS: Two replicate, double-blind, randomized, 12-week studies (ANHELTO 1 [NCT01694771] and ANHELTO 2 [NCT01696058]) evaluated the efficacy and safety of olodaterol 5 μg once daily (via Respimat(®)) combined with tiotropium 18 μg once daily (via HandiHaler(®)) versus tiotropium 18 μg once daily (via HandiHaler(®)) combined with placebo (via Respimat(®)) in patients with moderate to severe COPD. Primary efficacy end points were area under the curve from 0-3 hours of forced expiratory volume in 1 second (FEV1 AUC0-3) and trough FEV1 after 12 weeks (for the individual trials). A key secondary end point was health status by St George's Respiratory Questionnaire (SGRQ) total score (combined data set). RESULTS: Olodaterol + tiotropium resulted in significant improvements over tiotropium + placebo in FEV1 AUC0-3 (treatment differences: 0.117 L [P<0.001], ANHELTO 1; 0.106 L [P<0.001], ANHELTO 2) and trough FEV1 (treatment differences: 0.062 L [P<0.001], ANHELTO 1; 0.040 L [P=0.0029], ANHELTO 2); these were supported by secondary end points. These effects translated to improvements in SGRQ total scores (treatment difference -1.85; P<0.0001). The tolerability profile of olodaterol + tiotropium was similar to tiotropium monotherapy. CONCLUSION: These studies demonstrated that olodaterol (Respimat(®)) and tiotropium (HandiHaler(®)) provided bronchodilatory effects above tiotropium alone in patients with COPD. In general, both treatments were well tolerated. SN - 1178-2005 UR - https://www.unboundmedicine.com/medline/citation/25342898/Efficacy_and_safety_of_combining_olodaterol_Respimat_®__and_tiotropium_HandiHaler_®__in_patients_with_COPD:_results_of_two_randomized_double_blind_active_controlled_studies_ L2 - https://dx.doi.org/10.2147/COPD.S72482 DB - PRIME DP - Unbound Medicine ER -