Allergy and Airway |

Safety of the Combination of Olodaterol Respimat and Tiotropium HandiHaler Compared With Tiotropium: Results From Two Replicate 12-Week Studies FREE TO VIEW

Roger Abrahams; Lisa Allen; Gemzel Hernandez; Naitee Ting; Richard ZuWallack
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St Francis Hospital and Medical Center, Hartford, CT

Chest. 2014;146(4_MeetingAbstracts):47A. doi:10.1378/chest.1994418
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SESSION TITLE: COPD Treatment Posters

SESSION TYPE: Original Investigation Poster

PRESENTED ON: Wednesday, October 29, 2014 at 01:30 PM - 02:30 PM

PURPOSE: To evaluate the safety of combination therapy with the long-acting bronchodilators tiotropium 18 µg (via HandiHaler®) and olodaterol 5 µg (via Respimat®) [T+O], both given once daily in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Tiotropium 18 µg once daily (HandiHaler®) and placebo (Respimat®) served as the comparator [T+P] (ANHELTO-1 [NCT01694771] and ANHELTO-2 [NCT01696058]).

METHODS: Adverse events (AEs) in the two treatment groups were evaluated throughout the 12-week treatment and 21-day safety follow-up periods.

RESULTS: In ANHELTO-1, 45.3% (T+O; n=567) and 42.8% (T+P; n=565) of patients reported AEs and 7.1% and 4.6% reported serious AEs (SAEs), respectively. In ANHELTO-2, 40.1% (n=566) and 43.2% (n=569), respectively, reported AEs and 4.2% and 4.7% reported SAEs. Most events were mild to moderate in intensity and not considered related to study treatment. In total, 12 deaths occurred: there was a numerical imbalance in ANHELTO-1 (one T+P, five T+O) that was not seen in ANHELTO-2 (two T+P, three T+O). Three of the 12 occurred during randomized treatment: one with T+P (due to natural causes) and two with T+O (myocardial ischemia, cocaine/oxycodone toxicity). The remaining deaths occurred after discontinuation of study treatment: eight occurred during follow-up (two with T+P [convulsions and myocardial infarction] and six with T+O [hemorrhagic cerebral infarction, myocardial infarction/arteriosclerosis, acute respiratory failure (COPD during study treatment period also cited), COPD, cardiac arrest, and sudden death]); one further death occurred after the 21-day post-treatment follow-up (T+P [subarachnoid hemorrhage]).

CONCLUSIONS: The results of these two large-scale randomized studies demonstrate that the incidence of AEs was generally low and similar with T+O and T+P. These data support the established safety profile of olodaterol 5 μg once daily via Respimat® and its use in combination with tiotropium HandiHaler®.

CLINICAL IMPLICATIONS: These studies of the combination of tiotropium (HandiHaler®) and olodaterol (Respimat®) support the established safety profile of olodaterol 5 μg once daily via Respimat®. Funding: Boehringer Ingelheim. Editorial assistance: Complete HealthVizion.

DISCLOSURE: Roger Abrahams: Grant monies (from industry related sources): Clinical Research Grant from Boehringer-Ingelheim, Consultant fee, speaker bureau, advisory committee, etc.: Boehringer-Ingelheim steering committee Lisa Allen: Employee: Boehringer-Ingelheim Gemzel Hernandez: Employee: Boehringer-Ingelheim Naitee Ting: Employee: Boehringer-Ingelheim Richard ZuWallack: Consultant fee, speaker bureau, advisory committee, etc.: Honoraria from Boehringer-Ingelheim paid to my hospital, Grant monies (from industry related sources): Investigator initiated grants from Boehringer-Ingelheim to my institution, Consultant fee, speaker bureau, advisory committee, etc.: Honoraria from GSK for speaking paid to me

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