Drug updated on 12/11/2024
Dosage Form | Inhalation spray (oral: 2.5 mcg) |
Drug Class | Long-acting beta2-adrenergic agonist (LABA) |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Latest News
Summary
- This summary is based on the review of five systematic review(s)/meta-analysis(es). [1-5]
- Olodaterol/tiotropium demonstrated a lower moderate or severe exacerbation rate of 38.3% at 52 weeks compared to other long-acting beta(2)-agonist (LABA)/long-acting muscarinic antagonist (LAMA) and LABA/inhaled corticosteroid (ICS) combinations, such as formoterol/budesonide (41.0%), indacaterol/glycopyrronium (42.6%), and vilanterol/umeclidinium (53.0%).
- In lung function outcomes, vilanterol/umeclidinium showed the highest efficacy in trough forced expiratory volume in 1 second (FEV₁) change from baseline, while olodaterol/tiotropium showed similar efficacy to other LABA/LAMA combinations, with a gradual decline in trough FEV₁ over 24 weeks observed across all combinations except vilanterol/umeclidinium (0.029–0.041 L decrease).
- Across various LABA/LAMA FDCs (fixed-dose combinations), similar safety outcomes were observed for mortality, serious adverse events (SAEs), and withdrawal due to adverse events, with no significant safety differences reported compared to placebo.
- For cardiovascular safety, tiotropium/olodaterol (5/5 µg) demonstrated no significant increase in risks for arrhythmia, heart failure, myocardial infarction, or stroke compared to individual components, indicating an acceptable safety profile for cardiovascular outcomes.
- Among maintenance-naive patients with chronic obstructive pulmonary disease (COPD), tiotropium/olodaterol significantly improved lung function (measured by trough FEV₁), health status (St. George's Respiratory Questionnaire (SGRQ) score), and dyspnea severity (Transition Dyspnoea Index (TDI) score) compared to tiotropium alone, with no reported compromise in safety outcomes.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Striverdi Respimat (olodaterol) Prescribing Information. | 2021 | Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Romanian clinical guideline for diagnosis and treatment of COPD. | Journal of International Medical Research |