Tiotropium and Olodaterol Treatment for COPD Produces Mixed Bag of Results

Some chronic obstructive pulmonary disease (COPD) patients may benefit from treatment with tiotropium/olodaterol, but others may not find relief, according to a dossier assessment conducted by the German Institute for Quality and Efficiency in Health Care (IQWiG).

The researchers reviewed a report about the efficacy of the tiotropium/olodaterol treatment for COPD compared to the appropriate comparator therapy. The document was part of the early benefit assessment mandated by the Act on the Reform of the Market for Medical Products, which is supervised by the Federal Joint Committee (G-BA). After its publication, the G-BA makes a decision about the added benefit of the therapy.

The patients involved in the study were treated with tiotropium and olodaterol (Spiolto Respimat). The study authors determined no statistically significant differences between treatment groups with moderate COPD symptoms or severe COPD symptoms with fewer than two exacerbations per year. Patients with moderate COPD on the new drug treatment were compared to a long acting beta 2 sympathomimetic (such as formoterol, salmeterol) and/ or tiotropium. Patients with severe COPD symptoms were treated with inhaled corticosteroids (ICS). If a patient was previously using ICS, they continued use, even though the G-BA specified halting outside treatments.

For female patients treated with inhaled fixed dose combinations, there was what the researchers called a “moderate benefit.” Women taking the fixed dose inhaled combination demonstrated some positive effects surrounding quality of life and COPD related symptoms, such as shortness of breath. There appeared to be an added benefit of the tiotropium and olodaterol combination compared to the tiotropium alone, the researchers extrapolated. There was no such association found in male patients.

There were less benefits, and event disadvantages, for patients who had two or more flare ups per year, the researchers added in a press release.

Patients taking the fixed dose combination experienced more frequent severe exacerbations, which the researchers determined meant that there was proof of a lesser benefit in the tiotropium and olodaterol combination plus ICS patients groups in comparison with the tiotropium plus ICS patients.

After 24 weeks (the manufacturer’s endpoint) and at 52 weeks (the study group endpoint) there were no significant differences between the treatment groups, the researchers reported. Or, they continued, data were lacking in regards to COPD symptoms, exacerbations, quality of life or severe side effects.