Assessment by IQWiG of Spiolto Respimat (tiotropium + olodaterol) in chronic obstructive pulmonary disease finds evidence of minor benefits- Boehringer Ingelheim

The German Institute for Quality and Efficiency in Health Care (IQWiG) has examined in a dossier assessment whether the fixed-dose combination of Spiolto Respimat (tiotropium and olodaterol), from Boehringer Ingelheim, currently approved for maintenance treatment in adults with chronic obstructive pulmonary disease (COPD), offers an added benefit over the appropriate comparator therapy. The manufacturer presented data from two approval studies (TONADO 1 and TONADO 2) with patients diagnosed with moderate to severe COPD.

According to the findings, there were no statistically significant differences between the treatment groups for the totality of adults with moderate COPD symptoms (severity grade II) and higher severity grades (III-IV) and fewer than two flare-ups (exacerbations) per year. The data provided neither positive nor negative effects for men. Indications of a minor added benefit could only be derived for women in these COPD groups who inhaled the fixed-dose combination. In adults with higher severity grades (at least III) and at least two flare-ups per year, even disadvantages occurred, which resulted in proof of lesser benefit.

Comment: Spiolto Respimat/Stiolto Respimat is the fourth Respimat inhaled drug that the FDA has approved for market for chronic obstructive pulmonary disease. It is a once-a-day treatment that improves lung function in around five minutes and reduces patients’ dependence on rescue inhalers. In clinical trials of more than 5,000 patients with differing severities of COPD, Stiolto Respimat was able to provide greater improvements in lung function than Spiriva Respimat (tiotropium bromide) or Striverdi Respimat (olodaterol) alone. Spiriva Respimat was launched in the US in January 2015, following FDA approval in September 2014. Striverdi Respimat was approved a month earlier, while the older Combivent Respimat (ipratropium bromide & albuterol) gained approval in 2011.