Long-Term Post-Marketing Observational Study of the Safety of Roflumilast

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Observational study

Study drug and medical condition

• Medical condition to be studied:
  Chronic obstructive pulmonary disease

Population studied

• Short description of the study population:
  The study population comprised of patients aged 40 years or older diagnosed with chronic obstructive pulmonary disease (COPD) exposed or unexposed to the treatment of roflumilast identified through the databases in Germany, Sweden, the United States, and Norway.
• Age groups:
  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with chronic obstructive pulmonary disease
• Estimated number of subjects:
  21812

Study design details

• Main study objective:
  The objective of this study is to evaluate the long-term safety of roflumilast in the treatment of COPD, with focus primarily on all-cause mortality.
• Outcomes:
  The primary outcome for this study is all-cause 5 year mortality, Death by suicide or hospitalization due to suicide attempt, hospitalization for any cause, major cardiovascular events leading to hospitalization, hospitalization related to respiratory disease, new diagnosis of depression, new diagnosis of cancer, hospitalization due to diarrhea of non-infectious origin, abnormal unexplained weight loss, new diagnosis of tuberculosis or hepatitis B or C.
• Data analysis plan:
  The primary outcome (5-year all cause mortality) will be evaluated by a Cox proportional hazards regression model for counting processes, which allow the follow-up time to be divided into several periods and therefore control for baseline and time-dependent covariates, using the full observational period of available data, i.e. up to 9 years of follow up. The Cox proportional hazards regression will take into account the fact that individual matching was performed (based on age, sex and propensity score) by considering the exposed patient and his/her matched controls as one stratum and including this as a stratum in the Cox proportional hazards model. Additional variables will be included in the model if available.

Documents

Study results

DAXAS Final Study Report_Redacted_Reduced

Study report

DAXAS Final Study Report Addendum (NOR)_Redacted