Protocol for a Real-World Retrospective Study on Chronic Obstructive Pulmonary Disease Outcomes Among Individuals Switching to Heated Tobacco Products Compared to Continued and Former Cigarette Smokers in Japan
Moderator
Helene Karcher, PhD, Novartis AG, Basel, Switzerland
Speakers
Makoto Hibino; Shinichi Higashiue; Mohamad Haidar; Patrick Picavet; Daniel Boakye; Adam G Lenart, PhD, Neuchatel, Switzerland
OBJECTIVES: This real-world study aims to evaluate the impact of switching from cigarette (CIG) smoking to heated tobacco product (HTP) use, an alternative nicotine delivery system, on the time to subsequent chronic obstructive pulmonary disease (COPD) hospitalizations compared with continued CIG smoking.
METHODS: This retrospective cohort study will be conducted in Japan using electronic health data from approximately 75 hospitals, tobacco exposure data from patient- and relative-reported questionnaires, and tobacco purchase history from consumer databases. The study will reach out to approximately 30,000 patients who had a COPD-related hospitalization between May 2016 and December 2022 (index). The primary outcome is the time from index to a composite endpoint of subsequent COPD-related hospitalization and all-cause mortality. Patients will be followed until March 2025. The primary exposure of interest is HTP use during pre- and post-index periods, and the primary comparator is continued CIG smoking. A weighted Cox proportional hazards model, with propensity score weighting to balance potential confounders, will be used to compare outcomes between groups. Secondary outcomes include all-cause mortality, pneumonia-related hospitalizations, COPD-related hospitalizations, and all-cause hospitalizations. They will be assessed in the primary exposure groups and ancillary exposure groups of dual users of CIG and HTP and former CIG smokers.
RESULTS: This study expects a longer time from index to subsequent COPD hospitalizations and all-cause mortality for HTP users compared to CIG smokers.
CONCLUSIONS: This population-based study of COPD patients in Japan, identified in a nationally representative healthcare database, is one of the first large-scale studies to evaluate the effect of HTP use in the COPD patient population. The study could include patients with long-term HTP experience of approximately 8 years. It will provide evidence to address important public health questions on the clinical value of HTP use and smoking cessation versus continued CIG smoking in a real-world setting.
METHODS: This retrospective cohort study will be conducted in Japan using electronic health data from approximately 75 hospitals, tobacco exposure data from patient- and relative-reported questionnaires, and tobacco purchase history from consumer databases. The study will reach out to approximately 30,000 patients who had a COPD-related hospitalization between May 2016 and December 2022 (index). The primary outcome is the time from index to a composite endpoint of subsequent COPD-related hospitalization and all-cause mortality. Patients will be followed until March 2025. The primary exposure of interest is HTP use during pre- and post-index periods, and the primary comparator is continued CIG smoking. A weighted Cox proportional hazards model, with propensity score weighting to balance potential confounders, will be used to compare outcomes between groups. Secondary outcomes include all-cause mortality, pneumonia-related hospitalizations, COPD-related hospitalizations, and all-cause hospitalizations. They will be assessed in the primary exposure groups and ancillary exposure groups of dual users of CIG and HTP and former CIG smokers.
RESULTS: This study expects a longer time from index to subsequent COPD hospitalizations and all-cause mortality for HTP users compared to CIG smokers.
CONCLUSIONS: This population-based study of COPD patients in Japan, identified in a nationally representative healthcare database, is one of the first large-scale studies to evaluate the effect of HTP use in the COPD patient population. The study could include patients with long-term HTP experience of approximately 8 years. It will provide evidence to address important public health questions on the clinical value of HTP use and smoking cessation versus continued CIG smoking in a real-world setting.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
EPH52
Topic
Epidemiology & Public Health
Topic Subcategory
Public Health
Disease
SDC: Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)