Protocol for a Real-World Retrospective Study on Cardiovascular Outcomes in Japan Comparing Heated Tobacco Product Users, Cigarette Smokers, Former Smokers, and Never Smokers
Author(s)
Makoto Hibino, MD1, Shinichi Higashiue, MD, PhD2, Daniel Boakye, PhD, MPH3, Patrick Picavet, MD3, Mohamad Haidar, PhD3, Adam G. Lenart, PhD3, Helene Karcher, PhD3;
1Shonan Fujisawa Tokushukai Hospital, Respiratory Medicine, Kanagawa, Japan, 2Kishiwada Tokushukai General Hospital, Osaka, Japan, 3Philip Morris Products, SA, Neuchatel, Switzerland
1Shonan Fujisawa Tokushukai Hospital, Respiratory Medicine, Kanagawa, Japan, 2Kishiwada Tokushukai General Hospital, Osaka, Japan, 3Philip Morris Products, SA, Neuchatel, Switzerland
OBJECTIVES: This study will evaluate the impact of switching from cigarette (CIG) smoking to heated tobacco product (HTP) use, an alternative nicotine delivery system, on the time to first major adverse cardiovascular event (MACE, a composite outcome measure) compared with continued CIG smoking among patients with cardiovascular diseases.
METHODS: This retrospective cohort study will use health data from an electronic database of approximately 75 hospitals, tobacco exposure data from patient- and relative-reported questionnaires, and tobacco purchase history from consumer databases in Japan. The study will reach out to approximately 50,000 patients who had a cardiovascular event of non-fatal myocardial infarction, unstable angina, or urgent coronary revascularization procedure between May 2016 and December 2020 (index). The primary outcome is the time from index to first post-index MACE. Patients will be followed for outcome events until March 2025. The primary exposure of interest is HTP use during the pre- and post-index periods, while the primary comparator is continued CIG smoking. After accounting for potential confounders with propensity score weighting, a weighted log-rank test and weighted non-proportional Cox model will be used to compare the primary outcome between the HTP and CIG exposure groups. Dual users of CIG and HTP, former CIG smokers, and never smokers will also be analyzed as ancillary exposure groups to address secondary objectives.
RESULTS: This study expects a longer time to first MACE in HTP users as compared to CIG smokers.
CONCLUSIONS: This large-scale, population-based study in Japan will utilize multiple data sources to assess the health effects of switching from CIG to HTP in patients who previously experienced a cardiovascular event. The study findings 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 use health data from an electronic database of approximately 75 hospitals, tobacco exposure data from patient- and relative-reported questionnaires, and tobacco purchase history from consumer databases in Japan. The study will reach out to approximately 50,000 patients who had a cardiovascular event of non-fatal myocardial infarction, unstable angina, or urgent coronary revascularization procedure between May 2016 and December 2020 (index). The primary outcome is the time from index to first post-index MACE. Patients will be followed for outcome events until March 2025. The primary exposure of interest is HTP use during the pre- and post-index periods, while the primary comparator is continued CIG smoking. After accounting for potential confounders with propensity score weighting, a weighted log-rank test and weighted non-proportional Cox model will be used to compare the primary outcome between the HTP and CIG exposure groups. Dual users of CIG and HTP, former CIG smokers, and never smokers will also be analyzed as ancillary exposure groups to address secondary objectives.
RESULTS: This study expects a longer time to first MACE in HTP users as compared to CIG smokers.
CONCLUSIONS: This large-scale, population-based study in Japan will utilize multiple data sources to assess the health effects of switching from CIG to HTP in patients who previously experienced a cardiovascular event. The study findings 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
EPH93
Topic
Epidemiology & Public Health
Topic Subcategory
Public Health
Disease
SDC: Cardiovascular Disorders (including MI, Stroke, Circulatory)