Real-world data on COPD and ischemic heart disease hospitalizations before and after product launch in Japan

THS was introduced to the Japanese market in November 2014 under the IQOS brand name and rolled out nationally in 2015. As a first step in our approach to assessing real-world data, we considered available data on the number of hospitalizations for chronic obstructive pulmonary disease (COPD) exacerbations and acute Ischemic Heart Disease (IHD) before and after the introduction of THS to the Japanese market.

The data used for this analysis were taken from the Japanese Medical Data Vision database, specifically focusing on hospital admissions that were associated with medical codes for COPD exacerbation and acute IHD events between 2010 and 2019. In doing so, the data covered 5 years before and 5 years after the introduction of THS.

Based on the data from the first 5 years, a simple linear trend model was created. The actual number of hospitalizations between 2015 and 2019 was compared against the number predicted by the model if THS had not been introduced. Results showed that the numbers of hospitalizations due to COPD and IHD were below those predicted from the pre-launch trends.

This work shows that there might be a potential for using real-world data in the assessment of heated tobacco products. However, the collection of data indicating the patient exposure to and use history of tobacco products is an important factor to consider in further analyses. Also, the impact of other lifestyle or environmental factors (e.g., diet, pollution) as well as the accuracy of the prediction models based on historical data should be taken into account.

 

Watch Dr. van der Plas' presentation below:

 

Below is a transcript of the video:

Hello everyone, my name is Angela van der Plas, I am Manager, real-world evidence here at PMI and I am here to present to you our poster on real-world evidence. Keep in mind please that this is a proof of concept study.

As heated tobacco products become available in different markets, it also becomes important to assess their impact on the individual as well as the population as a whole. Because smoking-related diseases have long latencies, setting up prospective longitudinal studies shortly after marketing initiation is not ideal or recommendable. 

Other data sources that can help us assess the impact of these products on the population and the individual are real-world data sources. For example, we are talking about electronic health records or claims databases. These are abundantly available in the market, including the Japanese market.

A shortcoming of these types of data, however, is that they do not collect systematically, exposures, for instance, use of tobacco products including heated tobacco products.

So, in this proof concept, what we want to do is we aim at assessing the impact of the introduction of [THS] in the Japanese market, in the hospitalization rates for COPD exacerbation and ischemic heart diseases in the Japanese population.

For this, we use data from the medical data vision, or MDV database, for hospital admissions using ICD codes for COPD exacerbations and ischemic heart disease. MDV is a database based on health claims data and administrative data, or DPC, Diagnosis Procedure Combination data. This comes from over 300 Japanese acute hospitals, including records for over 20 million patients.

What we did was, we aggregated data from 2011 to 2019 on hospitalizations. The data was aggregated by year, with admissions per ICD10 codes expressed as a percentage of the total of admissions per year. Using only data from hospital submitting data for the entire study period.

Admissions per year were modeled as a simple linear regression based on the five years prior to the introduction of [THS] and the line of best fit extrapolated to the four years after the introduction of [THS]. No formal test of change in slope was performed.

For COPD, we found that pre-[THS], the proportion of hospital admissions was increasing slightly, and post-[THS], the proportion of hospital admissions continues to increase. However, the slope is slightly dampened. All points, as you can see, are below the expected trajectory.

For IHD, ischemic heart disease, we found that pre-[THS] hospital admissions were decreasing yearly, and post-[THS], there is a slight decrease in the expected number of IHD hospitalizations during this period.

Studies, such as ecological studies are frequently the first step into a new line of inquiry. And as such, have an important role in medical research, where their findings can prompt further study.

The preliminary analysis shows that a slight decline in hospitalizations due to both COPD exacerbations and IHD follow the introduction of [THS] in the Japanese market.

Our study is a first step at assessing the impact of the introduction of [THS] into the market and will help in the process of hypothesis generation. This type of studies, however, are not without limitations, and these results should be interpreted with caution.

Thank you very much for listening, and if you have any questions, please let me know.