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American Journal of Epidemiology Advance Access originally published online on April 1, 2008
American Journal of Epidemiology 2008 167(11):1358-1364; doi:10.1093/aje/kwn064
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American Journal of Epidemiology © The Author 2008. Published by the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oxfordjournals.org.

ORIGINAL CONTRIBUTIONS

Trend of Increase in the Incidence of Acute Myocardial Infarction in a Japanese Population

Takashima AMI Registry, 1990–2001

Nahid Rumana1, Yoshikuni Kita1, Tanvir Chowdhury Turin1, Yoshitaka Murakami1, Hideki Sugihara2, Yutaka Morita3, Nobuyoshi Tomioka4, Akira Okayama5, Yasuyuki Nakamura6, Robert D. Abbott1,7 and Hirotsugu Ueshima1

1 Department of Health Science, Shiga University of Medical Science, Shiga, Japan
2 Department of Internal Medicine, Takashima General Hospital, Shiga, Japan
3 Makino Hospital, Takashima, Japan
4 Department of Cardiology, Otsu Red Cross Hospital, Shiga, Japan
5 The First Institute for Health Promotion and Health Care, Tokyo, Japan
6 Kyoto Women's University, Kyoto, Japan
7 Division of Biostatistics and Epidemiology, University of Virginia School of Medicine, Charlottesville, VA

Correspondence to Yoshikuni Kita, Department of Health Science, Shiga University of Medical Science, Seta Tsukinowa-cho, Otsu City, Shiga 520-2192, Japan (e-mail: kita{at}belle.shiga-med.ac.jp).

Received for publication September 25, 2007. Accepted for publication February 19, 2008.


   ABSTRACT
TOP
 ABSTRACT
INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 References
 
The incidence and mortality of acute myocardial infarction (AMI) remain low in Japan despite major dietary changes and worsening cardiovascular risk factors, a situation that should have resulted in a substantial increase in AMI rates (Japanese paradox). The current trend in the incidence of AMI was examined for the period 1990–2001 by use of data from the Takashima AMI Registry covering a stable population of approximately 55,000 in central Japan. AMI incidence rates (per 100,000 person-years) and 95% confidence intervals were calculated for 1990–1992, 1993–1995, 1996–1998, and 1999–2001. The incidence trend was determined by calculating the average annual change in percentage across the years. There were 352 (men: n = 224; women: n = 128) registered first-ever AMI cases during 1990–2001. The age-adjusted incidence rate of all AMI showed a gradual increase from 39.9 (95% confidence interval (CI): 29.8, 50.0) in 1990–1992 to 62.6 (95% CI: 51.5, 73.7) in 1999–2001. In men, the age-adjusted incidence rate increased from 66.5 (95% CI: 46.4, 86.6) in 1990–1992 to 100.7 (95% CI: 78.6, 122.7) in 1999–2001. In women, fluctuation was observed after an initial steep increase. The average annual incidence increased by 7.6% (95% CI: 3.5, 11.7) among men and by 8.3% (95% CI: 1.02, 15.6) among women. To the best of the authors' knowledge, this is the first study to report an increasing trend of AMI in a Japanese population.

incidence; Japan; myocardial infarction; registries; trend

Abbreviations: AMI, acute myocardial infarction; CHD, coronary heart disease; CI, confidence interval; CPK, creatine phosphokinase; MONICA, Monitoring Trends and Determinants in Cardiovascular Disease; WHO, World Health Organization


   INTRODUCTION
TOP
 ABSTRACT
 INTRODUCTION
MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 References
 
The incidence and mortality from coronary heart disease (CHD) in Japan are reported to be among the lowest of all the industrialized countries (1–3). Since the 1970s, mortality from CHD in Japan has showed a trend to decline (2–4). Similar trends for CHD have been observed in other industrialized countries (5–7). The decline in CHD in Western countries has been attributed to a decrease in the incidence of acute myocardial infarction (AMI) (7). Similarly, in Japan, it has been reported that the incidence of AMI has declined over time (8, 9). Some evidence suggests that the incidence has leveled off during the last couple of decades (10, 11). Recently, an increase of CHD has been reported in population subgroups, such as the elderly and male workers (12, 13). However, no change was observed in the age-adjusted incidence of AMI (12). These reported trends have lagged behind the widely reported and steadily increasing dietary intake of fat and serum levels of total cholesterol (4, 10, 12–18), obesity (11–13, 16), and metabolic disorders (12, 16) associated with the Westernization of lifestyle in Japan. The incidence and mortality of AMI remain low in Japan despite major dietary changes and recent worsening of cardiovascular risk factors that should have resulted in a substantial increase in AMI rates (5). This phenomenon has been defined by some authors as the "Japanese paradox" (17, 19, 20). However, there has been a concern that, as a consequence of these changes in risk factor profiles, the incidence of AMI will increase over time.

A comprehensive registry is appropriate to monitor and track the incidence of a disease such as AMI over time. Although the World Health Organization (WHO) launched an initiative in 1984 to monitor temporal trends in CHD (21), Japan was not included in that study. Very few cardiovascular disease registries covering an entire community exist in Japan to define trends in the incidence of AMI over a prolonged time period. In accordance with the WHO-Monitoring Trends and Determinants in Cardiovascular Disease (MONICA) Study, we have monitored the incidence of AMI in Takashima County, Shiga Prefecture, in Japan for a number of years, compiling information from disease registration covering the entire population of the county. The purpose of this study was to explore the AMI incidence trend using a population-based disease registry that provides the most current status in the Japanese population.


   MATERIALS AND METHODS
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
RESULTS
 DISCUSSION
 References
 
The Takashima AMI Registry is an integrated part of the Takashima Cardio-cerebrovascular Disease Registration System. This registration system for AMI was established in 1988 in Takashima County, Shiga Prefecture, Japan. The objective of this registry was to measure trends in the incidence and case-fatalities of AMI and to compare these trends both inside and outside of Japan (20, 22).

The population of Takashima County remained stable over the 12-year study period. It is a community with inhabitants classified culturally into mainly a single subgroup with similar standards of living. The population included 55,451 persons (men: 49.2 percent; women: 50.7 percent) in the year 2000 (23). With an aging populace, 22.3 percent of the Takashima population is aged 65 or more years, and this is higher than what has been reported (17.4 percent) for the general Japanese population (23).

The methods used to identify and register cases, diagnostic criteria, items of registration, and data quality control are described in detail elsewhere (20). The AMI diagnostic criteria used in this study were established by the Monitoring System for Cardiovascular Disease commissioned by the Ministry of Health and Welfare, Japan (22). These criteria are in accordance with the WHO-MONICA Project (24). All suspected AMI cases in the population during the study period were identified and evaluated on the basis of information from medical history, clinical symptoms, and electrocardiography and from cardiac enzymes, including creatine phosphokinase (CPK) and CPK-MB isoenzyme findings. For cases of out-of-hospital cardiac death, electrocardiograph findings and cardiac enzyme levels were often not available. In such cases, we had to base evaluation on the patients' location and symptoms at onset and their history of CHD. This information was collected from emergency room records and ambulance records, while also supplemented with death certificate data. Research physicians and epidemiologists cross-checked the records for absolute verification regarding eligibility for inclusion in the registry as an AMI event. Patients' privacy was protected at all times. This study was approved by the Institutional Review Board of the Shiga University of Medical Science.

Registered cases were classified into one of the following categories: "definite AMI," "possible AMI," "ischemic cardiac arrest with successful resuscitation not fulfilling criteria for definite or possible myocardial infarction," "no AMI," or "fatal cases with insufficient data." Only first-ever definite and possible AMIs were considered in this study. An event was recorded as first-ever if the medical records for the current events had one of the following: the patient had no previous history of AMI; the patient had never had symptoms like those of the present event more than 28 days before the onset; or the patient has had a certain illness or operations without any mention of AMI among them.

With regard to statistical analysis, the present study covered a 12-year study period from January 1, 1990, to December 31, 2001. Although the registry was established in 1988, during approximately the first year until the middle of 1989, the mechanics of the registry went through a developmental phase during which the registration system was refined for accuracy and completeness. After a brief period for the registry to become fully operational, follow-up in the current report began in 1990, at which time we were confident that our case finding and registration were complete. Our analysis included all patients from the Takashima AMI Registry who suffered their first-ever AMI irrespective of outcome. We divided the total observation period of 12 years into four 3-year groups: 1990–1992, 1993–1995, 1996–1998, and 1999–2001. To ascertain an age-specific trend in incidence rate, we categorized the age at AMI onset into seven groups: ≤34 years, 35–44 years, 45–54 years, 55–64 years, 65–74 years, 75–84 years, and ≥85 years.

We calculated gender- and age-specific incidence rates of AMI per 100,000 person-years for the four study periods. The annual numbers of the Takashima population for the years 1990–2001 were used as the denominators for all incidence rate calculations. The population demographic data were derived from the routine census and vital statistics system and were collected annually for Takashima County for each year of the study period. These data provided the precise denominator for the calculations of different rates. To adjust the age distribution differences among the periods, we applied the direct method using the Japanese population from the 2000 census (23) as the standard population. For all the incidence rates, 95 percent confidence intervals were calculated by Byar's method (25).

To examine the incidence of AMI across time, we modeled the number of AMI events within a single year as an overdispersed integer response following a negative binomial distribution (26). Generalized linear models were used for the analysis with year as an independent variable. This method allows for estimation of trends across individual calendar years to obtain average annual percentage changes. The negative binomial regression procedure fits a model of the following form: log (incidence) = a + β (year). The exponent of the estimated regression coefficient "β (year)" is the relative risk per passing of each calendar year. On the basis of the corresponding estimated regression coefficient and standard error, a yearly change in AMI can be derived along with the 95 percent confidence interval. The regression coefficient of year multiplied by 100 gives the average annual change of incidence in percentages. The 95 percent confidence interval is calculated as exp(β ± 1.96 x SE), where "SE" is the standard error of "β." Other regression modeling options included a Poisson regression model. Although Poisson regression yielded results virtually identical to those of negative binomial regression, the results from the negative binomial model are preferred, because this model addresses the overdispersion issue and also requires fewer assumptions about patterns of variance; it, thus, is least restrictive in terms of assumptions. Model fit was evaluated through the use of a multiplicative overdispersion factor and the scaled deviance, a measure of how well the observed and predicted incidences agree. Residual plots and Cook's D statistics were also examined. Model fit was also explored by including nonlinear and interaction terms. On the basis of these procedures, there was no suggestion that the models we used were inappropriate.

To check for any departures from the case identification with time, we separately evaluated trends in the major diagnostic criteria (electrocardiography, pain symptoms, and CPK and CPK-MB isoenzyme) for the AMI events.

All statistical analyses were performed with SAS, version 9.1, software (SAS Institute, Inc., Cary, North Carolina).


   RESULTS
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
DISCUSSION
 References
 
During the years 1990–2001, we registered a total of 352 cases (men: n = 224; women: n = 128) of first-ever AMI incidence. The average age for men and women was 67.8 (standard deviation: 12.6) years and 75.4 (standard deviation: 10.2) years, respectively. The majority of subjects (72.4 percent) were aged 65 or more years at the time of their first-ever AMI (table 1).


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  		TABLE 1. Characteristics of the population and registered AMI* cases of the Takashima AMI Registry, Shiga, Japan, 1990–2001

 
Table 2 shows age-specific and age-adjusted incidence rates of first-ever AMI (per 100,000 person-years) for men, women, and both genders among the four observation periods. The incidence rate in men was higher than that in women for all age categories. The incidence rate for both genders increased with advancing age. The age-adjusted incidence rate of AMI cases increased gradually among the four time periods: 39.9 (95 percent confidence interval (CI): 29.8, 50.0) in 1990–1992; 48.6 (95 percent CI: 38.0, 59.2) in 1993–1995; 49.7 (95 percent CI: 39.5, 60.0) in 1996–1998; and 62.6 (95 percent CI: 51.5, 73.7) in 1999–2001. In men, the age-adjusted incidence rate increased from 66.5 (95 percent CI: 46.4, 86.6) in 1990–1992 to 100.7 (95 percent CI: 78.6, 122.7) in 1999–2001. In women, after an initial steep increase, the age-adjusted incidence rate showed fluctuation. The age-adjusted incidence rate increased from 18.7 (95 percent CI: 9.8, 27.6) in 1990–1992 to 35.7 (95 percent CI: 24.7, 46.6) in 1999–2001. The age-adjusted incidence rate for overall CHD (all registration categories combined) in the study population increased gradually across the four time periods: 44.6 (95 percent CI: 35.0, 56.0) in 1990–1992; 52.1 (95 percent CI: 41.8, 64.1) in 1993–1995; 60.0 (95 percent CI: 49.0, 72.7) in 1996–1998; and 78.2 (95 percent CI: 65.8, 90.5) in 1999–2001.


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  		TABLE 2. Age-specific and age-adjusted incidence rates of first-ever AMI* per 100,000 person-years in four observation periods for men, women, and both genders in the Takashima AMI Registry, Shiga, Japan, 1990–2001

 
The average annual change in the AMI incidence in Takashima County showed an increasing trend during the 12-year study period in all categories (table 3). The average annual increase in AMI incidence in the Takashima AMI Registry was 7.8 percent (95 percent CI: 4.6, 11.1) per year. The average annual change showed a significantly increasing trend in men, women, and those aged 65 or more years. The increasing trend observed among those aged 64 or less years was not significant. An increasing trend was also observed for nonfatal and fatal AMI, as well as for both hospitalized and nonhospitalized AMI cases. Overall CHD incidence showed an average annual increase of 10.25 percent (95 percent CI: 6.99, 13.5) across the study years. There was no significant interaction effect on the incidence of AMI between time and gender (p = 0.93).


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  		TABLE 3. Annual percent increase in the incidence of AMI* by gender and age categories, Takashima AMI Registry, Shiga, Japan, 1990–2001

 
The AMI event diagnosed by different major diagnostic criteria also showed an increasing trend across the study years: 9.2 percent (95 percent CI: 2.7, 10.7) per year for pain symptom criteria, 6.2 percent (95 percent CI: 2.3, 10.1) per year for electrocardiograph criteria, and 9.2 percent (95 percent CI: 4.9, 13.5) per year for cardiac enzymes (CPK and CPK-MB isoenzyme). These findings suggest that our observed increase in AMI incidence with time is likely to be real and not due to diagnostic misclassification.


   DISCUSSION
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
References
 
To the best of our knowledge, this is the first study to report an increasing trend in the age-adjusted incidence rate of AMI in a Japanese population over a 12-year period from 1990 through 2001. This present study is based on registry data and, thus, it is mainly a community-based surveillance system. The characteristics of the data do not assist in exploring the mechanisms or cause related to the increasing trend of AMI. Now, however, with identification of the increasing trend, an interesting and essential area for investigation will be to examine the factors behind the increase using longitudinal data.

The highest incidence rate for AMI in our registry population was in the period 1999–2001. Even this rate is lower than those found in North America and in European and Australian MONICA centers (19); the incidence rates of AMI for men in the United States (508/100,000), Canada (605/100,000), Finland (824/100,000), United Kingdom (823/100,000), France (314/100,000), Italy (270/100,000), and Australia (422/100,000) were markedly higher than in our population (101/100,000). Despite the fact that we observed an increasing incidence, the rates of AMI still remain lower in Japan than in other industrialized countries.

In the WHO-MONICA studies, it has been suggested that the trend in CHD could be explained to a significant extent by changes in the major risk factors, such as hypercholesterolemia, hypertension, and smoking, which indicate that changes in these factors are associated with trends in AMI incidence in a large number of countries around the world (27). Similarly, hypercholesterolemia, hypertension, smoking, and the metabolic syndrome are the well-known risk factors among the Japanese for developing CHD (3, 4, 10, 14, 28, 29). The Japanese have changed their lifestyle, as well as dietary habits, over the past years (2, 4). As a consequence, serum total cholesterol has increased substantially in Japan following an increase in dietary fat intake. The nationwide nutrition survey reported that the average serum total cholesterol level increased from 180 mg/dl in 1980 to 200 mg/dl in 2000 (3, 4, 14, 17, 18). The Ni-Hon-San Study (30) reported that the higher risk of developing CHD among Japanese men living in Hawaii and California in the United States was mainly attributed to their higher serum cholesterol levels compared with those of Japanese men living in Japan. Because cholesterol levels in Japan are also increasing, this should favor an increase in AMI incidence. Furthermore, the prevalence of obesity (11–13, 16) and diabetes (12, 16) has been reported to be increasing progressively with time; thus, anticipating an increase in AMI incidence might be in part explicable by changing risk factor profiles in the Japanese population. The prevalence of smoking has decreased in the Japanese population since the 1960s (3, 4, 14). The average smoking rate for men has declined considerably from 82.3 percent in 1965 to 70.2 percent in 1980 and 53.5 percent in 2000 (31). The smoking prevalence for women is still lower than that in Western countries, but it has gradually increased to more than 20 percent among young women (31). Although the smoking rates have declined, smoking is still very common in Japan, relative to the Western countries, which makes low rates of myocardial infarction even more paradoxical (14, 32). A large decline in the prevalence of hypertension and/or blood pressure levels was observed for both men and women in Japan until 1990, and the decreases after 1990 have been nominal (4, 14). Moreover, the increase of hypercholesterolemia and metabolic disorder may negate the beneficial effects of the decreasing prevalence of hypertension and smoking habit on the risk of AMI (14). These apparent unfavorably diverging trends in risk factors make it uncertain if the incidence of AMI will continue to be stable. It has been reported that many cardiologists and physicians are under the impression that the incidence of AMI in Japan is increasing (9, 10, 33). In this study, the significant increase in the incidence of AMI was observed mainly in men aged 65 years and older. Although an increasing trend was also observed in younger men, it was not significant, a possible consequence of fewer events occurring in the younger age groups and of limited statistical power. To best explain the significant increase that was observed largely in older men, we believe that tracking data are required on the time lag between risk factor changes occurring in our population and their effect on disease incidence. We do know, however, that the Japanese lifestyle and dietary habits have become more Westernized over the last few decades, resulting in a poorer cardiovascular risk factor profile. As a result, the findings from our study, in which there is a corresponding increase in the incidence of AMI, are reasonable to expect and might be more easily recognized in older population segments where the force of morbidity and mortality is the greatest. Importantly, the MONICA results also suggest the need to consider a time lag between changes in risk factor levels and a change in AMI incidence (27).

Previous studies in Japan have examined cardiovascular disease trends by use of the following methods: comparing incidence rates of hospitalized cases among different time periods (8, 9), dividing a long-term cohort follow-up period into several parts with subcohort studies (10, 13), performing multiple cross-sectional surveys on separate occasions in a population (11), or following multiple cohorts with different starting points (12). These methods, however, have a chance of being potentially biased by not being able to monitor an entire population. In contrast, registry data following an entire population continuously for a long period are very appropriate to determine the incidence of AMI as well as any trends over time. Thus, with a study design that covered the entire population, we were able to evaluate secular trends in AMI incidence over a 12-year period with a high degree of precision.

The comprehensiveness of the registration system for AMI is essential in determining the incidence and trend in a particular area. A system to capture all patients in the study area, together with accurate diagnosis, is required to ensure the comprehensiveness of the registration. The quality of our registration system was ensured by its completeness. Our registry system was planned to capture all the cases in the study area by covering all the hospitals in the county. It has been estimated that 98 percent of hospital admissions of Takashima County residents are covered by these institutions (20, 34). To ensure that eligible patients hospitalized outside the county were not excluded, registration procedures were also conducted at three high-level medical facilities outside the county. County ambulance records were also checked for this purpose. Even for referral cases to other hospitals, almost all the patients in the county are first taken to one of the three local hospitals by ambulance before transfer. Therefore, it unlikely that we missed any diagnosed cases of AMI.

In Japan, almost 100 percent of the residents are covered by health insurance under the auspices of the Ministry of Health and Welfare (34, 35). The usual practice in Japan is that people with health problems visit general physicians in the community, who almost always refer the patients with suspected AMI to secondary- or tertiary-level hospitals for extensive investigation. In addition, round-the-clock emergency ambulance service is available for residents without any charge. The common practice in Japan is to take patients with any acute disease condition to the emergency facility. Thus, we believe that extremely few patients would be left out of our registration system.

To distinguish AMI events from cases of out-of-hospital cardiac death, we had to carry out registration by evaluating the emergency room records, ambulance records, or death certificate data. Before 1993, deaths from heart attack in Japan were reported in generic terms, such as "acute heart failure," on the death certificates and thus were classified as "other heart disease" instead of CHD. For our registry, the available information for an event was evaluated by research physicians and epidemiologists for a decision on inclusion and classification in the registry as an AMI according to the registration criteria. Because we did not depend solely on the death certificate diagnosis for this purpose, we believe that the chances of misdiagnosis or misclassification were likely to be modest.

Unfortunately, the present study does not include environmental or other risk factor information that is often measured in a clinical setting. As a result, we could not identify the trends in the AMI risk factors in our population to explain the trends in the rates. Finally, the Takashima AMI Registry covers a rural and semiurban community in Japan, which is different from the metropolitan population. In an urban environment, changes in the lifestyle factors associated with the risk for AMI would be more prominent. Kitamura et al. (13) observed an increase in the incidence of CHD among male workers in Osaka, which is a highly industrialized and Westernized Japanese city. Therefore, we believe that the increasing trend of AMI incidence would also be a matter of concern in urban settings.

In conclusion, the incidence of AMI showed an increasing trend over the 12-year period from 1990 to 2001 in the study population. On average, the incidence increased significantly by 7.6 percent per year in men and 8.3 percent per year in women. However, the number of events is relatively small in our study, and the period of increase is relatively short. As such, generalizing our findings to all of Japan warrants caution and further confirmation. Nevertheless, given that Japan has gone through decades of increased exposure to the Westernized lifestyle, the findings from our study are reasonable to expect. Continued community surveillance of AMI, however, is needed to confirm our observed trend. Further efforts to identify the reasons for the increasing trend in AMI are also warranted.


   ACKNOWLEDGMENTS
 
This study was supported in part by grants from Research on Cardiovascular Disease (3A-1, 6A-5, and 7A-2) and Comprehensive Research on Cardiovascular and Lifestyle-related Diseases (H18-CVD-Ippan-029) of the Ministry of Health and Welfare, as well as by the Grants-in-Aid for Scientific Research (C-213670361 and B-17390186) of the Ministry of Education, Culture, Sports, Science, and Technology and the Japan Society for the Promotion of Science.

Conflict of interest: none declared.


   References
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 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 References
 

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