Pharmaceutical Industry at a Glance Trends in specific health checkup data and prescription drugs related to diabetes as seen in NDB open data

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The Office of Pharmaceutical Industry Research Shinji Tsubakihara, Senior Researcher

Summary

  • According to the results of the "Healthy Japan 21 (Second Stage)" survey in 2022, the number of people with strongly suspected diabetes in Japan is increasing but less than expected, and the number of patients with poor glycemic control is decreasing.
  • The Japanese Society for Dialysis Therapy has announced that the percentage of dialysis induction due to diabetic nephropathy has been decreasing in recent years.
  • Based on the results of these diabetes epidemiological studies, we analyzed the percentage trends of the groups with high HbA1c, urinary protein, and BMI, and the percentage trends of prescription drugs such as diabetes drugs recommended by the society according to the pathological conditions and complications of diabetes, from the NDB open data for fiscal years 2015 to 2022.
  • As a result of the percentage analysis of the specific health checkup examinees, the percentage of those with HbA1c of 8% or higher increased about 1% per year, the percentage of those with urinary protein of 2+ or higher decreased about 2% per year, and the percentage of those with BMI of 30 or higher increased about 5% per year.
  • The results of the percentage analysis of prescribed drugs showed a marked increase in SGLT2 inhibitors and GLP1 receptor agonists, which are recommended for diabetic nephropathy in the guidelines of the Japan Diabetes Society and the Japanese Society of Nephrology, suggesting a relationship with a decrease in the introduction of dialysis due to diabetic nephropathy.
  • Both of the above drugs are also recommended for type 2 diabetes with obesity. As the number of patients with severe obesity is suggested to be increasing, more attention should be paid to the trend change in the selection of diabetes drugs and prescribing trends in the future.

1. Introduction

In 2022, the Ministry of Health, Labour and Welfare (MHLW) released the final evaluation report1) of "Healthy Japan 21 (Second Phase)". The final evaluation year of the survey was 2019 (the first year of 2019), and the degree of target achievement was verified for cancer, cardiovascular disease, diabetes, and COPD, which are the target diseases of the "Targets for prevention of the onset and severity of major lifestyle-related diseases. Estimates of the number of diabetes prevalence have been estimated based on the estimates in the large-scale survey years of the National Health and Nutrition Examination Survey, but the National Health and Nutrition Examination Surveys for 2020 and 2021 were cancelled due to the new coronavirus infection epidemic. However, the National Health and Nutrition Examination Survey for 2020 and 2021 was cancelled due to the outbreak of the new coronavirus infection, and the data were not updated after 2016, making it difficult to evaluate the data. The number of "persons strongly suspected to have diabetes" was estimated to be about 11.5 million in 2019 (Figure 1). This figure is between the 2019 target of 10 million and the 12.7 million projected at the time the target was established, and although there is a trend toward improvement, it was evaluated that it would be difficult to reduce the number to the target figure. In contrast, the percentage of persons with poor glycemic control (HbA1c: JDS ≥ 8.0%, NGSP ≥ 8.4%) in the specified health checkup data was evaluated to be 0.94% in 2019, an improvement from 1.2% in 2009 and below the target of 1.0% for 2022 (Figure 2).

The report1) estimated that the number of "persons with metabolic syndrome and those in the pre-diabetic group" increased by approximately 1 million between 2008 and 2019, indicating that the number of people at risk of developing diabetes and other lifestyle-related diseases is increasing.

 Figure 1 Future projections at the time of formulation based on the 1997, 2002, and 2007 surveys of persons strongly suspected of having diabetes (dotted line), target values (thin solid line), and 2022 estimates based on the 2012 to 2022 surveys (thick solid line)
 Figure 2 Proportion of patients with poor glycemic control

The Japan Society of Dialysis Therapy reports information on dialysis patients annually in its "Current Status of Chronic Dialysis Therapy in Japan " 2), and the Health Japan 21 Final Evaluation Report cites these data. The number of newly inducted dialysis patients increased over the years until 2008, but increased and decreased after 2009, with a decrease of 919 patients in 2023 from the previous year (2.4% decrease). In the "Dynamics of Patients Reintroduced to Dialysis," "diabetic nephropathy" was the most common underlying cause of dialysis introduction at 38.3%, followed by "nephrosclerosis" at 19.3% and "chronic glomerulonephritis" at 13.6%. In recent years, a sustained increase in dialysis induction due to nephrosclerosis has been noticeable, while diabetic nephropathy, which had been on the rise since 1998 when it became the leading underlying disease for dialysis induction, began to decline around 2015 (43.7%) (Figure 3).

 Figure 3 Proportion of patients on dialysis with primary disease 1983-2023

Based on these epidemiological data, we used the NDB open data (hereinafter referred to as "NDBOD") 3) from FY 2015 (2nd) to FY 2022 (9th), and analyzed the following data: (1) trends in the percentage of high HbA1c, urine protein, and BMI groups based on data from the National Health Checkup (hereinafter referred to as "National Health Checkup"); (2) data from prescription drugs based on the Japan Diabetes Society "Guidelines for Diabetes Care 2024 (hereinafter referred to as "Guidelines for Diabetes Care"); and (3) data from the National Health Insurance Institute (NIH). (2) Data on prescription drugs were used to calculate the percentage of patients with "diabetic nephropathy" and "diabetes mellitus with obesity" in the "Guidelines for Diabetes Care 2024 (hereinafter referred to as "GL for diabetes care") 4)," and in the "Evidence-based CKD Clinical Practice Guidelines 2023 (hereinafter referred to as "CKD Clinical Practice Guidelines")5) ," by the Japan Society of Nephrology. 2023 (hereafter referred to as "CKD Practice Guidelines") 5) and "Diabetic Kidney Disease" of the Japan Society of Nephrology (JSN), and observe if the trends are related to the trends shown by the epidemiological data. (BMI: body mass index, CKD: chronic kidney disease)

Survey Methodology

Using the NDBOD (NDBOD No. 2 to No. 9), "HbA1c", "urinary protein", and "BMI" were calculated from the specific health checkup data of "distribution by sex and age group by prefecture" for men and women aged 40 to 74 years. BMI" were tabulated by age group, and the percentage of examinees with high test values was calculated. The quantity of prescription drugs was calculated by age group within the same range as that of the specified health checkups, and "diabetes drugs," "antihypertensives," "diuretics," and "injections" were counted from "Internal _ Outpatient (out-of-hospital) _ Quantity by sex and age group" and "Injections" from "Inpatient (out-of-hospital) _ Quantity by drug effect category by sex and age group. " from "Injections_ Quantity by sex and age by drug category Outpatient (in-hospital) (outpatient)" and "Other hormonal agents (including antihormonal agents)" from "Injections_ Quantity by sex and age by drug category Outpatient (in-hospital) (outpatient)". Insulin, insulin analogs, and GLP1 receptor agonists ("GLP1RAs") were counted, and the percentage of prescriptions of guideline-recommended drugs, etc. was calculated. The annualpercent change (APC) was calculated as 100 x ((exp(m)-1)) using the calculation method shown in Reference 6), in which the values for each year were natural logarithmized to derive a linear regression line and the exponential value (exp(m)) of the coefficient (m) was used.

The following are points to note about the NDBOD. (1) The NDBOD is grouped by gender and by 5-year age group, and if the total number of prescriptions in each group is less than 1,000, it is indicated by "-" (if there is one location with less than 1,000, all minimum values over 1,000 are indicated by "-"), and if the total number of receipts in each group is less than 10, it is indicated by "-" (if the total number of receipts in each group is less than 10, it is indicated by "-"). -(If there is one location with less than 10, all minimum values of 10 or more are indicated with "-".) Therefore, the aggregate results for the age groups do not match the total. (2) There is a one-year discrepancy in the year in which the data was obtained, as the data for the second specific health checkup was from FY2014 and the data for the prescription drugs was from FY2015. (iii) The tabulation of urine protein data started in the 3rd round. The data for specific health checkups were tabulated from FY2018 onward, but were excluded to ensure consistency with the previous data. (5) Until the 8th Survey, the top 100 prescription drugs were listed by drug category, but in the 9th Survey, the top 100, 300, and 500 drugs were published.

Results

(1) Specific health checkup data

The 9th edition included the top 100 items in order to be consistent with the previous data. The graphs below show the trends in the number of examinees with "high BMI " 4), which is the risk of developing or worsening diabetes, for each age group from 40 to 74 years old, based on the specific health checkup data of the NDBOD.

1.1 HbA1c (NGSP level)

Table 1-A at the end of this report shows the number of persons who received specific health checkups for which HbA1c data could be obtained for each year, and the APC for each APC. The APC of the number of examinees for whom data were obtained was 1.4% for both male and female examinees. As shown in Figure 4, the proportion of HbA1c ≥ 8.0% among the examinees was 1.8% in FY 2014 and 1.9% in FY 2021 for the male total, and the APC was 1.2%. The APC for women was 0.7% in FY 2014 and 0.7% in FY 2021, and the APC was 0.9%. For both men and women, there was an increase in the proportion of HbA1c ≥8.0% in FY2020, especially among those aged 65 years and older. 8.6% of men had an HbA1c ≥6.5% in FY14 and 9.6% in FY2021, with an APC of 1.8%. The percentage of women total was 4.4% in FY 2014 and 4.6% in FY 2021, with an APC of 1.0%.

 Figure 4 NDB specific health checkup data: HbA1c (NGSP value)

1.2 Urine protein

Table 1-B at the end of this report shows the number of examinees who underwent specific health checkups for which urine protein data were obtained in each fiscal year and the APC for each APC. The APCs of the number of examinees for whom data were obtained were 0.9% for males and 1.2% for females. As shown in Figure 5, the percentage of urine protein ≥2+ among the examinees was 1.4% in FY 2014 and 1.3% in FY 2021 for the male total, and the APC was -1.5%. The APC for females was 0.5% in FY2014 and 0.5% in FY2021, and the APC was -1.9%. The percentage of men with urinary protein ≥+ was 4.8% in FY2014 and 4.2% in FY2021, and the APC was -2.2%. The APC for females was 2.5% in FY2014 and 2.2% in FY2021, and the APC was -2.6%.

 Fig. 5 NDB specific health checkup data: urinary protein

1.3 BMI (body mass index)

Table 1-C at the end of this report shows the number of persons who underwent specific health checkups for which BMI data could be obtained and their respective APCs for each year. The APC of the number of examinees for whom data were obtained was 1.2% for males and 1.5% for females. As shown in Figure 6, the percentage of examinees with BMI≥30 was 4.8% in FY 2014 and 6.9% in FY 2021 for the male total, and the APC was 5.8%. The proportion of men with BMI ≥25 was 32.2% in FY2014 and 36.8% in FY2021, and the APC was 2.2%. The percentage of women was 18.7% in FY2014 and 21.7% in FY2021, with an APC of 2.4%.

 Fig. 6 NDB specific health checkup data: BMI

(2) Prescription drugs

Next, as in the specific health checkups, the following drugs were administered to subjects aged 40-74: SGLT2 inhibitors ("SGLT2Is") and DPP4 inhibitors ("DPP4Is"), both diabetes drugs; metformin, for which a dosage modification has recently been approved; GLP1RAs, a diabetes hormone; and angiotensin II receptor blockers, which are recommended to prevent the progression of diabetic nephropathy. metformin, which was recently approved, "GLP1RAs", a diabetic hormone, and "angiotensin II receptor blockers" ("ARBs"), which are recommended to control the progression of diabetic nephropathy, The graph below shows the percentage change in prescriptions of "mineralocorticoid receptor antagonists (MRAs)," which are recommended to prevent the progression of diabetic nephropathy.

2.1 Diabetic agents

Table 2-A at the end of this report shows the number of units of diabetic drugs prescribed for outpatient and out-of-hospital prescriptions (top 100 items) and their respective APCs for each year. The APCs for the number of units of diabetic drugs prescribed were 2.7% for males and 1.3% for females.

Figure 7 shows the percentage of SGLT2Is among diabetes drugs by age group (40-74 years old). SGLT2Is include fixed-dose combination with DPP4Is. The total number of male prescriptions was 1.1% in FY2015 and 17.4% in FY2022, while the APC was 42.9%. The APC for women was 1.1% in FY2015 and 15.5% in FY2022, with an APC of 39.4%. Next, looking at DPP4Is (Figure 8), the percentage of DPP4Is was 27.7% for males in FY2015 and 24.3% in FY2022, while the APC was -2.1%. The APC was -1.3% for females, 27.4% in FY2015 and 25.3% in FY2022. DPP4Is include fixed-dose combinations with diabetes drugs other than SGLT2Is. Similarly, looking at metformin monotherapy (Figure 9), the proportion of men receiving metformin monotherapy was 37.2% in FY2015 and 39.6% in FY2022, with an APC of 1.0%. For females, the percentages were 38.5% in FY 2015 and 40.7% in FY 2022, with an APC of 1.0% (Table 2-A).

 Fig. 7 NDB prescription drug data (outpatient outpatient prescription): SGLT2 inhibitor/diabetes drug
 Fig. 8 NDB Prescription Drug Data (Outpatient Outpatient Prescription): DPP4 Inhibitor/Diabetes Drug
 Fig. 9 NDB Prescription Drug Data (Outpatient Outpatient Prescription): metformin/diabetes drug

2.2 Hormones for diabetes

Table 2-B at the end of this report shows the prescription unit volume of injectable diabetic hormones for outpatient and in-office prescriptions and their respective APCs for each year. The APCs for the unit volume of diabetic hormone prescriptions were 3.3% for males and 2.4% for females. Figure 10 shows the trend of the percentage of prescription unit volume of GLP1RAs among diabetic hormones by each age group from 40 to 74 years old.The percentage of GLP1RAs was 4.6% in FY 2015 and 27.8% in FY 2022 for the male total, with an APC of 28.7%. The percentage of females was 5.4% in FY 2015 and 27.4% in FY 2022, with an APC of 25.4% (Table 2-B).

Note that the only oral GLP1RAs was launched in February 2021, but the total out-of-hospital prescription volume for all standards was approximately 14.8 million tablets in FY2021 and 62.3 million tablets in FY2022, so future changes in prescription volume will be of interest.

 Fig. 10 NDB Prescription Drug Data (Outpatient and Inpatient): GLP1 Receptor Agonist / Hormone for diabetes

2.3 Blood pressure lowering agents

The number of prescription units of oral antihypertensive agents for outpatient and out-of-hospital prescriptions (Table 2-C at the end of this report) showed a decreasing trend, and this trend was stronger among females (total APC for males: -0.0%, total APC for females: -1.3%). Figure 11 shows the percentage of ARBs among blood pressure-lowering drugs by age group (40-74 years). ARBs include diuretics and fixed-dose combination with Ca channel blockers. Both men and women accounted for more than 70% of the total prescriptions, with a slight increase in the proportion (0.2% for men and 0.4% for women in total APC). Similarly, when looking at MRAs (Figure 12, Table 2-C), the total for males was 1.5% in FY 2015 and 3.2% in FY 2022, while the APC was 17.4%. The APC for females was 1.1% in FY2015 and 2.7% in FY2022, and the APC was 19.0%. For reference, the percentage of angiotensin-converting enzyme inhibitors (ACEIs) and renin inhibitors in total remained around 3.5% for men and 2.5% for women, while the APC was negative (Table 2-C).

 Fig. 11 NDB prescription drug data (outpatient and inpatient): angiotensin II receptor blocker/antihypertensive
 Fig. 12 NDB prescription drug data (outpatient outpatient prescription): mineralocorticoid receptor antagonist/antihypertensive

2.4 Diuretics

The number of units of oral diuretics prescribed for outpatient and out-of-hospital prescriptions (Table 2-D at the end of this report) showed an increasing trend (total APC for men: 4.7%, total APC for women: 3.9%). Among diuretics, the percentage of units prescribed for spironolactone, a classic MRAs, remained around 20% for both men and women, with a decreasing trend for women (total APC for men: 0.5%, total APC for women: -0.9%). (no figure)

Summary and Discussion

In the final evaluation report of Healthy Japan 21 in 2022, it was reported that the estimated number of persons with strongly suspected diabetes mellitus was on the increase but lower than predicted, and that the increase in the proportion of poorly controlled patients with diabetes mellitus was under control. In addition, the "Current Status of Chronic Dialysis Therapy in Japan" by the Japan Society for Dialysis Therapy in 2023 reported that diabetic nephropathy is still the most common underlying cause of dialysis induction, but the percentage has been decreasing in recent years.

Based on this epidemiological background, we first used the NDB open data, which is a compilation of the results of specific health checkups for people aged 40-74 years with or without metabolic syndrome for the purpose of prevention, early detection, and early treatment of lifestyle-related diseases, and observed changes over time in the proportions of cases with high HbA1c, high urinary protein, and high BMI. Some discussion is given based on the results of the observation of changes over time.

High HbA1c level

Between FY 2014 and FY 2021, the APC of the proportion of HbA1c NGSP values of 6.5% or higher, or the average annual change rate, was 1.8% for men and 1.0% for women, while the APC of the proportion of NGSP values of 8.0% or higher was around 1% for men and women, indicating an increase in the number of persons with strongly suspected diabetes, but a suppression of the increase in poor glycemic control. This is presumably a reflection of the Health Japan 21 data, which showed an increase in the number of patients with strongly suspected diabetes, but a suppression of the increase in the number of patients with poor glycemic control. In addition to the efforts of physicians and medical specialists in diagnosis, treatment, and patient guidance, improved patient literacy may also be a factor in the reduction in the number of patients with poor glycemic control. As for the contribution of pharmaceuticals, the impact of diabetes drugs with novel mechanisms, which have become widely available since 2010 and are discussed in this paper, may also be a factor. However, the proportion of patients with HbA1c of 6.5% or higher increased significantly in the elderly group for both men and women (70-74 years APC: 3.6% for men and 2.6% for women). Whether this is due to the influence of HbA1c target values4) according to the status categories of elderly patients in the guidelines for diabetes care, future changes should be noted.

Although it is not possible to provide details on the reason for the increase in the percentage of patients with NGSP values of 8.0% or higher in FY2020, a report7) on diabetic patients withholding visits in the Corona Disaster states that an increase in HbA1c was observed in patients with a significant decrease in visits in FY2020. As shown in Table 1 at the end of this report, the number of patients receiving specific health checkups also showed a decrease in 2020, and future studies are expected to analyze the relationship between worsening glycemic control and coronary disasters in 2020.

High level of urinary protein

The GL for diabetes care states, "Many cohort studies and observational studies have shown that the appearance of trace albuminuria and progression to overt albuminuria, i.e., increased urinary albumin excretion, in Japanese diabetic patients is a risk factor for renal function decline. Proteinuria and albuminuria are strong risk factors for serious events such as end-stage renal failure, CVD death, and all-cause mortality, and are important diagnostic criteria for CKD .

From the NDBOD, the APC of the percentage of patients with urinary protein 2+ or higher and urinary protein + or higher decreased in both male and female groups between FY 2014 and FY 2021, suggesting a relationship with a decrease in the number of patients who underwent dialysis. However, the APCs for both 2+ and +/- were higher among male and female patients aged 70-74 years, and the fact that no significant changes were observed suggests a relationship with the aging of dialysis induction patients2) (APCs for urinary protein 2+: 0.2% for males and 0.1% for females, and for +/-: -0.0% for males and -0.0% for females, aged 70-74 years). (0.0%) for men and -0.0% for women.

 Fig. 13 CKD severity classification (modified from CKD Practice Guide 2012)

High BMI

In 2011, the results of a cross-sectional analysis of the association between BMI and diabetes in more than 900,000 subjects recruited in 18 cohorts in Asian countries including Japan8) were published, which reported a positive correlation between BMI and diabetes prevalence in all cohorts and all subgroups of the study population (Figure 14). The Diabetes Practice GL states, 'Obesity with a BMI of 25 or greater, especially visceral adipose obesity, is an important factor contributing to the development of diabetes and the progression and worsening of the disease. Diabetes with obesity is obesity, and the first priority is metabolic improvement through weight loss, along with the search for secondary obesity' .4)

The APCs of the percentage of high BMI from 2014 to 2021 as seen in the NDBOD were positive for both men and women above 25 and 30. In particular, a large APC was shown for 30 and above, and there is concern that severe obesity, which increases the risk of diabetes onset and progression, will increase markedly in the future, especially in middle age (APC of BMI ≥30 ratio, age 50-54 years: 7.0% for men and 6.3% for women).

 Fig. 14 Prevalence of diabetes by BMI and region after adjustment for gender and age

Second, some discussion is given based on our observations of changes in prescribing of diabetes-related medications recommended by medical practice guidelines according to the condition.

Recommended diabetic drugs for diabetic nephropathy

The 2024 edition of the Diabetes Care GL recommends new SGLT2Is for patients with diabetic nephropathy with albuminuria, and the 2023 edition of the CKD Care GL recommends new diabetic drugs for patients with diabetic kidney disease4)5). 5 ) 5 ) In addition, the CKD GL recommends GLP1RAs for the prevention of progression of nephropathy in patients with type 2 diabetes mellitus. In 2018, the two societies will define diabetic nephropathy as "diabetic nephropathy," which is a typical case of decreased renal function following the appearance and increase of proteinuria (albuminuria), and diabetic kidney disease or diabetes-related kidney disease, which includes renal disease related to diabetic conditions where renal function decreases despite the absence of increased albuminuria. The CKD GL is consistent in its use of the term "diabetic kidney disease" (DKD).

Analysis of the NDBOD for FY 2015-2022 showed that SGLT2Is accounted for 15-17% of diabetic drugs in FY 2022, and the APC, or average annual percentage change (APC) of the volume share, showed significant growth of approximately 40% for both men and women. The volume share of GLP1RAs in diabetes hormones has been increasing at an average annual rate of 25-29%, and will exceed 27% in FY2022 for both men and women. In the DAPA-CKD trial, SGLT2Is showed a 39% relative risk reduction compared to controls in the composite primary endpoint (≥50% reduction in eGFR + end-stage renal failure + death from renal events + death from cardiovascular events) and a 39% relative risk reduction in end-stage renal failure (eGFR <15 ml/min/1.73m2 + dialysis induction + renal transplantation). 9) As mentioned earlier, it is possible that the efforts and progress of medical personnel and professionals in early detection of diabetes and nutritional and lifestyle guidance in diabetes care, as well as the evolution of diabetes drugs, have contributed to the decrease in the number of patients who undergo dialysis due to diabetic nephropathy.

Recommended antidiabetic agents for diabetic nephropathy

Both guidelines have long recommended ACEIs and ARBs as blood pressure lowering agents for diabetic nephropathy, and MRAs have been newly added to the list of recommended agents for patients with albuminuria4)5). In particular, the Diabetes Care GL recommends finerenone, a new MRAs launched in 2022, but the NDBOD did not yet reflect the prescribed dose. The volume share of MRAs in blood pressure lowering drugs is about 3% for both men and women in 2022, but that share has increased at an average annual rate of 17-19% between 2015 and 2022, suggesting a continued increase in prescription volume. In addition, the volume share of spironolactone, a classic MRAs, in diuretics has remained at approximately 20% and has not changed significantly over time, while overall diuretic prescriptions have increased at an average annual rate of approximately 4%. The number of heart failure patients is estimated to have increased rapidly in recent years due to the aging of the population, 10) and the CKD GL suggests prescribing loop diuretics for CKD patients with fluid overload ,5) which may have contributed to the increase in prescriptions.

Recommended diabetic agents for diabetes with obesity

The Diabetes Care GL recommends SGLT2Is and GLP1RAs as drug therapy for obese patients with type 2 diabetes mellitus .4) SGLT2Is are thought to reduce body weight by inhibiting sugar reabsorption in the proximal tubule and promoting urinary excretion of sugar, while GLP1RAs act on pancreatic GLP1 receptors and promote insulin secretion. As is well known, GLP1RAs have been repositioned as a treatment for obesity in the U.S. and Europe, as they have been shown to markedly reduce body weight. As mentioned above, please refer to Diabetes GL3) for details of the evidence for each drug, but SGLT2Is, in addition to its weight-loss effect through urinary glucose excretion, also has a diuretic effect that decreases body fluid volume and blood pressure, and has been shown to reduce the incidence of kidney and brain microarterial damage, MACE (major adverse cardiovascular events), and cardiac inertia. GLP1RAs have also been shown in clinical trials and meta-analysis to reduce the incidence of MACE and complex renal events. In addition, metformin is listed as a diabetes agent with evidence of small but significant weight loss.

Based on the trends in NDBOD specific health examinations, there is concern that the proportion of people with high BMI will continue to increase in the future, possibly leading to an increase in the incidence of diabetes mellitus. Currently, the number of anti-obesity diabetes drugs is increasing, but it is likely that the number of pre-diabetics will increase even more, and the need for anti-obesity diabetes drugs will likely become even greater than it is now. In December 2023, the Japan Diabetes Society issued a warning against off-label use of GLP1RAs for cosmetic, slimming, and weight-loss purposes11), followed by a similar warning issued by marketing companies12). In May 2024, the Japan Diabetes Society fully revised the recommendations for incretin-related drugs including DPP4Is, and issued an alert for use in "elderly patients at high risk of sarcopenia/frail, " 13) and for SGLT2Is, in December 2024, the PMDA issued a revised indication for precautionary use regarding "prolonged ketoacidosis. In December 2024, the PMDA issued a revised instruction for the use of SGLT2Is regarding "prolonged ketoacidosis.

In recent years, the largest cohort study in Japan has been published15) , showing that obesity and sleep disorders and sleep apnea, which are indirectly affected by obesity, are associated with diabetes and hypertension, suggesting the importance of weight loss and treatment of sleep disorders in preventing the progression of diabetes and hypertension. While diabetes drugs with improved anti-obesity and renoprotective effects are expected to reduce renal events and MACE, it is extremely important for the pharmaceutical industry as well as medical professionals to monitor prescribing trends to ensure that these drugs are used appropriately in the right patients for safe, effective, and efficient treatment.

5. Conclusion

Recently, two comparative studies of diabetes drugs using domestic health insurance cohort data were published16)17). The incidence of type 2 diabetes is influenced by lifestyle and environmental factors such as overeating and lack of exercise, in addition to multiple genetic factors4) . 4), it is possible to link the results of specific health checkups, such as for severe obesity, with the receipts for guidance and treatment to evaluate the effectiveness of specific health checkups. Furthermore, since mid- to long-term data are needed to evaluate the effects of medical technologies such as drugs, especially for the evaluation of medical technologies for outcomes of chronic diseases, NDB data has much room to complement clinical trials in the evaluation of prevention of disease onset and treatment effects and in the study of improvement measures, and is expected to become even more important in the future. The promotion of the utilization of NDB data will also greatly contribute to the transparency of the actual use of medical technology and the promotion of its proper use.

In December 2024, the Cabinet Office released the "Interim Report on the Promotion of Regulatory Reform " 18) by the Council for Regulatory Reform. In this report, as part of the "Development of Legislation for Utilization of Medical and Other Data," it was decided that information from 11 public databases of medical and other data held by the government, including the NDB, as well as information from "authorized databases" held by businesses authorized under the Next Generation Medical Infrastructure Act, would be pseudonymized and consolidated within 2025 to provide an environment in which analysis can be performed. The decision was made. Accumulated medical data is a valuable asset that contributes to the health of the nation. In order for medical big data to be returned as a benefit to patients and the public as a whole, it is desirable to promptly establish a data analysis environment that brings precision to the evaluation of medical technologies and leads to the development of next-generation medical technologies. For this purpose, it is highly expected that the NDB will serve as a platform to link health/care insurance data, electronic medical record data, various health/medical/medical technology data accumulated by national medical institutions and medical/pharmaceutical societies, government statistics, etc., and that high-quality real-world data will be widely used by medical professionals, researchers, and healthcare-related industries. We expect that high-quality real-world data will be widely used by medical professionals, researchers, and health care-related industries.

 Table 1 NDBOD specific health checkup data (40-74 years old)
 Table 2 NDBOD prescription drug data (age 40-74)

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