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Journal Club 埼玉医科大学 総合医療センター 内分泌・糖尿病内科 Department of Endocrinology and Diabetes, Saitama Medical Center, Saitama Medical University 松田 昌文 坂下 杏奈 Matsuda,

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Presentation on theme: "Journal Club 埼玉医科大学 総合医療センター 内分泌・糖尿病内科 Department of Endocrinology and Diabetes, Saitama Medical Center, Saitama Medical University 松田 昌文 坂下 杏奈 Matsuda,"— Presentation transcript:

1 Journal Club 埼玉医科大学 総合医療センター 内分泌・糖尿病内科 Department of Endocrinology and Diabetes, Saitama Medical Center, Saitama Medical University 松田 昌文 坂下 杏奈 Matsuda, Masafumi, Sakashita, Anna 2013 年 10 月 3 日 8:30-8:55 8階 医局 White WB, Cannon CP, Heller SR, Nissen SE, Bergenstal RM, Bakris GL, Perez AT, Fleck PR, Mehta CR, Kupfer S, Wilson C, Cushman WC, Zannad F; the EXAMINE Investigators. Alogliptin after Acute Coronary Syndrome in Patients with Type 2 Diabetes. N Engl J Med Sep 2. [Epub ahead of print] Xu Y, Wang L, He J, Bi Y, Li M, Wang T, Wang L, Jiang Y, Dai M, Lu J, Xu M, Li Y, Hu N, Li J, Mi S, Chen CS, Li G, Mu Y, Zhao J, Kong L, Chen J, Lai S, Wang W, Zhao W, Ning G; 2010 China Noncommunicable Disease Surveillance Group. Prevalence and control of diabetes in Chinese adults. JAMA Sep 4;310(9): doi: /jama

2 試験名 TECOSEXAMINESAVOR-TIMI 53CAROLINA 対象 2 型糖尿病患者急性冠症候群を合併 した 2 型糖尿病患者 2 型糖尿病患者 薬剤名シタグリプチンアログリプチンサクサグリプチンリナグリプチン 対照薬プラセボ グリメピリド 登録例数 14,000 例 5,400 例 16,500 例 6,000 例 主要 エンドポイント 心血管死,非致死 的心筋梗塞,非致 死的脳卒中,不安 狭心症による複合 心血管死,非致死的 心筋梗塞,非致死的 脳卒中の複合 心血管死,非致死 的心筋梗塞,非致 死的虚血性脳卒中 の複合 心血管死,非致死 的心筋梗塞,非致 死的脳卒中,不安 狭心症による複合 観察期間 5 年間 4.75 年間 4 年間 8.33 年間 試験開始 2008 年 2009 年 2010 年 試験終了予定 2014 年 12 月 2013 年 12 月 2013 年 7 月 2018 年 9 月 綿田裕孝(順天堂大学大学院代謝内分泌内科学) Pharma Medica ;30,8, clinicaltrials.gov ( )をもとに一部改変 DPP-4 阻害薬の心血管アウトカム試験

3 N Engl J Med DOI: /NEJMoa SAVOR-TIMI 53

4 the University of Connecticut School of Medicine, Farmington (W.B.W.); Brigham and Women’s Hospital and Harvard Medical School (C.P.C.) and Harvard School of Public Health (C.R.M.) — all in Boston; University of Sheffield, Sheffield, United Kingdom (S.R.H.); Cleveland Clinic Foundation, Cleveland (S.E.N.); International Diabetes Center, Park Nicollet Clinic, Minneapolis (R.M.B.); University of Chicago Medicine, Chicago (G.L.B.); Takeda Development Center Americas, Deerfield, IL (A.T.P., P.R.F, S.K., C.W.); University of Tennessee College of Medicine, Memphis Veterans Affairs Medical Center, Memphis (W.C.C.); and INSERM Unite 9501, Universite de Lorraine and Centre Hospitalier Universitaire, Nancy, France (F.Z.). N Engl J Med DOI: /NEJMoa

5 Background To assess potentially elevated cardiovascular risk related to new antihyperglycemic drugs in patients with type 2 diabetes, regulatory agencies require a comprehensive evaluation of the cardiovascular safety profile of new antidiabetic therapies. We assessed cardiovascular outcomes with alogliptin, a new inhibitor of dipeptidyl peptidase 4 (DPP-4), as compared with placebo in patients with type 2 diabetes who had had a recent acute coronary syndrome.

6 Methods We randomly assigned patients with type 2 diabetes and either an acute myocardial infarction or unstable angina requiring hospitalization within the previous 15 to 90 days to receive alogliptin or placebo in addition to existing antihyperglycemic and cardiovascular drug therapy. The study design was a double-blind, noninferiority trial with a prespecified noninferiority margin of 1.3 for the hazard ratio for the primary end point of a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke.

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8 * Plus–minus values are means ±SD. There were no significant differences between the two groups for any baseline characteristic. ACS denotes acute coronary syndrome. † The body-mass index is the weight in kilograms divided by the square of the height in meters. ‡ Race or ethnic group was self- reported. § Values include the index event of the acute coronary syndrome. ¶ The estimated glomerular filtration rate was calculated with the use of the Modification of Diet in Renal Disease formula.

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10 * Diuretics included loop diuretics and thiazide diuretics. Renin–angiotensin system–blocking agents included angiotensin-converting–enzyme inhibitors and angiotensin II–receptor blockers.

11 This analysis resulted in a hazard ratio of 0.96 and an upper boundary of the one-sided repeated confidence interval of 1.17, findings that indicated noninferiority but not superiority of alogliptin to placebo, and the conditional power for superiority at 650 events was less than 20%; therefore, the data and safety monitoring committee recommended to the steering committee that the study be stopped. On March 9, 2013, the steering committee accepted the recommendation, and the sponsor agreed to stop enrollment in the study and proceed with a timely and orderly study closeout. The final date for evaluation of vital status was June 18, 2013.

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19 Results A total of 5380 patients underwent randomization and were followed for up to 40 months (median, 18 months). A primary end-point event occurred in 305 patients assigned to alogliptin (11.3%) and in 316 patients assigned to placebo (11.8%) (hazard ratio, 0.96; upper boundary of the one-sided repeated confidence interval, 1.16; P<0.001 for noninferiority). Glycated hemoglobin levels were significantly lower with alogliptin than with placebo (mean difference, −0.36 percentage points; P<0.001). Incidences of hypoglycemia, cancer, pancreatitis, and initiation of dialysis were similar with alogliptin and placebo.

20 Conclusions Among patients with type 2 diabetes who had had a recent acute coronary syndrome, the rates of major adverse cardiovascular events were not increased with the DPP-4 inhibitor alogliptin as compared with placebo. (Funded by Takeda Development Center Americas; EXAMINE ClinicalTrials.gov number, NCT )

21 Message 急性冠症候群を最近発症した 2 型糖尿病( DM ) 患者 5380 人を対象に、アログリプチン投与によ る心血管転帰を非劣性試験でプラセボと比較 ( EXAMINE 試験)。追跡期間中央値 18 カ月で の主要複合評価項目(心血管死、非致死性心筋梗 塞 / 脳卒中)発生率はアログリプチン群 11.3 %、 プラセボ群 11.8 %だった(非劣性 P < )。

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23 Guang Ning,MD, PhD, Key Laboratory for Endocrine and Metabolic Diseases of Ministry of Health, Department of Endocrine and Metabolic Diseases, Rui-Jin Hospital, Shanghai Jiao-Tong University School of Medicine, 197 Rui-Jin 2nd Rd, Shanghai, , China Zhao, PhD andWeiqingWang, MD, PhD JAMA Sep 4;310(9): doi: /jama

24 IMPORTANCE: Noncommunicable chronic diseases have become the leading causes of mortality and disease burden worldwide. OBJECTIVE: To investigate the prevalence of diabetes and glycemic control in the Chinese adult population.

25 DESIGN, SETTING, AND PARTICIPANTS Using a complex, multistage, probability sampling design, we conducted a cross-sectional survey in a nationally representative sample of Chinese adults in MAIN OUTCOMES AND MEASURES Plasma glucose and hemoglobin A1c levels were measured after at least a 10-hour overnight fast among all study participants, and a 2-hour oral glucose tolerance test was conducted among participants without a self-reported history of diagnosed diabetes. Diabetes and prediabetes were defined according to the 2010 American Diabetes Association criteria; whereas, a hemoglobin A1c level of <7.0% was considered adequate glycemic control.

26 Abbreviation: MET,metabolic equivalent. a There were 85missing values for body mass index (BMI), which is calculated as weight in kilograms divided by height in meters squared, and 75 missing values for waist circumference.

27 SI conversion factors: To convert plasma glucose to mmol/L, multiply by ; total, low- density lipoprotein, and high- density lipoprotein cholesterol to mmol/L multiply by ; and triglycerides to mmol/L, multiply by a There were 85 missing values for body mass index (BMI), which is calculated as weight in kilograms divided by height in meters squared, and 75 missing values for waist circumference.

28 Abbreviations: BMI, body mass index (BMI) is calculated as weight in kilograms divided by height in meters squared; HbA1c, hemoglobin A1c. SI conversion factor: To convert plasma glucose to mmol/L, multiply by a Data are weighted percentages.

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30 Abbreviation: HbA1c, hemoglobin A1c. SI conversion factor: To convert plasma glucose to mmol/L, multiply by a Data are weighted percentages. b Body mass index (BMI) is calculated as weight in kilograms divided by height in meters squared.

31 Abbreviation: BMI, body mass index, which is calculated as weight in kilograms divided by height in meters squared. a Awareness was defined as the proportion of individuals who reported a history of physician- diagnosed diabetes among all patients with diabetes. Treatment was defined as the proportion of individuals taking diabetes medications among all patients with diabetes. Control was defined as the proportion of individuals with a hemoglobin A1c level of less than 7.0% among patients with diabetes who were treated with diabetes medications. bData are weighted percentages.

32 Abbreviation: OR, odds ratio. SI conversion factors: To convert total, low-density lipoprotein, and high-density lipoprotein cholesterol to mmol/L, multiply by ; triglycerides to mmol/L, multiply by a There were 1432missing values for status of glucose regulation, 4 missing values for current smoking, 85 missing values for body mass index and 75 missing values for waist circumference. b Numbers for continuous variables are values of 1 standard deviation. c Overweight was defined as a body mass index (BMI), which is calculated as weight in kilograms divided by height in meters squared, of and obesity was defined as a BMI of 30.0 or higher. Central obesity was defined as waist circumference 90 cm or more in men and 80 cm or more in women.

33 RESULTS The overall prevalence of diabetes was estimated to be 11.6%(95%CI, 11.3%-11.8%) in the Chinese adult population. The prevalence among men was 12.1% (95%CI, 11.7%-12.5%) and among women was 11.0% (95%CI, 10.7%-11.4%). The prevalence of previously diagnosed diabetes was estimated to be 3.5%(95%CI, 3.4%-3.6%) in the Chinese population: 3.6%(95%CI, 3.4%-3.8%) in men and 3.4%(95%CI, 3.2%-3.5%) in women. The prevalence of undiagnosed diabetes was 8.1% (95%CI, 7.9%- 8.3%) in the Chinese population: 8.5%(95%CI, 8.2%-8.8%) in men and 7.7%(95%CI, 7.4%-8.0%) in women. In addition, the prevalence of prediabetes was estimated to be 50.1%(95%CI, 49.7%-50.6%) in Chinese adults: 52.1% (95%CI, 51.5%-52.7%) in men and 48.1%(95%CI, 47.6%-48.7%) in women. The prevalence of diabetes was higher in older age groups, in urban residents, and in persons living in economically developed regions. Among patients with diabetes, only 25.8% (95%CI, 24.9%-26.8%) received treatment for diabetes, and only 39.7%(95%CI, 37.6%- 41.8%) of those treated had adequate glycemic control.

34 CONCLUSIONS AND RELEVANCE The estimated prevalence of diabetes among a representative sample of Chinese adults was 11.6%and the prevalence of prediabetes was 50.1%. Projections based on sample weighting suggest this may represent up to million Chinese adults with diabetes and million with prediabetes. These findings indicate the importance of diabetes as a public health problem in China.

35 Message 中国人の成人全国代表標本 9 万 8658 人を対 象に、糖尿病の推定有病率を横断研究で調 査。有病率は糖尿病 11.6 %、前糖尿病 50.1 %と推定された。高齢者、都市居住者、 および経済発展地域の居住者ほど糖尿病有 病率が高かった。治療率は 25.8 %に過ぎず、 このうち十分な血糖コントロールが得られ ていたのは 39.7 %にみだった。

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