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Journal Club 2013年10月3日 8:30-8:55 8階 医局 埼玉医科大学 総合医療センター 内分泌・糖尿病内科

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Presentation on theme: "Journal Club 2013年10月3日 8:30-8:55 8階 医局 埼玉医科大学 総合医療センター 内分泌・糖尿病内科"— Presentation transcript:

1 Journal Club 2013年10月3日 8:30-8:55 8階 医局 埼玉医科大学 総合医療センター 内分泌・糖尿病内科
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 2013年10月3日 8:30-8:55 8階 医局 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

2 DPP-4阻害薬の心血管アウトカム試験 試験名 TECOS EXAMINE SAVOR-TIMI 53 CAROLINA 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 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 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 こちらは他のDPP-4阻害薬が実施している心血管イベントを評価項目とした臨床試験の一覧です。 これらの試験はFDAのガイダンスに基づき、心血管リスクのプラセボに対する非劣性を確認することを目的に実施されています。 EXAMINEは、急性冠症候群を合併したハイリスクな2型糖尿病患者を対象にしている点が他の試験と異なります。 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(http://clinicaltrials.gov/)をもとに一部改変

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

4 the University of Connecticut School of Medicine, Farmington (W. B. W
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
* 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
* 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
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<0.001)。

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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 2010. 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
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
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
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
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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