The Effect of Sitagliptin on Carotid Artery Atherosclerosis in Type 2 Diabetes: The PROLOGUE Randomized Controlled Trial

PLoS Medicine

Volumn 13, Issue 6, 2016, Pages

  Oyama, Jun Ichi ^a   Murohara, Toyoaki ^b   Kitakaze, Masafumi ^c   Ishizu, Tomoko ^d   Sato, Yasunori ^e   Kitagawa, Kazuo ^f   Kamiya, Haruo ^g   Ajioka, Masayoshi ^h   Ishihara, Masaharu ⁱ   Dai, Kazuoki ^j   Nanasato, Mamoru ^k   Sata, Masataka ^l   Maemura, Koji ^m   Tomiyama, Hirofumi ⁿ   Higashi, Yukihito ^o   Kaku, Kohei ^p   Yamada, Hirotsugu ^q   Matsuhisa, Munehide ^l   Yamashita, Kentaro ^b   Bando, Yasuko K ^b   Kashihara, Naoki ^p   Ueda, Shinichiro ^r   Inoue, Teruo ^s   Tanaka, Atsushi ^a   Node, Koichi ^a   more..

^a SAGA UNIVERSITY   (Japan)

^b NAGOYA UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^c NATIONAL CEREBRAL AND CARDIOVASCULAR CENTER   (Japan)

^d UNIVERSITY OF TSUKUBA   (Japan)

^e CHIBA UNIVERSITY   (Japan)

^f TOKYO WOMEN'S MEDICAL UNIVERSITY   (Japan)

^g JAPANESE RED CROSS NAGOYA FIRST HOSPITAL   (Japan)

^h TOSEI GENERAL HOSPITAL   (Japan)

ⁱ HYOGO COLLEGE OF MEDICINE   (Japan)

^j HIROSHIMA CITY HOSPITAL   (Japan)

^k NAGOYA DAINI RED CROSS HOSPITAL   (Japan)

^l UNIVERSITY OF TOKUSHIMA   (Japan)

^m NAGASAKI UNIVERSITY   (Japan)

ⁿ TOKYO MEDICAL UNIVERSITY   (Japan)

^o HIROSHIMA UNIVERSITY   (Japan)

^p KAWASAKI MEDICAL SCHOOL   (Japan)

^q TOKUSHIMA UNIVERSITY HOSPITAL   (Japan)

^r UNIVERSITY OF THE RYUKYUS   (Japan)

^s DOKKYO MEDICAL UNIVERSITY   (Japan)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ADIPONECTIN; ALBUMIN; CREATININE; CYSTATIN C; HEMOGLOBIN A1C; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; INSULIN; LOW DENSITY LIPOPROTEIN CHOLESTEROL; SITAGLIPTIN; DIPEPTIDYL PEPTIDASE IV INHIBITOR;

AGED; ARTERIAL WALL THICKNESS; ARTICLE; CAROTID ATHEROSCLEROSIS; CEREBROVASCULAR ACCIDENT; CONTROLLED STUDY; ECHOGRAPHY; FEMALE; FOLLOW UP; GLOMERULUS FILTRATION RATE; GLUCOSE BLOOD LEVEL; GLUCOSE METABOLISM; HEART FAILURE; HEART INFARCTION; HUMAN; HYPOGLYCEMIA; INSULIN RESISTANCE; KIDNEY FUNCTION; MAJOR CLINICAL STUDY; MALE; NON INSULIN DEPENDENT DIABETES MELLITUS; PANCREATITIS; RANDOMIZED CONTROLLED TRIAL; ADULT; ATHEROSCLEROSIS; CAROTID ARTERY; CLINICAL TRIAL; COMPLICATION; DIABETES MELLITUS, TYPE 2; DRUG EFFECTS; MIDDLE AGED; MULTICENTER STUDY; PROSPECTIVE STUDY;

ADULT; AGED; ATHEROSCLEROSIS; CAROTID ARTERIES; CAROTID INTIMA-MEDIA THICKNESS; DIABETES MELLITUS, TYPE 2; DIPEPTIDYL-PEPTIDASE IV INHIBITORS; FEMALE; HUMANS; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; SITAGLIPTIN PHOSPHATE;

EID: 84978123661     PISSN: 15491277     EISSN: 15491676     Source Type: Journal    
DOI: 10.1371/journal.pmed.1002051     Document Type: Article

References (59)

1. Wild S, Roglic G, Green A, Sicree R, King H, Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004;27:1047–1053. 15111519
2. Juutilainen A, Lehto S, Rönnemaa T, Pyörälä K, Laakso M, Type 2 diabetes as a “coronary heart disease equivalent”: an 18-year prospective population-based study in Finnish subjects. Diabetes Care. 2005;28:2901–2907. 16306552
3. Haffner SM, Lehto S, Rönnemaa T, Pyörälä K, Laakso M, Mortality from coronary heart disease in subjects with type 2 diabetes and in nondiabetic subjects with and without prior myocardial infarction. N Engl J Med. 1998;23;339:229–234. 9673301
4. Whiteley L, Padmanabhan S, Hole D, Isles C, Should diabetes be considered a coronary heart disease risk equivalent?: results from 25 years of follow-up in the Renfrew and Paisley survey. Diabetes Care. 2005;28:1588–1593. 15983305
5. Craven TE, Ryu JE, Espeland MA, Kahl FR, McKinney WM, Toole JF, et al. Evaluation of the associations between carotid artery atherosclerosis and coronary artery stenosis. A case-control study. Circulation. 1990;82:1230–1242. 2205416
6. Handa N, Matsumoto M, Maeda H, Hougaku H, Ogawa S, Fukunaga R, et al. Ultrasonic evaluation of early carotid atherosclerosis. Stroke. 1990;21:1567–1572. 2237950
7. Smith GD, Shipley MJ, Rose G, Intermittent claudication, heart disease risk factors, and mortality. The Whitehall Study. Circulation. 1990;82:1925–1931. 2242518
8. Khoury Z, Schwartz R, Gottlieb S, Chenzbraun A, Stern S, Keren A, Relation of coronary artery disease to atherosclerotic disease in the aorta, carotid, and femoral arteries evaluated by ultrasound. Am J Cardiol. 1997;80:1429–1433. 9399716
9. Chambless LE, Heiss G, Folsom AR, Rosamond W, Szklo M, Sharrett AR, et al. Association of coronary heart disease incidence with carotid arterial wall thickness and major risk factors: the Atherosclerosis Risk in Communities (ARIC) Study, 1987–1993. Am J Epidemiol. 1997;146:483–494. 9290509
10. Salonen JT, Salonen R, Ultrasound B-mode imaging in observational studies of atherosclerotic progression. Circulation. 1993;87:II56–II65. 8443925
11. Kasami R, Kaneto H, Katakami N, Sumitsuji S, Yamasaki K, Kuroda T, et al. Relationship between carotid intima-media thickness and the presence and extent of coronary stenosis in type 2 diabetic patients with carotid atherosclerosis but without history of coronary artery disease. Diabetes Care. 2011;34:468–470. doi: 10.2337/dc10-122221270201
12. Sivertsen J, Rosenmeier J, Holst JJ, Vilsbøll T, The effect of glucagon-like peptide 1 on cardiovascular risk. Nat Rev Cardiol. 2012;9:209–222. doi: 10.1038/nrcardio.2011.21122290234
13. Chrysant SG, Chrysant GS, Clinical implications of cardiovascular preventing pleiotropic effects of dipeptidyl peptidase-4 inhibitors. Am J Cardiol. 2012;109:1681–1685. doi: 10.1016/j.amjcard.2012.01.39822425330
14. Monami M, Ahrén B, Dicembrini I, Mannucci E, Dipeptidyl peptidase-4 inhibitors and cardiovascular risk: a meta-analysis of randomized clinical trials. Diabetes Obes Metab. 2013;15:112–120. doi: 10.1111/dom.1200022925682
15. Patil HR, Al Badarin FJ, Al Shami HA, Bhatti SK, Lavie CJ, Bell DS, et al. Meta-analysis of effect of dipeptidyl peptidase-4 inhibitors on cardiovascular risk in type 2 diabetes mellitus. Am J Cardiol. 2012;110:826–833. doi: 10.1016/j.amjcard.2012.04.06122703861
16. Scirica BM, Bhatt DL, Braunwald E, Steg PG, Davidson J, Hirshberg B, et al. Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med. 2013;369:1317–1326. doi: 10.1056/NEJMoa130768423992601
17. White WB, Cannon CP, Heller SR, Nissen SE, Bergenstal RM, Bakris GL, et al. Alogliptin after acute coronary syndrome in patients with type 2 diabetes. N Engl J Med. 2013;369:1327–1335. doi: 10.1056/NEJMoa130588923992602
18. Green JB, Bethel MA, Armstrong PW, Buse JB, Engel SS, Garg J, et al. Effect of sitagliptin on cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2015;373:232–242. doi: 10.1056/NEJMoa150135226052984
19. Oyama J, Ishizu T, Sato Y, Kodama K, Bando YK, Murohara T, et al. Rationale and design of a study to evaluate the effects of sitagliptin on atherosclerosis in patients with diabetes mellitus: PROLOGUE study. Int J Cardiol. 2014;174:383–384. doi: 10.1016/j.ijcard.2014.03.20424768387
20. Stein JH, Korcarz CE, Hurst RT, Lonn E, Kendall CB, Mohler ER, et al. Use of carotid ultrasound to identify subclinical vascular disease and evaluate cardiovascular disease risk: a consensus statement from the American Society of Echocardiography Carotid Intima-Media Thickness Task Force. Endorsed by the Society for Vascular Medicine. J Am Soc Echocardiogr. 2008;21:93–111. doi: 10.1016/j.echo.2007.11.01118261694
21. Touboul PJ, Hennerici MG, Meairs S, Adams H, Amarenco P, Desvarieux M, et al. Mannheim intima-media thickness consensus. Cerebrovasc Dis. 2004;18:346–349. 15523176
22. Sabetai MM, Tegos TJ, Nicolaides AN, Dhanjil S, Pare GJ, Stevens JM, Reproducibility of computer-quantified carotid plaque echogenicity: can we overcome the subjectivity?Stroke. 2000;31:2189–2196. 10978050
23. Lundby-Christensen L, Almdal TP, Carstensen B, Tarnow L, Wiinberg N, Carotid intima-media thickness in individuals with and without type 2 diabetes: a reproducibility study. Cardiovasc Diabetol. 2010;9:40. doi: 10.1186/1475-2840-9-4020727128
24. Yamasaki Y, Kodama M, Nishizawa H, Sakamoto K, Matsuhisa M, Kajimoto Y, et al. carotid intima-media thickness in Japanese type 2 diabetic subjects. Diabetes Care. 2000;9:1310–1315.
25. Kawasumi M, Tanaka Y, Uchino H, Shimizu T, Tamura Y, Sato F, et al. Strict glycemic control ameliorates the increase of carotid IMT in patients with type 2 diabetes. Endocr J. 2006;53:45–50. 16543671
26. Mazzone T, Meyer PM, Feinstein SB, Davidson MH, Kondos GT, D’Agostino RB, Sret al. Effect of pioglitazone compared with glimepiride on carotid intima-media thickness in type 2 diabetes. JAMA. 2006;296:2572–2581. 17101640
27. Oyama J, Node K. Data from: the effect of sitagliptin on carotid artery atherosclerosis in patients with type 2 diabetes: the PROLOGUE randomized controlled trial. Dryad Digital Repository. Avaiable: http://dx.doi.org/10.5061/dryad.qt743/2.
28. Chambless LE, Folsom AR, Clegg LX, Sharrett AR, Shahar E, Nieto FJ, et al. Carotid wall thickness is predictive of incident clinical stroke: the atherosclerosis risk in communities (ARIC) study. Am J Epidemiol. 2000;151:478–487. 10707916
29. Lorenz MW, Markus HS, Bots ML, Rosvall M, Sitzer M, Prediction of clinical cardiovascular events with carotid intima-media thickness: a systematic review and meta-analysis. Circulation. 2007;115:459–467. 17242284
30. Nambi V, Chambless L, Folsom AR, He M, Hu Y, Mosley T, et al. Carotid intima-media thickness and presence or absence of plaque improves prediction of coronary heart disease risk: the ARIC (Atherosclerosis Risk In Communities) study. J Am Coll Cardiol. 2010;55:1600–1607. doi: 10.1016/j.jacc.2009.11.07520378078
31. Polak JF, Pencina MJ, O’Leary DH, D’Agostino RB, Common carotid artery intima-media thickness progression as a predictor of stroke in multi-ethnic study of atherosclerosis. Stroke. 2011;42:3017–3021. doi: 10.1161/STROKEAHA.111.62518621885840
32. Espeland MA, O’leary DH, Terry JG, Morgan T, Evans G, Mudra H, Carotid intimal-media thickness as a surrogate for cardiovascular disease events in trials of HMG-CoA reductase inhibitors. Curr Control Trials Cardiovasc Med. 2005;6:3. 15760471
33. Künzli N, Jerrett M, Garcia-Esteban R, Basagaña X, Beckermann B, Gilliland F, et al. Ambient air pollution and the progression of atherosclerosis in adults. PLoS ONE. 2010;5:e9096. doi: 10.1371/journal.pone.000909620161713
34. Hsue PY, Lo JC, Franklin A, Bolger AF, Martin JN, Deeks SG, et al. Progression of atherosclerosis as assessed by carotid intima-media thickness in patients with HIV infection. Circulation. 2004;109:1603–1638. 15023877
35. Yamasaki Y, Katakami N, Furukado S, Kitagawa K, Nagatsuka K, Kashiwagi A, et al. Long-term effects of pioglitazone on carotid atherosclerosis in Japanese patients with type 2 diabetes without a recent history of macrovascular morbidity. J Atheroscler Thromb. 2010;17:1132–1140. 20686324
36. Greenland P, Alpert JS, Beller GA, Benjamin EJ, Budoff MJ, Fayad ZA, et al. 2010 ACCF/AHA guideline for assessment of cardiovascular risk in asymptomatic adults: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2010;122:e584–e636. doi: 10.1161/CIR.0b013e3182051b4c21098428
37. Goldberger ZD, Valle JA, Dandekar VK, Chan PS, Ko DT, Nallamothu BK, Are changes in carotid intima-media thickness related to risk of nonfatal myocardial infarction? A critical review and meta-regression analysis. Am Heart J. 2010;160:701–714. doi: 10.1016/j.ahj.2010.06.02920934565
38. Costanzo P, Perrone-Filardi P, Vassallo E, Paolillo S, Cesarano P, Brevetti G, et al. Does carotid intima-media thickness regression predict reduction of cardiovascular events? A meta-analysis of 41 randomized trials. J Am Coll Cardiol. 2010;56:2006–2020. doi: 10.1016/j.jacc.2010.05.05921126642
39. Amarenco P, Labreuche J, Lavallee P, Touboul PJ, Statins in stroke prevention and carotid atherosclerosis: systematic review and up-to-date meta-analysis. Stroke. 2004;35:2902–2909. 15514180
40. Riccioni G, Statins and carotid intima-media thickness reduction: an up-to-date review. Curr Med Chem. 2009;16:1799–1805. 19442146
41. US Food and Drug Administration. Clinical trial imaging endpoint process standards guidance for industry. Draft guidance. 2015 Mar [cited 24 May 2016]. Available: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm268555.pdf.
42. Langenfeld MR, Forst T, Hohberg C, Kann P, Lübben G, Konrad T, et al. Pioglitazone decreases carotid intima-media thickness independently of glycemic control in patients with type 2 diabetes mellitus: results from a controlled randomized study. Circulation. 2005;111:2525–2531. 15883215
43. Green BD, Irwin N, Duffy NA, Gault VA, O’Harte FP, Flatt PR, Inhibition of dipeptidyl peptidase-IV activity by metformin enhances the antidiabetic effects of glucagon-like peptide-1. Eur J Pharmacol. 2005;547:192–199.
44. Lindsay JR, Duffy NA, McKillop AM, Ardill J, O’Harte FP, Flatt PR, et al. Inhibition of dipeptidyl peptidase IV activity by oral metformin in type 2 diabetes. Diabet Med. 2005;22:654–657. 15842525
45. Katakami N, Yamasaki Y, Hayaishi-Okano R, Ohtoshi K, Kaneto H, Matsuhisa M, et al. Metformin or gliclazide, rather than glibenclamide, attenuate progression of carotid intima-media thickness in subjects with type 2 diabetes. Diabetologia. 2004;47:1906–1913. 15565373
46. Matsumoto K, Sera Y, Abe Y, Tominaga T, Yeki Y, Miyake S, Metformin attenuates progression of carotid arterial wall thickness in patients with type 2 diabetes. Diabetes Res Clin Pract. 2004;64:225–258. 15126012
47. Ishikawa S, Shimano M, Watarai M, Koyasu M, Uchikawa T, Ishii H, et al. Impact of sitagliptin on carotid intima-media thickness in patients with coronary artery disease and impaired glucose tolerance or mild diabetes mellitus. Am J Cardiol. 2014;114:384–388. doi: 10.1016/j.amjcard.2014.04.05024929624
48. Barbieri M, Rizzo MR, Marfella R, Boccardi V, Esposito A, Pansini A, et al. Decreased carotid atherosclerotic process by control of daily acute glucose fluctuations in diabetic patients treated by DPP-IV inhibitors. Atherosclerosis. 2013;227:349–354. doi: 10.1016/j.atherosclerosis.2012.12.01823375680
49. Mita T, Katakami N, Yoshii H, Onuma T, Kaneto H, Osonoi T, et al. Alogliptin, a dipeptidyl peptidase 4 inhibitor, prevents the progression of carotid atherosclerosis in patients with type 2 diabetes: the Study of Preventive Effects of Alogliptin on Diabetic Atherosclerosis (SPEAD-A). Diabetes Care. 2016;39:139–148. doi: 10.2337/dc15-078126628419
50. Mita T, Katakami N, Shiraiwa T, Yoshii H, Onuma T, Kuribayashi N, et al. Sitagliptin attenuates the progression of carotid intima-media thickening in insulin-treated patients with type 2 diabetes: the Sitagliptin Preventive Study of Intima-Media Thickness Evaluation (SPIKE): a randomized controlled trial. Diabetes Care. 2016;39:455–464. doi: 10.2337/dc15-214526822324
51. Mita T, Watada H, Ogihara T, Nomiyama T, Ogawa O, Kinoshita J, et al. Eicosapentaenoic acid reduces the progression of carotid intima-media thickness in patients with type 2 diabetes. Atherosclerosis. 2007;191:162–167. 16616147
52. Shiraki A, Oyama J, Komoda H, Asaka M, Komatsu A, Sakuma M, et al. The glucagon-like peptide 1 analog liraglutide reduces TNF-α-induced oxidative stress and inflammation in endothelial cells. Atherosclerosis. 2012;221:375–382. doi: 10.1016/j.atherosclerosis.2011.12.03922284365
53. Ishibashi Y, Matsui T, Takeuchi M, Yamagishi S, Glucagon-like peptide-1 (GLP-1) inhibits advanced glycation end product (AGE)-induced up-regulation of VCAM-1 mRNA levels in endothelial cells by suppressing AGE receptor (RAGE) expression. Biochem Biophys Res Commun. 2010;391:1405–1408. doi: 10.1016/j.bbrc.2009.12.07520026306
54. Liu H, Dear AE, Knudsen LB, Simpson RW, A long-acting glucagon-like peptide-1 analogue attenuates induction of plasminogen activator inhibitor type-1 and vascular adhesion molecules. J Endocrinol. 2009;201:59–66. doi: 10.1677/JOE-08-046819136619
55. Gaspari T, Liu H, Welungoda I, Hu Y, Widdop RE, Knudsen LB, et al. A GLP-1 receptor agonist liraglutide inhibits endothelial cell dysfunction and vascular adhesion molecule expression in an ApoE-/- mouse model. Diab Vasc Dis Res. 2011;8:117–124. doi: 10.1177/147916411140425721562063
56. Matsubara J, Sugiyama S, Sugamura K, Nakamura T, Fujiwara Y, Akiyama E, et al. A dipeptidyl peptidase-4 inhibitor, des-fluoro-sitagliptin, improves endothelial function and reduces atherosclerotic lesion formation in apolipoprotein E-deficient mice. J Am Coll Cardiol. 2012;59:265–276. doi: 10.1016/j.jacc.2011.07.05322240132
57. Vittone F, Liberman A, Vasic D, Ostertag R, Esser M, Walcher D, et al. Sitagliptin reduces plaque macrophage content and stabilises arteriosclerotic lesions in Apoe (-/-) mice. Diabetologia. 2012;55:2267–2275. doi: 10.1007/s00125-012-2582-522648661
58. Nyström T, Gutniak MK, Zhang Q, Zhang F, Holst JJ, Ahrén B, et al. Effects of glucagon-like peptide-1 on endothelial function in type 2 diabetes patients with stable coronary artery disease. Am J Physiol Endocrinol Metab. 2004;287:E1209–E1215. 15353407
59. Kubota Y, Miyamoto M, Takagi G, Ikeda T, Kirinoki-Ichikawa S, Tanaka K, et al. The dipeptidyl peptidase-4 inhibitor sitagliptin improves vascular endothelial function in type 2 diabetes. J Korean Med Sci. 2012;27:1364–1370. doi: 10.3346/jkms.2012.27.11.136423166419