Comparison of pioglitazone vs glimepiride on progression of coronary atherosclerosis in patients with type 2 diabetes: The PERISCOPE randomized controlled trial

JAMA

Volumn 299, Issue 13, 2008, Pages 1561-1573

  Nissen, Steven E ^a   Nicholls, Stephen J ^a   Wolski, Kathy ^a   Nesto, Richard ^b   Kupfer, Stuart ^c   Perez, Alfonso ^c   Jure, Horacio ^d   De Larochellière, Robert ^e   Staniloae, Cezar S ^f   Mavromatis, Kreton ^g   Saw, Jacqueline ^h   Hu, Bo ^a   Lincoff, A Michael ^a   Tuzcu, E Murat ^a  

^a LERNER RESEARCH INSTITUTE   (United States)

^b LAHEY HOSPITAL AND MEDICAL CENTER   (United States)

^c TAKEDA PHARMACEUTICALS   (United States)

^d Clinica Chutro   (Argentina)

^e LAVAL UNIVERSITY   (Canada)

^f ST VINCENT S HOSPITAL MANHATTAN   (United States)

^g ATLANTA VA MEDICAL CENTER   (United States)

^h VANCOUVER GENERAL HOSPITAL   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; ANGIOTENSIN RECEPTOR ANTAGONIST; ANTILIPEMIC AGENT; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; GLIMEPIRIDE; HIGH DENSITY LIPOPROTEIN; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; INSULIN; METFORMIN; PIOGLITAZONE; TRIACYLGLYCEROL; 2,4 THIAZOLIDINEDIONE DERIVATIVE; ANTIDIABETIC AGENT; SULFONYLUREA DERIVATIVE;

ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANGINA PECTORIS; ARTICLE; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORONARY ARTERY ATHEROSCLEROSIS; CREATININE BLOOD LEVEL; DIET RESTRICTION; DISEASE COURSE; DOUBLE BLIND PROCEDURE; DRUG DOSE TITRATION; DRUG EFFECT; DRUG EFFICACY; DRUG TOLERABILITY; EDEMA; FEMALE; FRACTURE; HEMATOCRIT; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPERTENSION; HYPOGLYCEMIA; IMAGE ANALYSIS; INTRAVASCULAR ULTRASOUND; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NON INSULIN DEPENDENT DIABETES MELLITUS; OUTCOME ASSESSMENT; PERIPHERAL EDEMA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REGRESSION ANALYSIS; SIDE EFFECT; UREA NITROGEN BLOOD LEVEL; ATHEROSCLEROSIS; COMPARATIVE STUDY; CORONARY BLOOD VESSEL; ECHOGRAPHY; ENDOSCOPIC ECHOGRAPHY; MIDDLE AGED;

AGED; ATHEROSCLEROSIS; CORONARY VESSELS; DIABETES MELLITUS, TYPE 2; DOUBLE-BLIND METHOD; FEMALE; HUMANS; HYPOGLYCEMIC AGENTS; MALE; MIDDLE AGED; SULFONYLUREA COMPOUNDS; THIAZOLIDINEDIONES; ULTRASONOGRAPHY, INTERVENTIONAL;

EID: 41649084422     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.299.13.1561     Document Type: Article

References (32)

1. UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33) [published correction appears in Lancet. 1999;354(9178):602]. Lancet. 1998;352(9131):837-853.
2. Stettler C, Allemann S, Jüni P, et al. Glycemic control and macrovascular disease in types 1 and 2 diabetes mellitus: meta-analysis of randomized trials. Am Heart J. 2006;152(1):27-38.
3. Bolen S, Feldman L, Vassy J, et al. Systematic review: comparative effectiveness and safety of oral medications for type 2 diabetes mellitus. Ann Intern Med. 2007;147(6):386-399.
4. Staels B, Fruchart JC. Therapeutic roles of peroxisome proliferator-activated receptor agonists. Diabetes. 2005;54(8):2460-2470.
5. Goldberg RB, Kendall DM, Deeg MA, et al. A comparison of lipid and glycemic effects of pioglitazone and rosiglitazone in patients with type 2 diabetes and dyslipidemia. Diabetes Care. 2005;28(7):1547-1554.
6. Dormandy JA, Charbonnel B, Eckland DJA, et al. Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a randomised controlled trial. Lancet. 2005;366(9493):1279-1289.
7. Mazzone T, Meyer PM, Feinsein SB, et al. Effect of pioglitazone compared with glimepiride on carotid intima-media thickness in type 2 diabetes; a randomized trial. JAMA. 2006;296(21):2572-2581.
8. Eurich DT, McAlister FA, Blackburn DF, et al. Benefits and harms of antidiabetic agents in patients with diabetes and heart failure: systematic review. BMJ. 2007;335(7618):497.
9. Nicholls SJ, Sipahi I, Schoenhagen P, Crowe T, Tuzcu EM, Nissen SE. Application of intravascular ultrasound in anti-atherosclerotic drug development. Nat Rev Drug Discov. 2006;5(6):485-492.
10. Nissen SE, Tsunoda T, Tuzcu EM, et al. Effect of recombinant ApoA-I Milano on coronary atherosclerosis in patients with acute coronary syndromes: a randomized controlled trial. JAMA. 2003;290(17):2292-2300.
11. Nissen SE, Tuzcu EM, Brown BG, et al. Effect of intensive compared with moderate lipid-lowering therapy on progression of coronary atherosclerosis: a randomized controlled trial JAMA. 2004;291(9):1071-1080.
12. Nissen SE, Tuzcu EM, Libby P, et al; CAMELOT Investigators. Effect of antihypertensive agents on cardiovascular events in patients with coronary disease and normal blood pressure: the CAMELOT study: a randomized controlled trial. JAMA. 2004;292(18):2217-2225.
13. Nissen SE, Tuzcu EM, Schoenhagen P, et al; Reversal of Atherosclerosis with Aggressive Lipid Lowering (REVERSAL) Investigators. Statin therapy, LDL cholesterol, C-reactive protein, and coronary artery disease. N Engl J Med. 2005;352(1):29-38.
14. Nissen SE, Nicholls SJ, Sipahi I, et al; ASTEROID Investigators. Effect of very high-intensity statin therapy on regression of coronary atherosclerosis: the ASTEROID trial. JAMA. 2006;295(13):1556-1565.
15. Nissen SE, Tuzcu EM, Brewer HB, et al; ACAT Intravascular Atherosclerosis Treatment Evaluation (ACTIVATE) Investigators. Effect of ACAT inhibition on the progression of coronary atherosclerosis [published correction appears in N Engl J Med. 2006;355(6):638. NEngl J Med. 2006;354(12):1253-1263.
16. Nissen SE, Tardif JC, Nicholls SJ, et al; ILLUSTRATE Investigators. Effect of torcetrapib on the progression of coronary atherosclerosis [published correction appears in N Engl J Med. 2007;357(8):835]. N Engl J Med. 2007;356(13):1304-1316.
17. Schoenhagen P, Sapp SK, Tuzcu EM, et al. Variability of area measurements obtained with different intravascular ultrasound catheter systems: impact on clinical trials and a method for accurate calibration. J Am Soc Echocardiogr. 2003;16(3):277-284.
18. Haffner SM, Lehto S, Ronnemaa T, Pyorala 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;339(4):229-234.
19. Brener SJ, Lytle BW, Casserly IP, Topol EJ, Lauer MS. Propensity analysis of long-term survival after surgical or percutaneous revascularization in patients with multivessel coronary disease and high-risk features. Circulation. 2004;109(19):2290-2295.
20. Scholte AJ, Schuijf JD, Kharagjitsingh AV, Jukema W, Pundziute G, van der Wall EE, Bax JJ. Prevalence of coronary artery disease and plaque morphology assessed by multi-slice computed tomography coronary angiography and calcium scoring in asymptomatic patients with type 2 diabetes. Heart. 2008;94 (3):290-295.
21. Waller BF, Palumbo PJ, Lie JT, Roberts WC. Status of the coronary arteries at necropsy in diabetes mellitus with onset after age 30 years: analysis of 229 diabetic patients with and without clinical evidence of coronary heart disease and comparison to 183 control subjects. Am J Med. 1980;69(4):498-506.
22. Gu K, Cowie CC, Harris MI. Diabetes and decline in heart disease mortality in US adults. JAMA. 1999;281(14):1291-1297.
23. Nicholls SJ, Tuzcu EM, Kalidindi S, et al. Effect of diabetes mellitus on progression of coronary atherosclerosis and arterial remodeling. J Am Coll Cardiol. In press.
24. Meigs JB, Singer DE, Sullivan LM, et al. Metabolic control and prevalent cardiovascular disease in non-insulin-dependent diabetes mellitus (NIDDM): The NIDDM Patient Outcome Research Team. Am J Med. 1997;102(1):38-47.
25. UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet. 1998;352(9131):837-853.
26. For Safety, NHLBI Changes Intensive Blood Sugar Treatment Strategy in Clinical Trial of Diabetes and Cardiovascular Disease [news release]. National Heart, Lung, and Blood Institute Communications Office; February 3, 2006. http://public.nhlbi.nih.gov/newsroom/home/GetPressRelease.aspx?id=2551 Accessed March 7, 2008.
27. Beckman JA, Creager MA, Libby P. Diabetes and atherosclerosis: epidemiology, pathophysiology, and management. JAMA. 2002;287(19):2570- 2582.
28. Fontbonne A, Charles MA, Thibult N, et al. Hyperinsulinaemia as a predictor of coronary heart disease mortality in a healthy population: the Paris Prospective Study, 15-year follow-up. Diabetologia. 1991; 34(5):356-361.
29. Avandia (rosiglitazone maleate) tablets: prescribing information [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2007. http://www.fda.gov/cder/foi/label/2007/021071s023lbl.pdf. Accessed March 6, 2008.
30. Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes [published correction appears in N Engl J Med. 2007;357(1):100]. N Engl J Med. 2007;356 (24):2457-2471.
31. Lincoff AM, Wolski K, Nicholls SJ, Nissen SE. Pioglitazone and risk of cardiovascular events in patients with type 2 diabetes mellitus: a meta-analysis of randomized trials. JAMA. 2007;298(10):1180-1188.
32. Rubin R. Heart attack warning added to Avandia label: FDA also asks drugmaker to conduct study. USA TODAY. http://www.usatoday.com/ printedition/life/20071115/d_avandia15.art.htm. Accessibility verified March 9, 2008.