Effect of the addition of rosiglitazone to metformin or sulfonylureas versus metformin/sulfonylurea combination therapy on ambulatory blood pressure in people with type 2 diabetes: a randomized controlled trial (the RECORD study)

Michel Komajda, Paula Curtis, Markolf Hanefeld, Henning Beck-Nielsen, Stuart J Pocock, Andrew Zambanini, Nigel P Jones, Ramon Gomis, Philip D Home, RECORD Study Group, Michel Komajda, Paula Curtis, Markolf Hanefeld, Henning Beck-Nielsen, Stuart J Pocock, Andrew Zambanini, Nigel P Jones, Ramon Gomis, Philip D Home, RECORD Study Group

Abstract

Background: Hypertension and type 2 diabetes are common co-morbidities. Preliminary studies suggest that thiazolidinediones reduce blood pressure (BP). We therefore used ambulatory BP to quantify BP lowering at 6-12 months with rosiglitazone used in combination with metformin or sulfonylureas compared to metformin and sulfonylureas in people with type 2 diabetes.

Methods: Participants (n = 759) in the multicentre RECORD study were studied. Those taking metformin were randomized (open label) to add-on rosiglitazone or sulfonylureas, and those on sulfonylurea to add-on rosiglitazone or metformin.

Results: 24-Hour ambulatory BP was measured at baseline, 6 months and 12 months. At 6 and 12 months, reductions in 24-hour ambulatory systolic BP (sBP) were greater with rosiglitazone versus metformin (difference at 6 months 2.7 [95% CI 0.5-4.9] mmHg, p = 0.015; 12 months 2.5 [95% CI 0.2-4.8] mmHg, p = 0.031). Corresponding changes for ambulatory diastolic BP (dBP) were comparable (6 months 2.7 [95% CI 1.4-4.0] mmHg, p < 0.001; 12 months 3.1 [95% CI 1.8-4.5] mmHg, p < 0.001). Similar differences were observed for rosiglitazone versus sulfonylureas at 12 months (sBP 2.7 [95% CI 0.5-4.9] mmHg, p = 0.016; dBP 2.1 [95% CI 0.7-3.4] mmHg, p = 0.003), but differences were smaller and/or not statistically significant at 6 months (sBP 1.5 [95% CI -0.6 to 3.6] mmHg, p = NS; dBP 1.3 [95% CI 0.0-2.5] mmHg, p = 0.049). Changes in BP were not accompanied by compensatory increases in heart rate, did not correlate with basal insulin sensitivity estimates and were not explained by changes in antihypertensive therapy between the various strata.

Conclusion: When added to metformin or a sulfonylurea, 12-month treatment with rosiglitazone reduces ambulatory BP to a greater extent than when metformin and a sulfonylurea are combined.

Trial registration: NCT00379769 http://clinicaltrials.gov/

Figures

Figure 1
Figure 1
Model-adjusted mean difference in ABPM for rosiglitazone compared to sulfonylurea and to metformin in combination therapy.

References

    1. Wingard DL, Barrett-Connor EL, Ferrara A. Is insulin really a heart disease risk factor. Diabetes Care. 1995;18:1299–1304.
    1. Kannel WB, D'Agostino RB, Wilson PW, Belanger AJ, Gagnon DR. Diabetes, fibrinogen, and risk of cardiovascular disease: the Framingham experience. Am Heart J. 1990;120:672–676. doi: 10.1016/0002-8703(90)90026-T.
    1. Stamler J, Vaccaro O, Neaton JD, Wentworth D. Diabetes, other risk factors, and 12-yr cardiovascular mortality for men screened in the Multiple Risk Factor Intervention Trial. Diabetes Care. 1993;16:434–444. doi: 10.2337/diacare.16.2.434.
    1. UK Prospective Diabetes Study (UKPDS) Group Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. BMJ. 1998;317:703–713.
    1. Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL, Jr., Jones DW, Materson BJ, Oparil S, Wright JT, Jr., Roccella EJ. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003;289:2560–2572. doi: 10.1001/jama.289.19.2560.
    1. International Diabetes Federation Clinical Guidelines Taskforce . Global Guideline for Type 2 Diabetes. Brussels: International Diabetes Federation; 2005.
    1. European Society of Hypertension (ESH) - European Society of Cardiology Guidelines Committee 2003 European Society of Hypertension-European Society of Cardiology guidelines for the management of arterial hypertension. J Hypertens. 2003;21:1011–1053. doi: 10.1097/00004872-200306000-00001.
    1. Brenner BM, Cooper ME, De Zeeuw D, Keane WF, Mitch WE, Parving HH, Remuzzi G, Snapinn S, Zhang Z, Shahinar S. Effects of Losartan on Renal and Cardiovascular Outcomes in Patients with Type 2 Diabetes and Nephropathy. N Engl J Med. 2001;345:861–869. doi: 10.1056/NEJMoa011161.
    1. Lewis EJ, Hunsicker LG, Clarke WR, Berl T, Pohlmann J, Arjomand H, Rohde R, Raz I. Renoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes. N Engl J Med. 2001;345:851–860. doi: 10.1056/NEJMoa011303.
    1. UK Prospective Diabetes Study (UKPDS) Group Cost effectiveness analysis of improved blood pressure control in hypertensive patients with type 2 diabetes: UKPDS 40. BMJ. 1998;317:720–726.
    1. De Backer G, Ambrosioni E, Borch-Johnsen K, Brotons C, Cifkova R, Dallongeville J, Ebrahim S, Faergeman O, Graham I, Mancia G, Manger C, V, Orth-Gomer K, Perk J, Pyorala K, Rodicio JL, Sans S, Sansoy V, Sechtem U, Silber S, Thomsen T, Wood D. European guidelines on cardiovascular disease prevention in clinical practice. Third Joint Task Force of European and Other Societies on Cardiovascular Disease Prevention in Clinical Practice. Eur Heart J. 2003;24:1601–1610. doi: 10.1016/S0195-668X(03)00347-6.
    1. Miyazaki Y, Glass L, Triplitt C, Matsuda M, Cusi K, Mahankali A, Mahankali S, Mandarino LJ, DeFronzo RA. Effect of rosiglitazone on glucose and non-esterified fatty acid metabolism in Type II diabetic patients. Diabetologia. 2001;44:2210–2219. doi: 10.1007/s001250100031.
    1. Carey DG, Cowin GJ, Galloway GJ, Jones NP, Richards JC, Biswas N, Doddrell DM. Effect of rosiglitazone on insulin sensitivity and body composition in type 2 diabetic patients [corrected] Obes Res. 2002;10:1008–1015.
    1. Virtanen KA, Hällsten K, Parkkola R, Janatuinen T, Lonnqvist F, Viljanen T, Ronnemaa T, Nuutila P. Differential effects of rosiglitazone and metformin on adipose tissue distribution and glucose uptake in type 2 diabetic subjects. Diabetes. 2003;52:283–290. doi: 10.2337/diabetes.52.2.283.
    1. Goldberg RB, Kendall DM, Deeg MA, Buse JB, Zagar AJ, Pinaire JA, Tan MH, Khan MA, Perez AT, Jacober SJ. A comparison of lipid and glycemic effects of pioglitazone and rosiglitazone in patients with type 2 diabetes and dyslipidemia. Diabetes Care. 2005;28:1547–1554. doi: 10.2337/diacare.28.7.1547.
    1. Haffner S, Greenberg AS, Weston WM, Chen H, Williams K, Freed MI. Effect of rosiglitazone treatment on nontraditional markers of cardiovascular disease in patients with type 2 diabetes mellitus. Circulation. 2002;106:679–684. doi: 10.1161/01.CIR.0000025403.20953.23.
    1. Stocker DJ, Taylor AJ, Langley RW, Jezior MR, Vigersky RA. A randomized trial of the effects of rosiglitazone and metformin on inflammation and subclinical atherosclerosis in patients with type 2 diabetes. Am Heart J. 2007;153:445–446. doi: 10.1016/j.ahj.2006.11.005.
    1. Mazzone T, Meyer PM, Feinstein SB, Davidson MH, Kondos GT, D'Agostino RB, Sr., Perez A, Provost JC, Haffner SM. Effect of pioglitazone compared with glimepiride on carotid intima-media thickness in type 2 diabetes: a randomized trial. JAMA. 2006;296:2572–2581. doi: 10.1001/jama.296.21.joc60158.
    1. Walker AB, Chattington PD, Buckingham RE, Williams G. The thiazolidinedione rosiglitazone (BRL-49653) lowers blood pressure and protects against impairment of endothelial function in Zucker fatty rats. Diabetes. 1999;48:1448–1453. doi: 10.2337/diabetes.48.7.1448.
    1. Bennett SM, Agrawal A, Elasha H, Heise M, Jones NP, Walker M, Wilding JP. Rosiglitazone improves insulin sensitivity, glucose tolerance and ambulatory blood pressure in subjects with impaired glucose tolerance. Diabet Med. 2004;21:415–422. doi: 10.1111/j.1464-5491.2004.01155.x.
    1. Negro R, Mangieri T, Dazzi D, Pezzarossa A, Hassan H. Rosiglitazone effects on blood pressure and metabolic parameters in nondipper diabetic patients. Diabetes Res Clin Pract. 2005;70:20–25. doi: 10.1016/j.diabres.2005.02.012.
    1. St John Sutton M, Rendell M, Dandona P, Dole JF, Murphy K, Patwardhan R, Patel J, Freed M. A comparison of the effects of rosiglitazone and glyburide on cardiovascular function and glycemic control in patients with type 2 diabetes mellitus. Diabetes Care. 2002;25:2058–2064. doi: 10.2337/diacare.25.11.2058.
    1. Natali A, Baldeweg S, Toschi E, Capaldo B, Barbaro D, Gastaldelli A, Yudkin JS, Ferrannini E. Vascular effects of improving metabolic control with metformin or rosiglitazone in type 2 diabetes. Diabetes Care. 2004;27:1349–1357. doi: 10.2337/diacare.27.6.1349.
    1. Honisett SY, Stojanovska L, Sudhir K, Kingwell BA, Dawood T, Komesaroff PA. Rosiglitazone lowers blood pressure and increases arterial compliance in postmenopausal women with type 2 diabetes. Diabetes Care. 2003;26:3194–3195. doi: 10.2337/diacare.26.11.3194.
    1. Calvo C, Lopez JE, Covelo M, Dominguez MJ, Martinez C, Lorenzo V, Ayala DE, Hermida RC. Diabetes and arteriosclerosis. The role of antagonists of PPAR-gamma. Am J Hypertens. 2002;15 (Suppl 1):A188–A189. doi: 10.1016/S0895-7061(02)02783-8.
    1. Sarafidis PA, Lasaridis AN, Nilsson PM, Pagkalos EM, Hitoglou-Makedou AD, Pliakos CI, Kazakos KA, Yovos JG, Zebekakis PE, Tziolas IM, Tourkantonis AN. Ambulatory blood pressure reduction after rosiglitazone treatment in patients with type 2 diabetes and hypertension correlates with insulin sensitivity increase. J Hypertens. 2004;22:1769–1777. doi: 10.1097/00004872-200409000-00022.
    1. Yosefy C, Magen E, Kiselevich A, Priluk R, London D, Volchek L, Viskoper RJ., Jr. Rosiglitazone improves, while glibenclamide worsens blood pressure control in treated hypertensive diabetic and dyslipidemic subjects via modulation of insulin resistance and sympathetic activity. J Cardiovasc Pharmacol. 2004;44:215–222. doi: 10.1097/00005344-200408000-00011.
    1. Raji A, Seely EW, Bekins SA, Williams GH, Simonson DC. Rosiglitazone improves insulin sensitivity and lowers blood pressure in hypertensive patients. Diabetes Care. 2003;26:172–178. doi: 10.2337/diacare.26.1.172.
    1. Home PD, Pocock SJ, Beck-Nielsen H, Gomis R, Hanefeld M, Dargie H, Komajda M, Gubb J, Biswas N, Jones NP. Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes (RECORD): study design and protocol. Diabetologia. 2005;48:1726–1735. doi: 10.1007/s00125-005-1869-1.
    1. World Health Organization . Definition, diagnosis and classification of diabetes mellitus and its complications. Document WHO/NCD/NCS/99.2. Geneva, WHO Department of Noncommunicable Disease Surveillance; 1999.
    1. European Diabetes Policy Group A desktop guide to type 2 diabetes. Diabet Med. 1999;16:716–730. doi: 10.1046/j.1464-5491.1999.00166.x.
    1. O'Brien E, Atkins N, Staessen J. State of the market. A review of ambulatory blood pressure monitoring devices. Hypertension. 1995;26:835–842.
    1. Diabetes Trials Unit University of Oxford HOMA calculator. 2005.
    1. Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med. 2007;356:2457–2471. doi: 10.1056/NEJMoa072761.
    1. Home PD, Pocock SJ, Beck-Nielsen H, Gomis R, Hanefeld M, Jones NP, Komajda M, McMurray JJV. Rosiglitazone evaluated for cardiovascular outcomes - an interim analysis. N Engl J Med. 2007;357:28–38. doi: 10.1056/NEJMoa073394.
    1. GlaxoSmithKline Advisory Committee Briefing Document. Cardiovascular Safety of Rosiglitazone. Endocrinologic and Metabolic Drugs Advisory Committee Drug Safety and Risk Management Advisory Committee Meeting on July 30. 2007.
    1. Dormandy JA, Charbonnel B, Eckland DA, Erdmann E, Massi-Benedetti M, Moules I, Skene A, Tan MH, Lefebvre PJ, Murray GD, Standl E, Wilcox RG, Wilhelmsen L, Betteridge DJ, Birkeland KI, Golay A, RJ H, Koranyi L, Laakso M, Mokan M, Norkus A, Pirags V, Podar T, Scheen A, Scherbaum W, Schernthaner G, Schmitz O, Skrha J, Smith U, Taton J, on behalf of the PROactive investigators 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;366:1279–1289. doi: 10.1016/S0140-6736(05)67528-9.
    1. Pfutzner A, Marx N, Lübben G, Langenfeld M, Walcher D, Konrad T, Forst T. Improvement of cardiovascular risk markers by pioglitazone is independent from glycemic control: results from the Pioneer study. J Am Coll Cardiol. 2005;45:1925–1931. doi: 10.1016/j.jacc.2005.03.041.
    1. Pistrosch F, Passauer J, Fischer S, Fuecker K, Hanefeld M, Gross P. In type 2 diabetes, rosiglitazone therapy for insulin resistance ameliorates endothelial dysfunction independent of glucose control. Diabetes Care. 2004;27:484–490. doi: 10.2337/diacare.27.2.484.
    1. Stuhlinger MC, Abbasi F, Chu JW, Lamendola C, McLaughlin TL, Cooke JP, Reaven GM, Tsao PS. Relationship between insulin resistance and an endogenous nitric oxide synthase inhibitor. JAMA. 2002;287:1420–1426. doi: 10.1001/jama.287.11.1420.
    1. Shargorodsky M, Wainstein G, Gavish E, Leibovitz Z, Matas D, Zimlichman R. Treatment with rosiglitazone reduces hyperinsulinemia and improves arterial elasticity in patients with type 2 diabetes mellitus. Am J Hypertens. 2003;16:617–622. doi: 10.1016/S0895-7061(03)00911-7.
    1. Buchanan TA, Meehan WP, Jeng YY, Yang D, Chan TM, Nadler JL, Scott S, Rude RK, Hsueh WA. Blood pressure lowering by pioglitazone. Evidence for a direct vascular effect. J Clin Invest. 1995;96:354–360. doi: 10.1172/JCI118041.
    1. Song J, Walsh MF, Igwe R, Ram JL, Barazi M, Dominguez LJ, Sowers JR. Troglitazone reduces contraction by inhibition of vascular smooth muscle cell Ca2+ currents and not endothelial nitric oxide production. Diabetes. 1997;46:659–664. doi: 10.2337/diabetes.46.4.659.
    1. Zhang F, Sowers JR, Ram JL, Standley PR, Peuler JD. Effects of pioglitazone on calcium channels in vascular smooth muscle. Hypertension. 1994;24:170–175.
    1. Brayden JE, Nelson MT. Regulation of arterial tone by activation of calcium-dependent potassium channels. Science. 1992;256:532–535. doi: 10.1126/science.1373909.
    1. Hernandez-Trujillo Y, Rodriguez-Esparragon F, Macias-Reyes A, Caballero-Hidalgo A, Rodriguez-Perez JC. Rosiglitazone but not losartan prevents Nrf-2 dependent CD36 gene expression up-regulation in an in vivo atherosclerosis model. Cardiovasc Diabetol. 2008;7:3. doi: 10.1186/1475-2840-7-3.
    1. Harte A, McTernan P, Chetty R, Coppack S, Katz J, Smith S, Kumar S. Insulin-mediated upregulation of the renin angiotensin system in human subcutaneous adipocytes is reduced by rosiglitazone. Circulation. 2005;111:1954–1961. doi: 10.1161/01.CIR.0000161954.17870.5D.
    1. Adler AI, Stratton IM, Neil HA, Yudkin JS, Matthews DR, Cull CA, Wright AD, Turner RC, Holman RR. Association of systolic blood pressure with macrovascular and microvascular complications of type 2 diabetes (UKPDS 36): prospective observational study. BMJ. 2000;321:412–419. doi: 10.1136/bmj.321.7258.412.
    1. Yusuf S, Sleight P, Pogue J, Bosch J, Davies R, Dagenais G. Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. The Heart Outcomes Prevention Evaluation Study Investigators. N Engl J Med. 2000;342:145–153. doi: 10.1056/NEJM200001203420301.
    1. Hansson L, Zanchetti A, Carruthers SG, Dahlof B, Elmfeldt D, Julius S, Menard J, Rahn KH, Wedel H, Westerling S. Effects of intensive blood-pressure lowering and low-dose aspirin in patients with hypertension: principal results of the Hypertension Optimal Treatment (HOT) randomised trial. HOT Study Group. Lancet. 1998;351:1755–1762. doi: 10.1016/S0140-6736(98)04311-6.
    1. Erdmann E, Dormandy JA, Charbonnel B, Massi-Benedetti M, Moules IK, Skene AM. The effect of pioglitazone on recurrent myocardial infarction in 2,445 patients with type 2 diabetes and previous myocardial infarction: results from the PROactive (PROactive 05) Study. J Am Coll Cardiol. 2007;49:1772–1780. doi: 10.1016/j.jacc.2006.12.048.
    1. McAfee AT, Koro C, Landon J, Ziyadeh N, Walker AM. Coronary heart disease outcomes in patients receiving antidiabetic agents. Pharmacoepidemiol Drug Saf. 2007;16:711–725. doi: 10.1002/pds.1443.
    1. Lipscombe LL, Gomes T, Levesque LE, Hux JE, Juurlink DN, Alter DA. Thiazolidinediones and cardiovascular outcomes in older patients with diabetes. JAMA. 2007;298:2634–2643. doi: 10.1001/jama.298.22.2634.

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