Efficacy of an olmesartan medoxomil-based treatment algorithm in patients with hypertension and type 2 diabetes: analysis of diurnal blood pressure control as assessed by 24-hour ambulatory blood pressure monitoring

Abstract

Objective: Secondary, prespecified analysis of a single-arm, open-label study evaluating the efficacy of olmesartan medoxomil (OM) plus hydrochlorothiazide (HCTZ) in patients with hypertension and type 2 diabetes.

Methods: After placebo run-in, 192 patients received OM 20 mg/day for 3 weeks. If blood pressure (BP) remained ≥120/70 mmHg, patients were uptitrated every 3 weeks to OM 40 mg/day, OM/HCTZ 40/12.5 mg/day, and OM/HCTZ 40/25 mg/day. Efficacy was evaluated by 24-hour ambulatory BP monitoring. Secondary endpoints included changes in ambulatory systolic BP (SBP) and diastolic BP (DBP) during daytime (08:00 to 16:00) and nighttime (22:00 to 06:00), as well as achievement of prespecified ambulatory BP targets in the total cohort and subgroups based on gender, race, hypertension severity, and age (≥65 or <65 years). Dipper status (nocturnal decrease in BP ≥10% of mean daytime BP) was assessed.

Results: At baseline, mean ambulatory BP was 151.2 ± 12.7/87.6 ± 9.0 mmHg during the daytime and 140.3 ± 13.1/78.1 ± 8.6 mmHg during the nighttime. Mean daytime and nighttime ambulatory BP was reduced from baseline by 22.3 ± 13.7/12.0 ± 8.9 mmHg and 18.8 ± 12.4/ 10.2 ± 7.2 mmHg, respectively. The reduction in daytime ambulatory SBP was 24.4 ± 11.8 mmHg in Blacks, 21.7 ± 14.2 mmHg in non-Blacks, 23.6 ± 12.3 mmHg in females, 21.2 ± 14.8 mmHg in males, 23.4 ± 11.6 mmHg in patients aged ≥65 years, and 21.9 ± 14.4 mmHg in those aged <65 years. Ambulatory BP targets of <130/80, <125/75, and <120/80 mmHg were reached by 51.7%, 36.0%, and 32.6% of patients during the daytime and 69.8%, 60.5%, and 50.6% of patients during the nighttime. After 12 weeks of treatment, 36.4% of baseline nondippers converted to dippers.

Conclusions: OM ± HCTZ effectively lowered ambulatory BP in patients with type 2 diabetes and hypertension, enabling them to achieve ambulatory BP targets during both the daytime and nighttime.

Keywords

ambulatory blood pressure monitoring circadian rhythm diabetes hypertension olmesartan medoxomil

References

Arauz-Pacheco, C. , Parrott, M.A. and Raskin, P. ( 2002) The treatment of hypertension in adult patients with diabetes . Diabetes Care 25: 134-147.

American Diabetes Association (2009) Standards of medical care in diabetes-2009 . Diabetes Care 32(Suppl 1): S13-S61.

Bakris, G.L. and Sowers, J.R. ( 2008) ASH Position Paper: Treatment of hypertension in patients with diabetes-an update. J Clin Hypertens ( Greenwich) 10: 707-713.

Bjorklund, K. , Lind, L. , Andren, B. and Lithell, H. ( 2002) The majority of nondipping men do not have increased cardiovascular risk: a population-based study. J Hypertens 20: 1501-1506.

Bouhanick, B. , Bongard, V. , Amar, J. , Bousquel, S. and Chamontin, B. ( 2008) Prognostic value of nocturnal blood pressure and reverse-dipping status on the occurrence of cardiovascular events in hypertensive diabetic patients. Diabetes Metab 34: 560-567.

Brewster, U.C. , Setaro, J.F. and Perazella, M.A. ( 2003) The renin-angiotensin-aldosterone system: cardiorenal effects and implications for renal and cardiovascular disease states. Am J Med Sci 326: 15-24.

Chavanu, K. , Merkel, J. and Quan, A.M. ( 2008) Role of ambulatory blood pressure monitoring in the management of hypertension. Am J Health Syst Pharm 65: 209-218.

Chobanian, A.V. , Bakris, G.L. , Black, H.R. , Cushman, W.C. , Green, L.A. , Izzo Jr, J.L. et al. (2003) Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure . Hypertension 42: 1206-1252.

Hansson, L. , Zanchetti, A. , Carruthers, S.G. , Dahlof, B. , Elmfeldt, D. , Julius, S. et al. (1998) 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 351: 1755-1762.

10.

Izzedine, H. , Launay-Vacher, V. and Deray, G. ( 2006) Abnormal blood pressure circadian rhythm: a target organ damage? Int J Cardiol 107: 343-349.

11.

Jerrard-Dunne, P. , Mahmud, A. and Feely, J. ( 2007) Circadian blood pressure variation: relationship between dipper status and measures of arterial stiffness. J Hypertens 25: 1233-1239.

12.

Mancia, G. , De Backer, G. , Dominiczak, A. , Cifkova, R. , Fagard, R. , Germano, G. et al. (2007) 2007 Guidelines for the management of arterial hypertension: The Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). Eur Heart J 28: 1462-1536.

13.

Manning, G. , Rushton, L. , Donnelly, R. and Millar-Craig, M.V. ( 2000) Variability of diurnal changes in ambulatory blood pressure and nocturnal dipping status in untreated hypertensive and normotensive subjects . Am J Hypertens 13: 1035-1038.

14.

Mochizuki, Y. , Okutani, M. , Donfeng, Y. , Iwasaki, H. , Takusagawa, M. , Kohno, I. et al. (1998) Limited reproducibility of circadian variation in blood pressure dippers and nondippers. Am J Hypertens 11: 403-409.

15.

Nakano, S. , Fukuda, M. , Hotta, F. , Ito, T. , Ishii, T. , Kitazawa, M. et al. (1998) Reversed circadian blood pressure rhythm is associated with occurrences of both fatal and nonfatal vascular events in NIDDM subjects. Diabetes 47: 1501-1506.

16.

Nakano, S. , Ito, T. , Furuya, K. , Tsuda, S. , Konishi, K. , Nishizawa, M. et al. (2004) Ambulatory blood pressure level rather than dipper/nondipper status predicts vascular events in type 2 diabetic subjects . Hypertens Res 27: 647-656.

17.

Neutel, J.M. , Kereiakes, D.J. , Waverczak, W.F. , Stoakes, K.A. , Xu, J. and Shojaee, A. (2010) Effects of an olmesartan medoxomil based treatment algorithm on 24-hour blood pressure control in patients with hypertension and type 2 diabetes. Curr Med Res Opin 26: 721-728.

18.

Parati, G. and Staessen, J.A. ( 2007) Day-night blood pressure variations: mechanisms, reproducibility and clinical relevance. J Hypertens 25: 2377-2380.

19.

Pickering, T.G. and Kario, K. ( 2001) Nocturnal non-dipping: what does it augur? Curr Opin Nephrol Hypertens 10: 611-616.

20.

Routledge, F. and McFetridge-Durdle, J. ( 2007) Nondipping blood pressure patterns among individuals with essential hypertension: a review of the literature. Eur J Cardiovasc Nurs 6: 9-26.

21.

Smith, D.H. , Dubiel, R. and Jones, M. ( 2005) Use of 24-hour ambulatory blood pressure monitoring to assess antihypertensive efficacy: a comparison of olmesartan medoxomil, losartan potassium, valsartan, and irbesartan. Am J Cardiovasc Drugs 5: 41-50.

22.

UK Prospective Diabetes Study Group (1998) Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. UK Prospective Diabetes Study Group. BMJ 317: 703-713.

23.

Van Der Steen, M.S. , Lenders, J.W. , Graafsma, S.J. , Den Arend, J. and Thien, T. ( 1999) Reproducibility of ambulatory blood pressure monitoring in daily practice. J Hum Hypertens 13: 303-308.

24.

Van Der Steen, M.S. , Pleijers, A.M. , Lenders, J.W. and Thien, T. ( 2000) Influence of different supine body positions on blood pressure: consequences for night blood pressure/dipper-status. J Hypertens 18: 1731-1736.

25.

Volpe, M. , Ruilope, L.M. , Mcinnes, G.T. , Waeber, B. and Weber, M.A. ( 2005) Angiotensin-II receptor blockers: benefits beyond blood pressure reduction? J Hum Hypertens 19: 331-339.

26.

Weber, M.A. ( 2003) Angiotensin II receptor blockers, In: Izzo, J.L. and Black, H.R. (eds). Hypertension Primer, 3rd edn, Lippincott, Williams and Wilkins: Philadelphia, PA.

27.

Wong, N.D. , Lopez, V.A. , L’italien, G. , Chen, R. , Kline, S.E. and Franklin, S.S. ( 2007) Inadequate control of hypertension in US adults with cardiovas- cular disease comorbidities in 2003-2004. Arch Intern Med 167: 2431-2436.