Effectiveness and Safety of Aliskiren and Aliskiren Hydrochlorothiazide (HCT) in a Multiethnic, Real-World Setting
Numerous randomized clinical trials have demonstrated the efficacy and tolerability of aliskiren and aliskiren hydrochlorothiazide (aliskiren HCT) single-pill combination therapy in patients with hypertension. The objective of the present study was to evaluate the effectiveness and safety of aliskiren-based therapy under daily life conditions in a multiethnic population.
This observational, multicenter, noninterventional study, conducted at 420 centers in Asia and the Middle East, included adult patients with hypertension who received treatment with aliskiren or aliskiren HCT as single or add-on therapy for a planned treatment period of at least 26 weeks. The main effectiveness assessments included the proportion of patients achieving therapeutic blood pressure (BP) goal (defined as systolic BP [SBP]/diastolic BP [DBP] <140/90 mmHg, or <130/80 mmHg in patients with diabetes) and BP response, and change in mean sitting BP from baseline to study end.
Of 4,826 patients (mean age 51.4 years, 65.9% male, 64.5% Asian, 41.5% diabetic) included in the study, 3,473 received aliskiren and 1,353 received aliskiren HCT. Almost half the study population (48.1%) received aliskiren or aliskiren HCT as add-on therapy. The therapeutic BP goal was achieved in 49.5% of patients treated with aliskiren and 48.3% of patients receiving aliskiren HCT; attainment of BP goal increased to more than 70% when a classic BP target of <140/90 mmHg was applied for all patients. Reductions in mean sitting SBP/DBP were significantly lower versus baseline for both aliskiren (24.1/12.2 mmHg) and aliskiren HCT (27.6/14.1 mmHg) and BP response rates were consistently achieved in more than 80% of all patients during the study. Aliskiren treatment was well tolerated with only a small proportion of patients experiencing adverse events (AEs; 2.1%) and serious AEs (0.3%).
In this real-world, naturalistic setting, antihypertensive treatment with an aliskiren-based regimen was effective and well-tolerated in this multiethnic population with arterial hypertension.
- Ezzati M, Lopez AD, Rodgers A, Vander Hoorn S, Murray CJ; Comparative Risk Assessment Collaborating Group. Selected major risk factors and global and regional burden of disease. Lancet. 2002;360:1347–1360. CrossRef
- Kearney PM, Whelton M, Reynolds K, Muntner P, Whelton PK, He J. Global burden of hypertension: analysis of worldwide data. Lancet. 2005;365:217–223.
- Chobanian AV, Bakris GL, Black HR, et al. The seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. JAMA. 2003;289:2560–2572. CrossRef
- Kannel WB, D’Agostino RB, Cobb JL. Effect of weight on cardiovascular disease. Am J Clin Nutr 1996;63(3 Suppl.): 419S–422S.
- Kannel WB. Fifty years of Framingham Study contributions to understanding hypertension. J Hum Hypertens. 2000;14:83–90. CrossRef
- Lawes CM, Vander Hoorn S, Rodgers A; International Society of Hypertension. Global burden of blood-pressure-related disease, 2001. Lancet. 2008;371:1513–1518. CrossRef
- Lewington S, Clarke R, Qizilbash N, Peto R, Collins R; Prospective Studies Collaboration. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet. 2002;360:1903–1913. CrossRef
- Wolf-Maier K, Cooper RS, Kramer H, et al. Hypertension treatment and control in five European counties, Canada, and the United States. Hypertension. 2004;43:10–17. CrossRef
- Antikainen RL, Moltchanov VA, Chukwuma C Sr, et al. Trends in the prevalence, awareness, treatment and control of hypertension: the WHO MONICA Project. Eur J Cardiovasc Prev Rehabil. 2006;13:13–29. CrossRef
- Sison J, Arceo LP, Trinidad E, et al. Philippine Heart Association-Council on Hypertension Report on survey of hypertension and target organ damage (PRESYON 2-TOD). A report on prevalence of hypertension, awareness, treatment profile and control rate. Philipp J Cardiol. 2007;35:1–9.
- Burnier M, Brown RE, Ong SH, Keskinaslan A, Khan ZM. Issues in blood pressure control and the potential role of single-pill combination therapies. Int J Clin Pract. 2009;63:790–798. CrossRef
- Azizi M, Webb R, Nussberger J, Hollenberg NK. Renin inhibition with aliskiren: where are we now, and where are we going? J Hypertens. 2006;24:243–256. CrossRef
- Müller DN, Luft FC. Direct renin inhibition with aliskiren in hypertension and target organ damage. Clin J Am Soc Nephrol. 2006;1:221–228. CrossRef
- Black HR, Kribben A, Aguirre Palacios F, Bijarnia M, Laflamme AK, Baschiera F. Aliskiren alone or in combination with hydrochlorothiazide in patients with the lower ranges of stage 2 hypertension: The ACQUIRE randomized double-blind study. J Clin Hypertens (Greenwich). 2010;12:917–926. CrossRef
- Krone W, Hanefeld M, Meyer HF, et al. Comparative efficacy and safety of aliskiren and irbesartan in patients with hypertension and metabolic syndrome. J Hum Hypertens. 2011;25:186–195. CrossRef
- Whaley-Connell A, Purkayastha D, Yadao A, Sowers JR. Central pressure and biomarker responses to renin inhibition with hydrochlorothiazide and ramipril in obese hypertensives: the ATTAIN study. Cardiorenal Med. 2011;1:53–66. CrossRef
- Duprez DA, Munger MA, Botha J, Keefe DL, Charney AN. Aliskiren for geriatric lowering of systolic hypertension: a randomized controlled trial. J Hum Hypertens. 2010;24:600–608. CrossRef
- Verpooten GA, Aerts A, Coen N, et al. Antihypertensive effectiveness of aliskiren for the “real-world” management of hypertension: multilevel modelling of 180-day blood pressure outcomes (the Belgian DRIVER Study). Int J Clin Pract. 2011;65:54–63. CrossRef
- De Cotret P, Steele A, Leclerc JM, et al. Real-life blood pressure reductions in hypertension patients treated with aliskiren. Interim results of the Canadian Anchor registry (4A.05). J Hypertens. 2011 (eSuppl. A); 29:e48.
- Zeymer U, Dechend R, Deeg E, et al. Aliskiren for the treatment of essential hypertension under real-life practice conditions: design and baseline data of the prospective 3A registry. Int J Clin Pract. 2012;66:251–261. CrossRef
- American Heart Association Committee. American Heart Association Committee report on blood pressure determination. Hypertension. 1988;1210A–1222A.
- Düsing R. Overcoming barriers to effective blood pressure control in patients with hypertension. Curr Med Res Opin. 2006;22:1545–1553. CrossRef
- Saleem F, Hassali AA, Shafie AA. Hypertension in Pakistan: time to take some serious action. Br J Gen Pract. 2010;60:449–450 [Letter]. CrossRef
- Abdulle AM, Nagelkerke NJ, Abouchacra S, Pathan JY, Adem A, Obineche EN. Under-treatment and under diagnosis of hypertension: a serious problem in the United Arab Emirates. BMC Cardiovasc Disord. 2006;6:24. CrossRef
- ACCORD Study Group, Cushman WC, Evans GW, et al. Effects of intensive blood-pressure control in type 2 diabetes mellitus. N Engl J Med. 2010;362:1575–1585. CrossRef
- Mancia G, Laurent S, Agabiti-Rosei E, et al. Reappraisal of European guidelines on hypertension management: a European Society of Hypertension Task Force document. J Hypertens. 2009;27:2121–2158. CrossRef
- Ruggenenti P, Perna A, Loriga G, et al. Blood-pressure control for renoprotection in patients with non-diabetic chronic renal disease (REIN-2): multicentre, randomised controlled trial. Lancet. 2005;365:939–946. CrossRef
- Wright JT Jr., Bakris G, Greene T, et al. Effect of blood pressure lowering and antihypertensive drug class on progression of hypertensive kidney disease: results from the AASK trial. JAMA. 2002;288:2421–2431. CrossRef
- Peralta CA, Norris KC, Li S, et al. Blood pressure components and end-stage renal disease in persons with chronic kidney disease: the Kidney Early Evaluation Program (KEEP). Arch Intern Med. 2012;172:41–47. CrossRef
- Andersen K, Weinberger MH, Egan B, et al. Comparative efficacy and safety of aliskiren, an oral direct renin inhibitor, and ramipril in hypertension: a 6-month, randomized, double-blind trial. J Hypertens. 2008;26:589–599. CrossRef
- Parving HH, Brenner BM, McMurray JJ, et al. Cardiorenal end points in a trial of aliskiren for type 2 diabetes. N Engl J Med. 2012;367:2204–2213. CrossRef
- Hussain SM, Boonshuyar C, Ekram ARMS. Non-adherence to antihypertensive treatment in essential hypertensive patients in Rajshahi, Bangladesh. AKMMC J. 2011;2:9–14.
- Wagner AK, Valera M, Graves AJ, Laviña S, Ross-Degnan D. Costs of hospital care for hypertension in an insured population without an outpatient medicines benefit: an observational study in the Philippines. BMC Health Serv Res. 2008;8:161. CrossRef
- Effectiveness and Safety of Aliskiren and Aliskiren Hydrochlorothiazide (HCT) in a Multiethnic, Real-World Setting
- Open Access
- Available under Open Access This content is freely available online to anyone, anywhere at any time.
Advances in Therapy
Volume 30, Issue 2 , pp 176-189
- Cover Date
- Print ISSN
- Online ISSN
- Springer Healthcare Communications
- Additional Links
- Aliskiren HCT
- Direct renin inhibitor
- Middle East
- Industry Sectors
- Author Affiliations
- 15. D.No.8-2-330/A/2, CARE Hospital, Banjara Hills, Road No. 5, Opposite Nokia Towers, Hyderabad, India
- 25. Al Zahra Hospital, Sharjah, UAE
- 35. Anwer Khan Modern Medical College, Dhanmondi, Dhaka, Bangladesh
- 45. Hariri University Hospital, Beirut, Lebanon
- 55. Saint Luke’s Medical Center, Quezon City, Philippines, USA
- 65. Hameed Latif Hospital, Lahore, Pakistan
- 85. the National Hospital Lahore, Lahore, Pakistan
- 75. Novartis Pharma AG, Basel, Switzerland