Real-world effectiveness of valsartan on hypertension and total cardiovascular risk: Review and implications of a translational research program

Vascular Health and Risk Management

Volumn 7, Issue 1, 2011, Pages 209-235

  Abraham, Ivo ^a,b   MacDonald, Karen ^b   Hermans, Christine ^c   Aerts, Ann ^c   Lee, Christopher ^b,d   Brié, Heidi ^c   Vancayzeele, Stefaan ^c  

^a UNIVERSITY OF ARIZONA   (United States)

^b Matrix45 ^*  (United States)

^c Novartis Pharma   (Belgium)

^d OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

Author keywords

Angiotensin II receptor blocker; Effectiveness; Hypertension; Pharmaco epidemiology; Total cardiovascular risk; Valsartan

Indexed keywords

ANGIOTENSIN 1 RECEPTOR ANTAGONIST; ANTIHYPERTENSIVE AGENT; DRUG DERIVATIVE; TETRAZOLE DERIVATIVE; VALINE; VALSARTAN;

BLOOD PRESSURE; CARDIOVASCULAR DISEASE; DRUG COMBINATION; DRUG EFFECT; EVIDENCE BASED MEDICINE; HEALTH CARE QUALITY; HUMAN; HYPERTENSION; META ANALYSIS; PATHOPHYSIOLOGY; REVIEW; RISK ASSESSMENT; RISK FACTOR; TRANSLATIONAL RESEARCH; TREATMENT OUTCOME;

ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKERS; ANTIHYPERTENSIVE AGENTS; BLOOD PRESSURE; CARDIOVASCULAR DISEASES; DRUG THERAPY, COMBINATION; EVIDENCE-BASED MEDICINE; HUMANS; HYPERTENSION; PROGRAM EVALUATION; RISK ASSESSMENT; RISK FACTORS; TETRAZOLES; TRANSLATIONAL RESEARCH; TREATMENT OUTCOME; VALINE;

EID: 79958805004     PISSN: 11766344     EISSN: 11782048     Source Type: Journal    
DOI: 10.2147/VHRM.S9434     Document Type: Review

References (77)

1. Saseen J, Carter B. Hypertension. In: DiPiro J, Talbert R, Yee G, Matzke G, Wells B, Posey L, editors. Pharmacotherapy: A Pathophysiologic Approach. 6th ed. New York: McGraw-Hill; 2005:187-217.
2. Black HR, Bailey J, Zappe D, Samuel R. Valsartan: more than a decade of experience. Drugs. 2009;69(17):2393-2414.
3. Bissessor N, White H. Valsartan in the treatment of heart failure or left ventricular dysfunction after myocardial infarction. Vasc Health Risk Manag. 2007;3(4):425-430.
4. Chrysant SG. Fixed combination therapy of hypertension: focus on valsartan/hydrochlorothiazide combination (Diovan/HCT). Expert Rev Cardiovasc Ther. 2003;1(3):335-343.
5. Chrysant SG, Chrysant GS. Clinical experience with angiotensin receptor blockers with particular reference to valsartan. J Clin Hypertens (Greenwich). 2004;6(8):445-451.
6. Fogari R, Zoppi A. A drug safety evaluation of valsartan. Expert Opin Drug Saf.
7. Abraham I. Conceptual and methodological issues in effectiveness research [In Japanese]. Kango Kenkyu-The Japanese Journal of Nursing Research. 2008;41(6):463-467.
8. Westfall JM, Mold J, Fagnan L. Practice-based research-"Blue Highways" on the NIH roadmap. JAMA. 2007;297(4):403-406.
9. Mancia G, De Backer G, Dominiczak A, et al. 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). J Hypertens. 2007;25(6):1105-1187.
10. Mancia G, Laurent S, Agabiti-Rosei E, et al. Reappraisal of European guidelines on hypertension management: a European Society of Hypertension Task Force document. Blood Press. 2009;18(6):308-347.
11. Conroy RM, Pyorala K, Fitzgerald AP, et al. Estimation of ten-year risk of fatal cardiovascular disease in Europe: the SCORE project. Eur Heart J. 2003;24(11):987-1003.
12. Abraham I. Integrating blood pressure and HbA1c outcomes into TCVR as a treatment outcome (e-Letter). Ann Intern Med. December. http:// www.annals.org/content/152/11/689.full/reply#annintmed_el_124829. Accessed December 7, 2010.
13. 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. 2010;65(1):54-63.
14. Steinwachs D, Wu A, Cagney K. Outcomes research and quality of care. In: Spilker B, editor. Quality of Life and Pharmacoeconomics in Clinical Trials. 2nd ed. Philadelphia: Lippincott-Raven; 1996: 747-752.
15. Abraham I, Reel L, Armstrong E. A definition of comparative effectiveness research (e-Letter). BMJ. http://www.bmj.com/content/341/bmj. c4662/reply#bmj_el_241642. Accessed December 7, 2010.
16. Chobanian AV. The hypertension paradox-more uncontrolled disease despite improved therapy. N Engl J Med. 2009;361(9): 878-887.
17. 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: the JNC 7 report. JAMA. 2003;289(19):2560-2572.
18. Guidelines Committee. European Society of Hypertension-European Society of Cardiology guidelines for the management of arterial hypertension. J Hypertens. 2003;21(6):1011-1053.
19. Van der Niepen P, Woestenburg A, Brie H, et al. Effectiveness of valsartan for treatment of hypertension: patient profiling and hierarchical modeling of determinants and outcomes (the PREVIEW study). Ann Pharmacother. 2009;43(5):849-861.
20. Berlowitz DR, Ash AS, Hickey EC, et al. Inadequate management of blood pressure in a hypertensive population. N Engl J Med. 1998;339(27):1957-1963.
21. Fagard RH, Van Den Enden M, Leeman M, Warling X. Survey on treatment of hypertension and implementation of World Health Organization/ International Society of Hypertension risk stratification in primary care in Belgium. J Hypertens. 2002;20(7):1297-1302.
22. Van der Niepen P, Giot C, van de Borne P. Prevalence of isolated uncontrolled systolic blood pressure among treated hypertensive patients in primary care in Belgium: results of the I-inSYST survey. J Hypertens. 2008;26(10):2057-2063.
23. Ong KL, Cheung BM, Man YB, Lau CP, Lam KS. Prevalence, awareness, treatment, and control of hypertension among United States adults 1999-2004. Hypertension. 2007;49(1):69-75.
24. Staessen JA, Wang JG, Thijs L. Cardiovascular prevention and blood pressure reduction: a quantitative overview updated until 1 March 2003. J Hypertens. 2003;21(6):1055-1076.
25. Kannel WB. Elevated systolic blood pressure as a cardiovascular risk factor. Am J Cardiol. 2000;85(2):251-255.
26. Hajjar I, Kotchen TA. Trends in prevalence, awareness, treatment, and control of hypertension in the United States, 1988-2000. JAMA. 2003;290(2):199-206.
27. Chapman RH, Benner JS, Petrilla AA, et al. Predictors of adherence with antihypertensive and lipid-lowering therapy. Arch Intern Med. 2005;165(10):1147-1152.
28. Hyman DJ, Pavlik VN. Self-reported hypertension treatment practices among primary care physicians: blood pressure thresholds, drug choices, and the role of guidelines and evidence-based medicine. Arch Intern Med. 2000;160(15):2281-2286.
29. Sisson SD, Rastegar D, Rice TN, Prokopowicz G, Hughes MT. Physician familiarity with diagnosis and management of hypertension according to JNC 7 guidelines. J Clin Hypertens (Greenwich). 2006;8(5):344-350.
30. Choudhry NK, Fletcher RH, Soumerai SB. Systematic review: the relationship between clinical experience and quality of health care. Ann Intern Med. 2005;142(4):260-273.
31. Birtwhistle RV, Godwin MS, Delva MD, et al. Randomised equivalence trial comparing three month and six month follow up of patients with hypertension by family practitioners. BMJ. 2004;328(7433):204.
32. Johnson ML, Pietz K, Battleman DS, Beyth RJ. Therapeutic goal attainment in patients with hypertension and dyslipidemia. Med Care. 2006;44(1):39-46.
33. Abraham I, Lee C, MacDonald K. Patient adherence in pre-and postregistration studies: different objectives, different approaches. Invited Lecture at the 14th European Symposium on Patient Adherence, Compliance and Persistence, Łodz, Poland. http://www.espacomp.eu/ pdf/Abraham%20.pdf. Accessed December 22, 2010.
34. D'Agostino RB Sr, Grundy S, Sullivan LM, Wilson P. Validation of the Framingham coronary heart disease prediction scores: results of a multiple ethnic groups investigation. JAMA. 2001;286(2): 180-187.
35. Abraham I, Lee C, Song M, et al. "Later, lazier, and unluckier": a heuristic profile of high vulnerability is an independent predictor of uncontrolled blood pressure (the PREVIEW study). Int J Gen Med. 2010;3:163-166.
36. Van der Niepen P, Brié H, Vancayzeele S, et al. Effectiveness of valsartan for the treatment of hypertension: hierarchical linear and logistic modeling of determinants and outcomes (the Belgian IMPROVE study). Poster presented at the 2009 meeting of the Belgian Association of Pharmaceutical Physicians, Brussels. 2009.
37. Novartis. ADVANCE Data on file.
38. Lins R, Brié H, Vancayzeele S, et al. Effectiveness of valsartan 160/ HCTZ25 for treatment of hypertension in difficult-to-treat or treatmentresistant patients: hierarchical linear and logistic modeling of determinants and outcomes (the Belgian INSIST study). Poster presented at the 2009 meeting of the Belgian Association of Pharmaceutical Physicians, Brussels. 2009.
39. Novartis. eNOVA data on file.
40. Lins R, Coen N, Aerts A, et al. Modeling of blood pressure and total cardiovascular risk outcomes after second-line valsartan therapy: the BSCORE study. Arch Cardiovasc Dis. In Press.
41. Lins R, Aerts A, Coen N, et al. Effectiveness of amlodipine-valsartan single-pill combinations: hierarchical modeling of blood pressure and total cardiovascular risk outcomes (the EXCELLENT Study). Ann Pharmacother. In Press.
42. Basile JN, Chrysant S. The importance of early antihypertensive efficacy: the role of angiotensin II receptor blocker therapy. J Hum Hypertens. 2006;20(3):169-175.
43. Kreft IGG, De Leeuw J. Introduction to Multilevel Modeling. Thousand Oaks, CA: Sage; 2002.
44. Verbeke G, Molenberghs G. Linear Mixed Models for Longitudinal Data. New York, NY: Springer-Verlag; 2000.
45. Kleinbaum DG, Klein M. Losistic Regression. 2nd ed. New York, NY: Springer-Verlag; 2005.
46. Law MR, Wald Mj, Morris JK, Jordan RE. Value of low dose combination treatment with blood pressure lowering drugs: analysis of 354 randomized trials. BMJ. 2003:326(7404):1427-1434.
47. Bramlage P, Bohm M, Volpe M, et al. A global perspective on blood pressure treatment and control in a referred cohort of hypertensive patients. J Clin Hypertens (Greenwich). 2010;12(9):666-677.
48. Egan BM, Zhao Y, Axon RN. US trends in prevalence, awareness, treatment, and control of hypertension, 1988-2008. JAMA. 2010;303(20): 2043-2050.
49. Wilkins K, Campbell NR, Joffres MR, et al. Blood pressure in Canadian adults. Health Rep. 2010;21(1):37-46.
50. Grassi G, Cifkova R, Laurent S, et al. Blood pressure control and cardiovascular risk profile in hypertensive patients from central and eastern European countries: results of the BP-CARE study. Eur Heart J. 2010;32(2):218-225.
51. Falaschetti E, Chaudhury M, Mindell J, Poulter N. Continued improvement in hypertension management in England: results from the Health Survey for England 2006. Hypertension. 2009;53(3):480-486.
52. Leenen FH, Schiffrin EL. Control rates of hypertension in North America. Hypertension. 2010;56(4):571-572.
53. Sheridan SL, Viera AJ, Krantz MJ, et al. The effect of giving global coronary risk information to adults: a systematic review. Arch Intern Med. 2010;170(3):230-239.
54. Ahmad T, Mora S. Providing patients with global cardiovascular risk information: is knowledge power? Arch Intern Med. 2010;170(3): 227-228.
55. Agarwal R, Bills JE, Hecht TJ, Light RP. Role of home blood pressure monitoring in overcoming therapeutic inertia and improving hypertension control: a systematic review and meta-analysis. Hypertension. 2011;57(1):29-38.
56. Gasse C, Hense HW, Stieber J, Doring A, Liese AD, Keil U. Assessing hypertension management in the community: trends of prevalence, detection, treatment, and control of hypertension in the MONICA Project, Augsburg 1984-1995. J Hum Hypertens. 2001;15(1): 27-36.
57. Primatesta P, Poulter NR. Hypertension management and control among English adults aged 65 years and older in 2000 and 2001. J Hypertens. 2004;22(6):1093-1098.
58. Ostchega Y, Dillon CF, Hughes JP, Carroll M, Yoon S. Trends in hypertension prevalence, awareness, treatment, and control in older US adults: data from the National Health and Nutrition Examination Survey 1988 to 2004. J Am Geriatr Soc. 2007;55(7):1056-1065.
59. Lloyd-Jones DM, Evans JC, Levy D. Hypertension in adults across the age spectrum: current outcomes and control in the community. JAMA. 2005;294(4):466-472.
60. Abraham I, Demosthenes L, MacDonald K, et al. Hierarchical linear and logistic modeling of outcomes of antihypertensive treatment in elderly patients: findings from the PREVIEW study. Arch Gerontol Geriatr. 2010;51(1):45-53.
61. Bailey KR, Grossardt BR, Graves JW. Novel use of Kaplan-Meier methods to explain age and gender differences in hypertension control rates. Hypertension. 2008;51(4):841-847.
62. MacDonald K, Lee CS, Chen HC, et al. Gender-specific, multi-level determinants of outcomes of antihypertensive treatment: a sub-analysis of the Belgian PREVIEW study. J Hum Hypertens. 2011.
63. Eddy DM. Evidence-based medicine: a unified approach. Health Aff (Millwood). 2005;24(1):9-17.
64. Aapro M, Van Erps J, MacDonald K, et al. Managing cancer-related anaemia in congruence with the EORTC guidelines is an independent predictor of haemoglobin outcome: initial evidence from the RESPOND study. Eur J Cancer. 2009;45(1):8-11.
65. Abraham I. Bringing the evidence-base to patient care: micro-evidence, micro-trialing, and e2-learning. Distinguished Lectureship, University of Arizona, 3 November 2006. Available at http://stream.nursing.ari zona.edu:8080/ramgen/presentation/IvoAbrahamEvidenceBase_3 No v2006.rm. Last accessed 24 December 2010.
66. Abraham I. Diagnostic discrepancy and clinical inference: a social-cognitive analysis. Genet Soc Gen Psychol Monogr. 1986;112:41-102.
67. DiMatteo MR, Giordani PJ, Lepper HS, Croghan TW. Patient adherence and medical treatment outcomes: a meta-analysis. Med Care. 2002; 40(9):794-811.
68. Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005;353(5):487-497.
69. Aapro M, Ludwig H, Bokemeyer C, et al. Modeling of treatment response to erythropoiesis-stimulating agents as a function of centerand patient-related variables: results from the Anemia Cancer Treatment (ACT) study. Ann Oncol. 2009;20(10):1714-1721.
70. Benson K, Hartz AJ. A comparison of observational studies and randomized, controlled trials. N Engl J Med. 2000;342(25):1878-1886.
71. Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med. 2000;342(25):1887-1892.
72. US Department of Health and Human Services: The Health Consequences of Smoking: A Report of the Surgeon General. Atlanta, GA: US Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2004.
73. Port FK, Pisoni RL, Bragg-Gresham JL, et al. DOPPS estimates of patient life years attributable to modifiable hemodialysis practices in the United States. Blood Purif. 2004;22(1):175-180.
74. Sechrest L, Perrin E, Bunker J. Research Methodology: Strengthening Causal Interpretations of Nonexperimental Data (Conference Proceedings, Tucson, AZ, 8-10 April 1987; PHS Report 90-3454). In: Department of Health and Human Services PHS, Agency for Health Care Policy and Research, ed. Vol Available on CD-ROM from the National Technical Information Service, Springfield, VA, PB90-101387. Rockville, MD.
75. Mosteller F. Improving research methodology. In: Sechrest L, Perrin E, Bunker J, editors. Research Methodology: Strengthening Causal Interpretations of Nonexperimental Data (Conference Proceedings, Tucson, AZ, 8-10 April 1987; PHS Report 90-3454). Department of Health and Human Services, Public Health Services, Agency for Health Care Policy and Research; 1990, pp. 221-230. Available on CD-ROM from the National Technical Information Service, Springfield, VA, PB90-101387; 1987:221-230.
76. Lispey M. Theory as method: small theories of treatments. In: Sechrest L, Perrin E, Bunker J, editors. Research Methodology: Strengthening Causal Interpretations of Nonexperimental Data (Conference Proceedings, Tucson, AZ, 8-10 April 1987; PHS Report 90-3454). Department of Health and Human Services, Public Health Services, Agency for Health Care Policy and Research; 1990, pp. 221-230. Available on CD-ROM from the National Technical Information Service, Springfield, VA, PB90-101387; 1987:33-52.
77. Harrell F. Confounding in observational studies. Paper presented at: the National Institutes of Health and the Agency for Healthcare Research and Quality conference on Methodological Challenges in Comparative Effectiveness Research; 2010 December 2-3;Bethesda, MD, USA.