A randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of dual ACE/NEP inhibitor GW660511X in mild-to-moderate hypertensive patients

Journal of Human Hypertension

Volumn 20, Issue 7, 2006, Pages 496-503

  Johnson, A G ^a   Pearce, G L ^b   Danoff, T M ^a  

^a GLAXOSMITHKLINE   (United States)

^b Innovative Data Resources   (United States)

Author keywords

ACE NEP inhibitor; Efficacy; GW660511X; Safety and tolerability

Indexed keywords

ANGIOTENSIN 2 RECEPTOR ANTAGONIST; ATRIAL NATRIURETIC FACTOR; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; CALCIUM ANTAGONIST; DIPEPTIDYL CARBOXYPEPTIDASE; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; ENKEPHALINASE INHIBITOR; GW 660511X; PLACEBO; UNCLASSIFIED DRUG;

ADULT; AGED; ARTICLE; BONE PAIN; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; DIARRHEA; DIASTOLIC BLOOD PRESSURE; DISEASE SEVERITY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG SAFETY; ENZYME ACTIVITY; ENZYME BLOOD LEVEL; FATIGUE; FEMALE; HEADACHE; HEART PALPITATION; HUMAN; HYPERTENSION; HYPOSALIVATION; LIVER DYSFUNCTION; MAJOR CLINICAL STUDY; MALAISE; MALE; MULTICENTER STUDY; MYALGIA; NAUSEA; PARALLEL DESIGN; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SYSTOLIC BLOOD PRESSURE; URINARY FREQUENCY; VOMITING;

ADOLESCENT; ADULT; AGED; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; ANTIHYPERTENSIVE AGENTS; ATRIAL NATRIURETIC FACTOR; BLOOD PRESSURE; CYCLIC GMP; DIZZINESS; DOUBLE-BLIND METHOD; FEMALE; HEADACHE; HUMANS; HYPERTENSION; MALE; MIDDLE AGED; NEPRILYSIN; PEPTIDYL-DIPEPTIDASE A; PLACEBOS; THIAZOLES; TREATMENT OUTCOME;

EID: 33745226182     PISSN: 09509240     EISSN: 14765527     Source Type: Journal    
DOI: 10.1038/sj.jhh.1002009     Document Type: Article

References (27)

1. Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo Jr JL 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: 2560-2572.
2. Moser M, Black HR. The role of combination therapy in the treatment of hypertension. Am J Hypertens 1998; 11: 73S-78S; discussion 95S-100S.
3. Quaschning T, Galle J, Wanner C. Vasopeptidase inhibition: A new treatment approach for endothelial dysfunction. Kidney Int Suppl 2003; 84: S54-S57.
4. Burnett Jr JC. Vasopeptidase inhibition: A new concept in blood pressure management. J Hypertens Suppl 1999; 17: S37-S43.
5. Koller KJ, Goeddel DV. Molecular biology of the natriuretic peptides and their receptors. Circulation 1992; 86: 1081-1088.
6. Tabrizchi R. Dual ACE and neutral endopeptidase inhibitors: Novel therapy for patients with cardiovascular disorders. Drugs 2003; 63: 2185-2202.
7. Nathisuwan S, Talbert RL. A review of vasopeptidase inhibitors: A new modality in the treatment of hypertension and chronic heart failure. Pharmacotherapy 2002; 22: 27-42.
8. Campbell DJ. Vasopeptidase inhibition: A double-edged sword? Hypertension 2003; 41: 383-389.
9. Asmar R, Fredebohm W, Senftlebr I, Chang PI, Gressin V, Saini RK. Omapatrilat compared with lisinopril in treatment of hypertension as assessed by ambulatory blood pressure monitoring. Am J Hypertens 2000; 13(Part 2): 143A. Abstract A 085.
10. Campese VM, Lasseter KC, Ferrario CM, Smith WB, Ruddy MC, Grim CE et al. Omapatrilat versus lisinopril: Efficacy and neurohormonal profile in salt-sensitive hypertensive patients. Hypertension 2001; 38: 1342-1348.
11. Kostis JB, Packer M, Black HR, Schmieder R, Henry D, Levy E. Omapatrilat and enalapril in patients with hypertension: The Omapatrilat Cardiovascular Treatment vs Enalapril (OCTAVE) trial. Am J Hypertens 2004; 17: 103-111.
12. Wallis EJ, Ramsay LE, Hettiarachchi J. Combined inhibition of neutral endopeptidase and angiotensin-converting enzyme by sampatrilat in essential hypertension. Clin Pharmacol Ther 1998; 64: 439-449.
13. Norton GR, Woodiwiss AJ, Hartford C, Trifunovic B, Middlemost S, Lee A et al. Sustained antihypertensive actions of a dual angiotensin-converting enzyme neutral endopeptidase inhibitor, sampatrilat, in black hypertensive subjects. Am J Hypertens 1999; 12: 563-571.
14. Laurent S, Boutouyrie P, Azizi M, Marie C, Gros C, Schwartz JC et al. Antihypertensive effects of fasidotril, a dual inhibitor of neprilysin and angiotensin-converting enzyme, in rats and humans. Hypertension 2000; 35: 1148-1153.
15. Coats AJ. Omapatrilat - the story of overture and octave. Int J Cardiol 2002; 86: 1-4.
16. Morazzoni G, Allievi L, Branca E, Da Ros B, Ferlenga P, Legnani GF et al. In vitro and ex vivo characterization of Z13752A, a new dual acting ACE/NEP inhibitor. Eur J Pharmacol Sci 1998; 6: S35. Abstract 139.
17. Bani M, Colantoni A, Guillaume M, Macchi F, Moroni G, Persiani S. A double-blind, placebo-controlled study to assess tolerability, pharmacokinetics and preliminary pharmacodynamics of single escalating doses of Z13752A, a novel dual inhibitor of the metalloproteases ACE and NEP, in healthy volunteers. Br J Clin Pharmacol 2000; 50: 338-349.
18. Zusman R, Atlas S, Kochar M, Adler E, Levy E. Efficacy and safety of omapatrilat, a vasopeptidase inhibitor. Am J Hypertens 1999; 12: 125A. Abstract D060.
19. Staessen JA, Thijs L, Fagard R, O'Brien ET, Clement D, de Leeuw PW et al. Predicting cardiovascular risk using conventional vs ambulatory blood pressure in older patients with systolic hypertension. Systolic Hypertension in Europe Trial Investigators. JAMA 1999; 282: 539-546.
20. Pickering T. Recommendations for the use of home (self) and ambulatory blood pressure monitoring. American Society of Hypertension Ad Hoc Panel. Am J Hypertens 1996; 9: 1-11.
21. Imai Y. Prognostic significance of ambulatory blood pressure. Blood Pressure Monit 1999; 4: 249-256.
22. Wambach G, Schittenhelm U, Stimpel M, Bonner G, Kaufmann W. Natriuretic action of ANP is blunted by ACE inhibition in humans. J Cardiovasc Pharmacol 1989; 13: 748-753.
23. Motwani JG, Lang CC, Cramb G, Struthers AD. Natriuretic response to neutral endopeptidase inhibition is blunted by enalapril in healthy men. Hypertension 1995; 25: 637-642.
24. Weber MA. Vasopeptidase inhibitors. Lancet 2001; 358: 1525-1532.
25. Blais Jr C, Rouleau JL, Brown NJ, Lepage Y, Spence D, Munoz C et al. Serum metabolism of bradykinin and des-Arg9-bradykinin in patients with angiotensin-converting enzyme inhibitor-associated angioedema. Immunopharmacology 1999; 43: 293-302.
26. Nussberger J, Cugno M, Amstutz C, Cicardi M, Pellacani A, Agostoni A. Plasma bradykinin in angio-oedema. Lancet 1998; 351: 1693-1697.
27. Heudi O, Ramirez-Molina C, Marshall P, Amour A, Peace S, McKeown S et al. Investigation of bradykinin metabolism in human and rat plasma in the presence of the dual ACE/NEP inhibitors GW660511X and omapatrilat. J Pept Sci 2002; 8: 591-600.