Effects of the fixed combination of manidipine plus delapril in the treatment of hypertension inadequately controlled by monotherapy with either component: A phase III, multicenter, open-label, clinical trial

Current Therapeutic Research - Clinical and Experimental

Volumn 64, Issue 7, 2003, Pages 422-433

  Zoppi, Annalisa ^a   Mugellini, Amedeo ^a   Preti, Paola ^a   Rinaldi, Andrea ^a   Celentano, Aldo ^b   Arezzi, Emma ^b   Alberici, Marco ^c   Fogari, Roberto ^a,d  

^a UNIVERSITY OF PAVIA   (Italy)

^b UNIVERSITY OF NAPLES FEDERICO II   (Italy)

^c CHIESI FARMACEUTICI S P A   (Italy)

^d Dept of Int Med and Therapeutics   (Italy)

Author keywords

Delapril; Hypertension therapy; Manidipine

Indexed keywords

CALCIUM CHANNEL BLOCKING AGENT; DELAPRIL; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; MANIDIPINE;

ABDOMINAL PRESSURE; ADULT; AGED; ANKLE EDEMA; ANTIHYPERTENSIVE THERAPY; ARTICLE; BLOOD PRESSURE REGULATION; CLINICAL TRIAL; CONFUSION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; DIASTOLIC BLOOD PRESSURE; DRUG EFFECT; DRUG MEGADOSE; DRUG TOLERABILITY; EPIGASTRIC PAIN; ERYTHEMA; FATIGUE; FEMALE; HEADACHE; HEART ATRIUM FIBRILLATION; HEART PALPITATION; HUMAN; HYPERTENSION; LOW DRUG DOSE; MALE; MONOTHERAPY; MORBIDITY; MORTALITY; MULTICENTER STUDY; NAUSEA; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; SIDE EFFECT; SYSTOLIC BLOOD PRESSURE; TREATMENT OUTCOME; VERTIGO;

EID: 0141729405     PISSN: 0011393X     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0011-393X(03)00109-7     Document Type: Article

References (40)

1. Sever PS. Blood pressure control for the hypertensive patient: What can we do better? Am J Hypertens. 1997;10:128S-130S.
2. Berlowitz DR, Ash AS, Hickey EC, et al. Inadequate management of blood pressure in a hypertensive population. N Engl J Med. 1998;339:1957-1963.
3. Sheps SG. Overview of JNC VI: New directions in the management of hypertension and cardiovascular risk. Am J Hypertens. 1999;12:65S-72S.
4. Dusing R, Weisser B, Mengden T, Vetter H. Changes in antihypertensive therapy - the role of adverse effects and compliance. Blood Press. 1998;7:313-315.
5. Zyczynski TM, Coyne KS. Hypertension and current issues in compliance and patient outcomes. Curr Hypertens Rep. 2000;2:510-514.
6. Weber MA. Rationalizing the treatment of hypertension. Am J Hypertens. 2001;14:3S-7S.
7. Materson BJ, Reda DJ, Cushman WC, et al, for the Department of Veterans Affairs Cooperative Study Group on Antihypertensive Agents. Single-drug therapy for hypertension in men. A comparison of six antihypertensive agents with placebo. N Engl J Med. 1993;328:914-921.
8. Chalmers J. The place of combination therapy in the treatment of hypertension in 1993. Clin Exp Hypertens. 1993;15:1299-1313.
9. UK Prospective Diabetes Study Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. BMJ. 1998;317:707-713.
10. Hansson L, Zanchetti A, Carruthers SG, et al, for the HOT Study Group. Effects of intensive blood-pressure lowering and low-dose aspirin in patients with hypertension: Principal results of the Hypertension Optimal Treatment (HOT) randomised trial. Lancet. 1998;351:1755-1762.
11. Weir MR, Dworkin LD. Antihypertensive drugs, dietary salt, and renal protection: How low should you go and with which therapy? Am J Kidney Dis. 1998;32:1-22.
12. Weir MR. Diabetes and hypertension: How low should you go and with which drugs? Am J Hypertens. 2001;14:17S-26S.
13. Waeber B, Brunner HR. Combination antihypertensive therapy: Does it have a role in rational therapy? Am J Hypertens. 1997;10:131S-137S.
14. Neutel JM. Low-dose antihypertensive combination therapy: Its rationale and role in cardiovascular risk management. Am J Hypertens. 1999;12:73S-79S.
15. Sica DA, Riplet E. Low-dose fixed-combination antihypertensive therapy. In: Oparil S, Weber MA, eds. Hypertension: A Companion to Brenner & Rector's The Kidney. Philadelphia, Pa: WB Saunders; 2000:497-504.
16. Dolley CT. Pharmacological basis for combination therapy of hypertension. Annu Rev Pharmacol Toxicol. 1977;17:311-323.
17. Guazzi MD, De Cesare N, Galli C, et al. Calcium-channel blockade with nifedipine and angiotensin-converting enzyme inhibition with captopril in the therapy of patients with severe primary hypertension. Circulation. 1984;80:279-284.
18. Bainbridge AD, MacFadyen RJ, Stark S, et al. The antihypertensive efficacy and tolerability of a low dose combination of ramipril and felodipine ER in mild to moderate essential hypertension. Br J Clin Pharmacol. 1993;36:323-330.
19. Gradman AH, Cutler RN, Davis PJ, et al, for the Enalapril-Felodipine ER Factorial Study Group. Combined enalapril and felodipine extended-release (ER) for systemic hypertension. Am J Cardiol. 1997;79:431-435.
20. Fogari R, Zoppi A, Lusardi P, et al. Fixed combination of benazepril and low-dose amlodipine in the treatment of mild to moderate essential hypertension: Evaluation by 24-hour noninvasive ambulatory blood pressure monitoring. J Cardiovasc Pharmacol. 1997;30:176-181.
21. Mancia G, Omboni S, Grassi G. Combination treatment in hypertension: The VeraTran Study. Am J Hypertens. 1997;10:153S-158S.
22. Messerli FH. Combinations in the treatment of hypertension: ACE inhibitors and calcium antagonists. Am J Hypertens. 1999;12:86S-90S.
23. Messerli FH, Oparil S, Feng Z. Comparison of efficacy and side effects of combination therapy of angiotensin-converting enzyme inhibitor (benazepril) with calcium antagonist (either nifedipine or amlodipine) versus high-dose calcium antagonist monotherapy for systemic hypertension. Am J Cardiol. 2000;86:1182-1187.
24. Kaplan NM. Low-dose combination therapy: The rationalization for an ACE inhibitor and a calcium channel blockerin higher risk patients. Am J Hypertens. 2001;14:8S-11S.
25. Weir MR. Effects of low dose combination therapy with amlodipine/benazepril on systolic blood pressure. Cardiovasc Rev Rep. 1999;20:368-374.
26. Razzetti R, Acerbi D. Pharmacokinetic and pharmacologic properties of delapril, a lipophilic nonsulfhydryl angiotensin-converting enzyme inhibitor. Am J Cardiol. 1995;75:7F-12F.
27. Fogari R, Zoppi A, Mugellini A, et al. Efficacy of delapril in the treatment of mild to moderate essential hypertension: Evaluation by 24-hour ambulatory blood pressure monitoring. Adv Ther. 1997;14:254-261.
28. Iimura O, Shimamoto K. Efficacy and mode of action of manidipine: A new calcium antagonist. Am Heart J. 1993;125:635-641.
29. Fogari R, Zoppi A, Lusardi P, Mugellini A, for the Manidipine Efficacy in Long-Term Treatment Group. Efficacy and tolerability of manidipine hydrochloride in the long-term treatment of mild-moderate hypertension. Blood Press Suppl. 1996;5:24-28.
30. Menard J. Critical assessment of combination therapy development. Blood Press Suppl. 1993;1:5-9.
31. The sixth report of the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure. Arch Intern Med. 1997;157:2413-2446.
32. Kasiske BL, Ma JZ, Kalil RS, Louis TA. Effects of antihypertensive therapy on serum lipids. Ann Intern Med. 1995;122:133-141.
33. Lithell HO. Hyperinsulinemia, insulin resistance, and treatment of hypertension. Am J Hypertens. 1996;9:150S-154S.
34. Sowers JR. Effects of calcium antagonists on insulin sensitivity and other metabolic parameters. Am J Cardiol. 1997;79:24-28.
35. Henry PD. Calcium antagonists as anti-atherosclerotic agents. Arteriosclerosis. 1990;10:963-965.
36. Dahlof B, Pennert K, Hansson L. Reversal of left ventricular hypertrophy in hypertensive patients. A metaanalysis of 109 treatment studies. Am J Hypertens. 1992;5:95-110.
37. Kasiske B, Kalil R, Ma JZ. Effect of antihypertensive therapy on the kidney in patients with diabetes: A meta-regression analysis. Ann Intern Med. 1993;118:129-138.
38. Rajagopalan S, Harrison DG. Reversing endothelial dysfunction with ACE inhibitors. A new trend. Circulation. 1996;94:240-243.
39. Tatti P, Pahor M, Byington RP, et al. Outcome results of the fosinopril versus amlodipine cardiovascular events randomized trial (FACET) in patients with hypertension and NIDDM. Diabetes Care. 1998;21:597-603.
40. Bakris GL, Weir MR, DeQuattro V, McMahon FG. Effects of an ACE inhibitor/calcium antagonist combination on proteinuria in diabetic nephropathy. Kidney Int. 1998;54:1283-1289.