Fixed combination of manidipine and delapril in the treatment of mild to moderate essential hypertension: Evaluation by 24-hour ambulatory blood pressure monitoring

Blood Pressure

Volumn 14, Issue SUPPL.1, 2005, Pages 6-13

  Mugellini, Amedeo ^a   Vaccarella, Alvaro ^b   Celentano, Aldo ^c   Scanferla, Flavio ^d   Zoppi, Annalisa ^a   Fogari, Roberto ^a  

^a UNIVERSITY OF PAVIA   (Italy)

^b INRCA   (Italy)

^c Istituto di Medicina Interna   (Italy)

^d Unità Operativa di Nefrologia   (Italy)

Author keywords

Ambulatory blood pressure; Combination treatment; Delapril; Essential hypertension; Manidipine

Indexed keywords

DELAPRIL; MANIDIPINE; PLACEBO; ANTIHYPERTENSIVE AGENT; DIHYDROPYRIDINE DERIVATIVE; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; INDAN DERIVATIVE;

ADULT; AGED; ARTICLE; BLOOD PRESSURE MONITORING; BLOOD PRESSURE REGULATION; CLINICAL PROTOCOL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE SEVERITY; DRUG EFFICACY; ESSENTIAL HYPERTENSION; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MULTICENTER STUDY; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; STATISTICAL SIGNIFICANCE; TREATMENT FAILURE; TREATMENT OUTCOME; BLOOD PRESSURE; DRUG COMBINATION; HYPERTENSION; META ANALYSIS; MIDDLE AGED; RANDOMIZATION; TIME;

ADULT; AGED; ANTIHYPERTENSIVE AGENTS; BLOOD PRESSURE; BLOOD PRESSURE MONITORING, AMBULATORY; DIHYDROPYRIDINES; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; INDANS; MALE; MIDDLE AGED; TIME FACTORS; TREATMENT OUTCOME; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; HYPERTENSION; RANDOM ALLOCATION;

EID: 22544483567     PISSN: 08037051     EISSN: 16511999     Source Type: Journal    
DOI: 10.1080/08038020510040621     Document Type: Article

References (45)

1. Materson BJ, Reda DJ, Cushman WC, Massie BM, Freis ED, Kochar MS, et al. 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.
2. Burt VL, Cutler JA, Higgins M, Horan MJ, Labarthe D, Whelton P, et al. Trend in the prevalence, awarenes, treatment and control of hypertension in the adult US population: data from the health examination surveys, 1960 to 1991. Hypertension. 1995;26:60-69.
3. Chamontin B, Poggi L, Lang T, Ménard J, Chevalier H, Gallois H, et al. Prevalence, treatment and control of hypertension in the French population. Data from a survey on high blood pressure in general practice, 1994. Am J Hypertens. 1998;11:759-762.
4. Ambrosioni E, Leonetti G, Pessina AC, Rappelli A, Trimarco B, Zanchetti A, on behalf of the Scientific Committee of the Italian Pharmacoepidemiological Survey on Antihypertensive Therapy. Patterns of hypertension management in Italy: Results of a pharmacoepidemiological survey on antihypertensive therapy. J Hypertens. 2000;18:1691-1699.
5. Hansson L, Zanchetti A, Carruthers SG, Dahlof B, Elmfeldt D, Julius S, et al. 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. 1998;351:1755-1762.
6. Guidelines Subcommittee of the World Health Organization-International Society of Hypertension (WHO-I8H) Mild Hypertension Liaison Committee. 1999 World Health Organization-International Society of Hypertension Guidelines for the Management of Hypertension. J Hypertens. 1999;17:151-183.
7. Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure: The sixth report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure (JNC VI) National Institutes of Health Publication no. 98-40801997: 1-68.
8. Zanchetti A. Contribution of fixed low-dose combinations to initial therapy in hypertension. Eur Heart J. 1991;1 Suppl L:L5-L9.
9. Waeber B, Brunner HR. Combination antihypertensive therapy: Does it have a role in rational therapy? Am J Hypertens. 1997;10:131S-137S.
10. De Leeuw PW, Kroon AA. Fixed low-dose combination of an angiotensin converting enzyme inhibitor and a calcium channel blocker drug in the treatment of essential hypertension. J Hypertens. 1997;15 Suppl 2:S39-S42.
11. Kaplan NM. Low-dose combination therapy: The rationalisation for and ACE-inhibitor and a calcium channel blocker in higher risk patients. Am J Hypertens. 2001;14:8S-11S.
12. Sica DA, Current concepts of pharmacotherapy in hypertension: Combination calcium channel blocker therapy in the treatment of hypertension. J Clin Hypertens. 2001;3:322-327.
13. Gottnieder JS, Reda DJ, Massie BM, Materson BJ, Williams DW, Anderson RJ, for the VA Cooperative Study Group on Antihypertensive Agents. Effect of single drug therapy on reduction of left ventricular mass in mild to moderate hypertension. Circulation. 95:2007-2014.
14. Henry PD. Calcium antagonists as anti-atherosclerotic agents. Arteriosclerosis. 1990;10:963-965.
15. Rajagopalan S, Harrison DG. Reversing endothelial dysfunction with ACE-inhibition. A new trend? Circulation. 1996;94:240-243.
16. Tatti P, Pahor M, Byington RP, Di Mauro P, Guarisco R, Strollo G, 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.
17. Bakris GL, Weir MR, de Quattro V, McMahon FG. Effects of an ACE-inhibitor/calcium antagonist combination on proteinuria in diabetic nephropathy. Kidney Int. 1998;54:1283-1289.
18. Imura O, Shimamoto K. Efficacy and mode of action of manidipine: A new calcium antagonist. Am Heart J. 1993;54:1283-1289.
19. Razzetti A, Acerbi D. Pharmacokinetic and pharmacological properties of delapril, a lipophilic, non-sulphydril ACE inhibitor. Am J Cardiol. 1995;75:7F-12F.
20. Tomiyama H, Kimura Y, Sakuma Y, Shiojima K, Yamamoto A, Saito I, et al. Effects of an ACE inhibitor and a calcium channel blocker on cardiovascular autonomic nervous system an carotid distensibility in patients with mild to moderate hypertension. Am J Hypertens. 1998;11:682-689.
21. Ogihara T. Practitioner's Trial on the Efficacy of Antihypertensive Treatment in the Elderly Hypertension (The PATE-Hypertension Study) in Japan. Am J Hypertens. 2000;13:461-467.
22. Fogari R, Zoppi A, Lusardi P, Preti P, Poletti L, Mugellini A. Evaluation by 24-hour ambulatory blood pressure monitoring of efficacy of manidipine hydrochloride 10, 20 or 40 mg once daily as compared to placebo in treating mild to moderate essential hypertension: A double-blind, randomized, parallel group, placebo-controlled study. Blood Press. 1996;5 Suppl 5:16-23.
23. Fogari R, Zoppi A, Mugellini A, Vanasia A, Poletti L, Corradi L. 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.
24. Mancia G, Omboni S, Agabiti-Rosei E, Casati R, Fogari R, Leonetti G, et al. Antihypertensive efficacy of manidipine and enalapril in hypertensive diabetic patients. J Cardiovasc Pharmacol. 2000;35:926-931.
25. Omboni S, Fogari R, Mancia G. A smooth blood pressure control is obtained over 24h by delapril in mild to moderate essential hypertensives. Blood Press. 2001;10:170-175.
26. Zanchetti A, Omboni S, La Commare P, De Cesaris R, Palatini P. Efficacy, tolerability, and impact on quality of lire of long-term treatment with manidipine or amlodipine in patients with essential hypertension. J Cardiovasc Pharmacol. 2001;38:642-650.
27. Lipicky RJ. Trough:peak ratio: The rationale behind the United States Food and Drug Administration recommendations. J Hypertens. 1994;12:S17-S18.
28. Omboni S, Parati G, Zanchetti A, Mancia G. Calculation of trough:peak ratio of antihypertensive treatment from ambulatory blood pressure: Methodological aspects. J Hypertens. 1995;13:1105-1112.
29. Rizzoni D, Castellano M, Muiesan ML, Porteri E, Agabiti-Rosei E. Beyond trough:peak ratio: A new index of the smoothness of the antihypertensive effect of a drug. High Blood Press. 1997;6:110-115.
30. Parati G, Omboni S, Rizzoni D, Agabiti-rosei E, Mancia G. The smoothness index: A new, reproducible and clinically relevant measure of the homogeneity of the blood pressure reduction with treatment for hypertension. J Hypertens. 1998;16:1685-1691.
31. Omboni S, Parati G, Mancia G. The trough:peak ratio and the smoothness index in the evaluation of control of 24h blood pressure by treatment in hypertension. Blood Press Monit. 1998;3:201-204.
32. Parati G, Bosi S, Castellano M, Cristofari M, Di Rienzo M, Germanò G, et al. Guidelines for 24h non-invasive ambulatory blood pressure monitoring: Report from a working group of the Italian Society of Hypertension. High Blood Press. 1995;4:168-174.
33. Mancia G, Omboni S, Ravogli A, Parati G, Zanchetti A. Ambulatory blood pressure monitoring in the evaluation of antihypertensive treatment: Additional information from a large data base. Blood Press. 1995;4:148-156.
34. Mancia G, Omboni S, Parati G. Assessment of antihypertensive treatment by ambulatory blood pressure. J Hypertens. 1997;15 Suppl I:S43-S50.
35. Zanchetti A. The physiologic relevance of smooth twenty-four-hour blood pressure control. J Hypertens. 1994;12 Suppl 2:S17-S23.
36. Frattola A, Parati G, Cuspidi C, Albini F, Mancia G. Prognostic value of 24h blood pressure variability. J Hypertens. 1993;11:1133-1137.
37. Rizzoni D, Muiesan ML, Slavetti M, Castellano M, Bettoni G, Monteduro C, et al. The smoothness index, but not the trough-to-peak ratio predicts changes in carotid artery wall tickness during antihypertensive treatment. J Hypertens. 2001;19:703-711.
38. Fogari R, Zoppi A, Corradi L, Preti P, Malalamani GD, Mugellini A. Effects of different dihydropyridine calcium antagonists on plasma norepinephrine in essential hypertension. J Hypertens. 2000;18:1871-1875.
39. Grossman H, Messerli FH. Effect of calcium antagonists on plasma norepinephrine levels, heart rate and blood pressure. Am J Cardiol. 1997;80:1453-1458.
40. Kannel WB, Kannel C, Paffenbarger RS Jr, Cupples LA. Heart rate and cardiovascular mortality: The framingham Study. Am J Heart J. 1987;6:1489-1494.
41. Palatini P, Julius S. Heart rate and the cardiovascular risk. J Hypertens. 1997;15:3-17.
42. Ohkubo T, Imai Y, Tsuji I, Nagai K, Ito S, Satoh H, et al. Reference values for 24-hour ambulatory blood pressure monitoring based on a prognostic criterion. The Osahama Study. Hypertension. 1998;32:255-259.
43. O'Brien E, Coats A, Owens P, Petrie J, Padfield PL, Littler WA, et al. Use and interpretation of ambulatory blood pressure monitoring: Recommendations of the British Hypertension Society. BMJ. 2000;320:1128-1134.
44. Mancia G, Omboni S, Parati G, Ravogli A, Parati G, Zanchetti A. Lack of placebo effect on ambulatory blood pressure. Am J Hypertens. 1995;8:311-315.
45. Conway J, Coats AJS. Ambulatory blood pressure monitoring in the design of antihypertensive drug trials. J Hypertens. 1991;9 Suppl 8:S57-S58.