Determining the trough-to-peak ratio in parallel-group trials

Hypertension

Volumn 29, Issue 2, 1997, Pages 659-667

  Staessen, Jan A ^a   Thijs, Lutgarde ^b   Bijttebier, Geert ^b   Clement, Denis ^b   O'Brien, Eoin T ^b   Palatini, Paolo ^b   Rodicio, José L ^b   Rosenfeld, Joseph ^b   Fagard, Robert ^b  

^a UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^b NONE

Author keywords

blood pressure; blood pressure monitoring, ambulatory; clinical trials

Indexed keywords

ENALAPRIL; HYDROCHLOROTHIAZIDE; NITRENDIPINE;

ADULT; AGED; ANTIHYPERTENSIVE THERAPY; ARTICLE; BLOOD PRESSURE MONITORING; DRUG EFFECT; FEMALE; FOOD AND DRUG ADMINISTRATION; GENETIC VARIABILITY; HUMAN; HYPERTENSION; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; SYSTOLIC HYPERTENSION;

EID: 0031017408     PISSN: 0194911X     EISSN: None     Source Type: Journal    
DOI: 10.1161/01.HYP.29.2.659     Document Type: Article

References (43)

1. Rose M, McMahon FG. Some problems with antihypertensive drug studies in the context of the new guidelines. Am J Hypertens. 1990; 3:151-155.
2. Meredith PA, Elliott HL. FDA guidelines on trough:peak ratios in the evaluation of antihypertensive agents. J Cardiovasc Pharmacol. 1994;23(suppl 5):S26-S30.
3. Meredith PA. Trough/peak ratios for antihypertensive agents: the issue in perspective. Drugs. 1994;48:661-666.
4. Lipicky RJ. Trough:peak ratio: the rationale behind the United States Food and Drug Administration recommendations. J Hypertens. 1994; 12(suppl 8):S17-S19.
5. Coats AJS, Radaeili A, Clark SJ, Conway J, Sleight P. The influence of ambulatory blood pressure monitoring on the design and interpretation of trials in hypertension. J Hypertens. 1992;10:385-391.
6. Staessen JA, Bieniaszewski L, Buntinx F, Celis H, O'Brien ET, Van Hoof R, Fagard R, on behalf of the APTH Investigators. The trough-to-peak ratio as an instrument to evaluate antihypertensive drugs. Hypertension. 1995;26:942-949.
7. Amery A, Birkenhäger W, Bulpitt CJ, Clement D, De Leeuw P, Dollery CT, Fagard R, Fletcher A, Forette F, Leonetti G, O'Brien ET, O'Malley K, Rodicio JL, Rosenfeld J, Staessen J, Strasser T, Terzoli L, Thijs L, Tuomilehto J, Webster J. Syst-Eur: a multicentre trial on the treatment of isolated systolic hypertension in the elderly: objectives, protocol and organisation. Aging. 1991;3:287-302.
8. Staessen J, Amery A, Clement D, Cox J, De Cort P, Fagard R, Guo C, Marin R, O'Brien ET, O'Malley K, Mancia G, Parati G, Ravogli A, Thijs L, Webster J. Twenty-four hour blood pressure monitoring in the Syst-Eur trial. Aging. 1992;4:85-91.
9. White WB, Berson AS, Robbins C, Jamieson MJ, Prisant ML, Roccella E, Sheps SG. National standard for measurement of resting and ambulatory blood pressures with automated sphygmomanometers. Hypertension. 1993;21:504-509.
10. O'Brien E, Petrie J, Littler W, de Swiet M, Padfield PL, O'Malley K, Jamieson M, Altman D, Bland M, Atkins N. The British Hypertension Society protocol for the evaluation of automated and semi-automated blood pressure measuring devices with special reference to ambulatory systems. J Ambul Monit. 1991;4:207-228.
11. Staessen JA, Thijs L, Bieniaszewski L, O'Brien ET, Palatini P, Davidson C, Dobovisek J, Jääskivi M, Laks T, Lehtonen A, Vanhanen H, Webster J, Fagard R, on behalf of the Syst-Eur Investigators. Ambulatory monitoring uncorrected for placebo overestimates long-term antihypertensive action. Hypertension. 1996;27:414-420.
12. Thijs L, Celis H, Clement D, Gil-Extremera B, Kawecka-Jaszcz K, Mancia G, Parati G, Salvetti A, Sarti C, van den Meiracker AH, O'Brien E, Staessen JA, Fagard R, on behalf of the Syst-Eur Investigators. Conventional and ambulatory blood pressure measurement in older patients with isolated systolic hypertension: second progress report on the ambulatory blood pressure monitoring project in the Syst-Eur trial. Blood Press Monit. 1996;1:95-103.
13. Staessen J, Bulpitt CJ, Fagard R, Lijnen P, Mancia G, O'Brien ET, Vyncke G, Amery A. Reference values for the ambulatory blood pressure and the blood pressure measured at home: a population study. J Hum Hypertens. 1991;5:355-361.
14. Thijs L, Staessen J, Fagard R. Analysis of the diurnal blood pressure curve. High Blood Press Cardiovasc Prev. 1992;1:17-28.
15. van Ittersum FJ, Ijzerman RG, Stehouwer CDA, Donker AJM. Analysis of twenty-four-hour ambulatory blood pressure monitoring: what time period to assess blood pressures during waking and sleeping. J Hypertens. 1995;13:1053-1058.
16. Fagard R, Brguljan J, Thijs L, Staessen J. Prediction of the actual awake and asleep blood pressures by various methods of 24 h pressure analysis. J Hypertens. 1996;14:557-563.
17. Goa KL, Sorkin EM. Nitrendipine: a review of its pharmacodynamic and pharmacokinetic properties and therapeutic efficacy in the treatment of hypertension. Drugs. 1987;33:123-155.
18. Frohlich ED. Clinical pharmacology of calcium antagonists. Satellite Symposium on Calcium Antagonists. Hypertension. 1988:11(suppl I):I-222-I-224.
19. Staessen JA, Celis H, Thijs L, Fagard R, Amery AK. Efficacy of antihypertensive drugs given once a day: the calcium antagonists revisited. J Hypertens. 1994:12(suppl 8):S107-S115.
20. Shapiro SS, Wilk MB. An analysis of variance test for normality (complete samples). Biometrika. 1965;52:591-611.
21. Byikit D. Statistics Today. A Comprehensive Introduction. Menlo Park, Calif: The Benjamin/Cummings Publishing Co Inc; 1983:83-89.
22. Campbell MJ, Garder MJ. Calculating confidence intervals for some non-parametric analyses. In: Gardner MJ, Altman DG, eds. Statistics with Confidence. London, UK: British Medical Journal; 1989:71-79.
23. Whelton A, Eff J, Magner DJ. Sustained antihypertensive activity of diltiazem SR: double-blind, placebo-controlled study with 24-hour ambulatory blood pressure monitoring. J Clin Pharmacol. 1992;33: 808-815.
24. Armitage P, Berry G. Statistical Methods in Medical Research. Oxford UK: Blackwell Scientific Publications; 1987:93-140.
25. Cole JWL, Grizzle JE. Applications of multivanate analysis of variance to repeated measures experiments. Biometrics. 1966;22:810-828.
26. Friedman LM, Furberg DC, DeMets DL. Fundamentals of Clinical Trials. Littleton, Mass: PSG Publishing Co Inc; 1985:33-69.
27. Byar DP, Simon RM, Friedewald WT, Schlesselman JJ, DeMets DL, Ellenberg JH, Gail MH, Ware JH. Randomized clinical trials: perspectives on some recent ideas. N Engl Med. 1976;295:74-80.
28. Ménard J, Chattelier G, Day M, Vaur L. Self-measurement of blood pressure at home to evaluate drug effects by the trough:peak ratio. J Hypertens. 1994;12(suppl 8):S21-S25.
29. 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.
30. Christensen HR, Kampmann JP, Simonsen K. A randomized comparison of isradipine slow release given once daily with isradipme twice daily on 24 hour blood pressure in hypertensive patients. J Hum Hypertens. 1991;5:121-127.
31. Carr AA, Bottini PB, Feig P, Prisant LM, Mulligan S, Devane JG, Fisher L, Rhoades RB, MacCarty EP. Effectiveness of once-daily monotherapy with a new nifedipine sustained release calcium antagonist. Am J Cardiol. 1992;69:28E-32E.
32. Massie BM, Der E, Herman TS, Topolski P, Park GD, Stewart WH. 24-hour efficacy of once-daily diltiazem in essential hypertension. Clin Cardiol. 1992;15:365-368.
33. Salvetti A, Di Venanzio L. Clinical pharmacology of long-acting calcium antagonists: what relevance for therapeutic effects? J Cardiovasc Pharmacol. 1994;23(suppl 5):S31-S34.
34. Ford NF, Fulmor IE, Nichola PS, Alpin PG, Herron JM. Fosinopril monotherapy: relationship between blood pressure reduction and time of administration. Clin Cardiol. 1993,16:324-330.
35. Zanchetti A, for the Italian Nifedipine GITS Study Group. Trough and peak effects of a single daily dose of nifedipine gastrointestinal therapeutic system (GlTS) as assessed by ambulatory blood pressure monitoring. J Hypertens. 1994;12(suppl 5):S23-S27.
36. Zanchetti A, for the Italian Nifedipine GITS Study Group, Branchi L, Bozza M, Omboni S, Villani A, Ravogli A. Antihypertensive effects of nifedipine GITS on clinic and ambulatory blood pressures in essential hypertensives. High Blood Press Cardiovasc Prev. 1994; 3:45-56.
37. Jespersen CM, Frederiksen M, Fischer Hansen J, Klitgaard NA, Sorum C. Circadian variation in the pharmacokinetics of verapamil. Eur J Clin Pharmacol. 1989;37:613-615.
38. Staessen JA, Thijs L, Mancia G, Parati G, O'Brien ET, on behalf of the Syst-Eur Investigators. Clinical trials with ambulatory bood pressure monitoring: fewer patients needed? Lancet. 1994;344: 1552-1556.
39. Edmonds D, Baumgart P, Vetter H, Vetter W. Verapamil 240 mg: effective blood pressure reduction with a single daily dose? J Hypertens. 1986;4(suppl 5):S455-S457.
40. Lacourcière Y, Poirier L, Provencher P. Comparison of the effects of amlodipine and captopril on clinic and ambulatory blood pressure. J Hum Hypertens. 1992;6(suppl 1):S25-S28.
41. White WB, Smith VE, McCabe EJ, Meeran MK. Effects of chronic nitrendipine on casual (office) and 24-hour ambulatory blood pressure. Clin Pharmacol Ther. 1985;38:60-64.
42. Elliott HL, Meredith PA. Methodological considerations in calculation of the trough:peak ratio. J Hypertens. 1994;12(suppl 8):S3-S7.
43. Elliott HL. Trough:peak ratio and twenty-four-hour blood pressure control. J Hypertens. 1994;12(suppl 5):S29-S33.