ESTIMATION OF ANTIHYPERTENSIVE EFFECT EQUABILITY FOR TWO PRESENTATIONS OF NIFEDIPINE WITH DAILY BLOOD PRESSURE MONITORING

Aim. To compare information value of antihypertensive effect equability parameters for two drug formulations of nifedipine: long-acting one (nifedipine-XL) and short-acting one (nifedipine-sa).

Material and methods. 147 patients with arterial hypertension (age 53,8±12,5 years) were included into multicenter, cross over design study. Duration of wash-out period was 2 weeks; duration of each treatment course – 4 weeks; interval between courses – 1 week. The following doses of drugs were used: nifedipine-XL – 30-60 mg once daily, nifedipine-sa – 10-20 mg three times a day. Daily blood pressure monitoring (DBPM – Schiller BR-102) was made initially, at the end of each treatment course and at the end of interval between courses. To assess the equability of drug antihypertensive effect “smoothness index” (SI) and coefficient trough effect/peak effect were used (COTP). Information value of these indexes (treatment vs. initial) was assessed by the logical regress analysis.

Results. Nifedipine-XL and nifedipine-sa had significant antihypertensive effect according to DBPM data and clinical measurements. Equability of both drugs was similar. χ2 Wald range was 14,7-18,7 (p<0,0001) for SI and 12,7-22,8 for COTP (p<0,001-0,0001).

Conclusion. Similar information value of SI and COTP can be explained by the homogeneity of studied patients. Usage both of these indexes for estimation of antihypertensive effect equability is connected with same methodical limits.

1. Профилактика, диагностика и лечение артериальной гипертензии. Российские рекомендации (второй пересмотр). Кардиоваскулярная терапия и профилактика 2004;6 (приложение).

2. Omboni S., Fogari R., Palatini P. et al. Reproducibility and clinical value of Trough-to-Peak ratio of the antihypertensive effect. Hypertension 1998;32:424-429.

3. Parati G., Mancia G. Assessing effective and balanced twenty-fourhour blood pressure reduction by treatment: methodological aspects. J Hypertens 1999;17:455-456.

4. Ruzicka M., Leenen F.H. Relevance of 24 hour blood pressure profile and sympathetic activity for outcome on short-vs long-acting 1,4- dihydropyridines. Am J Hypertens 1996;9:86-94.

5. Leenen F.H., Holliwell D.L. Antihypertensive effect of felodipine asso￾ciated with persistent sympathetic activation and minimal regression of left ventricular hypertrophy. Am J Cardiol 1992;69:639-645.

6. Cruickshank J.M., Lewis J., Moore V., Dodd C. Reversibility of left ventricular hyper-trophy by different types of antihypertensive therapy. J Hum Hypertens 1992;6:85-90.

7. Горбунов В.М., Метелица В.И., Дуда С.Г., Филатова Н.П., Деев А.Д.. Оценка эффекта антигипертензивных препаратов при длительном приеме с помощью 24-часового мониторирования артериального давления. Кардиология, 1995;12:13-17.

8. Марцевич С.Ю., Алимова Е.В., Горбунов В.М., Деев А.Д., Хирманов В.Н., Соколова Л.А., Подзолков В.И., Карпов Ю.А. Эффективность новой лекарственной формы нифедипина пролонгированного действия – Нифекарда-XL при лечении артериальной гипертонии. Российский Кардиологический Журнал 2003;5:55-58.

9. Rizzoni D., Castellano M., Muiesan M.L. et al. Beyond trough: peak ratio: a new index of the smoothness of the antihypertensive effect of a drug. High Blood Press 1997;6:110-115.

10. Горбунов В.М., Оганов Р.Г., Деев А.Д. Сравнительная информативность различных способов анализа результатов суточного мониторирования артериального давления в оценке эффективности антигипертензивной терапии. Кардиоваскулярная терапия и профилактика 2003;1:17-25.

11. SAS User`s Guide: Statistics Version 5 Edition. Cary NC:SAS Institute Inc. 1985. 956pp.

12. Verdecchia P. Prognostic value of ambulatory blood pressure. Current evidence and clinical implications. Hypertension 2000; 35:844- 851.

13. Горбунов В.М. Рациональное использование 24-часового мониторирования артериального давления для оценки эффективности антигипертензивной терапии. Автореферат дисс. докт. мед. наук., М. 2003.

14. Parati G., Omboni S., Rizzoni D. et al. Smoothness index: a new, reproducible and clinically relevant measure of the homogeneity of the blood pressure reduc-tion with treatment for hypertension. J Hypertens 1998;16:1685-1691.

15. Zannad F., Matzinger A., Larche J. Trough/peak ratios of once daily angiotensin converting enzyme inhibitors and calcium antagonists. Am J Hypertens 1996;9:633-643.

16. Staessen J.A., Bieniaszewski L., Buntinx F. et al. The trough-to-peak ratio as an instru-ment to evaluate antihypertensive drugs. Hypertension 1995;26 [part 1]:942-949.

17. Parati G. Blood pressure variability: its measurement and significance in hypertension. J Hypertens 2005; 23 (suppl 1):S19-S25.

18. Antonicelli R., Omboni S., Giovanni D.C. et al. Smooth blood pressure control obtained with extended-release felodipine in elderly patients with hypertension: evaluation by 24-hour ambulatory blood pressure monitoring. Drugs Aging 2002; 19 (7):541-551.

19. Palatini P., Malacco E., Di S.S. et al. Trough:peak ratio and smoothness index in the evaluation of 24-h blood presuure control in hypertension: a comparative study between valsartan/ hydrochlorothiazide combination and amlodipine. Eur J Clin Pharmacol 2002; 57 (11):765-770.