Abpm and duration of the antihypertensive effect: a study with a new formulation of sustained release losartan (CRONOS)
DOI:
https://doi.org/10.31053/1853.0605.v69.n4.20884Abstract
Antihypertensive drugs action should last at least 24 h in order to enhance adherence, with positive impact on CV morbimortality. ABPM allow us to evaluate duration of action of drugs, against placebo, using Trough:Peak Ratio, antihypertensive effect in the last 4 h interdosis, and calculating the rate of BP morning surge. Losartán is an Antagonist At1 with good antihypertensive efficacy and renal, cardiac and cerebrovascular protection. Some studies shows less than 24 hs of action, that suggest twice a day dosing. The merge of a new formulation, Losartan Cronos, a bilayer tablet containing 50 mg of Losartan immediate release (IR) and 50 mg extended release (ER) would allow 24 h coverage, maintaining the previous advantages. Objectives: To assess antihypertensive duration of action of Losartán Cronos in patients with essential hypertension throughout a 24-h dosing interval, using ABPM and response rates, AASI and Smoothness Index. Methods: 97 essential hypertensives, where included and received a single morning dose of Losartán Cronos (50 mg of regular release and 50 mg of controlled and retarded release) during 8 weeks. Performed valid ABPM post placebo and post active treatment. Results Mean age 58 (26-86), 60% women. 63% treatment naïve. The mean reduction in BP from baseline to week 8 (end of treatment) was statistically significant for all times analyzed (24 hours, daytime, night-time, and last 4 hours monitoring). There were no significant changes in 24h heart rate. BP morning surge (mmHg/hour) decreased from 4.53 to 3,68 (p=0.03).T:P Ratio was 0.91 for SBP and 1.14 for DBP. Smoothness Index: SBP 2.86 (95% CI 1.84-3.7) - DBP 3.17 (95% CI 2.03-3.9) 19 patients had adverse events, no-one cough, all mild, without discontinuations. Conclusion Losartán Cronos demonstrated efficacy and safety, decreases BP without significant effects in heart rate, it reduces the pulse pressure, and its effect lasts for 24 hs, assessed by T:P ratio, last 4 hours effects, decreasing morning surge, also presenting homogeneous effect, since its Smoothness Index is high. Our results suggests daily monodose administration.Downloads
References
Dahlöf B, et al Cardiovascular morbidity and mortality in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): a randomised trial against atenolol. Lancet. 2002 Mar 23;359(9311):995-1003.
Okin PM, et al Regression of electrocardiographic left ventricular hypertrophy is associated with less hospitalization for heart failure in hypertensive patients. Ann Intern Med. 2007 Sep 4;147(5):311-9.
Sonoda M,et al A one-year study of the antiatherosclerotic effect of the angiotensin-II receptor blocker losartan in hypertensive patients. A comparison with angiotension-converting enzyme inhibitors. Int Heart J. 2008 Jan;49(1):95-103.
Suganuma E, et al Antiatherogenic effects of angiotensin receptor antagonism in mild renal dysfunction. J Am Soc Nephrol. 2006 Feb;17(2):433-41.
CsajkaC.,Buclin T. at al. Pharmacokinetic -pharmacodynamic profile of angiotensin II receptor antagonists. Clin Pharmacokinetic 32:1,1997.
Pharmacological properties of angiotensin II receptor antagonists Timmermans PBWM Can J Cardiol 1999;15:26-28
Stergiou GS, Efstathiou SP, Skeva II, Baibas NM, Roussias LG, Mountokalakis TD Comparison of the smoothness index, the trough : peak ratio and the morning : evening ratio in assessing the features of the antihypertensive drug effect.. . J Hypertens. 2003 May;21(5):913-20. .
Kuschnir E, Bendersky M, Resk J, Pañart MS, Guzman L, Mancia G and Wagener G Effects of the combination of low-dose nifedipine GITS 20 mg and losartan 50 mg in patients with mild to moderate hypertension J Cardiovasc Pharmacol 43(2):300-5 (2004),
Bendersky M., Kuschnir E. El MAPA en la evaluación de la efectividad de drogas antihipertensivas. Rev Fed Arg Cardiol 23:19,1994.
Bendersky M.,Resk J.,Roldán E., Kuschnir E. Relación valle:pico por MAPA en HTA esencial. Rev Fed Arg Cardiol 25:317,1996.
White WB. Analysis of ambulatory BP data in antihypertensive drug trials. J Hypertens 9 (Sup I):27S,1991.
White WB.,Zanchetti A. Chronobiology in cardiovascular disease.Proceedings from the European Society of Cardiology. Blood Pressure Monitoring 3:27,1998.
Verdecchia P.,Porcellati C.,Schillaci G., et al. Ambulatory blood pressure: an independent predictor of prognosis in essential hypertension. Hypertension 24:793,1994.
Staessen J., Bieniaszewski L.,O´Brien E et al. Nocturnal BP fall on ambulatory monitoring in a large international database. Hypertension 29:30,1997
Reappraisal of European guidelines on hypertension management: a European Society of Hypertension Task Force document.. Blood Press. 2009;18(6):308-47
Actualización de las recomendaciones sobre el uso de la monitorización ambulatoria de presión arterial. Documento de consenso de la Sociedad Chilena de Hipertensión Rev Méd Chile 2009; 137: 1235-1247
Consenso de Hipertensión Arterial. Cons Arg de Hipertensión Arterial Rev Arg Cardiol Vol 75 Supl 3 Nov - Dic 2007
RA. Sanchez, M Bendersky,et al, on behalf of the Latin America Expert Group Latin American guidelines on hypertension J Hypertens. 2009 May;27(5):905-22.
Chronotherapeutics for cardiovascular disease Anwar YA White WB Drugs 1998;55:631-143
Mancia G, Parati G. Office compared with ambulatory blood pressure in assessing response to antihypertensive treatment:a meta-analysis. J Hypertens 2004;22:435-45.
White WB. Advances in ambulatory blood pressure monitoring for the evaluation of antihypertensive therapy in research and practice. In: White WB, ed. Blood pressure monitoring in cardiovascular medicine and therapeutics. Totowa, N.J.: humana Press, 2001:273-94.
Verdecchia P Porcellati C, Schillaci G, Borgioni C, Ciucci A, Battistelli M. Ambulatory blood pressure. An independent predictor of prognosis in essential hypertension [published erratum appears in Hypertension 1995; 3:462] [see comments]Hypertension 1994;24:793-801
Kikuya M, Hansen TW, Thijs L, Björklund-Bodegård K, Kuznetsova T, Ohkubo T, Richart T, Torp-Pedersen C, Lind L, Ibsen H, Imai Y, Staessen JA; IDACO investigators.Diagnostic thresholds for ambulatory blood pressure monitoring based on 10-year cardiovascular risk.Blood Press Monit. 2007 Dec;12(6):393-5.
Quyyumi AA Circardian rhythms in cardiovascular disease Am Heart J 1990;120:726-733
Cohen MC, Rohtla KM, Lavery CE, Muller JE, Mittleman MA Meta-analysis of the morning excess of acute myocardial infarction and sudden cardiac death. : Am J Cardiol 1997;79:1512-1515
Increased onset of sudden cardiac death in the first three hours after awakening. Willich SN Goldberg RJ Maclure M Perriello L Muller JE Am J Cardiol 1992;70:65-68
Chronobiological aspects of acute cerebrovascular diseases Gallerani M Manfredini R Ricci L Cocurullo A Goldoni C Bigoni M Acta Neurol Scand 1993;87:482-487
Chronobiology and chronotherapeutics in primary care: patient care Smolensky MH Bing ML Clin Focus 1997;1-15
Circadian variation in cardiovascular events Mulcahy D Blood Press Monit 1998;3:29-34
Ambulatory blood pressure monitoring. Mancia G, Parati G, Omboni S, Ulian L, Zanchetti A. Clin Exp Hypertens 1999;21:703-715
Ambulatory blood pressure is superior to clinic blood pressure in predicting treatment-induced regression of left ventricular hypertrophy:SAMPLE Study Group—Study on Ambulatory Monitoring of Blood Pressure and Lisinopril Evaluation. Mancia GZanchetti AAgabiti-Rosei EBenemio GDe Cesaris RFogari R, et al. for the Study on Ambulatory Monitoring of Blood Pressure and Lisinopril Evaluation (SAMPLE) Study Group Circulation 1997;1464-1470
The effect of prescribed daily dose frequency on patient medication compliance. Eisen SA, Miller DK, Woodward RS, Spitznagel E, Przybeck TR. Arch Intern Med 1990;150:1881-4
Prognostic significance of night-time, early morning, and daytime blood pressures on the risk of cerebrovascular and cardiovascular mortality: the Ohasama Study. Metoki H; OhkuboT; Kikuya M; Asayama K; Obara T; Hara A; Hirose T; Hashimoto J; Totsune K; Hoshi H; Satoh H; Imai Y J Hypertens. 24(9):1841-1848,
Guias de la SAHA (Sociedad Argentina de Hipertensión Arterial) diagn, estudio, tratam y seguim de la HTA 2011.
Pulse pressure compared with other blood pressure indexes in the prediction of 25-year cardiovascular and all-cause m mortality rates - The Chicago Heart Association detection Project in Industry Study Miura K, Dyer A, Greenland P, Daviglus M, Hill M, Liu K, Garside D. Hypertension 2001;232-237 27
Downloads
Published
How to Cite
Issue
Section
License
The Faculty of Medical Sciences Journal (RFCM) subscribes to the Open Access policy and does not charge authors fees for publishing, nor does it charge readers fees for accessing published articles (APC).
