cardiovascularКардиоваскулярная терапия и профилактикаCardiovascular Therapy and Prevention1728-88002619-0125«SILICEA-POLIGRAF» LLCcardiovascular-2108Research ArticleКЛИНИЧЕСКИЕ ИССЛЕДОВАНИЯCLINICAL STUDIESЛерканидипин у пациентов с хронической почечной недостаточностью: исследование ZAFRALercanidipine in patients with chronic renal failure: the ZAFRA StudyRoblesN. R.RoblesN. R.nroblesp@meditex.esOconJ.OconJ.GomezC F.GomezC. F.ManjonM.ManjonM.PastorL.PastorL.HerreraJ.HerreraJ.VillatoroJ.VillatoroJ.CallsJ.CallsJ.TorrijosJ.TorrijosJ.RodríguezV. I.RodríguezV. I.RodriguezM. M. A.RodriguezM. M. A.MendezM. L.MendezM. L.MoreyA.MoreyA.MartinezF. I.MartinezF. I.MarcoJ.MarcoJ.LiebanaA.LiebanaA.RinconB.RinconB.TorneroF.TorneroF.Unidad de HTA, Hospital Infanta Cristina, BadajozSpainFundación Puigvert, BarcelonaSpainHospital Gregorio Marañón, MadridSpainHospital Clínico, GranadaSpainHospital Miguel Servet, ZaragozaSpainHospital General de Asturias, OviedoSpainHospital General de Castellón, Castellón de la PlanaSpainHospital Fundación de Manacor, MenorcaSpainHospital Severo Ochoa, Leganes, MadridSpainHospital La Inmaculada, Huercal-Overa, AlmeriaSpainHospital Nuestra Señora de la Candelaria, TenerifeSpainClinica Miramar, BarcelonaSpainHospital de Galdacano, BilbaoSpainHospital Son Dureta, MallorcaSpainHospital Ciudad de Jaen, JaenSpainHospital Virgen de la Luz, CuencaSpain201020082010948187Copyright © Robles N.R., Ocon J., Gomez C.F., Manjon M., Pastor L., Herrera J., Villatoro J., Calls J., Torrijos J., Rodríguez V.I., Rodriguez M.M., Mendez M.L., Morey A., Martinez F.I., Marco J., Liebana A., Rincon B., Tornero F., 20102010Robles N.R., Ocon J., Gomez C.F., Manjon M., Pastor L., Herrera J., Villatoro J., Calls J., Torrijos J., Rodríguez V.I., Rodriguez M.M., Mendez M.L., Morey A., Martinez F.I., Marco J., Liebana A., Rincon B., Tornero F.Robles N.R., Ocon J., Gomez C.F., Manjon M., Pastor L., Herrera J., Villatoro J., Calls J., Torrijos J., Rodríguez V.I., Rodriguez M.M., Mendez M.L., Morey A., Martinez F.I., Marco J., Liebana A., Rincon B., Tornero F.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://cardiovascular.elpub.ru/jour/article/view/2108

Цель. Оценить безопасность нового антагониста кальция лерканидипина у больных с хронической почечной недостаточностью (ХПН); протективный эффект лерканидипина на функцию почек у пациентов, ранее лечившихся ингибиторами ангиотензин-превращающего фермента (ИАПФ) или антагонистами рецепторов ангиотензина (АРА). Материал и методы. В исследовании участвовали 203 пациента с ХПН: концентрация креатинина (Кр.) >1,4 мг/дл у мужчин и >1,2 мг/дл у женщин, либо клиренс креатинина< 70 мл/мин. Все больные получали ранее назначенные ИАПФ (63,4 %) либо АРА (36,6 %), однако уровень артериального давления (АД) превышал цифры, рекомендуемые при ХПН (130/85 мм рт.ст.). Никто из пациентов не принимал диуретики. Клиническое обследование с анализами крови и мочи проводили спустя 1, 3 и 6 мес. от начала терапии лерканидипином. При необходимости назначали третий антигипертензивный препарат (АГП) (не диуретик). Клиренс креатинина определяли, оценивая суточный объем мочи. Результаты. Протокол исследования был полностью выполнен 175 пациентами (средний возраст 63,9±11,9); 52,9 % мужчин и 47,1 % женщин. Средний уровень АД достоверно снизился со 162±17/93±8,3 мм рт.ст. до 132±12/78±6 мм рт.ст. Статистически достоверное снижение АД наблюдалось у 89,2 % больных. У 58,1 % пациентов был достигнут оптимальный контроль АД (<130/85 мм рт.ст.). У 7 больных (3,4 %) имели место побочные эффекты (ПЭ). Не было зарегистрировано ни одного случая периферических отеков; частота ПЭ, обусловленных вазодилатацией, была крайне низкой (у 3 больных, 1,48 %). Уровень Кр. плазмы существенно не изменился (1,9±0,5 мг/дл исходно и 1,9±0,6 мг/дл через 6 мес.). В то же время клиренс креатинина увеличился с 41,8±16,0 мл/мин исходно до 45,8±18,0 мл/мин через 6 мес. (р=0,019). Уровень холестерина плазмы снизился с 221±46 мг/дл до 211±35 мг/дл (р=0,001). Заключение. Лерканидипин продемонстрировал хороший антигипертензивный эффект у больных с ХПН. Он обладал хорошей переносимостью и снижал уровень липидов плазмы. На фоне приема лерканидипина было отмечено улучшение функции почек, оценивавшейся по клиренсу креатинина. Ключевые слова: лерканидипин, хроническая почечная недостаточность, гипертензия><130/85 мм рт.ст.). У 7 больных (3,4 %) имели место побочные эффекты (ПЭ). Не было зарегистрировано ни одного случая периферических отеков; частота ПЭ, обусловленных вазодилатацией, была крайне низкой (у 3 больных, 1,48 %). Уровень Кр. плазмы существенно не изменился (1,9±0,5 мг/дл исходно и 1,9±0,6 мг/дл через 6 мес.). В то же время клиренс креатинина увеличился с 41,8±16,0 мл/мин исходно до 45,8±18,0 мл/мин через 6 мес. (р=0,019). Уровень холестерина плазмы снизился с 221±46 мг/дл до 211±35 мг/дл (р=0,001). Заключение. Лерканидипин продемонстрировал хороший антигипертензивный эффект у больных с ХПН. Он обладал хорошей переносимостью и снижал уровень липидов плазмы. На фоне приема лерканидипина было отмечено улучшение функции почек, оценивавшейся по клиренсу креатинина.

Aim. To evaluate the safe use of a new calcium channel blocker, lercanidipine, in patients with chronic renal failure (CRF); the protective effect of calcium channel blocker on renal function in CRF patients previously treated with ACE inhibitors or angiotensin receptor blockers (ARB). Material and methods. The study included 203 CRF patients (creatinine >1,4 mg/dL for men, >1,2 mg/dL for women; or creatinine clearance <70 mL/min). All patients were receiving ACE inhibitors (63,4 %) or angiotensin II antagonist (36,6 %) therapy, but they had higher blood pressure than recommended for CRF (130/85 mmHg). No patients received diuretics. Patients were clinically evaluated 1, 3, and 6 months after starting treatment with lercanidipine. Urine and blood samples were taken during the examination. When needed, a third drug was added to the treatment, excluding diuretics. Creatinine clearance was measured using 24 h urine collection. Results. 175 patients completed the study protocol (age 63,9±11,9 years, 52,9 % males and 47,1 % females). Blood pressure (BP) significantly decreased from 162±17/93±8.3 mm Hg to 132±12/78±6 mm Hg. 89,2 % of patients showed a significant BP reduction, and 58,1 % achieved optimal BP control (<130/85 mmHg). Seven patients (3,4 %) showed adverse effects. No single case of oedema was detected, and the prevalence of adverse effects related to vasodilatation was extremely low (3 patients, 1,48 %). Plasmatic creatinine did not change (1,9±0,5 baseline vs.1,9±0,6 mg/dL), but creatinine clearance increased at the end visit (41,8±16,0 baseline vs. 45,8±18,0 mL/min, p=0,019). Plasmatic cholesterol also decreased from 221±46 to 211±35 mg/dL (p=0,001). Conclusion: Lercanidipine showed a high antihypertensive effect in CRF patients. It had a good tolerability profile and showed an interesting effect on plasmatic lipids. An improvement in renal function, assessed by creatinine clearance, was detected.

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The authors declare that there are no conflicts of interest present.