Fixed Combination Lisinopril Plus Hydrochlorothiazide in the Treatment of Essential Arterial Hypertension: An Opened, Multi-Centre, Prospective Clinical Trial

Abstract

The aim of this trial was to examine the efficacy and safety of antihypertensive fixed combination lisinopril plus hydrochlorothiazide (Lopril H, Bosnalijek dd) in the treatment of essential arterial hypertension. In our trial we included 297 patients, aged 54.65+/-9.6 years, with treated or untreated hypertension and with high risk of cardiac events, in an opened trial of therapy based on lisinopril plus hydrochlorothiazide. Upon the examination by physicians, patients were divided into three groups in accordance with European Society of Cardiology guidelines for the management of arterial hypertension. Patients from five European countries were followed up for a period of 12 weeks. Duration of treatment was 12 weeks. We adjusted daily doses of lisinopril plus hydrochlorothiazide after every clinical examination and recorded adverse effects of drugs. After 12 weeks of treatment, 288 patients (96%) were evaluated for efficacy, tolerability and safety. In almost 81.5% patients with mild, moderate and severe hypertension, we recorded a reduction in blood pressure to approximately normal values SBP and DBP (140/90 mmHg). Drug-related side-effects occurred in 11 patients (3.66%). The most commonly reported adverse effects associated with lisinopril plus hydrochlorothiazide were cough (5) and dry mouth (5). This research has proved good efficacy of fixed combination lisinopril plus hydrochlorothiazide with more than 97% patients. Based on subjective estimation by patients: this drug improved quality of life in all cases.

Pharmacokinetic and Bioequivalence Study of Lisinopril/Hydrochlorothiazide Tablet Under Fasting and Postprandial Conditions in Healthy Chinese Subjects

“…The study demonstrated that patients taking lisinopril/hydrochlorothiazide FDC tablets had a greater reduction in both diastolic and systolic blood pressure, 27 and was safe and effective in most patients, improving their quality of life, 14 which is consistent with our findings.…”

“…The combination of drugs is a widely used treatment option for hypertension, 5,17 offering not only effective blood pressure control and improved patient compliance, 6 but also protection against cardiovascular disease. 9,12,14 Lisinopril/hydrochlorothiazide is one of the commonly prescribed FDC tablets for first-line therapy in patients with Grade 2 hypertension, comorbidities, and with cardiovascular risk factors. 9,13,17,18 In this study, we compared the bioequivalence of FDC tablets of lisinopril and hydrochlorothiazide in a 10:12.5 ratio (test and reference) in the fasting and postprandial states based on the PK characteristics of 96 subjects.…”

“…The combination of lisinopril and hydrochlorothiazide provides better control of blood pressure due to their different antihypertensive mechanisms. 13,14 Studies have demonstrated that lisinopril/hydrochlorothiazide is a safe and effective antihypertensive medication for treating mild to moderate hypertension. 9,13 However, although previous research has established the efficacy and safety of lisinopril/hydrochlorothiazide, bioequivalence studies of FDC tablets of lisinopril/hydrochlorothiazide have not yet been conducted in healthy Chinese volunteers.…”

“…Hydrochlorothiazide lowers blood pressure by reducing plasma volume and peripheral resistance. The combination of lisinopril and hydrochlorothiazide provides better control of blood pressure due to their different antihypertensive mechanisms 13,14 …”

Fixed Low-Dose Combination of Lisinopril and Hydrochlorothiazide in the Prevention of Cardiovascular Events in Hypertensive Patients

“…Несмотря на то, что свободная комбинация лекарственных средств позволяет более точно подобрать дозировки, ее потенциальными недостатками могут явиться нежелание больного принимать «несколько таблеток» и более высокая стоимость по сравнению с фиксированной комбинацией [18]. Gerc V. et al [19] изучали эффективность и безопасность фиксированной комбинации лизиноприла (20 мг) и гидрохлортиазида (12,5 мг). В исследовании приняли участие 297 больных АГ в возрасте 54,7±9,6 лет.…”