The results of the international clinical study VICTORY: efficacy and safety of antihypertensive monotherapy with valsartan (Valsacor®) and its fixed combination with hydrochlorothiazide (Valsacor® H) in routine clinical practice in patients with grade 1 and grade 2 hypertension
Objective. The VICTORY study aimed to evaluate effectiveness and safety of monotherapy with valsartan (Valsacor®) and its fixed combination with hydrochlorothiazide (Valsacor® H) in clinical practice in patients with stage 1 and stage 2 hypertension. Materials and methods. In the prospective, random...
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| Format: | Article |
| Language: | Russian |
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IP Morozov P.V.
2017-06-01
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| Series: | Системные гипертензии |
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| Online Access: | https://syst-hypertension.ru/2075-082X/article/viewFile/29204/pdf |
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| author | I E Chazova T V Martynyuk R Accetto Yu Sirenko J Vincelj Jr JWidimsky B Barbič-Žagar M V Arhipov Yu I Grinshtein O D Ostroumova A S Galjavich O P Rotar' L A Haisheva S V Nedogoda |
| author_facet | I E Chazova T V Martynyuk R Accetto Yu Sirenko J Vincelj Jr JWidimsky B Barbič-Žagar M V Arhipov Yu I Grinshtein O D Ostroumova A S Galjavich O P Rotar' L A Haisheva S V Nedogoda |
| author_sort | I E Chazova |
| collection | DOAJ |
| description | Objective. The VICTORY study aimed to evaluate effectiveness and safety of monotherapy with valsartan (Valsacor®) and its fixed combination with hydrochlorothiazide (Valsacor® H) in clinical practice in patients with stage 1 and stage 2 hypertension. Materials and methods. In the prospective, randomized, open-label, international multicentre study involved 356 patients with grade 1 and grade 2 hypertension from 5 countries, including 130 patients from Russia. In Russia the study was conducted in 7 cities, in 8 clinical centers. The patients, who were receiving antihypertensive therapy at the moment of screening, underwent a 7 days wash-out period. The starter dose of valsartan (Valsacor®, KRKA, Slovenia) was 80 mg (except for Russia where 160 mg of Valsacor® were given at the first visit, what did not influence the study results). After 4 weeks of treatment in case of blood pressure (BP) >140/90 or 130/80 mm Hg the dose was increased to 160 mg (in Russia - to 320 mg) or combined therapy with Valsacor® H (KRKA, Slovenia) was prescribed. In 4 weeks the dose of valsartan was increased to 320 or 160/12.5 mg in case of previous dose insufficiency. If target BP levels were not reached in the next 4 weeks, the dose was increased to 320/12.5 mg. The primary endpoints included evaluation of antihypertensive effect of valsartan and its fixed combination with hydrochlorothiazide on BP levels; evaluation of the drugs’ influence on aortal stiffness; comparison of absolute average means of achieved decrease in central and peripheral BP compared with baseline; evaluation of the impact on aortic augmentation index. The secondary endpoints included comparison of primary endpoints when using mono and combined therapy; evaluation and comparison of the effect on erectile function in men by questionnaires at baseline and after 16 weeks of treatment; evaluation of adverse events frequency. Results. Data on 365 patients - 196 (54.0%) female and 169 (46.0%) male aged 54.6±12.0 years were analyzed. Mean initial value of systolic (SBP) and diastolic BP (DBP) were 156.6±8.9 and 95.6±6.0 mm Hg, respectively and 130.1±8.2 and 80.9±5.8 mm Hg, respectively after 16 weeks of treatment. The mean absolute decrease of SBP and DBP was 26.6±10.4 and 14.8±7.6 mm Hg. The decrease of SBP and DBP was statistically significant in all treatment periods (p |
| first_indexed | 2024-12-10T05:31:47Z |
| format | Article |
| id | doaj.art-61c6fb1afe6e4d50bb09da4218139fcd |
| institution | Directory Open Access Journal |
| issn | 2075-082X 2542-2189 |
| language | Russian |
| last_indexed | 2024-12-10T05:31:47Z |
| publishDate | 2017-06-01 |
| publisher | IP Morozov P.V. |
| record_format | Article |
| series | Системные гипертензии |
| spelling | doaj.art-61c6fb1afe6e4d50bb09da4218139fcd2022-12-22T02:00:31ZrusIP Morozov P.V.Системные гипертензии2075-082X2542-21892017-06-01142808926303The results of the international clinical study VICTORY: efficacy and safety of antihypertensive monotherapy with valsartan (Valsacor®) and its fixed combination with hydrochlorothiazide (Valsacor® H) in routine clinical practice in patients with grade 1 and grade 2 hypertensionI E Chazova0T V Martynyuk1R Accetto2Yu Sirenko3J Vincelj4Jr JWidimsky5B Barbič-Žagar6M V Arhipov7Yu I Grinshtein8O D Ostroumova9A S Galjavich10O P Rotar'11L A Haisheva12S V Nedogoda13National Medical Research Center for Cardiology of the Ministry of Health of the Russian FederationNational Medical Research Center for Cardiology of the Ministry of Health of the Russian FederationDepartment of Hypertension, University Medical Centre Ljubljana, Hospital Dr. Peter DržajInstitute of CardiologyInstitute of Cardiovascular Diseases, Dubrava University HospitalCentre for Hypertension, 3rd Internal Department, General Faculty Hospital, 1st Medical Faculty, Charles UniversityKrka d.dUral State Medical University of the Ministry of Health of the Russian FederationProf. V.F.Voino-Yasenetski Krasnoyarsk State Medical University of the Ministry of Health of the Russian FederationA.I.Evdokimov Moscow State University of Medicine and Dentistry of the Ministry of Health of the Russian FederationKazan State Medical University of the Ministry of Health of the Russian FederationDepartment of Epidemiology of non-communicable diseases, Almazov National Medical Research CentreRostov State Medical UniversityVolgograd State Medical University of Ministry of Health of the Russian FederationObjective. The VICTORY study aimed to evaluate effectiveness and safety of monotherapy with valsartan (Valsacor®) and its fixed combination with hydrochlorothiazide (Valsacor® H) in clinical practice in patients with stage 1 and stage 2 hypertension. Materials and methods. In the prospective, randomized, open-label, international multicentre study involved 356 patients with grade 1 and grade 2 hypertension from 5 countries, including 130 patients from Russia. In Russia the study was conducted in 7 cities, in 8 clinical centers. The patients, who were receiving antihypertensive therapy at the moment of screening, underwent a 7 days wash-out period. The starter dose of valsartan (Valsacor®, KRKA, Slovenia) was 80 mg (except for Russia where 160 mg of Valsacor® were given at the first visit, what did not influence the study results). After 4 weeks of treatment in case of blood pressure (BP) >140/90 or 130/80 mm Hg the dose was increased to 160 mg (in Russia - to 320 mg) or combined therapy with Valsacor® H (KRKA, Slovenia) was prescribed. In 4 weeks the dose of valsartan was increased to 320 or 160/12.5 mg in case of previous dose insufficiency. If target BP levels were not reached in the next 4 weeks, the dose was increased to 320/12.5 mg. The primary endpoints included evaluation of antihypertensive effect of valsartan and its fixed combination with hydrochlorothiazide on BP levels; evaluation of the drugs’ influence on aortal stiffness; comparison of absolute average means of achieved decrease in central and peripheral BP compared with baseline; evaluation of the impact on aortic augmentation index. The secondary endpoints included comparison of primary endpoints when using mono and combined therapy; evaluation and comparison of the effect on erectile function in men by questionnaires at baseline and after 16 weeks of treatment; evaluation of adverse events frequency. Results. Data on 365 patients - 196 (54.0%) female and 169 (46.0%) male aged 54.6±12.0 years were analyzed. Mean initial value of systolic (SBP) and diastolic BP (DBP) were 156.6±8.9 and 95.6±6.0 mm Hg, respectively and 130.1±8.2 and 80.9±5.8 mm Hg, respectively after 16 weeks of treatment. The mean absolute decrease of SBP and DBP was 26.6±10.4 and 14.8±7.6 mm Hg. The decrease of SBP and DBP was statistically significant in all treatment periods (phttps://syst-hypertension.ru/2075-082X/article/viewFile/29204/pdfhypertensioncombined antihypertensive therapyvalsartanhydrochlorothiazide |
| spellingShingle | I E Chazova T V Martynyuk R Accetto Yu Sirenko J Vincelj Jr JWidimsky B Barbič-Žagar M V Arhipov Yu I Grinshtein O D Ostroumova A S Galjavich O P Rotar' L A Haisheva S V Nedogoda The results of the international clinical study VICTORY: efficacy and safety of antihypertensive monotherapy with valsartan (Valsacor®) and its fixed combination with hydrochlorothiazide (Valsacor® H) in routine clinical practice in patients with grade 1 and grade 2 hypertension Системные гипертензии hypertension combined antihypertensive therapy valsartan hydrochlorothiazide |
| title | The results of the international clinical study VICTORY: efficacy and safety of antihypertensive monotherapy with valsartan (Valsacor®) and its fixed combination with hydrochlorothiazide (Valsacor® H) in routine clinical practice in patients with grade 1 and grade 2 hypertension |
| title_full | The results of the international clinical study VICTORY: efficacy and safety of antihypertensive monotherapy with valsartan (Valsacor®) and its fixed combination with hydrochlorothiazide (Valsacor® H) in routine clinical practice in patients with grade 1 and grade 2 hypertension |
| title_fullStr | The results of the international clinical study VICTORY: efficacy and safety of antihypertensive monotherapy with valsartan (Valsacor®) and its fixed combination with hydrochlorothiazide (Valsacor® H) in routine clinical practice in patients with grade 1 and grade 2 hypertension |
| title_full_unstemmed | The results of the international clinical study VICTORY: efficacy and safety of antihypertensive monotherapy with valsartan (Valsacor®) and its fixed combination with hydrochlorothiazide (Valsacor® H) in routine clinical practice in patients with grade 1 and grade 2 hypertension |
| title_short | The results of the international clinical study VICTORY: efficacy and safety of antihypertensive monotherapy with valsartan (Valsacor®) and its fixed combination with hydrochlorothiazide (Valsacor® H) in routine clinical practice in patients with grade 1 and grade 2 hypertension |
| title_sort | results of the international clinical study victory efficacy and safety of antihypertensive monotherapy with valsartan valsacor r and its fixed combination with hydrochlorothiazide valsacor r h in routine clinical practice in patients with grade 1 and grade 2 hypertension |
| topic | hypertension combined antihypertensive therapy valsartan hydrochlorothiazide |
| url | https://syst-hypertension.ru/2075-082X/article/viewFile/29204/pdf |
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