scholarly journals Fleita is a Russian randomized, open-label, multicenter, comparative program for the evaluation of the efficacy and safety of the fixed combination drug Tarka (ABBOTT Laboratories, USA) versus optional sustained-release antihypertensive drugs in the treatment of patients with arterial hypertension and cognitive disorders (stepwise strategy)

2009 ◽  
Vol 6 (4) ◽  
pp. 34-34
Author(s):  
Irina Evgen'evna Chazova ◽  
Ol'ga Dmitrievna Ostroumova
Keyword(s):  
Sustained Release ◽  
Arterial Hypertension ◽  
Cognitive Functions ◽  
Antihypertensive Drugs ◽  
Cognitive Disorders ◽  
Fixed Dose ◽  
Efficacy And Safety ◽  
Open Label ◽  
Combination Drug ◽  
The Impact

Lesion of the brain as a target organ in arterial hypertension (AH) is manifested not only by strokes, but also impaired cognitive functions. A number of foreign studies have revealed an independent association of death with cognitive impairment in elderly patients. However, the impact of AH on higher mental functions, including that in geriatric patients, has been little studied so far. The effect of antihypertensive drugs, including their fixed-dose combinations that are to be preferred in the pharmacotherapy of AH due to their high efficacy and safety, on cognitive functions also remains to be investigated. In this connection, the Russian FLEITA randomized, open-label, multicenter, comparative program for the evaluation of the efficacy and safety of the fixed-dose combination drug Tarka (ABBOTT Laboratories, USA) versus optional sustained-release antihypertensive drugs in the treatment of patients with arterial hypertension and cognitive disorders (stepwise strategy), its national coordinator being Professor I.E. Chazova, is being implemented under the aegis of the Russian Medical AH Society. The objective of the clinical FLEITA program is to study the clinical efficacy, tolerance, and safety of Tarka used in patients with AH and cognitive disorders. The paper also gives the task of the study, inclusion/exclusion criteria, and the design of the program.

scholarly journals The abilities of losartan in angioprotection in hypertensive patients with hyperuricemia

2012 ◽  
Vol 9 (4) ◽  
pp. 16-21
Author(s):  
S V Nedogoda ◽  
A A Ledyaeva ◽  
E V Chumachok ◽  
V V Tsoma ◽  
A S Salasyuk
Keyword(s):  
Uric Acid ◽  
Arterial Hypertension ◽  
Conventional Therapy ◽  
Antihypertensive Drugs ◽  
Vascular Wall ◽  
Antihypertensive Activity ◽  
Angiotensin Ii Receptor Blocker ◽  
Angiotensin Ii Receptor ◽  
Open Label ◽  
Losartan Group

Aim: to evaluate the ability of the angiotensin II receptor blocker losartan (Lorista, KPKA) to reduce the level of uric acid and to correct the parameters of vascular wall elasticity in patients with arterial hypertension, hyperuricemia, and gout. Subjects and methods. An open-label, randomized, controlled, parallel group comparative (losartan versus conventional therapy with other antihypertensive drugs for 24 weeks) trial enrolled 40 patients with arterial hypertension, hyperuricemia, and gout. Results. No significant differences were found between the groups of losartan (Lorista) and conventional therapy with other antihypertensive drugs groups in their antihypertensive activity. At the same time the losartan group showed a considerably more decrease in uric acid levels than did the conventional group (34,7% versus 7,8% in the group of therapy with other antihypertensive drugs (p

scholarly journals Effect of the fixed-dose combination Ekvator on blood pressure level and cognitive functions in elderly patients with arterial hypertension

2013 ◽  
Vol 10 (1) ◽  
pp. 76-79
Author(s):  
O D Ostroumova ◽  
E I Pervichko
Keyword(s):  
Blood Pressure ◽  
Elderly Patients ◽  
Arterial Hypertension ◽  
Antihypertensive Drug ◽  
Cognitive Functions ◽  
Blood Pressure Level ◽  
Pressure Level ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Dose Combination

The paper gives the data of the authors’ trial of the effect of the fixed-dose combination antihypertensive drug lisinopril + amlodipine on blood pressure level and cognitive functions in 25 elderly patients with grades 1–2 arterial hypertension. The test drug has a high antihypertensive efficacy, as shown by both routine blood pressure measurements and 24-hour monitoring data. The findings suggest that the fixed-dose combination antihypertensive drug lisinopril + amlodipine improves a number of parameters characterizing cognitive functions

scholarly journals The choice of antihypertensive therapy in correction of cognitive impairments and prevention of dementia: possibilities of valsartan and fixed-dose combination of valsartan and hydrochlorothiazide

2016 ◽  
Vol 13 (4) ◽  
pp. 47-55
Author(s):  
O D Ostroumova ◽  
I A Garelik ◽  
E A Karavashkina
Keyword(s):  
Cognitive Function ◽  
Arterial Hypertension ◽  
Antihypertensive Drugs ◽  
Cognitive Impairments ◽  
Cerebral Protection ◽  
Fixed Dose Combination ◽  
Fixed Dose ◽  
Angiotensin Ii Receptor ◽  
Receptor Blockers ◽  
Dose Combination

This article discusses the definition, classification and pathogenetic mechanisms of cognitive functions in arterial hypertension. The authors discuss the capabilities of the different classes of antihypertensive drugs in correction of cognitive impairments and prevention of dementia. The authors also discuss the advantages of the angiotensin II receptor blockers in prevention of dementia and in their potential mechanisms of cerebral protection. The article describes in detail the possibilities of valsartan in correction of cognitive impairments associated with arterial hypertension, the advantages of valsartan in comparison with calcium antagonists and its unique neuroprotective mechanisms. We show our own results of the study concerning fixed-dose combination of valsartan and hydrochlorothiazide, and find out that this combination has high antihypertensive and cerebral protection (capacity to improve cognitive function) and effectiveness.

scholarly journals New targets and old therapies for arterial hypertension

2019 ◽  
pp. 46-52
Author(s):  
S. R. Gilyarevsky ◽  
N. G. Bendeliani ◽  
M. V. Golshmid ◽  
G. Yu. Zakharova ◽  
I. M. Kuzmina ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Arterial Hypertension ◽  
Randomized Clinical Trials ◽  
Antihypertensive Drugs ◽  
Experimental Studies ◽  
The Elderly ◽  
Published Data ◽  
Efficacy And Safety ◽  
Adoption And Implementation ◽  
Moderate Cognitive Impairment

The article discusses approaches to the choice of antihypertensive drugs, which may be based on the adoption and implementation of new clinical guidelines for the management of patients with arterial hypertension. This paper provides data on the efficacy and safety of candesartan, an antihypertensive drug, which advantages were identified during a large number of randomized clinical trials. It discusses the recently published data on the effectiveness of more intensive regimens of antihypertensive therapy to reduce the risk of moderate cognitive impairment in patients with arterial hypertension. In this regard, the authors provide data of the previously completed studies, which showed the effect of candesartan on the rate of cognitive decline in patients with arterial hypertension in the elderly and senile age. The features of the pharmacological characteristics of candesaratan that can remotely explain its clinical efficacy are considered. The data of experimental studies of candesartan in animals, which contribute to the concept of the possible effects of candesartan, are presented.

scholarly journals What do we Mean by “Ideal” Blood Pressure Control?

Kardiologiia ◽  
2021 ◽  
Vol 61 (7) ◽  
pp. 68-78
Author(s):  
O. D. Ostroumova ◽  
A. I. Kochetkov ◽  
N. A. Arablincky ◽  
N. A. Shatalova ◽  
R. R. Romanovsky ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Antihypertensive Drugs ◽  
Real Life ◽  
Cognitive Disorders ◽  
Pressure Control ◽  
Fixed Dose ◽  
Cerebrovascular Complications ◽  
Dose Combination ◽  
Numerous Data ◽  
Cognitive Disorders And Dementia

Arterial hypertension (AH) is one of the most important risk factors for development of myocardial infarction, chronic heart failure, stroke, cognitive disorders and dementia, and chronic kidney disease. Currently, special attention is paid to increased blood pressure variability (BPV) as a new risk factor for development of cardiovascular and cerebrovascular complications. The available evidence-based body of clinical studies demonstrates the importance of reducing not only the blood pressure itself but also the increased BPV to provide significant improvement of the prognosis and limits the risk of complications. This notion has been validated in consensus documents on the management of patients with AH. Among antihypertensive drugs, the fixed-dose combination (FC) amlodipine/perindopril has demonstrated a unique capability for reducing all types of BPV (visit-to-visit, day-to-day, during 24 h). According to current clinical guidelines, this combination belongs to first-line FCs indicated for most patients with AH. A distinctive feature of the FC amlodipine/perindopril is numerous data from real-life clinical practice, which support both its high antihypertensive efficacy and the ability to decrease high BPV. Therefore, the FC amlodipine/perindopril can be recommended for a broad range of AH patients to achieve BP control and to improve the prognosis.

scholarly journals Effects of Molidustat in the Treatment of Anemia in CKD

2018 ◽  
Vol 14 (1) ◽  
pp. 28-39 ◽  
Author(s):  
Iain C. Macdougall ◽  
Tadao Akizawa ◽  
Jeffrey S. Berns ◽  
Thomas Bernhardt ◽  
Thilo Krueger
Keyword(s):  
Oral Treatment ◽  
Hypoxia Inducible Factor ◽  
Mean Value ◽  
Fixed Dose ◽  
Target Range ◽  
Efficacy And Safety ◽  
Open Label ◽  
Once Daily ◽  
Endogenous Erythropoietin ◽  
Dose Trial

Background and objectivesThe efficacy and safety of molidustat, a hypoxia-inducible factor-prolyl hydroxylase inhibitor, have been evaluated in three 16-week, phase 2b studies in patients with CKD and anemia who are not on dialysis (DaIly orAL treatment increasing endOGenoUs Erythropoietin [DIALOGUE] 1 and 2) and in those who are on dialysis (DIALOGUE 4).Design, setting, participants, & measurementsDIALOGUE 1 was a placebo-controlled, fixed-dose trial (25, 50, and 75 mg once daily; 25 and 50 mg twice daily). DIALOGUE 2 and 4 were open-label, variable-dose trials, in which treatment was switched from darbepoetin (DIAGLOGUE 2) or epoetin (DIALOGUE 4) to molidustat or continued with the original agents. Starting molidustat ranged between 25–75 and 25–150 mg daily in DIAGLOGUE 2 and 4, respectively, and could be titrated to maintain hemoglobin levels within predefined target ranges. The primary end point was the change in hemoglobin level between baseline and the mean value from the last 4 weeks of the treatment period.ResultsIn DIAGLOGUE 1 (n=121), molidustat treatment was associated with estimated increases in mean hemoglobin levels of 1.4–2.0 g/dl. In DIAGLOGUE 2 (n=124), hemoglobin levels were maintained within the target range after switching to molidustat, with an estimated difference in mean change in hemoglobin levels between molidustat and darbepoetin treatments of up to 0.6 g/dl. In DIAGLOGUE 4 (n=199), hemoglobin levels were maintained within the target range after switching to molidustat 75 and 150 mg, with estimated differences in mean change between molidustat and epoetin treatment of −0.1 and 0.4 g/dl. Molidustat was generally well tolerated, and most adverse events were mild or moderate in severity.ConclusionsThe overall phase 2 efficacy and safety profile of molidustat in patients with CKD and anemia enables the progression of its development into phase 3.

scholarly journals Effect of dose adjustments on the efficacy and safety of tofacitinib in patients with rheumatoid arthritis: a post hoc analysis of an open-label, long-term extension study (ORAL Sequel)

2022 ◽  
Author(s):  
Ruediger B. Mueller ◽  
Hendrik Schulze-Koops ◽  
Daniel E. Furst ◽  
Stanley B.  Cohen ◽  
Kenneth Kwok ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Minimum Clinically Important Difference ◽  
Extension Study ◽  
Efficacy And Safety ◽  
Open Label ◽  
Post Hoc Analysis ◽  
Clinically Important Difference ◽  
Post Hoc ◽  
The Impact

Abstract Introduction/objectives We assess the impact of switching versus staying on the same tofacitinib dose on efficacy and safety in patients with rheumatoid arthritis (RA). Methods ORAL Sequel was an open-label, long-term extension study of patients with RA receiving tofacitinib 5 or 10 mg BID for up to 9.5 years. Tofacitinib doses could be switched during the study at investigator discretion. In this post hoc analysis, data from ORAL Sequel were stratified into four groups: 5 → 10 mg BID (Dose-up); 5 mg BID (Stay-on 5); 10 → 5 mg BID (Dose-down); and 10 mg BID (Stay-on 10). Efficacy assessments over 12 months included: change from baseline in 4-component Sisease Activity Score in 28 joints, erythrocyte sedimentation rate (DAS28), and DAS28 minimum clinically important difference, remission, and low disease activity (LDA) rates. Safety was assessed for the study duration. Results Generally, DAS28 improvements and minimum clinically important difference rates were significantly greater (p < 0.05) in Dose-up versus Stay-on 5 up to month 12. DAS28 remission rates were significantly greater in Dose-up versus Stay-on 5 at month 12. Change from baseline in DAS28 was similar in Dose-down and Stay-on 10. No significant differences in DAS28 LDA rates were observed between groups. Safety data were similar overall across the four groups. Conclusion In patients with RA receiving open-label tofacitinib, this analysis found that some benefited from increasing dose from 5 to 10 mg BID and did not find that reducing dose from 10 to 5 mg BID affected efficacy or that dose switching in either direction affected safety. Study registration ClinicalTrials.gov number NCT00413699. Registered December 20, 2006. https://clinicaltrials.gov/ct2/show/NCT00413699 Key Points• This post hoc analysis of data from the long-term extension study, ORAL Sequel, assessed the impact of dose switching between tofacitinib 5 and 10 mg twice daily (BID), at the investigator’s discretion, on efficacy and safety in patients with rheumatoid arthritis (RA).• Dosing up from tofacitinib 5 to 10 mg BID was associated with improved efficacy up to 12 months versus staying on 5 mg BID, and dosing down from 10 to 5 mg BID was not generally associated with a significant loss of efficacy.• Safety outcomes were generally consistent across dose groups and did not change markedly after switching dose in either direction.• These findings can help to inform physicians on what may be expected in terms of efficacy and safety when adjusting tofacitinib dose according to clinical need. The recommended tofacitinib dosage for the treatment of RA in most jurisdictions is 5 mg BID.

scholarly journals Efficacy of irbesartan in arterial hypertension and metabolic syndrome

2013 ◽  
Vol 10 (2) ◽  
pp. 53-56
Author(s):  
O D Ostroumova ◽  
A A Zykova ◽  
T A Polosova ◽  
O V Bondarets
Keyword(s):  
Metabolic Syndrome ◽  
Angiotensin Ii ◽  
Arterial Hypertension ◽  
Antihypertensive Drugs ◽  
Angiotensin Ii Receptor Blockers ◽  
Efficacy And Safety ◽  
Angiotensin Ii Receptor ◽  
Hypertensive Patients ◽  
Receptor Blockers

The paper gives the data of Russian guidelines for the diagnosis and approaches to treating metabolic syndrome. It considers the choice of antihypertensive drugs in the treatment of hypertensive patients with metabolic syndrome. The benefits of angiotensin II receptor blockers are shown. The results of a number of trials evaluating the efficacy and safety of irbesartan used to manage arterial hypertension in metabolic syndrome are analyzed.

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