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Pharmaceutical composition comprising valsartan

A composition, the technology of valsartan, applied in the field of pharmaceutical composition containing valsartan

Inactive Publication Date: 2006-08-09
NOVARTIS AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Identification of independent predictors of AF and treatments that can prevent its occurrence may improve patient outcomes

Method used

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  • Pharmaceutical composition comprising valsartan
  • Pharmaceutical composition comprising valsartan
  • Pharmaceutical composition comprising valsartan

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0066] The incidence of AF in symptomatic HF patients (EF2.9) enrolled in the Val-HeFT trial (listed in Example 2) was evaluated based on adverse event reports. Patients were randomized to receive valsartan or placebo in addition to prescribed heart failure treatment. At the 23-month follow-up of the study, reported AF was 328 / 5000 patients (6.6%), 132 / 2506 (5.27%) of those assigned valsartan and 196 / 2494 of those assigned placebo ( 7.86%) (p=0.0002). Logistic regression analysis showed: heart failure of ischemic etiology (RR: 1.35; 95% confidence interval (CI): 1.06-1.71), age > 70 years (RR: 1.49; 95% CI: 1.17-1.89) and valsa Tan treatment (RR: 0.65; 95% CI: 0.52-0.82) was independently associated with the incidence of AF.

[0067] Cox multivariate regression analysis showed that the occurrence of AF was independently associated with poor prognosis: in patients with and without AF, the overall (all-cause) mortality within 23 months was 30.2% and 18.8% (RR: 1.43 ; 95% CI: ...

Embodiment 2

[0070] 1 Introduction

[0071] CHF is a complex clinical syndrome with multiple pathophysiological and clinical manifestations. It is well known that overt heart failure is characterized by activation of the RAS and other neuroendocrine systems [1,2]. Increased activity of the RAS is thought to be responsible for vasoconstriction, sodium retention with volume expansion, cardiac sympathetic release of norepinephrine, and cardiac hypertrophy. The course of the disease in patients with heart failure results in progressive LV dysfunction due to loss of compensatory mechanisms [3].

[0072] ACE inhibitors block the formation of Ang II from angiotensin (Ang I), and are thus expected to inhibit the deleterious effects of activated RAS. In clinical trials, ACE inhibitors were found to lower blood pressure, improve left ventricular hypertrophy, reduce the morbidity and mortality of congestive heart failure, and prevent patients with ventricular dysfunction or myocardial infarction fr...

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Abstract

The invention relates to pharmaceutical compositions and a method of preventing or reducing the incidence of AF and thereby reducing the risk of morbidity and mortality in patients having symptomatic heart failure comprising administering to such patient an effective amount of valsartan, or pharmaceutically acceptable salts thereof, alone or in combination with another therapeutic agent, optionally in the presence of a pharmaceutically acceptable carrier.

Description

Background of the invention [0001] Angiotensin II receptor blockers (ARBs) such as valsartan are known as antihypertensives, they selectively block the interaction of angiotensin II (Ang II) with AT 1 Binding of the receptor causes vasodilation and decreases aldosterone secretion. ARBs are also known for the treatment of congestive heart failure (CHF). [0002] Atrial fibrillation (AF) is generally considered a negative prognostic factor in heart failure patients. Recent studies have shown that: renin-angiotensin system (RAS) inhibitors may reduce the incidence of AF. Identification of independent predictors of AF and treatments that can prevent its occurrence may improve patient outcomes. [0003] We have now found in a large clinical study that administration of valsartan reduces AF in a patient cohort. Summary of the invention [0004] In one embodiment, the present invention relates to a method of reducing the occurrence of AF, thereby reduci...

Claims

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Application Information

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IPC IPC(8): C07D257/04A61K31/41A61K45/06
CPCC07D257/04A61K31/41A61K45/06A61P3/10A61P3/04A61P3/06A61P43/00A61P9/00A61P9/04A61P9/12A61K2300/00
Inventor J·N·科恩R·D·格莱泽R·拉蒂尼A·P·马焦尼G·托尼奥尼
Owner NOVARTIS AG
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