Document Detail

A drug safety evaluation of valsartan.
MedLine Citation:
PMID:  21142805     Owner:  NLM     Status:  MEDLINE    
INTRODUCTION: Angiotensin receptor blockers (ARBs) as a class are generally considered safe and better tolerated than other antihypertensive drugs. The purpose of this report is to review the main data on the safety and tolerability of the second generation ARB valsartan after > 10 years since its initial approval.
AREAS COVERED: We searched Medline for clinical studies published between 1997 and 2010 that involve valsartan and focus on its safety and tolerability profile. The main large-scale studies in hypertension, heart failure, post-myocardial infarction (MI) and chronic kidney disease are reviewed.
EXPERT OPINION: Valsartan demonstrates to be safe and well tolerated both in monotherapy and in combination therapy of hypertension in a broad range of patients, including the elderly, children, diabetics, obese patients and patients at high cardiovascular risk. The most frequently reported adverse events (AEs) are malaise/fatigue, dizziness, headache and nausea/vomiting, whose incidence, however, is similar to that observed with placebo. Cough, a common class effect of ACE inhibitors, occurs less frequently with valsartan. When combined with hydrochlorothiazide, valsartan counteracts the adverse metabolic effects of the diuretic, whereas it reduces ankle edema formation when combined with amlodipine. In diabetic hypertensives, valsartan does not adversely affect glucose and lipid metabolism and even improves it. In post-MI patients, the rate of discontinuation due to AE, mainly hypotension, cough and increased serum creatinine, is lower in valsartan than in ACE inhibitor treated patients. Valsartan is also safe and well tolerated in patients with nephropathy although serum potassium levels need to be monitored more closely.
Roberto Fogari; Annalisa Zoppi
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Publication Detail:
Type:  Journal Article; Review     Date:  2010-12-11
Journal Detail:
Title:  Expert opinion on drug safety     Volume:  10     ISSN:  1744-764X     ISO Abbreviation:  Expert Opin Drug Saf     Publication Date:  2011 Mar 
Date Detail:
Created Date:  2011-02-23     Completed Date:  2011-06-20     Revised Date:  2013-11-06    
Medline Journal Info:
Nlm Unique ID:  101163027     Medline TA:  Expert Opin Drug Saf     Country:  England    
Other Details:
Languages:  eng     Pagination:  295-303     Citation Subset:  IM    
Clinica Medica II, Centro Ipertensione e Fisiopatologia Cardiovascolare, Department of Internal Medicine and Therapeutics, Fondazione IRCC Policlinico San Matteo, Piazzale Golgi 19, 27100 Pavia, Italy.
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MeSH Terms
Age Factors
Angiotensin II Type 1 Receptor Blockers / administration & dosage,  adverse effects*,  therapeutic use
Antihypertensive Agents / administration & dosage,  adverse effects*,  therapeutic use
Drug Therapy, Combination
Hypertension / drug therapy
Risk Factors
Tetrazoles / administration & dosage,  adverse effects*,  therapeutic use
Valine / administration & dosage,  adverse effects,  analogs & derivatives*,  therapeutic use
Reg. No./Substance:
0/Angiotensin II Type 1 Receptor Blockers; 0/Antihypertensive Agents; 0/Tetrazoles; 137862-53-4/valsartan; 7004-03-7/Valine

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