A drug safety evaluation of valsartan.

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. 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. 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.