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The safety of valsartan: results of a postmarketing surveillance study on 12 881 patients in England

Journal of Human Hypertension volume 16, pages 795–803 (2002)Cite this article

Abstract

Valsartan is a second class of angiotensin II receptor antagonist, indicated for the treatment of hypertension. The objective of the study was to monitor the safety of valsartan using the technique of prescription event monitoring (PEM), in patients who were prescribed this drug by general practitioners (GPs) in England. PEM is a noninterventional observation cohort technique. Exposure data were obtained from dispensed prescriptions issued between December 1996 and November 1998. Outcome data were obtained by sending questionnaires to prescribing GPs. The cohort comprised 12 881 patients. Events most frequently reported as suspected adverse drug reactions were malaise/lassitude (37; 0.3% of total cohort), dizziness (19; 0.1%), and unspecified side effects (57; 0.4%). Events with the highest incidence density (ID1 per 1000 patient–months of treatment) in the first month of treatment were malaise/lassitude (15.6), dizziness (11.8), and headache/migraine (10.9). Most frequent reasons for stopping valsartan were not effective (847; 6.6% of total cohort), malaise/lassitude (265; 21%), and dizziness (146; 1.1%). No unexpected serious adverse events were identified. Other events assessed as possibly related to valsartan use were impotence (37), dizziness (19), cough (9), facial oedema (5), hyperkalaemia (3), and angioneurotic oedema (1). There were four reports of exposure during pregnancy and 203 deaths (1.5%) in this cohort. In conclusion, this study monitored the safety profile of valsartan in a large cohort of patients in general practice in England. No untoward features other than dizziness were identified that were not mentioned in the prescribing guidance.

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Acknowledgements

We thank the very many GPs who have, without payment, participated in this study. We also thank the prescription pricing Authority, The office of the National Statistics, and the Regional Authorities of the NHS, without whose support PEM could not have been undertaken. Special thanks goes to Mrs. Gillian Pearce, Data Processing Manager, Mr. Shayne Freemantle, IT Manager for providing the data required for this study, and Mrs. Lesley Flowers for typing the manuscript. The DSRU is a medical charity, which has received unconditional grants from many pharmaceutical companies, including the manufacturer of valsartan. The organisations have no control over the decision to undertake a study, or the conduct and reporting of the studies.

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Authors and Affiliations

  1. Drug Safety Research Unit, Bursledon Hall, Southampton, SO31 1AA, UK

    P N Biswas, L V Wilton & S W Shakir

  2. London School of Hygiene and Tropical Medicine, London, UK

    S W Shakir

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  1. P N Biswas
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  2. L V Wilton
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  3. S W Shakir
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Correspondence to P N Biswas.

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Biswas, P., Wilton, L. & Shakir, S. The safety of valsartan: results of a postmarketing surveillance study on 12 881 patients in England. J Hum Hypertens 16, 795–803 (2002). https://doi.org/10.1038/sj.jhh.1001490

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