Abstract
A prospective observational cohort study of the angiotensin inhibitor, ramipril, was undertaken in four countries within the European Community-Netherlands, United Kingdom, Germany and Belgium. A total of 10,377 consecutive patients with essential hypertension were recruited to the study with the aim of follow-up for one year. Overall 37% of doctors who agreed to participate in the study actually enrolled at least one patient. One third of the doctors who enrolled patients in the study entered two thirds of patients studied. Some 15% of participating males and 27% of females were aged over 70 years.
Newly diagnosed hypertensives comprised 22% of the study cohort, the proportion being highest in UK and Netherlands, whereas 53% were established hypertensives of two or more years' duration, the proportion being highest in Germany and Belgium. There were substantial differences among the participating countries in the concurrent treatment these patients were receiving for hypertension, with two or more co-therapies being most frequent in Germany and Belgium. There were also substantial differences in co-therapies for concurrent diseases among the participating countries, reflecting both standard therapeutic practices in local areas and differences in marketing of drugs in the different countries.
This report describes the initial findings of this multinational study and emphasises the need to consider several major potentially confounding variables in the analysis of the outcome events both in this study and in other collaborative observational international monitoring schemes for adverse drug reactions.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
Dollery CT, Rawlins MD (1977) Monitoring adverse reactions to new drugs. Br Med J 1:96–97
Lawson DH, Henry DA (1977) Monitoring adverse reactions to new drugs: restricted release or monitored release? Br Med J 1:691–692
Inman WHW (1981) Postmarketing surveillance of adverse drug reactions in general practice. Br Med J 282: 1131–1132 and 1216–1217
Stricker BH, Barendregt M, Herings RM, De Jong-van der Berg LT, Cornel MC, de Smet PA (1992) Ad hoc tracing of a cohort of patients exposed to acitretin (Neotigason) on a nationwide scale. Eur J Clin Pharmacol 42:555–557
Kapp JF, Zentgraf R, Widner A, Schopf E (1991) A need to intensify drug surveillance in Germany. Klin Wochenschr 69:775–779
Maggini M, Menniti FI, Alegiane SS, Traversa G, Fortuni M (1991) Drug utilisation studies within the VIDEOFAR project. Ann 1st Super Sanita 27:201–206
Albengres E, Gauthier F, Tillemar JP, (1990) Current French system of postmarketing drug surveillance. Int J Clin Pharmacol Toxicol 28:312–314
Kosasayawa A, Yoshida M, Okade S (1992) Postmarketing surveillance of probucol in Japan. Artery 19:147–161
Tilson H (1986) Postmarketing surveillance: the way forward. Centre for Medicines Research, London
Grahame-Smith DG (1986) Report of the Adverse Working Party to the Committee on Safety of Medicines, Department of Health
Harcus AW, Ward AE, Smith DW (1979) Methodology of monitored release of a new preparation: buprenorphine. Br Med J:163–165
Colin-Jones D, Langman MJS, Lawson DH, Vessey MP (1982) Cimetidine use and gastric cancer: a preliminary report from a postmarketing surveillance study. Br Med J 285:1311–1313
Maclay WP, Crowder D, Spiros, Turner P (1984) Postmarketing surveillance: practical experience with ketotifen. Br Med J 288:911–914
Speirs CJ, Dollery CT, Inman WHW, Pawson NS, Wilton LV. (1988) Postmarketing surveillance of enalapril: Investigation of the potential role of enalapril in deaths with renal failure. Br Med J 297:830–832
Fletcher AP (1990) Profile of a large-scale cohort study. Drugs 40 [Suppl 5]:43–47
Jenner PN (1990) A 12-month postmarketing surveillance study of nabumetone: a preliminary paper. Drugs 40 [Suppl 5]:80–86
Waller PC, Wood SM, Langman MJS, Breckenridge AM, Rawlins MD (1992) Review of company postmarketing surveillance studies. Br Med J 304:1470–1472
Cooper WD, Sheldon D, Brown D, Kimber GR, Isitt VL, Currie WJC (1987) Postmarketing surveillance of enalapril: experience in 11710 hypertensive patients in general practice. J Roy Coll Gen Pract 37:346–349
Chalmers D, Dombey SL, Lawson DH (1987) Postmarketing surveillance of captopril (for hypertension): A preliminary report. Br J Clin Pharmacol 29:343–349
Chalmers D, Whitehead A, Lawson DH (1992) Postmarketing surveillance of captopril for hypertension. Br J Clin Pharmacol 34:215–223
Inman WHW, Rawson NSB, Wilton LV, Pearse GL, Speirs CJ (1988) Postmarketing surveillance of enalapril. I: Results of prescription event monitoring. Br Med J 297:826–829
Speirs CJ, Dollery CT, Inman WHW, Rawson NSB, Wilton LV (1988) Postmarketing surveillance of enalapril II: Investigation of the potential role of enalapril in deaths with renal failure. Br Med J 297:830–832
Hill PL, Bridgman KM (1992) A multicentre post marketing surveillance study to evaluate the safety of bisoprolol in the treatment of hypertension and ischemic heart disease. Br J Clin Res 3:85
Garrow JS (1988) Health Implications of obesity. In Obesity and Related Diseases. Churchill Livingstone, London
Barkley DEH, Higson DI, Paterson KR (1993) The safety and tolerability of the beta-2 agonist Salbutamol in an event monitoring study of an oral controlled release formulation (Volmax). Pharmacoepidemiology Drug Safety 2:205
Inman WHW, Pearce G (1993) Prescriber profile and postmarketing surveillance. Lancet 342:658–661
Leufkens HGM, Urquhart J (1993) Prescriber profile and postmarketing surveillance. Lancet 342:1178
Fletcher AP (1993) Prescriber profile and postmarketing surveillance. Lancet 342:1179
Hense HW, Tennis P (1990) Changing patterns of antihypertensive drug use in a German population between 1984 and 1987. Eur J Clin Pharmacol 39:1–7
Hense HW, Doring A, Steiber J, Keil U (1992) The association of antihypertensive treatment patterns and adverse lipid effects in population-based studies. J Clin Epidemiol 45:1423–1430
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
Lawson, D.H., Bridgman, K., de Bock, G.H. et al. European postmarketing surveillance of ramipril in hypertension. Eur J Clin Pharmacol 49, 73–79 (1995). https://doi.org/10.1007/BF00192362
Received:
Accepted:
Issue Date:
DOI: https://doi.org/10.1007/BF00192362