Pharmacological Research 53 (2006) 197–201 Pharmacoeconomic consequences of amlodipine besylate therapy in patients undergoing PTCA Francesca Rossetti b , Simona De Portu a , Enrica Menditto a, , Luciana Scalone b , Silvia Bustacchini c , Claudio Cricelli d , Lorenzo Giovanni Mantovani a,b a CIRF, Facolt` a di Farmacia, Universit` a degli Studi di Napoli Federico II, Napoli, Italy b Centro di Farmacoeconomia, Facolt` a di Farmacia, Universit` a degli Studi di Milano, Italy c Outcome Research Unit, Pfizer Italia s.r.l., Italy d Societa’ Italiana Medicina Generale, Italy Accepted 6 October 2005 Abstract In Italy, revascularization interventions increased from 44,600 in 1996 to more than 100,000 in 2001. In particular, the occurrence of percutaneous transluminal coronary angioplasty (PTCA) increased from 239 cases per million population in 1994 to about 1300 cases per million population in 2001. This trend has caused a concomitant increase in revascularization costs, which have doubled in few years, rising from D 421 millions in 1996 to D 850 millions in 2001. In 2001, PTCA amounted to 55% of total cost of revascularizations. The aim of this study was to assess the pharmacoeconomic consequences of amlodipine besylate therapy administered in patients at high risk of restenosis after PTCA. We conducted a cost-effectiveness analysis comparing therapy with amlodipine besylate added to standard care versus standard care alone. Information on clinical outcomes was drawn from the Coronary Angioplasty Amlodipine Restenosis Study (CAPARES). Medical costs were estimated with reference to drug therapy and hospitalizations for coronary events and revascularization procedures. The study was conducted from the perspective of the Italian third party payer (National Health Service). The analysis was applied to a time horizon of 4 months. Amlodipine besylate resulted less expensive and more effective than standard care. It reduced mortality, morbidity for coronary reasons and the need of revascularization procedures. The cost per 1000 patients was estimated at D 1,166,000 in the placebo and D 950,000 in the amlodipine besylate group, resulting into a cost saving of D 216,000, that is 18.5% of total cost of standard care. Results are sensitive to the cost of amlodipine besylate and the cost of hospitalizations, but therapy with amlodipine besylate resulted dominant even in the most unfavorable hypothesis. © 2005 Published by Elsevier Ltd. Keywords: Cost-effectiveness; Amlodipine besylate; Coronary artery disease 1. Introduction Coronary artery disease is the most frequent cause of mor- bidity and mortality in the industrialized countries despite a decline in the past decades [1–3]. Since it was introduced in 1977 [4,5], percutaneous transluminal coronary angioplasty (PTCA) has had an exponential growth, becoming the most commonly performed revascularization procedure in the management of patients with coronary artery disease [6–7]. In the United States, PTCA procedures have increased by 266% from 1987 to 2001. In that year 51% of procedures were performed on people aged 65 [6]. Data from a survey conducted by the Coronary Cir- Corresponding author. culation working group of the European Society of Cardiology showed that in 1994 the annual incidence of PTCA reached a mean of 458 procedures per million population in Europe, with an increase of 31% compared to the previous year and an increase of 57% compared to 1992. Germany, France, Great Britain and Italy, comprising approximately 50% of the European popula- tion, performed 72% of all PTCAs in Europe [8]. In Italy, according to the Hospital Discharge Charts [9], revas- cularization interventions increased from 44,613 in 1996 to 103,008 in 2001, that is from 3.9% to 8.2% of all hospitaliza- tions for diseases and disorders of the circulatory system (Major Diagnostic Category number 5). In particular, the utilization of PTCA increased highly, rising from 239 cases per million pop- ulation in 1994 [8] to about 1300 cases per million population in 2001 [9]. This trend has caused a concomitant increase in 1043-6618/$ – see front matter © 2005 Published by Elsevier Ltd. doi:10.1016/j.phrs.2005.10.002