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Use of aliskiren in a ‘real-life’ model of hypertension management: analysis of national Web-based drug-monitoring system in Italy

Volpe, Massimoa,b; Tocci, Giulianoa,b; Bianchini, Francescac; De Rosa, Marisad; Fedozzi, Elisabettad; Covezzoli, Annad; Maggioni, Aldo P.cAIFA Drug Monitoring Program: Aliskiren Registry

doi: 10.1097/HJH.0b013e32834e1c66
Original papers: Therapeutics aspects

Introduction In Italy, prescriptions of the direct renin inhibitor aliskiren (aliskiren) to high-risk hypertensive patients must be electronically filled by specialized physicians only when at least two antihypertensive drug classes (independently of the dosages), fails to normalize blood pressure (BP) levels.

Aim To analyze the effects of the addition of aliskiren 150–300 mg daily to antihypertensive therapy in a population of high cardiovascular risk hypertensive patients with uncontrolled BP levels.

Methods Clinical data were derived from patients included in the national Web-based drug-monitoring system. Follow-up visits were required for measuring BP levels, and collecting data on drug safety and tolerability.

Results Between March 2009 and February 2010, aliskiren was prescribed by 6464 specialized physicians to 11 511 treated, uncontrolled hypertensive patients (47.6% women, aged 68.0 ± 11.1 years, BMI 28.4 ± 4.9 kg/m2) with organ damage or comorbidities. During 6-month observation, only a few drug-related side-effects were reported (n = 33). At the entry and 1-month follow-up visits (n = 8197; 70.6%), BP levels were 158.9 ± 16.8 and 142.1 ± 15.2 mmHg for SBP and 90.8 ± 9.6 and 83.1 ± 8.5 mmHg for DBP, respectively. At 6-month (n = 4907; 42.3%), SBP and DBP levels were 137.9 ± 13.9 and 81.3 ± 8.0 mmHg, respectively. A consistent reduction in the use of all classes of concomitant antihypertensive drugs was recorded.

Conclusion Although data derived from national registries need to be interpreted with caution, the Italian Web-based drug-monitoring system provided information on ‘real-life’ use of aliskiren in hypertension. In this uncontrolled, high-risk treated hypertensive population, SBP and DBP levels recorded during treatment with aliskiren were consistently lower than those recorded at entry visits in a context of a very low rate of reported side-effects.

aDivision of Cardiology, Department of Clinical and Molecular Medicine, Faculty of Medicine, University of Rome ‘Sapienza’, Sant’Andrea Hospital, Rome

bIRCCS Neuromed, Pozzilli

cANMCO Research Center, Florence

dCare Systems Department, CINECA, Consortium of Italian Universities, Casalecchio di Reno, Italy

Correspondence to Aldo P. Maggioni, MD, ANMCO Research Center, Florence, Italy E-mail:

Abbreviations: ACE, angiotensin-converting enzyme; AIFA, Agenzia Italiana del Farmaco (Italian Medicine Agency); ARBs, angiotensin II receptor blockers; BP, blood pressure; CCBs, calcium-channel blockers; DMS, drugmonitoring system; DRI, direct renin inhibitor; ISEARCH, International Survey Evaluating Microalbuminuria Routinely by Cardiologists in Patients with Hypertension; RAS, renin–angiotensin system

Received 5 August, 2011

Accepted 13 October, 2011

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© 2012 Lippincott Williams & Wilkins, Inc.