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.
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.
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.
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.
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: firstname.lastname@example.org
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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