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.