An Observational, Prospective, Open-Label, Multicentre Evaluation of Aliskiren in Treated, Uncontrolled Patients: A Real-Life, Long-Term, Follow-Up, Clinical Practice in Italy
High Blood Pressure & Cardiovascular Prevention, 08/21/2012
Tocci G et al. – In this observational, prospective, open–label, multicentre study, the authors reported the 12–month clinical effectiveness, safety and tolerability of adding aliskiren to treated, uncontrolled, hypertensive patients in a ‘real–life’ setting in Italy. This strategy leads to a significantly improved BP control rate and low incidence of drug–related side effects or discontinuations.Methods
- Clinical data were derived from medical databases of treated, uncontrolled, hypertensive patients followed by specialized physicians operating in different clinical settings (hospital divisions or outpatient clinics) in Italy.
- Aliskiren was added to stable antihypertensive treatment, including at least two drug classes (independently of class or dosage) and unable to achieve BP control.
- Follow–up visits for measuring clinic BP levels and collecting data on drug safety and tolerability were planned at time intervals of 1, 6 and 12 months.
- At each predefined follow–up visit, aliskiren could be up–titrated from 150 to 300mg daily if BP control was not achieved.
- From May 2009 to June 2011, a total of 1186 treated, uncontrolled, hypertensive patients (46.3% female, aged 65.2±11.7 years, mean duration of hypertension 13.2±9.3 years, mean clinic BP levels 156.5±15.9/90.3±9.5mmHg) were enrolled.
- Systolic and diastolic BP levels were 141.1/82.4, 134.9/79.8 and 133.6/78.9 mmHg at 1–, 6– and 12–month follow–up visits, respectively (p<0.0001 vs baseline for all comparisons).
- These effects were consistent in all predefined subgroups, including those with left ventricular hypertrophy, renal disease, diabetes mellitus, coronary artery disease or cerebrovascular disease.
- Reduced levels of microalbuminuria were also reported, without affecting other renal and electrolyte parameters.
- Overall, compliance to study medication was high (93.0%), with a very low proportion of patients experiencing adverse events leading to drug discontinuation (3.6%).