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An Observational, Prospective, Open-Label, Multicentre Evaluation of Aliskiren in Treated, Uncontrolled Patients

A Real-Life, Long-Term, Follow-Up, Clinical Practice in Italy

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Abstract

Introduction: The addition of the direct renin inhibitor aliskiren is demonstrated to improve blood pressure (BP) control rate and reduce progression of organ damage in treated hypertensive patients in clinical trials with a relatively short follow-up period.

Aim: The objective of this study was to assess the effectiveness, safety and tolerability of aliskiren as an addon antihypertensive therapy in high-risk, treated, hypertensive patients, who were not controlled with concomitant treatment with at least two antihypertensive drugs under ‘real-life’ conditions, during a planned observation and treatment period of at least 12 months in Italy.

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 300 mg daily if BP control was not achieved.

Results: 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%).

– In this observational, prospective, open-label, multicentre study, we 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.

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Acknowledgements

No sources of funding were used to assist in the preparation of this review. The authors have no conflicts of interest that are directly relevant to the content of this review.

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Authors and Affiliations

  1. IRCCS Neuromed, Pozzilli, Isernia, Italy

    Giuliano Tocci &  Massimo Volpe MD, FAHA, FESC

  2. Division of Internal Medicine, Hospital Unit of Gavardo, Desenzano del Garda Hospital, Gavardo, Brescia, Italy

    Gianpiero Aimo

  3. Division of Internal Medicine, San Giovanni di Dio e Ruggi D’Aragona Salerno Hospital, Salerno, Italy

    Dario Caputo

  4. Division of Cardiovascular Prevention and Rehabilitation, Hospital Unit of San Felice a Cancello, San Felice a Cancello, Caserta, Italy

    Carmine De Matteis

  5. Division of Cardiology and Intensive Cure Unit, Hospital Unit of Santa Maria della Speranza, Battipaglia, Salerno, Italy

    Tommaso Di Napoli

  6. Division of Cardiology, Hospital Unit of Tivoli, San Giovanni Evangelista Hospital, Tivoli, Rome, Italy

    Antonino Granatelli

  7. Division of Emergency Medicine, M.G. Vannini Hospital, Figlie di San Camillo Institute, Rome, Italy

    Pietro Lentini

  8. Hypertension Unit, Division of General Medicine, Department of Internal Medicine, Hospital Unit of Santa Chiara, University Hospital of Pisa, Pisa, Italy

    Armando Magagna

  9. Cardiology Outpatient Clinic, Mazzoni Hospital, ASUR Marche, Azienda Sanitaria Unica Regionale, Ascoli Piceno, Italy

    Alfonso A. Matarrese

  10. Cardiology Outpatient Clinic, Poliambulatorio Patria, Alessandria District, Alessandria, Italy

    Davide Perona

  11. Division of Nephrology and Dialysis, Scientific Institute of Pavia, Fondazione Salvatore Maugeri IRCCS, Pavia, Italy

    Giuseppe Villa

  12. Chair and Division of Cardiology, Department of Clinical and Molecular Medicine, Faculty of Medicine, University of Rome Sapienza, Sant’ Andrea Hospital, Via di Grottarossa 1035-9, 00189, Rome, Italy

    Massimo Volpe MD, FAHA, FESC

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  1. Giuliano Tocci
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  2. Gianpiero Aimo
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  8. Armando Magagna
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  9. Alfonso A. Matarrese
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  12. Massimo Volpe MD, FAHA, FESC
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Correspondence to Massimo Volpe MD, FAHA, FESC.

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Tocci, G., Aimo, G., Caputo, D. et al. An Observational, Prospective, Open-Label, Multicentre Evaluation of Aliskiren in Treated, Uncontrolled Patients. High Blood Press Cardiovasc Prev 19, 73–83 (2012). https://doi.org/10.1007/BF03262457

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