An observational, prospective, open-label, multicentre evaluation of aliskiren in treated, uncontrolled patients: A real-life, long-term, follow-up, clinical practice in italy

Giuliano Tocci, Gianpiero Aimo, Dario Caputo, Carmine De Matteis, Tommaso Di Napoli, Antonino Granatelli, Pietro Lentini, Armando Magagna, Alfonso A. Matarrese, Davide Perona, Giuseppe Villa, Massimo Volpe

Research output: Contribution to journalArticle

6 Citations (Scopus)

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%). Conclusions: 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.

Original languageEnglish
Pages (from-to)73-83
Number of pages11
JournalHigh Blood Pressure and Cardiovascular Prevention
Volume19
Issue number2
DOIs
Publication statusPublished - 2012

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Italy
Blood Pressure
Antihypertensive Agents
Safety
Pharmaceutical Preparations
Kidney
Cerebrovascular Disorders
aliskiren
Left Ventricular Hypertrophy
Therapeutics
Ambulatory Care
Ambulatory Care Facilities
Drug-Related Side Effects and Adverse Reactions
Renin
Electrolytes
Multicenter Studies
Coronary Artery Disease
Diabetes Mellitus
Observation
Clinical Trials

Keywords

  • aliskiren
  • antihypertensive therapy
  • direct renin inhibitors
  • high blood pressure
  • Hypertension
  • renin-angiotensin system

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Internal Medicine

Cite this

An observational, prospective, open-label, multicentre evaluation of aliskiren in treated, uncontrolled patients : A real-life, long-term, follow-up, clinical practice in italy. / Tocci, Giuliano; Aimo, Gianpiero; Caputo, Dario; De Matteis, Carmine; Di Napoli, Tommaso; Granatelli, Antonino; Lentini, Pietro; Magagna, Armando; Matarrese, Alfonso A.; Perona, Davide; Villa, Giuseppe; Volpe, Massimo.

In: High Blood Pressure and Cardiovascular Prevention, Vol. 19, No. 2, 2012, p. 73-83.

Research output: Contribution to journalArticle

Tocci, Giuliano ; Aimo, Gianpiero ; Caputo, Dario ; De Matteis, Carmine ; Di Napoli, Tommaso ; Granatelli, Antonino ; Lentini, Pietro ; Magagna, Armando ; Matarrese, Alfonso A. ; Perona, Davide ; Villa, Giuseppe ; Volpe, Massimo. / An observational, prospective, open-label, multicentre evaluation of aliskiren in treated, uncontrolled patients : A real-life, long-term, follow-up, clinical practice in italy. In: High Blood Pressure and Cardiovascular Prevention. 2012 ; Vol. 19, No. 2. pp. 73-83.
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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{\%}). Conclusions: 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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T2 - A real-life, long-term, follow-up, clinical practice in italy

AU - Tocci, Giuliano

AU - Aimo, Gianpiero

AU - Caputo, Dario

AU - De Matteis, Carmine

AU - Di Napoli, Tommaso

AU - Granatelli, Antonino

AU - Lentini, Pietro

AU - Magagna, Armando

AU - Matarrese, Alfonso A.

AU - Perona, Davide

AU - Villa, Giuseppe

AU - Volpe, Massimo

PY - 2012

Y1 - 2012

N2 - 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%). Conclusions: 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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KW - antihypertensive therapy

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KW - renin-angiotensin system

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