title: An observational, prospective, open-label, multicentre evaluation of aliskiren in treated, uncontrolled patients: a real-life, long-term, follow-up, clinical practice in Italy.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  The objective of this study was to assess the effectiveness, safety and tolerability of aliskiren as an add-on 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 ± 9.5 mmHg) 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.
authors.affiliation: IRCCS Neuromed, Pozzilli, Isernia, Italy.
authors.forename: Giuliano
authors.initials: G
authors.lastname: Tocci
authors.forename: Gianpiero
authors.initials: G
authors.lastname: Aimo
authors.forename: Dario
authors.initials: D
authors.lastname: Caputo
authors.forename: Carmine
authors.initials: C
authors.lastname: De Matteis
authors.forename: Tommaso
authors.initials: T
authors.lastname: Di Napoli
authors.forename: Antonino
authors.initials: A
authors.lastname: Granatelli
authors.forename: Pietro
authors.initials: P
authors.lastname: Lentini
authors.forename: Armando
authors.initials: A
authors.lastname: Magagna
authors.forename: Alfonso A
authors.initials: AA
authors.lastname: Matarrese
authors.forename: Davide
authors.initials: D
authors.lastname: Perona
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Villa
authors.forename: Massimo
authors.initials: M
authors.lastname: Volpe
mesh_terms: D000319:Adrenergic beta-Antagonists / Q000008:administration & dosage; D000328:Adult; D000367:Age Factors; D000368:Aged; D000419:Albuminuria / Q000652:urine; D000577:Amides / Q000009:adverse effects / Q000627:therapeutic use*; D057911:Angiotensin Receptor Antagonists / Q000008:administration & dosage; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000008:administration & dosage; D000959:Antihypertensive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects*; D002121:Calcium Channel Blockers / Q000008:administration & dosage; D003971:Diastole / Q000187:drug effects; D004232:Diuretics / Q000008:administration & dosage; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D005650:Fumarates / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D007558:Italy; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D011446:Prospective Studies; D013599:Systole / Q000187:drug effects; D000092502:Renin Inhibitors
chemical_list: D000319:Adrenergic beta-Antagonists; D000577:Amides; D057911:Angiotensin Receptor Antagonists; D000806:Angiotensin-Converting Enzyme Inhibitors; D000959:Antihypertensive Agents; D002121:Calcium Channel Blockers; D004232:Diuretics; D005650:Fumarates; D000092502:Renin Inhibitors; C446481:aliskiren