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

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 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.

Antiarrhythmic drug therapy after radiofrequency catheter ablation in patients with atrial fibrillation.

OBJECTIVES: The use of antiarrhythmic drugs after ablation is a controversial issue when evaluating the efficacy of atrial fibrillation (AF) ablation. This study compares in a prospective and randomized fashion the impact of an antiarrhythmic drug in preventing AF recurrence after AF ablation. METHODS: From February 2004 to May 2005, 107 consecutive patients (mean age 57 +/- 10 years, 69 men), with paroxysmal (60%) or persistent (40%) drug refractory AF, were randomly assigned to ablation alone (Group A, 53 patients) or combined with the best antiarrhythmic therapy, preferably amiodarone (Group B, 54 patients). All patients underwent cavo-tricuspid and left inferior pulmonary vein (PV)-mitral isthmus ablation plus circumferential PV ablation, using a guided electro-anatomical approach. Standard electrocardiograms (ECG), and ambulatory and transtelephonic ECG monitoring were used to assess AF recurrences. Recurrences during the first month after ablation were excluded from this analysis. RESULTS: At 12 months of follow-up, no significant difference was observed in the rates of AF recurrences between Group A (18/53 patients, 34%) and Group B (16/54 patients, 30%). The percentage of patients with >/= 1 asymptomatic AF episode was higher in Group B than in Group A (10/16 patients, 63%, vs 5/18 patients, 28%, P = 0.04). CONCLUSIONS: Continuing antiarrhythmic drug therapy in patients who undergo catheter ablation for AF did not lower the rate of AF recurrences. Antiarrhythmic drugs increased the proportion of patients with asymptomatic AF episodes.

Long-term results of hybrid therapy in patients with atrial fibrillation who develop atrial flutter during flecainide infusion.

The flecainide infusion test has been proposed to screen candidates for hybrid pharmacological and ablation therapy. We report the long-term follow-up of 154 consecutive patients with paroxysmal or persistent atrial fibrillation (AF) who developed atrial flutter (AFL) during flecainide infusion (IC AFL), treated with inferior vena cava-tricuspid annulus isthmus catheter ablation and oral flecainide (hybrid therapy). Over a mean of 54.1 +/- 13.1 months 82 patients (53%) remained free of AF and AFL. Flecainide was discontinued because of adverse effects in 6 patients (4%). A history of persistent AF, and the documentation of >/=1 spontaneous AFL episode before the flecainide test were independent predictors of successful hybrid therapy. In patients with paroxysmal AF without documented spontaneous AFL, the long-term efficacy of hybrid therapy was 38.5% (P = 0.03). The flecainide infusion test reliably detects candidates for hybrid therapy. The efficacy of this therapy is maintained over the long-term with a high patient compliance.