[Tolerability and efficacy of aldosterone inhibition with canrenone in heart failure: the real-world experience of an outpatient heart failure clinic].

BACKGROUND

The aim of this study was to evaluate retrospectively the tolerability, safety and efficacy of antialdosterone therapy in patients with heart failure admitted to our ambulatory from June 1995 to September 2003.

METHODS

One hundred and fifty-seven consecutive patients (mean age 64 +/- 11.6 years) were enrolled in the study; they were in NYHA class I-IV, on ACE-inhibitor or angiotensin receptor blocker therapy, and were treated with canrenone if they were in NYHA class I-IV having experienced a previous cardiac event and did not show asymptomatic left ventricular dysfunction or creatinine levels at baseline > or = 2.5 mg/dl, hyperkalemia > or = 5.2 mEq/l, and poor compliance. The mean follow-up was 38.7 +/- 21.2 months. Patients were divided into two groups according to either therapy (group 1: 124 patients, 79%, on antialdosterone therapy; group 2: 33 patients, 21%, on no antialdosterone therapy) or ischemic and non-ischemic etiology (group A: 71 patients, 45.2%, and group B: 86 patients, 54.8%, respectively). Serum creatinine and plasma potassium levels, left ventricular ejection fraction, NYHA class, adverse effects, and mortality were evaluated.

RESULTS

The mean dose of canrenone was 37 +/- 19.9 mg/day. Creatinine levels did not change significantly whereas potassium levels slightly increased in group 1 vs group 2 (p < 0.01) and in group A vs group B (p < 0.01). Treatment was discontinued by only 12 patients (8.1%) due to hyperkalemia in 8 cases (6.5%), gynecomastia in 2 cases (1.6%), urticaria in 1 case (0.8%), and nausea in 1 case (0.8%). Left ventricular ejection fraction increased in all groups (p < 0.001) with the exception of the subgroup B/group 2 (p = NS). The NYHA class improved significantly in group 1 (p < 0.01). The total mortality rate was 10.8% (17 cases), of which 10.5% (13 cases) in group 1 and 12.1% (4 cases) in group 2 and due to sudden death in 3 group 1 patients (2.4%) and in 2 group 2 patients (6%).

CONCLUSIONS

This study shows a good tolerability, safety, and efficacy, and poor adverse effects of canrenone therapy in combination with ACE-inhibitors, angiotensin receptor blockers and beta-blockers in patients with chronic heart failure. Therapy should be monitored by serial clinical and laboratory controls and gradually titrated up to the maximal tolerated dosage.