To evaluate the efficacy on blood pressure reduction, safety and tolerability of two different dosages of canrenone as add-on therapy in patients already treated with Angiotensin Converting-Enzyme Inhibitors (ACE-I) or Angiotensin II Receptor Blockers (ARBs) and diuretics at the maximum dosage.Objective:
In this multi-centre, phase IV, randomized, controlled, open-label, parallel groups trial, we enrolled 165 Caucasian patients affected by uncomplicated, essential hypertension, not well controlled by concomitant administration of ACE-I or ARBs and diuretics at the maximum dosage.Objective:
At baseline patients were randomized to canrenone, 50 mg, or canrenone 100 mg once a day, in addition to their current therapy, for three months.Objective:
We evaluated at the baseline, and after 3 months: systolic (SBP) and diastolic blood pressure (DBP), pulse pressure (PP), heart rate, fasting plasma glucose (FPG), homeostasis model assessment insulin (HOMA-index), lipid profile, electrolytes, uric acid, estimated glomerular filtration rate (eGFR), plasmatic urea.Objective:
We observed a reduction of SBP, DBP, and PP with both the dosages of canrenone (p < 0.01 vs baseline for both), with a greater decrease recorded with canrenone 100 mg compared to 50 mg (p < 0.05). We did not record any variation of hearth rate, FPG, HOMA-index with neither of two treatments. Regarding lipid profile, we observed a slight increase of triglycerides with canrenone 50 mg (p < 0.05 vs baseline), not significant in group to group comparison. Regarding electrolytes, we recorded an increase of potassium in both groups (p < 0.05 vs baseline with canrenone 50 mg, and p < 0.01 vs baseline with canrenone 100 mg), even if potassium level reached with canrenone 100 mg was higher compared to canrenone 50 mg (p < 0.05). Considering renal function, there was an increase of creatinine and plasmatic urea compared to baseline with canrenone 100 mg (p < 0.01 vs baseline).Objective:
Despite a slightly greater decrease of blood pressure, canrenone 100 mg seems to give a greater increase of potassium, and an increase of creatinine not recorded with canrenone 50 mg although non clinically relevant. Both treatments did not result in any increase of adverse events.Objective:
Canrenone should be recommended in hypertensive patients already taking ACE-I or ARBs and diuretic at the maximum dosage.