[PP.13.10] EFFICACY AND SAFETY OF TWO DIFFERENT DOSAGES OF CANRENONE AS ADD-ON THERAPY IN HYPERTENSIVE PATIENTS TAKING ACE-INHIBITORS OR SARTANS AND DIURETICS AT MAXIMUM DOSAGE: THE ESCAPE TRIAL

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Abstract

Objective:

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.

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