Effect of drospirenone on serum potassium and drospirenone pharmacokinetics in women with normal or impaired renal function.
This open-label study investigated whether drospirenone, a novel progestin with antimineralocorticoid properties, increases the risk for hyperkalemia in subjects with renal impairment. Women with normal renal function and mild or moderate renal impairment were given drospirenone 3 mg/d for 14 days. Mean serum potassium concentrations did not significantly change during steady-state drospirenone treatment. No difference in drospirenone effects on serum potassium concentrations in subjects with renal insufficiency versus subjects with normal renal function was found. Steady-state pharmacokinetics was similar in subjects with normal renal function and mild renal impairment, whereas, due to results from 1 subject, drospirenone exposure was slightly higher in the moderate renal impairment group. Given the reported tolerability of drospirenone, this small increase in serum drospirenone is not expected to be clinically significant. In conclusion, this study demonstrated that drospirenone has no significant effect on serum potassium levels in patients with mild to moderate renal insufficiency.
Schürmann
Rolf
R
Corporate Clinical Development G+A, Schering AG Berlin.
Blode
Hartmut
H
Benda
Norbert
N
Cronin
Maureen
M
Küfner
Andreas
A
D000328:Adult; D000736:Androstenes / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics*; D003404:Creatinine / Q000097:blood; D005260:Female; D006801:Humans; D006947:Hyperkalemia / Q000097:blood* / Q000139:chemically induced; D008875:Middle Aged; D000451:Mineralocorticoid Receptor Antagonists / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics*; D008954:Models, Biological; D011188:Potassium / Q000097:blood*; D012016:Reference Values; D012044:Regression Analysis; D051437:Renal Insufficiency / Q000097:blood* / Q000378:metabolism; D012720:Severity of Illness Index; D012964:Sodium / Q000097:blood
D000736:Androstenes; D000451:Mineralocorticoid Receptor Antagonists; D012964:Sodium; D003404:Creatinine; C035144:drospirenone; D011188:Potassium