Potassium values in women taking the oral contraceptive YAZ® (drospirenone 3 mg/ee 20 mcg 24/4 regimen) concomitantly with medications that may increase serum potassium

Abstract

OBJECTIVE: To assess serum potassium levels and hyperkalemia-related adverse events among women taking YAZ concomitantly with medications that may increase serum potassium. DESIGN: This was a post hoc analysis of a 13-cycle, international, multicenter, noncomparative study assessing the efficacy and safety of YAZ. MATERIALS AND METHODS: Healthy women (n=1,027) aged 17–36 years at risk of pregnancy and requesting contraception were recruited. Serum potassium levels were measured at baseline, at cycles 1, 6, 13 and at final examination (day 10–17 after last pill intake or at discontinuation). Women taking concomitant medications that may increase serum potassium levels (e.g. angiotensin-converting enzyme [ACE] inhibitors, angiotensin-II receptor antagonists, potassium-sparing diuretics, heparin, aldosterone antagonists, and non-steroidal anti-inflammatory drugs [NSAIDs]) were identified using the Anatomical Therapeutic Chemical codes logged and medication(s) used. RESULTS: Overall, 169 (16.5%) women reported taking ≥1 medications that may increase serum potassium. The most commonly used medications were NSAIDs [162 (95.9%) women], followed by heparin [5 (3.0%)], and ACE inhibitors [2 (1.2%)]. One woman received potassium supplementation and concurrently used an NSAID. Forty-one women (24.3%) used their concomitant medication for >5 days (range 6 days through to the entire study duration). The concomitant medication was taken at the time of serum collection in 120 (70.0%) women; while the relationship of use to time of collection was unknown for 28 (16.6%) women. Mean change from baseline in potassium levels are summarized in Table 1. Four (2.4%) women had on-treatment potassium levels >5.0 mM (range 5.3–9.7 mM). Among the women with elevated potassium, all continued treatment and subsequent assessments were within normal range. There were no hyperkalemia-related adverse events. Table 1Serum potassium levels: mean change from baselineCycles1613Final ExamN164152133168Mean change from baseline in potassium levels (mM)0.033−0.114−0.024−0.128 Open table in a new tab CONCLUSIONS: The use of YAZ concomitantly with medications that may increase serum potassium was not associated with clinically significant potassium elevation and nor with adverse events associated with hyperkalemia. The safety profile of YAZ among the cohort of women evaluated is consistent with that in the general study population.