The Association Between Drospirenone and Hyperkalemia

A Comparative-safety Study

Steven T Bird; Salvatore R Pepe; Mahyar Etminan; Xinyue Liu; James M Brophy; Joseph AC Delaney

Disclosures

BMC Clin Pharmacol. 2011;11(23):1-6. 

In This Article

Results

OCs and Hyperkalemia

The cohort included 1,148,183 women exposed to a progestin-based OC and 880,014 person-years of follow-up time. Patients in the study averaged 28.8 years of age and had a mean follow up time of 280 days. There were 2325 cases of hyperkalemia, representing 0.20% of the population. Baseline characteristics are shown in Table 1.

The adjusted hazard ratio (HR) for a recorded diagnosis of hyperkalemia while exposed to drospirenone compared to levonorgestrel was 1.10 (95% CI 0.95–1.26). Other OCs were unassociated with hyperkalemia: desogestrel HR 1.00 (95%CI: 0.85–1.17), ethynodiol diacetate HR 0.71 (95%CI: 0.49–1.02), norethindrone acetate HR 1.08 (95%CI: 0.91–1.29), norgestrel HR 1.00 (95%CI: 0.76–1.33), although there was an unexpected signal with norethindrone HR 1.15 (95%CI: 1.00–1.33) and norgestimate HR 1.27 (95%CI: 1.11–1.46) (Table 2). Additionally, the analysis found no interaction between drospirenone and spironolactone for hyperkalemia in the regression model (HR 1.08, 95%CI: 0.78–1.49). Other interactions with drospirenone in the regression model were as follows: ACEI/ARB HR 0.78 (95%CI 0.55–1.10) and NSAID HR 1.09 (95%CI 0.80–1.48).

Utilization

The utilization study evaluated all 2,925,407 patients that met the initial study inclusion criteria. 18,869 patients in this population were taking both spironolactone and an OC. The odds of receiving spironolactone while on drospirenone were 2.66 (95%CI 2.53–2.80) times higher than the odds of receiving spironolactone while on levonorgestrel. The ORs for receiving spironolactone while on other progestin-based OCs compared to levonorgestrel are as follows: desogestrel 1.46 (95%CI 1.38–1.55), ethynodiol diacetate 2.85 (95%CI 2.62–3.11), norethindrone acetate 1.01 (95%CI 0.93–1.08), norethindrone 0.78 (95%CI 0.74–0.83), norgestimate 1.34 (95%CI 1.27–1.41), and norgestrel 0.98 (95%CI 0.89–1.08). The Yasmin® and Yaz® package inserts recommend potassium monitoring within the first treatment cycle for patient taking other medications known to cause hyperkalemia. Of the 5,752 patients who took drospirenone and spironolactone concomitantly, only 376 (6.5%) patients underwent a serum potassium assay within 180 days of starting concomitant therapy.

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