Survey on the occurrence of hyperkalemia after administration of MINNEBRO tablets in patients with hypertension -MID-NET Cohort Study-

JRCT ID: jRCT2031210423

Registered date:12/11/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: hypertension
• Date of first enrollment: 01/01/2009
• Target sample size: 1600
• Study type: Observational

Outcome(s)

• Primary Outcome: Development of hyperkalemia

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) The diagnostic of hypertension exists during the enrollment period (May 1, 2019 to May 31, 2023).
2) MINNEBRO tablets or eplerenone has been prescribed during the enrollment period. The earliest prescription date of this drug or eplerenone during the enrollment period is the cohort entry date.
3) The diagnosis of hypertension exists from 30 days before the cohort entry date to the cohort entry date.
4) The earliest medical record date after the data period start date is more than 180 days before the cohort entry date.

Exclude criteria

1) The prescription period of eplerenone is included for at least one day between 180 days before the cohort entry date and the cohort entry date.
2) Serum potassium levels have never been measured during the follow-up period.
3) Serum potassium levels have never been measured between 120 days before the cohort entry date and the cohort entry date.
4) Between 120 days before the cohort entry date and the cohort entry date, the serum potassium value on the measurement date closest to the cohort entry date exceeds 5.0 mEq / L.
5) Between 120 days before the cohort entry date and the cohort entry date, the eGFR on the measurement date closest to the cohort entry date is less than 60 mL/min/1.73 m2.
6) The prescription period of the following drugs includes the start date of the follow-up period.
i) potassium sparing diuretic (spironolactone, triamterene and potassium canrenoate)
ii) potassium preparations (potassium chloride, potassium gluconate, potassium aspartate, potassium iodide and potassium acetate)
iii) itraconazole, ritonavir, and nelfinavir
7) Between 180 days before the cohort entry date and the cohort entry date, there is severe hepatic dysfunction.
8) Between 180 days before the cohort entry date and the cohort entry date, there is diabetes mellitus with albuminuria or proteinuria.

Related Information

• Primary Sponsor: Matsuoka Yomei