Limits...
Risk of hyperkalemia in patients with moderate chronic kidney disease initiating angiotensin converting enzyme inhibitors or angiotensin receptor blockers: a randomized study.

Espinel E, Joven J, Gil I, Suñé P, Renedo B, Fort J, Serón D - BMC Res Notes (2013)

Bottom Line: The percentage of patients presenting hyperkalemia higher than 5 mmol/L did not differ between treatments: 37% for olmesartan and 40% for enalapril.The decreases in microalbuminuria were also similar (23% in olmesartan and 29% in enalapril patients) in the 4 weeks time point.The percentage of patients presenting hyperkalemia, even after a two month period, did not differ between treatments.

View Article: PubMed Central - HTML - PubMed

ABSTRACT

Background: Angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers are renoprotective but both may increase serum potassium concentrations in patients with chronic kidney disease (CKD). The proportion of affected patients, the optimum follow-up period and whether there are differences between drugs in the development of this complication remain to be ascertained.

Methods: In a randomized, double-blind, phase IV, controlled, crossover study we recruited 30 patients with stage 3 CKD under restrictive eligibility criteria and strict dietary control. With the exception of withdrawals, each patient was treated with olmesartan and enalapril separately for 3 months each, with a 1-week wash-out period between treatments. Patients were clinically assessed on 10 occasions via measurements of serum and urine samples. We used the Cochran-Mantel-Haenszel statistics for comparison of categorical data between groups. Comparisons were also made using independent two-sample t-tests and Welch's t-test. Analysis of variance (ANOVA) was performed when necessary. We used either a Mann-Whitney or Kruskal-Wallis test if the distribution was not normal or the variance not homogeneous.

Results: Enalapril and olmesartan increased serum potassium levels similarly (0.3 mmol/L and 0.24 mmol/L respectively). The percentage of patients presenting hyperkalemia higher than 5 mmol/L did not differ between treatments: 37% for olmesartan and 40% for enalapril. The mean e-GFR ranged 46.3 to 48.59 ml/mint/1.73 m2 in those treated with olmesartan and 46.8 to 48.3 ml/mint/1.73 m2 in those with enalapril and remained unchanged at the end of the study. The decreases in microalbuminuria were also similar (23% in olmesartan and 29% in enalapril patients) in the 4 weeks time point. The percentage of patients presenting hyperkalemia, even after a two month period, did not differ between treatments. There were no appreciable changes in sodium and potassium urinary excretion.

Conclusions: Disturbances in potassium balance upon treatment with either olmesartan or enalapril are frequent and without differences between groups. The follow-up of these patients should include control of potassium levels, at least after the first week and the first and second month after initiating treatment.

Trial registration: The trial EudraCT "2008-002191-98".

Show MeSH

Related in: MedlinePlus

Flow diagram of participants through each stage of the trial indicating for each group the number of participants assigned that received intended treatment and were analyzed for the primary outcome.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC3750227&req=5

Figure 1: Flow diagram of participants through each stage of the trial indicating for each group the number of participants assigned that received intended treatment and were analyzed for the primary outcome.

Mentions: Among patients attending our outpatient clinic for management of CKD in a tertiary care teaching hospital, patients with stage 3 CKD, i.e. estimated GFR (eGFR) between 30 and 60 ml/min/1.73 m2, stable clinical condition, aged 18–75 years, serum potassium concentration <5 mmol/L and blood pressure (BP) ranging between 130/80 mmHg and 180/100 mmHg, were considered for inclusion (n = 120). The use of calcium channel blockers or alpha-adrenergic blockers was not an exclusion criterion. For enrollment, strict exclusion criteria were established to exclude the presence of confounding factors that could alter the incidence of potassium disturbances during the treatment period as outlined in Table 1. No patient with a known arterial renal stenosis was included. The attending physicians identified 34 eligible patients, 4 of whom were discarded during the screening visits due to failure to follow a balanced diet that was relatively low in sodium and contained 80–90 mmol/day of potassium as assessed via repeated measurement of electrolytes in 24-h urine samples. To fulfill restrictive eligibility criteria and strict dietary control patients were also instructed not to ingest salt substitutes or herbs. Finally we recruited 30 patients with stage 3 CKD who were informed about the trial and invited to participate and sign the informed consent approved by our institutional review board. Patients received olmesartan and enalapril sequentially, (Figure 1) and we chose the two-period design for simplicity. Raised serum potassium levels and lack of adherence were defined as reasons for withdrawal.


Risk of hyperkalemia in patients with moderate chronic kidney disease initiating angiotensin converting enzyme inhibitors or angiotensin receptor blockers: a randomized study.

Espinel E, Joven J, Gil I, Suñé P, Renedo B, Fort J, Serón D - BMC Res Notes (2013)

Flow diagram of participants through each stage of the trial indicating for each group the number of participants assigned that received intended treatment and were analyzed for the primary outcome.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3750227&req=5

Figure 1: Flow diagram of participants through each stage of the trial indicating for each group the number of participants assigned that received intended treatment and were analyzed for the primary outcome.
Mentions: Among patients attending our outpatient clinic for management of CKD in a tertiary care teaching hospital, patients with stage 3 CKD, i.e. estimated GFR (eGFR) between 30 and 60 ml/min/1.73 m2, stable clinical condition, aged 18–75 years, serum potassium concentration <5 mmol/L and blood pressure (BP) ranging between 130/80 mmHg and 180/100 mmHg, were considered for inclusion (n = 120). The use of calcium channel blockers or alpha-adrenergic blockers was not an exclusion criterion. For enrollment, strict exclusion criteria were established to exclude the presence of confounding factors that could alter the incidence of potassium disturbances during the treatment period as outlined in Table 1. No patient with a known arterial renal stenosis was included. The attending physicians identified 34 eligible patients, 4 of whom were discarded during the screening visits due to failure to follow a balanced diet that was relatively low in sodium and contained 80–90 mmol/day of potassium as assessed via repeated measurement of electrolytes in 24-h urine samples. To fulfill restrictive eligibility criteria and strict dietary control patients were also instructed not to ingest salt substitutes or herbs. Finally we recruited 30 patients with stage 3 CKD who were informed about the trial and invited to participate and sign the informed consent approved by our institutional review board. Patients received olmesartan and enalapril sequentially, (Figure 1) and we chose the two-period design for simplicity. Raised serum potassium levels and lack of adherence were defined as reasons for withdrawal.

Bottom Line: The percentage of patients presenting hyperkalemia higher than 5 mmol/L did not differ between treatments: 37% for olmesartan and 40% for enalapril.The decreases in microalbuminuria were also similar (23% in olmesartan and 29% in enalapril patients) in the 4 weeks time point.The percentage of patients presenting hyperkalemia, even after a two month period, did not differ between treatments.

View Article: PubMed Central - HTML - PubMed

ABSTRACT

Background: Angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers are renoprotective but both may increase serum potassium concentrations in patients with chronic kidney disease (CKD). The proportion of affected patients, the optimum follow-up period and whether there are differences between drugs in the development of this complication remain to be ascertained.

Methods: In a randomized, double-blind, phase IV, controlled, crossover study we recruited 30 patients with stage 3 CKD under restrictive eligibility criteria and strict dietary control. With the exception of withdrawals, each patient was treated with olmesartan and enalapril separately for 3 months each, with a 1-week wash-out period between treatments. Patients were clinically assessed on 10 occasions via measurements of serum and urine samples. We used the Cochran-Mantel-Haenszel statistics for comparison of categorical data between groups. Comparisons were also made using independent two-sample t-tests and Welch's t-test. Analysis of variance (ANOVA) was performed when necessary. We used either a Mann-Whitney or Kruskal-Wallis test if the distribution was not normal or the variance not homogeneous.

Results: Enalapril and olmesartan increased serum potassium levels similarly (0.3 mmol/L and 0.24 mmol/L respectively). The percentage of patients presenting hyperkalemia higher than 5 mmol/L did not differ between treatments: 37% for olmesartan and 40% for enalapril. The mean e-GFR ranged 46.3 to 48.59 ml/mint/1.73 m2 in those treated with olmesartan and 46.8 to 48.3 ml/mint/1.73 m2 in those with enalapril and remained unchanged at the end of the study. The decreases in microalbuminuria were also similar (23% in olmesartan and 29% in enalapril patients) in the 4 weeks time point. The percentage of patients presenting hyperkalemia, even after a two month period, did not differ between treatments. There were no appreciable changes in sodium and potassium urinary excretion.

Conclusions: Disturbances in potassium balance upon treatment with either olmesartan or enalapril are frequent and without differences between groups. The follow-up of these patients should include control of potassium levels, at least after the first week and the first and second month after initiating treatment.

Trial registration: The trial EudraCT "2008-002191-98".

Show MeSH
Related in: MedlinePlus