Background: Ef cacy of chlorthalidone (CT) and thiazides is considered low in low kidney function (LKF). Methods: A parallel-arm,non-inferiority study was done on CT effects in hypertensives with LKF and hypertensives without LKF (Italian Drug Agency Registry ID#671).Study design included:screening visit,baseline visit, 8-week CT treatment with visits at week 1,2,4,6 and 8.The screening visit selected patients on antihypertensive treatment with uncontrolled hypertension (SBP140 or DBP90),ages 25-74,complete diagnostic workup. Eligible patients were prescribed lab evaluations and re-examined after 1-2 week (baseline).Exclusion criteria were treatment with diuretics,CT contraindications,refused consent,SBP180 or DBP110, severe co-morbidities.At baseline, 25 mg CT was prescribed on the top of ongoing treatments to 60 patients with LKF (eGFR by CKD-Epi equation stably <60 mL/min) and 60 patients without LKF (Control, eGFR stably 60 mL/min). Blood pressure was measured at each visit by blinded trained physicians according to WHO guidelines.Lab evaluations were repeated at visit 8. Study power was 80% (=0.01,one sided test,=15,difference in SBP reduction=8). Results: LKF and Control were similar for men% (70.2% and 64.2%),age (mean= 57 and 53),baseline blood pressure (SBP/DBP= 150/90 and 150/91) but differed for eGFR (mean= 39 and 76, range=15-59 and 60-104).Changes over baseline were signi cant at week 8 in LKF and Control for SBP (mean= -20 and -23; 95%CI= -22/-18 and -26/-19) and DBP (-9 and -10; -11/-7 and -13/-8).Differences between groups were not signi cant for changes in SBP (-3; -7/+1) and DBP (-1; -4/+2). Baseline eGFR did not predict SBP/DBP changes in either groups (R<0.18,P>0.17). Week 8 changes were signi cant for eGFR (LKF and Control, mL/min= -2 and -5; -4/-1 and -7/-3), serum potassium (mmol/L= -0.2 and -0.2; -0.3/-0.1 and -0.3/-1), serum uric acid (mg/dL= +0.8 and +0.9; +0.5/+1.1 and +0.7/+1.1). Adverse events incidence was 13.3% in both groups. The commonest events were serum sodium <135 mmol/L and SBP/DBP <110/90. Conclusions: Data do not support the idea of reduced CT ef cacy in low kidney function.

8-Week Study on Effects of Chlorthalidone in Hypertensives with Low eGFR

CIRILLO, Massimo;BILANCIO, GIANCARLO
2013

Abstract

Background: Ef cacy of chlorthalidone (CT) and thiazides is considered low in low kidney function (LKF). Methods: A parallel-arm,non-inferiority study was done on CT effects in hypertensives with LKF and hypertensives without LKF (Italian Drug Agency Registry ID#671).Study design included:screening visit,baseline visit, 8-week CT treatment with visits at week 1,2,4,6 and 8.The screening visit selected patients on antihypertensive treatment with uncontrolled hypertension (SBP140 or DBP90),ages 25-74,complete diagnostic workup. Eligible patients were prescribed lab evaluations and re-examined after 1-2 week (baseline).Exclusion criteria were treatment with diuretics,CT contraindications,refused consent,SBP180 or DBP110, severe co-morbidities.At baseline, 25 mg CT was prescribed on the top of ongoing treatments to 60 patients with LKF (eGFR by CKD-Epi equation stably <60 mL/min) and 60 patients without LKF (Control, eGFR stably 60 mL/min). Blood pressure was measured at each visit by blinded trained physicians according to WHO guidelines.Lab evaluations were repeated at visit 8. Study power was 80% (=0.01,one sided test,=15,difference in SBP reduction=8). Results: LKF and Control were similar for men% (70.2% and 64.2%),age (mean= 57 and 53),baseline blood pressure (SBP/DBP= 150/90 and 150/91) but differed for eGFR (mean= 39 and 76, range=15-59 and 60-104).Changes over baseline were signi cant at week 8 in LKF and Control for SBP (mean= -20 and -23; 95%CI= -22/-18 and -26/-19) and DBP (-9 and -10; -11/-7 and -13/-8).Differences between groups were not signi cant for changes in SBP (-3; -7/+1) and DBP (-1; -4/+2). Baseline eGFR did not predict SBP/DBP changes in either groups (R<0.18,P>0.17). Week 8 changes were signi cant for eGFR (LKF and Control, mL/min= -2 and -5; -4/-1 and -7/-3), serum potassium (mmol/L= -0.2 and -0.2; -0.3/-0.1 and -0.3/-1), serum uric acid (mg/dL= +0.8 and +0.9; +0.5/+1.1 and +0.7/+1.1). Adverse events incidence was 13.3% in both groups. The commonest events were serum sodium <135 mmol/L and SBP/DBP <110/90. Conclusions: Data do not support the idea of reduced CT ef cacy in low kidney function.
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11386/4308053
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