ABSTRACT
BACKGROUND: Left ventricular hypertrophy and asymmetric dimethylarginine (ADMA) are surrogate markers of cardiovascular disease (CVD) in the dialysis population. This study aimed to evaluate the effect of a calcium channel blocker-based antihypertensive regimen compared to a beta-blocker-based antihypertensive regimen on left ventricular mass index (LVMI) and ADMA levels in hypertensive patients on hemodialysis (HD). METHODS: This was a parallel-design, open-label, single-center randomized controlled trial on 46 hypertensive patients on maintenance HD, with no history of CVD. Patients were randomly assigned to receive amlodipine 10âmg/d (nâ=â23) or bisoprolol 10âmg/d (nâ=â23). Office-based blood pressure (BP) was targeted to ≤ 140/ 90âmm Hg. The outcome was the change in LVMI and ADMA from baseline to 6âmonths. RESULTS: Baseline demographic and clinical characteristics did not vary between groups. After 6âmonths of treatment, amlodipine-based therapy induced a greater reduction in LVMI from baseline than bisoprolol-based treatment (35â±â34.2 vs 9.8â±â35.9âgm/m2; Pâ=â.017). A similar reduction in the mean BP occurred with treatment in both groups. ADMA concentration decreased significantly from baseline in the amlodipine group (0.75â±â0.73 to 0.65â±â0.67ânmol/mL; Pâ=â.001), but increased nonsignificantly in the bisoprolol group (0.64â±â0.61 to 0.78â±â0.64ânmol/mL; Pâ=â.052). CONCLUSION: This study showed that compared to a bisoprolol-based regimen, an amlodipine-based antihypertensive regimen resulted in a significantly greater reduction in LVMI and ADMA levels from baseline in hypertensive patients on HD despite similar BP reduction in both groups. These findings support the re-evaluation of amlodipine as a potential first-line antihypertensive treatment in patients on HD without previous CVD. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT04085562, registered September 2019.
Subject(s)
Amlodipine/therapeutic use , Antihypertensive Agents/therapeutic use , Bisoprolol/therapeutic use , Hypertension/drug therapy , Hypertrophy, Left Ventricular/drug therapy , Kidney Failure, Chronic/therapy , Renal Dialysis/adverse effects , Adult , Aged , Amlodipine/pharmacology , Antihypertensive Agents/pharmacology , Blood Pressure/drug effects , Female , Humans , Hypertension/etiology , Hypertrophy, Left Ventricular/etiology , Male , Middle Aged , Treatment OutcomeABSTRACT
Nifedipine is one of calcium channel blockers that commonly used clinically to treat hypertension and angina in Egyptian patients. A sustained-release (SR) formulation of nifedipine is available in the Egyptian community and administered twice daily. This study aimed to to compare the pharmacokinetics and safety profiles of a 20 mg SR and IR (immediate release) formulation of nifedipine after single-dose administration in healthy Egyptian subjects. Randomized, crossed open-label two- way clinical trial, in 16 healthy adult volunteers, of 24.75±5.20 years, with BMI 23.26±1.756 were assessed. Blood samples were collected at predefined times for 48 h and analyzed for Nifedipine plasma concentrations using validated reversed phase liquid chromatography method with ultraviolet detection. Pharmacokinetics was determined using non- compartmental model pharmacokinetics and analyzed using one-way ANOVA (P≤0.05). Following a single oral administration, SR formulation had a lower Cmax, compared to IR formulation (54.46±17.75 , 107.45±29.85 ng/mL, respectively), and Tmax was significantly longer (2.97 vs. 1.13 h) for the SR and IR formulation, respectively. There was no significant difference between the SR and the IR formulations for AUC0-last and AUC0-∞ (326.7±98.28 vs. 309.27±105.53 ng·h·mL-1 and 380.9 ± 105.24 vs. 334.36±108.1 ng·h·mL-1, respectively). SR formulation of nifedipine showed similar pharmacokinetics to the IR Formulation (F%=1.049), but it additionally allows a less frequent administration. Therefore, The nifedipine SR and IR formulations were well tolerated and displayed comparable safety profiles.