RESUMO
UNLABELLED: Hypercalcemia-hyperphosphatemia is an unavoidable consequence of end-stage chronic kidney disease and common in hemodialytic patients. Calcium carbonate (CaCO3) is one type of phosphate binder used widely and prescribed in patients undergoing hemodialysis, aiming to control the levels of calcium and phosphate. These drugs are most effective if taken with meals. This study aimed to evaluate the use of phosphate binders in hemodialysis patients and the factors that influence the success of phosphate binder therapy by experimental studies with retrospective data collection through the medical records and prospectively through the questionnaire and interviews with patients. The research was conducted in the Unit Hemodialysis building floor 8 of Cipto Mangunkusumo Hospital, Jakarta. The data were collected in a retrospective way for two months (January-February 2013) and a prospective study in March-April 2013. Patients included were stage 5 chronic kidney disease patients who underwent hemodialysis in hemodialysis ward of Cipto Mangunkusumo Hospital. Patients who had data of serum levels at the beginning of the use of calcium phosphate and the final data in 2013 got the phosphate binder therapy. RESULTS: Ninety six patients with stage 5 chronic kidney disease who underwent hemodialysis had been using phosphate binder for 3 years in average. Patient evaluation showed that hypocalcemia was obtained in 23%; normokalemia in 42.7% and hypercalcemia in 34.3%. While the percentage of patients with hipofosfatemia14, 6%, normofosfatemia 32.3% and 53.1% hyperphosphatemia. Results obtained by the prospective analysis of factors that affect the success of the use of phosphate binder therapy are related to how the routine use of phosphate binders is made by the patient. Chi square test showed a significance of 0.000 (p < 0.05), the effect of 54%. CONCLUSION: We can conclude there are many events happening such as hyperphosphatemia in hemodialysis patients that use phosphate binders. Monitoring of serum levels of calcium phosphate in patients with chronic kidney disease undergoing hemodialysis should be performed every month. Education and the role of clinical staff required to assist compliance and therapeutic efficacy of phosphate binder are necessary.
RESUMO
A double-blind, randomized, parallel and active-controlled clinical study was conducted to evaluate the anti-hypertensive effect as well as the tolerability of Olive leaf extract in comparison with Captopril in patients with stage-1 hypertension. Additionally, this study also investigated the hypolipidemic effects of Olive leaf extract in such patients. It consisted of a run-in period of 4 weeks continued subsequently by an 8-week treatment period. Olive (Olea europaea L.) leaf extract (EFLA(®)943) was given orally at the dose of 500 mg twice daily in a flat-dose manner throughout the 8 weeks. Captopril was given at the dosage regimen of 12.5 mg twice daily at start. After 2 weeks, if necessary, the dose of Captopril would be titrated to 25 mg twice daily, based on subject's response to treatment. The primary efficacy endpoint was reduction in systolic blood pressure (SBP) from baseline to week-8 of treatment. The secondary efficacy endpoints were SBP as well as diastolic blood pressure (DBP) changes at every time-point evaluation and lipid profile improvement. Evaluation of BP was performed every week for 8 weeks of treatment; while of lipid profile at a 4-week interval. Mean SBP at baseline was 149.3±5.58 mmHg in Olive group and 148.4±5.56 mmHg in Captopril group; and mean DBPs were 93.9±4.51 and 93.8±4.88 mmHg, respectively. After 8 weeks of treatment, both groups experienced a significant reduction of SBP as well as DBP from baseline; while such reductions were not significantly different between groups. Means of SBP reduction from baseline to the end of study were -11.5±8.5 and -13.7±7.6 mmHg in Olive and Captopril groups, respectively; and those of DBP were -4.8±5.5 and -6.4±5.2 mmHg, respectively. A significant reduction of triglyceride level was observed in Olive group, but not in Captopril group. In conclusion, Olive (Olea europaea) leaf extract, at the dosage regimen of 500 mg twice daily, was similarly effective in lowering systolic and diastolic blood pressures in subjects with stage-1 hypertension as Captopril, given at its effective dose of 12.5-25 mg twice daily.