OS 03-08 EFFICACY OF TELMISARTAN 40 MG (T40) AND HYDROCHLOROTHIAZIDE 25 MG (H25) MONOTHERAPY IN HIGH SODIUM INTAKE PATIENTS WITH MILD TO MODERATE HYPERTENSION (THAT STUDY)
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Objective: To compare the BP lowering effect of ARBs and thiazide diuretics in high sodium intake patients with mild to moderate hypertension. Design and Method: This research was a multicenter randomized double-blinded parallel controlled trial. Eligible participants were randomly divided into T40 and H25 groups, with 3 follow-ups, scheduled on the 15th, 30th and 60th day to compare the difference of average BP decrease, blood pressure control rates, FBG (fast blood glucose), hypokalemia and other adverse events between two groups after intervention. Results: 1333 participants were enrolled from 14 county hospitals in high-salt-intake area of China in 2014, with average sodium intake of 5893 mg per day. Baseline characteristics were well balanced between groups. In general, SBP/DBP reduction in T40 group was 12.5/8.0, 14.3/9.1 and 12.8/7.2 mmHg at 15 days, 30 days and 60 days of follow-up, respectively, while the counterparts in H25 group was 11.0/5.8, 13.6/7.1 and 11.5/5.3 mmHg, respectively. BP reduction in T40 group was greater than that in H25 group at 3 follow-up visits, but with only statistical significance for DBP. When controlled by gender, age, body mass index and baseline BP, subgroup analysis showed that DBP reduction was still higher in T40 group than that in H25 group (P < 0.001) regardless of the amount of urine sodium excretion and pulse pressure (PP). SBP reduction was positively related to increasing urine sodium and PP level for patients in both groups, but increased faster with increasing PP in H25 group than that in T40 group (P = 0.0238 for group*PP). Compared with T40, patients in H25 group showed more hypokalemia (T:0.4% vs H:4.5%, P < 0.001). Conclusions: Telmisartan 40 mg showed better DBP lowering effect and less hypokalemia than HCTZ 25 mg among high sodium intake patients with mild to moderate hypertension. Effect superiority of HCTZ among patients with large pulse pressure might exist and needs further test.Keywords:
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การศกษาแบบตดขวางนมวตถประสงคเพอทราบความชกและปจจยทสมพนธกบภาวะโพแทสเซยมในเลอดตำในผปวยความดนโลหตสงทรกษาดวยยา Hydrochlorothiazide ขนาด 25 มลลกรมตอวน กลมตวอยางคอผปวยความดนโลหตสง ทมารกษาทแผนกผปวยนอกของโรงพยาบาล ในจงหวดนครสวรรค ระหวางเดอนมถนายน พ.ศ. 2555 ถงพฤษภาคม พ.ศ. 2556 จำนวน 384 ราย โดยบนทกขอมลพนฐาน ซกประวต ตรวจรางกายและสงตรวจเลอดทางหองปฏบตการโดยระดบโพแทสเซยมในเลอดทนอยกวา 3.5 มลลโมลตอลตร จะวนจฉยภาวะโพแทสเซยมในเลอดตำวเคราะหขอมลโดยหาคาความถรอยละ คาเฉลย และสวนเบยงเบนมาตรฐานและทดสอบปจจยทมผล โดยใชสถต Chi-square และ t-test ผลการศกษาพบวาระดบโพแทสเซยมในเลอดของผปวย มการกระจายคาอยระหวาง 1.9-4.9 มลลโมลตอลตร และพบความชกของภาวะโพแทสเซยมในเลอดตำเทากบรอยละ 43.5 โดยมระดบตำเลกนอย (3.0-3.4 มลลโมลตอลตร) รอยละ 33.9 ตำปานกลาง (2.5-2.9 มลลโมลตอลตร) รอยละ 9.1 และตำมาก (นอยกวา 2.5 มลลโมลตอลตร) รอยละ 0.5 และพบวาการใชยา Enalapril รวมกบ Hydrochlorothiazide สามารถปองกนภาวะโพแทสเซยมในเลอดตำอยางมนยสำคญทางสถต (OR=0.43, 95 percent CI=0.28-0.65, p-value < 0.001) โดยคาเฉลยระดบโพแทสเซยมในเลอดของกลมทใชยา Enalapril สงกวากลมทไมใชยาอยางมนยสำคญทางสถต (Mean diff = 0.23, 95 percent CI=0.14-0.31, p-value <0.001) โดยสรป พบความชกของภาวะโพแทสเซยมในเลอดตำในผปวยความดนโลหตสง ทรกษาดวย ยา Hydrochlorothiazide คอนขางสง จงควรมการประเมนและเฝาตดตามระดบโพแทสเซยมในเลอด ของผปวยทใชยานทกราย Prevalence and associated factors of hypokalemia in therapeutic use of hydrochlorothiazide in hypertensive patients . A cross-sectional study was conducted to determine the prevalence and factors that induced hypokalemia in treating hypertension with Hydrochlorothiazide 25 mg once daily. The 384 patients who diagnosed as hypertension and treated at outpatient unit of hospital in Nakhonsawan province during June 2012 to May 2013 were recruited into the study. The baseline data, medical history, physical examination and blood chemistry were recorded. The less than 3.5 mmol/l of serum potassium was determined as hypokalemia. Data was analyzed by using chi-square and t-test and reported the prevalence and associated factors. The results revealed that the serum potassium levels of patients had a distribution ranging from 1.9 to 4.9 mmol/l and the prevalence of hypokalemia was 43.5 percent. Of these, mild hypokalemia (3.0-3.4 mmol/l) was 33.9 percent, moderate hypokalemia (2.5- 2.9 mmol/l) was 9.1 percent and severe hypokalemia (< 2.5 mmol/l) was 0.5 percent. The significant protective factor that decreased hypokalemia was the combined using of Enalapril with Hydrochlorothiazide (OR= 0.43, 95 percent CI=0.28-0.65, p-value < 0.001) and the mean serum potassium of the combined Enalapril group was significantly higher than non-using group. (Mean diff= 0.23, 95 percent CI=0.14-0.31, p-value < 0.001) In conclusion, the prevalence of hypokalemia in treatment hypertensive patients with Hydrochlorothiazide was very high. This study findings support the importance of assessing and monitoring the serum potassium level in every patient who treated with this drug.
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Thiazide diuretics are the cornerstone of treatment of hypertension in most patients. Hydrochlorothiazide is the most commonly used thiazide diuretic in the United States, but interest in chlorthalidone is increasing. The authors summarize the literature comparing these two agents.
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Benzothiadiazines
Chlorothiazide
Cornerstone
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Hydrochlorothiazide, a drug which is often initially prescribed for mild to moderate hypertension, failed to lower blood pressures in 9 of 43 patients but concomitantly elevated plasma norepinephrine (NE) levels in all patients with hypertension. 20 The 9 obese hydrochlorothiazide-resistant patients were then given fenfluramine, an anorectic, in addition to the thiazide. They were reevaluated after 2 and 5 wk, at which times there were reductions in blood pressures and marked reductions in the plasma NE levels which had been elevated by the hydrochlorothiazide. Since iatrogenic sympathetic activation seems undesirable in treating hypertension, fenfluramine may be useful in obese thiazide-resistant hypertensive patients when used in combination with a thiazide diuretic. Clinical Pharmacology and Therapeutics (1980) 28, 22–27; doi:10.1038/clpt.1980.125
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Clinical Pharmacology
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Essential hypertension
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Introduction: Thiazide diuretics are among the major anti-hypertensive medications. Hydrochlorothiazide and indapamide are among the most commonly used thiazides. Common side effects include impaired renal function and electrolyte disturbances. Whether hydrochlorothiazide and indapamide cause the same amount of disturbance at equivalent doses is uncertain.
Methodology: Patient data from four different clinics was analyzed. Patients whose thiazide diuretic was initiated or dose escalated were included if they met the inclusion criteria. Patient characteristics, including demographics, comorbidities, medications, renal function, and electrolyte values at the initial visit and control visit, and hydrochlorothiazide or indapamide exposure per milligram, were acquired. Indapamide doses were multiplied by ten to convert into equivalent thiazide doses. Changes in renal function and electrolyte values, and renal function and electrolyte changes per equivalent thiazide exposure, were calculated.
Results: The uric acid increase and potassium decrease were different for the indapamide and hydrochlorothiazide groups. However, when these changes were analyzed per equivalent thiazide exposure, potassium was not different, but the uric acid increase was still significantly different between indapamide and hydrochlorothiazide (.05(.08) vs .03 (.08) mg/dL per equivalent mg thiazide, p = .049).
Discussion: This study demonstrated that indapamide’s hyperuricemic effect is more profound than that of hydrochlorothiazide. Choosing hydrochlorothiazide instead of indapamide may be more appropriate in patients with higher initial uric acid levels.
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In a double-blind study comprising 31 patients with essential hypertension not satisfactorily controlled on hydrochlorothiazide 25 mg o.m., a fixed-ratio combination of metoprolol 100 mg and hydrochlorothiazide 12.5 mg, given as 2 tablets o.m. has been compared with hydrochlorothiazide 50 mg o.m. monotherapy. With the combination regimen a significant reduction of blood pressure was achieved while doubling of the thiazide dose did not adequately control the blood pressure. In 7 patients in the thiazide-group the therapy was changed to the combination during a follow-up period and their blood pressure was normalised. During the follow-up period, 22 patients were thus treated with the fixed combination; 50% of them were controlled on one tablet o.m. The tolerability was good in both groups and no changes were observed regarding laboratory variables except for an increase in serum uric acid in the thiazide-group. The study indicates that a fixed-ratio combination of hydrochlorothiazide 12.5 mg and metoprolol 100 mg in a dose of one or two tablets once daily is a well tolerated and more effective therapy than hydrochlorothiazide 50 mg once daily monotherapy.
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Fixed-dose combination
Tolerability
Essential hypertension
Combination therapy
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Plasma renin activity
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Hydrochlorothiazide and other thiazide-like diuretics are considered as a first-line drug for initial therapy in uncomplicated arterial hypertension [1]. There are several reports [2–6] of thiazide-induced cholecystitis, but here we report a case of serious hepatotoxicity associated with hydrochlorothiazide treatment.
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Nephrology
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Is hydrochlorothiazide (HCTZ) a better choice than chlorthalidone for hypertension?
No trials compare HCTZ with other thiazide diuretics in terms of cardiovascular or mortality outcomes. We must rely on less rigorous study designs and other outcomes.
Available data suggest HCTZ is at best equal
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Thiazide
Benzothiadiazines
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