| Objective: Hypertension was the most common risk factors for cardiovascular diseases. The morbidity and mortality of cardiovascular cerebralvascular diseases was decreased significantly by actively antihypertensive therapy . A great lot of clinical experiments showed blood pressure in thirty percent patients got satisfactory controll by single medicine treatment,and seventy percent patients need combined drug therapy.Thus fixed-dose combination of antihypertensive drugs that had an exact effect on antihypertension and can decrease or cancell adverse effect and improve the compliableness of patients. Compound valsartan was composed of valsartan and hydrochlorothiazide. Valsartan as angiotensin II receptor antagonist (ARB), can play a antihypertensive role through effective inhibition of the binding of AngiotensinII (AngII) to its AngiotensinII type 1 receptor (AT1) acceptor. Hydrochlorothiazide as thiazide diuretic. can decrease blood pressure by decreasing blood-volume. Two-drug combinationthe can effectively decrease blood pressure ,and patients had a good tolerance to it.The aim of this study was to investigate the efficacy and safety of compound valsartan (fixed combination valsartan 80mg/hydrochlorothiazide 12.5mg) in patients with mild-to-moderate essential hypertension .Methods: 49 patients with mild-to-moderate essential hypertension participated in this randomized,double-blind, double-dummy,active-controlled,paralled-group study. After informed consents were obtained from all the participants, previously treated hypertensive patients had gradually stopped taking antihypertensive drugs, and then the patient (MSDBP≥95mmHg and<110mmHg)entered a single-blind treatment stage after two-week wash-out period. However,previously untreated hypertensive patients (MSDBP≥95 mmHg and <110 mmHg ) entered a single-blind treatment stage directly . They received valsartan 80 mg once a day for 4 weeks in the single-blind treatment stage. At the end of the single-blind treatment stage, 34 patients(MSDBP≥90 mmHg and<110 mmHg)were randomized in 1:1 ratio to the group of both double-blind treatments(valsartan 80mg o.d or valsartan 80mg/hydrochlorothiazide12.5mg)for 8.weeks. Safety and efficacy was assessed every 4 weeks during the double blind phase.Results:1. In the double-blind stage, due to the compound valsartan group, the value of mean sitting systolic blood pressure (MSSBP) was 144.13±6.56 mmHg at 0 week, and the following 4th and 8th week, the values of MSSBP were 135.14±4.53 mmHg and 132.24±3.73 mmHg respectively; Due to the valsartan group , the values of MSSBP were 144.12±6.23 mmHg at 0 week, and the following 4th and 8th week the values of MSSBP were 139.22±4.65mmHg and 137.14±4.09 mmHg respectively. There was no statistical difference(P>0.05) at 0 week, however ,there were statistical difference (P<0.05 and P<0.01) at the 4th week and the 8th week between the two groups. MSSBP was reduced in the compound valsartan group by 8.99±2.87 mmHg and in the valsartan group by 4.89±3.23 mmHg after 4 weeks; MSSBP was reduced by 11.89±3.53 mmHg and 6.98±5.53 mmHg after 8 weeks in the two group, respectively. The extent of the MSSBP reduction in the compound valsartan group was superior to the valsartan group, there was significant difference (P<0.01) between the two groups.2. In the double-blind stage, due to the compound valsartan group, the value of MSDBP was 96.24±4.59 mmHg at 0 week, and the following 4th and 8th week, the values of MSDBP were 87.80±3.50 mmHg and 85.53±3.49 mmHg respectively; Due to the valsartan group ,the values of MSDBP were 96.19±4.91 mmHg at 0 week, and the following 4th and 8th week, the values of MSDBP were 91.91±4.15 mmHg and 89.53±3.14 mmHg respectively. There was no statistical difference(P>0.05) at 0 week, however ,there were statistical difference (P<0.01) at the 4th week and the 8th week between the two groups. MSDBP was reduced in the compound valsartan group by 8.44±2.03 mmHg and in the valsartan group by 4.28±1.90 mmHg after 4 weeks; MSDBP was reduced by 10.71±2.79mmHg and 6.66±2.41 mmHg after 8 weeks in the two group, respectively. The extent of the MSDBP reduction in the compound valsartan group was superior to the valsartan group, there was significant difference (P<0.01) between the two groups.3. In the double-blind stage, the total effective rate was 70.59% in the compound valsartan group and 29.41% in the valsartan group, there was difference (P<0.05) between the two groups; The total effective rate was 94.12% in the compound valsartan group and 52.94% in the valsartan group, the higher significantly total effective rate was observed in the compound valsartan group(P<0.01) after 8 weeks.4. In the double-blind stage, comparison in the every group : the heart rates did not change significantly after the treatmeat of the two drugs(P>0.05), and there was no significant difference between the two groups(P>0.05).5. There was no striking difference(P>0.05) after our experiment in the two groups in blood routine and urime routine test, FBG, blood-lipid, ion, hepatic and renal function ,uric acid and creatinkinase, and there was also no striking difference(P>0.05) between the two groups in adverse reaction, and no serious adverse events happened in the two groups.Conclusion:1. The compound valsartan could decrease the BP of patients with mild to moderate essential hypertension more quickly and more effectively than valsartan monotherapy. Applying compound valsartan, the effective rates of the patiens'BP were superior to those who only applied valsartan.2. The compound valsartan can significantly enhance the patient compliance in treatment.3. The compound valsartan had no significant effect on FBG, blood-lipid, electrolyte, hepatic and renal function, uric acid and creatinkinase, applied to patiens with. mild to moderate essential hypertension.4. The incidence of adverse events in the compound valsartan group is similar to the valsartan group. No severe side reactions were seen in the course of the treatment in the two groups.Thus compound valsartan is safe and effective in patients with mild-to-moderate essential hypertension, and it is worthy of applying for the clinical treatment.
|
PDF Full Text Request