奥美沙坦酯和氨氯地平联合治疗原发性高血压的研究

目的:观察奥美沙坦酯和氨氯地平联合治疗控制血压的疗效和安全性。方法:70例2、3级高血压病患者随机接受奥美沙坦酯20 mg与氨氯地平5 mg联合治疗或缬沙坦80 mg与氨氯地平5 mg联合治疗,1次/d,总疗程8周。结果:奥美沙坦酯组和缬沙坦组治疗后血压下降幅度分别为(24.5±9.5/16.0±6.8)mm Hg(1 mm Hg=0.133 kPa)和(24.3±9.2/15.7±6.6)mm Hg,2组间差异无统计学意义(P>0.05)。奥美沙坦酯与氨氯地平和缬沙坦与氨氯地平联合治疗组降压总有效率分别为91.4%和88.6%,2组间差异无统计学意义(P>0.05)。2组不良反应发生率差异无统计学意义(P>0.05)。结论:2、3级高血压病治疗,奥美沙坦酯与氨氯地平和缬沙坦与氨氯地平联合治疗疗效和不良反应均类似。     

Antihypertensive efficacy and safety of olmesartan medoxomil compared with amlodipine for mild-to-moderate hypertension

The antihypertensive efficacy of the angiotensin II receptor blocker olmesartan medoxomil has been shown to compare favourably with that of other antihypertensive agents. This randomized, double-blind study compared the antihypertensive efficacy of the starting dose of olmesartan medoxomil with that of the calcium channel blocker amlodipine besylate (amlodipine) in subjects with mild-to-moderate hypertension. Following a 4-week, single-blind, placebo run-in period, 440 subjects aged >/=18 years were randomized to the starting dose of olmesartan medoxomil (20 mg/day), amlodipine (5 mg/day), or placebo for 8 weeks. Subjects were evaluated by 24-h ambulatory blood pressure monitoring (ABPM) and by seated cuff blood pressure (BP) measurements at trough. The primary end point was the change from baseline in mean 24-h diastolic blood pressure (DBP) by ABPM at Week 8. Secondary end points included change from baseline in mean 24-h ambulatory systolic blood pressure (SBP) at 8 weeks, change from baseline in mean seated trough cuff DBP and SBP measurements, and response and control rates for DBP <90 and <85 mmHg. Control rates for SBP <140 and <130 mmHg were also calculated. Olmesartan medoxomil and amlodipine produced significantly greater reductions in ambulatory and seated DBP and SBP compared with placebo. Mean reductions in ambulatory and seated BP were similar between the two active agents; however, in the olmesartan medoxomil group, significantly more patients achieved the SBP goal of <130 mmHg and the DBP goal of <85 mmHg. Both drugs were well tolerated at the recommended starting dose. Although amlodipine was associated with a higher incidence of oedema, this did not reach statistical significance. Olmesartan medoxomil is an effective antihypertensive agent, with BP-lowering efficacy at the starting dose similar to that of amlodipine, and is associated with more patients achieving the rigorous BP goals of SBP <130 mmHg and DBP <85 mmHg.     

Clinical effects of combined olmesartan medoxomil and amlodipine on clinic and ambulatory blood pressure in elderly patients with resistant hypertension

Elderly patients with resistant hypertension are at increased risk for cardiovascular events. Clinical trials suggest that resistant hypertension involves perhaps 10–15% of hypertension study participants. In this study, 157 resistant hypertension patients older than 60 years were randomized to 8 weeks double-blind treatment with placebo, AML 10 mg/day, OM 40 mg/day and AM × L (10 mg/day) + OM (40 mg/day). Research outcomes suggested that ALM + OM combination therapy had superior efficacy than ALM or OM monotherapies in terms of the clinic blood pressure and 24-h ambulatory blood pressure. In addition, more patients receiving combination therapy (62.5%) achieved BP goal than those treated with placebo (18.4%), AML (37.5) or OM (38.5%) monotherapies. The adverse events in both groups were comparable. Thus, the combination of AML + OM provides a safe and effective option for the treatment of resistant hypertension in challenging elderly patient populations.     

奥美沙坦酯对自发性高血压大鼠主动脉衰老的作用

目的探讨奥美沙坦酯对自发性高血压大鼠（SHR）主动脉衰老的作用。方法实验大鼠分为对照组（WKY组）、SHR组和SHR奥美沙坦酯处理组（OLM组）。每2周测鼠尾动脉压,饲养6周后处死取主动脉组织,一部分制做冰冻切片后β-半乳糖苷酶（β-gal）染色,其余用Western blot法测定Ras、p53、p21及β-actin蛋白的表达。结果与WKY组相比,各检测时间点SHR组血压升高（P〈0.05）,给药后OLM组血压降低（P〈0.05）。WKY组主动脉β-gal染色未见蓝染颗粒;SHR组可见大量蓝染颗粒;OLM组也可见蓝染颗粒,但与SHR组相比明显减少。与WKY组相比,SHR组Ras、p53及p21的蛋白表达增加（P〈0.05）,OLM组上述指标降低（P〈0.05）。结论 SHR通过Ras-p53/p21途径导致主动脉衰老,奥美沙坦酯对其具有显著的抑制作用,在降低血压的同时抑制血管病变的发生。     

Clinical effects of combined olmesartan medoxomil and amlodipine on clinic and ambulatory blood pressure in elderly patients with resistant hypertension

Elderly patients with resistant hypertension are at increased risk for cardiovascular events. Clinical trials suggest that resistant hypertension involves perhaps 10–15% of hypertension study participants. In this study, 157 resistant hypertension patients older than 60 years were randomized to 8 weeks double-blind treatment with placebo, AML 10 mg/day, OM 40 mg/day and AM × L (10 mg/day) + OM (40 mg/day). Research outcomes suggested that ALM + OM combination therapy had superior efficacy than ALM or OM monotherapies in terms of the clinic blood pressure and 24-h ambulatory blood pressure. In addition, more patients receiving combination therapy (62.5%) achieved BP goal than those treated with placebo (18.4%), AML (37.5) or OM (38.5%) monotherapies. The adverse events in both groups were comparable. Thus, the combination of AML + OM provides a safe and effective option for the treatment of resistant hypertension in challenging elderly patient populations.     

Comparative effectiveness of an angiotensin receptor blocker,olmesartan medoxomil,in older hypertensive patients

The efficacy and safety of olmesartan medoxomil (OM) vs active control (AC) monotherapy among elderly patients aged 60‐79 years (N = 4487) was evaluated by meta‐analysis (25 studies). In all patients, change from baseline to end point in blood pressure (BP) was significantly greater with OM vs AC (−19.5/−11.9 vs −16.8/−10.7 mm Hg). Greater proportions of OM‐ vs AC‐treated patients achieved BP goals. In patients with impaired renal function (estimated glomerular filtration rate <60 mL/min/1.73 m²), OM treatment resulted in a greater mean change from baseline in systolic BP vs AC (−21.2 vs −18.7 mm Hg, respectively) and a greater proportion of patients achieving BP goals. These parameters were similar in both groups for elderly patients with diabetes. OM was well tolerated with few adverse events. OM monotherapy can be used as an initial treatment for hypertension in elderly patients, including those with renal impairment or diabetes.     

Efficacy and safety of amlodipine in hypertensive patients with renal dysfunction

Amlodipine, a dihydropyridine calcium antagonist, was administered at 2.5-5.0 mg/day for 8 weeks to 35 hypertensive patients with renal dysfunction, and its efficacy and safety were evaluated. The target reduction in blood pressure was achieved in 28 of the 35 patients (80%), while blood pressure was decreased in 4 patients (11.4%) and unchanged in 3 patients (8.6%). A side effect of mild headache was reported by one patient (2.9%). In addition, abnormal changes in laboratory values were observed in five patients, but all of the changes were mild. Blood urea nitrogen and serum creatinine levels both increased in two of these five patients, and serum creatinine levels increased in another two patients. Serum amlodipine concentration was 4.86 ± 2.57 ng/ml (n = 8) and 3.01 ± 1.02 ng/ml (n = 8) in patients receiving a daily dose of 2.5 mg for 2-5 weeks and 8-10 weeks, respectively. Serum concentration in patients receiving 5 mg from Weeks 2-6 was 9.72 ± 6.89 ng/ml (n = 6) after 7-9 weeks, suggesting no tendency for the accumulation of this drug. The drug was rated as of clinical benefit in 27 of the 35 patients (77.1%), and as slightly beneficial in another 5 patients (14.3%). Thus, amlodipine significantly decreased the blood pressure while causing little or no aggravation of renal dysfunction in hypertensive patients with renal impairment.     

Long-term efficacy and safety of triple-combination therapy with olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide for hypertension

J Clin Hypertens (Greenwich). 2012;14:149–157. ©2012 Wiley Periodicals, Inc. Most patients with hypertension require combination therapy in order to achieve blood pressure (BP) goals. This 40‐week open‐label extension of the 12‐week double‐blind Tri ple Therapy With Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide in Hyperten si ve Patient s Study (TRINITY) evaluated the efficacy and safety of triple‐combination treatments with olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide (OM/AML/HCTZ) in 2112 participants with moderate to severe hypertension. Following 2 weeks of initial treatment with OM 40/AML 5/HCTZ 12.5 mg, participants not achieving BP goal were titrated to OM 40/AML 5/HCTZ 25 mg or OM 40/AML 10/HCTZ 12.5 mg on a randomized basis. At week 16, participants who did not achieve BP goal were further titrated to OM 40/AML 10/HCTZ 25 mg. At the end of the study, 44.5% to 79.8% of participants reached BP goal and the mean BP decreased from 168.6/100.7 mm Hg (baseline BP at randomization) to 125.0 to 136.8 mm Hg/77.8 to 82.5 mm Hg, depending on treatment. Long‐term treatment with OM/AML/HCTZ was well tolerated and effective with no new safety concerns.     

奥美沙坦酯与氯沙坦钾治疗中国轻、中度原发性高血压患者8周的疗效与安全性比较

目的 通过与氯沙坦钾比较评价奥美沙坦酯治疗轻、中度原发性高血压患者的疗效和安全性。方法采用随机、双盲、双模拟、阳性对照、平行分组、多中心临床试验方法。共入选287例轻、中度原发性高血压患者,按照1：1的比例随机分组,分别接受奥美沙坦酯20mg或氯沙坦钾50mg,每天1次口服治疗。在用药4周后对患者进行血压评价,如果患者舒张压（DBP）仍≥90mmHg（1mmHg=0．133kPa）,则试验药物剂量加倍,直至8周试验结束;治疗4周后DBP〈90mmHg的患者则维持原剂量继续治疗至第8周。结果（1）治疗4周后,奥美沙坦酯组坐位DBP谷值平均下降11．72mmHg,氯沙坦钾组平均下降9．23mmHg,两组间比较P=0．004。（2）治疗8周后,奥美沙坦酯组坐位DBP谷值平均下降12．94mmHg,氯沙坦钾组平均下降11．01mmHg,两组间比较P=0．035。（3）治疗4周后,奥美沙坦酯组有效数为81例（65．3％）,氯沙坦钾组有效数为68例（52．7％）,两组间比较P=0．028;治疗8周后,两组有效病例数和有效率相当,P〉0．05。（4）治疗8周后,24h动态血压监测显示,奥美沙坦酯组DBP和SBP的个体和总体谷／峰比值均高于氯沙坦钾组,奥美沙坦酯在24h内的作用持续时间比氯沙坦钾组长。（5）奥美沙坦酯组和氯沙坦钾组发生的与试验药物有关的不良事件的发生率分别为10．5％和13．9％,P〉0．05。结论奥美沙坦酯每日口服20～40mg能够有效、安全地治疗高血压。与氯沙坦钾每日口服50-100mg相比,奥美沙坦酯的降压效果优于氯沙坦钾。     

The use of olmesartan medoxomil as monotherapy or in combination with other antihypertensive agents in elderly hypertensive patients in Japan

The efficacy and safety of the angiotensin receptor blocker olmesartan medoxomil (OLM) was assessed in 550 elderly Japanese hypertensive patients who were followed for 24 weeks in daily clinical practice. Patients were given OLM alone or in combination with other antihypertensive drugs at the discretion of the investigators. After 24 weeks of treatment, systolic and diastolic blood pressure (BP) significantly decreased from baseline (P<.0001). When patients were classified as either young-old (65-74 years) or older-old (75 years and older), with either isolated systolic hypertension (ISH) or systolic-diastolic hypertension (SDH), the reduction of diastolic BP in ISH patients was significantly smaller than that in SDH patients (5.0 vs 15.2 mm Hg; P<.0001), indicating that OLM did not cause excessive reduction of diastolic BP in ISH patients. Treatment was well tolerated in all groups. In conclusion, the medication was safe and effective in reducing BP levels in ISH patients aged 75 years and older, as well as in other elderly hypertensive patients.     

Olmesartan/amlodipine vs olmesartan/hydrochlorothiazide in hypertensive patients with metabolic syndrome: the OLAS study

We studied the effects of treatment with olmesartan/amlodipine and olmesartan/hydrochlorothiazide on inflammatory and metabolic parameters (including new-onset diabetes as a secondary endpoint) in non-diabetic hypertensive patients with metabolic syndrome (MetS). A total of 120 patients with MetS and stage I and II hypertension were randomized to olmesartan 20?mg/amlodipine 5?mg or olmesartan 20?mg/hydrochlorothiazide 12.5?mg. If target systolic blood pressure (<140?mm?Hg) was not reached, doses were doubled after 13 weeks; doxazosin 4?mg was added after 26 weeks, and doubled after 39 weeks; follow-up ended at 78 weeks. At each visit, blood pressure (BP), fasting plasma glucose, insulin, adiponectin, tumour necrosis factor-α, C-reactive protein (CRP), intercellular adhesion molecule-1, vascular cell adhesion molecule-1, interleukins-1β, -6 and -8, and albuminuria were measured; BP was similarly reduced in both groups; 80% of patients reached target BP. Reductions in albuminuria were also similar (50%). Only olmesartan/amlodipine reduced the insulin resistance index (24%, P<0.01), increased plasma adiponectin (16%, P<0.05) and significantly reduced all of the inflammation markers studied, except CRP, which showed a similar reduction in each group. The risk of new-onset diabetes was significantly lower with olmesartan/amlodipine (P=0.02). Both olmesartan-based combinations were effective, but the amlodipine combination resulted in metabolic and anti-inflammatory effects that may have advantages over the hydrochlorothiazide combination.     

An evaluation of the efficacy of olmesartan medoxomil in Black patients with hypertension

Blacks appear to have a more modest blood pressure (BP) response to angiotensin receptor blocker (ARB) monotherapy than non-Blacks. This post-hoc analysis compared the BP-lowering efficacy of olmesartan medoxomil (OM), losartan potassium (LOS), and valsartan (VAL) in Black versus non-Black participants in a randomized, forced-titration study. Patients were randomized to OM 20, LOS 50, and VAL 80 mg/day or placebo for 4 weeks and uptitrated to 40, 100, and 320 mg/day doses, respectively, by study end. The primary end point was the mean change from baseline in diastolic BP (DBP) at week 8. All treatments produced significant reductions in mean DBP and systolic BP (SBP) in Blacks (n = 150; P < .001). BP <140/90 mm Hg was achieved in 35.0%, 15.6%, 29.7%, and 5.0% of Blacks receiving OM, LOS, VAL, and placebo, respectively, and in 41.0%, 21.1%, 28.8%, and 14.5% of non-Blacks receiving OM, LOS, VAL, and placebo, respectively, after 8 weeks. BP-lowering efficacy of the three agents was similar at 3 months. OM had the greatest early efficacy, with numerically greater mean reductions in DBP and SBP, and a higher proportion of Black and non-Black patients achieving goal BP of 140/90 mm Hg at week 8.     

Efficacy of fixed combination amlodipine/valsartan in hospitalized patients with hypertensive disease

Efficacy and tolerability of fixed amlodipine/valsartan combination was studied in 86 patients with hypertensive disease hospitalized in departments of general internal medicine or cardiology. All patients had indications for antihypertensive therapy and were randomized either to fixed combination amlodipine/valsartan (n=43) or to therapy which corresponded to the hospital formulary (n=43). Correction of antihypertensive therapy was performed by treating physician at daily rounds. Self-control of blood pressure (BP) was performed by patients with the use of UA767PC apparatus. Results of BP self-control were compared with clinical measurements in order to detect concealed inefficacy of treatment. Results. Rate of achievement of target BP with fixed combination amlodipine/valsartan (93%) was comparable with that on traditional therapy (90%). But the use of fixed combination amlodipine/valsartan compared with traditional therapy was associated with lower clinical and self measured BP, quicker achievement of target BP (5.8+/-2.3 and 9.2+/-1.8 days, respectively, p<0.05), lesser number of antihypertensive drugs (2.5+/-0.6 and 3.0+/-0.9 days, respectively), lower rate of concealed inefficacy of treatment (12 and 31%, respectively, p<0.05). Conclusions. We have demonstrated appropriateness of inhospital administration of fixed amlodipine/valsartan combination as an approach allowing to achieve target BP in shorter time, with the use of fewer antihypertensive drugs, and diminishing concealed inefficacy of treatment.     

奥美沙坦酯治疗轻度及中度原发性高血压疗效和安全性的评价

目的:评价奥美沙坦酯治疗轻度及中度原发性高血压的疗效和安全性。方法:80例轻度及中度原发性高血压患者随机接受奥美沙坦酯20 mg或缬沙坦80 mg治疗,每日1次,总疗程8周。结果:奥美沙坦酯组治疗前的收缩压(SBP)/舒张压(DBP)为(155.2±11.4)/(96.1±5.2)mmHg(1 mmHg=0.133 kPa),治疗后的血压为(138.8±10.2)/(86.5±4.8)mmHg,血压下降幅度为(16.4±8.1/9.6±5.1)mmHg。缬沙坦组治疗前的SBP/DBP为(156.1±12.2)/(97.2±5.1)mmHg,治疗后的血压为(139.5±10.4)/(88.0±5.5)mmHg,血压下降幅度为(15.6±7.8/9.1±4.9)mmHg。2组治疗前后血压下降幅度差异均有统计学意义(P<0.01),2组间差异无统计学意义(P>0.05)。奥美沙坦酯组和缬沙坦组降压显效率分别为59.0%和60.5%,总有效率分别为87.2%和86.8%,2组间差异无统计学意义。本实验中奥美沙坦酯组出现不良反应者少。结论:奥美沙坦酯治疗轻度及中度原发性高血压疗效确切,且安全可靠。     

奥美沙坦酯与苯磺酸氨氯地平治疗高血压晨峰血压的疗效对比

目的:评价奥美沙坦治疗高血压晨峰血压(MBPS)的疗效。方法:103例原发性高血压MBPS患者随机分为2组,分别接受奥美沙坦(53例,20 mg/d)和苯磺酸氨氯地平(50例,5 mg/d)治疗8周,于治疗前和治疗后4、8周做24 h动态血压监测,调整药物剂量和观测服药前后清晨血压变化。结果:2组药物治疗8周,24 h、白天、夜间及最后2~4 h平均血压均降至正常范围。奥美沙坦组最后2~4 h舒张压(DBP)的降低幅度大于氨氯地平组(19.3±11.8 vs 9.0±6.6 mmHg,P=0.031)。2组降晨峰血压(MBPS)的幅度相近,△收缩压(15.8±6.7 vs 17.0±6.8 mmHg,P0.05);△舒张压(12.8±5.9 vs 9.3±2.1 mmHg,P0.05)。2组治疗后脉率均稍有上升(3.4±1.8 vs 4.2±1.3次/min,P0.05)。2组治疗后收缩压和舒张压的平滑指数(SI)无统计学差异。结论:奥美沙坦酯能有效平稳的控制原发性高血压MBPS,奥美沙坦能强效抑制清晨舒张压的波动。     

小剂量氨氯地平联合用药治疗老年高血压的疗效和安全性评价

目的 评价小剂量氨氯地平联合复方阿米洛利或者替米沙坦治疗老年高血压的临床疗效和安全性.方法 采用随机开放对照盲终点评估的方法,入选老年原发性高血压患者106例,随机分为氨氯地平+复方阿米洛利(阿米洛利组)和氨氯地平+替米沙坦组(替米沙坦组),均服药12 w,每2周随访一次,观察收缩压、舒张压、心率、降压达标率、有效率和不良反应.结果 治疗第2周末,阿米洛利组和替米沙坦组的达标率分别为58.5%和47.2%,组间比较有统计学差异(P<0.05).而治疗12 w后,两组降压达标率分别为67.9%和71.7%,有效率分别为81.1%和83.0%,组间比较差异均无统计学意义(P>0.05).阿米洛利组收缩压下降值为(24.3±15.8)mmHg,舒张压下降值为(15.2±9.2)mmHg,替米沙坦组收缩压下降值为(26.8±13.4)mmHg,舒张压下降值为(15.7±9.4)mmHg,较治疗前均有显著差异(P<0.01);两组不良反应发生率分别为9.4%和7.6%(P>0.05),实验室检查均无明显改变,未见低血钾及体位性低血压的发生.结论 小剂量氨氯地平联合复方阿米洛利或替米沙坦能显著降低老年高血压患者血压,耐受性好,不良反应少;氨氯地平联合复方阿米洛利方案在尽早达标方面更具优势.     

国产与进口奥美沙坦酯对轻中度原发性高血压患者降压疗效与安全性的比较

目的通过与进口奥美沙坦酯比较,评价国产奥美沙坦酯治疗轻中度原发性高血压患者的疗效和安全性。方法采用随机、双盲、双模拟、阳性对照、多中心临床试验方法。入选轻中度原发性高血压患者222例,按11比例随机分为试验组110例和对照组112例,分别接受国产或进口奥美沙坦酯20mg口服治疗。4周后如诊室坐位血压<140/90mm Hg(1mm Hg=0.133kPa)则维持原剂量;血压未达标者加量至国产奥美沙坦酯40mg+安慰剂2片,或进口奥美沙坦酯40mg+安慰剂2片,服药至8周末。在基线和第8周时分别进行24h动态血压监测,观察治疗前后血压变化。结果与基线比较,治疗4周后,试验组与对照组诊室坐位血压平均降幅分别为(20.24±13.13)/(15.03±6.79)mm Hg vs(18.66±10.41)/(14.24±5.90)mm Hg;8周后分别为(22.50±11.61)/(16.57±6.33)mm Hg vs(21.78±11.24)/(16.08±6.02)mm Hg,差异无统计学意义(P>0.05)。治疗8周后,试验组与对照组24h血压平均降幅分别为(8.8±3.0)/(10.8±2.8)mm Hg vs(8.9±4.0)/(9.2±4.2)mm Hg,差异无统计学意义(P>0.05)。结论轻中度原发性高血压患者服用国产奥美沙坦酯治疗能有效、安全地降低血压,其降压幅度及平稳性与进口奥美沙坦酯相似。     

Systolic blood pressure reduction with olmesartan medoxomil versus nitrendipine in elderly patients with isolated systolic hypertension

OBJECTIVE: The prevalence of isolated systolic hypertension (ISH) is high in the elderly, and the objective of this study was to compare the antihypertensive efficacy of olmesartan medoxomil with that of nitrendipine in elderly (65-74 years) and very elderly (>/= 75 years) male and female patients with ISH. METHODS: Patients were randomized to 24 weeks of treatment with either olmesartan medoxomil 20 mg daily (n = 256) or nitrendipine 20 mg (n = 126) twice daily, with possible dose increase (to 40 mg daily) and addition of hydrochlorothiazide (HCTZ) 12.5 or 25 mg daily if required. RESULTS: On the primary endpoint [reduction in mean sitting systolic blood pressure (SBP) after 12 weeks of treatment], the two treatments were similar (olmesartan medoxomil, -30.0 mmHg; nitrendipine, -31.4 mmHg). No significant difference between the treatment groups was observed, and non-inferiority of olmesartan medoxomil to nitrendipine was demonstrated using an analysis of covariance (ANCOVA) model. Reductions in mean sitting and standing SBP and diastolic blood pressure (DBP) up to week 24 were also similar with both treatments. Blood pressure (BP) goal attainment rates (sitting SBP 相似文献