国产奥美沙坦酯治疗轻中度原发性高血压的单中心疗效和安全性评价

目的：通过与进口奥关沙坦酯（商品名傲坦）比较,单中心评价国产奥美沙坦酯单药治疗轻、中度原发性高血压的疗效和安全性;验证本药与原研药等效。方法：采用随机、双盲、双模拟、阳性对照方法进行研究。57例轻、中度原发性高血压患者分为奥关沙坦酯组（27人、国产奥关沙坦酯20mg＋傲坦模拟片1片20mg）和傲坦组（30人、傲坦20mg＋国产奥关沙坦酯模拟片1片20mg）,治疗期为8周,每2周随访1次,观察降压效果和不良反应;治疗2周后若患者坐位舒张压≥90mmHg（1mmHg===0．133kPa）和（或）收缩压≥140mmHg,则将剂量加一倍,至疗程结束。若坐位舒张压〈90mmHg,则维持原剂量。结果：与治疗前比较,治疗8周后奥关沙坦酯组和傲坦组收缩压分别下降（22．5士9．5）mmHg和（21．4±9．5）mmHg（均P〈0．001）,舒张压分别下降（16．1±5．5）mmHg和（14．7±4．4）mmHg（均P〈0．001）,两组间比较差异无统计学意义（P〉0．05）。国产奥美沙坦酯组与傲坦组降压总有效率（96．30％VS92．60％）和不良反应发生率比较,差异均无统计学意义（P〉0．05）。结论：国产奥关沙坦酯片20～40mg,每日1次是治疗轻中度原发性高血压的安全有效药物。     

奥美沙坦酯与氨氯地平或氢氯噻嗪联合治疗原发性高血压的疗效比较

目的比较奥美沙坦酯联合氨氯地平与奥美沙坦酯联合氢氯噻嗪治疗原发性高血压的疗效。方法将206例2—3级原发性高血压患者完全随机分为观察组（奥美沙坦酯联合氨氯地平）和对照组（奥美沙坦酯联合氢氯噻嗪）,每组103例,监测2组治疗前和治疗8周后24h动态血压,分析2组间降压效果及血压变异的差异,并观察治疗期间药物不良反应。结果治疗后2组患者24h平均收缩压及舒张压、白昼收缩压及舒张压、夜间收缩压及舒张压均较治疗前明显降低[观察组：（133±9）mmHg（1mmHg=0．133kPa）比（166±10）mmHg,（73±8）mmHg比（96±9）mmHg;（134±9）mmHg比（164±9）mmHg,（76±8）mmHg比（100±8）mmHg;（120±9）mmHg比（158±11）mrllHg;（72±7）mmHg比（94±8）mmHg。对照组：（130±7）mmHg比（164±11）mmHg,（75±7）mmHg比（97±8）mmHg;（131±8）mmHgI;L（164±10）mmHg,（79±7）mmHg比（101±8）mmHg;（129±8）mmHg比（160±9）mmHg,（80±8）mmHg比（102±8）InlllHg],差异有统计学意义（P〈0．05）,组间比较差异无统计学意义（P〉0．05）。白昼和夜间血压变异性2组差异有统计学意义（P〈0．05）。观察组和对照组降压总有效率分别为97．1％（100／103）和96．1％（99／103）,差异无统计学意义（P〉0．05）。治疗期间2组不良反应发生率差异无统计学意义（P〉0．05）。结论奥美沙坦酯联合氨氯地平与氢氯噻嗪对原发性高血压患者降压效果较好,疗效相当且安全,奥美沙坦酯联用氨氯地平在血压变异性上控制较好。     

奥美沙坦酯与缬沙坦治疗中度原发性高血压临床研究

目的对奥美沙坦酯与缬沙坦治疗中度原发性高血压临床进行研究,把奥美沙坦酯、缬沙坦分成两组,对治疗原发性高血压效果和安全性进行比较。方法随机抽取本院500例原发性高血压患者,用6周的时间,采取人数比例1：1方法分别对奥美沙坦酯、缬沙坦两组以30～60mg／d、80～160mg／d进行治疗。对其治疗的效果进行观察。结果治疗2周后,奥美沙坦酯平均降低原发性高血压患者（10．22±6．33）mmHg,缬沙坦平均降低原发性高血压患者为（9．23±7．33）mmHg;两组实验的效果较为明显,结果测得几率P=0．004,说明差异具有统计学意义。奥美沙坦组和缬沙坦组分别有58％、63％的患者需要加倍,加量有效率不是很明显,分别为50．03％、51．22％;在治疗5周后,奥美沙坦酯、缬沙坦两组治疗原发性高血压,血压平均下降到（15．324±5．03）mmHg、（13．124±5．75）mmHg。结论奥美沙坦酯胶囊的口服量控制在30～60mg／d,次数控制1d,效果是24h血压稳定,缬沙坦80～160mg／d的降压效果与奥美沙坦酯降压效果较近。     

国产坎地沙坦酯与依那普利治疗原发性轻中度高血压疗效比较

目的：探讨国产坎地沙坦酯对原发性轻中度高血压患者的疗效和安全性。方法：将60例原发性轻中度高血压患者随机分为坎地沙坦酯组和依那普利组,采用双盲双模拟平行对照研究。经过2周的安慰剂清洗期后两组患者分别接受坎地沙坦酯8mg／d或依那普利10mg／d。4周后若达到预期降压效果,则继续原剂量服药至8周。如降压效果不理想,加用氢氯噻嗪片（每次12．5mg,每日1次）,继续服药4周。观察所有入选患者8周内的血压、不良反应和生化指标变化。结果：治疗结束时坎地沙坦酯组收缩压下降20．2mmHg（1mmHg=0．133kPa）,舒张压下降13．9mmHg;依那普利组收缩压下降19．6mmHg,舒张压下降13．8mmHg。两组相比差异无统计学意义。两组均未见严重不良反应。结论：国产坎地沙坦酯治疗原发性轻中度高血压安全、有效。     

坎地沙坦酯对高血压谷峰比值、平滑指数的影响

目的探讨坎地沙坦酯治疗轻中度原发性高血压的疗效及对患者血压谷峰比值和平滑指数的影响。方法50例轻中度原发性高血压患者,口服坎地沙坦酯8mg,每天1次,疗程4周,于治疗前后进行24h动态血压监测并计算其谷峰比值（T／P）和平滑指数。结果治疗4周后,24h平均收缩压（148．2±10．7）mmHg和24h平均舒张压（97．6±6．5）mm Hg、白昼平均收缩压（152．5±9．8）mm Hg和平均舒张压（96．0±5．3）mmHg、夜间平均收缩压（138．3±7．6）mmHg和平均舒张压（89．2±8．3）mmHg、收缩压负荷值（87．5±12．2）％和舒张压负荷值（36．48±26．4）％与治疗前的（130．2±7．2）mmHg、（79．5±7．8）mm Hg、（133．4±7．2）mmHg、（81．8±6．6）mmHg、（121．9±7．3）mmHg、（72．1±7．4）mmHg、（84．7±9．9）％、（26．7±8．3）％比较差异均有统计学意义（均P〈0．01）;治疗后收缩压和舒张压T／P分别为70％和63％、平滑指数分别为（1．21±0．82）和（1．13±0．51）,均符合要求。结论坎地沙坦酯治疗原发性高血压安全有效,均能获得良好的T／P比值及平滑指数。     

奥美沙坦酯治疗原发性高血压的疗效和安全性

目的：评价奥美沙坦酯治疗原发性高血压的疗效和安全性。方法：选择轻、中度高血压患者64例，随机分为奥美沙坦酯治疗组（n=34例）和缬沙坦对照组（n=30例），每日1次口服奥美沙坦酯20mg或缬沙坦80mg，2周后如舒张压≥90mmHg，则剂量加倍，进行8周的临床观察。结果：两组患者血压均得到明显降低（P〈0．01），奥关沙坦酯组，总有效率88．2％；缬沙坦组总有效率86．7％。两组比较无统计学差异（P〉0．05）。结论：奥美沙坦酯治疗原发性高血压疗效显著，与进口同类药缬沙坦相当，不良反应少，安全有效。     

阿齐沙坦与奥美沙坦酯治疗轻中度原发性高血压的疗效比较

目的 比较阿齐沙坦与奥美沙坦酯治疗轻中度原发性高血压的临床疗效。方法 2015年9月—2017年2月从全国多家研究中心筛选轻、中度原发性高血压304例,随机分为奥美沙坦酯组和阿齐沙坦组。受试者从起始剂量开始,阿齐沙坦片20 mg/次和奥美沙坦酯片模拟剂,1次/d,或奥美沙坦酯片20 mg/次和阿齐沙坦片模拟剂,1次/d,开始治疗。用药后第8周末对受试者进行血压评价,如果服药前（药物浓度谷值时）坐位收缩压≥140 mmHg（1 mmHg=133 Pa）和/或舒张压≥90 mmHg则试验药物剂量加倍（阿齐沙坦片40 mg/次口服或奥美沙坦酯片40 mg/次,1次/d）继续治疗8周,如果服药前（药物浓度谷值时）坐位收缩压<140 mmHg且舒张压<90 mmHg则维持原剂量继续治疗8周。治疗总周期16周。观察两组的有效率和达标率。比较两组治疗前,治疗8、12、16周收缩压、舒张压,血压与治疗前差值的变化情况。结果 用药8、16周,奥美沙坦酯组有效率分别是66.89%、69.59%;阿齐沙坦组有效率分别是59.60%、58.94%,两组有效率比较差异没有统计学意义。用药8、16周,奥美沙坦酯组达标率分别是62.16%、61.49%;阿齐沙坦组达标率分别是56.95%、56.29%,两组达标率比较差异均没有统计学意义。治疗8、12、16周,两组受试者的坐位收缩压、舒张压逐渐降低,与同组治疗前比较差异均有统计学意义（P<0.05）;治疗后,两组血压比较差异无统计学意义。用药后两组受试者的坐位收缩压和舒张压均逐渐降低,至16周末时,两组间坐位舒张压下降值比较差异具有统计学意义（P<0.05）;16周末时两组收缩压下降值差异均没有统计学意义。结论 有效性方面,阿齐沙坦组疗效未达非劣效于奥美沙坦酯组,但阿齐沙坦自身的降压效果显著并具临床意义;安全性方面,阿齐沙坦组与奥美沙坦酯组不良事件、严重不良事件、不良反应发生率相当,安全性良好。     

奥美沙坦酯与缬沙坦治疗轻中度原发性高血压的疗效与安全性比较

目的 评价奥美沙坦酯与缬沙坦(均为抗高血压药,血管紧张素Ⅱ受体拮抗剂)治疗轻中度原发性高血压的疗效和安全性比较.方法 人选240例轻、中度原发性高血压患者,按照1∶1随机分组,分别接受奥美沙坦酯20～40mg.d-1或缬沙坦80～160 mg·d-1治疗,共8周.结果 治疗4周后,奥美沙坦酯组与缬沙坦组SeDBP平均下降(10.58±6.82)mmHg及(9.38±7.16)mmHg;奥美沙坦组与缬沙坦组分别有60%及61.74%患者剂量加倍,加量有效率分别为52.22%及51.85%.治疗8周后,2组SeDBP平均下降(15.72±6.03)mmHg及(14.12±6.79)mmHg.治疗4周后,奥美沙坦酯组与缬沙坦组的药物不良反应发生率分别为3.33%及7.5%(P＞0.05).结论 每日1次口服奥美沙坦酯胶囊20～40 mg·d-1,能24 h平稳降压,其8周总有效率79.65%;与缬沙坦80～160 mg·d-1的降压疗效相近.2组药物不良反应发生率无显著差异.     

贝那普利与氯沙坦联合应用对高血压患者动态血压和尿微量白蛋白的影响

目的：观察贝那普利、氯沙坦及两药联合对高血压患者动态血压和尿微量白蛋白的影响,探讨贝那普利与氯沙坦联的临床疗效。方法选择原发性高血压患者102例,按数字表法随机分成贝那普利组、氯沙坦组和联用组,每组34例。贝那普利组患者服用贝那普利10 mg／d;氯沙坦组患者服用50 mg／d;联用组患者服用贝那普利10 mg／d、氯沙坦50 mg／d。三组患者均连续治疗4周,比较各组治疗前后血压、尿蛋白变化。结果贝那普利联用氯沙坦治疗后收缩压为（127．3±5．4）mmHg,舒张压为（70．0±6．1）mmHg,显著低于单用药物组（t＝3．1、5．3、4．6、2．5,均P＜0．05）,总有效率为94．12％,显著高于单用药物组（χ^2＝2．34、2.79,均P＜0．05）;治疗后的尿微量白蛋白为（67．33±34．62）μg／min,显著低于单用药物组（t＝5．43、6．76,均P＜0．05）。结论贝那普利联用氯沙坦治疗原发性高血压较单用贝那普利或氯沙坦在降低血压和尿微量白蛋白方面疗效更佳。     

奥美沙坦酯片治疗轻、中度原发性高血压的疗效和安全性

目的观察奥美沙坦酯片治疗轻、中度原发性高血压的疗效和安全性。方法61例轻、中度原发性高血压患者随机分为奥美沙坦酯组(n=30)和氯沙坦组(n=31),治疗8wk,观察2组治疗前后的血压、心率、心电图和血、尿实验室检查的变化。结果奥美沙坦酯组与氯沙坦组比较,坐位收缩压和舒张压降低程度都有显著差异,分别为(132±13 vs 139±13)mmHg(P<0.01)和(85±9 vs 87±9)mmHg(P<0.05)。奥美沙坦酯组降压有效率为83%;每日1次服用奥美沙坦酯作用可持续24h,药物降低收缩压和舒张压的谷峰比值均>50%。2组药物不良反应发生分别为1例和3例,2组比较无显著差别。结论奥美沙坦酯治疗轻、中度原发性高血压患者,能24h平稳降压,谷峰比满意,且耐受性较好。     

奥美沙坦酯与缬沙坦治疗中度原发性高血压临床研究

目的比较奥美沙坦酯和缬沙坦治疗中度原发性高血压的疗效和安全性。方法入选482例中度原发性高血压患者,按照1∶1随机分组,分别接受奥美沙坦酯20～40 mg/d或缬沙坦80～160 mg/d治疗,共8周。观察并比较其降压效果。结果治疗4周后,奥美沙坦酯组SeDBP平均下降了(10.58±6.82)mmHg,缬沙坦组下降了(9.38±7.16)mmHg;两组比较,P=0.004。奥美沙坦组与缬沙坦组分别有60%、61.74%的患者剂量加倍,加量有效率分别为52.22%、51.85%;治疗8周后,两组SeDBP平均下降(15.72±6.03)mmHg及(14.12±6.79)mmHg;治疗4周后,两组的药物不良反应发生率分别为3.33%、7.5%(P>0.05)。结论口服奥美沙坦酯胶囊20～40 mg/d,1次/d,能保持24 h平稳降压,8周总有效率为79.65%;与缬沙坦80～160 mg/d的降压疗效相近。而两组药物不良反应发生率差异无统计学意义。     

Efficacy and Safety of Olmesartan Medoxomil and Hydrochlorothiazide Compared with Benazepril and Amlodipine Besylate

BACKGROUND: Most patients with stage 2 hypertension require two or more antihypertensive agents in order to achieve the BP goals recommended in current treatment guidelines. Accordingly, combinations of two drugs with different mechanisms of antihypertensive action are widely used. OBJECTIVE: The aim of this randomized, double-blind, multicenter 12-week study was to compare the efficacy, safety, and tolerability of a combination of olmesartan medoxomil/hydrochlorothiazide (HCTZ) with that of benazepril plus amlodipine besylate in patients with stage 2 hypertension. METHODS: Patients were eligible for randomization following a 3- to 4-week placebo run-in period if they had either (i) mean seated DBP>or=90 mm Hg but<115 mm Hg and mean seated SBP>or=160 mm Hg but <200 mm Hg, or (ii) mean seated DBP>or=100 mm Hg but<115 mm Hg. The difference in mean seated SBP measured on two separate visits during the run-in period was required to beor=95 mm Hg and<115 mm Hg or SBP>145 mm Hg and相似文献   

奥美沙坦酯治疗老年高血压的疗效及安全性观察

目的：评价奥美沙坦酯治疗老年高血压的疗效和安全性。方法：选取2009年1-8月我院42例老年高血压患者,随机分为两组。治疗组（21例）服用奥美沙坦酯每次20mg,每日1次;对照组（21例）服用氯沙坦每次50mg,每日1次。总疗程均为8周。结果：奥美沙坦酯组和氯沙坦组治疗前后血压下降幅度差异均有统计学意义（P〈0.01）。奥美沙坦酯组和氯沙坦组降压显效率分别为69.0%和68.4%,总有效率分别为90.4%和89.7%,两组间差异无统计学意义（P〉0.05）。奥美沙坦酯组和氯沙坦组均未出现药品不良反应。结论：奥美沙坦酯治疗老年高血压效果明显,安全性好。     

Blood pressure reduction with olmesartan in mild-to-moderate essential hypertension: a planned interim analysis of an open label sub-study in German patients

OBJECTIVE: To present the baseline characteristics and open-label treatment phase results for German patients in OLMEBEST, a European, multinational, partially randomized, partially double-blind study in patients with mild-to-moderate essential hypertension. RESEARCH DESIGN AND METHODS: After a 2-week placebo run-in, patients received olmesartan 20 mg for 8 weeks. Controlled patients (mean sitting diastolic blood pressure [sDBP] < 90 mmHg) continued on olmesartan 20 mg/day for a further 4 weeks. Non-controlled patients (sDBP > 90 mmHg) were randomized to olmesartan 40 mg/day or olmesartan 20 mg/day plus 12.5 mg hydrochlorothiazide for 4 weeks. Of 823 patients included, 558 continued olmesartan 20 mg treatment and 228 patients were randomized to olmesartan 40 mg/day or combination therapy. Efficacy variables included the change from baseline in mean sitting DBP and systolic blood pressure [sSBP] at Week 8 (and Week 12 for controlled patients), and the proportion of controlled patients and responders (mean sDBP < 90 mmHg or improvement of > 10 mmHg from baseline at Week 8). RESULTS: After 8 weeks of olmesartan medoxomil 20 mg, mean reduction from baseline in sDBP was 11.8 mmHg and in sSBP was 17.1 mmHg. In controlled patients continuing open-label olmesartan medoxomil 20 mg, mean reduction from baseline at 12 weeks in sDBP was 14.9 mmHg and in sSBP was 20.1 mmHg. At Week 8, the response rate was 76% and the control rate was 70%. Olmesartan medoxomil 20 mg/day was well tolerated; 30.9% of patients experienced an adverse event, and the majority of these events were judged by the investigators to be mild. CONCLUSION: Olmesartan medoxomil monotherapy at the recommended dosage of 20 mg once daily is effective and well tolerated in patients with mild-to-moderate hypertension.     

Effect of an Olmesartan Medoxomil-Based Treatment Algorithm on Systolic Blood Pressure in Patients with Stage 1 or 2 Hypertension

Background and Objective

Elevated systolic BP (SBP) is a major contributor to cardiovascular disease. SBP control reduces the occurrence of stroke, heart failure, and cardiovascular and total mortality. The aim of this study was to analyze the magnitude of SBP reductions and the achievement of individual SBP targets in the original BENIFORCE study.

Methods

An olmesartan medoxomil-based treatment algorithm was evaluated in a double-blind, placebo-controlled titration study in 276 patients with stage 1 (47.1%) or 2 (52.9%) hypertension. After placebo run-in, patients were randomized to placebo (12 weeks) or olmesartan medoxomil 20 mg/day (weeks 1–3). Olmesartan medoxomil was uptitrated to 40 mg/day (weeks 4–6), then olmesartan medoxomil/hydrochlorothiazide (HCTZ) 40/12.5 mg per day (weeks 7–9), and olmesartan medoxomil/HCTZ 40/25 mg per day (weeks 10–12) if BP remained ≥120/80 mmHg at any time interval.

Setting

The BENIFORCE study was a multicenter (29 sites) study conducted between January and October 2007 in the US.

Results

In patients receiving olmesartan medoxomil-based therapy, 81.0%, 67.2%, and 46.6% of patients with stage 1 hypertension and 70.4%, 49.4%, and 23.5% of patients with stage 2 hypertension achieved SBP targets of <140, <130, and <120 mmHg, respectively (all p<0.01 vs placebo). The proportions of patients achieving SBP targets increased with escalating doses of olmesartan medoxomil and HCTZ, administered alone or in combination, and was highest for combination therapy. Similarly, escalating doses of olmesartan medoxomil or olmesartan medoxomil/HCTZ increased the proportion of patients achieving SBP reductions of >15 but ≤30, >30 but ≤45, and >45 mmHg compared with placebo.

Conclusion

An olmesartan medoxomil-based treatment algorithm effectively reduced SBP and achieved SBP targets in patients with stage 1 or 2 hypertension. This regimen resulted in >80% of patients achieving SBP reductions of ≥15 mmHg while 44% achieved SBP reductions of >30 mmHg.     

单次及多次口服奥美沙坦酯在中国健康受试者体内药代动力学研究

目的：分析中国健康受试者单剂量或多次口服奥美沙坦酯后体内药代动力学的特征。方法单剂量实验：12名筛选合格的受试者,采用开放、随机、单剂量、三周期、3＆#215;3拉丁方设计方法将试验分为3组,每组4名,每周期分别服用相对应剂量的药物,且每周期服药前经过7 d的洗脱期。多次给药试验：12名健康受试者每天服用20 mg奥美沙坦酯,连续4 d。采集服药前0 h及服药后48 h内的血样,分析体内药物各PK参数。结果单剂量服用奥美沙坦（20、40、80 mg）后体内血浆最大浓度（Cmax）分别为（1016±349）、（1503±266）、（2516±1196） ng/ml;消除半衰期（t1/2）为（5.2±1.2）、（5.6±1.6）、（6.2±0.9）h;多次服用奥美沙坦20 mg后Cmax和t1/2分别为（894±301）ng/ml、（6.4±1.2） h,单次给药和多次给药间t1/2差异无统计学意义。单剂量试验中,当服药剂量在20∽80 mg范围,AUC0-肄、AUC0-48、Cmax等PK参数与药物剂量呈线性关系。结论奥美沙坦酯20 mg,1 d/次的给药方案在体内不会造成蓄积作用。     

Blood pressure reduction with olmesartan in mild-to-moderate essential hypertension:a planned interim analysis of an open label sub-study in German patients

ABSTRACT

Objective: To present the baseline characteristics and open-label treatment phase results for German patients in OLMEBEST, a European, multinational, partially randomized, partially double-blind study in patients with mild-to-moderate essential hypertension.

Research design and methods: After a 2‐week placebo run-in, patients received olmesartan 20?mg for 8 weeks. Controlled patients (mean sitting diastolic blood pressure [sDBP] < 90?mmHg) continued on olmesartan 20?mg/day for a further 4 weeks. Non-controlled patients (sDBP > 90?mmHg) were randomized to olmesartan 40?mg/day or olmesartan 20?mg/day plus 12.5?mg hydrochlorothiazide for 4 weeks. Of 823 patients included, 558 continued olmesartan 20?mg treatment and 228 patients were randomized to olmesartan 40?mg/day or combination therapy. Efficacy variables included the change from baseline in mean sitting DBP and systolic blood pressure [sSBP] at Week 8 (and Week 12 for controlled patients), and the proportion of controlled patients and responders (mean sDBP < 90?mmHg or improvement of > 10?mmHg from baseline at Week 8).

Results: After 8 weeks of olmesartan medoxomil 20?mg, mean reduction from baseline in sDBP was 11.8?mmHg and in sSBP was 17.1?mmHg. In controlled patients continuing open-label olmesartan medoxomil 20?mg, mean reduction from baseline at 12 weeks in sDBP was 14.9?mmHg and in sSBP was 20.1?mmHg. At Week 8, the response rate was 76% and the control rate was 70%. Olmesartan medoxomil 20?mg/day was well tolerated; 30.9% of patients experienced an adverse event, and the majority of these events were judged by the investigators to be mild.

Conclusion: Olmesartan medoxomil monotherapy at the recommended dosage of 20?mg once daily is effective and well tolerated in patients with mild-to-moderate hypertension.     

Seated cuff blood pressure-lowering efficacy of an olmesartan medoxomil-based treatment regimen in patients with type 2 diabetes mellitus

Background: Hypertension is a common co-morbidity in patients with type 2 diabetes mellitus, and well tolerated, effective therapies are needed to achieve guideline-recommended blood pressure (BP) goals in these patients.Objective: The aim of this study was to present the results of a prespecified analysis of key secondary endpoints from a 12-week, open-label, single-arm study evaluating the efficacy and safety of olmesartan medoxomil plus hydrochlorothiazide (HCTZ) in patients with hypertension and type 2 diabetes.Study Design and Methods: After a placebo run-in period, 192 patients received olmesartan medoxomil 20mg/day for 3 weeks. If BP remained ≥120/70mmHg, patients were uptitrated at 3-week intervals to olmesartanmedoxomil 40mg/day, olmesartan medoxomil/HCTZ 40/12.5mg/day, and olmesartan medoxomil/HCTZ 40/25mg/day.Main Outcome Measure: Endpoints evaluated in this analysis were the change from baseline in mean seated cuff BP (SeBP), proportions of patients achieving SeBP goals, and distribution of SeBP reductions.Results: Mean SeBP was 158.1/90.0mmHg at baseline. The mean±standard error of BP reductions at 12 weeks for systolic and diastolic BP were 21.3±1.1mmHg and 9.8±0.6 mmHg, respectively (p<0.0001 for each). At the end of the study, the proportion of patients with diabetes achieving the recommended SeBP goal of <130/80 mmHg was 41.1%.Conclusions: An olmesartan medoxomil±HCTZ treatment regimen significantly reduced BP from baseline in patients with hypertension and type 2 diabetes.Clinical Trials Registration: ClinicalTrials.gov identifier: {"type":"clinical-trial","attrs":{"text":"NCT00403481","term_id":"NCT00403481"}}NCT00403481     

Combination Therapy with Olmesartan Medoxomil and Hydrochlorothiazide

Background

The combination of olmesartan medoxomil and hydrochlorothiazide (HCTZ) [olmesartan medoxomil/HCTZ] has previously been shown to produce significantly greater SBP/DBP reductions than monotherapy with either agent alone in a randomized, double-blind, factorial study in patients with stage 2 hypertension. Compared with the evaluation of a single mean BP reduction in a patient population, determining the efficacy of an antihypertensive agent in achieving multiple BP targets provides additional information about the range of BP reductions attainable within this study population.

Objective

To conduct a secondary analysis of this study to evaluate the proportion of patients achieving combined SBP/DBP targets recommended in current hypertension treatment guidelines as well as individual SBP and DBP targets.

Methods

A total of 502 patients with DBP ≥100 and ≤115 mmHg were randomized to 8 weeks of treatment with placebo, HCTZ 12.5 or 25 mg/day, olmesartan medoxomil 10, 20, or 40 mg/day, or olmesartan medoxomil/HCTZ 10/12.5, 10/25, 20/12.5, 20/25, 40/12.5, or 40/25 mg/day. Mean baseline SBP ranged from 151.9 to 156.6 mmHg and mean baseline DBP ranged from 102.6 to 104.4 mmHg across the twelve treatment arms. The chi-squared test was used to compare the proportion of patients achieving each BP goal in each of the 11 active treatment regimens with that in the placebo group.

Results

The proportion of patients achieving an SBP <140 or <130 mmHg, DBP <90, <85, or <80 mmHg and combined SBP/DBP <140/90, <130/85, <130/80, or <120/80 mmHg typically increased with escalating dosages of olmesartan medoxomil and HCTZ when administered alone or in combination, but was always highest in those treated with the combination. As the BP goal became progressively more stringent, the proportion of patients achieving the BP goal decreased in each treatment group, although the trend toward greater reductions in patients treated with combination therapy remained intact. All combined SBP/DBP goals were achieved by a statistically significant proportion of patients (p<0.05) in the olmesartan medoxomil/HCTZ 20/25, 40/12.5, and 40/25 treatment groups.

Conclusions

A majority of patients with uncomplicated stage 2 hypertension can achieve recommended BP goals when treated with the combination of olmesartan medoxomil and HCTZ.