ST LOUIS (MD Consult) - On July 26, 2010, Daiichi Sankyo announced that the US Food and Drug Administration has approved Tribenzor (olmesartan medoxomil [an angiotensin II receptor antagonist], amlodipine [a calcium channel blocker], hydrochlorothiazide [a diuretic]) for the treatment of patients with hypertension whose blood pressure has not been adequately controlled using any 2 of the following antihypertensive drug classes: angiotensin receptor blockers, calcium channel blockers, and diuretics. Tribenzor is not considered a first-line antihypertensive therapy.

Daiichi Sankyo remarks that the use of Tribenzor has the potential to simplify dosing regimens, reduce pill burden, and lower prescription copays because the product is a 3-in-1 combination product and is only taken once daily. According to the manufacturer's press release, approximately 56% of patients receiving antihypertensive therapies do not achieve current recommended blood pressure goals. In addition, more than 66% of patients with hypertension will require the use of 2 or more antihypertensive medications to achieve desired blood pressure targets.

An analysis of results from a pivotal registration trial that included 2,492 patients with hypertension (mean baseline blood pressure, 168.5/100.9 mm Hg) demonstrated the efficacy of Tribenzor. Study patients' antihypertensive regimens were switched to Tribenzor (40/10/25 mg) from each of the following 3 dual-combination therapies: amlodipine/ hydrochlorothiazide (10/25 mg), olmesartan/hydrochlorothiazide (40/25 mg), and olmesartan/ amlodipine (40/10 mg). After 8 weeks of Tribenzor treatment, patients experienced a further mean reduction in blood pressure (8.1/5.4 mmHg, 7.6/5.4 mm Hg, and 8.4/4.5 mm Hg, respectively) (P < .0001 vs each dual-combination therapy).

The most common adverse reactions reported with Tribenzor use in clinical trials include dizziness, peripheral edema, headache, fatigue, nasopharyngitis, muscle spasms, nausea, upper respiratory tract infection, diarrhea, urinary tract infection, and joint swelling.

Tribenzor is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs. In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients, symptomatic hypotension may occur after initiation of treatment with Tribenzor. Patients, particularly those with severe obstructive coronary artery disease, may experience increased frequency, duration, or severity of angina or acute myocardial infarction when starting calcium channel blocker therapy or at the time of dosage increases. The use of Tribenzor in patients with severely impaired renal function should be avoided.

Treatment with Tribenzor should start under close medical supervision.

圣路易斯(MD Consult) ——日本第一三共公司宣布，美国食品药品管理局(FDA)已经批准，在应用下列任意2种抗高血压药物(血管紧张素受体阻滞剂、钙通道阻滞剂和利尿剂)仍无法充分控制患者血压的情况下，可考虑使用Tribenzor[奥美沙坦酯(一种血管紧张素II受体拮抗剂)，氨氯地平(一种钙通道阻滞剂)，氢氯噻嗪(一种利尿剂)]治疗高血压患者。但不宜将Tribenzor用作一线抗高血压药。

 

第一三共公司评价说，使用Tribenzor有可能简化给药方案，减少药丸负荷，并可以减少整张处方的费用，因为该产品是一种3合1的混合型药物，且每日只需服药1次。据该药制造商召开的新闻发布会介绍，在目前接受抗高血压治疗的患者中，大约有56%的患者在血压控制方面并未达到现行推荐目标。此外，有超过66%的高血压患者需要联用2种或2种以上的抗高血压药物方能达到期望的血压控制目标。

 

对一项关键性注册研究试验结果进行的分析证明了Tribenzor的有效性，该试验共纳入2,492例高血压患者(平均基线血压为168.5/100.9 mmHg)。在患者接受了氨氯地平/氢氯噻嗪(10/25 mg)，奥美沙坦/氢氯噻嗪(40/25 mg)和奥美沙坦/氨氯地平(40/10 mg)这3种双药组合疗法中的其中一种后，医生开始改用Tribenzor(40/10/25 mg)对患者进行抗高血压治疗。在接受了为期8周的Tribenzor治疗后，患者的平均血压进一步降低(分别为8.1/5.4 mmHg、7.6/5.4 mmHg和8.4/4.5 mmHg，对每一种双药组合治疗而言，P值均<0.0001)。

 

据临床试验结果报告，与使用Tribenzor相关的最常见不良反应包括头晕、外周水肿、头痛、乏力、鼻咽炎、肌肉痉挛、恶心、上呼吸道感染、腹泻、尿道感染和关节肿胀。

 

Tribenzor禁用于无尿或对其他磺胺类药物过敏的患者。对肾素-血管紧张素业已激活的患者[如那些血容量耗竭和(或)盐耗竭的患者]而言，其一旦开始接受Tribenzor治疗后便有可能发生症状性低血压。当患者(尤其是那些存在严重阻塞性冠状动脉疾病的患者)开始接受钙通道阻滞剂治疗或增加给药剂量时，其可能会出现心绞痛发作频率增高、持续时间延长，或病情严重程度加重，其发生急性心肌梗死的几率也会增高。应该避免对那些存在严重肾功能损害的患者使用Tribenzor。

应对使用Tribenzor治疗的患者保持密切医学监控。