近日Tribenzor已通过美国FDA批准，其是一种治疗高血压的三合一药物。

Tribenzor含氨氯地平（同辉瑞公司销售的络活喜）、奥美沙坦酯（同日本第一三共制药销售的Benicar）、氢氯噻嗪。Tribenzor被批准用于那些应用抗高血压药物的其他组合不能使高血压得到很好控制的患者。

该最新批准的药物由新泽西州帕西帕尼市的日本第一三共制药公司（Daiichi Sankyo）美国总部生产。

高血压是一种常见的多发性疾病，有效平稳控制血压是目前治疗高血压的主要目标。但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。

Tribenzor是一种三合一的混合型药物，且每日只需服药1次，有望简化血压难以控制患者的给药方案，减少药丸负荷，并可以减少整张处方的费用。

一项研究试验结果证明了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)。

Tribenzor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。

TRIBENZOR 20/5/12.5mg

Indication(s):

Hypertension. Not for initial therapy.

Pharmacology:

Tribenzor combines antihypertensive agents representative of three drug classes: an angio­tensin 2 receptor blocker (ARB), a calcium channel blocker (CCB), and a diuretic. It is ­indicated to treat hypertension that is not ­adequately controlled on opt­imal doses of any two of these drug classes, or it may be substituted for the individually-titrated components.

Olmesartan, an ARB, blocks the binding of angi­o­tensin II to the AT1 receptor in vascular smooth muscle, thereby reducing vasoconstriction mediated by angiotensin II. Amlodipine is a dihydropyridine CCB that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Hydrochlo­rothiazide is a thiazide diuretic that increases the excretion of sodium and chloride ions.

Clinical Trials:

A study was conducted in 2492 ­patients to evaluate the efficacy of Tribenzor in the treatment of hypertension. Patients were randomized to receive one of the three dual therapy combinations for 2–4 weeks, then they were randomized to either continue on the dual therapy or to receive triple therapy. After 8 weeks, triple therapy produced greater reductions in both systolic and ­diastolic blood pressures compared to each of the three dual combination therapies.

Legal Classification:

Rx

Adults:

One tablet daily. Titrate at 2-week intervals; max one 40/10/25mg tablet daily. Replacement ther­apy: may be substituted for individually titrated components. Add-on/switch therapy: may be used to provide additional BP lowering for patients not adequately controlled on max tolerated, labeled or usual doses of any two ­antihypertensive classes: ARBs, calcium channel blockers, and diuretics.

Children:

Not recommended.

Contraindication(s):

Anuria. Sulfonamide allergy.

Warnings/Precautions:

Severe renal impairment (CrCl ≤30mL/min): not recommended. Renal artery stenosis. Suspend if renal dysfunction progresses. Correct salt/volume depletion prior to starting therapy. Severe hepatic dysfunction. Severe CHF or obstructive coronary disease. Severe aortic stenosis. Diabetes. Postsympathec­to­my. SLE. Gout. Monitor electrolytes. Elderly (>75 years). Pregnancy (Cat.C in 1^st trimester; Cat.D in 2^nd and 3^rd trimesters; avoid). Nursing mothers: not recommended.

Interaction(s):

Digitalis, lithium toxicity. Adjust anti­di­abetic, antigout medications. ACTH, ampho­ter­i­cin B, corticosteroids increase hypo­ka­le­mia risk. Orthostatic hypotension potenti­ated by alcohol, CNS depressants. Antagonized by NSAIDs. Poten­tiates other antihypertensives. May potentiate nondepolarizing muscle relaxants. May antagonize norepinephrine. May ­interfere with parathyroid tests.

Adverse Reaction(s):

Dizziness, peripheral edema, headache, fatigue, nasopharyngitis, muscle spasms, GI upset, URI, UTI, joint swelling, hyperuricemia, orthostatic hypotension, electrolyte disturbances.

How Supplied:

Tabs—30, 90

Last Updated:

10/14/2010