ST LOUIS (MD Consult) - On October 19, 2009, Boehringer Ingelheim announced that the US Food and Drug Administration (FDA) has granted approvals for 2 of their drug products. The first of these drugs is Micardis (telmisartan), an angiotensin II receptor blocker (ARB). The other approval was for Twynsta (telmisartan/amlodipine), a combination of the ARB telmisartan and the calcium channel blocker amlodipine.
Micardis, in 80-mg tablet strength, is now indicated for reduction of the risk of myocardial infarction, stroke, or death from cardiovascular causes in patients aged ≥55 years who are at high risk of experiencing major cardiovascular events and who are unable to take angiotensin-converting enzyme (ACE) inhibitor agents. The approval of this additional indication for Micardis was granted on the basis of results from a trial that involved more than 31,000 patients who were either considered at high risk for cardiovascular events but were normotensive, or who were being treated for hypertension and had a history of a broad range of cardiovascular diseases. Study results demonstrated that Micardis therapy was more effective than placebo.
Micardis was originally approved by the FDA in 1998 for the treatment of hypertension.
Twynsta received FDA approval for the treatment of hypertension alone or in combination with other antihypertensive agents. The drug may be used as initial antihypertensive therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals. The FDA approval of Twynsta was granted on the basis of results from 1 placebo-controlled and 2 active-controlled trials involving a total of 3,505 patients with stage 1 or stage 2 hypertension. Results showed that Twynsta was generally well tolerated and provided significant blood pressure reductions in a variety of hypertensive patient populations, compared with placebo or monotherapy.
In the placebo-controlled factorial design study involving Twynsta, discontinuation as a result of adverse effects occurred in 2.2% of patients treated with the telmisartan/amlodipine combination and in 4.3% of patients in the placebo group. The most common reasons for discontinuation of therapy with Twynsta were peripheral edema (0.5%), dizziness (0.4%), and hypotension (0.4%). The most common adverse reactions that occurred in ≥2% of patients and at a higher incidence than placebo were peripheral edema, dizziness, and back pain.
Twynsta is not indicated for cardiovascular risk reduction. The medication will be available in pharmacies in November 2009 in the following strengths (telmisartan/amlodipine): 40/5 mg, 40/10 mg, 80/5 mg, and 80/10 mg.
Drugs that act directly on the renin-angiotensin system, such as Micardis and Twynsta, can cause injury and even death to a developing fetus. Therefore, neither drug should be taken during pregnancy.
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圣路易斯(MD Consult)——2009年10月19日，勃林格殷格翰公司宣布，其2种药品已获美国食品药品管理局(FDA)批准。其一为血管紧张素II受体拮抗剂(ARB)美卡素(替米沙坦)；另一获批准的药物为Twynsta(替米沙坦/氨氯地平)，该药为ARB替米沙坦和钙通道阻滞剂氨氯地平的复合剂。
美卡素获准用于那些具有主要心血管事件高危因素以及无法使用血管紧张素转换酶(ACE) 抑制剂的55岁及以上患者。80 mg美卡素片剂现可用于减少以上患者发生心肌梗死、脑卒中或心源性死亡的风险。美卡素此项适应证得以获准是依据一项涉及超过31,000例患者的研究结果。受试者或是具有发生主要心血管事件的高危因素，但血压正常；或是正接受抗高血压治疗，并具有不同心血管疾病病史。研究结果显示，使用美卡素治疗较安慰剂更有效。
FDA曾于1998年批准美卡素用于治疗高血压。
FDA批准单独应用Twynsta或联合应用其他抗高血压药物治疗高血压。该药物可作为初始抗高血压药物治疗那些可能需要多种药物来控制血压的患者。FDA批准使用Twynsta是依据一项安慰剂对照研究和2项活性对照研究的结果。三项研究共涉及3,505例患I期或 II 期高血压患者。结果显示，从总体上讲，与安慰剂或单独药物治疗相比，Twynsta具有很好的耐受性，且对各种高血压患者人群均具有显著的降压作用。
在一项涉及Twynsta的安慰剂对照析因设计研究中，因不良反应而停药的患者，在替米沙坦/氨氯地平联合治疗组有2.2%，而在安慰剂组则有4.3%。中止Twynsta治疗最常见的原因是外周性水肿(0.5%)、头晕(0.4%)和低血压(0.4%)。发生于≥2%患者的最常见且发生率高于安慰剂组的不良反应是外周性水肿、头晕和背痛。
Twynsta尚未显示出具有降低心血管疾病风险的效果。2009年11月将可在药房购得下列剂型的Twynsta(替米沙坦/氨氯地平)：40/5 mg、40/10 mg、80/5 mg和80/10 mg。
像美卡素和Twynsta这些直接作用于肾素-血管紧张素系统的药物，会导致发育中胎儿受损，甚至死亡。因此，两种药物均不能在孕期使用。
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