欧盟的批准是基于涵盖5000多名患者的临床试验，其结果表明，与氨氯地平相比，Exforge疗效更好且水肿发生率更低
诺华公司日前宣布，欧盟已授予Exforge作为治疗高血压的高效、单片新药的上市批准Exforge是在单片里结合了两种最常处方的高血压品牌药物—代文（缬沙坦）和络活喜（苯磺酸氨氯地平）。Exforge适用于那些接受氨氯地平或缬沙坦单一药物治疗而血压不能完全得以控制的患者。
Exforge即将在德国上市，随后取决于络活喜专利保护到期的情况还将在今年陆续在大部分其他欧盟国家上市。继获得美国的临时批准和瑞士的批准之后，Exforge又获得了欧盟的批准决定，该决定适用于所有27个欧盟成员国以及冰岛和挪威的是的。
“高血压是一个严重的卫生问题，如不加以控制，可引发心脏病，中风，心脏和肾脏衰竭，继而死亡，”德国波恩大学内科Rainer
Dusing教授说，“将这两种著名的、强效的抗高血压药物合二为一，可帮助患者血压达标并得以保持，且耐受性良好。”
涵盖5000多名患者的临床试验表明，Exforge可使10个患者中有9个达标（即舒张压低于90毫米汞柱，或基线降低超过10毫米汞柱）。试验显示，Exforge可使血压降低36毫米汞柱或在某些人群中降低43毫米汞柱。
总而言之，临床试验表明Exforge具有高效、良好耐受等品质，且副作用方面比单独使用氨氯地平要有显著提高。尤其是，与氨氯地平单一治疗相比，Exforge可降低周围水肿的发生。
“Exforge有望成为吸引患者的治疗选择，因为它将两种最强的作用机制结合到一种药物中，”诺华制药公司全球药品开发总裁James Shannon博士说，“将两种成份复合成一片药物可提高患者的依从性。研究表明，提高高血压患者的依从性可降低医疗成本，降低住院的风险，且降低门诊病人的资源占用。”
FDA批准治高血压的复方制剂Exforge HCT
FDA已批准诺华公司出品的Exforge HCT，该药是唯一同时含有三种抗高血压处方药物成分的复合制剂，这三种成分分别为Exforge (氨氯地平+缬沙坦)和双氢克尿塞。
诺华表示，有研究结果显示，85%的高血压患者需要多种药物——其中多数人需要3种以上抗压药联合治疗控制血压才能达到预定效果。
至此，采用任何两种下列药物治疗后效果不理想的患者可转用Exforge HCT，这些抗压药包括：钙通道阻滞剂、血管紧张素受体阻滞剂和利尿剂。实验表明，患者使用最高剂量的Exforge HCT治疗2周之后，降压效果非常理想。
有专家表示，这种药物为患者带来了一种便利的治疗方式，它每天仅用药一次，在减轻高血压患者治疗负担上具有重要意义。
同等剂量的Exforge和Exforge HCT在美国地区的售价相同。目前，该药也正在接受欧盟委员会的审批。
INDICATIONS
EXFORGE and EXFORGE HCT are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake.
EXFORGE may be used for patients not adequately controlled on monotherapy with an angiotensin receptor blocker (ARB) or a dihydropyridine calcium channel blocker (DHP-CCB).
EXFORGE may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. The choice of EXFORGE as initial therapy for hypertension should be based on an assessment of potential benefits and risks including whether the patient is likely to tolerate the lowest dose of EXFORGE, the baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination product compared to monotherapy.
EXFORGE HCT is not indicated for the initial therapy of hypertension.
EXFORGE HCT may be used for patients not adequately controlled on any two of the following antihypertensive classes: CCBs, ARBs, and diuretics.
IMPORTANT SAFETY INFORMATION
WARNING: FETAL TOXICITY
When pregnancy is detected, discontinue EXFORGE or EXFORGE HCT as soon as possible. (5.1)
Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1)
Contraindications: Do not use in patients with known hypersensitivity to any component of either product. In addition, EXFORGE HCT is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs.
Do not coadminister aliskiren with EXFORGE or EXFORGE HCT in patients with diabetes.
Hypotension: Excessive hypotension was seen in 0.4% of patients treated with EXFORGE and, including orthostatic hypotension, in 1.7% of patients treated with EXFORGE HCT 10/320/25 mg in controlled trials. In patients with an activated renin-angiotensin-aldosterone system (RAAS), such as volume- and/or salt-depleted patients receiving high doses of diuretics, symptomatic hypotension may occur in patients receiving angiotensin receptor blockers. Correct this condition before administering EXFORGE or EXFORGE HCT. Caution should be observed when initiating therapy with EXFORGE in patients with heart failure or recent myocardial infarction and in patients undergoing surgery or dialysis. Do not initiate treatment with EXFORGE HCT in patients with aortic or mitral stenosis or obstructive hypertrophic cardiomyopathy.
Risk of MI or Increased Angina: Worsening angina and acute myocardial infarction (MI) can develop after starting or increasing the dose of amlodipine, particularly in patients with severe obstructive coronary artery disease.
Renal Considerations: Changes in renal function, including acute renal failure, can be caused by drugs that inhibit the RAAS and by diuretics. Patients whose renal function may depend in part on the activity of the RAAS (eg, patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing acute renal failure on EXFORGE HCT. Monitor renal function periodically in these patients. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on EXFORGE or EXFORGE HCT.
Monitor renal function periodically in patients receiving valsartan and non-steroidal anti-inflammatory drugs (NSAIDs) who are also elderly, volume-depleted (including those on diuretics), or who have compromised renal function due to potential reversible deterioration of renal function, including acute renal failure. The antihypertensive effect of ARBs, including valsartan, may be attenuated by NSAIDs.
Avoid use of aliskiren with EXFORGE or EXFORGE HCT in patients with renal impairment (GFR <60 mL/min).
Potassium Abnormalities: In the controlled trial of EXFORGE HCT in moderate to severe hypertensive patients, the incidence of hypokalemia (serum potassium <3.5 mEq/L) at any time post-baseline with the maximum dose of EXFORGE HCT (10/320/25 mg) was 10% compared to 25% with HCTZ/amlodipine (25/10 mg), 7% with valsartan/HCTZ (320/25 mg), and 3% with amlodipine/valsartan (10/320 mg). One patient (0.2%) discontinued therapy due to an adverse event of hypokalemia in each of the EXFORGE HCT and HCTZ/amlodipine groups. The incidence of hyperkalemia (serum potassium >5.7 mEq/L) was 0.4% with EXFORGE HCT compared to 0.2-0.7% with the dual therapies.
Concomitant use of EXFORGE or EXFORGE HCT with other agents that block the RAAS, potassium-sparing diuretics, potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium. Monitor serum electrolytes periodically.
Important Considerations Due to the HCTZ Component of EXFORGE HCT: Hypersensitivity reactions may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history. Thiazides have been reported to cause exacerbation or activation of systemic lupus erythematosus. Lithium generally should not be given with thiazides.
Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction resulting in transient myopia and angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Discontinue hydrochlorothiazide as rapidly as possible in these patients. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.
Dual Blockade of the RAAS: Dual blockade of the RAAS with angiotensin receptor blockers, angiotensin-converting enzyme inhibitors (ACEIs), or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Closely monitor blood pressure, renal function, and electrolytes in patients on EXFORGE or EXFORGE HCT and other agents that affect the RAAS.
Common Adverse Events: The most common adverse events that occurred more frequently with EXFORGE than placebo were peripheral edema (5% vs 3%), nasopharyngitis (4% vs 2%), upper respiratory tract infection (3% vs 2%), and dizziness (2% vs 1%).
The most frequent adverse events that occurred in ≥2% of patients treated with EXFORGE HCT were dizziness (8.2%), edema (6.5%), headache (5.2%), dyspepsia (2.2%), fatigue (2.2%), muscle spasms (2.2%), back pain (2.1%), nausea (2.1%) and nasopharyngitis (2.1%).
Please see accompanying full Prescribing Information, including Boxed WARNING, for EXFORGE and EXFORGE HCT.
Reference: 1. Data on file. Fingertip Formulary. January 2012.
Novartis Pharmaceuticals Corp.
* Source: National formulary data are provided by Fingertip Formulary and are accurate as of January 2012. Data from the Department of Veterans Affairs, Department of Defense, Indian Health Service, Kaiser Permanente, and HealthTrans are not included. Please note that formularies are subject to change and many health plans offer more than one formulary. Please check with the health plan directly to confirm coverage for individual patients. Tier status may include step edits and/or prior authorizations. Inclusion on formulary or formulary status does not imply superior clinical efficacy or safety. Includes plans listing products in any cost-sharing tier and certain plans may have quantity limits, prior authorizations, or step edits in place. Patient costs may vary significantly among plans.
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