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Duexis（布洛芬800mg/法莫替丁26.6mg）复方片剂

2011-06-28 01:19:45 作者：新特药房来源：中国新特药网天津分站浏览次数：384 文字大小：【大】【中】【小】

简介： 布洛芬法莫替丁片Marketed by: Horizon Pharma (Northbrook, IL)Indication: The FDA approved Duexis (ibuprofen and famotidine) tablets for the relief of the signs and symptoms of rheumatoid ...

关键字：Duexis（布洛芬800mg/法莫替丁26.6mg）复方片剂

布洛芬法莫替丁片
Marketed by:
Horizon Pharma (Northbrook, IL)
Indication:
The FDA approved Duexis (ibuprofen and famotidine) tablets for the relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis, and to decrease the risk of the development of an upper gastrointestinal ulcer in patients taking ibuprofen for those indications. Duexis is a fixed-dose
combination of the nonsteroidal anti-inflammatory drug ibuprofen and the histamine 2 -receptor antagonist famotidine.
The recommended dose is 1
tablet taken 3 times daily. Duexis carries a boxed warning for the risk of serious cardiovascular and gastrointestinal events.
Dosage Form:
Tablets: ibuprofen 800 mg and famotidine 26.6 mg

一种含有固定剂量布洛芬（800mg）和法莫替丁（26.6mg）的新型复方片剂Duexis（布洛芬/法莫替丁）近日获美国FDA批准。
FDA批准该药是基于对关键性临床试验REDUCE-1和REDUCE-2的数据支持，这两项试验结果显示；与单独接受布洛芬治疗相比，接受Duexis治疗的患者发生上消化道溃疡的发生率明显要低。在1500多例中度至重度疼痛或关节炎患者中对Duexis进行了研究。REDUCE-1试验结果达到了主要临床终末点的要求，即在使用Duexis治疗的6个月期间，受试者胃溃疡的发生率明显降低。研究结果显示，与单独接受布洛芬治疗的患者相比，Duexis组患者的上消化道溃疡发生率的降低情况在统计学上具有显著意义（20.0%对10.5%）。
Duexis（布洛芬/法莫替丁）的最常见不良反应为恶心、腹泻、便秘、上腹部疼痛和头痛。总体而言，在REDUCE-1和REDUCE-2研究中，接受Duexis治疗的患者因不良反应而停止治疗的发生率与单独使用布洛芬相似。

Duexis Approved To Relieve Symptoms of Arthritis, Reduce Risk for GI Ulcers

On April 25, Horizon Pharma, Inc., announced the FDA approval of its drug, Duexis, a novel tablet formulation containing a fixed-dose combination of ibuprofen (800 mg) and famotidine (26.6 mg). Duexis is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk for developing upper gastrointestinal ulcers, which may occur in patients on long-term therapy with ibuprofen to treat these conditions.

The FDA approval was supported by data from the REDUCE-1 and REDUCE-2 studies, which showed that patients taking Duexis experienced significantly fewer upper gastrointestinal ulcers compared with patients who received ibuprofen alone. Duexis demonstrated a significant reduction in the incidence of gastric ulcers compared with ibuprofen alone in both the REDUCE-1 (8.7% vs. 17.6%) and REDUCE-2 (10.5% vs. 20%) trials. Overall, Duexis was tested on more than 1,500 patients with mild to moderate pain or arthritis.

The most common adverse reactions associated with Duexis were nausea, diarrhea, constipation, upper abdominal pain and headache. The discontinuation rates in the REDUCE-1 and REDUCE-2 studies due to adverse events were similar for patients receiving Duexis and ibuprofen alone.