日前，一种同时含有延释肠溶型萘普生（naproxen）和速释型埃索美拉唑镁（esomeprazole magnesium）的混合剂量片剂（商品名为Vimovo，生产商为阿斯利康和Pozen公司）获得美国食品药品监督管理局（FDA）批准用于治疗关节炎。
这种非甾体抗炎药（NSAID）/质子泵抑制剂的复方制剂适用于缓解骨关节炎（osteoarthritis）、类风湿性关节炎（rheumatoid arthritis）和强直性脊椎炎（ankylosing spondylitis）的体征和症状，同时在易感患者中可降低因NSAID引起的胃溃疡风险。骨关节炎常用诸如萘普生之类的NSAID进行治疗，大约有2700万美国人患有此病。根据阿斯利康公司所发布的消息称，有50%之多的NSAID长期使用者伴有胃肠道溃疡的风险。阿斯利康的首席医疗专家Howard Hutchinson博士在一份公司新闻发布稿中说到，“通过一种单独的药丸，Vimovo可提供一种有效的疼痛缓解剂和一种嵌入式的‘质子泵抑制剂’，以用于治疗伴有NSAID相关性胃溃疡风险的关节炎患者。”
据PN400-301和PN400-302两项为期6个月的关键性研究的数据显示，与每天给予2次500mg肠溶型萘普生相比，每天2次使用萘普生/埃索美拉唑延释片可降低内镜检查下的胃溃疡的发生率（分别为4.1%比23.1%，和7.1%比24.3%；两项研究的P值均小于0.001）。
VIMOVO的重要安全信息
心血管风险
VIMOVO的其中一个组份萘普生，可能会增加严重心血管血栓事件，心肌梗死和中风的风险，而且这可能是致命的。患有心血管疾病或心血管疾病的危险因素的患者可能会面临更大的风险。
VIMOVO是不应用于治疗冠状动脉旁路移植血管（CABG）手术时的围手术期疼痛。
胃肠道风险
NSAIDs（非甾体抗炎药），包括萘普生，会增加了严重的消化道不良反应的风险，包括出血、溃疡。而且这可以发生在任何时间，并且其在使用过程中，没有任何警告症状。老年患者存在更大的风险。

销售国家
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General Information
Vimovo is a fixed dose combination of the proton pump inhibitor esomeprazole magnesium, with the non-steroidal anti-inflammatory drug (NSAID) naproxen in a single tablet.
Vimovo is specifically indicated for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAIDassociated gastric ulcers.
Vimovo is supplied as a tablet for oral administration. The recommended initial dose is one tablet twice daily of 375 mg naproxen and 20 mg of esomeprazole or 500 mg naproxen and 20 mg of esomeprazole. The tablets are to be swallowed whole with liquid. Do not split, chew, crush or dissolve the tablet. Vimovo is to be taken at least 30 minutes before meals.
Clinical Results
FDA Approval
The FDA approval of Vimovo was based on the following studies:
Gastric Ulcers
Two randomized, multi-center, double blind trials (Study 1 and Study 2) compared the incidence of gastric ulcer formation in 428 patients taking Vimovo and 426 patients taking enteric-coated naproxen. Vimovo given as 500 mg/20 mg twice daily statistically significantly reduced the 6- month cumulative incidence of gastric ulcers compared to enteric-coated naproxen 500 mg twice daily: Study 1 9% versus 50%, respectively and Study 2 15% versus 51%, respectively (p < 0.001 for both studies).
Signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis
Two 12-week randomized, double-blind, placebo-controlled trials enrolled patients with osteoarthritis (OA) of the knee. Vimovo was given as 500 mg/20 mg twice daily. In each trial, patients receiving Vimovo had significantly better results compared to patients receiving placebo as measured by change from baseline of the WOMAC pain subscale and the WOMAC physical function subscale and a Patient Global Assessment Score.
Based on studies with enteric-coated naproxen, improvement in patients treated for rheumatoid arthritis was demonstrated by a reduction in joint swelling, a reduction in duration of morning stiffness, a reduction in disease activity as assessed by both the investigator and patient, and by increased mobility as demonstrated by a reduction in walking time. In patients with ankylosing spondylitis, naproxen has been shown to decrease night pain, morning stiffness and pain at rest.
Side Effects
Adverse events associated with the use of Vimovo may include, but are not limited to, the following:
•Erosive gastritis
•Dyspepsia
•Gastritis
•Diarrhea
•Gastric ulcer
•Upper abdominal pain
•Nausea
Mechanism of Action
Vimovo is a fixed dose combination of the proton pump inhibitor esomeprazole magnesium, with the non-steroidal anti-inflammatory drug (NSAID) naproxen in a single tablet. Vimovo has been developed as a delayed release tablet whereby esomeprazole (20 mg) is released first in the stomach, prior to the dissolution of enteric-coated naproxen (500 mg) in the small intestine. The mechanism of action of the naproxen, like that of other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition. By acting specifically on the proton pump, esomeprazole blocks the final step in acid production, thus reducing gastric acidity.