低劑量Diclofenac可改善骨關節炎之疼痛


  【24drs.com】根據一篇第3期開放標籤研究,對於骨關節炎病患,屬於非類固醇抗發炎藥物(NSAID)的diclofenac(SoluMatrix細粒專利技術研發(商品名Zorvolex, Iroko Pharmaceuticals藥廠),可改善健康相關生活品質、生理功能和疼痛。
  
  研究作者、Iroko Pharmaceuticals藥廠員工Clarence Young醫師在美國風濕病學會2014年會中解釋,我們重新設計diclofenac,讓它可以在較低劑量下使用,符合NSAIDs最短期間、最低劑量使用之警語。
  
  他報告指出,我們發現,在研究期間,所有的生理功能項目都有改善,這是對骨關節炎疼痛相當有效的治療。
  
  細粒專利技術可建立次微米藥物顆粒,比傳統的藥物顆粒小。
  
  研究作者、史丹佛大學Vibeke Strand醫師表示,新配方對醫療而言相當重要,因為它吸收更佳,所以可以用較低的劑量,效果相同且耐受度更好。不過,這些結果還需要藥品-藥品直接比較的研究驗證。
  
  這篇研究納入的602名病患都診斷為髖骨或膝蓋骨關節炎,有長期使用NSAID和/或乙醯氨酚(acetaminophen),大部份是新納入,只有141名病患是來自一個12週的diclofenac配方研究。
  
  全部病患都在40歲以上,45%年齡60歲以上,平均年齡59.7歲,61.9%是女性,84.2%是白人。
  
  Young醫師等人使用SF-36健康調查問卷第2版,在研究開始時以及第12、24、32、40、48和52週時,評估這些病患的健康相關生活品質結果。
  
  所有病患的起始劑量都是diclofenac 35mg、每天2次,約50%病患在研究期間都是使用這個處方;有302名患者劑量增加到每天3次,約40%依舊用這處方。
  
  有360名患者(59.8%)完成52週研究。
  
  臨床有意義的改善定義為,SF-36的平均生理功能分數至少增加2.5分,在第12週和到第52週的所有時間點都顯著改善(P< .0001)。
  
  在生理功能(P< .0001)、生理角色(P< .0001)、身體疼痛(P< .0001)、活力(P< .0001)、社會功能(P< .0001)以及情緒角色(P= .0004)這些部份都比開始時有顯著改善。
  
  未參與此次研究的佛羅里達大學Roland Staud醫師表示,這個配方對於治療骨關節炎疼痛的患者而言是個進展,因為可以用比較低劑量的NSAIDs。
  
  他解釋,治療的副作用主要是與劑量相關,病患知道這點,所以他們喜歡使用最低的可用劑量;有許多患者會把藥丸剝半或用其他方法,讓自己用比較少的藥物達到想要的效果。
  
  資料來源:http://www.24drs.com/professional/list/content.asp?x_idno=7134&x_classno=0&x_chkdelpoint=Y
  

Lower-Dose Diclofenac Improves Pain in Osteoarthritis

By Alice Goodman
Medscape Medical News

BOSTON — For patients with osteoarthritis, a formulation of the nonsteroidal anti-inflammatory drug (NSAID) diclofenac, developed with SoluMatrix fine-particle technology (Zorvolex, Iroko Pharmaceuticals), improves health-related quality of life, physical function, and pain, according to a phase 3 open-label study.

"We re-engineered diclofenac to enable lower doses to be used, in line with the black box warning to use the lowest effective dose of NSAIDs for the shortest duration of time," study researcher Clarence Young, MD, an employee of Iroko Pharmaceuticals, explained here at the American College of Rheumatology 2014 Annual Meeting.

"We saw improvement in all physical domains over the course of the study," he reported. "This is a promising treatment for osteoarthritis pain."

The fine-particle technology is a patented process that creates submicron drug particles that are smaller than the conventional drug particles.

The new formulation is an important addition to the armamentarium, because it "allows better absorption so you can use a lower dose, and it is better tolerated with similar efficacy," study researcher Vibeke Strand, MD, from Stanford University in Palo Alto, California, told Medscape Medical News. However, he noted, these results have not been "proven in a head-to-head comparison."

The 602 patients enrolled in the study were diagnosed with hip or knee osteoarthritis and reported chronic NSAID and/or acetaminophen use. Most were newly enrolled, but 141 patients were rolled over from a 12-week study of the diclofenac formulation.

All patients were 40 years or older, and 45% were older than 60 years. Mean age was 59.7 years, 61.9% of the participants were women, and 84.2% were white.

Clinically Meaningful Improvement

Dr. Young and his team used the SF-36 Health Survey, version 2, to assess health-related quality-of-life outcomes in patients at baseline and at weeks 12, 24, 32, 40, 48, and 52.

All patients were treated with a starting dose of diclofenac 35 mg twice daily, and about 50% of patients remained on that regimen for the duration of the study. Of the 302 patients whose dosage was increased to 3 times daily, about 40% remained on that regimen.

The 52-week study was completed by 360 patients (59.8%).

Clinically meaningful improvement, defined as an increase in the mean physical component score of the SF-36 of at least 2.5, was significant at week 12 and at all time points up to 52 weeks (P < .0001).

Significant improvement from baseline was also seen for domains of the physical component score, including physical functioning (P < .0001), physical role (P < .0001), body pain (P < .0001), vitality (P < .0001), social functioning (P < .0001), and emotional role (P = .0004).

"This formulation is an advance in treating patients with osteoarthritis pain, allowing lower doses of NSAIDs to be used," said Roland Staud, MD, from the University of Florida in Gainesville, who was not involved in the study.

"Side effects of treatments are mainly dose-related. Patients know that, and they like to use the lowest possible dose. Many of them do pill-splitting and other maneuvers to try to get the desired effects with less drug," he explained.

Dr. Young is an employee of Iroka Pharmaceuticals. Dr. Strand is a consultant for AbbVie, Afferent, Amgen, Biogen Idec, Bioventus, BMS, Carbylan, Celgene, Celltrion, CORRONA, Crescendo, Genentech/Roche, GSK, Hospira, Iroko, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Sanofi, SKK, Takeda, UCB, and Vertex. Dr. Staud reports receiving research funding from Pfizer and Forest Labs.

American College of Rheumatology (ACR) 2014 Annual Meeting: Abstract 249. Presented November 16, 2014.

    
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