作者：Alison Palkhivala
出處：WebMD醫學新聞
September 17, 2008(蒙特婁魁北克)－根據於9月14至15日間舉行的美國骨骼和礦物質學會(ASBMR)第30屆年會中發表的海報，每月一次的ibandronate治療，和每週一次的risedronate或者alendronate的實際骨折預防效果一樣。
第一篇海報的主要作者、同時也是第二篇海報的資深作者、加州大學舊金山分校臨床醫學教授、Steven T. Harris 醫師向Medscape醫學新聞表示，我們認為有一些病患偏好使用每月一次的治療而非每週一次的治療，特別是有這些必須空腹、只能喝水等待給藥的藥物處方時，根據他的研究，如果人們偏好使用每月一次的雙磷酸鹽藥物，無須感到遺憾，因為他們並沒有為了便利性而犧牲效果。
Creighton大學醫學院醫學教授、Robert Recker醫師向Medscape醫學新聞表示，長期使用雙磷酸鹽治療者常有所謂的「藥物疲勞」問題，至少可以用每月治療的方式來部份緩解此現象；他出席ASBMR研討會，但是未參與此研究，他表示，很難讓經年累月服用雙磷酸鹽的人認同成功表示什麼都沒有發生，人們對於每月一次治療的順從度比每週一次的治療為佳，但他也認為藥物順從性難以追蹤。
對於Evaluation of Ibandronate Efficacy(VIBE)研究，研究者使用醫療需求資料庫來辨識於2005年4至12月間，7,345名45歲以上的婦女，這些是新開方每月一次 ibandronate 150 mg的病患，以及56,837名處方每週一次alendronate (35 mg或者70 mg)或者risedronate (35mg)的人，參與者遵守其治療方式至少90天，沒有癌症或者Paget氏症；研究者校正潛在的共變項之後，使用回歸分析比較兩組之間的骨折率，平均追蹤期間為7個月。
兩組髖骨骨折、非脊椎骨折、所有骨折風險相似，每週一次雙磷酸鹽治療的所有骨折比率為1.5%，每月一次ibandronate治療的骨折比率為1.4%；有趣的是，每月一次ibandronate治療的脊椎骨折比率略低(0.11% vs. 0.24%; P= .006)。
Harris醫師表示，這個特殊分析的含意是進行全面的敏感度分析，所以，如果取出這一小群患者、或者取出那一小群患者，結果還會一樣嗎？答案是「是的」；敏感度分析包括排除於指標前期服用雌激素、抑鈣激素或者raloxifene的病患；服用糖化皮質類固醇的病患；發生過骨折的病患；服用胃腸道藥物的病患；服用糖化皮質類固醇和/或骨質缺乏和/或使用alendronate的病患。這些都不會顯著影響結果。
Harris醫師表示，另一篇海報發表的次分析只包括了65歲以上的婦女，考量年長病患的效果是否和年輕預防病患不同；當把分析限制在65歲以上者，骨質疏鬆患者比率自然增加，骨質缺乏或者其他問題的患者也增加；研究再次發現類似的結果。
Harris醫師表示，看來每月一次[ibandronate]治療的患者，其骨折率和每週一次[risedronate 或者alendronate]治療的患者相當；有趣的是，每月一次[ibandronate]的患者，其脊椎骨折風險降低較多。
Recker醫師表示，每月一次[ibandronate]的效果對於這幾類病患都不錯，雖然不太令人意外；這些資料有助於確認和再度保證。
本研究由GlaxoSmithKline藥廠合作主導，Harris醫師接受GlaxoSmithKline、Amgen、Eli Lilly和Merck等藥廠的資金。
美國骨骼和礦物質學會 (ASBMR) 第30屆年會：海報Su408 和 M367。發表於2008年9月14日和15日。
Monthly Ibandronate as Effective as Weekly Risedronate or Alendronate
By Alison Palkhivala
Medscape Medical News
September 17, 2008 (Montreal, Quebec) ?Monthly ibandronate therapy is as effective in the prevention of fractures as weekly therapy with risedronate or alendronate in a real-world setting, according to posters presented on September 14 and 15 here at the American Society for Bone and Mineral Research (ASBMR) 30th Annual Meeting.
"It's been our feeling all along that there are some patients who would prefer to take once-a-month therapy rather than once-a-week therapy, particularly if you look at [the administration regimen] of these compounds, where you have to take them on an empty stomach with plain water and wait," Steven T. Harris MD, FACP, clinical professor of medicine at the University of California at San Francisco, told Medscape Medical News. He is lead author of the first poster and senior author of the second. According to his research, "people don't have to apologize if they prefer to take a monthly dose [of bisphosphonate] because they're not sacrificing efficacy for convenience."
"Medication fatigue" associated with long-term bisphosphonate therapy is a common problem that can be at least partly remedied with once monthly-therapy, Robert Recker, MD, professor of medicine at Creighton University School of Medicine, in Omaha, Neraska, told Medscape Medical News. He attended the ASBMR conference but was not involved in this research. "It's hard to get people to take bisphosphonates for months and years when success means nothing happens.?.?.?. People comply much better with a once-a-month therapy than a once-a-week therapy," he said, although he acknowledged that adherence to medication is tough to track.
For the Evaluation of Ibandronate Efficacy (VIBE) study, the researchers used medical-claims databases to identify 7345 women, 45 years or older, who were newly prescribed once-monthly ibandronate 150?mg and 56,837 prescribed once-weekly alendronate (35?mg or 70?mg) or risedronate (35?mg) between April and December 2005. The participants had been adherent to their therapy for at least 90 days and did not have cancer or Paget's disease. The researchers used regression analysis to compare fracture rates between the 2 groups, after adjustment for potential confounding factors. Mean follow-up was approximately 7 months.
The risk for hip fracture, nonvertebral facture, and all fracture was similar in both groups, with an all-fracture rate of 1.5% with weekly bisphosphonate therapy and 1.4% with monthly ibandronate. Interestingly, vertebral fracture rates were actually a little bit lower with monthly ibandronate (0.11% vs 0.24%; P?= .006).
"The intent of this particular analysis is to do a whole bunch of sensitivity analyses, so that if you take out this subgroup of patients, or you take out that subgroup of patients, are findings the same? And the answer is yes," said Dr. Harris. Sensitivity analyses involved excluding patients taking estrogen, calcitonin, or raloxifene; patients taking glucocorticoids; patients who experienced a fracture; patients taking gastrointestinal medication; and patients on glucocorticoids and/or with osteopenia and/or on alendronate during the preindex period. None of these exclusions significantly affected the results.
A subanalysis presented in a separate poster involved only women 65 years or older. "There's been a concern that maybe among older patients efficacy might be different than among the younger prevention population," said Dr. Harris. "When you restrict your analysis to the over-65 group, you're enriching your population of osteoporotic patients, as opposed to patients who might be osteopenic or something of the sort." Once again, the findings were similar.
"It looks like the fracture rates for patients getting monthly [ibandronate] were very comparable to those of patients getting weekly [risedronate or alendronate]," said Dr. Harris. "If anything, interestingly, there's a little bit of a trend favoring a reduction of vertebral fractures for patients who got monthly [ibandronate]."
"It's good that [once-a-month ibandronate] is effective in all these types of patients," said Dr. Recker, "and it's not hugely unexpected. [These data] provide confirmation and reassurance."
This research was conducted in collaboration with GlaxoSmithKline, and Dr. Harris has received funding from GlaxoSmithKline, Amgen, Eli Lilly, and Merck.
American Society for Bone and Mineral Research (ASBMR) 30th Annual Meeting: Posters Su408 and M367. Presented September 14, 2008 and September 15, 2008.
[ 本帖最後由 goodcat1111 於 2008-9-29 13:05 編輯 ] |
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