JP4870686B2 - 抗炎症剤の投与に関連する心血管リスクを評価するための心臓ホルモンの使用 - Google Patents
抗炎症剤の投与に関連する心血管リスクを評価するための心臓ホルモンの使用 Download PDFInfo
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- JP4870686B2 JP4870686B2 JP2007551689A JP2007551689A JP4870686B2 JP 4870686 B2 JP4870686 B2 JP 4870686B2 JP 2007551689 A JP2007551689 A JP 2007551689A JP 2007551689 A JP2007551689 A JP 2007551689A JP 4870686 B2 JP4870686 B2 JP 4870686B2
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- G01N2333/58—Atrial natriuretic factor complex; Atriopeptin; Atrial natriuretic peptide [ANP]; Brain natriuretic peptide [BNP, proBNP]; Cardionatrin; Cardiodilatin
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- G01—MEASURING; TESTING
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Description
Topol EJ. Failing the public health--rofecoxib, Merck, and the FDA. N Engl J Med 2004; 351: 1707-9 Bombardier C, Laine L, Reicin A, Shapiro D, Burgos-Vargas R, Davis B, Day R, Ferraz MB, Hawkey CJ, Hochberg MC, Kvien TK, Schnitzer TJ; VIGOR Study Group. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group. N Engl J Med 2000; 343: 1520-8 Jueni P, Nartey L, Reichenbach S, Sterchi R, Dieppe PA, Egger M. Risk of cardiovascular events and rofecoxib: cumulative meta-analysis. Lancet 2004; online ahead Fitzgerald GA. Coxibs and cardiovascular disease. N Engl J Med 2004; 351: 1709-1711. Mukherjee D, Nissen SE, Topol EJ. Risk of cardio cardiovascular events associated with selective Cox-2 Inhibitors. JAMA 2001; 286: 954-959.
a)心臓ホルモンのレベルを測定するステップ、
b)測定したレベルを、患者の種々の程度のリスクに関連した既知レベルと比較することによって、患者のリスクを診断するステップ
を含む方法により達成される。
a)心臓ホルモンのレベルを好ましくはin vitroで測定するステップ、
b)測定したレベルを、患者の種々の程度のリスクに関連した既知レベルと比較することによって、患者のリスクを診断するステップ
を含む方法により達成される。
a)患者における心臓ホルモンレベルを好ましくはin vitroで測定するステップ、
b)測定したレベルを、患者の種々の程度のリスクに関連した既知レベルと比較するステップ、
c)場合によって、心臓内科医による患者の検査を開始するステップ、
d)場合によって、心臓内科医による患者の検査結果を考慮して、治療の開始または治療の中止を推奨するステップ、
を含む方法により達成される。
NT-proBNPを用いれば前分析がより着実なものとなり、中央試験室への試料の輸送が簡単になる(Mueller T、Gegenhuber A、Dieplinger B、Poelz W、Haltmayer M、Long-term stability of endogenous B-type natriuretic peptide (BNP) and amino terminal proBNP (NT-proBNP) in frozen plasma samples、Clin Chem Lab Med、2004年、42:942〜4)。血液試料は室温で数日間保存することもできるし、または回収の損失なしに郵送もしくは出荷することもできる。対照的に、BNPを室温または4℃で48時間保存した場合には、少なくとも20%の濃度喪失が生じる(Mueller T、Gegenhuber A、et al、Clin Chem Lab Med 2004;42:942〜4、前掲;Wu AH、Packer M、Smith A、Bijou R、Fink D、Mair J、Wallentin L、Johnston N、Feldcamp CS、Haverstick DM、Ahnadi CE、Grant A、Despres N、Bluestein B、Ghani F、Analytical and clinical evaluation of the Bayer ADVIA Centaur automated B-type natriuretic peptide assay in patients with heart failure: a multisite study、Clin Chem 2004年、50:867〜73)。
心血管疾患に罹患した個体は、安定狭心症(SAP)を罹患する個体である可能性があり、さらに急性冠症候群(ACS)を罹患する個体である可能性もある。ACS患者は、不安定狭心症(UAP)を示す可能性があり、そうでなければ、これらの個体は既に、心筋梗塞(MI)に罹っているかもしれない。MIは、ST上昇型MIである可能性も、非ST上昇型MIである可能性もある。MIの発症に続いて、左心室機能障害(LVD)が発症することがある。最後に、LVD患者は、約15%の死亡率で鬱血性心不全(CHF)を発症する。
「心血管リスク」という用語は、心血管合併症発症のリスクに関する。
本発明は、抗炎症剤またはCox-2インヒビター、特にNSAID、ステロイド、または選択的Cox-2インヒビターの投与により発症する「心血管合併症」に関する。心血管合併症はまた、「心血管事象」としても知られる。以下、もっぱらまたは大抵、「心血管合併症」という用語を用いる。
心血管疾患の症状としては、例えば、新たなQ波もしくは脚ブロック、非致命的な脳卒中の徴候、浮腫の発症または下肢の既存の浮腫の悪化によって示される心不全の発症または悪化、聴診によるラ音または肺のうっ血、動脈高血圧の新たな発症または既存の動脈高血圧の悪化、および静脈血栓症などが挙げられる。
心不全は、「代償性」であっても、「非代償性」であってもよい。代償性とは、身体における通常の酸素需要を満たすことがまだできることを意味し、一方、非代償性とは、身体における通常の酸素需要が既に満たされていないことを意味する。
抗炎症剤の例としては、アルクロフェナック;ジプロピオン酸アルクロメタゾン;アルゲストンアセトニド;アルファアミラーゼ;アムシナファル(Amcinafal);アムシナフィド(Amcinafide);アンフェナクナトリウム;塩酸アミプリロース;アナキンラ;アニロラク(Anirolac);アニトラザフェン(Anitrazafen);アパゾン;バルサラジド二ナトリウム;ベンダザック;ベノキサプロフェン;塩酸ベンジダミン;ブロメライン;ブロペラモール(Broperamole);ブデソニド;カルプロフェン;シクロプロフェン(Cicloprofen);シンタゾン(Cintazone);クリプロフェン(Cliprofen);プロピオン酸クロベタゾール;酪酸クロベタゾン;クロピラク(Clopirac);プロピオン酸クロチカゾン(Cloticasone Propionate);酢酸コルメタゾン(Cormethasone Acetate);コルトドキソン;セレコキシブ; ロフェコキシブ (VIOXX); エトリコキシブ; バルデコキシブ; パレコキシブ; ルミラコキシブ; デフラザコルト;デソニド;デスオキシメタゾン;ジプロピオン酸デキサメタゾン;ジクロフェナク;ジクロフェナクカリウム;ジクロフェナックナトリウム;酢酸ジフロラゾン;ジフルミドンナトリウム(Diflumidone Sodium);ジフルニサル;ジフルプレドナート;ジフタロン;ジメチルスルホキシド;ドロシノニド(Drocinonide);エンドリゾン(Endrysone);エンリモマブ(Enlimomab);エノリカムナトリウム(Enolicam Sodium);エピリゾール;エトドラク;エトフェナメート(Etofenamate);フェルビナク;フェナモール(Fenamole);フェンブフェン;フェンクロフェナック;フェンクロラック(Fenclorac);フェンドサル(Fendosal);フェンピパロン(Fenpipalone);フェンチアザク;フラザロン(Flazalone);フルザコート(Fluazacort);フルフェナム酸;フルミゾール;酢酸フルニソリド;フルニキシン;フルニキシンメグルミン;フルオコルチンブチル(Fluocortin Butyl);酢酸フルオロメトロン;フルカゾン(Fluquazone);フルルビプロフェン;フルレトフェン(Fluretofen);プロピオン酸フルチカゾン;フラプロフェン(Furaprofen);フロブフェン;ハルシノニド;プロピオン酸ハロベタゾール;酢酸ハロプレドン;イブフェナック;イブプロフェン;イブプロフェンアルミニウム;イブプロフェンピコノール;イロニダップ(Ilonidap);インドメタシン;インドメタシンナトリウム;インドプロフェン;インドキソール(Indoxole);イントラゾール(Intrazole);酢酸イソフルプレドン;イソクセパック(Isoxepac);イソキシカム;ケトプロフェン;塩酸ロフェミゾール(Lofemizole Hydrochloride);ロルノキシカム;エタボン酸ロテプレドノール;メクロフェナム酸ナトリウム;メクロフェナム酸;ブチル酸メクロリゾン(Meclorisone Dibutyrate);メフェナム酸;メロキシカム(MobicTM); メサラミン;メセクラゾン;スレプタン酸メチルプレドニゾロン;モルニフルメート(Morniflumate);ナブメトン;ナプロキセン;ナプロキセンナトリウム;ナプロキソール(Naproxol);ニマゾン(Nimazone);オルサラジンナトリウム;オルゴテイン;オルパノキシン(Orpanoxin);オキサプロジン;オキシフェンブタゾン;塩酸パラニリン(Paranyline Hydrochloride);ペントサン多硫酸ナトリウム;フェンブタゾンナトリウムグリセラート(Phenbutazone Sodium Glycerate);パーフェニドン;ピロキシカム;ケイ皮酸ピロキシカム;ピロキシカムオラミン;ピルプロフェン;プレドナゼート(Prednazate);プリフェロン(Prifelone);プロドリックアシッド(Prodolic Acid);プロクアゾン(Proquazone);プロキサゾール(Proxazole);クエン酸プロキサゾール(Proxazole Citrate);リメキソロン(Rimexolone);ロマザリツ(Romazarit);サルコレックス(Salcolex);サルンアセジン(Salnacedin);サルサラート;サリチル酸;塩化サンギナリウム(Sanguinarium Chloride);セクラゾン(Seclazone);セルメタシン(Sermetacin);スドキシカム(Sudoxicam);スリンダク;スプロフェン;タルメタシン(Talmetacin);タルニフルメート(Talniflumate);タロサレート(Talosalate);テブフェロン(Tebufelone);テニダップ;テニダップナトリウム;テノキシカム;テシカム(Tesicam);テシミド(Tesimide);テトリダミン(Tetrydamine);チオピナク(Tiopinac);ピバル酸チクソコルトール;トルメチン;トルメチンナトリウム;トリクロナイド(Triclonide);トリフルミデート(Triflumidate);ジドメタシン(Zidometacin);およびゾメピラックナトリウム;エタネルセプト; レネルセプト(Lenercept); インフリキシマブ; コルチゾン; フルオコルトロン; ヒドロコルチゾン; メチルプレドニゾロン; プレドニソロン; プレドニソンおよびプレドニリデンが挙げられる。
別の好ましい実施形態において、本発明は、(a)炎症マーカー、(b)内皮機能マーカー、(c)虚血マーカー、(d)血小板活性化マーカー、(e)アテローム性動脈硬化活性化マーカー、および(f)血管内凝固の活性化マーカー、からなる群から選択される少なくとも1つのマーカーのレベルを追加的に測定することに関する。
患者のリスクがいったん診断されれば、それは、以下に記載されるように、後続の治療に影響を与えることができる。(このような治療の決定に関する非限定的な例を、図1に示す)。下記のリスク程度は、特に、上記のNT-proBNPレベルに関連したリスク程度を指す。
a)心臓ホルモンのレベルを測定するステップ;および
b)測定したレベルを、患者の種々の程度のリスクに関連した既知レベルと比較することによって、患者のリスクを診断するステップ、
を含む、上記方法。
a)心臓ホルモンのレベルを測定するステップ;および
b)測定したレベルを、患者の種々の程度のリスクに関連した既知レベルと比較することによって、患者のリスクを診断するステップ、
を含む、上記方法。
a)炎症マーカー;
b)内皮機能マーカー;
c)虚血マーカー;
d)血小板活性化マーカー;
e)アテローム性動脈硬化活性化マーカー;および
f)血管内凝固の活性化マーカー、
からなる群から選択されるマーカーの少なくとも1つのレベルをさらに測定する、1〜14のいずれかの方法。
a)患者における心臓ホルモンレベルを好ましくはin vitroで測定するステップ;
b)測定したレベルを、患者の種々の程度のリスクに関連した既知レベルと比較するステップ;
c)場合によって、心臓内科医による患者の検査を開始するステップ;および
d)場合によって、心臓内科医による患者の検査結果を考慮して治療の開始または治療の中止を推奨するステップ、
を含む、上記方法。
a)患者における心臓ホルモンレベルを好ましくはin vitroで測定するステップ;
b)測定したレベルを、患者の種々の程度のリスクに関連した既知レベルと比較することによって、患者のリスクを診断するステップ;
c)ここで、場合により心臓内科医による患者の検査結果を考慮して、
ca)リスクが高くなっていないと診断された場合、治療の開始を推奨する、および/または
cb)リスクが高くなっているもしくは非常に高くなっていると診断された場合、治療の中止を推奨する、ステップ、
を含む、上記方法。
21. 選択的Cox-2インヒビターの投与対象である患者の心血管リスクを診断するために、または選択的Cox-2インヒビターを用いた治療を受けている患者の心血管リスクを監視するための、患者の心臓ホルモンのレベル、好ましくはナトリウム利尿ペプチドを測定することができる診断手段の使用であって、当該心臓ホルモンのレベルは、患者の体液または組織試料中で測定される、上記使用。
NT-proBNPの測定
NT-proBNPは、Elecsys 2010を用いた電気化学発光免疫アッセイ(ElecsysproBNPサンドイッチ免疫アッセイ;Roche Diagnostics社、Mannheim、Germany)で測定できる。このアッセイは電気化学発光サンドイッチ免疫アッセイの原理に従って機能する。第1ステップでは、ビオチン標識されたIgG(1〜21)捕獲抗体と、ルテニウム標識されたF(ab’)2(39〜50)シグナル抗体と、20μlの試料とを37℃で9分間インキュベートした。その後、ストレプトアビジンでコーティングされた磁性微粒子を添加し、混合物をさらに9分間インキュベートした。第2のインキュベーションの後に、反応混合物を装置の測定セルに移した。ビーズは、そこで磁力により電極の表面に捕捉される。結合しなかった標識は、測定セルを緩衝液で洗浄することによって除去した。
NT-proANPは、Sundsfjord,J.A.、Thibault,G.ら(1988)、Idenfication and plasma concentrations of the N-terminal fragment of proatrial natriuretic factor in man、J Clin Endocrinol Metab 66:605〜10の改変法による磁性固相技術を用いた競合的結合放射免疫アッセイで、同じウサギ抗ラットproANPポリクローナル血清と、標準試料としてPeninsula Lab(Bacherm社、St. Helene、UK)からのヒトproANP(1〜30)と、放射標識用にHPLCで精製されたヨウ素化proANP1〜30とを用いて測定した。高い感度と良好な精度とを実現するために、固相として、ヒツジ抗ウサギIgG(Dynal Biotech社、Oslo、Norway)を備えたDynabeads M280を用い、また二次抗体を使用した。
70歳の高齢の患者は、重篤な関節リウマチに罹患し、また長期間イブプロフェンによる治療を受けていた。イブプロフェン治療の間に、彼は、胃腸出血を含む胃腸副作用に罹患した。医師は、選択的Cox-2インヒビターを用いることに治療を変えようと考え、NT-proBNPの測定を行った。NT-proBNPレベルは223 pg/mlであった。患者は、診断のために心臓内科医に診せた。心エコー図によって、心臓内科医は、虚血性機能不全および選択的Cox-2インヒビターを用いた治療のリスクを診断した。心機能不全が重篤ではないために、選択的Cox-2インヒビターを用いた断続的な治療を、NT-proBNPの綿密な監視下で開始した。
55歳の高齢の女性患者は、II型糖尿病を6年間治療しており、慢性的な痛みを伴うリウマチ疾患を罹患していた。そのため、彼女の医師は、Cox-2インヒビターを用いた治療を検討した。NT-proBNP値を測定し、647 pg/mlであることを決定した。患者は、さらなる診断のために心臓内科医に診せた。高いNT-proBNP値および糖尿病の併存疾患のために、Cox-2インヒビターを用いた治療は開始しなかった。
72歳の高齢の患者であって、健康であり喫煙者であるが、心疾患についての従来のリスク要因をさらに有さない患者は、ひざの極度の関節痛を罹患していた(おそらく、長期のスポーツ活動によるものである)。患者は、自身の胃が非常に敏感であることを知っていた。そのため、選択的Cox-2インヒビターを用いた治療が検討された。血漿のNT-proBNPの測定値は、65 pg/mlであると測定された。PROCAMスコアが40未満であり、かつ従来のリスク要因が喫煙だけであるため、選択的Cox-2インヒビターを用いた治療を開始した。
抗炎症剤の投与による心血管合併症に罹患するリスクを評価するためのNT-proBNPの使用。
Cox-2インヒビター群:
Cox-2インヒビターにより治療された55人の患者のうち、11人の患者はまたNSAIDを受け、10人の患者はまたステロイドを受け、9人の患者はまたNSAIDおよびステロイドを受けた。
NSAIDにより治療された157人の患者のうち39人の患者はまた、ステロイドを受けた。
ステロイドのみを用いて治療された41人の患者。
抗炎症剤(Cox-2インヒビター、NSAIDおよびステロイド)を用いて治療されていない180人の患者。鎮痛薬を用いた別の治療は可能である。
表4は、多変量回帰分析の結果を示す。年齢、性別および糖尿病について調整した後でも、患者がCox-2インヒビターを受けた場合、高いNT-proBNPは独立して有害転帰の前兆であり続けた。NSAIDまたはステロイドをレスキュー薬剤または併用薬剤として与えた場合も、同様の傾向が見られた。
Claims (22)
- Cox-2阻害化合物の投与による急性心血管合併症に罹患する患者のリスクを予測または決定する方法であって、以下のステップ:
a)患者由来の体液または組織試料中のBNPおよびNT-proBNPからなる群から選択される心臓ホルモンのレベルをin vitroにて測定するステップ、
b)測定したレベルと、患者における種々の程度のリスクに関連した既知レベルとを比較することによって、患者のリスクを予測または決定するステップ、
を含み、該患者は既存の心血管疾患および心血管合併症の症状を示さず、かつ、該患者は心血管合併症のいかなる既知の病歴も有さず、
ここで該リスクは血液容量もしくは血管内容量の増大によるものではない、上記方法。 - 心臓ホルモンが、NT-proBNPである、請求項1記載の方法。
- 80 pg/ml未満のNT-proBNPの血漿レベルが、心血管合併症に罹患する高いリスクに関連していない、請求項1または2に記載の方法。
- NT-proBNPの血漿レベルが、125 pg/ml未満である、請求項3記載の方法。
- 125を超え500 pg/ml未満のNT-proBNPの血漿レベルが、心血管合併症に罹患する高いリスクに関連している、請求項1〜4のいずれか1項に記載の方法。
- 500 pg/mlを超えるNT-proBNPの血漿レベルが、心血管合併症に罹患する非常に高いリスクに関連している、請求項1〜5のいずれか1項に記載の方法。
- 選択的Cox-2インヒビターを用いた治療の監視において実施される、請求項1〜6のいずれか1項に記載の方法。
- 選択的Cox-2インヒビターを用いた断続的な治療を監視するための、請求項7記載の方法。
- 選択的Cox-2インヒビターを用いた断続的な治療が、心臓ホルモンのレベルが特定の値に達した場合に中止され、該レベルが特定の値以下になった場合には、場合によって再開される、請求項8記載の方法。
- Cox-2阻害化合物が、セレコキシブ、ロフェコキシブ、エトリコキシブ、バルデコキシブ、パレコキシブおよびルミラコキシブからなる群から選択される、請求項1〜9のいずれか1項に記載の方法。
- さらに、以下:
a)炎症マーカー
b)内皮機能マーカー
c)虚血マーカー
d)血小板活性化マーカー
e)アテローム性動脈硬化活性化マーカー
f)血管内凝固の活性化マーカー
からなる群から選択される少なくとも1つのマーカーレベルをin vitroにて測定する、請求項1〜10のいずれか1項に記載の方法。 - 心血管合併症が、冠状動脈性心臓病、安定狭心症、急性冠症候群、不安定狭心症、心筋梗塞、ST上昇型心筋梗塞、非ST上昇型心筋梗塞または脳卒中である、請求項1〜11のいずれか1項に記載の方法。
- 心臓ホルモンのレベルが、尿、血液、血漿または血清試料中にて測定される、請求項1〜12のいずれか1項に記載の方法。
- 心臓ホルモンのレベルが、特異的に結合するリガンド、アレイ、微小流体装置、化学発光分析器およびロボット装置からなる群より選択される1以上の手段を用いて測定される、請求項1〜13のいずれか1項に記載の方法。
- 特異的に結合するリガンドが、抗体またはアプタマーである、請求項14記載の方法。
- 選択的Cox-2インヒビターを用いた治療を受けている患者の心血管リスクを監視することをさらに含む、請求項1〜15のいずれか1項に記載の方法。
- 患者が選択的Cox-2インヒビターの投与対象である、請求項1〜16のいずれか1項に記載の方法。
- 選択的Cox-2インヒビターを投与する前に実施する、請求項17記載の方法。
- Cox-2阻害特性を有する化合物を用いて、既存の心血管疾患、心血管リスクおよび心血管合併症の症状を示さない患者の治療を開始するか否かを決定するための情報を提示する方法であって、
a)患者由来の体液または組織試料におけるBNPまたはNT-proBNPの心臓ホルモンレベルをin vitroで測定するステップ、
b)測定したレベルと、患者における種々の程度のリスクに関連した既知レベルとを比較することによって、患者のリスクを決定するステップ、ならびに
c)ステップa)およびb)からの検査の結果に基づき以下を決定するステップ、
ca)リスクが高くないと決定された場合、治療の開始を推奨する、および/または
cb)リスクが高い、または非常に高いと決定された場合、治療の中止を推奨する、
を含む、上記方法。 - 心臓ホルモンがNT-proBNPであり、かつ化合物が選択的Cox-2インヒビターである、請求項19記載の情報を提示する方法。
- 選択的Cox-2インヒビターが、セレコキシブ、ロフェコキシブ、エトリコキシブ、バルデコキシブ、パレコキシブおよびルミラコキシブからなる群から選択される、請求項20記載の情報を提示する方法。
- a)測定されたNT-proBNPの血漿または血清レベルが、100 pg/mlまたはそれ以上、特に125 pg/mlまたはそれ以上である場合、患者を治療しないことを推奨するか、または心血管監視下にて、および/もしくは低用量の選択的Cox-2インヒビターを用いた治療を承認することを推奨するステップ、ならびに/あるいは
b)測定されたNT-proBNPの血漿または血清レベルが400 pg/mlまたはそれ以上、特に500 pg/mlを超えるかそれ以上である場合、患者を治療しないことを推奨するステップ、
を含む、請求項19〜21のいずれか1項に記載の情報を提示する方法。
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