JP2010525050A - ビタミンd不足および欠乏症の治療方法 - Google Patents
ビタミンd不足および欠乏症の治療方法 Download PDFInfo
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- JP2010525050A JP2010525050A JP2010504912A JP2010504912A JP2010525050A JP 2010525050 A JP2010525050 A JP 2010525050A JP 2010504912 A JP2010504912 A JP 2010504912A JP 2010504912 A JP2010504912 A JP 2010504912A JP 2010525050 A JP2010525050 A JP 2010525050A
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Abstract
Description
米国特許法第119条第(e)項により2007年4月25日に出願の米国特許仮出願第60/913849号に基づく利益をこれによって請求する。
25−ヒドロキシビタミンD3と25−ヒドロキシビタミンD2との各種組合せの共投与は、25−ヒドロキシビタミンD3単独での治療で観察される毒性を軽減する
25−ヒドロキシビタミンD3の25−ヒドロキシビタミンD2との共投与に付随する毒性の低減を25−ヒドロキシビタミンD3単独と比較して調べるために、90匹の雄性スプラーグドーリーラットを、25−ヒドロキシビタミンD3と25−ヒドロキシビタミンD2との各種組合せで連続して5日間静脈内で治療する。研究開始の1日前に、ラットを、ランダムに選択し、群に割り振り、表3に従って治療した。
25−ヒドロキシビタミンD3と25−ヒドロキシビタミンD2との各種組合せの共投与が、25−ヒドロキシビタミンD3単独での治療によって観察される毒性を軽減することについてのもう1つの研究
25−ヒドロキシビタミンD3の25−ヒドロキシビタミンD2との共投与の効果を25−ヒドロキシビタミンD3の単独と比較して評価するために、102匹の雄性スプラーグドーリーラットで、もう1つの研究を実施した。約3日齢で体重が約175〜250gのラットをそれぞれ6匹のオスの群に分割した。該群に、下表5に従って、25−ヒドロキシビタミンD3と25−ヒドロキシビタミンD2との各種組合せ(または同容積の対照ビヒクル)を、頚静脈カテーテルを介する静脈内にて1日1回で連続5日間投与した。
ビタミンDホルモンの高投与量製剤で治療される進行性前立腺癌患者における効力および安全性研究
25−ヒドロキシビタミンD2経口製剤の効力および安全性を、1週間に1回の高投与量カルシトリオールで治療されている進行性前立腺癌を有する患者についての3カ月間の研究で検討した。この研究では、25−ヒドロキシビタミンD2は、軟質ゼラチンカプセルに製剤化した。高投与量のカルシトリオールおよびドセタキセルでの治療を受けている進行性前立腺癌を有する40名の患者を2つの均等な群に分割した。週1回のカルシトリオール投与に加え、群#1には2〜20μgの25−ヒドロキシビタミンD2を与え、一方、群#2にはプラセボを与える。登録に先立って、すべての対象は、血清中カルシウム、血漿中全分子PTH、および血清中25−ヒドロキシビタミンDの治療前ベースライン値を確立するために、少なくとも1週間隔離されて空腹時早朝血液検体を2回提出する。血清中カルシウムおよび血清中25−ヒドロキシビタミンDを測定するために、週1回のカルシトリオールの投与24時間後に、各対象からさらなる空腹時血液検体および24時間尿収集物を収得する。研究の初めから終わりまで、すべての対象は、栄養士の継続した指導の下に、元素としてほぼ1,000〜1,500mgの1日当たりカルシウム摂取量(自己選択の食事および必要ならカルシウムサプリメントから)に固守する。研究終結の時点で、検査データを、ベースライン値についての適正な補正の後に、治療群に関しておよび試験製剤に関して解析する。すべての群は、血清中25−ヒドロキシビタミンD(範囲:10.7〜20.9ng/mL)および血清中カルシウム(範囲:8.72〜9.31mg/dL)に関して類似の平均ベースライン値を有すると予想される。プラセボ(対照)群では、血清中カルシウムに関する検査平均値の研究過程にわたる増加が観察されると予想されるが、治療群では、血清中カルシウム濃度のはるかにより小さな変化(例えば、無変化または増加の縮小)が観察されると予想される。25−ヒドロキシビタミンD2を与えた治療群の対象は、最初の2〜3カ月間の投与中に、漸増する血清中25−ヒドロキシビタミンD濃度を示し、その後、定常状態に到達すると予想される。10.2mg/dLを超える血清中カルシウムとして定義される高カルシウム血症の発現は、治療群に比べてプラセボ群でより頻繁に観察されると予想される。この研究からのデータは、高投与量のカルシトリオールで前立腺癌患者を治療する際の血清中カルシウムの上昇を、治療計画に25−ヒドロキシビタミンD2を付加することによって、全体的に調節または軽減できることを立証すると予想される。
ビタミンD欠乏症を示している終末ステージの腎臓病患者における効力および安全性研究
静脈内25−ヒドロキシビタミンD3/25−ヒドロキシビタミンD2組合せの、血清中25−ヒドロキシビタミンDを最適濃度(>30ng/mL)に戻す上での効果および安全性を、定期的血液透析を必要とし、かつビタミンD不足と診断された終末ステージの腎臓病(ESRD)を有する患者についての3カ月間の研究で調べた。この研究で調べる製剤は、20μgの25−ヒドロキシビタミンD3を単独で(試験製剤#1)、または10μgの25−ヒドロキシビタミンD2と組み合わせて(試験製剤#2)含有する等張性無菌水性溶液である。全部で75名の健康な白人、アジア人、ヒスパニックおよびアフリカ系アメリカ人対象が、この研究に参加し、そのすべては、定期的血液透析を少なくとも4カ月間続け、15ng/mL未満の血清中25−ヒドロキシビタミンD濃度を有する。登録に先立って、すべての対象は、血清中カルシウム、血漿中全分子PTH、および血清中25−ヒドロキシビタミンDの治療前ベースライン値を確立するために、少なくとも1週間隔離されて空腹時早朝血液検体を2回提出する。1日目の朝に、対象は、3つの治療群の1つにランダムに割り振られ、試験製剤#1または#2での、あるいは似合ったプラセボでの週3回の投与を開始する。すべての投与は、定期的に予定された血液透析の際に行われ、血液透析機から出て行く血液中に徐々に注射する(1〜5分間にわたる時間)ことによって完遂される。血清中カルシウム、血漿中全分子PTHおよび血清中25−ヒドロキシビタミンDを測定するために、4分の1の間隔で各対象からさらなる空腹時血液検体および24時間尿収集物を収得する。研究の初めから終わりまで、すべての対象は、栄養士の継続した指導の下に、元素としてほぼ1,000〜1,500mgの1日当たりカルシウム摂取量(自己選択の食事および必要ならカルシウムサプリメントから)を固守する。研究終結の時点で、検査データを、ベースライン値についての適正な補正の後に、治療群に関しておよび試験製剤に関して解析する。すべての群は、血清中25−ヒドロキシビタミンD(範囲:10.7〜11.9ng/mL)、血漿中全分子PTH(範囲:45.3〜52.1pg/mL)および血清中カルシウム(範囲:8.72〜9.31mg/dL)に関して類似の平均ベースライン値を有すると予想される。プラセボ(対照)群では、研究過程にわたって、いずれの検査平均値も有意な変化は観察されないと予想される。25−ヒドロキシビタミンD3の単独を与えた治療群、または25−ヒドロキシビタミンD3/25−ヒドロキシビタミンD2の組合せを与えた治療群の両方の対象は、最初の3カ月間の投与中に、漸増する血清中25−ヒドロキシビタミンD濃度を示し、その後、定常状態濃度に到達すると予想される。平均血清中カルシウムは、25−ヒドロキシビタミンD3を与えた治療群においてベースラインから有意に増加すると予想され、プラセボ群で観察されるものと比べて有意に高いと予想される。25−ヒドロキシビタミンD3/25−ヒドロキシビタミンD2の組合せを与えた治療群の対象は、25−ヒドロキシビタミンD3の単独治療群について観察されるものに比べて有意に低い血清中カルシウム濃度を示すが、プラセボ群で観察されるものと比べて有意に異なることはないと予想される。10.2mg/dLを超える血清中カルシウムとして定義される高カルシウム血症の発現は、25−ヒドロキシビタミンD3のみを与えた治療群でより頻繁に観察されると予想される。この研究からのデータは、25−ヒドロキシビタミンD2と組み合わせた25−ヒドロキシビタミンD3の静脈内製剤が、25−ヒドロキシビタミンD3の単独からなる製剤と比べて、血清中カルシウム濃度の有意な上昇を引き起こさないで、血清中25−ヒドロキシルビタミンDを増加させる上で等しいかあるいはより有効であることを立証すると予想される。この研究からの結論は、25−ヒドロキシビタミンD3と25−ヒドロキシビタミンD2を組み合わせることは、血清中25−ヒドロキシビタミンD濃度を高める安全な方策であることを支持すると予想される。
Claims (36)
- 対象にビタミンD3サプリメントおよびビタミンD2サプリメントを共投与することを含む、治療方法。
- 治療上有効な量のビタミンD3サプリメントを投与すること、およびビタミンD2サプリメントをビタミンDの毒性を低減するのに有効な量で投与することを含む、請求項1に記載の方法。
- 前記ビタミンD3サプリメントが、コレカルシフェロール、25−ヒドロキシビタミンD3、またはこれらの類似体を含有する、請求項1または2に記載の方法。
- 前記ビタミンD3サプリメントが、25−ヒドロキシビタミンD3またはその類似体を含有する、請求項3に記載の方法。
- 前記ビタミンD2サプリメントが、エルゴカルシフェロール、25−ヒドロキシビタミンD2、またはこれらの類似体を含有する、請求項1から4までのいずれか1項に記載の方法。
- 前記ビタミンD2サプリメントが、25−ヒドロキシビタミンD2またはその類似体を含有する、請求項5に記載の方法。
- 前記ビタミンD3サプリメントが1,25−ヒドロキシビタミンD3またはその類似体を含有し、前記ビタミンD2サプリメントが1,25−ヒドロキシビタミンD2またはその類似体を含有する、請求項1から6までのいずれか1項に記載の方法。
- ビタミンD3サプリメントのビタミンD2サプリメントに対する比率が、100:1〜1:20の範囲である、請求項1から7までのいずれか1項に記載の方法。
- 前記ビタミンD3サプリメントのビタミンD2サプリメントに対する比率が、少なくとも1:1である、請求項8に記載の方法。
- 前記ビタミンD3サプリメントのビタミンD2サプリメントに対する比率が、少なくとも1.5:1である、請求項9に記載の方法。
- 前記ビタミンD3サプリメントのビタミンD2サプリメントに対する比率が、少なくとも2:1である、請求項10に記載の方法。
- コレカルシフェロールを1μg/kg/日を超える量で、25−ヒドロキシビタミンD3を2μg/kg/日を超える量で、または1,25−ジヒドロキシビタミンD3を0.01μg/kg/日を超える量で投与することを含む、請求項1から11までのいずれか1項に記載の方法。
- 前記ビタミンD3サプリメントおよび前記ビタミンD2サプリメントを互いに6時間以内に投与することを含む、請求項1から12までのいずれか1項に記載の方法。
- 最初に前記ビタミンD3サプリメント投与すること、次いで前記ビタミンD2サプリメントを、ビタミンD3サプリメントまたはその代謝産物のどちらかが血清中で検出可能である時点に投与することを含む、請求項13に記載の方法。
- 最初に前記ビタミンD2サプリメント投与すること、次いで前記ビタミンD3サプリメントを、ビタミンD2サプリメントまたはその代謝産物のどちらかが血清中で検出可能である時点に投与することを含む、請求項13に記載の方法。
- 前記ビタミンDサプリメント類を、ビタミンDの不足および/または欠乏症と診断された患者に投与することを含む。請求項1から15までのいずれか1項に記載の方法。
- 前記ビタミンDサプリメント類を、対象の血清中25−ヒドロキシビタミンD濃度を少なくとも30ng/mLに上昇させ、および/または維持するのに十分な量で投与することを含む、請求項1から16までのいずれか1項に記載の方法。
- 前記対象がヒトである、請求項1から17までのいずれか1項に記載の方法。
- 50μgを超える25−ヒドロキシビタミンD3、および医薬として許容し得る賦形剤を含有する単位剤形を含む組成物。
- エルゴカルシフェロール、25−ヒドロキシビタミンD2、またはこれらのどちらかの類似体を含む群から選択されるビタミンD2サプリメントをさらに含む、請求項19に記載の組成物。
- 前記ビタミンD2サプリメントが、ビタミンDの毒性を低減するのに有効な量で存在する、請求項20に記載の組成物。
- 前記ビタミンD2サプリメントが、25−ヒドロキシビタミンD2を含む、請求項20または21に記載の組成物。
- 50μgを超えるコレカルシフェロール、および医薬として許容し得る賦形剤を含有する単位剤形を含む組成物。
- エルゴカルシフェロール、25−ヒドロキシビタミンD2、またはこれらのどちらかの類似体を含む群から選択されるビタミンD2サプリメントをさらに含む、請求項23に記載の組成物。
- 前記ビタミンD2サプリメントが、ビタミンDの毒性を低減するのに有効な量で存在する、請求項24に記載の組成物。
- 前記ビタミンD2サプリメントが、エルゴカルシフェロールを含有する、請求項24または25に記載の組成物。
- ビタミンD3サプリメントおよびビタミンD2サプリメントの両方を含有し、ビタミンD3サプリメントのビタミンD2サプリメントに対する比率が、100:1〜1:20の範囲である、請求項19から26までのいずれか1項に記載の組成物。
- 前記ビタミンD3サプリメントのビタミンD2サプリメントに対する比率が、少なくとも1:1である、請求項27に記載の組成物。
- 前記ビタミンD3サプリメントのビタミンD2サプリメントに対する比率が、少なくとも1.5:1である、請求項29に記載の組成物。
- 前記ビタミンD3サプリメントのビタミンD2サプリメントに対する比率が、少なくとも2:1である、請求項30に記載の組成物。
- ビタミンD3サプリメントおよびビタミンD2サプリメントの少なくとも1種、ならびに対象に該サプリメント類を共投与するための説明書を含むキット。
- ビタミンDサプリメントおよびビタミンD2サプリメントの少なくとも1種が、25−ヒドロキシビタミンD化合物を含む、請求項31に記載のキット。
- 25−ヒドロキシビタミンD3を含む、請求項32に記載のキット。
- ヒト対象に前記サプリメント類を投与するための説明書をさらに含む、請求項31から33までのいずれか1項に記載のキット。
- ビタミンDの不足および/または欠乏と診断された患者に前記サプリメント類を投与するための説明書をさらに含む、請求項31から34までのいずれか1項に記載のキット。
- 前記サプリメント類の少なくとも1種が単位剤形である、請求項31から35までのいずれか1項に記載のキット。
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Publication number | Publication date |
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WO2009047644A3 (en) | 2009-05-28 |
ES2403107T3 (es) | 2013-05-14 |
DK2148684T3 (da) | 2013-04-22 |
CA2683628A1 (en) | 2009-04-16 |
US11752158B2 (en) | 2023-09-12 |
PT2148684E (pt) | 2013-04-19 |
HK1205936A1 (en) | 2015-12-31 |
KR20100017238A (ko) | 2010-02-16 |
CN101668532B (zh) | 2014-08-20 |
US20100120728A1 (en) | 2010-05-13 |
JP2014055184A (ja) | 2014-03-27 |
CA2683628C (en) | 2018-03-06 |
EP2148684A2 (en) | 2010-02-03 |
PL2148684T3 (pl) | 2013-06-28 |
CN104257667A (zh) | 2015-01-07 |
JP5855633B2 (ja) | 2016-02-09 |
EP2148684B1 (en) | 2013-01-16 |
WO2009047644A2 (en) | 2009-04-16 |
CN101668532A (zh) | 2010-03-10 |
KR101495578B1 (ko) | 2015-02-25 |
JP5444212B2 (ja) | 2014-03-19 |
CN104257667B (zh) | 2019-06-04 |
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