JP2016539164A5 - - Google Patents

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JP2016539164A5
JP2016539164A5 JP2016536659A JP2016536659A JP2016539164A5 JP 2016539164 A5 JP2016539164 A5 JP 2016539164A5 JP 2016536659 A JP2016536659 A JP 2016536659A JP 2016536659 A JP2016536659 A JP 2016536659A JP 2016539164 A5 JP2016539164 A5 JP 2016539164A5
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JP6665094B2 (ja
JP2016539164A (ja
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Claims (19)

  1. 対象における主要有害心血管事象(MACE)の危低減において使用するための、ナルトレキソン又は薬学的に許容されるその塩及びブプロピオン又は薬学的に許容されるその塩を含む組成物。
  2. 対象が、MACEの危険が増大しているものである、請求項1に記載の組成物。
  3. 現在MACEの高い危険がない対象におけるMACEの発症を予防しまたは遅延する、請求項1に記載の組成物。
  4. 対象が、処置の時点で、次の特徴:II型糖尿病;既存の心血管疾患若しくは心血管疾患の高い可能性;うっ血性心不全;心血管疾患の家族歴;現在の喫煙者;心血管疾患に遺伝的に罹患しやすい;心不整脈を有する若しくは有したことがある;心房細動、心室細動若しくは頻脈性不整脈を有する若しくは有したことがある;洞性不整脈を有さない;不安定アンギナを有する;高血圧を有する;脳卒中を有したことがある若しくは脳卒中の高い危険がある;動脈瘤を有する;又はトリグリセリドの上昇、LDLの上昇及び/又は低HDLを有する、の1つ又は複数を有する、請求項1から3のいずれか一項に記載の組成物
  5. 対象が心血管疾患の確定診断又は心血管疾患の高い可能性のいずれかを有し、前記対象が、同定より前の3ヵ月超の確認された心筋梗塞の病歴;冠血行再建の病歴;頸動脈若しくは末梢血行再建の病歴;虚血性変化を伴うアンギナ;段階的運動試験でのECG変化;心臓画像検査陽性;同定より前の2年以内の足関節上腕血圧指数<0.9;又は、処置前の2年以内の冠動脈、頸動脈若しくは下肢動脈の50%超狭窄の少なくとも1つを有する、請求項4に記載の組成物
  6. 対象が心房細動の病歴を有する、請求項4に記載の組成物
  7. 対象が肥満又は体重過多である、請求項1から6のいずれか一項に記載の組成物
  8. 対象が肥満又は体重過多ではない、請求項1から6のいずれか一項に記載の組成物
  9. 対象が心血管系状態、糖尿病、高血圧、脂質異常症血糖状態及び抑うつからなる群から選択される1つ又は複数の状態の管理のための投薬療法を同時に受けている、請求項1から8のいずれか一項に記載の組成物
  10. 対象が2型糖尿病を6年未満有していたことがある、請求項1から9のいずれか一項に記載の組成物
  11. 対象が現在、2型糖尿病を有さない喫煙者である、請求項1から9のいずれか一項に記載の組成物
  12. MACE、四点拡張MACE、五点拡張MACE、心血管(CV死、非致死性心筋梗塞(MI、脳卒中、致死性脳卒中、非致死性脳卒中、非致死性HUSA(不安定アンギナのための入院)、冠血行再建手順及び/又は全死因死亡率からなる群から選択される1つ又は複数の事象の最初の発生までの時間を増加させる、請求項1から11のいずれか一項に記載の組成物
  13. 前記主要有害心血管事象が心血管死、非致死性心筋梗塞、心不整脈又は非致死性脳卒中である、請求項1から12のいずれか一項に記載の組成物
  14. 前記主要有害心血管事象が心血管死である、請求項1から12のいずれか一項に記載の組成物
  15. 前記組成物を投与する工程が前記対象の体重の5%、4%、3%、2%又は1%より多くの体重減少をもたらす、請求項1から14のいずれか一項に記載の組成物
  16. ナルトレキソン及びブプロピオンの1つ若しくは両方又は薬学的に許容されるそれらの塩が、徐放性製剤で処方される、請求項1から15のいずれか一項に記載の組成物
  17. ナルトレキソン及びブプロピオンが徐放性ナルトレキソン32mg及び徐放性ブプロピオン360mg又は薬学的に許容されるそれらの塩の一日量で投与される、請求項1から16のいずれか一項に記載の組成物
  18. 前記対象が少なくとも12週間処置される、請求項1から17のいずれか一項に記載の組成物
  19. 対象が、
    処置の第1週に毎日、前記徐放性ナルトレキソン又は薬学的に許容されるその塩8mg及び前記徐放性ブプロピオン又は薬学的に許容されるその塩90mg;
    処置の第2週に毎日、前記徐放性ナルトレキソン又は薬学的に許容されるその塩16mg及び前記徐放性ブプロピオン又は薬学的に許容されるその塩180mg;
    処置の第3週に毎日、前記徐放性ナルトレキソン又は薬学的に許容されるその塩24mg及び前記徐放性ブプロピオン又は薬学的に許容されるその塩270mg;並びに
    処置の第4週及び処置の任意の続く週に毎日、前記徐放性ナルトレキソン又は薬学的に許容されるその塩32mg及び前記徐放性ブプロピオン又は薬学的に許容されるその塩360mg、
    を投与される、請求項1から18のいずれか一項に記載の組成物
JP2016536659A 2013-12-06 2014-12-04 主要有害心血管事象を低減するための組成物及び方法 Active JP6665094B2 (ja)

Applications Claiming Priority (9)

Application Number Priority Date Filing Date Title
US201361913216P 2013-12-06 2013-12-06
US61/913,216 2013-12-06
US201361914938P 2013-12-11 2013-12-11
US61/914,938 2013-12-11
US201461984580P 2014-04-25 2014-04-25
US61/984,580 2014-04-25
US14/322,810 US8969371B1 (en) 2013-12-06 2014-07-02 Compositions and methods for weight loss in at risk patient populations
US14/322,810 2014-07-02
PCT/US2014/068527 WO2015085044A1 (en) 2013-12-06 2014-12-04 Compositions and methods for reducing major adverse cardiovascular events

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JP2016539164A JP2016539164A (ja) 2016-12-15
JP2016539164A5 true JP2016539164A5 (ja) 2018-01-18
JP6665094B2 JP6665094B2 (ja) 2020-03-13

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US (8) US8969371B1 (ja)
EP (2) EP3076971B1 (ja)
JP (2) JP6665094B2 (ja)
KR (3) KR102472432B1 (ja)
CN (3) CN105899210A (ja)
AU (1) AU2014360492A1 (ja)
BR (1) BR112016012755A2 (ja)
CA (1) CA2932127C (ja)
CL (1) CL2016001362A1 (ja)
CR (1) CR20160313A (ja)
CY (1) CY1125114T1 (ja)
DK (1) DK3076971T3 (ja)
EA (1) EA201690964A1 (ja)
EC (1) ECSP16057765A (ja)
ES (1) ES2903391T3 (ja)
HR (1) HRP20220058T1 (ja)
HU (1) HUE057551T2 (ja)
IL (3) IL300870A (ja)
JO (1) JOP20140344B1 (ja)
LT (1) LT3076971T (ja)
MX (2) MX2016007231A (ja)
PE (1) PE20161034A1 (ja)
PL (1) PL3076971T3 (ja)
PT (1) PT3076971T (ja)
RS (1) RS62846B1 (ja)
RU (1) RU2711638C2 (ja)
SG (1) SG10201808055QA (ja)
SI (1) SI3076971T1 (ja)
TN (1) TN2016000231A1 (ja)
TW (1) TWI661826B (ja)
UY (1) UY35864A (ja)
WO (1) WO2015085044A1 (ja)
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