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Dulaglutide/ja
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Created page with "この医薬品の第3相臨床試験プログラムでは、0.75 mgと1.5 mgの用量でヘモグロビンA1cが約1％減少し、平均で約5ポンドの体重減少が認められた。2020年に承認された3.0& mgと4.5& mgの高用量では、ヘモグロビンA1cの減少が1.5%に近く、体重減少もわずかに多かった。"
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Created page with "== Further reading == * {{cite journal | vauthors = Scott LJ | title = Dulaglutide: A Review in Type 2 Diabetes | journal = Drugs | volume = 80 | issue = 2 | pages = 197–208 | date = February 2020 | pmid = 32002850 | doi = 10.1007/s40265-020-01260-9 | s2cid = 210954338 }} * {{cite journal | vauthors = Edwards KL, Minze MG | title = Dulaglutide: an evidence-based review of its potential in the treatment of type 2 diabetes | journal = Core Evidence | volume = 10 | pages..."
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この医薬品の第3相臨床試験プログラムでは、0.75 mgと1.5 mgの用量でヘモグロビンA1cが約1％減少し、平均で約5ポンドの体重減少が認められた。2020年に承認された3.0& mgと4.5& mgの高用量では、ヘモグロビンA1cの減少が1.5%に近く、体重減少もわずかに多かった。
この医薬品の第3相臨床試験プログラムでは、0.75 mgと1.5 mgの用量でヘモグロビンA1cが約1％減少し、平均で約5ポンドの体重減少が認められた。2020年に承認された3.0& mgと4.5& mgの高用量では、ヘモグロビンA1cの減少が1.5%に近く、体重減少もわずかに多かった。


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2017年の[[meta-analysis/ja|メタアナリシス]]では、GLP-1作動薬またはDPP-4阻害薬による治療が2型糖尿病患者の全死亡を増加させるという示唆は支持されなかった。
A 2017 [[meta-analysis]] did not support the suggestion that treatment with GLP-1 agonists or DPP-4 inhibitors increased all-cause mortality in type 2 diabetics.
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==副作用==
==Side effects==
{{Anchor|Side effects}}
The most common side effects include gastrointestinal disorders, such as [[dyspepsia]], [[decreased appetite]], [[nausea]], [[vomiting]], [[abdominal pain]], [[diarrhea]]. Some patients may experience serious adverse reactions: [[acute pancreatitis]] (symptoms include persistent severe abdominal pain, sometimes radiating to the back and accompanied by vomiting), [[hypoglycemia]], [[renal impairment]] (which may sometimes require hemodialysis). The risk of hypoglycemia is increased if the drug is used in combination with [[sulfonylurea]]s or [[insulin]]. There is also a potential risk of [[medullary thyroid carcinoma]] associated with the use of the drug.
最も一般的な副作用は、[[dyspepsia/ja|消化不良]]、[[decreased appetite/ja|食欲減退]]、[[nausea/ja|吐き気]]、[[vomiting/ja|嘔吐]]、[[abdominal pain/ja|腹痛]]、[[diarrhea/ja|下痢]]などの胃腸障害である。
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重篤な副作用を経験する患者もいる： [[acute pancreatitis/ja|急性膵炎]]（症状には持続性の激しい腹痛が含まれ、時に背中に放散し、嘔吐を伴う）、[[hypoglycemia/ja|低血糖症]]、[[renal impairment/ja|腎障害]]（時に血液透析を必要とすることがある）。低血糖のリスクは、薬物を[[sulfonylurea/ja|スルホニルウレア]]または[[insulin/ja|インスリン]]と併用した場合に増大する。薬物の使用に関連した[[medullary thyroid carcinoma/ja|甲状腺髄様がん]]の潜在的リスクもある。


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==禁忌==
==Contraindications==
{{Anchor|Contraindications}}
The compound is contraindicated in subjects with [[hypersensitivity]] to the [[active ingredient]] or any of the product's components.
本剤は、[[active ingredient/ja|有効成分]]または本剤の成分に対して[[hypersensitivity/ja|過敏症]]のある被験者には禁忌である。
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[[multiple endocrine neoplasia/ja|甲状腺髄様癌]]（MTC）の個人歴や家族歴のある人、あるいは[[multiple endocrine neoplasia/ja|多発性内分泌腫瘍]]2型に罹患している人は、これらの癌のリスクを高める可能性があるため、デュラグルチドを服用すべきではない。
People with a personal or family history of [[medullary thyroid cancer]] (MTC) or affected by [[multiple endocrine neoplasia]] type 2 should not take dulaglutide, because it could increase the risk of these cancers.
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==作用機序==
==Mechanism of action==
{{Anchor|Mechanism of action}}
Dulaglutide binds to glucagon-like peptide 1 receptors, slowing gastric emptying and increases insulin secretion by pancreatic Beta cells. Simultaneously the compound reduces the elevated glucagon secretion by inhibiting alpha cells of the pancreas, as glucagon is known to be inappropriately elevated in diabetic patients. GLP-1 is normally secreted by [[L cell]]s of the gastrointestinal mucosa in response to a meal.
デュラグルチドはグルカゴン様ペプチド1受容体に結合し、胃排出を遅らせ、膵β細胞からのインスリン分泌を増加させる。同時に、糖尿病患者ではグルカゴンが不適切に上昇することが知られているため、この化合物は膵臓のα細胞を阻害することにより、上昇したグルカゴンの分泌を抑える。GLP-1は通常、食事に反応して消化管粘膜の[[L cell/ja|L細胞]]から分泌される。
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==歴史==
==History==
{{Anchor|History}}
The safety and effectiveness of dulaglutide were evaluated in six clinical trials in which 3,342 subjects with type 2 diabetes received dulaglutide. Subjects receiving dulaglutide had an improvement in their blood sugar control as observed with reductions in HbA1c level (hemoglobin A1c is a measure of blood sugar control).
デュラグルチドの安全性と有効性は、3,342人の2型糖尿病患者を対象とした6つの臨床試験で評価された。デュラグルチドを投与された被験者は、HbA1c値（ヘモグロビンA1cは血糖コントロールの指標）の低下により観察されるように、血糖コントロールの改善を認めた。
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米国[[Food and Drug Administration/ja|食品医薬品局]]（FDA）はデュラグルチドを[[Risk Evaluation and Mitigation Strategies/ja|リスク評価と軽減戦略]]（REMS）付きで承認し、[[Eli Lilly and Company|イーライリリー・アンド・カンパニー]]にトルリシティの承認を認めた。REMSは、膵炎のリスクと薬物に関連する[[medullary thyroid carcinoma/ja|甲状腺髄様癌]]の潜在的なリスクを医師に認識させるためにイーライリリーがとるいくつかのステップから構成されている。
The U.S. [[Food and Drug Administration]] (FDA) approved dulaglutide with a [[Risk Evaluation and Mitigation Strategies|Risk Evaluation and Mitigation Strategy]] (REMS), and granted the approval of Trulicity to [[Eli Lilly and Company]]. The REMS consists of a number of steps that Eli Lilly will take to make physicians aware of the risk of pancreatitis and the potential risk of [[medullary thyroid carcinoma]] associated with the drug.
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2020年、FDAはAWARD-11試験の結果に基づいて、3.0&nbsp;mgと4.5&nbsp;mgの2種類の高用量医薬品を承認した。
In 2020, the FDA approved two higher doses of the medication, 3.0&nbsp;mg and 4.5&nbsp;mg, based on results of the AWARD-11 trial demonstrating improved glucose lowering and weight benefits.
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== Further reading ==
== Further reading ==
* {{cite journal | vauthors = Scott LJ | title = Dulaglutide: A Review in Type 2 Diabetes | journal = Drugs | volume = 80 | issue = 2 | pages = 197–208 | date = February 2020 | pmid = 32002850 | doi = 10.1007/s40265-020-01260-9 | s2cid = 210954338 }}
* {{cite journal | vauthors = Scott LJ | title = Dulaglutide: A Review in Type 2 Diabetes | journal = Drugs | volume = 80 | issue = 2 | pages = 197–208 | date = February 2020 | pmid = 32002850 | doi = 10.1007/s40265-020-01260-9 | s2cid = 210954338 }}
* {{cite journal | vauthors = Edwards KL, Minze MG | title = Dulaglutide: an evidence-based review of its potential in the treatment of type 2 diabetes | journal = Core Evidence | volume = 10 | pages = 11–21 | date = 2015 | pmid = 25657615 | pmc = 4295897 | doi = 10.2147/CE.S55944 | doi-access = free }}
* {{cite journal | vauthors = Edwards KL, Minze MG | title = Dulaglutide: an evidence-based review of its potential in the treatment of type 2 diabetes | journal = Core Evidence | volume = 10 | pages = 11–21 | date = 2015 | pmid = 25657615 | pmc = 4295897 | doi = 10.2147/CE.S55944 | doi-access = free }}
* {{cite journal | vauthors = Romera I, Cebrián-Cuenca A, Álvarez-Guisasola F, Gomez-Peralta F, Reviriego J | title = A Review of Practical Issues on the Use of Glucagon-Like Peptide-1 Receptor Agonists for the Management of Type 2 Diabetes | journal = Diabetes Therapy | volume = 10 | issue = 1 | pages = 5–19 | date = February 2019 | pmid = 30506340 | pmc = 6349277 | doi = 10.1007/s13300-018-0535-9 }}
* {{cite journal | vauthors = Romera I, Cebrián-Cuenca A, Álvarez-Guisasola F, Gomez-Peralta F, Reviriego J | title = A Review of Practical Issues on the Use of Glucagon-Like Peptide-1 Receptor Agonists for the Management of Type 2 Diabetes | journal = Diabetes Therapy | volume = 10 | issue = 1 | pages = 5–19 | date = February 2019 | pmid = 30506340 | pmc = 6349277 | doi = 10.1007/s13300-018-0535-9 }}
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{{Oral hypoglycemics and insulin analogs/ja|state=expanded}}
{{Oral hypoglycemics and insulin analogs|state=expanded}}
{{Portal bar | Medicine}}
{{Portal bar | Medicine}}
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{{二次利用|date=7 February 2024}}
[[Category:Drugs developed by Eli Lilly and Company]]
[[Category:Drugs developed by Eli Lilly and Company]]
[[Category:GLP-1 receptor agonists]]
[[Category:GLP-1 receptor agonists]]
[[Category:Peptide therapeutics]]
[[Category:Peptide therapeutics]]
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