急性冠動脈症候群を有するスリランカのコホートにおける40mg対80mgのアトルバスタチンの有効性,安全性および費用対効果:単一センターでのランダム化制御臨床試験のプロトコル
Kavindya Fernando1,2, Nilshan Fernando3, Chiranthi Welhenge3
1Department of Biochemistry and Clinical Chemistry, Faculty of Medicine, University of Kelaniya, Kelaniya, Sri Lanka. kavindyam@kln.ac.lk.
Trials
|September 2, 2025
まとめ
この研究では,スリランカの急性冠動脈症候群 (ACS) の患者でアトルバスタチン40mgと80mgを比較した. 南アジア人におけるスタチン治療の有効性,安全性,費用対効果を調査しています.
科学分野:
- 心臓病科
- 薬理学について
- 臨床試験
背景:
- 高強度スタチンは,急性冠動脈症候群 (ACS) の二次予防に推奨されます.
- アジアの集団はスタチンに対する感受性が高まり,投与量を調整する必要がある.
- アトルバスタチンの投与量については,スリランカのACS患者に関する事前のデータはありません.
研究 の 目的:
- スリランカのACS患者でアトルバスタチン40 mgと80 mgの有効性と安全性を比較する.
- 異なるアトルバスタチン用量の費用対効果を評価する.
- 南アジア人群におけるスタチンの最適な処方に関する証拠を提供するためです.
主な方法:
- 単一センター,前向き,ランダム化,制御,オープンラベル試験.
- スリランカでのスタチン未使用ACS患者の募集
- ランダム化してアトルバスタチン40 mgまたは80 mgを標準治療で投与する.
- 低密度脂質タンパク質コレステロール (LDL- C) レベルと6,12,24週間の有害事象の評価
- 主要エンドポイント: 12週間のLDL-C ≤70 mg/dL (治療計画分析).
主要な成果:
- 12週後のLDL-Cの減少に関するプライマリエンドポイントデータ
- 薬の副作用の分析
- 平均値とインクリメンタル値を含む費用対効果評価
結論:
- これは,南アジアのコホートにおけるアトルバスタチン40mgと80mgの対照比較です.
- 南アジア系ACS患者におけるアトルバスタチン40 mgの使用の有効性と安全性については,この結果から判断できる.
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