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閉経後のホルモン療法が心血管疾患に与える影響を研究する際に,医薬品ライセンス文書の価値
1National Research and Development Centre for Welfare and Health, Health Services Research Unit, Helsinki, Finland. elina.hemminiki@stakes.fi
Lancet (London, England)
|February 22, 2000
まとめ
閉経後のホルモン療法 (PHT) は,心血管上の利点の証拠を示していません. フィンランドからの未発表の試験データは,PHTが心血管疾患のリスク低下と関連していないことを示し,以前の発見を変更しませんでした.
科学分野:
- 心血管科学 心血管科学
- エンドクリノロジー エンドクリノロジー
- クリニック・トライアル 臨床試験
背景:
- 以前の公開試験の総合分析では,心血管疾患の軽減のための閉経後のホルモン療法 (PHT) を支持する証拠は見つかりませんでした.
- 心血管疾患に対するPHTの有効性と安全性は,研究と臨床上の懸念の重要な分野であり続けています.
研究 の 目的:
- PHT研究のためのフィンランド製薬許可申請からの臨床試験報告書の入手と利用の可行性を評価する.
- これらの未発表の試験報告が,PHTと心血管疾患に関する既存の発見を裏付けるか否かを判断する.
主な方法:
- フィンランド社会保健省からの特別な許可を得て,医薬品の認可申請書に含まれる機密の臨床試験データにアクセスしました.
- フィンランド医薬品庁に提出されたPHT薬申請書の臨床セクションを分析し,PHTをプラセボまたは対照と比較した試験に焦点を当てました.
- 心血管,血栓塞栓性イベント,または表面性炎を報告した新しい試験のデータを,以前に発表された試験データで特定し,まとめました.
主要な成果:
- 17件のPHT薬の認可申請が審査され,試験報告の質の有意な変動が明らかになった.
- 含有基準を満たす6つの新しい試験が特定されたが,そのデータは全体的な分析にほとんど加えられなかった.
- PHTとPHTなしの心臓血管および血栓栓塞栓イベントの総合確率比は1.97 (95%CI 0.84-4.63) であり,以前の研究の1.65 (0.65-4.21) に似ています.
結論:
- フィンランド製薬許可申請からの未公開の臨床試験データは,データタイプと報告の質のため,限られた追加の情報を提供した.
- この新しいデータの含有は,確立された結論を変更しませんでした:臨床試験は,PHTが心血管疾患に有益な影響を及ぼすことを支持していません.
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