心血管疾患の初次および二次予防のためのポリピルの有効性 (PolyIran):プラグマティックなクラスターランダム化試験

Gholamreza Roshandel¹, Masoud Khoshnia¹, Hossein Poustchi²

¹Digestive Disease Research Center, Digestive Disease Research Institute, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran; Golestan Research Center of Gastroenterology and Hepatology, Golestan University of Medical Sciences, Gorgan, Iran.

Lancet (London, England)

|August 27, 2019

まとめ

PolyIranの研究では,ポリピル戦略が参加者の主要な心血管疾患を 34% 減少させたことが示されました. 特に低所得国や中所得国での使用は高い遵守率と低い有害事象によって支持されています

科学分野:

心血管疾患の予防
公衆衛生の介入
薬学療法

背景:

心血管疾患 (CVD) は,特に低・中所得国 (LMICs) で,世界的な健康上の大きな負担となっている.
定量併用療法,またはポリピル戦略は,治療レジメンを簡素化し,CVDの予防のための遵守を改善するための有望なアプローチを提供します.
4つの成分からなるポリピルの有効性と安全性を調べたのがPolyIran研究でした.

研究の目的:

主要な心血管疾患の減少におけるポリピル戦略の有効性を評価する.
ポリピル療法の安全性と適合率を評価する.
LMICにおけるCVD制御のための公衆衛生ツールとしてのポリピルの可能性を決定する.

主な方法:

プラグマティックなクラスターランダム化試験で,イランの40歳から75歳の6838人の参加者が参加した.
参加者はランダムに最小限のケア (非薬学的介入) または最小限のケアと毎日ポリピル (アスピリン,アトルバスタチン,ヒドロクロチアジド,エナラプリル/バルサタン) を受けた.
主要評価項目は,60ヶ月の追跡期間における重症心血管疾患の発生と,治療意図の分析でした.

主要な成果:

ポリピル群は,最小限の治療群と比較して,主要な心血管疾患の発生率が34%減少した (調整HR 0. 66; 95% CI 0. 55- 0. 80).
ポリピル治療のメディアンは高い (80. 5%) であった.
頭蓋内出血および上部胃腸出血を含む有害事象の発生率は,両グループ間で類似した.

結論:

ポリピル戦略は重大な心血管疾患の予防に有効であることが示されました
高度な服薬順守と良好な安全性プロファイルがポリピルの有用性を裏付けています
ポリピルアプローチは心血管疾患の管理に有効で効果的な戦略です特に資源の限られた環境ではです

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