米国FDA：NSAIDｓ使用と心発作・卒中リスク増加に対してさらなる警告

今のところは、選択的COX2阻害剤や非選択的NSAIDｓ区別無く警告



Non-aspirin Nonsteroidal Anti-inflammatory Drugs (NSAIDs): Drug Safety Communication - FDA Strengthens Warning of Increased Chance of Heart Attack or Stroke
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm454141.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery


Prescription NSAID labels will be revised to reflect the following information:

• The risk of heart attack or stroke can occur as early as the first weeks of using an NSAID. The risk may increase with longer use of the NSAID.：NSAID使用初回週など早期に心臓発作・卒中リスクが生じる。リスクはNSAID長期使用にて増加。
• The risk appears greater at higher doses.：薬剤量依存的にリスク増加
• It was previously thought that all NSAIDs may have a similar risk. Newer information makes it less clear that the risk for heart attack or stroke is similar for all NSAIDs; however, this newer information is not sufficient for us to determine that the risk of any particular NSAID is definitely higher or lower than that of any other particular NSAID.：全てのNSAIDｓは同等のリスクとかつて考えられていたが、新規情報だと心発作・卒中リスクが全てのNSAIDｓで同様とははっきり言えない。；しかし、特定のNSAIDｓのリスクが他の特定のNSAIDより低いと決定できるほどの新しい情報を有していない。
• NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease. A large number of studies support this finding, with varying estimates of how much the risk is increased, depending on the drugs and the doses studied.：NSAIDｓは心発作既往有無・心疾患リスク要素有無に関わらず、心発作・卒中リスクを増加させる。この知見に関しては多くの研究が有り、リスク増加がどの程度か様々な推定があり、それは薬剤や投与量に依存した推定である。
• In general, patients with heart disease or risk factors for it have a greater likelihood of heart attack or stroke following NSAID use than patients without these risk factors because they have a higher risk at baseline.：一般に心疾患患者・心疾患リスク要素揺する患者では、ベースラインリスク要素それらリスクがない患者よりNSAID使用後の心発作・卒中尤度増加する。
• Patients treated with NSAIDs following a first heart attack were more likely to die in the first year after the heart attack compared to patients who were not treated with NSAIDs after their first heart attack.：心発作後NSAIDｓ治療患者はNSAIDs治療のない患者に比べ初年度死亡率増加する。
• There is an increased risk of heart failure with NSAID use.：NSAID使用は心不全リスク増加する