ST LOUIS (MD Consult) - On January 21, 2010, the US Food and Drug Administration (FDA) issued a statement about sibutramine (marketed as Meridia) to follow up regarding earlier concerns that use of the drug may elevate the risk of adverse cardiovascular events. Meridia was approved by the FDA in 1997 for the management of obesity, including weight loss and maintenance of weight loss, in conjunction with a reduced-calorie diet.

This FDA notification was issued after the completion of a review of additional data from the Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event (SCOUT) study. Approximately 10,000 overweight or obese patients, aged ≥55 years with a history of cardiovascular disease (CVD) or type 2 diabetes plus 1 additional cardiovascular risk factor, were included in the study. Preliminary results from the SCOUT study indicated that cardiovascular events occurred in 11.4% of patients receiving sibutramine compared with 10% of patients receiving placebo, a difference that was higher than expected. Additional data from the SCOUT study now indicates that the increased risk for cardiovascular events with sibutramine occurred only in patients with a history of CVD.

 

Because of the serious nature of the review findings, a new contraindication is being added to the sibutramine product label stating that sibutramine is not to be used for patients with CVD, including those with the following:

 

• history of coronary artery disease (eg, myocardial infarction, angina);
• history of stroke or transient ischemic attack;
• history of cardiac arrhythmias;
• history of congestive heart failure;
• history of peripheral arterial disease; and
• uncontrolled hypertension (eg, with blood pressure readings of >145/90 mm Hg).

 

Health care professionals are advised to regularly monitor the blood pressure and heart rate of patients receiving sibutramine, and if sustained increases in blood pressure and/or heart rate are observed, sibutramine should be discontinued. Additionally, sibutramine should be discontinued in patients who do not lose at least 5% of their baseline body weight within the first 3 to 6 months of treatment because continued treatment is unlikely to be effective and exposes the patient to unnecessary risk.

 

After the FDA completes its review of the full study report for SCOUT (expected to be available in March 2010) and other relevant information related to sibutramine's potential benefits and risks, an open public advisory committee meeting will be convened to determine whether additional regulatory actions should be taken to ensure safe use of the medication.

圣路易斯(MD Consult)——鉴于早先就有舆论担心使用该药可能会增加不良心血管事件的风险，美国食品药品管理局(FDA)于2010年1月21日发布了一项对西布曲明西布曲明(商品名Meridia)进行进一步调查的声明。 FDA于1997年批准Meridia用于肥胖症的治疗，包括减轻体重，以及与低热量饮食联合使用以维持体重减轻。

 

FDA在对SCOUT(“具有心血管风险的超重或肥胖受试者应用西布曲明后心血管疾病患病率/病死率结果”)研究的附加数据审核完毕后，发布了该通告。 约有10,000例超重或肥胖患者参与了此项研究，这些患者的年龄均≥55岁，且均有心血管疾病(CVD)史或2型糖尿病+1项心血管危险因素。 SCOUT研究的初步结果表明，服用西布曲明的患者心血管事件发生率为11.4%，而与之相比，服用安慰剂的患者仅为10%，这一差异要高于预期结果。来自SCOUT研究的附加数据表明，服用西布曲明会导致心血管事件风险增高，但仅限于那些有心血管疾病史的患者。

 

因为这一审查结果的严重性，西布曲明的产品标签加入了一项新禁忌证说明，即心血管疾病患者应禁用西布曲明，包括那些伴有如下情况的患者：

 

• 冠状动脉疾病史(例如心肌梗死和心绞痛)
• 卒中史或短暂性脑缺血发作
• 心律失常史
• 充血性心力衰竭史
• 外周动脉疾病史，及
• 顽固性高血压(例如，血压读数大于145/90 mm Hg)

 

FDA建议医务工作者定期监测服用西布曲明患者的血压和心率，如果观察到血压和(或)心率持续升高，就应当停用西布曲明。此外，在治疗的最初3~6个月中患者的基线体重至少应降低5%，否则也应停用西布曲明，因为继续使用该药已经不太可能起效了，还使患者暴露于不必要的风险之中。

 

在完成对SCOUT完整研究报告(预期将于2010年3月发表)和西布曲明潜在益处和风险相关信息的审查后，FDA将召开一次公开的公众顾问委员会会议，以确认是否需要采取进一步监管措施，以确保安全使用该药。