Indobufen valuable option for secondary stroke prevention among patients intolerant to Aspirin

Explaining study background, researchers from the Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China, said that Aspirin is recommended for secondary stroke prevention in patients with a history of moderate-to-severe ischaemic Stroke. It causes gastrointestinal intolerance and bleeding. In some countries, Indobufen is used as an alternative antiplatelet agent despite a need for more data and clinical trials for this indication.

Considering this background, researchers in the present study hypothesised that indobufen is non-inferior to Aspirin in reducing the risk of new Stroke at 90 days in patients with a history of moderate-to-severe ischaemic Stroke.

The conclusive study points are:

• The trial was conducted at 163 tertiary and district general hospitals in China.
• Eighty-four thousand ninety-three patients were screened.
• Participants in the indobufen and aspirin groups were2715 and 2723, respectively.
• The age of participants was 18–80 years.
• Researchers assigned participants 1:1 (randomisation sequence computer generated) within 72 h of the onset of symptoms to receive either indobufen (100 mg tablet twice per day) or Aspirin (100 mg tablet once per day) for 90 days.
• The random code was assigned to investigators by Masked local investigators to patients in ascending order.
• The treatment kit was provided corresponding to the random code.
• The outcomes measured were the new Stroke and severe or moderate bleeding within 90 days.
• Safety analyses were done in the safety-analysis population.
• The researchers assessed the non-inferiority of indobufen versus Aspirin using the one-sided upper limit of the 95% CI of the hazard ratio (HR) with a prespecified non-inferiority margin of 1·25.
• In the indobufen and aspirin groups, Stroke occurred within 90 days in 213 and 175 patients, respectively.
• Moderate or severe bleeding occurred in 18 and 28 patients, respectively.
• Adverse events occurred in 666 and 679 patients, respectively.

They said, “We found that indobufen is not non-inferior to aspirin.”

We do not support indobufen use for secondary stroke prevention in patients with moderate-to-severe ischaemic Stroke.

As acknowledged, the research received funding from Hangzhou Zhongmei Huadong Pharmaceutical and the Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences.

Further reading:

https://www.thelancet.com/journals/laneur/article/PIIS1474-4422(23)00113-8/fulltext#%20