NICE guidance to prevent strokes and heart attacks lacks evidence
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《英国医生杂志》
An expert adviser for a report that was used to develop the guidance from the National Institute for Health and Clinical Excellence (NICE) claims that the guidance is not supported by adequate evidence from clinical trials.
The NICE guidance recommends that a combination of modified release dipyridamole and aspirin should be used in patients who have had an ischaemic stroke or a transient ischaemic attack for two years from the most recent event. After that time, or if dipyridamole is not tolerated, preventive therapy should revert to standard care (including long term treatment with low dose aspirin).
Cathie Sudlow, senior lecturer and honorary consultant neurologist at the University of Edinburgh, was one of the experts who developed the report used by the NICE committee to develop its guidance. She said, "NICE appears to have based its recommenation... on one trial with around 3000 participants that I consider too small from which to draw conclusions for treating all patients in . It also compared the combination with an inadequate dose of aspirin to make a fair comparison."
The trial showed that the combination of modified release dipyridamole and aspirin prevented further stroke, but this was in contrast to other studies, although these had used different preparations of dipyridamole, Dr Sudlow said. She added, "But NICE made a blanket recommendation on the basis of this one trial."
Dr Sudlow was concerned that the possibly premature recommendation of modified release dipyridamole plus aspirin for stroke prevention, rather than just aspirin on its own, could prove difficult for patients to comply with on a long term basis, particularly if they were also on several other drugs. "The decision was made in isolation from the realities of clinical practice," she argued.
"This is the first time experts are suggesting that NICE should not be going for the more expensive treatment option. It is usually the other way around," Dr Sudlow pointed out. "I think a much larger, randomised, prospective trial is required to compare modified release dipyridamole and aspirin with an adequate dose of aspirin alone to clarify the risk-benefit balance for each regimen."(Susan Mayor)
The NICE guidance recommends that a combination of modified release dipyridamole and aspirin should be used in patients who have had an ischaemic stroke or a transient ischaemic attack for two years from the most recent event. After that time, or if dipyridamole is not tolerated, preventive therapy should revert to standard care (including long term treatment with low dose aspirin).
Cathie Sudlow, senior lecturer and honorary consultant neurologist at the University of Edinburgh, was one of the experts who developed the report used by the NICE committee to develop its guidance. She said, "NICE appears to have based its recommenation... on one trial with around 3000 participants that I consider too small from which to draw conclusions for treating all patients in . It also compared the combination with an inadequate dose of aspirin to make a fair comparison."
The trial showed that the combination of modified release dipyridamole and aspirin prevented further stroke, but this was in contrast to other studies, although these had used different preparations of dipyridamole, Dr Sudlow said. She added, "But NICE made a blanket recommendation on the basis of this one trial."
Dr Sudlow was concerned that the possibly premature recommendation of modified release dipyridamole plus aspirin for stroke prevention, rather than just aspirin on its own, could prove difficult for patients to comply with on a long term basis, particularly if they were also on several other drugs. "The decision was made in isolation from the realities of clinical practice," she argued.
"This is the first time experts are suggesting that NICE should not be going for the more expensive treatment option. It is usually the other way around," Dr Sudlow pointed out. "I think a much larger, randomised, prospective trial is required to compare modified release dipyridamole and aspirin with an adequate dose of aspirin alone to clarify the risk-benefit balance for each regimen."(Susan Mayor)