Reviewing the ART-123 P3 Japanese Study
The study compared the clinical effects of ART-3 vs lo molecular weight heparin for the treatment of DIC. I read this over two times and I may be missing some of the finepoints,, but this was my take.
They studied about 240 patients in over 100 hospitals, about two patients per hosp. Their major assertation was AT3 increased "resolution" of DIC and created fewer bleeding complications than Heparin (after seven days). This contention was backed up by the usual convolution of statistical terms (eg the CI or confidence interval) and syntex leger de main as first perfected by the 19th century patent medicine salesmen.
What I notice was you could divide their patients into two clinical groups. One being DIC related to malignancy particularly hematological,,(eg leukemia) In this group it looked like ART-3 was of some benefit in resolving the condition. The second group was DIC secondary to infection. In this group, ART-3 was clearly not as effective. The important point here is DIC secondary to infection (without malignancy) is a clinically more important group then end stage cancer. There is no claim in this paper the 28day mortality was improved in either group. Rather than dividing into two groups they decided to combine them. My guess is they were not all that happy with the infection group and used the cancer data to make things look a little better.
There were other minor concerns,,,,their diagnostic criteria was not very clear.... basically agree with Dew ..not a very impressive trial.
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