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Cream Comprising Acne Drug Did Not Cause Deaths
With the aid of the records and original study data, the researchers identified 108 patients in the tretinoin group and 76 in the control group, who had died before the end of the intervention period, and an additional 14 in each group who had died before the end of the study period (November 2004).
After considering other factors that might increase the risk of death-such as smoking, age and co-occurring illnesses-there was still a significantly higher risk of death in the treatment group.
The researchers, however, insisted that additional analyses appeared to show that tretinoin was not the cause of death, as there was no clear association between the number of tubes of cream used and death, and there was no consistency in the causes of death among participants.
However, in the treatment group, 15 patients died of non-small cell lung cancer, 12 of vascular disorders, and 15 of respiratory and other chest disorders-causes associated with smoking, which some previous studies have suggested interacts with compounds in some ways similar to tretinoin, but administered systemically, to produce additional health risks.
The researchers said that the participants were asked whether they smoked, but their smoking status was not verified, which potentially affected the detected associations.
"The biological implausibility, lack of specificity of causes of death, inconsistency with previous experience, weakness of other supportive evidence in our data and weak statistical signal cast doubt on a potential causal association of topical tretinoin with death in the VATTC Trial," the authors write.
"We do not conclude that this trial provides appropriate grounds for hesitating to use topical tretinoin in clinical practice in the absence of additional evidence," they add.
Source-ANI
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