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Topical tretinoin therapy and all-cause mortality.

Topical tretinoin therapy and all-cause mortality

Weinstock MA, Bingham SF, Lew RA et. al.

Arch Dermatol, 2009, 145, 18-24.

Retinoids have multiple effects on the skin [1] and are used both orally and topically in clinical practice to treat acne and psoriasis. Topical retinoic acid is also sold as Renova[R] for the treatment of photodamage. Retinoid compounds have also shown promise in treating preneoplastic and cancerous lesions. From the outset, this study was designed to investigate the potential use of high dose topical retinoic acid (0.1%) as a skin chemopreventative for the elderly. The study population included 1131 subjects (average age 71 years) randomised to tretinoin vs placebo control, with 97% of the subjects being male. These authors report that the treatment and study had to be stopped 6 months early clue to an observed high number of deaths in the group receiving tretinoin.

This investigation began in 1998 as the Veterans Affairs Topical Tretinoin Chemoprevention trial (VATTC). Study participants were recruited from six Veterans Affairs Medical Centers in the US. By 2004, interim data analysis showed that subject death was significantly greater in the group receiving tretinoin and the central Cooperative Studies Program Coordinating Center Human Rights Committee voted to stop the study with a continued follow-up of study participants. Because the study was not designed at the outset for the observed outcome, all the data necessary to determine whether death was in fact linked to treatment or was due to some other influence had not been collected nor was available from medical records. Specific causes of death were examined in both treated and control groups, and a statistically significant number of subjects died from vascular disorders in the treated group, although the total number was small (nine subjects). Although no single cause of death could account for the overall difference in mortality, there were an excessive number of deaths possibly related to a history of smoking. In fact, there is discussion that tretinoin can increase the incidence of pulmonary-related mortality [2]; this was ultimately rejected by Weinstock et al. due to the lack of statistical interaction between tretinoin use and smoking with mortality from the data which was available in the study.

Nevertheless, use of retinoids has grown steadily over the last few decades due to the positive clinical outcomes for a wide variety of skin disorders and for the treatment of mild to moderate photodamage. Clearly, future studies involving the use of topical retinoids should monitor mortality and mortality risk factors, especially if they are conducted in elderly patients and include subjects who are current or former smokers.


[1.] Lee DD, Stojadinovic O, Kryzanowska A, Vouthounis C. Blumenberg M, Tomic-Canic M. Retinoid-responsive transcriptional changes in epidermal keratinocytes. J Cell Physiol, 2009. 220, 427-439.

[2.] Kali KA, Topical tretinoin, lung cancer, and lung-related mortality. Arch Dermatol, 2008. 144, 945-946.
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Author:Knaggs, Helen
Publication:Clinical Dermatology
Date:Jun 1, 2009
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