Unexpected cutaneous reactions in diabetic and prediabetic patients treated with salsalate

Objective: the most commonly reported side effects of salsalate are gastrointestinal events, and few reports are available on its cutaneous side effects. we therefore assessed cutaneous side effects among diabetic/pre-diabetic patients treated with salsalate.methodology: in a randomized placebo-controlled trial, we evaluated cutaneous side effects in 52 diabetic and 124 pre-diabetic patients, 90 of whom received 3 g/day salsalate and 86 of whom receive a placebo for four weeks. the evaluation was carried out every week using a checklist completed by a single general practitioner.results: the difference between the salsalate- and placebo-treated groups in overall prevalence of cutaneous reactions was not significant (26.7% versus 17.4%; p < 0.05). side effects included urticaria (nine (10.1%) salsalate-treated versus six (6.9%) placebo-treated), rashes (five (5.5%) salsalate-treated versus three (3.4%) placebo-treated), pruritus (six (6.7%) salsalate-treated versus three (3.4%) placebo-treated), and edema (two (2.2%) salsalate-treated versus one (1.2%) placebo-treated); in addition, one (1.1%) case of erythema nodosum and one (1.1%) of vasculitis were observed in the salsalate-treated group. in the salsalate group, therapy was discontinued by the physician for three (3.3%) patients because of acute and severe vasculitis, erythema nodosum and urticaria and two (2.2%) patients stopped the treatment themselves because of mild urticaria compared with two patients who stopped using the placebo.conclusions: salsalate can cause several and, in some cases, severe cutaneous side effects in patients with diabetes/pre-diabetes. because these cutaneous eruptions can raise various concerns, including patient non-compliance, greater attention should be paid to dermatological problems in patients under salsalate treatment