Título / Title

LONG-TERM RESULTS OF TRIMETHOPRIM–SULFAMETHOXAZOLE VERSUS PLACEBO TO REDUCE THE RISK OF RECURRENT TOXOPLASMA GONDII RETINOCHOROIDITIS

Introdução / Purpose

Purpose: To compare the effects of one year of treatment with trimethoprim–sulfamethoxazole (TMP-SMZ) versus placebo in reducing the risk of recurrence of toxoplasmic retinochoroiditis during a six-year follow-up period.

Material e Método / Methods

Design: Randomized, double-masked clinical trial.
Methods: This cohort included 141 subjects recruited in Campinas, Brazil. The inclusion criterion was unilateral active recurrent toxoplasma retinochoroiditis. All subjects were treated with one dose of TMP-SMZ (160 mg/800 mg) twice daily for 45 days, and all lesions healed after this treatment. After this initial treatment, subjects were randomly assigned to Group 1 (1 TMP-SMZ dose every other day for 311 days) or Group 2 (one identical placebo tablet containing starch with no active ingredients every other day for 311 days). Between the second and sixth years of follow-up appointments, none of the subjects received treatment unless a new recurrence episode had occurred. The primary outcomes were recurrent toxoplasmic retinochoroiditis within the first year of follow up and recurrent toxoplasmic retinochoroiditis in the six years of follow up.

Resultados / Results

Results: The cumulative probability of recurrence 1, 2, 3, 4, 5, and 6 years after the initial infection was, respectively, 13.0% (9/69), 17.4% (12/69), 20.3% (14/69), 23.2% (16/69), 26.1% (18/69), and 27.5% (19/69) in the placebo group and 0%, 0%, 0%, 0%, 0%, and 1.4% (1/72) in the TMP-SMZ group (p<0.001; log-rank test). There were three cases (3/69; 4.3%) of multiple recurrences in the same individual in the placebo group. No treatment-limiting toxicity or side effects were observed in either group. New recurrences were more frequent among female subjects.

Discussão e Conclusões / Conclusion

Conclusions: TMP-SMZ may be used safely for prophylaxis of recurrent toxoplasmic retinochoroiditis and may provide long-term benefits.

Palavras Chave

Ocular toxoplasmosis, Recurrence, Retinochoroiditis