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Safety and Efficacy of 2% Pirenzepine Ophthalmic Gel in Children WithMyopia

2004; American Medical Association; Volume: 122; Issue: 11 Linguagem: Inglês

10.1001/archopht.122.11.1667

1538-3601

R. Michael Siatkowski, Susan A. Cotter, Joseph M. Miller, Colin Scher, R. S. Crockett, Gary D. Novack,

Ophthalmology and Eye Disorders

Objective To evaluate the safety and efficacy of the relatively selective M 1 antagonist pirenzepine hydrochloride in slowing the progression ofmyopia in school-aged children. Methods This was a parallel-group, placebo-controlled, double-masked study inhealthy children, aged 8 to 12 years, with a spherical equivalent of −0.75to −4.00 diopters (D) and astigmatism of 1.00 D or less. Patients underwenta baseline complete eye examination and regular examinations during a 1-yearperiod. The setting was 13 US academic clinics and private practices. Patientswere randomized in a 2:1 ratio to receive 2% pirenzepine ophthalmic gel ora placebo control twice daily for 1 year. Results At study entry, the spherical equivalent was mean ± SD−2.098 ± 0.903 D for the pirenzepine group (n = 117)and −1.933 ± 0.825 D for the placebo group (n = 57, P = .22). At 1 year, there was a mean increasein myopia of 0.26 D in the pirenzepine group vs 0.53 D in the placebo group( P < .001). No patients in the placebogroup and 13 (11%) of 117 patients in the pirenzepine group discontinued participationin the study because of adverse effects (5 [4%] of 117 due to excessive antimuscariniceffects). Conclusions Pirenzepine is effective and relatively safe in slowing the progressionof myopia during a 1-year treatment period.