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Effect of nilvadipine on central visual field in retinitis pigmentosa: a 30-month clinical trial.

Ophthalmologica. Journal international d'ophtalmologie. International journal of ophthalmology. Zeitschrift fur Augenheilkunde (2010-10-16)
Mitsuru Nakazawa, Hiroshi Ohguro, Kimio Takeuchi, Yasuhiro Miyagawa, Tadashi Ito, Tomomi Metoki
RÉSUMÉ

To assess the effects of nilvadipine on the progression of central visual field defect in retinitis pigmentosa (RP). Prospective, randomized, nonmasked, single-center trial. Patients with RP were randomly divided into a treated group receiving oral nilvadipine at 4 mg/day for ≥30 months and a control group receiving tocopherol nicotinate at 300 mg/day, helenien at 15 mg/day or no medication for the same periods. Progression of RP was evaluated using the 10-2 SITA Fast Program of the Humphrey Visual Field Analyzer, and regression coefficients calculated from the time courses of mean deviation (MD slope) were compared between groups. Nineteen patients in the treated group and 14 patients in the control group completed the follow-up for ≥30 months. The mean (±standard deviation) duration of observation was 48.8 ± 11.8 months (median 48 months, range 30-66 months) for the treated group and 49.2 ± 18.1 months (median 48 months, range 30-90 months) for the control group (p = 0.94). Mean (±standard error of the mean, SEM) regression coefficients of the averaged MD values for the initial 30 months were -0.35 ± 0.17 dB/year in the treated group and -0.75 ± 0.06 dB/year in the control group (p < 0.01). Mean (±SEM) MD slopes for total observational periods were -0.49 ± 0.17 dB/year in the treated group and -0.89 ± 0.16 dB/year in the control group (mean ± SEM, p = 0.042). Nilvadipine at 4 mg/day significantly retarded progression of central visual field defects in RP in this small patient series.

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(±)-α-Tocopherol nicotinate