Effect of nilvadipine on central visual field in retinitis pigmentosa: a 30-month clinical trial.
OBJECTIVE
To assess the effects of nilvadipine on the progression of central visual field defect in retinitis pigmentosa (RP).


METHODS
Prospective, randomized, nonmasked, single-center trial.


METHODS
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.


RESULTS
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).


CONCLUSIONS
Nilvadipine at 4 mg/day significantly retarded progression of central visual field defects in RP in this small patient series.
Department of Ophthalmology, Hirosaki University Graduate School of Medicine, 5 Zaifu-cho, Hirosaki, Japan. mitsuru@cc.hirosaki-u.ac.jp
Mitsuru
M
Nakazawa
Hiroshi
H
Ohguro
Kimio
K
Takeuchi
Yasuhiro
Y
Miyagawa
Tadashi
T
Ito
Tomomi
T
Metoki
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D002121:Calcium Channel Blockers / Q000627:therapeutic use*; D018450:Disease Progression; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D014975:Lutein / Q000031:analogs & derivatives / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009543:Nifedipine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010865:Pilot Projects; D011446:Prospective Studies; D012174:Retinitis Pigmentosa / Q000188:drug therapy* / Q000503:physiopathology; D024505:Tocopherols / Q000627:therapeutic use; D014786:Vision Disorders / Q000503:physiopathology / Q000517:prevention & control*; D058609:Visual Field Tests; D014794:Visual Fields / Q000187:drug effects* / Q000502:physiology; D055815:Young Adult
D002121:Calcium Channel Blockers; C035100:nilvadipine; D009543:Nifedipine; D024505:Tocopherols; C042447:xanthophyll dipalmitate; D014975:Lutein