| Title: |
Safety and efficacy of ripasudil in Japanese patients with glaucoma or ocular hypertension: 12-month interim analysis of ROCK-J, a post-marketing surveillance study |
| Authors: |
Hidenobu Tanihara, Takahiko Kakuda, Tetsuro Sano, Takashi Kanno, Ryoji Gunji |
| Source: |
BMC Ophthalmology, Vol 20, Iss 1, Pp 1-11 (2020) |
| Publisher Information: |
BMC, 2020. |
| Publication Year: |
2020 |
| Collection: |
LCC:Ophthalmology |
| Subject Terms: |
Efficacy, Glaucoma, Intraocular pressure, Ripasudil, ROCK inhibitor, Safety, Ophthalmology, RE1-994 |
| More Details: |
Abstract Background Ripasudil is approved in Japan for glaucoma or ocular hypertension (OH) when other treatments are ineffective or cannot be administered. Its long-term safety and efficacy are being examined in a post-marketing surveillance study; 12-month data are described here. Methods This prospective, open-label, observational study enrolled patients with glaucoma or OH who started ripasudil during routine care. The key safety outcome was the incidence of adverse drug reactions (ADRs), focusing on allergy and/or inflammation-related ADRs such as blepharitis (including allergic) or conjunctivitis (including allergic). The primary efficacy endpoint was least squares mean (LSM) ± standard error (SE) change in intraocular pressure (IOP) from baseline to 12 months in all patients and in diagnostic groups. Secondary endpoints were change in IOP in groups stratified by treatment initiation pattern, number of concomitant drugs, and baseline IOP. Results Overall, 3359 patients (48% male, mean age ± standard deviation [SD] 69.1 ± 12.7 years) were evaluated for safety and 3323 for efficacy. Diagnoses were primary open-angle glaucoma (43.9%), normal-tension glaucoma (36.6%), secondary glaucoma (8.7%), OH (4.2%), and primary closed-angle glaucoma (2.4%). Mean ± SD observation period was 300.1 ± 122.4 days; 1010 patients (30.1%) discontinued ripasudil by 12 months. ADRs occurred in 626 patients (18.6%); the most common were conjunctival hyperemia and blepharitis. Allergy and/or inflammation-related ADRs occurred in 388 patients (11.6%), most commonly blepharitis (5.6%) and conjunctivitis (4.2%). IOP decreased significantly from a mean ± SD 18.1 ± 6.1 mmHg at baseline; the LSM ± SE IOP change throughout 12 months of ripasudil treatment was − 2.6 ± 0.1 mmHg (− 14.0 ± 0.4%; p |
| Document Type: |
article |
| File Description: |
electronic resource |
| Language: |
English |
| ISSN: |
1471-2415 |
| Relation: |
http://link.springer.com/article/10.1186/s12886-020-01490-1; https://doaj.org/toc/1471-2415 |
| DOI: |
10.1186/s12886-020-01490-1 |
| Access URL: |
https://doaj.org/article/c8929445c45844e58800be16fdc53139 |
| Accession Number: |
edsdoj.8929445c45844e58800be16fdc53139 |
| Database: |
Directory of Open Access Journals |
