Naturalistic, Prospective Study of Glaucoma and Ocular Hypertension Treatment in France: Strategies, Clinical Outcomes, and Costs at 2 Years
Authors: Rouland J.-F. , Le Pen C. , Benhaddi H. , Piriou E. , Lilliu H. , Kenigsberg P.-A. ,   Glaucoma Study Group, Abellan Pascal , Arnoux Michel , Attia Annie , Baudouin Christophe , Bérard Dominique , Boussion Bertrand , Bove Gilles , Cochener Béat Rice , Cohn Howard , Denis Philippe , Filippi Jean-Michel , Garbolino Nicolas , Gazagne Christophe , Gruber Denis , Haaz Nicolas , Hamard Pascale , Lachkar Yves , Laroudie Claude , Lec Marie-Hélène , Le Grignou Alain , Malet Florence , Meftah Abderrahmane , Mialhe Jean-Paul , Montard Michel , Nordmann Jean-Philippe , Pagot Roland , Peigné Guillaume , Renard Jean- Paul , Riss Isabelle , Rouland Jean-François , Scemama Joël , Sellem Eric , Sitruk Alain-David , Subirana Xavier , Timsit Jean-Claude , Williamson Wilfrid , Zaluski Serge 
Published: January 2018

Purpose To prospectively observe second-line treatment strategies, their clinical outcomes, and treatment costs in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OH) in France. Methods Second-line patients were recruited from September 14, 1998, to December 20, 2000, in 37 centers and were followed for up to 2 years. Outcomes were numbers of and reasons for treatment changes, changes in clinical parameters (intraocular pressure (IOP) levels, visual field defects, and optic nerve excavation), and direct medical costs associated with glaucoma management. This article reports results of the final analysis of 2-year follow-up data for patients with at least two contacts with a study ophthalmologist. Results Data were analyzed for 346 patients and 672 treated eyes. Monotherapy was used as first-line therapy in 92.0% of eyes. Second-line treatment was initiated an average of 2.8±0.2 years after diagnosis, primarily due to insufficient IOP control (60.3%) and adverse drug reactions (18.3%). Relative risk (RR) (95% CI) for adverse drug reactions (ADR) under monotherapy was 1.00 (1.00–1.00) under beta blockers (n=116) versus 0.40 (0.16–0.64) under latanoprost (n=21), 2.30 under carbonic anhydrase inhibitors (n=29), and 2.90 under adrenergics (n=38); RR for ADR under combination therapy was 1.00 (1.00–1.00) for unfixed combinations without latanoprost (n=66) versus 0.11 (0.00–0.22) for unfixed combinations of latanoprost + timolol (n=3). Cardiac or pulmonary problems have been reported in 26.9% of patients. Persistency on initial therapy was 62.5% (95% CI 53.0–72.0) for latanoprost monotherapy versus 41.1% (34.8–47.4) for beta-blocker monotherapy and 43.6% (26.6–60.6) for the latanoprost + timolol combination versus 29.8% (15.2–44.4) for combination therapies that did not include latanoprost. Average daily cost for latanoprost monotherapy was similar to that for patients who failed beta-blocker monotherapy: latanoprost + timolol did not cost more than therapeutic combinations without latanoprost. Conclusions Insufficient IOP control and adverse drug reactions are the two main reasons for changing first-line treatment in patients with POAG or OH. After 2 years, second-line treatment with latanoprost, as monotherapy or combined with timolol, provides superior safety and persistency to treatment at an acceptable cost.