A multicenter, retrospective chart review study comparing index therapy change rates in open-angle glaucoma or ocular hypertension patients newly treated with latanoprost or travoprost-Z monotherapy
BMC Ophthalmology
A multicenter, retrospective chart review study comparing index therapy change rates in open- angle glaucoma or ocular hypertension patients newly treated with latanoprost or travoprost-Z monotherapy
Joel M Fain 2
Sameer Kotak 1
Jack Mardekian 1
Jason Bacharach 0
Deepak P Edward 4
Steven Rauchman 3
Teresa Brevetti 1
Janet L Fox 1
Cherie Lovelace 1
0 North Bay Eye Associates , Petaluma, CA , USA
1 Pfizer Ophthalmics , New York, NY , USA
2 Pfizer Ophthalmics , Chicago, IL , USA
3 North Valley Eye , Mission Hills, CA , USA
4 Summa Health System , Akron, OH , USA
Background: Because latanoprost and the original formulation of travoprost that included benzalkonium chloride (BAK) have been shown to be similar with regard to tolerability, we compared initial topical intraocular pressure (IOP)-lowering medication change rates in patients newly treated with latanoprost or travoprost-Z monotherapy. Methods: At 14 clinical practice sites, medical records were abstracted for patients with a diagnosis of open-angle glaucoma or ocular hypertension and who were 40 years of age, had a baseline and at least one follow-up visit, and had no prior history of ocular prostaglandin use. Data regarding demographics, ocular/systemic medical histories, clinical variables, therapy initiations and reasons for changes, adverse events, and resource utilization were recorded from randomly chosen eligible charts. Primary outcomes were rates of and reasons for changing from the initial therapy within six months and across the full study period (1000 days). Results: Data from 900 medical charts (latanoprost, 632; travoprost-Z, 268) were included. For both cohorts, average follow-up was >1 year. Cohorts were similar with regard to age (median ~67 years), gender distribution (>50% female), and diagnosis (~80% with open-angle glaucoma). Within six months, rates of index therapy change for latanoprost versus travoprost-Z were 21.2% (134/632) and 28.7% (77/268), respectively (p = 0.0148); across the full study period, rates were 34.5% (218/632) and 45.2% (121/268), respectively (p = 0.0026). Among those who changed their index therapy, insufficient IOP control was the most commonly reported reason followed by adverse events; hyperemia was the most commonly reported adverse event at index therapy change. Conclusions: In this real world study of changes in therapy in patients prescribed initial monotherapy with latanoprost with BAK or travoprost-Z with SofZia, medication changes were common in both treatment groups but statistically significantly more frequent with travoprost-Z.
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Background
Research has demonstrated that progression of ocular
hypertension to glaucoma and progression of
glaucomatous damage can be delayed or halted with the use of
topical ocular hypotensive agents [1-4]. Patients can
benefit from these therapies only if they are taken as directed
* Correspondence:
1Pfizer Ophthalmics, Chicago, IL, USA
Full list of author information is available at the end of the article
over the long term; however, medication discontinuation
and changes may complicate patient management and
make intraocular pressure (IOP) control problematic.
Unfortunately, persistence with ocular hypotensives
generally has been shown to be poor [5-11] although better
with prostaglandin analogs than with agents in other
classes [5,7,8,12]. Therapeutic interruptions may occur
for many reasons. In patients treated with latanoprost,
travoprost, or bimatoprost, the Glaucoma Adherence and
Persistence Study (GAPS) [11] identified the need for
additional IOP reduction and the presence of ocular
adverse events, especially hyperemia, to be the main
factors affecting continuation with therapy and medication
changes.
All three prostaglandins evaluated in the GAPS [11]
were preserved with benzalkonium chloride (BAK).
Currently the most widely used preservative in ocular
hypotensive formulations, BAK has been in use for more than
50 years [13,14]. While it has been suggested that
preservative-free formulations could improve ocular tolerability
and thereby reduce treatment discontinuation [15], such
formulations pose their own risks because preservatives
are added to multiple-use containers of ophthalmic
preparations in order to prevent bacterial contamination
[16] and to reduce the risk of serious infections such as
infectious keratitis [14]. Moreover, the contribution of
BAK to ocular toxicity remains unclear. While animal
studies [17-20] and studies of cultured corneal [21] and
conjunctival cells [22] have reported dose-dependent,
BAK-induced epithelial cellular damage, these findings
may not accurately reflect ocular surface conditions in
humans, and the levels of BAK contained in ophthalmic
solutions are not likely to cause clinically significant
adverse corneal effects [23-27].
An alternative preservative, SofZia, currently is used
as the preservative in travoprost-Z. Although latanoprost
with BAK has been found to exhibit more effective
microbial (...truncated)