A multicenter, open-label study of netarsudil for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension in a real-world setting.

OBJECTIVE: Assess the real-world efficacy of netarsudil, either as monotherapy or concomitant therapy, in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) requiring modification of intraocular pressure (IOP)-lowering treatment. METHODS: Multicenter, prospective, interventional, open-label, Phase 4 study, clinical trial registration number: NCT03808688. Netarsudil ophthalmic solution 0.02% was prescribed at the recommended once-daily dosage, with treatment regimens determined by the investigators. Netarsudil could be used alone or in combination with other IOP-lowering medications, consistent with standard clinical practice. Primary efficacy endpoint: percentage reduction from baseline IOP at week 12. RESULTS: Among 261 enrolled patients, 242 received ≥1 netarsudil dose and had ≥1 follow-up IOP measurement (efficacy population). Mean IOP in patients who were treatment-naïve at baseline and using netarsudil as monotherapy (n = 24) decreased by 16.9%. Netarsudil monotherapy was comparable in efficacy to prior therapy across subgroups, and those who replaced prostaglandin analog (n = 57) monotherapy demonstrated reduction of 2.5% from prostaglandin analog-treated baseline values. Among patients who used netarsudil as concomitant therapy (n = 151), reductions in mean IOP (± standard deviation) to week 12 were seen across subgroups who added netarsudil to a single agent (4.3 ± 2.88 mmHg; 20.5%) or ≥2 classes of concomitant therapy (4.5 ± 4.08 mmHg; 20.9%) and who used netarsudil to replace ≥1 other drug classes (0.4 ± 2.47 mmHg; 1.7%). Of 260 netarsudil-treated patients, 41 (15.8%) discontinued, including 29 (11.2%) due to adverse events. CONCLUSIONS: In the real-world treatment of patients with OAG or OHT, netarsudil consistently maintained IOP control when it replaced previous IOP-lowering therapies and provided additional IOP-lowering efficacy when added to other treatments.

Characteristics and Treatment Patterns of Newly Diagnosed Open-Angle Glaucoma Patients in the United States: An Administrative Database Analysis.

PURPOSE: To characterize newly diagnosed primary open-angle glaucoma (OAG) patients and to describe their treatment journey in United States clinical practice according to the use of topical therapy, laser trabeculoplasty, and surgical procedures. DESIGN: Retrospective claims database study. PARTICIPANTS: Patients with at least 2 diagnoses of OAG 7 days or more apart and within 1 year, with the first (index) diagnosis in 2010, at least 30 months of continuous enrollment before index diagnosis with no OAG diagnosis or medication (exception for ocular hypertension diagnosis), and 48 months of continuous enrollment. METHODS: Analysis of United States healthcare insurance claims database (July 2007-December 2014). MAIN OUTCOME MEASURES: Treatment patterns and ophthalmology visits were evaluated over 48 months in 4 cohorts based on initial therapy after the index diagnosis: (1) drug monotherapy, (2) combination drug therapy, (3) glaucoma procedure, or (4) no claims for treatment. Treatment modification was defined as an addition to or change in drug therapy or procedure. RESULTS: In total, 83.0% of patients (5120/6172) began a drug therapy (69.5%) or underwent a procedure initially (13.5%); topical prostaglandin analogs (n = 2887/5120 [56.4%]) and laser trabeculoplasty (n = 705/5120 [13.8%]) were the most common. During the 4-year follow-up, 58.3% of patients (2109/3620) who began drug monotherapy experienced no further treatment modification. Over this period, 43.8% of patients who began treatment (2242/5120) experienced a treatment modification to the first treatment. Two thirds (1505/2242 [67.1%]) of these patients subsequently underwent a third treatment modification. Ophthalmology visits declined over time regardless of initial therapy, with the greatest decrease among the untreated and first-treatment procedure cohorts. CONCLUSIONS: The high rates of 2 or 3 treatment modifications over the 4-year period suggest an unmet need for glaucoma therapies with durable and predictable actions.

Economic and Clinical Burden Associated With Intensification of Glaucoma Topical Therapy: A US Claims-based Analysis.

PRECIS: Incremental addition of intraocular pressure-lowering topical drops is associated with shorter-lasting benefit and higher health-related costs with each additional agent, suggesting a need for new treatment options to improve disease control and reduce treatment burden. PURPOSE: The purpose of this study was to evaluate treatment intensification as a driver of clinical and economic burden in patients receiving topical glaucoma medications for open-angle glaucoma/ocular hypertension. METHODS: This retrospective analysis of administrative claims data (January 2011 to July 2017) from the IQVIA PharMetrics Plus database included diagnosed patients who initiated or intensified treatment with 1 to 4 topical glaucoma medications of a different drug class between January 2012 and July 2015 (index date being the first such event during this period). Patients with prior open-angle glaucoma surgery or an equal or greater number of topical glaucoma medication classes during the preindex period were excluded. Treatment intensification rates and eye-related outpatient costs were assessed over 24 months postindex. RESULTS: Of 48,402 patients (mean age: 61.4 y), 22,874 (47.3%), 16,214 (33.5%), 7137 (14.7%), and 2177 (4.5%) received a first, second, third, or fourth medication class, respectively, as their first observed initial or intensified regimen. Among cohorts receiving 1, 2, 3, or 4 medication classes, 7.8%, 12.2%, 17.2%, and 22.6% of patients and 12.6%, 18.5%, 25.9%, and 33.7% of patients had subsequent treatment augmentation (class addition or glaucoma procedure, laser or surgical) within 12 and 24 months postindex, respectively. Eye-related outpatient costs over 24 months increased with each additional topical glaucoma medication class at index [mean (SD): $1610 ($3460), $2418 ($4863), $2872 ($5110), and $3751 ($6608) in the 1, 2, 3, or 4 class cohorts, respectively]. CONCLUSION: Multiple-drop therapies yielded shorter-lasting benefits with each additional agent and were associated with the increased clinical and economic burden.

Patient adherence and persistence with topical ocular hypotensive therapy in real-world practice: a comparison of bimatoprost 0.01% and travoprost Z 0.004% ophthalmic solutions.

BACKGROUND: Effective control of intraocular pressure is predicated upon patient compliance with pharmacotherapy. We compared patient adherence and persistence with two new ocular hypotensive formulations, using real-world utilization data. METHODS: This observational cohort study employed pharmacy claims data from the Source(®) Lx (Wolters Kluwer Pharma Solutions) database. Patients with an initial (index) prescription for topical bimatoprost 0.01% or travoprost Z (April to June 2011) and no claim for ophthalmic prostaglandin or prostamide analogs within the previous 18 months were identified. Treatment adherence was expressed as proportion of days covered with study medication during the first 365 days after the index prescription. Treatment persistence with study medication was assessed over the first 12 months using Kaplan-Meier survival analyses, allowing a maximum 30-day gap for prescription refill. Treatment status was determined monthly over this period. RESULTS: A total of 12,985 patients were assessed for treatment adherence, and 10,470 for treatment persistence. Adherence was better with bimatoprost 0.01% than with travoprost Z (mean proportion of days covered 0.540 versus [vs] 0.486, P<0.001), and more patients showed high adherence (proportion of days covered >0.80) with bimatoprost 0.01% than travoprost Z (29.1% vs 22.3%, P<0.001). Continuous 12-month persistence was higher with bimatoprost 0.01% than with travoprost Z (29.5% vs 24.2%, P<0.001). At month 12, more patients were on treatment with bimatoprost 0.01% than travoprost Z (48.8% vs 45.7%, P<0.01). Similar findings were demonstrated in cohorts of ocular hypotensive treatment-naïve patients, branded latanoprost switchers, and older patients (age ≥65 years), and after inclusion of patient characteristics as covariates. CONCLUSION: For patients with glaucoma or ocular hypertension, bimatoprost 0.01% offers compliance advantages over travoprost Z.

Evaluation of eye drop administration technique in patients with glaucoma or ocular hypertension.

OBJECTIVE: To evaluate eye drop administration by patients at multiple visits in the setting of a randomized controlled trial. STUDY DESIGN AND METHODS: Patients with glaucoma or ocular hypertension were randomized to 12 weeks of treatment with topical ocular hypotensive medication in a multicenter, investigator-masked trial. At baseline, patients were given a questionnaire for self-assessment of difficulty with drop administration. At baseline and 12 weeks, patients demonstrated drop instillation using a bottle of artificial tears. MAIN OUTCOME MEASURES: Patient self-assessment of difficulty with drop administration and observed patient difficulty with drop administration, defined as bottle touching eye/adnexa, drop missing the ocular surface, or administering more than 1 drop. RESULTS: Of 164 enrolled patients, 50% had previously been treated with ocular hypotensive medication for ≥3 years. Only 11.4% of patients reported difficulty with eye drop administration at study entry. At baseline, 18.2% of patients touched their eye/adnexa with the bottle and 10.3% missed the eye. At 12 weeks, 18.5% and 8.6% of patients, respectively, had similar difficulties. Overall, difficulty with drop instillation was observed in 42.1% of patients. Difficulty at both visits was seen in 35.3% of patients who reported difficulty at entry and in 17.2% of patients who denied difficulty. The relative risk of demonstrating difficulty at either visit was 2.0 times greater for patients who self-reported difficulty at study entry (P = 0.004). The relative risk of demonstrating difficulty at week 12 was 3.8 times greater for patients with observed difficulty at baseline (P < 0.001). Limitations of the study design included self-administration of drops to the eye of the patient's choice and observation in an office setting. CONCLUSIONS: Patients with experience instilling topical glaucoma medications continue to have difficulties with eye drop administration, including patients who do not self-report difficulty. The risk of difficulty with eye drop administration is increased in patients who self-report difficulty and in patients who have been previously observed to have difficulty. CLINICAL TRIAL REGISTRY NUMBER: NCT01253902.

Bimatoprost 0.03% preservative-free ophthalmic solution versus bimatoprost 0.03% ophthalmic solution (Lumigan) for glaucoma or ocular hypertension: a 12-week, randomised, double-masked trial.

BACKGROUND/AIM: To evaluate efficacy and safety of bimatoprost 0.03% preservative-free (PF) ophthalmic solution versus bimatoprost 0.03% (Lumigan) ophthalmic solution for glaucoma or ocular hypertension. METHODS: In this double-masked, parallel-group study, patients were randomised to bimatoprost PF or bimatoprost for 12 weeks. The primary analysis for non-inferiority was change from baseline in worse eye intraocular pressure (IOP) in the per-protocol population at week 12. For equivalence, it was average eye IOP in the intent-to-treat population at each time point at weeks 2, 6 and 12. RESULTS: 597 patients were randomised (bimatoprost PF, n=302 and bimatoprost, n=295). The 95% CI upper limit for worse eye IOP change from baseline was <1.5 mm Hg at each week 12 time point, meeting prespecified non-inferiority criteria. The 95% CI upper limit for the treatment difference for average IOP was 0.69 mm Hg and the lower limit was -0.50 mm Hg at all follow-up time points (hours 0, 2 and 8 at weeks 2, 6 and 12), meeting equivalence criteria. Both treatments showed decreases in mean average eye IOP at all follow-up time points (p<0.001), were safe and well tolerated. CONCLUSIONS: Bimatoprost PF is non-inferior and equivalent to bimatoprost in its ability to reduce IOP-lowering with a safety profile similar to bimatoprost.

Objective assessment of compliance and persistence among patients treated for glaucoma and ocular hypertension: a systematic review.

PURPOSE: This study summarizes findings from objective assessments of compliance (or adherence) and persistence with ocular hypotensive agents in patients with glaucoma and ocular hypertension. DESIGN: Systematic literature review. METHODS: A PubMed and reference list search was conducted across publication years 1970-2010, using these terms and variants: "compliance," the equivalent term "adherence," and "persistence" in patients with these conditions and therapies. Summaries of selected studies were stratified by measurement method (electronic monitor, prescription fills review, medical chart review). Measures of central tendency across studies were calculated for commonly-reported compliance or persistence measures. RESULTS: Fifty-eight articles met all inclusion/exclusion criteria: measurement of compliance-electronic monitoring (seven studies reported in 14 articles), measurement of compliance/ persistence-prescription records (36 studies in 38 articles), and measurement of persistence- medical chart review (six studies in six articles). From electronic monitoring, most therapy-experienced patients took medication consistently, but ≥20% met criteria for poor compliance. From prescription records, only 56% (range 37%-92%) of the days in the first therapy year could be dosed with the medication supply dispensed over this period. At 12 months from therapy start, only 31% (range 10%-68%) of new therapy users had not discontinued, and 40% (range 14%-67%) had not discontinued or changed the initial therapy. From medical chart review, only 67% (range 62%-78%) of patients remained persistent 12 months after starting therapy. CONCLUSIONS: Evidence provided by this review suggests that poor compliance and persistence has been and remains a common problem for many glaucoma patients, and is especially problematic for patients new to therapy. The direction of empirical research should shift toward a greater emphasis on understanding of root causes and identification and testing of solutions for this problem.

Incidence of new coding for dry eye and ocular infection in open-angle glaucoma and ocular hypertension patients treated with prostaglandin analogs: retrospective analysis of three medical/pharmacy claims databases.

BACKGROUND: To investigate the clinical relevance of two different preservative formulations, we compared 1-year incidence rates of additional coding of dry eye, ocular infection, or ocular surface disease (either dry eye or ocular infection) in open-angle glaucoma and ocular hypertension patients newly treated with latanoprost with benzalkonium chloride (BAK) or with travoprost-Z with SofZia®. METHODS: This was a retrospective study of three U.S.-based patient-centric medical/pharmacy claims databases (MedStat, PharMetrics, i3-Ingenix). Patients were eligible if they filled a prescription for latanoprost or travoprost-Z between October 2006 and Q2 2008 (prescription date = index date) AND were continuously enrolled 6 months prior through 12 months after the index date AND had any open-angle glaucoma or ocular hypertension diagnosis within 90 days prior to the index date AND did not have an ocular surface disease diagnosis during the 180 days prior to the index date AND if they had not had a prescription for the index agent in the 180 days prior to the index date. Time to incidence of new coding for ocular surface disease in the first year post-index was estimated with a composite endpoint: diagnosis of dry eye or ocular infection by ICD-9-CM or Current Procedural Terminology code OR by prescription for cyclosporine ophthalmic emulsion or ocular antibiotics. RESULTS: In all, 15,933 patients were treated with latanoprost and 7670 with travoprost-Z. Over 1 year, 4.3% of latanoprost and 4.5% of travoprost-Z patients were identified with dry eye (p = 0.28), and 10.9% and 11.1%, respectively, were identified with an ocular infection (p = 0.79). The 1-year incidence of new coding for ocular surface disease also was similar across treatments (13.9% vs 14.3%, respectively; p = 0.48). CONCLUSIONS: The retrospective analysis of three large prescription databases revealed that open-angle glaucoma and ocular hypertension patients newly treated with latanoprost preserved with BAK or travoprost-Z preserved with SofZia did not differ statistically in rates of dry eye, ocular infection, or ocular surface disease (either dry eye or ocular infection) during the first year post-index. Claims-based analyses are limited by nonrandomization and the inability to account for over-the-counter use or samples.

Persistence on prostaglandin ocular hypotensive therapy: an assessment using medication possession and days covered on therapy.

BACKGROUND: Prior research has demonstrated that medication persistence (continued acquisition of therapy over time) is far from optimal among patients with glaucoma. The purpose of the present study was to evaluate persistence with prostaglandin analogs among glaucoma patients in the first therapy year using a modification of a previously published technique. METHODS: This retrospective analysis of medical and pharmacy claims database included treatment-naive patients dispensed bimatoprost, latanoprost, or travoprost between 1/1/04-12/31/04. "Index agent" was defined as the first agent filled; "index date" was defined as the fill date. Follow-up continued for 358 days. Persistence measures for first therapy year were: (1) whether last fill had sufficient days supply to achieve medication possession at year's end, and (2) number of days for which the index agent was available (days covered). Associations between index agent and medication possession (logistic regression) and days covered (linear regression) were evaluated. Models were adjusted for gender, age, and previous ocular hypertension diagnosis. RESULTS: 7873 patients met inclusion criteria (bimatoprost, n = 1464; latanoprost, n = 4994; travoprost, n = 1415). Medication possession was 28% and days covered was 131 when using the unadjusted (pharmacy-reported) days supply estimates and rose to 47-48% and days covered to 228-236 days when days supply was imputed. Compared to latanoprost, odds of achieving medication possession at first year's end were 26-34% lower for bimatoprost and 34-36% lower for travoprost (p

Hyperemia-associated costs of medication changes in glaucoma patients treated initially with prostaglandin analogs.

AIMS: To develop a model to estimate and compare the cost of changing therapy due to hyperemia in glaucoma patients treated initially either with latanoprost, bimatoprost, or travoprost monotherapy. METHODS: Data collected from the HealthCore Integrated Research Database, as part of the Glaucoma Adherence and Persistency Study (GAPS), were used to populate the model. Patients with a documented diagnosis of glaucoma who were newly treated (no ocular hypotensive medication and no glaucoma-related procedure during 6 months before first prescription) with latanoprost, bimatoprost, or travoprost monotherapy were identified. The time horizon for the base-case model was the duration of chart abstraction (mean = 4.1 years); a 3-month model also was developed. Physician-reported rates of hyperemia were obtained from chart reviews of 300 patients. Transition rates reflected events related to reports of hyperemia where a physician-driven change (switch or discontinuation) in therapy was documented. The per-patient direct cost (2008) due to hyperemia-driven change in therapy was calculated as the sum of the cost of the initial prescription plus the cost of the office visit where the patient was evaluated and the decision to change therapy was made. Costs were stratified by whether patients were hyperemia free or discontinued the initial therapy due to hyperemia. RESULTS: From the sample of 13,977 newly treated patients, 8,743 patients were started on a prostaglandin monotherapy only. Of these, 5,726 received latanoprost, 1,633 were treated with bimatoprost, and 1,384 received travoprost index monotherapy. Across all treatment groups, costs among hyperemia-free patients were US$73.67 versus US$140.02 for those who discontinued the initial prostaglandin due to hyperemia. Per-patient costs were lowest in the group treated initially with latanoprost. For the base-case model, with latanoprost as the reference, total per-patient incremental costs due to hyperemia-driven change in therapy were US$5.92 for bimatoprost and US$5.43 for travoprost. Results were not highly sensitive to increases either in the incidence of hyperemia among latanoprost-treated patients or in the cost of latanoprost. CONCLUSIONS: Hyperemia results in increased overall costs in patients treated with latanoprost, bimatoprost, and travoprost. Treatment with latanoprost is associated with lower hyperemia-related costs than treatment with bimatoprost or travoprost.

Adherence and persistence with glaucoma therapy.

Adherence and persistence with chronic therapies is crucial to prevent disease progression, such as in glaucoma. Patients report high rates of adherence, which are not supported by pharmacy claims analysis. This article reviews the literature regarding methods to assess adherence and persistence and the patient behaviors that pose challenges to proper treatment. Rates for persistence are generally below 50% at 1 year. Differentiating efficacy of eyedrops from lack of adherence presently confounds ophthalmic treatment. Additionally, as intraocular pressure (IOP) can appear controlled by short-term adherence, the physician can be fooled into believing the patient's glaucoma is well-controlled. Likewise, when progressive worsening is noted despite good IOP control, it can be problematic whether the patient's target pressure needs to be lowered or adherence needs to be improved. White-coat adherence is common, in which patient adherence rises sharply 1 week before the appointment with the physician, then declines rapidly following the appointment. White-coat adherence may make it difficult to assess IOP control over the longer term; cycling behavior with medication use is well-documented. Adherence and persistence rates differ by class of drug, with higher rates associated with prostaglandin use. We review findings from The Glaucoma Adherence and Persistency Study that identified behaviors associated with poor adherence. Greater physician awareness of adherence and persistence issues is necessary in order to help the patient become more adherent.

Accounting for restart rates in evaluating persistence with ocular hypotensives.

PURPOSE: Persistence with ocular hypotensive medication is important as a long-term outcome, and rates of persistence typically are low. This study assessed restart rates for 3 prostaglandin analogs by determining the percentage of patients who discontinued and then restarted therapy. DESIGN: Retrospective cohort study of pharmacy claims submitted to a large national administrative claims database. PARTICIPANTS: In all, 4356 patients initiating prostaglandin therapy were identified. METHODS: Claims for 3 prostaglandin analogs (bimatoprost, latanoprost, travoprost [index prostaglandin]) submitted between 2001 and 2002 were analyzed. Patients were excluded if they did not have coverage in the plan for the preceding 180 days or had been prescribed any ocular prostaglandin in the prior 180 days. MAIN OUTCOME MEASURES: Persistence was defined as neither discontinuing nor changing the index prostaglandin. The number of current users of the index prostaglandin at day 180 was the sum of patients who persisted with the index prostaglandin plus patients who restarted the index prostaglandin after a discontinuation. RESULTS: Of the 4356 patients initiating prostaglandin therapy, 2503 (57%) were potential current users (were still plan members and had not switched ocular hypotensive therapies after 180 days). Just over half, (1356/2503 [54%]) were current users, including 879 (35%) who persisted with their index prostaglandin and 477 (19%) who restarted their index prostaglandin. Of patients discontinuing their index prostaglandin, more than half failed to restart any topical therapy (827/1624 [51%]). CONCLUSIONS: Previous studies showing low persistence rates for glaucoma therapy failed to evaluate restarts. Restart analyses are crucial for assessing long-term treatment of chronic diseases such as glaucoma. In general, persistence remains a challenge, and our findings demonstrate the importance of clinicians' identifying patients who are not persistent and encouraging them either to restart or to initiate treatment with an alternative therapy.

Compliance and persistency in glaucoma follow-up treatment.

PURPOSE OF REVIEW: To summarize research published between 1980 and October 2004 regarding compliance (the extent to which patients' behaviors correspond with providers' recommendations) and persistency (total time on therapy) in patients diagnosed with open-angle glaucoma or ocular hypertension; to suggest approaches ophthalmologists might consider to improve compliance and persistency; and to identify areas warranting future research. RECENT FINDINGS: Medication compliance, the focus of most compliance-related research, has been measured using a variety of methods including patient self-reports, the medication possession ratio, and electronic monitoring. Noncompliance rates of at least 25% commonly have been reported. The primary obstacles to medication compliance appear to be situational/environmental (e.g., being away from home or a change in routine) or related to the medication regimen (e.g., side effects or complexity). Persistency with ocular hypotensive therapies has been found to be poor. Retrospective cohort studies using survival analyses have reported that fewer than 25% of patients are persistent over 12 months. SUMMARY: Accurately assessing patient compliance and persistency is important to optimizing patient care. Physicians may mistake either medication noncompliance or lack of persistency with poor efficacy. Such errors would likely increase health care costs if they result in unnecessary changes to a patient's therapeutic regimen or in surgery.

Patient persistency with topical ocular hypotensive therapy in a managed care population.

PURPOSE: To evaluate persistency with topical ocular hypotensive therapies in patients new to pharmacological management of elevated intraocular pressure (IOP). DESIGN: Retrospective, cohort study; Protocare Sciences managed care database; approximately 3 million members in commercial health maintenance organizations and preferred provider organizations and in Medicare risk plans. METHODS: Patients were at least 20 years of age initiating therapy between July 1, 1996, and June 30, 2002, with betaxolol, bimatoprost, brimonidine, dorzolamide, latanoprost, timolol, or travoprost as monotherapy. Patients must have been continuously enrolled and not have received glaucoma surgery in the 180 days before the index prescription fill. Prescription refill records for all ocular hypotensive drugs were extracted through June 30, 2002. Outcome measures were (1) discontinuation of index drug, and (2) either discontinuation or change in index drug. Changing therapy was defined as switching to or adding another ocular hypotensive. Rates of discontinuation and discontinuation/change were compared using Cox regression models. RESULTS: In all, 28,741 patients met the inclusion criteria. Compared with latanoprost, those treated with other drugs were from 37% (timolol) to 72% (bimatoprost) more likely to discontinue and from 20% (timolol) to 58% (dorzolamide) more likely to discontinue/change therapy (P <.001 for all comparisons). At 12 months, 33% of patients treated with latanoprost and 19% of those receiving other ocular hypotensives had not discontinued therapy; 23% and 13%, respectively, had not discontinued or changed therapy. Compared with latanoprost, significantly higher percentages of patients treated with each alternate agent had only one fill of their index drugs (P <.001). CONCLUSIONS: Although persistency rates were low across agents, latanoprost-treated patients demonstrated significantly greater persistency than did those treated with other topical ocular hypotensive therapies.

Persistency with latanoprost or timolol in primary open-angle glaucoma suspects.

PURPOSE: To evaluate persistency of pharmacotherapy in primary open-angle glaucoma suspects (glaucoma suspects) treated with latanoprost and timolol. DESIGN: Retrospective, cohort study using the Protocare Sciences managed care database; approximately 3 million members in commercial health maintenance organizations and preferred provider organizations and in Medicare risk plans. METHODS: Patients 20 years of age or older beginning therapy between January 1, 1997, and June 30, 2002, with latanoprost or timolol monotherapy were included. Patients must have been continuously enrolled and not undergone glaucoma surgery in the year preceding the index prescription fill and had glaucoma suspect diagnoses before and after the index date. Prescription refill records for all ocular hypotensives were extracted through June 30, 2002. The two outcome measures were (1) discontinuation of index drug, and (2) either discontinuation or change in index drug. Changing therapy was defined as switching to or adding another ocular hypotensive. Rates of discontinuation and discontinuation/change were compared using Cox regression models. RESULTS: In all, 1,474 patients met the inclusion criteria. Latanoprost was prescribed for 583 patients (40%) and timolol for 891 (60%). Compared with latanoprost, those treated with timolol were 39% more likely to discontinue and 27% more likely to discontinue/change therapy (P <.001 for both comparisons). At 12 months, 39% of patients receiving latanoprost and 25% of those treated with timolol had not discontinued therapy; no discontinuation or change in therapy was seen in 30% and 18%, respectively. CONCLUSIONS: Latanoprost-treated glaucoma suspects demonstrated significantly greater persistency than did patients treated with timolol. The reasons for this difference and its impact on intraocular pressure control and disease progression require further research.

Patient persistency with ocular prostaglandin therapy: a population-based, retrospective study.

BACKGROUND: Open-angle glaucoma affects an estimated 33 million individuals worldwide. An intraocular pressure >21 mm Hg in individuals with no evidence of optic nerve damage is termed ocular hypertension, a risk factor for glaucoma that has been estimated to affect as many as 10% of individuals 40 years of age or older. OBJECTIVE: The purpose of this research was to assess persistency (time on therapy) with prostaglandin analogues in the treatment of glaucoma or ocular hypertension. METHODS: This population-based, retrospective cohort study used the Protocare Sciences managed care database, which includes prescription and medical claims data from multiple managed care organizations. Patients 20 years of age or older who initiated therapy with latanoprost, bimatoprost, or travoprost (index drugs) between April 2001 and June 2002 were included. Patients were required to be continuously enrolled in the same plan for the 180 days preceding index prescription fill. Follow-up continued through June 30, 2002. Two outcome measures were analyzed: (1) discontinuation of the index prostaglandin and (2) either discontinuation or change in the index prostaglandin regimen. Changing therapy was defined as switching to or adding another ocular hypotensive agent. Cox regression models were used to compare rate ratios of discontinuation and discontinuation/change. Patient data were censored on termination of insurance coverage or at the end of the study period. RESULTS: Overall, 7527 patients were prescribed a prostaglandin analogue; 4356 patients met the inclusion criteria (n = 2376, 993, and 987 for latanoprost, bimatoprost, and travoprost, respectively). A total of 58% of patients were women, and 74% were 65 years of age or older. Compared with latanoprost, those treated with bimatoprost were 38% more likely to discontinue and 31% more likely to discontinue/change therapy, and patients treated with travoprost were 36% more likely to discontinue and 29% more likely to discontinue/change therapy (P < 0.001 for each comparison). CONCLUSION: Latanoprost-treated patients demonstrated significantly (P < 0.001) greater persistency than did those treated with either bimatoprost or travoprost.

Patient preferences for eye drop characteristics: a willingness-to-pay analysis.

OBJECTIVE: To determine the importance that patients place on the characteristics of topical therapy for lowering intraocular pressure. METHODS: We administered a willingness-to-pay instrument to 230 patients from 4 glaucoma subspecialty practices, asking them how much they would be willing to pay to obtain particular characteristics in an eye drop. Data about the subjects' demographics, economic status, attitudes toward eye drops and systemic medications, and symptoms from eye drops were correlated with their willingness to pay using 2-part models. RESULTS: Of our subjects, 169 (77%) were using eye drops to lower their intraocular pressure. Fatigue, blurred vision, and tearing were the most commonly reported symptoms. Eye drop medications most valued by the subjects did not produce blurring, drowsiness, or inhibition of sexual performance; 85% were willing to pay more for an eye drop that did not cause blurring, and on average they were willing to pay 40% more. Higher educational levels and income were generally associated with a willingness to pay more for eye drops with desirable attributes. MAIN OUTCOME MEASURE: Willingness to pay more (in dollars). CONCLUSIONS: Patient preferences for eye drop characteristics can be assessed using a willingness-to-pay instrument. Patients place differing value on various eye drop characteristics. A better understanding of patient preference could lead to better compliance.