A combined analysis of five observational studies evaluating the efficacy and tolerability of bimatoprost/timolol fixed combination in patients with primary open-angle glaucoma or ocular hypertension

Abstract

ObjectiveThe aim of this study was to evaluate the safety and efficacy of a fixed combination of bimatoprost 0.03% and timolol (BTFC) in a clinical setting, in a large sample of patients with primary open-angle glaucoma or ocular hypertension and insufficient intraocular pressure (IOP) lowering on prior therapy.MethodsPatient data were combined (n = 5556) from five multicenter, observational, non-controlled, open-label studies throughout Europe. Patients were identified from 830 sites in Austria, France, Germany, The Netherlands, and Switzerland. Assessments were made at baseline, 6 weeks (in Austrian, German and Swiss centers), and 12 weeks in all centers.ResultsBTFC lowered mean IOP from baseline by 5.4 mmHg over the 12-week duration of the studies (P < 0.0001). At study entry, 92.9% of patients were receiving another ocular hypotensive medication. In patients with no previous treatment (n = 311), BTFC reduced IOP by −9.1 mmHg, corresponding to a reduction from baseline of 36.4% (P < 0.0001). In patients receiving prior therapy of a prostaglandin analog, a β-blocker, or a fixed combination, BTFC reduced IOP by a further 24.5%, 25.9%, and 21.4%, respectively. The majority of patients (90.3%) reported no adverse events. The most common adverse events were conjunctival hyperemia (3.2%) and eye irritation (2.8%). BTFC was rated as “good” or “very good” by 92.5% of physicians and 88.0% of patients. Most patients (96.3%) were equally or more compliant with BTFC than with their previous treatment.ConclusionIn routine clinical practice, BTFC achieved consistent IOP lowering in both previously treated and untreated patients with primary open-angle glaucoma or ocular hypertension. BTFC was associated with significant IOP reductions, good tolerability, and good compliance.

Efficacy and safety of fixed-combination travoprost 0.004%/timolol 0.5% in patients transitioning from bimatoprost 0.03%/timolol 0.5% combination therapy

“…19 However, not all patients achieve this target IOP with prostaglandin analog and timolol combination therapy, and some may require discontinuation because of AEs. 20 , 21 In such cases, patients may benefit from transition to another prostaglandin analog and timolol combination therapy. 21 – 23 In the current study, patients whose IOP was uncontrolled with and patients who were unable to tolerate a BAK-preserved bimatoprost-based combination regimen showed a reduction in IOP from 20.0 to 16.3 mmHg (18.8% reduction) at 4 weeks that was maintained over 3 months of treatment with TTFC.…”

Preservative-free fixed combination of bimatoprost and timolol in the evolution of compliance and treatment effectiveness in patients with primary open-angle glaucoma

“…По данным литературы, такая ситуация отмечается в 40-75 % случаев [29,30] [33]. Анализ большой популяции пациентов с глаукомой (n = 5556) в 5 комбинированных исследованиях показал, что использование ФКБТ позволяло достичь выраженного снижения ВГД как у пациентов, которые ранее лечились, так и у тех, кто ранее лечения не получал [34].…”

“…[34,45] исследовали ФКБТ БК и также показали ее высокую эффективность и переносимость: пациенты отмечали значительное улучшение окулярных симптомов, в том числе снижение умеренной/сильной гиперемии, сухости глаз и умеренной/сильной боли в глазах. ФКБТ БК редко ассоциировалась с побочными эффектами, и никакие непредвиденные побочные реакции не отмечались [34,45]. Авторы считают ФКБТ БК оптимальным препаратом для пациентов, чувствительных к консерванту.…”

Ocular Surface Disease Index in Glaucomatous Patients Treated with Bimatoprost

“…Glaucoma is a chronic, multifactorial, progressive optic neuropathy that needs long-term treatment with topical hypotensive medications. Several classes of drugs are currently available to treat this condition, including notselective and selective beta-blockers, carbonic anhydrase inhibitor, prostaglandin (PG) and prostamide analogues as well as fixed combinations (Fcs) of prostaglandin/prostamide analogues combined with 0.50% timolol maleate [1]- [3]. In the Literature, there is also a bimatoprost formulated in DuraSite [4].…”

“…Beta-blockers are often used to treat glaucoma and were considered the "gold standard" for starting glaucoma treatment until recently, when they were replaced by prostaglandin and prostamide analogues. Beta-blockers have many systemic side-effects, including bradycardia, and bronchospasms, as well as effects on the central nervous system [2] [3].…”