Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 72
Filtrar
1.
Graefes Arch Clin Exp Ophthalmol ; 262(1): 179-190, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37615697

RESUMO

PURPOSE   : To compare the efficacy and safety of the fixed-dose combination (FDC) of netarsudil 0.02%/latanoprost 0.005% ophthalmic solution (NET/LAT; Roclanda®) with bimatoprost 0.03%/timolol maleate 0.5% (BIM/TIM; Ganfort®) ophthalmic solution in the treatment of open-angle glaucoma (OAG) and ocular hypertension (OHT). METHODS: MERCURY-3 was a 6-month prospective, double-masked, randomized, multicenter, active-controlled, parallel-group, non-inferiority study. Patients (≥ 18 years) with a diagnosis of OAG or OHT in both eyes that was insufficiently controlled with topical medication (IOP ≥ 17 mmHg in ≥ 1 eye and < 28 mmHg in both eyes) were included. Following washout, patients were randomized to once-daily NET/LAT or BIM/TIM for up to 6 months; efficacy was assessed at Week 2, Week 4, and Month 3; safety was evaluated for 6 months. Comparison of NET/LAT relative to BIM/TIM for mean IOP at 08:00, 10:00, and 16:00 h was assessed at Week 2, Week 6, and Month 3. Non-inferiority of NET/LAT to BIM/TIM was defined as a difference of ≤ 1.5 mmHg at all nine time points through Month 3 and ≤ 1.0 mmHg at five or more of nine time points through Month 3. RESULTS: Overall, 430 patients were randomized (NET/LAT, n = 218; BIM/TIM, n = 212), and all received at least one dose of study medication. Efficacy analyses were performed at Month 3 on 388 patients (NET/LAT, n = 184; BIM/TIM, n = 204). NET/LAT demonstrated non-inferiority to BIM/TIM, with a between-treatment difference in IOP of ≤ 1.5 mmHg achieved at all time points and ≤ 1.0 mmHg at the majority of time points (six of nine) through Month 3. Mean diurnal IOP during the study ranged from 15.4 to 15.6 mmHg and 15.2 to 15.6 mmHg in the NET/LAT and BIM/TIM groups respectively, with no between-group statistically significant difference. No significant differences were observed in key secondary endpoints. No serious, treatment-related adverse events (AEs) were observed, and AEs were typically mild/moderate in severity. The most common treatment-related AEs were conjunctival hyperemia (NET/LAT, 30.7%; BIM/TIM, 9.0%) and cornea verticillata (NET/LAT, 11.0%; BIM/TIM, 0%). CONCLUSIONS: Once-daily NET/LAT was non-inferior to BIM/TIM in IOP reduction in OAG and OHT, with AEs consistent with previous findings. NET/LAT offers a compelling alternative FDC treatment option for OAG and OHT.


Assuntos
Benzoatos , Glaucoma de Ângulo Aberto , Hipertensão Ocular , beta-Alanina/análogos & derivados , Humanos , Glaucoma de Ângulo Aberto/diagnóstico , Glaucoma de Ângulo Aberto/tratamento farmacológico , Timolol/efeitos adversos , Bimatoprost/uso terapêutico , Latanoprosta/efeitos adversos , Estudos Prospectivos , Pressão Intraocular , Anti-Hipertensivos/efeitos adversos , Tonometria Ocular , Hipertensão Ocular/diagnóstico , Hipertensão Ocular/tratamento farmacológico , Soluções Oftálmicas , Resultado do Tratamento , Método Duplo-Cego
2.
Indian J Ophthalmol ; 72(3): 427-431, 2024 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-38146971

RESUMO

PURPOSE: To study and compare the efficacy and safety profile of Rho-kinase inhibitor (netarsudil 0.02%) and prostaglandin analog (bimatoprost 0.01%) both as monotherapy and in combination. DESIGN: Prospective, randomized, monocentric, open-label clinical trial. METHODS: Patients ≥20 years of age with primary open-angle glaucoma or ocular hypertension (IOP >21 mmHg) were recruited and randomized to receive either netarsudil 0.02%, netarsudil 0.02% + bimatoprost 0.01%, or bimatoprost 0.01% once daily for a period of 12 weeks. IOP and side effects were documented at 4, 8, and 12 weeks. RESULTS: The mean treated IOP ranged 17.51-18.57 mmHg for netarsudil, 15.80-16.46 mmHg for bimatoprost, and 14.00-14.87 mmHg for the combination therapy group. The mean IOP reduction from baseline at 4, 8, and 12 weeks was found to be statistically significant ( P < 0.001) in all three groups. The safety profile of netarsudil/bimatoprost combination was consistent with each constituent individually. The only frequently observed ocular adverse event was conjunctival hyperemia, which was seen mostly in netarsudil and netarsudil + bimatoprost groups ( P < 0.001). CONCLUSION: The IOP-lowering effect of netarsudil 0.02% once daily is non-inferior to bimatoprost 0.01% in patients with POAG and ocular hypertension with acceptable ocular safety, and the combination therapy achieved a higher IOP-lowering effect. This group of medications can be a useful adjunct in patients on maximal therapy.


Assuntos
Benzoatos , Glaucoma de Ângulo Aberto , Glaucoma , Hipertensão Ocular , beta-Alanina/análogos & derivados , Humanos , Lactente , Bimatoprost/uso terapêutico , Glaucoma de Ângulo Aberto/tratamento farmacológico , Estudos Prospectivos , Pressão Intraocular , Anti-Hipertensivos/uso terapêutico , Hipertensão Ocular/tratamento farmacológico , Glaucoma/tratamento farmacológico , Resultado do Tratamento , Soluções Oftálmicas
3.
Indian J Ophthalmol ; 71(5): 1768-1776, 2023 05.
Artigo em Inglês | MEDLINE | ID: mdl-37203029

RESUMO

Glaucoma is a major cause of irreversible blindness worldwide. Reducing intraocular pressure (IOP) is currently the only approach to prevent further optic nerve head damage. Pharmacotherapy is the mainstay of treatment for glaucoma patients. In recent years, a significant milestone in glaucoma treatment has been a transition to prostaglandin analogs (PGAs) as the first line of drugs. The rapid shift from traditional ß-blockers to PGAs is primarily due to their excellent efficacy, convenient once-a-day usage, better diurnal control of IOP, and systemic safety profiles. This review article aims to provide information regarding the various PGAs in practice and also the newer promising drugs.


Assuntos
Glaucoma , Oftalmologia , Prostaglandinas F Sintéticas , Humanos , Bimatoprost/uso terapêutico , Cloprostenol/efeitos adversos , Travoprost/uso terapêutico , Latanoprosta/uso terapêutico , Prostaglandinas F Sintéticas/uso terapêutico , Anti-Hipertensivos/uso terapêutico , Amidas , Prostaglandinas Sintéticas/uso terapêutico , Glaucoma/tratamento farmacológico , Glaucoma/induzido quimicamente , Pressão Intraocular
4.
Sci Rep ; 13(1): 6438, 2023 04 20.
Artigo em Inglês | MEDLINE | ID: mdl-37081101

RESUMO

Bimatoprost ophthalmic solution 0.03% (PGF2α analogues) combined with narrowband ultraviolet B (NB-UVB) was reported to be an effective treatment for vitiligo. To investigate the efficacy and safety of treatment for non-segmental/segmental vitiligo compared among bimatoprost ophthalmic solution 0.01% combined with NB-UVB phototherapy, bimatoprost monotherapy, and placebo. This single-blind randomized controlled study enrolled stable Thai vitiligo patients with at least three similarly sized lesions in the same anatomical area. The treatment duration was 6 months with 1- and 2-month post-treatment follow-ups. The 3 selected lesions on each patient were randomized to receive combination therapy, monotherapy, or placebo. The Vitiligo Area Scoring Index (VASI) was used to evaluate lesion response. Of the 25 initially enrolled subjects, 19 patients were analyzed. There were 13 and 6 non-segmental and segmental vitiligo cases, respectively. Eight and 11 cases had face/neck and non-face/neck lesions, respectively. Non-segmental vitiligo and non-face/neck vitiligo patients in the combination group had significant improvement in VASI score at 3 months, 6 months, and at the 2-month follow-up. No side effects were observed/reported. Bimatoprost combination therapy was shown to be safe and effective for treating Thai patients with non-segmental vitiligo in non-face/neck areas of the body.


Assuntos
Terapia Ultravioleta , Vitiligo , Humanos , Vitiligo/tratamento farmacológico , Vitiligo/radioterapia , Bimatoprost/uso terapêutico , Método Simples-Cego , Resultado do Tratamento , Terapia Combinada , Soluções Oftálmicas/uso terapêutico
6.
J Ocul Pharmacol Ther ; 39(1): 55-62, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-36378864

RESUMO

Purpose: To evaluate the time course of biodegradation of an intracameral, biodegradable, sustained-release bimatoprost implant that lowers intraocular pressure without the need for daily eye drops. Methods: In 2 identically designed, randomized, phase 3 clinical trials, adults with open-angle glaucoma or ocular hypertension and open iridocorneal angles inferiorly in the study eye were administered 10- or 15-µg bimatoprost implant (day 1 and weeks 16 and 32) or twice-daily topical timolol 0.5%. Implants were assessed on gonioscopy throughout the studies. Investigators reported whether implants were visible, estimated the size of visible implants relative to their initial size at implantation, and reported the implant location. Data for 10-µg implant placed on day 1 were pooled from both studies for analysis. Results: A total of 372 patients received the 10-µg bimatoprost implant. The degree of implant biodegradation at each follow-up time point was variable among patients. The implant frequently swelled during the initial phase of biodegradation from 6 to 28 weeks. Accelerated biodegradation occurred between 31 and 52 weeks, resulting in 82% of implants absent or ≤25% of initial size by 52 weeks. By month 20, 95% of implants had biodegraded to absent or ≤25% of initial size. The implant was predominantly located inferiorly in the iridocorneal angle. Conclusions: Bimatoprost implant biodegradation in phase 3 studies showed some degree of variability among patients. Clinically significant implant biodegradation was observed in the majority of patients by 12 months. Clinical studies are in progress to further understand implant biodegradation and the ideal timing for implant re-administration. ClinicalTrials.gov NCT02247804; ClinicalTrials.gov NCT02250651.


Assuntos
Glaucoma de Ângulo Aberto , Glaucoma , Hipertensão Ocular , Adulto , Humanos , Amidas/uso terapêutico , Anti-Hipertensivos/uso terapêutico , Bimatoprost/uso terapêutico , Cloprostenol/uso terapêutico , Glaucoma/tratamento farmacológico , Glaucoma de Ângulo Aberto/tratamento farmacológico , Glaucoma de Ângulo Aberto/cirurgia , Pressão Intraocular , Hipertensão Ocular/tratamento farmacológico , Timolol/uso terapêutico
8.
Graefes Arch Clin Exp Ophthalmol ; 260(11): 3577-3585, 2022 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-35524800

RESUMO

PURPOSE: Peripheral anterior synechiae (PAS) have been reported as a complication after argon laser trabeculoplasty, but rarely reported after selective laser trabeculoplasty (SLT). This study aims to determine the incidence and predictors of this potential complication in phakic eyes of Chinese patients. METHODS: A retrospective review of consecutive Chinese phakic patients who underwent SLT for primary open-angle glaucoma or ocular hypertension from 2011 to 2015 was analyzed for post-operative outcomes, including the development of PAS. RESULTS: There was a total of 292 patients (509 eyes) that were of Chinese ethnicity and eligible in our analysis. The 4-year incidence of PAS was 13.57% for the 221 eyes with documented gonioscopy after SLT, and the time, since first SLT, to PAS diagnosis was 5.62 years (2052 ± 75.2 days). After accounting for the inter-eye correlation by the mixed effect Cox regression model (AUC = 0.885), the predictors of earlier PAS diagnosis were baseline intraocular pressure (≥ 18 versus < 18) (HR = 4.6, p = 0.031), baseline use of bimatoprost (HR = 14.97, p = 0.006), and pre-existing hypertension (HR = 11.78, p = 0.016). There was no significant association of earlier PAS diagnosis with age (p = 0.434), baseline number of medications used (p = 0.693), and baseline use of brinzolamide (p = 0.326). CONCLUSION: PAS development after SLT appears to be more common in Chinese patients, with a presumed 4-year incidence of 13.6%, based on retrospective review of eyes with subsequent documented gonioscopy findings. TRIAL REGISTRATION: Hong Kong University Clinical Trials Registry (HKUCTR-2350).


Assuntos
Doenças da Córnea , Glaucoma de Ângulo Aberto , Doenças da Íris , Terapia a Laser , Trabeculectomia , Humanos , Trabeculectomia/efeitos adversos , Bimatoprost/uso terapêutico , Argônio/uso terapêutico , Pressão Intraocular , Terapia a Laser/efeitos adversos , Doenças da Córnea/cirurgia , China/epidemiologia , Lasers , Resultado do Tratamento
9.
Adv Ther ; 39(8): 3501-3521, 2022 08.
Artigo em Inglês | MEDLINE | ID: mdl-35524840

RESUMO

INTRODUCTION: The VISIONARY study demonstrated statistically significant intraocular pressure (IOP) reductions with the preservative-free fixed-dose combination of tafluprost 0.0015% and timolol 0.5% (PF tafluprost/timolol FC) in open-angle glaucoma (OAG) or ocular hypertension (OHT) patients, sub-optimally controlled with topical prostaglandin analogue (PGA) or beta-blocker monotherapy. Current subanalyses have examined these data according to the baseline monotherapy. METHODS: A European, prospective, observational study included adults (aged ≥ 18 years) with OAG or OHT, who were switched to the PF tafluprost/timolol FC from PGA or beta-blocker monotherapy. Treatment outcomes were reported according to prior monotherapy subgroup: beta-blocker, preserved latanoprost, PF-latanoprost, bimatoprost, tafluprost, and travoprost. Endpoints included the mean change from baseline regarding IOP, conjunctival hyperemia, and corneal fluorescein staining (CFS) at Week 4 and Week 12, and at Month 6. RESULTS: The subanalysis included 577 patients. All prior monotherapy subgroups demonstrated statistically significant IOP reductions from baseline at Week 4, that were maintained through Month 6 (p < 0.001). Mean (SD) IOP change at Month 6 was 6.6 (4.16), 6.3 (4.39), 5.6 (3.67), 4.9 (2.97), 4.6 (4.39), and 4.7  (3.64) mmHg for prior beta-blocker, preserved latanoprost, PF-latanoprost, tafluprost, bimatoprost, and travoprost subgroups, respectively. The largest IOP change was observed in the preserved latanoprost subgroup for each of the ≥ 20%, ≥ 25%, ≥ 30%, and ≥ 35% IOP reduction categories at Month 6, demonstrating respective reductions of 8.06, 9.20, 10.64, and 11.55 mmHg. CFS was significantly reduced at Month 6 in the prior bimatoprost subgroup (p = 0.0013). Conjunctival hyperemia severity was significantly reduced at each study visit for prior preserved latanoprost users (p < 0.001). CONCLUSION: PF tafluprost/timolol FC therapy provided statistically and clinically significant IOP reductions from Week 4 over the total 6-month period, in patients with OAG/OHT, regardless of the type of prior PGA or beta-blocker monotherapy used. Conjunctival hyperemia severity and CFS decreased significantly in prior bimatoprost and preserved latanoprost users, respectively. CLINICAL STUDY NUMBER: European Union electronic Register of Post-Authorization Studies (EU PAS) register number: EUPAS22204.


Assuntos
Glaucoma de Ângulo Aberto , Glaucoma , Hiperemia , Hipertensão Ocular , Adulto , Anti-Hipertensivos/efeitos adversos , Bimatoprost/uso terapêutico , Combinação de Medicamentos , Glaucoma/tratamento farmacológico , Glaucoma de Ângulo Aberto/tratamento farmacológico , Humanos , Hiperemia/induzido quimicamente , Hiperemia/tratamento farmacológico , Pressão Intraocular , Latanoprosta/uso terapêutico , Hipertensão Ocular/induzido quimicamente , Hipertensão Ocular/tratamento farmacológico , Estudos Prospectivos , Prostaglandinas A/uso terapêutico , Prostaglandinas F , Timolol/efeitos adversos , Travoprost/uso terapêutico
10.
J Glaucoma ; 31(10): e96-e100, 2022 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-35513899

RESUMO

PRCIS: We investigate the efficacy of triple-fixed-combination of bimatoprost/brimonidine/timolol once and twice a day, demonstrating higher intraocular pressure reduction with once-a-day use, and discuss possible implications based on previous literature. PURPOSE: The purpose of this study was to compare the efficacy of a fixed combination bimatoprost-timolol-brimonidine (Triplenex) instilled once-daily with twice-daily in primary open angle glaucoma. PATIENTS AND METHODS: A randomized clinical trial at a public eye care institution. Thirty patients with primary open angle glaucoma were followed up for 3 months. The right and left eyes of these patients were randomly assigned to once-daily (10:00 pm ) or twice-daily (10:00 am ; 10:00 pm ) regimens of fixed combination bimatoprost-timolol-brimonidine. Intraocular pressure peaks were obtained with the water drinking test before the introduction of this medication (basal WDT0), 1 month (WDT1), 2 months (WDT2), and 3 months (WDT3) after starting the use of the fixed combination of bimatoprost/timolol/brimonidine (Triplenex). Variation from peak intraocular pressure at WDT3 to peak at WDT0 was compared within groups of 2 versus once-daily regimen. RESULTS: Sixty eyes of 30 patients (age: 70.67±9.70 y) were included in this study. Baseline clinical characteristics were comparable between groups. The mean reduction in peak intraocular pressure from WDT0 to WDT3 was 6.1±6.1 mm Hg (30.5%) in the eyes receiving 1 drop per day and 4.3±5.7 mm Hg (21.5%) in the eyes receiving 2 drops per day ( P =0.023). Mean reduction in peak intraocular pressure considering all WDT was also higher in the group with once-a-day treatment (5.90±6.03 vs. 4.46±4.28 mm Hg, P =0.006). CONCLUSION: Fixed combination of bimatoprost 0.01%, brimonidine tartrate 0.15%, and timolol maleate 0.5% once-a-day is more effective in reducing peak intraocular pressure as measured by the WDT than twice-a-day dosing.


Assuntos
Glaucoma de Ângulo Aberto , Hipertensão Ocular , Idoso , Idoso de 80 Anos ou mais , Anti-Hipertensivos/uso terapêutico , Bimatoprost/uso terapêutico , Tartarato de Brimonidina/uso terapêutico , Método Duplo-Cego , Glaucoma de Ângulo Aberto/induzido quimicamente , Glaucoma de Ângulo Aberto/tratamento farmacológico , Humanos , Pressão Intraocular , Pessoa de Meia-Idade , Hipertensão Ocular/induzido quimicamente , Hipertensão Ocular/tratamento farmacológico , Soluções Oftálmicas , Timolol/uso terapêutico , Água
11.
J Ocul Pharmacol Ther ; 38(4): 311-318, 2022 05.
Artigo em Inglês | MEDLINE | ID: mdl-35442770

RESUMO

Purpose: To assess the intraocular pressure (IOP)-lowering effect of a biodegradable bimatoprost implant following selective laser trabeculoplasty (SLT) in a canine model. Methods: Unilateral SLT was performed in 11 normotensive, treatment-naive beagle dogs. IOP was measured at baseline (pre-SLT) and weekly post-SLT (≤10 weeks). After IOP returned to baseline or at 10 weeks (whichever occurred first), a sustained-release bimatoprost implant was administered bilaterally in the anterior chamber of each animal. IOP was measured weekly for 4 weeks and then every 2 weeks up to week 42. Results: The main outcomes included the IOP change (%) from baseline, calculated in both eyes in the overall population, SLT responder subgroup (defined by peak IOP reduction from baseline ≥3 mmHg or ≥15% for >1 week post-SLT), and SLT nonresponder subgroup (defined by peak IOP reduction from baseline <3 mmHg or <15%). The bimatoprost implant lowered IOP similarly in both the SLT-treated and fellow SLT-naive eyes. Following bimatoprost implant administration, the mean (standard deviation [SD]) peak IOP reduction from baseline was 34.4% (8.5%) in SLT-treated eyes and 35.7% (5.9%) in fellow SLT-naive eyes. The bimatoprost implant lowered IOP comparably (P > 0.17) in eyes that responded to SLT (mean [SD] peak IOP reduction, 34.6% [10.7%]; n = 6) and those that did not (mean [SD] peak IOP reduction, 34.1% [6.1%]; n = 5). Conclusion: The bimatoprost implant effectively lowered IOP in eyes pretreated with SLT, regardless of response to SLT. The current data suggest that eyes previously treated with SLT can still benefit from the intracameral bimatoprost implant.


Assuntos
Terapia a Laser , Hipertensão Ocular , Trabeculectomia , Animais , Bimatoprost/farmacologia , Bimatoprost/uso terapêutico , Preparações de Ação Retardada , Cães , Pressão Intraocular , Lasers , Resultado do Tratamento
12.
Ann Med ; 54(1): 343-358, 2022 12.
Artigo em Inglês | MEDLINE | ID: mdl-35076329

RESUMO

Glaucoma is a progressive optic neuropathy and a leading cause of irreversible blindness. The disease has conventionally been characterized by an elevated intraocular pressure (IOP); however, recent research has built the consensus that glaucoma is not only dependent on IOP but rather represents a multifactorial optic neuropathy. Although many risk factors have been identified ranging from demographics to co-morbidities to ocular structural predispositions, IOP is currently the only modifiable risk factor, most often treated by topical IOP-lowering medications. However, topical hypotensive regimens are prone to non-adherence and are largely inefficient, leading to disease progression in spite of treatment. As a result, several companies are developing sustained release (SR) drug delivery systems as alternatives to topical delivery to potentially overcome these barriers. Currently, Bimatoprost SR (DurystaTM) from Allergan plc is the only FDA-approved SR therapy for POAG. Other SR therapies under investigation include: bimatoprost ocular ring (Allergan) (ClinicalTrials.gov identifier: NCT01915940), iDose® (Glaukos Corporation) (NCT03519386), ENV515 (Envisia Therapeutics) (NCT02371746), OTX-TP (Ocular Therapeutix) (NCT02914509), OTX-TIC (Ocular Therapeutix) (NCT04060144), and latanoprost free acid SR (PolyActiva) (NCT04060758). Additionally, a wide variety of technologies for SR therapeutics are under investigation including ocular surface drug delivery systems such as contact lenses and nanotechnology. While challenges remain for SR drug delivery technology in POAG management, this technology may shift treatment paradigms and dramatically improve outcomes.


Assuntos
Glaucoma , Pressão Intraocular , Anti-Hipertensivos/uso terapêutico , Bimatoprost/uso terapêutico , Ensaios Clínicos como Assunto , Preparações de Ação Retardada/uso terapêutico , Glaucoma/tratamento farmacológico , Humanos
13.
Br J Ophthalmol ; 106(5): 640-647, 2022 05.
Artigo em Inglês | MEDLINE | ID: mdl-33397657

RESUMO

BACKGROUND/AIMS: To assess the comparative efficacy of latanoprostene bunod (LBN), a novel prostaglandin analogue (PGA), to other medications for open-angle glaucoma and ocular hypertension on lowering intraocular pressure (IOP). METHODS: A systematic literature review adapted from the Li et al (Ophthalmology, 2016) study was conducted. Medline, Embase and PubMed were searched for randomised controlled trials published between 1 January 2014 and 19 March 2020. Studies had to report IOP reduction after 3 months for at least two different treatments among placebo, PGAs (bimatoprost 0.01%, bimatoprost 0.03%, latanoprost, LBN, tafluprost, unoprostone) or apraclonidine, betaxolol, brimonidine, brinzolamide, carteolol, dorzolamide, levobunolol, timolol, travoprost. A Bayesian network meta-analysis was performed to provide the relative effect in terms of mean difference (95% credible interval) of IOP reduction and ranking probabilities. Surface under the cumulative ranking curve (SUCRA) was generated. RESULTS: A total of 106 trials were included with data for 18 523 participants. LBN was significantly more effective than unoprostone (-3.45 (-4.77 to -2.12)). Although relative effect was not significative, compared with other PGAs, LBN numerically outperformed latanoprost (-0.70 (-1.83 to 0.43)) and tafluoprost (-0.41 (-1.87 to 1.07)), was similar to bimatoprost 0.01% (-0.02(-1.59 to 1.55)) and was slightly disadvantaged by bimatoprost 0.03% (-0.17 (-1.42 to 1.07)). LBN was significantly more efficient than the beta-blockers apraclonidine, betaxolol, brimonidine, brinzolamide, carteolol, dorzolamide and timolol. According to SUCRA, LBN was ranked second after bimatoprost 0.03%, followed by bimatoprost 0.01%. CONCLUSION: LBN was significantly more effective than the PGA unoprostone and most of the beta-blockers. Compared with the most widely used PGAs, LBN numerically outperformed latanoprost and travoprost and was similar to bimatoprost 0.01%.


Assuntos
Carteolol , Glaucoma de Ângulo Aberto , Hipertensão Ocular , Prostaglandinas F Sintéticas , Amidas/uso terapêutico , Anti-Hipertensivos/uso terapêutico , Teorema de Bayes , Betaxolol/uso terapêutico , Bimatoprost/uso terapêutico , Tartarato de Brimonidina/uso terapêutico , Carteolol/uso terapêutico , Glaucoma de Ângulo Aberto/tratamento farmacológico , Humanos , Pressão Intraocular , Latanoprosta , Metanálise em Rede , Hipertensão Ocular/tratamento farmacológico , Prostaglandinas A/uso terapêutico , Timolol/uso terapêutico , Travoprost/uso terapêutico
14.
Semin Ophthalmol ; 37(3): 385-390, 2022 Apr 03.
Artigo em Inglês | MEDLINE | ID: mdl-34586961

RESUMO

BACKGROUND: Sustained release drug delivery has the potential to change glaucoma care by decreasing the challenge of medication adherence. Many approaches are in development, but this review focuses on Durysta (Allergan plc, Dublin, Ireland), the only FDA-approved sustained release intracameral treatment available at this time. KEY FINDINGS: Durysta is a bimatoprost sustained release (BimSR) intracameral implant. Clinical trials have demonstrated that BimSR implants can provide comparable levels of intraocular pressure (IOP) control as topical eyedrops. BimSR has advantages such as decreasing concerns regarding drop adherence, reducing ocular surface and periocular side effects from topical drops, and decreased daily treatment burden for patients. In addition, studies have shown continued IOP lowering in some eyes during extended follow-up periods when all of the BimSR medication has already been delivered. Hypothesized mechanisms to explain this finding include increased matrix metalloproteinase expression that causes extracellular matrix reorganization to permit greater aqueous outflow, as well as decreased episcleral venous pressure. The major safety concern at this time for Durysta and future intracameral implants is corneal endothelial cell loss, which was worse with repeat BimSR administration compared to single dosing. Several studies are underway to investigate mechanisms of action and to better understand safe and effective dosing of medications in this class.


Assuntos
Anti-Hipertensivos , Hipertensão Ocular , Anti-Hipertensivos/uso terapêutico , Bimatoprost/farmacologia , Bimatoprost/uso terapêutico , Preparações de Ação Retardada/uso terapêutico , Humanos , Injeções Intraoculares , Pressão Intraocular , Hipertensão Ocular/tratamento farmacológico
15.
Drugs ; 81(17): 2017-2033, 2021 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-34724172

RESUMO

OBJECTIVE: To evaluate the intraocular pressure (IOP)-lowering efficacy and safety of 10 and 15 µg bimatoprost implant in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). METHODS: This randomized, 20-month, multicenter, masked, parallel-group, phase 3 trial enrolled 528 patients with OAG or OHT and an open iridocorneal angle inferiorly in the study eye. Study eyes were administered 10 or 15 µg bimatoprost implant on day 1, week 16, and week 32, or twice-daily topical timolol maleate 0.5%. Primary endpoints were IOP and IOP change from baseline through week 12. Safety measures included treatment-emergent adverse events (TEAEs) and corneal endothelial cell density (CECD). RESULTS: Both 10 and 15 µg bimatoprost implant met the primary endpoint of noninferiority to timolol in IOP lowering through 12 weeks. Mean IOP reductions from baseline ranged from 6.2-7.4, 6.5-7.8, and 6.1-6.7 mmHg through week 12 in the 10 µg implant, 15 µg implant, and timolol groups, respectively. IOP lowering was similar after the second and third implant administrations. Probabilities of requiring no IOP-lowering treatment for 1 year after the third administration were 77.5% (10 µg implant) and 79.0% (15 µg implant). The most common TEAE was conjunctival hyperemia, typically temporally associated with the administration procedure. Corneal TEAEs of interest (primarily corneal endothelial cell loss, corneal edema, and corneal touch) were more frequent with the 15 than the 10 µg implant and generally were reported after repeated administrations. Loss in mean CECD from baseline to month 20 was ~ 5% in 10 µg implant-treated eyes and ~ 1% in topical timolol-treated eyes. Visual field progression (change in the mean deviation from baseline) was reduced in the 10 µg implant group compared with the timolol group. CONCLUSIONS: The results corroborated the previous phase 3 study of the bimatoprost implant. The bimatoprost implant met the primary endpoint and effectively lowered IOP. The majority of patients required no additional treatment for 12 months after the third administration. The benefit-risk assessment favored the 10 over the 15 µg implant. Studies evaluating other administration regimens with reduced risk of corneal events are ongoing. The bimatoprost implant has the potential to improve adherence and reduce treatment burden in glaucoma. CLINICALTRIALS. GOV IDENTIFIER: NCT02250651.


Assuntos
Anti-Hipertensivos/uso terapêutico , Bimatoprost/uso terapêutico , Implantes de Medicamento/uso terapêutico , Glaucoma de Ângulo Aberto/tratamento farmacológico , Hipertensão Ocular/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Anti-Hipertensivos/administração & dosagem , Anti-Hipertensivos/efeitos adversos , Bimatoprost/administração & dosagem , Bimatoprost/efeitos adversos , Relação Dose-Resposta a Droga , Método Duplo-Cego , Implantes de Medicamento/administração & dosagem , Implantes de Medicamento/efeitos adversos , Feminino , Humanos , Pressão Intraocular/efeitos dos fármacos , Masculino , Pessoa de Meia-Idade , Soluções Oftálmicas , Timolol/uso terapêutico , Adulto Jovem
16.
J Ocul Pharmacol Ther ; 37(10): 556-564, 2021 12.
Artigo em Inglês | MEDLINE | ID: mdl-34610257

RESUMO

Purpose: To investigate the influence of benzalkonium chloride (BAK) on ocular surface disease (OSD) in glaucoma patients receiving ocular-hypotensive agent. Methods: Patients were randomized to receive BAK-containing latanoprost (Xalatan) or preservative-free bimatoprost (Lumigan PF). Intraocular pressure (IOP), basal Schirmer's test, noninvasive keratograph tear-breakup time (TBUT), conjunctival redness score (R score), OSD index (OSDI), and corneal Oxford staining were recorded and compared between the 2 groups at 1-month and 4-month visits. The influence of BAK was analyzed by a generalized estimating equation model. Results: We enrolled 74 and 76 eyes treated with latanoprost and bimatoprost, respectively. The IOP decreased in both groups, although greater reduction was observed for latanoprost (13.95 vs. 15.42 mmHg, P = 0.0264). There was a significantly negative association between tear flow and latanoprost use (ß = -0.763, P = 0.0243). The first and average TBUT did not show intergroup differences, but the area with unstable tear film increased with latanoprost use and showed marginal significance at 4-month visit (9.33% vs. 5.94% P = 0.055). In both groups, OSDI decreased, whereas Oxford stain increased over time, and R scores showed improvement after transient increase in the first month. The bimatoprost group had significantly worse conjunctival hyperemia, whereas a negative association with conjunctival hyperemia was revealed for latanoprost use (R score-bulbar nasal: ß = -0.045, P = 0.0423). Conclusions: BAK-containing latanoprost was associated with decreased tear secretion and may be associated with tear-film instability, whereas bimatoprost was associated with worse conjunctival hyperemia. Ocular surface side effects should be considered when prescribing BAK-containing medication to glaucoma patients.


Assuntos
Compostos de Benzalcônio/uso terapêutico , Bimatoprost/uso terapêutico , Glaucoma/tratamento farmacológico , Latanoprosta/uso terapêutico , Soluções Oftálmicas/uso terapêutico , Conservantes Farmacêuticos/uso terapêutico , Adulto , Idoso , Compostos de Benzalcônio/efeitos adversos , Bimatoprost/efeitos adversos , Comorbidade , Conjuntivite/induzido quimicamente , Feminino , Humanos , Pressão Intraocular/efeitos dos fármacos , Latanoprosta/efeitos adversos , Masculino , Pessoa de Meia-Idade , Soluções Oftálmicas/efeitos adversos , Conservantes Farmacêuticos/efeitos adversos , Estudos Prospectivos , Lágrimas/efeitos dos fármacos
17.
Bull Cancer ; 108(10): 963-980, 2021 Oct.
Artigo em Francês | MEDLINE | ID: mdl-34304865

RESUMO

Alopecia, although long considered an unavoidable consequence of cancer therapy, currently presents a multifaceted challenge. The knowledge of the physiology of the hair and consequently of the pathophysiology of alopecia has led to show that there is not one but several types of alopecia. Transposed to the world of oncology, different types of alopecia and subsequently molecular pathways have been characterized, allowing a better understanding of the underlying mechanisms. Thus, in patients with cancer, alopecia can be iatrogenic (chemotherapies, endocrine therapies, targeted therapies, immunotherapies, radiotherapy, surgery) or directly the consequence of the disease itself (malnutrition, scalp metastases, paraneoplastic syndromes). Knowledge of the incriminated mechanism(s) could thus make it possible to deploy an appropriate care component, whether on the preventive or curative sides or in terms of supportive care. These are particularly essential regarding the psychological repercussions caused by alopecia, with significant consequences on the quality of life of patients and with a potential impact on treatment compliance. On the preventive side, the last few years have seen the advent of the automated scalp cooling therapy, supported by several randomized clinical trials. On the curative side, several therapeutic proposals are currently deployed or under development in order to provide relevant treatments.


Assuntos
Alopecia/etiologia , Doença Iatrogênica , Neoplasias/complicações , Neoplasias/terapia , Alopecia/prevenção & controle , Alopecia/psicologia , Alopecia/terapia , Anti-Hipertensivos/uso terapêutico , Antineoplásicos/efeitos adversos , Bimatoprost/uso terapêutico , Cabelo/fisiologia , Cabelo/transplante , Folículo Piloso/fisiologia , Humanos , Imunoterapia , Minoxidil/uso terapêutico , Terapia de Alvo Molecular/efeitos adversos , Qualidade de Vida , Radioterapia/efeitos adversos , Dermatoses do Couro Cabeludo/complicações , Espironolactona/uso terapêutico
19.
J Craniofac Surg ; 31(5): 1284-1286, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32516215

RESUMO

The purpose of this retrospective study was to evaluate the effectiveness of blepharoptosis surgery in patients with deepening of the upper eyelid sulcus (DUES). This case series included 10 consecutive patients (19 eyes) with DUES associated with use of a prostaglandin analog for glaucoma. Patients who had used bimatoprost and developed DUES were changed to an alternative prostaglandin analog and observed for ≥3 months. If there was no improvement, they underwent levator resection for blepharoptosis and were followed up for ≥6 months postoperatively. Improvement in margin reflex distance-1 and surgical complications was evaluated. After discontinuation of bimatoprost in 3 cases (6 eyes), mild subjective and objective improvement in DUES was seen in 2 cases (4 eyes) but without improvement in blepharoptosis. The prostaglandin analog used before surgery was travoprost in 4 eyes (21.0%), tafluprost in 7 eyes (36.9%; including 4 eyes switched from bimatoprost), and latanoprost in 8 eyes (42.1%; including 2 eyes switched from bimatoprost). The mean margin reflex distance-1 value was 1.11 ±â€Š0.96 mm before surgery and 3.72 ±â€Š0.81 mm at the final postoperative follow-up; the difference was significant (P = 3.32 × -10). There were no intraoperative or postoperative complications. Levator resection is a useful and safe procedure for blepharoptosis with DUES.


Assuntos
Blefaroptose/cirurgia , Idoso , Bimatoprost/uso terapêutico , Pálpebras , Feminino , Humanos , Latanoprosta/uso terapêutico , Masculino , Prostaglandinas F/uso terapêutico , Estudos Retrospectivos , Travoprost/uso terapêutico
20.
Medicine (Baltimore) ; 99(23): e20356, 2020 Jun 05.
Artigo em Inglês | MEDLINE | ID: mdl-32501980

RESUMO

BACKGROUND: Bimatoprost has been reported to treat primary open-angle glaucoma (POAG) effectively. However, up-to-date, no systematic review has specifically addressed the efficacy and safety of bimatoprost for the treatment of POAG. Therefore, this study will propose to appraise the efficacy and safety of bimatoprost for the treatment of POAG. METHODS: We will perform a systematic search in MEDLINE, EMBASE, CINAHI, Cumulative Index to Nursing and Allied Health Literature, Allied and Complementary Medicine Database, Web of Science, Cochrane Library, Chinese Biomedical Literature Database, and China National Knowledge Infrastructure from inception up to the March 1, 2020. We will include randomized controlled trials (RCTs) for evaluating the efficacy and safety of bimatoprost for the treatment of POAG. Primary outcome is the mean intraocular pressure (IOP) reduction from baseline to the endpoint, and change in best corrected visual acuity. Secondary outcomes are contrast sensitivity, rate of progression of glaucoma, quality of life, and incidence of adverse events. Study quality will be examined by Cochrane Collaboration tool, and strength of evidence will be evaluated by Grading of Recommendations Assessment Development and Evaluation tool. RESULTS: This proposed study will outline the current RCTs to assess the efficacy and safety of bimatoprost for the treatment of POAG. CONCLUSION: The findings of this study will confirm whether bimatoprost is beneficial to patients with POAG. SYSTEMATIC REVIEW REGISTRATION: INPLASY202040118.


Assuntos
Anti-Hipertensivos/uso terapêutico , Bimatoprost/uso terapêutico , Glaucoma de Ângulo Aberto/tratamento farmacológico , Anti-Hipertensivos/administração & dosagem , Anti-Hipertensivos/efeitos adversos , Bimatoprost/administração & dosagem , Bimatoprost/efeitos adversos , Humanos , Pressão Intraocular/efeitos dos fármacos , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa , Metanálise como Assunto
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA
...