AIM:To investigate the treatment pattern and safety of tafluprost for glaucoma and ocular hypertension(OH)in clinical practice in China.METHODS:This post-marketing observational study included patients who received ta...AIM:To investigate the treatment pattern and safety of tafluprost for glaucoma and ocular hypertension(OH)in clinical practice in China.METHODS:This post-marketing observational study included patients who received tafluprost to lower intraocular pressure(IOP)within 30d between September 2017 and March 2020 in 20 hospitals in China.Adverse drug reactions(ADRs)during tafluprost treatment and within 30d after the treatment were collected.RESULTS:A total of 2544 patients were included in this study,of them 58.5%(1488/2544)had primary open angle glaucoma(POAG),21.9%(556/2544)had OH and 19.7%(500/2544)used tafluprost for other reasons.Of 359 ADRs occurred in 10.1%(258/2544)patients,and no serious adverse event occurred.The most common ADR was conjunctival hyperemia(128 ADRs in 124 patients,4.9%).Totally 1670 participants(65.6%)combined tafluprost with carbonic anhydrase inhibitors(CAIs;37.1%,620/1670),sympathomimetics(33.5%,559/1670),β-blockers(33.2%,555/1670),other prostaglandin analogs(PGAs;15.6%,260/1670)and other eye drops(15.1%,253/1670).The highest incidence of conjunctival hyperemia was noted in patients who received tafluprost in combination with other PGAs(23 ADRs in 23 patients,8.8%,23/260)and the lowest was in combination with CAIs(16 ADRs in 16 patients,2.6%,16/620).Tafluprost was applied in primary angle-closure glaucoma(41.6%,208/500),after glaucoma surgery(17.8%,89/500)and after non-glaucoma surgery(15.8%,79/500).CONCLUSION:Tafluprost is safe for POAG and OH,and tolerable when combined with other eye drops and under various clinical circumstances.展开更多
AIM:To evaluate the intraocular pressure(IOP)-lowering efficacy and safety of tafluprost 0.0015%eye drops[benzalkonium chloride(BAK)0.1 mg/mL]compared with that of latanoprost 0.005%eye drops(BAK 0.2 mg/mL)for primary...AIM:To evaluate the intraocular pressure(IOP)-lowering efficacy and safety of tafluprost 0.0015%eye drops[benzalkonium chloride(BAK)0.1 mg/mL]compared with that of latanoprost 0.005%eye drops(BAK 0.2 mg/mL)for primary open angle glaucoma(POAG)and ocular hypertension(OHT).METHODS:All the randomized controlled trials(RCTs)about treating POAG and OHT comparing tafluprost and latanoprost were collected by searching PubMed,Embase,Cochrane Library,CNKI and VIP.The outcomes of interest to evaluate the clinical efficacy and adverse effects included IOP and patient-related drop discomfort.RESULTS:Five RCTs involving 888 glaucoma patients were included.The results showed that,1)at the end of the study,no statistically significant differences were observed in IOP reduction[standard mean difference(SMD)=0.48,95%CI 0.07 to 0.88,P=0.085]between tafluprost and latanoprost;2)No statistically significant differences were observed in adverse events of foreign-body sensation[relative risk(RR)=0.62,95%CI 0.26 to 1.46,P=0.269],eye irritation(RR=1.16,95%CI 0.49 to 2.75,P=0.744),eye pain(RR=2.000,95%CI 0.949 to 4.216,P=0.07),iris hyperpigmentation(RR=0.741,95%CI 0.235 to 2.334,P=0.61),dry eye(RR=1.154,95%CI 0.409 to 3.256,P=0.79)and eye pruritus(RR=1.600,95%CI 0.536 to 4.774,P=0.4)between tafluprost and latanoprost.However,tafluprost showed more reported incidence of conjunctival hyperaemia than latanoprost(RR=2.11,95%CI 1.24 to 3.59,P=0.006).CONCLUSION:Tafluprost 0.0015%eye drops(BAK 0.1 mg/mL)and latanoprost 0.005%eye drops(BAK 0.2 mg/mL)are comparable in lowering IOP for open angle glaucoma(OAG)and OHT.It does not differ in the incidence of foreign-body sensation,eye irritation,eye pain,iris hyper-pigmentation,dry eye and eye pruritus,but tafluprost shows less ocular tolerability because of more incidence of conjunctival hyperaemia.展开更多
Purpose: Fixed-combination medication to treat glaucoma can reduce intraocular pressure (IOP) without negative effects of concomitant medication. Tafluprost/timolol fixed-combination ophthalmic solution (TTFC) has bee...Purpose: Fixed-combination medication to treat glaucoma can reduce intraocular pressure (IOP) without negative effects of concomitant medication. Tafluprost/timolol fixed-combination ophthalmic solution (TTFC) has been reported to show similar effectiveness in lowering IOP, compared with concomitant use of its component drugs, tafluprost and timolol. However, the difference in IOP-lowering effects between TTFC and concomitant use of tafluprost and gel-forming timolol is unknown. Hence, we conducted this switching study from tafluprost and gel-forming timolol to TTFC in glaucoma patients undergoing multi-drug therapy. Design: Multi-center, open-label, interventional clinical study. Methods: Twenty-eight patients (28 eyes;safety analysis set) with primary open-angle glaucoma and ocular hypertension, who had completed the 4-week-concomitant phase of tafluprost and gel-forming timolol, were treated for 8 weeks with TTFC. IOP, adherence, ocular surface safety, and the usability of ophthalmic solution were compared before and after switching. This study was approved by the ethics committees of Kitasato University Hospital and all other study sites. All patients provided written informed consent to participate. Results: IOP at 8 weeks after switching was significantly lower than before switching (P = 0.0001) in the efficacy analysis set (n = 24). The self-reported adherence rate remained high after switching;moreover, there was no meaningful change in ocular surface safety. Patient questionnaires regarding usability of medication revealed that 85.7% of patients preferred their instillation prescription after switching, including TTFC. Among the safety analysis set (n = 28), no adverse events were reported in relation to the study drug. Conclusion: TTFC showed greater IOP reduction than concomitant therapy. Thus, TTFC may be a better option in glaucoma patients than concomitant therapy.展开更多
AIM： To draw a Meta-analysis over the comparison of the intraocular pressure （lOP）-lowering efficacy and safety between the commonly used fixed-combinations of prostaglandin analogs and 0.5% timolol with prostaglan...AIM： To draw a Meta-analysis over the comparison of the intraocular pressure （lOP）-lowering efficacy and safety between the commonly used fixed-combinations of prostaglandin analogs and 0.5% timolol with prostaglandin analogs （PGAs） monotherapy. METHODS： After searching the published reports from MEDLINE, EMBASE, the Cochrane Library, all randomized controlled clinical trials （RCTs） comparing the fixed combination of PGAs/timolol therapy （FCs） and PGAs monotherapy with treatment duration at least 6mo were included. The efficacy outcomes were mean diurnal lOP, percentage of participants whose lOP were lower than 18 mm Hg, incidence of visual field change, while the safety outcomes included corneal side effects, hyperemia and eye irritation. The analysis was carried out in RevMan version 5.3 software. RESULTS： After six-month medical intervention, the mean diurnal lOP of FCs was lower than PGAs （MD -1.14, 95% CI -1.82 to -0.46, P=0.001）; the percentage of target lOP achieving between FCs and PGAs showed no significant difference （RR 1.18, 95% Cl 0.97 to 1.43, P=0.10）. No statistically significant differences of the incidence of hyperemia （RR 0.67, 95% CI 0.45 to 1.01, p=0.06） and eye irritation （RR 1.20, 95% CI 0.95 to 1.51, P=0.12） between the FCs and PGAs monotherapy were detected. Only one research involved in corneal events, result of this trial revealed no difference between two intervention groups regarding corneal effects （central endothelial cell density, MD -0.20, 95% CI -0.72 to 0.32, P=0.45; central corneal thickness, MD -0.01, 95% Cl -0.02 to 0.00, P=0.23）. The evaluation of visual field change was not performed due to the limited duration of the trials included in this Meta-analysis. CONCLUSION： The long-term efficacy of the FCs overweighed the PGAs monotherapy in lowering lOP, but in the incidence of hyperemia and eye irritation syndromes, the differences are not statically significant. More RCTs with detailed and authentic data over the assessments of visual functions and morphology of optic nerve heads are hoped to be conducted.展开更多
基金Supported by Santen Pharmaceutical(China)Co.,Ltd.
文摘AIM:To investigate the treatment pattern and safety of tafluprost for glaucoma and ocular hypertension(OH)in clinical practice in China.METHODS:This post-marketing observational study included patients who received tafluprost to lower intraocular pressure(IOP)within 30d between September 2017 and March 2020 in 20 hospitals in China.Adverse drug reactions(ADRs)during tafluprost treatment and within 30d after the treatment were collected.RESULTS:A total of 2544 patients were included in this study,of them 58.5%(1488/2544)had primary open angle glaucoma(POAG),21.9%(556/2544)had OH and 19.7%(500/2544)used tafluprost for other reasons.Of 359 ADRs occurred in 10.1%(258/2544)patients,and no serious adverse event occurred.The most common ADR was conjunctival hyperemia(128 ADRs in 124 patients,4.9%).Totally 1670 participants(65.6%)combined tafluprost with carbonic anhydrase inhibitors(CAIs;37.1%,620/1670),sympathomimetics(33.5%,559/1670),β-blockers(33.2%,555/1670),other prostaglandin analogs(PGAs;15.6%,260/1670)and other eye drops(15.1%,253/1670).The highest incidence of conjunctival hyperemia was noted in patients who received tafluprost in combination with other PGAs(23 ADRs in 23 patients,8.8%,23/260)and the lowest was in combination with CAIs(16 ADRs in 16 patients,2.6%,16/620).Tafluprost was applied in primary angle-closure glaucoma(41.6%,208/500),after glaucoma surgery(17.8%,89/500)and after non-glaucoma surgery(15.8%,79/500).CONCLUSION:Tafluprost is safe for POAG and OH,and tolerable when combined with other eye drops and under various clinical circumstances.
基金Supported by Program of Scientific and Technological Plan of Xi’an[No.2017116SF/YX010(10)]Program of Key Research and Invention Plan of Shaanxi(No.2017SF-266).
文摘AIM:To evaluate the intraocular pressure(IOP)-lowering efficacy and safety of tafluprost 0.0015%eye drops[benzalkonium chloride(BAK)0.1 mg/mL]compared with that of latanoprost 0.005%eye drops(BAK 0.2 mg/mL)for primary open angle glaucoma(POAG)and ocular hypertension(OHT).METHODS:All the randomized controlled trials(RCTs)about treating POAG and OHT comparing tafluprost and latanoprost were collected by searching PubMed,Embase,Cochrane Library,CNKI and VIP.The outcomes of interest to evaluate the clinical efficacy and adverse effects included IOP and patient-related drop discomfort.RESULTS:Five RCTs involving 888 glaucoma patients were included.The results showed that,1)at the end of the study,no statistically significant differences were observed in IOP reduction[standard mean difference(SMD)=0.48,95%CI 0.07 to 0.88,P=0.085]between tafluprost and latanoprost;2)No statistically significant differences were observed in adverse events of foreign-body sensation[relative risk(RR)=0.62,95%CI 0.26 to 1.46,P=0.269],eye irritation(RR=1.16,95%CI 0.49 to 2.75,P=0.744),eye pain(RR=2.000,95%CI 0.949 to 4.216,P=0.07),iris hyperpigmentation(RR=0.741,95%CI 0.235 to 2.334,P=0.61),dry eye(RR=1.154,95%CI 0.409 to 3.256,P=0.79)and eye pruritus(RR=1.600,95%CI 0.536 to 4.774,P=0.4)between tafluprost and latanoprost.However,tafluprost showed more reported incidence of conjunctival hyperaemia than latanoprost(RR=2.11,95%CI 1.24 to 3.59,P=0.006).CONCLUSION:Tafluprost 0.0015%eye drops(BAK 0.1 mg/mL)and latanoprost 0.005%eye drops(BAK 0.2 mg/mL)are comparable in lowering IOP for open angle glaucoma(OAG)and OHT.It does not differ in the incidence of foreign-body sensation,eye irritation,eye pain,iris hyper-pigmentation,dry eye and eye pruritus,but tafluprost shows less ocular tolerability because of more incidence of conjunctival hyperaemia.
文摘Purpose: Fixed-combination medication to treat glaucoma can reduce intraocular pressure (IOP) without negative effects of concomitant medication. Tafluprost/timolol fixed-combination ophthalmic solution (TTFC) has been reported to show similar effectiveness in lowering IOP, compared with concomitant use of its component drugs, tafluprost and timolol. However, the difference in IOP-lowering effects between TTFC and concomitant use of tafluprost and gel-forming timolol is unknown. Hence, we conducted this switching study from tafluprost and gel-forming timolol to TTFC in glaucoma patients undergoing multi-drug therapy. Design: Multi-center, open-label, interventional clinical study. Methods: Twenty-eight patients (28 eyes;safety analysis set) with primary open-angle glaucoma and ocular hypertension, who had completed the 4-week-concomitant phase of tafluprost and gel-forming timolol, were treated for 8 weeks with TTFC. IOP, adherence, ocular surface safety, and the usability of ophthalmic solution were compared before and after switching. This study was approved by the ethics committees of Kitasato University Hospital and all other study sites. All patients provided written informed consent to participate. Results: IOP at 8 weeks after switching was significantly lower than before switching (P = 0.0001) in the efficacy analysis set (n = 24). The self-reported adherence rate remained high after switching;moreover, there was no meaningful change in ocular surface safety. Patient questionnaires regarding usability of medication revealed that 85.7% of patients preferred their instillation prescription after switching, including TTFC. Among the safety analysis set (n = 28), no adverse events were reported in relation to the study drug. Conclusion: TTFC showed greater IOP reduction than concomitant therapy. Thus, TTFC may be a better option in glaucoma patients than concomitant therapy.
基金Supported by the National Outstanding Youth Science Fund Project(No.81202726)
文摘AIM： To draw a Meta-analysis over the comparison of the intraocular pressure （lOP）-lowering efficacy and safety between the commonly used fixed-combinations of prostaglandin analogs and 0.5% timolol with prostaglandin analogs （PGAs） monotherapy. METHODS： After searching the published reports from MEDLINE, EMBASE, the Cochrane Library, all randomized controlled clinical trials （RCTs） comparing the fixed combination of PGAs/timolol therapy （FCs） and PGAs monotherapy with treatment duration at least 6mo were included. The efficacy outcomes were mean diurnal lOP, percentage of participants whose lOP were lower than 18 mm Hg, incidence of visual field change, while the safety outcomes included corneal side effects, hyperemia and eye irritation. The analysis was carried out in RevMan version 5.3 software. RESULTS： After six-month medical intervention, the mean diurnal lOP of FCs was lower than PGAs （MD -1.14, 95% CI -1.82 to -0.46, P=0.001）; the percentage of target lOP achieving between FCs and PGAs showed no significant difference （RR 1.18, 95% Cl 0.97 to 1.43, P=0.10）. No statistically significant differences of the incidence of hyperemia （RR 0.67, 95% CI 0.45 to 1.01, p=0.06） and eye irritation （RR 1.20, 95% CI 0.95 to 1.51, P=0.12） between the FCs and PGAs monotherapy were detected. Only one research involved in corneal events, result of this trial revealed no difference between two intervention groups regarding corneal effects （central endothelial cell density, MD -0.20, 95% CI -0.72 to 0.32, P=0.45; central corneal thickness, MD -0.01, 95% Cl -0.02 to 0.00, P=0.23）. The evaluation of visual field change was not performed due to the limited duration of the trials included in this Meta-analysis. CONCLUSION： The long-term efficacy of the FCs overweighed the PGAs monotherapy in lowering lOP, but in the incidence of hyperemia and eye irritation syndromes, the differences are not statically significant. More RCTs with detailed and authentic data over the assessments of visual functions and morphology of optic nerve heads are hoped to be conducted.
