Preservative-free tafluprost in the treatment of naive patients with glaucoma and ocular hypertension

Ines Lanzl,1 Thomas Hamacher,2 Klaus Rosbach,3 Mohammed Osman Ramez,4 Robert Rothe,5 Eva Ružicková,6 Marta Karhanová,7 Friedemann Kimmich81Private practice, Prien, Germany; 2Private practice, Starnberg, Germany; 3Private practice, Mainz, Germany; 4Private practice, Buxtehude, G...

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Autores principales:	Lanzl I, Hamacher T, Rosbach K, Ramez MO, Rothe R, Růžičkov&aacute; E, Karhanov&aacute; M, Kimmich F
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2013
Materias:	Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/d3e0e4f3b3424315a02f16b0cdd73a45
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spelling	oai:doaj.org-article:d3e0e4f3b3424315a02f16b0cdd73a452021-12-02T01:53:26ZPreservative-free tafluprost in the treatment of naive patients with glaucoma and ocular hypertension1177-54671177-5483https://doaj.org/article/d3e0e4f3b3424315a02f16b0cdd73a452013-05-01T00:00:00Zhttp://www.dovepress.com/preservative-free-tafluprost-in-the-treatment-of-naive-patients-with-g-a13070https://doaj.org/toc/1177-5467https://doaj.org/toc/1177-5483Ines Lanzl,1 Thomas Hamacher,2 Klaus Rosbach,3 Mohammed Osman Ramez,4 Robert Rothe,5 Eva Ružicková,6 Marta Karhanová,7 Friedemann Kimmich81Private practice, Prien, Germany; 2Private practice, Starnberg, Germany; 3Private practice, Mainz, Germany; 4Private practice, Buxtehude, Germany; 5Private practice, Minden, Germany; 6General Faculty Hospital, Praha Czech Republic; 7Faculty Hospital Olomouc, Czech Republic; 8eyecons, Pfinztal, GermanyPurpose: The study reported here investigated the efficacy, tolerability, and safety of the preservative-free prostaglandin analog tafluprost 0.0015% in treatment-naive patients.Patients and methods: Data were collected in two non-interventional, prospective, multicenter, observational, open-label studies of identical design that were conducted in Germany and the Czech Republic. All subjects received preservative-free tafluprost 0.0015% once daily. Intraocular pressure (IOP) levels were recorded for each eye at untreated baseline and 3 months after initiation of medical treatment. The primary outcome was change in mean IOP from baseline to month 3. In the primary open-angle glaucoma (POAG) and ocular hypertension (OH) patient subgroups, analyses were stratified by the level of baseline IOP: ≥20 to 23 mmHg versus ≥24 mmHg. In addition, responder rates and the achievement of pre-specified IOP levels at month 3 were evaluated. Local tolerance of preservative-free tafluprost was evaluated by the patients at final visit. Overall satisfaction with the medical treatment was evaluated by both patients and physicians. All adverse events were recorded.Results: A total of 579 treatment-naive patients with POAG (n = 349), OH (n = 105), normal tension glaucoma (n = 71), exfoliative glaucoma (n = 27), or other glaucomas (n = 27) were included in this observational study. Mean IOP level at baseline for all patients was 23.6 ± 4.0 mmHg. Mean IOP at month 3 was 16.8 ± 2.9 mmHg (—28.8% vs baseline). At month 3, significant reductions in mean IOP (P < 0.001) were seen in all patients and all subgroups. Preservative-free tafluprost lowered mean IOP significantly in patients with POAG and OH with IOP levels ≥ 20 to 23 mmHg from 21.9 ± 1.1 mmHg at baseline to 16.5 ± 2.2 mmHg, and in the subgroup with IOP levels ≥ 24 mmHg from 26.2 ± 2.4 mmHg to 17.9 ± 2.4 mmHg. In the subgroups of patients with POAG and OH, an IOP response ≥20%, ≥30%, and ≥40% was achieved by 83.4%, 44.1%, and 12.8%, respectively. Overall, patients with higher baseline IOP values showed a better response than patients with lower baseline IOP levels. Preservative-free tafluprost was well tolerated and safe. After 3 months, 97.9% of all patients remained on therapy.Conclusion: In this real-world observational study, treatment with once-daily preservative-free tafluprost proved efficacious, well tolerated, and safe in treatment-naive patients.Keywords: intraocular pressure, prostaglandin analogs, responders, first-line treatment, preservatives, local tolerabilityLanzl IHamacher TRosbach KRamez MORothe RRůžičkov&aacute; EKarhanov&aacute; MKimmich FDove Medical PressarticleOphthalmologyRE1-994ENClinical Ophthalmology, Vol 2013, Iss default, Pp 901-910 (2013)
institution	DOAJ
collection	DOAJ
language	EN
topic	Ophthalmology RE1-994
spellingShingle	Ophthalmology RE1-994 Lanzl I Hamacher T Rosbach K Ramez MO Rothe R Růžičkov&aacute; E Karhanov&aacute; M Kimmich F Preservative-free tafluprost in the treatment of naive patients with glaucoma and ocular hypertension
description	Ines Lanzl,1 Thomas Hamacher,2 Klaus Rosbach,3 Mohammed Osman Ramez,4 Robert Rothe,5 Eva Ružicková,6 Marta Karhanová,7 Friedemann Kimmich81Private practice, Prien, Germany; 2Private practice, Starnberg, Germany; 3Private practice, Mainz, Germany; 4Private practice, Buxtehude, Germany; 5Private practice, Minden, Germany; 6General Faculty Hospital, Praha Czech Republic; 7Faculty Hospital Olomouc, Czech Republic; 8eyecons, Pfinztal, GermanyPurpose: The study reported here investigated the efficacy, tolerability, and safety of the preservative-free prostaglandin analog tafluprost 0.0015% in treatment-naive patients.Patients and methods: Data were collected in two non-interventional, prospective, multicenter, observational, open-label studies of identical design that were conducted in Germany and the Czech Republic. All subjects received preservative-free tafluprost 0.0015% once daily. Intraocular pressure (IOP) levels were recorded for each eye at untreated baseline and 3 months after initiation of medical treatment. The primary outcome was change in mean IOP from baseline to month 3. In the primary open-angle glaucoma (POAG) and ocular hypertension (OH) patient subgroups, analyses were stratified by the level of baseline IOP: ≥20 to 23 mmHg versus ≥24 mmHg. In addition, responder rates and the achievement of pre-specified IOP levels at month 3 were evaluated. Local tolerance of preservative-free tafluprost was evaluated by the patients at final visit. Overall satisfaction with the medical treatment was evaluated by both patients and physicians. All adverse events were recorded.Results: A total of 579 treatment-naive patients with POAG (n = 349), OH (n = 105), normal tension glaucoma (n = 71), exfoliative glaucoma (n = 27), or other glaucomas (n = 27) were included in this observational study. Mean IOP level at baseline for all patients was 23.6 ± 4.0 mmHg. Mean IOP at month 3 was 16.8 ± 2.9 mmHg (—28.8% vs baseline). At month 3, significant reductions in mean IOP (P < 0.001) were seen in all patients and all subgroups. Preservative-free tafluprost lowered mean IOP significantly in patients with POAG and OH with IOP levels ≥ 20 to 23 mmHg from 21.9 ± 1.1 mmHg at baseline to 16.5 ± 2.2 mmHg, and in the subgroup with IOP levels ≥ 24 mmHg from 26.2 ± 2.4 mmHg to 17.9 ± 2.4 mmHg. In the subgroups of patients with POAG and OH, an IOP response ≥20%, ≥30%, and ≥40% was achieved by 83.4%, 44.1%, and 12.8%, respectively. Overall, patients with higher baseline IOP values showed a better response than patients with lower baseline IOP levels. Preservative-free tafluprost was well tolerated and safe. After 3 months, 97.9% of all patients remained on therapy.Conclusion: In this real-world observational study, treatment with once-daily preservative-free tafluprost proved efficacious, well tolerated, and safe in treatment-naive patients.Keywords: intraocular pressure, prostaglandin analogs, responders, first-line treatment, preservatives, local tolerability
format	article
author	Lanzl I Hamacher T Rosbach K Ramez MO Rothe R Růžičkov&aacute; E Karhanov&aacute; M Kimmich F
author_facet	Lanzl I Hamacher T Rosbach K Ramez MO Rothe R Růžičkov&aacute; E Karhanov&aacute; M Kimmich F
author_sort	Lanzl I
title	Preservative-free tafluprost in the treatment of naive patients with glaucoma and ocular hypertension
title_short	Preservative-free tafluprost in the treatment of naive patients with glaucoma and ocular hypertension
title_full	Preservative-free tafluprost in the treatment of naive patients with glaucoma and ocular hypertension
title_fullStr	Preservative-free tafluprost in the treatment of naive patients with glaucoma and ocular hypertension
title_full_unstemmed	Preservative-free tafluprost in the treatment of naive patients with glaucoma and ocular hypertension
title_sort	preservative-free tafluprost in the treatment of naive patients with glaucoma and ocular hypertension
publisher	Dove Medical Press
publishDate	2013
url	https://doaj.org/article/d3e0e4f3b3424315a02f16b0cdd73a45
work_keys_str_mv	AT lanzli preservativefreetafluprostinthetreatmentofnaivepatientswithglaucomaandocularhypertension AT hamachert preservativefreetafluprostinthetreatmentofnaivepatientswithglaucomaandocularhypertension AT rosbachk preservativefreetafluprostinthetreatmentofnaivepatientswithglaucomaandocularhypertension AT ramezmo preservativefreetafluprostinthetreatmentofnaivepatientswithglaucomaandocularhypertension AT rother preservativefreetafluprostinthetreatmentofnaivepatientswithglaucomaandocularhypertension AT ruzickovampaacutee preservativefreetafluprostinthetreatmentofnaivepatientswithglaucomaandocularhypertension AT karhanovampaacutem preservativefreetafluprostinthetreatmentofnaivepatientswithglaucomaandocularhypertension AT kimmichf preservativefreetafluprostinthetreatmentofnaivepatientswithglaucomaandocularhypertension
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Preservative-free tafluprost in the treatment of naive patients with glaucoma and ocular hypertension

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