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Ines Lanzl, Thomas Hamacher, Friedemann Kimmich; Preservative-free tafluprost in the treatment of naïve patients with glaucoma and ocular hypertension. Invest. Ophthalmol. Vis. Sci. 2013;54(15):454.
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Efficacy, tolerability and safety of the preservative-free prostaglandin analogue (PGA) tafluprost 0.0015% were investigated in treatment-naïve patients.
Data were collected in two non-interventional, prospective, multi-center, observational, open label studies of identical design conducted in Germany and Czech Republic. 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 POAG and OH patient subgroup 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 and overall satisfaction with the medical treatment were evaluated. All adverse events were recorded.
Five-hundred and seventy nine treatment-naïve patients with primary open-angle glaucoma (POAG) (N=349), ocular hypertension (OH) (N=105), normal-tension glaucoma (NTG) (N=71), exfoliative glaucoma (PEX) (N=27) or 'other glaucomas‘ (N=27) were included in this study. Mean IOP was lowered significantly from 23.6 ± 4.0 mmHg at baseline to 16.8 ± 2.9 mmHg at month 3 in all patients and subgroups of patients by diagnosis (p<0.001). Preservative-free tafluprost lowered mean IOP significantly in the subgroup of POAG and OH patients with lower IOP-levels from 21.9 ± 1.1 mmHg at baseline to 16.5 ± 2.2 mmHg and in the higher IOP-level subgroup of from 26.2 ± 2.4 mmHg to 17.9 ± 2.4 mmHg. In the subgroup of patients with POAG and OH an IOP response of ≥ 20 %, ≥ 30 % and ≥ 40 % was achieved by 83.4 %, 44.1 % and 12.8 % respectively. Overall, patients with higher baseline IOP-values (≥ 24 mmHg) showed a better response compared to patients with lower baseline IOP-levels (≥ 20 mmHg to 23 mmHg). Preservative-free tafluprost was well tolerated and safe. After 3 months, 97.9% of all patients remained on therapy.
In this ,real world' observational study, treatment with once daily preservative-free tafluprost was efficacious and safe in treatment naïve patients. Preservative-free tafluprost is a valuable first-choice treatment for POAG and OH patients when long term IOP control and tolerability are desirable.
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