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Travoprost: Russian experience of use

E.A. Egorov, J.G. Oganezova

Department of Ophthalmology of Medical Faculty

GOU VPO Russian State Medical University of Roszdrav, Moscow

Literary review presents results of multicenter studies: “START” “Travatan long–term treatment” carried out in Russian sites during 2003–2007. It also includes results of independent research of effect and safety of Travatan usage in patients with low pressure glaucoma, angle–closed glaucoma and before phacoemulsification.

prostaglandin-type drugs stand out among other drugs used to reduce intraocular pressure (IOP) in glaucoma due to their pronounced hypotensive effect, the absence of systemic and minor local side effects, the absence of addiction, a persistent effect and a convenient mode of use (once a day), which improves quality of life of patients and increases their adherence to treatment [4,9,15, 17,27,29,30,37]. Thanks to this, having appeared on the Russian market in the late 90s of the 20th century, prostaglandins took a strong place in the treatment of patients with glaucoma.

Travatan (travoprost 0.004%) is one of the representatives of this group, celebrating this year the eighth anniversary of its successful use in the world and the fifth anniversary in Russia. During this time, a number of multicenter and initiative studies were conducted on the use of Travatan in glaucoma patients in various situations.

Study " Travatan as an alternative therapy for glaucoma"

(START)" was held in many countries of the world, including Russia, in 2003–2005. In Russia, this was a 12-week open study in 50 medical institutions, in which 1389 patients took part. The purpose of the study was to evaluate the effectiveness of Travatan in patients with newly diagnosed glaucoma and patients who had previously received antihypertensive therapy but did not achieve adequate IOP control. When analyzing the results of the Swiss [20] and Russian studies, it can be said that the average reduction in IOP one month after starting the use of a 0.004% travoprost solution was comparable. However, in the Russian study, in all comparable groups there was a greater decrease in IOP levels by the 3rd month of use. This trend can be seen in groups of patients with newly diagnosed glaucoma with a tonometric IOP of more than 25 mm Hg. (according to Maklakov), as well as patients using latanoprost, β-blockers, carbonic anhydrase inhibitors.

In this study, in all cases, both when using Travatan in patients with newly diagnosed glaucoma, and in patients who failed to achieve an adequate reduction in IOP during therapy with other antiglaucoma drugs used as mono- or combination therapy, Travatan provided additional reduction IOP from 2 to 9 mm Hg. Art. (Tables 1, 2) The magnitude of the additional reduction in IOP depended on the drug from which group of antiglaucoma drugs the patient was transferred to Travatan. However, based on the data that a decrease in IOP by 1 mm Hg. reduces the risk of glaucoma progression by 10%, Travatan gives an additional chance to preserve vision for patients with glaucoma.

Study " Travatan Long-Term Therapy"

"was carried out in more than 50 clinics in 30 cities of Russia over 9 months. Design: open, prospective, uncontrolled, non-randomized. Objective: to evaluate the effectiveness of long-term monotherapy with Travatan in patients with newly diagnosed primary open-angle glaucoma (POAG) and those in whom the glaucomatous process continued to progress despite therapy with other drugs.

1777 patients (2746 eyes) were included in the study, 1430 people (2244 eyes) completed it on Travatan monotherapy (16% of patients were transferred to combination therapy or underwent surgery).

Regardless of the previous treatment received, throughout the entire 9 months of observation, travoprost monotherapy stabilized the course of the disease, providing an additional reduction in IOP compared to the baseline (Fig. 1).

In the group of patients with newly diagnosed glaucoma with elevated IOP, after 4 weeks of travoprost monotherapy, the group average IOP was less than 21 mmHg. (initial exceeded 28 mmHg) and remained at this level until the end of the study. This result indicates not only the high hypotensive activity of the drug, but also the persistence of the effect, which was confirmed by the results of correlation analysis. However, it is worth noting that after 36 weeks of treatment, patients with stage IIIb glaucoma experienced an increase in IOP, which became significantly higher than in patients with stages I and II (ρ<0.001). This trend is natural for glaucoma, therefore, more active therapy is recommended for patients with advanced stages to achieve lower IOP values [2,5,15].

In the group of patients with newly diagnosed glaucoma with normal IOP (IOP), the decrease in IOP was less pronounced and amounted to 17.17% by the end of the study. The recommended reduction in IOP by 30% of the initial value [5] after 36 weeks of travoprost monotherapy was achieved by only 15.79% of patients with stage I glaucoma and not a single patient with stages II and III. The results obtained are consistent with literature data [10,25,39] and once again confirm the relevance of combination therapy for patients with GND and the need to search for combinations of drugs that could be used for it.

Another group with a smaller decrease in IOP than the others was the group of patients switched to travoprost treatment from latanoprost monotherapy. To date, there is no clear opinion about the advantage of one prostaglandin drug over others [18,27,28, 30,33,41]. However, it is known that travoprost has higher selectivity for FP receptors. It is the high affinity for receptors of this type that can provide a more pronounced effect on ophthalmotonus [2]. In this study, after 36 weeks, travoprost provided an additional statistically significant reduction in IOP by 14.28%. But throughout the entire observation period, the IOP level in this group was significantly higher than in other patients (p <0.02). In addition, in 15% of patients the IOP level exceeded 25 mm Hg, and in 16% of patients there was an increase in IOP compared to baseline. The results obtained indicate that in a number of patients travoprost may be more effective than latanoprost, and replacing one drug with another may provide stabilization of the glaucomatous process. But at the same time, in almost a third of patients such a change in treatment is not justified - combination therapy might be more rational for them.

Regarding the tolerability of long-term monotherapy with travoprost, no systemic side effects were recorded in any patient. Side effects were identified in 621 patients (43.43%) and were mainly represented by conjunctival hyperemia of varying severity (30.56% of cases), darkening and increased eyelash growth (7.41%). Only in 0.84% were side effects the reason for discontinuation of the drug.

It should be noted that only 0.73% of patients refused to continue participating in the study due to financial difficulties, i.e. the majority of patients demonstrated a willingness to purchase travoprost. This aspect should be taken into account by Russian ophthalmologists when prescribing treatment.

We investigated the use of combinations of prostaglandin drugs with drugs from other groups as part of an initiative study in patients with GND

. The effectiveness and tolerability of 3 combinations were compared: travoprost with betaxolol, brinzolamide, timolol. Design: long-term (6 months), open, prospective, comparative, randomized, uncontrolled.

45 patients (82 eyes) with GND were included and, after randomization, were assigned to one of the specified combinations. All combinations provided a stable reduction in IOP in all patients over the 6-month study period. However, by the end of the observation period, in no subgroup the average IOP was lower than the initial one by the recommended 30%. The combination with brinzolamide had the least hypotensive effect (Fig. 2): throughout the entire period of combination therapy, the IOP of these patients exceeded the IOP of other patients (ρ<0.03). The remaining combinations showed comparable activity.

As for perimetric indicators, all patients showed positive dynamics in increasing retinal sensitivity and reducing the number of defects, and it was the best in the subgroup additionally receiving brinzolamide, the worst in the Fotil subgroup (Fig. 3). All patients showed positive dynamics in ERG and ERG parameters, with more pronounced changes recorded in the brinzolamide subgroup.

Worse treatment tolerability was found in the Fotil subgroup: a third of patients refused to continue participating in the study due to side effects affecting their quality of life.

Thus, the combination of travoprost with brinzolamide, despite the rather weak antihypertensive activity, caused the most pronounced improvement in perimetry, ERG and ERG parameters and demonstrated good tolerability.

Such results can be explained based on the characteristics of the pathogenesis of normal pressure glaucoma, in which vascular factors, in particular ischemia and vasospase, play an important role [1]. Therefore, the doctor’s focus only on the IOP level cannot be considered correct [1,7] - when choosing a drug, one should take into account not only its hypotensive activity, but also the possible effect on hemodynamics.

We also studied the effect of prostaglandin drugs on the course of the glaucomatous process in patients with primary angle-closure glaucoma ( PACG)

). The studies described in the literature were mostly carried out on representatives of the Mongoloid race, who, due to their anatomical and physiological characteristics, are more susceptible to the development of PACG. In these patients, prostaglandins showed a high antihypertensive effect and a positive effect on ocular perfusion [12,13,19,34,38,40].

Our study involved 30 Caucasian patients (56 eyes) with laser-operated PACG. Design: duration – 3 months, open, prospective. Monotherapy with travoprost demonstrated pronounced antihypertensive activity and good tolerability. Thus, a statistically significant decrease in IOP was observed after 2 weeks and was maintained throughout the entire observation period, amounting to 20.89% of the initial value after 3 months of treatment. The ease of churn rate increased by 35%. Regarding the effect on visual function, the increase in visual acuity did not reach the level of statistical significance; the number of scotomas of 1st, 2nd and 3rd orders decreased after 3 months of treatment by 32.44, 51.92 and 48.82%, respectively (ρ<0.03). The dynamics of the ERG and ERG indicators were positive, but the changes did not reach the level of statistical significance. The most common side effect of the treatment was conjunctival hyperemia.

Thus, travoprost can also be used in patients with laser-operated PACG to stabilize IOP (which has been confirmed by foreign studies).

We also studied the effect of travoprost on the course of the postoperative period.

after phacoemulsification of cataract with intraocular lens implantation (FEC+IOL) in patients without glaucoma and with the presence of this disease. Design: duration – 2 weeks, open, prospective, comparative, randomized, controlled.

There is no consensus in the literature about the positive or negative effect of prostaglandins on the severity of postoperative reactive syndrome. A number of studies indicate the hypotensive effect of these drugs in the postoperative period [6,8,11,14,35], others do not note a significant effect on ophthalmotonus [20,21,31,32]. Some authors report the absence of side effects associated with the pre- and postoperative use of prostaglandins [16,26,36,42], others indicate an increased incidence of macular edema [23,24].

In our study, 2 hours before surgery, patients of the main groups were instilled with Travatan once; no instillation was performed in the control groups. Depending on the presence or absence of glaucoma in the operated patients, we obtained slightly different results.

In all patients, despite general measures taken to reduce intraocular and blood pressure, an increase in IOP was observed before surgery, probably associated with psycho-emotional factors. The increase in ophthalmotonus was more pronounced in the control group and among patients without glaucoma, which may indicate more active local antihypertensive therapy, which should be used even in patients without glaucoma.

Among patients with cataracts

the most pronounced increase in ophthalmotonus was observed on the 1st day after surgery (Fig. 4).

IOP in the control group during the first 5 days exceeded the IOP in the main group, which is most likely due to the greater number of patients in it with corneal edema (ρ<0.003). And a higher incidence of corneal edema could lead to lower values of visual acuity in the control group compared to the main group: thus, visual acuity was significantly higher in the travoprost group on days 3, 7 and 14 after surgery (ρ<0.04). At the same time, there were significantly more patients with conjunctival hyperemia, on the contrary, in the main group: on days 1, 2, 3 and 14 there were more in the travoprost group than in the control (ρ<0.04).

The described results allow us to conclude that it is important and necessary to prescribe to patients without glaucoma who are preparing for FEC + IOL instillation of antiglaucoma drugs both before surgery and in the first days after it, in order to influence ocular hypertension as a component of the reactive syndrome and improve visual functions.

In patients with glaucoma

2 almost equal IOP peaks were observed: on the 1st and 7th day after surgery, more pronounced in the control group than in the main group (Fig. 5).

However, there were no statistically significant differences in the level of IOP throughout the study between the control and main groups (ρ>0.07). There were again more patients with corneal edema in the control group, but in this case the differences were not statistically significant (ρ>0.06). No significant differences were found in the dynamics of visual acuity values (ρ>0.09), which may be due to the previous indicator. Among patients with glaucoma, conjunctival hyperemia was observed more often than in patients without this disease, and when comparing the control and main groups, there were significantly more patients with this phenomenon in the main group only on the 1st day after surgery (ρ<0.04).

The results obtained indicate a longer duration of the reactive syndrome in patients with glaucoma and the desirable prescription of additional local antihypertensive drugs to those received.

Summarizing the above, we can conclude that Travatan has high antihypertensive activity, good tolerability, safety and financial acceptability. This drug can be recommended for widespread use as monotherapy and in combination with drugs from other groups for the treatment of patients with POAG (including those not stabilized on existing therapy), with GND and PAOG, as well as for the preoperative preparation of patients before FEC + IOL .

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