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Comparision Effects of Solifenacin, Darifenacin, Propiverine on Ocular Parameters in Eyes: a Prospective Study ______

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Comparision Effects of Solifenacin, Darifenacin, Propiverine on Ocular Parameters in Eyes: a Prospective Study ______ ORIGINAL ARTICLE Vol. 46 (2): 185-193, March - April, 2020 doi: 10.1590/S1677-5538.IBJU.2019.0094 Comparision effects of solifenacin, darifenacin, propiverine on ocular parameters in eyes: A prospective study _______________________________________________ Mahmut Taha Ölçücü 1, Kerem Teke 1, Kadir Yildirim 2, Mesut Toğaç 3, Burcu Işık 3, Yusuf Cem Yilmaz 3 1 Department of Urology, Agri State Hospital, Agri, Turkey; 2 Department of Urology, Elaziğ Education and Research Hospital, Elazig, Turkey; 3 Department of Ophthalmology, Agri State Hospital, Agri, Turkey ABSTRACT ARTICLE INFO Objective: To evaluate the effects of solifenacin, darifenacin, and propiverine on Mahmut Taha Ölçücü nasal-, subfoveal-, temporal choroidal thicknesses (NCT, SFCT, TCT), intraocular http://orcid.org/0000-0002-4721-2807 pressure (IOP) and pupil diameter (PD). Materials and Methods: Patients with overactive bladder (OAB) diagnosed accord- Keywords: ing to The International Continence Society were administered with solifenacin, Pressure; Urinary Bladder; darifenacin or propiverine on a daily basis between November 2017 and May 2018. Overactive; Anisocoria NCT, SFCT, TCT, IOP, and PD of these patients were measured and compared as Int Braz J Urol. 2020; 46: 185-93 initial, fourth and twelfth weeks. Results: A total of 165 patients (330 eyes) with OAB were evaluated. Solifenacin (n=140) signifi cantly reduced IOP from 17.30±2.72 mmHg to 16.67±2.56 mmHg _____________________ (p=0.006) and 16.57±2.41 mmHg (p=0.002), at the fourth and twelfth weeks, re- Submitted for publication: spectively. Darifenacin (n=110) signifi cantly reduced NCT from 258.70±23.96 μm February 08, 2019 to 257.51±22.66 μm (p=0.002) and 255.36±19.69 μm (p=0.038), at the fourth and _____________________ twelfth weeks, respectively. Propiverine (n=80) signifi cantly increased PD from Accepted after revision: 4.04±0.48 mm to 4.08±0.44 mm (p=0.009) and 4.09±0.45 mm (p=0.001), at the October 13, 2019 fourth and twelfth weeks, respectively. _____________________ Published as Ahead of Print: Conclusion: These fi ndings can help to decide appropriate anticholinergic drug November 30, 2019 choice in OAB patients. We fi nally suggest further well-designed randomized pro- spective studies with a larger population to evaluate the anticholinergic-related complications in eyes. INTRODUCTION the mainstay method (4). Oral anticholinergics are the fi rst-line drugs in medical treatment (5). Due Both sexes are affected by an overactive to various settlements of cholinergic (muscarinic) bladder (OAB), which is a common disorder with receptors (M1-M5) in the body, the side effects of a reported prevalence between 11.8% and 16.9%. anticholinergics emerge in accordance with this Symptoms of OAB include urgency, frequent uri- (6). These drugs can cause side effects such as dry nation, and nocturia with or without urge in- mouth, constipation, nausea, vomiting, headache, continence (1-3). Lifestyle modifi cations and and confusion (7, 8). behavioral therapies are the fi rst steps taken into There are extensive M receptors in iris treatment, however, medical therapy constitutes sphincter muscle, ciliary muscle and trabecular 185 IBJU | EFFECTS OF ANTICHOLINERGICS ON EYES cells (9-11). Iris sphincter muscle and ciliary mus- linergic agents, angle-closure glaucoma, ocu- cles are relevant with accommodation and chan- lar trauma, ocular surgery, high refractive error ging of pupil diameter (PD) (12, 13). M3 receptors (>±6D), intraocular drug injection, photodynamic are most common cholinergic receptors than the or photocoagulation laser treatments, use of topi- other types in iris sphincter and ciliary muscle cells cal ophthalmologic drops, pathology in ophthal- (10, 14). Trabecular cells control intraocular pressu- mologic examinations and refusing follow-ups or re (IOP) by changing the aqueous humor drainage discontinue the medicines for any reason were ex- (15). Blockage of these receptors may lead to blur- cluded from the study (Figure-1). No patient gave red vision, dry eyes, and increased IOP in angle- up on OAB treatment because of ocular findings -closure glaucoma (16, 17). Choroid is one of the or ocular side effects. most vascularised areas in the body, allowing outer Patients with OAB were administered with retina to become vascularised (18). Increased cho- 5mg solifenacin 1x1, 7.5mg darifenacin 1x1 or roidal thickness (CT) can cause haemorrhage and 30mg sustained-release propiverine 1x1 on a dai- exudation. Reducing this thickness can decrease ly basis. When we analyzed retrospectively, we blood flow of retina (18). Age-specific (haemorrha- found that the most preferred anticholinergics gic and exudated) choroidal thickening is known to were solifenacin, darifenacin, propiverine, oxy- be a poor prognostic factor in age-related macu- butynin, and trospium, respectively in our clinic. lar degeneration. It is reported that choroidal layer Hence we aimed to compare the eyes of patients contains smooth muscles with intense cholinergic who were treated with most preferred three anti- innervations (18, 19). cholinergics (solifenacin, darifenacin, propiverine) In this context, since anticholinergic dru- for OAB treatment. As known, the effects of anti- gs may affect ocular M receptors, we herein aimed cholinergics are similar. But more adverse effects to evaluate the effects of solifenacin, darifenacin, can be observed with some anticholinergics than and propiverine on nasal-, subfoveal-, temporal others. Two urologists (MTO and KT) distributed CTs (NCT, SFCT, TCT), IOP and PD in the eyes. the anticholinergics in a regular order to the pa- tients with OAB. We did not make any rando- MATERIALS AND METHODS mization in this study. We tried to keep equally the number of groups. Some factors affected the The study was designed prospectively number of participants who have finished the non-randomized in accordance with the Helsinki study among groups. Those factors included: pa- Declaration after approval of Erzurum Atatürk tients who gave up the anticholinergic because University Medical Faculty Ethics Committee (Ap- of adverse effects, did not come to follow-up, proval Number: B.30.2.ATA.0.01.00/128). Patients and were discordant throughout treatment. In who were diagnosed with OAB in urology clinic method, we have specified those factors as the between November 2017 and May 2018 were in- excluded criteria described above. We observed cluded and referred to ophthalmologic clinic af- more adverse effects in propiverine group. And ter receiving the informed consents from patients. it affected the number of propiverine group. The The diagnosis of OAB was made according to the ophthalmologists who examined the patients did description described earlier by the International not know which anticholinergics were used by Continence Society (ICS) (20). Informed consent the patients. SFCT, NCT, TCT, IOPs, and PDs in forms were obtained from patients who wanted eyes of the patients in the fourth and twelfth we- to participate in the study. The costs of the drugs eks were evaluated by ophthalmologists. CT was were paid by the patient’s own health insurance. measured at 500-micron intervals of the section As a result of detailed urological and ophthalmo- from 1mm nasal and temporal to the subfoveal logical evaluations, patients with histories of any center via an optical coherence tomography de- systemic diseases (e.g. diabetes mellitus, hyperten- vice (Topcon 3d Oct-2000 Fa Plus, Topcon Inc., sion, coronary artery disease), renal insufficiency, Japan). IOP was measured with a computerized urinary tract infections, previous use of anticho- tonometer (Topcon Ct-800, Topcon Inc., Japan), 186 IBJU | EFFECTS OF ANTICHOLINERGICS ON EYES Figure 1 - Flow-chart of the our prospective cohort study. Number of participants calculated and determined as minimum 37 patients Individual excluded required for each anticholinergic drugs using with power analysis. -Systemic diseases (e.g. diabetes mellitus, hypertension, coronary artery disease), renal insufficiency, - urinary tract infections, - previous use of anticholinergic agents, - angle-closure glaucoma, ocular trauma, Patients included in the cohort at the ocular surgery, high refractive error (> ± begining of treatment (n = 223) 6 D), intraocular drug injection, photodynamic or photocoagulation laser Solifenacin (n = 75) treatments, use of topical ophthalmologic drops, pathology in ophthalmologic Darifenacin (n=77) examinations, Propiverine (n = 71) - refusing follow-ups or discontinue the Individual excluded medicines for any reason. -give up anticholinergics because of side effects, -discordant throughout treatment, -do not come to follow-up After 12 weeks treatment, participants included in analysis (n = 165) Solifenacin (n = 70) Darifenacin (n=55) Propiverine (n = 40) and PD was measured by an autorefractometerFigure 1. Flow-chart of ourKruskal prospective Wallis cohort test study. was used after the descriptive (Topcon Kr-800, Topcon Inc., Japan). statistics, and two samples paired t-test was used When we assigned the statistical power as to compare the values measured in the fourth and 0.8, the alpha as 0.05, effect size as 0.3 and group twelfth weeks for the same individuals depending size as 3 the power analysis has shown minimum on the medicines used. A value of p <0.05 was required sample size as 111. So a minimum of 37 deemed statistically significant. patients were required for each anticholinergic drug. The mean values of the measurements for RESULTS both eyes were
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