{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,8]],"date-time":"2026-01-08T19:55:04Z","timestamp":1767902104806,"version":"3.49.0"},"reference-count":22,"publisher":"MDPI AG","issue":"10","license":[{"start":{"date-parts":[[2025,9,25]],"date-time":"2025-09-25T00:00:00Z","timestamp":1758758400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Adamed Pharma S.A.","award":["ADM\/COMBO\/2024"],"award-info":[{"award-number":["ADM\/COMBO\/2024"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceuticals"],"abstract":"<jats:p>Background: Fixed-dose combination medications (FDCs) are recognized methods of increasing adherence to polytherapy in chronic diseases. However, the role of FDCs in patients with benign prostatic hyperplasia (BPH) associated with lower urinary tract symptoms (LUTS) remains uncertain. We designed this study to assess persistence, adherence, and patient satisfaction with FDCs recently introduced to the Polish pharmaceutical market, which contain tamsulosin (an \u03b11-adrenergic receptor antagonist) in combination with solifenacin (a muscarinic receptor antagonist) or dutasteride (a 5-\u03b1 reductase inhibitor). Methods: The analysis included 50,435 men (67.8 \u00b1 8.8 years old) managed by urologists for BPH-associated LUTS, who had been on combination therapies for at least 3 months. Two study visits, with an interval of 2.1 \u00b1 1.4 months, were conducted between February and December 2024. Results: Single-component drugs (83.1%) were more common forms of therapy compared to FDCs (16.9%). ARAs (\u03b11-adrenergic receptor antagonists) with 5-\u03b1 reductase inhibitors comprised 70.2%, while ARAs with muscarinic receptor antagonists or \u03b23-adrenergic agonists comprised 29.5%. Persistence with therapy across two visits was 82.0% for single-component drugs and 93.6% for FDCs (p &lt; 0.001); OR = 1.31 (95% CI: 1.02\u20131.63). Similarly, adherence was better in patients treated with FDCs (96.6% vs. 91.0% at visit 1, p &lt; 0.001; 99.3% vs. 97.9% at visit 2, p &lt; 0.05). Patients prescribed FDCs were satisfied with therapy more often than those prescribed single-component drugs (62.6% and 76.8% vs. 50.6% and 67.5% at visits 1 and 2, respectively; p &lt; 0.001). Conclusions: 1. Combination therapies are still more commonly administered as separate tablets than FDCs in patients with BPH-associated LUTS. 2. The use of FDCs increases short-term satisfaction and persistence with therapy, with a mild effect on adherence.<\/jats:p>","DOI":"10.3390\/ph18101439","type":"journal-article","created":{"date-parts":[[2025,9,25]],"date-time":"2025-09-25T12:05:13Z","timestamp":1758801913000},"page":"1439","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Impact of Fixed-Dose Combination Versus Single-Component Therapy for Benign Prostatic Hyperplasia-Related Urinary Symptoms on Persistence, Adherence, and Satisfaction in a Real-Life Setting"],"prefix":"10.3390","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0009-0004-4435-4238","authenticated-orcid":false,"given":"Mateusz","family":"Ma\u0142kowski","sequence":"first","affiliation":[{"name":"Adamed Pharma S.A., 05-152 Czosnow, Poland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6140-4602","authenticated-orcid":false,"given":"Anna","family":"Chudek","sequence":"additional","affiliation":[{"name":"Department of Pharmacovigilance, Europharma Research & Science Centre Co., Ltd., 40-061 Katowice, Poland"},{"name":"Health Promotion and Obesity Management Unit, Department of Pathophysiology, Faculty of Medical Sciences in Katowice, Medical University of Silesia in Katowice, 40-752 Katowice, Poland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6766-8123","authenticated-orcid":false,"given":"Agnieszka","family":"Almgren-Rachtan","sequence":"additional","affiliation":[{"name":"Department of Pharmacovigilance, Europharma Research & Science Centre Co., Ltd., 40-061 Katowice, Poland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6367-7794","authenticated-orcid":false,"given":"Jerzy Tadeusz","family":"Chudek","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Oncological Chemotherapy, Medical Faculty in Katowice, Medical University of Silesia, 40-055 Katowice, Poland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5919-4060","authenticated-orcid":false,"given":"Piotr Ludwik","family":"Ch\u0142osta","sequence":"additional","affiliation":[{"name":"Department of Urology, Jagiellonian University Medical College, 31-008 Krakow, Poland"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2025,9,25]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"207","DOI":"10.1016\/j.eururo.2023.04.008","article-title":"Summary Paper on the 2023 European Association of Urology Guidelines on the Management of Non-neurogenic Male Lower Urinary Tract Symptoms","volume":"84","author":"Gravas","year":"2023","journal-title":"Eur. Urol."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"557","DOI":"10.1056\/NEJM199802263380901","article-title":"The effect of finasteride on the risk of acute urinary retention and the need for surgical treatment among men with benign prostatic hyperplasia. Finasteride Long-Term Efficacy and Safety Study Group","volume":"338","author":"McConnell","year":"1998","journal-title":"N. Engl. J. Med."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"123","DOI":"10.1016\/j.eururo.2009.09.035","article-title":"The effects of combination therapy with dutasteride and tamsulosin on clinical outcomes in men with symptomatic benign prostatic hyperplasia: 4-year results from the CombAT study","volume":"57","author":"Roehrborn","year":"2010","journal-title":"Eur. Urol."},{"key":"ref_4","doi-asserted-by":"crossref","unstructured":"Kim, H.J., Sun, H.Y., Choi, H., Park, J.Y., Bae, J.H., Doo, S.W., Yang, W.J., Song, Y.S., Ko, Y.M., and Kim, J.H. (2017). Efficacy and safety of initial combination treatment of an alpha blocker with an anticholinergic medication in benign prostatic hyperplasia patients with lower urinary tract symptoms: Updated meta-analysis. PLoS ONE, 12.","DOI":"10.1371\/journal.pone.0169248"},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"558","DOI":"10.1097\/JU.0000000000000309","article-title":"Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA\/SUFU Guideline Amendment 2019","volume":"202","author":"Lightner","year":"2019","journal-title":"J. Urol."},{"key":"ref_6","unstructured":"European Association of Urology (2024, June 06). EAU Guidelines: Urinary Incontinence. Available online: https:\/\/uroweb.org\/guideline\/urinary-incontinence\/."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"8","DOI":"10.1111\/j.1464-410X.2007.06881.x","article-title":"Maximizing anticholinergic therapy for overactive bladder: Has the ceiling been reached?","volume":"99","author":"Macdiarmid","year":"2007","journal-title":"BJU Int."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"35","DOI":"10.1186\/1477-7525-1-35","article-title":"The impact of urinary incontinence on self-efficacy and quality of life","volume":"1","author":"Broome","year":"2003","journal-title":"Health Qual. Life Outcomes"},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"2019","DOI":"10.1007\/s00345-020-03429-z","article-title":"Trends in the pharmacological treatment of benign prostatic hyperplasia in the UK from 1998 to 2016: A population-based cohort study","volume":"39","author":"Ayele","year":"2021","journal-title":"World J. Urol."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"105","DOI":"10.1007\/s11906-020-01115-4","article-title":"Strategies to Improve Adherence to Anti-Hypertensive Medications: A Narrative Review","volume":"22","author":"Izeogu","year":"2020","journal-title":"Curr. Hypertens. Rep."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"37","DOI":"10.5414\/CP203549","article-title":"Persistence and adherence to dutasteride\/tamsulosin fixed-dose versus free-combination alpha blocker\/5ARI therapy in patients with benign prostate hyperplasia in Germany","volume":"58","author":"Eisen","year":"2020","journal-title":"Int. J. Clin. Pharmacol. Ther."},{"key":"ref_12","doi-asserted-by":"crossref","unstructured":"Drake, M.J., Bowditch, S., Arbe, E., Hakimi, Z., Guelfucci, F., Amri, I., and Nazir, J. (2017). A retrospective study of treatment persistence and adherence to \u03b1-blocker plus antimuscarinic combination therapies, in men with LUTS\/BPH in the Netherlands. BMC Urol., 17.","DOI":"10.1186\/s12894-017-0226-2"},{"key":"ref_13","first-page":"e13616","article-title":"A retrospective analysis comparing persistence and adherence to treatment with free-vs fixed-dose combination of an alfa blocker and an antimuscarinic agent in men with LUTS in Spain","volume":"75","author":"Landeira","year":"2020","journal-title":"Int. J. Clin. Pract."},{"key":"ref_14","doi-asserted-by":"crossref","unstructured":"Cindolo, L., Pirozzi, L., Sountoulides, P., Fanizza, C., Romero, M., Castellan, P., Antonelli, A., Simeone, C., Tubaro, A., and de Nunzio, C. (2015). Patient\u2019s adherence on pharmacological therapy for benign prostatic hyperplasia (BPH)-associated lower urinary tract symptoms (LUTS) is different: Is combination therapy better than monotherapy?. BMC Urol., 15.","DOI":"10.1186\/s12894-015-0090-x"},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"431","DOI":"10.1007\/s11255-015-0920-5","article-title":"Depressive symptoms in patients diagnosed with benign prostatic hyperplasia","volume":"47","author":"Pietrzyk","year":"2015","journal-title":"Int. Urol. Nephrol."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1016\/j.archger.2018.09.005","article-title":"Antimuscarinic use and discontinuation in an older adult population","volume":"80","author":"Vouri","year":"2019","journal-title":"Arch. Gerontol. Geriatr."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"2123","DOI":"10.1002\/nau.23256","article-title":"Comparing anticholinergic persistence and adherence profiles in overactive bladder patients based on gender, obesity, and major anticholinergic agents","volume":"36","author":"Lua","year":"2017","journal-title":"Neurourol. Urodyn."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"434","DOI":"10.1007\/s00508-015-0751-5","article-title":"Patient\u2019s and physician\u2019s behavior on the management of benign prostatic hyperplasia among the patients at the risk of clinical progression. A multicenter noninterventional trial in Slovakia by \u201cProstate and Expectations of Treatment: Epidemiology Research\u201d (PETER) study group","volume":"127","author":"Weibl","year":"2015","journal-title":"Wien. Klin. Wochenschr."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"1579","DOI":"10.1016\/j.jsxm.2018.09.011","article-title":"The Risk of Sexual Dysfunction and Effectiveness of Treatment of Benign Prostatic Hyperplasia With Severe Lower Urinary Tract Dysfunction With Combination of Dutasteride and Solifenacin","volume":"15","author":"Kosilov","year":"2018","journal-title":"J. Sex. Med."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"3423","DOI":"10.21037\/tau-21-588","article-title":"A randomized placebo-controlled study: Phellodendron Bawei tablets combined with standard management can improve storage symptoms, sleep quality, and medication compliance in patients with benign prostatic hyperplasia compared to placebo with standard management","volume":"10","author":"Gong","year":"2021","journal-title":"Transl. Androl. Urol."},{"key":"ref_21","first-page":"639","article-title":"Drug adherence and drug-related problems in pharmacotherapy for lower urinary tract symptoms related to benign prostatic hyperplasia","volume":"69","author":"Zabkowski","year":"2018","journal-title":"J. Physiol. Pharmacol."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"67","DOI":"10.1097\/00005650-198601000-00007","article-title":"Concurrent and predictive validity of a self-reported measure of medication adherence","volume":"24","author":"Morisky","year":"1986","journal-title":"Med. Care"}],"container-title":["Pharmaceuticals"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/1424-8247\/18\/10\/1439\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,9]],"date-time":"2025-10-09T18:49:40Z","timestamp":1760035780000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/1424-8247\/18\/10\/1439"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,9,25]]},"references-count":22,"journal-issue":{"issue":"10","published-online":{"date-parts":[[2025,10]]}},"alternative-id":["ph18101439"],"URL":"https:\/\/doi.org\/10.3390\/ph18101439","relation":{},"ISSN":["1424-8247"],"issn-type":[{"value":"1424-8247","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,9,25]]}}}