Use of phosphodiesterase 5 inhibitors is not associated with ocular adverse events
© The Author(s) 2023. Published by Oxford University Press on behalf of The International Society of Sexual Medicine. All rights reserved. For permissions, please e-mail: journals.permissionsoup.com..
BACKGROUND: Phosphodiesterase 5 inhibitor (PDE5i) use has been linked to a number of ocular side effects, such as serous retinal detachment (SRD), retinal vascular occlusion (RVO), and ischemic optic neuropathy (ION).
AIM: We investigated the risk for SRD, RVO, and ION in patients using PDE5is.
METHODS: We utilized the IBM MarketScan (2007-2021) Commercial and Medicare Supplemental Databases (version 2.0) for this analysis. To estimate overall events risk, Cox proportional hazard models were applied to calculate the hazard ratios (HRs) for erectile dysfunction (ED) diagnosis and the different treatments, adjusting for region, median age, obesity, diabetes mellitus, hyperlipidemia, smoking, hypertension, coronary artery disease, and sleep apnea. Additionally, the same analyses were performed to calculate the HRs for benign prostatic hyperplasia (BPH) diagnosis and the different treatments.
OUTCOMES: HRs for SRD, RVO, and ION.
RESULTS: In total, 1 938 262 men with an ED diagnosis were observed during the study period. Among them, 615 838 (31.8%) were treated with PDE5is. In total, 2 175 439 men with a BPH diagnosis were observed during the study period. Among them, 175 725 (8.1%) were treated with PDE5is. On adjusted Cox regression analysis, PDE5i use was not associated with SRD, RVO, ION, and any ocular event when compared with ED diagnosis and other ED treatments. Importantly, as the intensity of ED treatment increased, so did the risk of ocular events. In addition, PDE5i use was not associated with SRD and ION when compared with BPH diagnosis and other BPH treatments. In contrast, in patients with BPH, PDE5i use was associated with RVO (HR, 1.14; 95% CI, 1.06-1.23). Importantly, patients with BPH receiving other medical treatment (ie, 5a reductase/alpha blocker; HR, 1.11; 95% CI, 1.06-1.16) or surgical treatment (HR, 1.10; 95% CI, 1.02-1.19) had a higher risk of RVO.
CLINICAL IMPLICATIONS: We did not observe any consistent association between PDE5i use and any ocular adverse events (SRD, RVO, and ION).
STRENGTHS AND LIMITATIONS: Because we did not have access to the patients' medical records, we recorded outcome definitions using ICD-9 and ICD-10 coding.
CONCLUSIONS: Patients using PDE5is for ED or BPH indications did not have an increased risk of ocular events, even when compared with other treatments for ED or BPH.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:20 |
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| Enthalten in: |
The journal of sexual medicine - 20(2023), 12 vom: 30. Nov., Seite 1399-1406 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Belladelli, Federico [VerfasserIn] |
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| Links: |
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| Themen: |
Adverse events |
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| Anmerkungen: |
Date Completed 04.12.2023 Date Revised 06.03.2024 published: Print Citation Status MEDLINE |
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| doi: |
10.1093/jsxmed/qdad137 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 245 | 1 | 0 | |a Use of phosphodiesterase 5 inhibitors is not associated with ocular adverse events |
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| 500 | |a Date Completed 04.12.2023 | ||
| 500 | |a Date Revised 06.03.2024 | ||
| 500 | |a published: Print | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © The Author(s) 2023. Published by Oxford University Press on behalf of The International Society of Sexual Medicine. All rights reserved. For permissions, please e-mail: journals.permissionsoup.com. | ||
| 520 | |a BACKGROUND: Phosphodiesterase 5 inhibitor (PDE5i) use has been linked to a number of ocular side effects, such as serous retinal detachment (SRD), retinal vascular occlusion (RVO), and ischemic optic neuropathy (ION) | ||
| 520 | |a AIM: We investigated the risk for SRD, RVO, and ION in patients using PDE5is | ||
| 520 | |a METHODS: We utilized the IBM MarketScan (2007-2021) Commercial and Medicare Supplemental Databases (version 2.0) for this analysis. To estimate overall events risk, Cox proportional hazard models were applied to calculate the hazard ratios (HRs) for erectile dysfunction (ED) diagnosis and the different treatments, adjusting for region, median age, obesity, diabetes mellitus, hyperlipidemia, smoking, hypertension, coronary artery disease, and sleep apnea. Additionally, the same analyses were performed to calculate the HRs for benign prostatic hyperplasia (BPH) diagnosis and the different treatments | ||
| 520 | |a OUTCOMES: HRs for SRD, RVO, and ION | ||
| 520 | |a RESULTS: In total, 1 938 262 men with an ED diagnosis were observed during the study period. Among them, 615 838 (31.8%) were treated with PDE5is. In total, 2 175 439 men with a BPH diagnosis were observed during the study period. Among them, 175 725 (8.1%) were treated with PDE5is. On adjusted Cox regression analysis, PDE5i use was not associated with SRD, RVO, ION, and any ocular event when compared with ED diagnosis and other ED treatments. Importantly, as the intensity of ED treatment increased, so did the risk of ocular events. In addition, PDE5i use was not associated with SRD and ION when compared with BPH diagnosis and other BPH treatments. In contrast, in patients with BPH, PDE5i use was associated with RVO (HR, 1.14; 95% CI, 1.06-1.23). Importantly, patients with BPH receiving other medical treatment (ie, 5a reductase/alpha blocker; HR, 1.11; 95% CI, 1.06-1.16) or surgical treatment (HR, 1.10; 95% CI, 1.02-1.19) had a higher risk of RVO | ||
| 520 | |a CLINICAL IMPLICATIONS: We did not observe any consistent association between PDE5i use and any ocular adverse events (SRD, RVO, and ION) | ||
| 520 | |a STRENGTHS AND LIMITATIONS: Because we did not have access to the patients' medical records, we recorded outcome definitions using ICD-9 and ICD-10 coding | ||
| 520 | |a CONCLUSIONS: Patients using PDE5is for ED or BPH indications did not have an increased risk of ocular events, even when compared with other treatments for ED or BPH | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, N.I.H., Extramural | |
| 650 | 4 | |a PDE5i | |
| 650 | 4 | |a adverse events | |
| 650 | 4 | |a erectile dysfunction | |
| 650 | 7 | |a Phosphodiesterase 5 Inhibitors |2 NLM | |
| 700 | 1 | |a Li, Shufeng |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Chiyuan A |e verfasserin |4 aut | |
| 700 | 1 | |a Muncey, Wade |e verfasserin |4 aut | |
| 700 | 1 | |a Del Giudice, Francesco |e verfasserin |4 aut | |
| 700 | 1 | |a Glover, Frank |e verfasserin |4 aut | |
| 700 | 1 | |a Seranio, Nicolas |e verfasserin |4 aut | |
| 700 | 1 | |a Basran, Satvir |e verfasserin |4 aut | |
| 700 | 1 | |a Fallara, Giuseppe |e verfasserin |4 aut | |
| 700 | 1 | |a Montorsi, Francesco |e verfasserin |4 aut | |
| 700 | 1 | |a Salonia, Andrea |e verfasserin |4 aut | |
| 700 | 1 | |a Eisenberg, Michael L |e verfasserin |4 aut | |
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