PMID- 37452334 OWN - NLM STAT- MEDLINE DCOM- 20230717 LR - 20230718 IS - 1471-2415 (Electronic) IS - 1471-2415 (Linking) VI - 23 IP - 1 DP - 2023 Jul 14 TI - The efficacy and safety of varenicline nasal spray for the management of dry eye signs: a systematic review and meta-analysis. PG - 319 LID - 10.1186/s12886-023-03069-y [doi] LID - 319 AB - BACKGROUND: Dry eye disease (DED) is caused by a persistently unstable tear film leading to ocular discomfort and is treated mainly with tear supplementation. There is emerging evidence that nicotinic acetylcholine receptor (nAChR) agonists (e.g., varenicline and simpinicline) nasal sprays are effective for DED. Our systematic review and meta-analysis assessed the efficacy and safety of varenicline nasal spray (VNS) for DED treatment. METHODS: The Medline, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) databases were searched. Only randomized controlled trials (RCTs) that evaluated the efficacy of VNS versus placebo were included. The efficacy endpoint was the mean change in the anesthetized Schirmer test score (STS), a measure of basal tear production, from baseline. The safety endpoints were serious adverse events (SAEs) and adverse events (AEs). The standardized mean difference (SMD) was used for continuous outcomes, while the risk ratio (RR) was used to demonstrate dichotomous variables. The certainty of the evidence was rated utilizing the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. The risk of bias assessment was conducted using the Revised Cochrane risk of bias tool for randomized trials. RESULTS: Three RCTs (n = 1063) met the eligibility criteria. All RCTs had a low risk of bias. The meta-analysis found a statistically significant increase in the mean STS change from baseline on day 28. The pooled analysis found no significant difference between VNS and placebo in the frequency of SAEs and ocular AEs. However, VNS had a significant effect on developing nasal cavity-related AEs. CONCLUSION: VNS caused a highly significant improvement regarding the efficacy endpoint but caused an increased frequency of some nasal cavity-related AEs (i.e., cough and throat irritation). However, it caused neither SAEs nor ocular AEs. Included studies had a low risk of bias. CI - (c) 2023. The Author(s). FAU - Bashrahil, Bader AU - Bashrahil B AD - College of Medicine, King Saud bin Abdulaziz University for Health Sciences, Jeddah, Saudi Arabia. Badrbashrahil@gmail.com. AD - King Abdullah International Medical Research Center, Jeddah, Saudi Arabia. Badrbashrahil@gmail.com. FAU - Taher, Nada AU - Taher N AD - College of Medicine, King Saud bin Abdulaziz University for Health Sciences, Jeddah, Saudi Arabia. AD - King Abdullah International Medical Research Center, Jeddah, Saudi Arabia. FAU - Alzahrani, Ziyad AU - Alzahrani Z AD - College of Medicine, King Saud bin Abdulaziz University for Health Sciences, Jeddah, Saudi Arabia. AD - King Abdullah International Medical Research Center, Jeddah, Saudi Arabia. FAU - Alnabihi, Ahmed AU - Alnabihi A AD - College of Medicine, King Saud bin Abdulaziz University for Health Sciences, Jeddah, Saudi Arabia. AD - King Abdullah International Medical Research Center, Jeddah, Saudi Arabia. FAU - Aldahlawi, Abdulaziz AU - Aldahlawi A AD - College of Medicine, King Saud bin Abdulaziz University for Health Sciences, Jeddah, Saudi Arabia. AD - King Abdullah International Medical Research Center, Jeddah, Saudi Arabia. FAU - Alkhathlan, Mohammed AU - Alkhathlan M AD - College of Medicine, King Saud bin Abdulaziz University for Health Sciences, Jeddah, Saudi Arabia. AD - King Abdullah International Medical Research Center, Jeddah, Saudi Arabia. FAU - Alghamdi, Saeed AU - Alghamdi S AD - College of Medicine, King Saud bin Abdulaziz University for Health Sciences, Jeddah, Saudi Arabia. AD - King Abdullah International Medical Research Center, Jeddah, Saudi Arabia. AD - Department of Ophthalmology, Ministry of the National Guard-Health Affairs, Jeddah, Saudi Arabia. LA - eng PT - Journal Article PT - Meta-Analysis PT - Systematic Review DEP - 20230714 PL - England TA - BMC Ophthalmol JT - BMC ophthalmology JID - 100967802 RN - 0 (Nasal Sprays) RN - W6HS99O8ZO (Varenicline) SB - IM MH - Humans MH - *Nasal Sprays MH - Varenicline MH - *Dry Eye Syndromes/drug therapy PMC - PMC10347795 OTO - NOTNLM OT - Dry eye disease OT - Nasal spray OT - Varenicline COIS- The authors declare no competing interests. EDAT- 2023/07/15 10:42 MHDA- 2023/07/17 06:42 PMCR- 2023/07/14 CRDT- 2023/07/14 23:36 PHST- 2022/09/29 00:00 [received] PHST- 2023/07/03 00:00 [accepted] PHST- 2023/07/17 06:42 [medline] PHST- 2023/07/15 10:42 [pubmed] PHST- 2023/07/14 23:36 [entrez] PHST- 2023/07/14 00:00 [pmc-release] AID - 10.1186/s12886-023-03069-y [pii] AID - 3069 [pii] AID - 10.1186/s12886-023-03069-y [doi] PST - epublish SO - BMC Ophthalmol. 2023 Jul 14;23(1):319. doi: 10.1186/s12886-023-03069-y.