{"title":"Efficacy and safety of 2% isosorbide cream in systemic sclerosis patients with digital ulcers and Raynaud's phenomenon.","authors":"Suwassa Namvijit, Chingching Foocharoen, Siraphop Suwannaroj, Patnarin Pongkulkait, Tippawan Onchan, Ajanee Mahakkanukrauh","doi":"10.1515/rir-2025-0006","DOIUrl":null,"url":null,"abstract":"<p><strong>Background and objectives: </strong>Raynaud's phenomenon (RP) and digital ulcers (DUs) impact the quality of life (QoL) of systemic sclerosis (SSc) patients. Calcium channel blockers (CCBs) and phosphodiesterase-5 inhibitors (PDE-5i) have been used to improve blood flow. However, vasodilators are limited in patients with low blood pressure. We aimed to determine the eficacy and safety of 2% isosorbide dinitrate (ISDN) cream as an adjunctive for treating DUs and RP.</p><p><strong>Methods: </strong>A cohort study was conducted at the Scleroderma Clinic at Khon Kaen University's Srinagarind Hospital in Khon Kaen, Thailand between January 2021 and December 2022. The study included adult SSc patients, who had received 2% ISDN cream for treatment of DUs or RP as adjuvant and with/or without receiving CCBs and/or PDE-5i as a background treatment for DUs and RP. Patients had to have follow-up data between 2 and 4 months after starting treatment. The median treatment duration was 2.8 months. Dosages of sustained-release nifedipine ranged from 10-80 mg and sildenafil ranged from 12.5-150 mg. Topical 2% ISDN cream was thinly applied three times a day. The treatment responses of DUs (ulcer size and pain) and RP (frequency and duration of attack) were according to patients' self-assessment, categorized into 3 levels Improvement Stable and Worsening. Before and after the treatment period of 2% ISDN cream the Quality of life was evaluated by using the EuroQoL five dimensions (EQ-5D) assessment by attending physicians.</p><p><strong>Results: </strong>In terms of anxiety, QoL, as evaluated by the EQ-5D, significantly improved after treatment with 2% ISDN cream in patients with DUs compared to before treatment. When used as an adjunct to CCB, 2% ISDN cream resulted in stability or improvement of RP in 43.2% of patients, DUs in 41.4% of patients, and both RP and DUs in 41.0% of patients. When used as an adjunct to PDE-5i as background therapy, it resulted in stability or improvement of RP in 13.5% of patients, DUs in 13.8% of patients, and both RP and DUs in 15.4% of patients.</p><p><strong>Conclusions: </strong>Topical 2% ISDN cream may help to reduce anxiety when DUs were improved and improve overall QoL.</p>","PeriodicalId":74736,"journal":{"name":"Rheumatology and immunology research","volume":"6 1","pages":"52-58"},"PeriodicalIF":0.0000,"publicationDate":"2025-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11966196/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Rheumatology and immunology research","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1515/rir-2025-0006","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/3/1 0:00:00","PubModel":"eCollection","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
Abstract
Background and objectives: Raynaud's phenomenon (RP) and digital ulcers (DUs) impact the quality of life (QoL) of systemic sclerosis (SSc) patients. Calcium channel blockers (CCBs) and phosphodiesterase-5 inhibitors (PDE-5i) have been used to improve blood flow. However, vasodilators are limited in patients with low blood pressure. We aimed to determine the eficacy and safety of 2% isosorbide dinitrate (ISDN) cream as an adjunctive for treating DUs and RP.
Methods: A cohort study was conducted at the Scleroderma Clinic at Khon Kaen University's Srinagarind Hospital in Khon Kaen, Thailand between January 2021 and December 2022. The study included adult SSc patients, who had received 2% ISDN cream for treatment of DUs or RP as adjuvant and with/or without receiving CCBs and/or PDE-5i as a background treatment for DUs and RP. Patients had to have follow-up data between 2 and 4 months after starting treatment. The median treatment duration was 2.8 months. Dosages of sustained-release nifedipine ranged from 10-80 mg and sildenafil ranged from 12.5-150 mg. Topical 2% ISDN cream was thinly applied three times a day. The treatment responses of DUs (ulcer size and pain) and RP (frequency and duration of attack) were according to patients' self-assessment, categorized into 3 levels Improvement Stable and Worsening. Before and after the treatment period of 2% ISDN cream the Quality of life was evaluated by using the EuroQoL five dimensions (EQ-5D) assessment by attending physicians.
Results: In terms of anxiety, QoL, as evaluated by the EQ-5D, significantly improved after treatment with 2% ISDN cream in patients with DUs compared to before treatment. When used as an adjunct to CCB, 2% ISDN cream resulted in stability or improvement of RP in 43.2% of patients, DUs in 41.4% of patients, and both RP and DUs in 41.0% of patients. When used as an adjunct to PDE-5i as background therapy, it resulted in stability or improvement of RP in 13.5% of patients, DUs in 13.8% of patients, and both RP and DUs in 15.4% of patients.
Conclusions: Topical 2% ISDN cream may help to reduce anxiety when DUs were improved and improve overall QoL.
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