Journal of Pharmacy Technology最新文献

{"title":"Incidence of Adverse Effects and Misuse of Zolpidem.","authors":"Fabiana Schuelter-Trevisol, Francieli Cipriano Felippe, Bruna Camargo, Beatriz Schuelter Trevisol, Leonan José Raimundo, Daisson José Trevisol","doi":"10.1177/87551225251324856","DOIUrl":"https://doi.org/10.1177/87551225251324856","url":null,"abstract":"<p><strong>Study objectives: </strong>Zolpidem is a widely prescribed medication for treating insomnia due to its effectiveness as a sedative-hypnotic. This study aimed to estimate the incidence of potential adverse effects associated with the use and misuse of zolpidem.</p><p><strong>Methods: </strong>Retrospective cohort study. Participants were selected from consumers who had purchased zolpidem in a commercial pharmacy in Brazil and submitted an interviewed. Descriptive analysis was used to present the results. Pearson's chi-square tests were used to compare adverse reactions to zolpidem with categorical variables, and Student's t-tests were used to compare means. The significance level adopted was 5%.</p><p><strong>Results: </strong>The study involved 65 participants, with a mean age of 52.7 years, 76.9% of whom were women. Of the total sample, 69.2% used zolpidem for the treatment of long-term insomnia, and 77.4% used it continuously. Among the interviewees, 55.4% reported experiencing adverse reactions, with amnesia, insomnia, and sleepwalking being the most reported. A statistically significant association was found between the occurrence of adverse reactions and continuous use (<i>P</i> value = 0.048), as well as among those with lower mean age (<i>P</i> value = 0.042).</p><p><strong>Conclusion: </strong>Despite being a prescription-controlled medication, zolpidem was used excessively and inappropriately in the studied sample. Given the high prevalence of adverse effects identified in this study, the risk/benefit ratio of pharmacological treatments for insomnia warrants careful evaluation during prescription and dispensing. Incidence of adverse effects and misuse of zolpidem.</p>","PeriodicalId":16796,"journal":{"name":"Journal of Pharmacy Technology","volume":" ","pages":"87551225251324856"},"PeriodicalIF":1.1,"publicationDate":"2025-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11909643/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143649437","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Thiamine and Ascorbic Acid in Sepsis and Septic Shock: A Review of Evidence for their Role in Practice.","authors":"Justin P Reinert, Kegan Becker, Martin J Ohlinger","doi":"10.1177/87551225251320873","DOIUrl":"https://doi.org/10.1177/87551225251320873","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the evidence for the use of ascorbic acid, thiamine, or a combination of both agents without corticosteroids in the management of sepsis and septic shock.</p><p><strong>Data sources: </strong>A review of the literature was conducted through August 2023 on PubMed, MEDLINE, Web of Science, and CINAHL using the following terminology: \"ascorbic acid\" OR \"vitamin C\" OR \"thiamine\" OR \"vitamin B\" OR \"vitamin B 1\" AND \"sepsis\" OR \"septic shock\" NOT \"steroid\" OR \"hydrocortisone\" OR \"corticosteroid.\"</p><p><strong>Study selection and data extraction: </strong>Trials that described patient outcomes, medication efficacy, and medication safety data were considered for inclusion, while reports describing the use of either or both thiamine and ascorbic acid for a non-sepsis indication and reports that were not readily translatable to English were excluded. Studies that allowed corticosteroid use in both the intervention and control cohorts as part of a standard-of-care protocol were eligible for inclusion.</p><p><strong>Data synthesis: </strong>Heterogeneity of data exists, marked by divergent quantifications for successful pharmacotherapy interventions. Whereas some data support changes in patient outcome scores or critical illness indices, others have failed to demonstrate any meaningful benefit to ICU length of stay, ventilator status, or mortality.</p><p><strong>Conclusion: </strong>Exploring the individual and synergistic effects of ascorbic acid and thiamine on key pathways implicated in sepsis pathophysiology has not yielded unequivocal evidence supporting their use without concomitant corticosteroids.</p>","PeriodicalId":16796,"journal":{"name":"Journal of Pharmacy Technology","volume":" ","pages":"87551225251320873"},"PeriodicalIF":1.1,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11866329/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143542344","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sotatercept: A First-In-Class Activin Signaling Inhibitor for Pulmonary Arterial Hypertension.","authors":"Aimon C Miranda, Cyrille K Cornelio, Bao Anh C Tran, Joel Fernandez","doi":"10.1177/87551225251317957","DOIUrl":"10.1177/87551225251317957","url":null,"abstract":"<p><p><b>Objective:</b> The objective of the study is to review the characteristics, efficacy, safety, and clinical relevance of sotatercept in pulmonary arterial hypertension (PAH). <b>Data Sources:</b> A literature search containing search terms related to sotatercept and PAH was conducted. Embase via Elsevier, MEDLINE via Ovid, the medRxiv preprint server, Cochrane Library CENTRAL trials registry, and ClinicalTrials.gov were searched from inception through October 31, 2024. The package insert was utilized to obtain drug information and additional data. <b>Study Selection and Data Extraction:</b> Phase II-III clinical trials investigating sotatercept for PAH were included. Articles written in English were extracted while animal studies and phase I clinical trials were excluded. <b>Data Synthesis:</b> In patients with WHO Group 1, functional class II-III PAH, adding sotatercept to background therapy increased 6-minute walk distance in phase II-III trials. Pooled analysis from PULSAR (phase II) and STELLAR (phase III) showed improvements in pulmonary vascular resistance and NT-proBNP. Exploratory data from PULSAR revealed that BMPR2 genetic variant status was not associated with significant differences in treatment effects. SPECTRA (phase IIb) demonstrated improved right ventricular structure and function. Interim analysis from SOTERIA showed that treatment effects persist at 1 year. <b>Conclusions:</b> Sotatercept is a viable add-on therapy for patients with PAH Group 1 and functional class II-III. Additional data are needed to assess long-term outcomes among treatment-naïve patients and those with the most severe symptomatology.</p>","PeriodicalId":16796,"journal":{"name":"Journal of Pharmacy Technology","volume":" ","pages":"87551225251317957"},"PeriodicalIF":1.1,"publicationDate":"2025-02-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11847314/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143492509","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prostaglandin Intracameral Implants for Ocular Hypertension and Open-Angle Glaucoma.","authors":"Christine M Cheng, Cameron Rehmani, Jordan Chin","doi":"10.1177/87551225251313707","DOIUrl":"10.1177/87551225251313707","url":null,"abstract":"<p><p><b>Background:</b> Sustained-release prostaglandin intracameral implants are new targeted treatment options for open-angle glaucoma or ocular hypertension that lower intraocular pressure (IOP) and reduce or eliminate the need for topical eye drops. <b>Objective:</b> To summarize evidence supporting prostaglandin intracameral implants for treatment of ocular hypertension or open angle glaucoma and identify patient populations most likely to benefit from these treatments. <b>Data sources:</b> A PubMed search (1/1/2016 to 10/1/2024) was conducted to identify randomized, controlled clinical trials for bimatoprost 10-μg and travoprost 75-μg intracameral implants. Manufacturer prescribing information, formulary dossiers, Food and Drug Administration (FDA) clinical reviews and glaucoma clinical treatment guidelines were also reviewed. <b>Study selection and data extraction:</b> English-language randomized controlled trials involving bimatoprost 10-μg or travoprost 75-μg intracameral implants were included. <b>Data synthesis:</b> Bimatoprost and travoprost intracameral implants demonstrated noninferior IOP reduction compared to timolol eye drops in phase 3 trials, with sustained effects up to 12 and 36 months, respectively. The FDA-approved implants are limited to a single administration to the affected eye to minimize corneal risks. The travoprost implant contains a titanium reservoir and requires surgical placement, while the bimatoprost implant is biodegradable and can be placed in a clinic setting. There are no studies directly comparing the safety and efficacy of the two intracameral implants. <b>Conclusions:</b> Prostaglandin intracameral implants are a novel approach to reducing medication burden while delivering sustained IOP reducing effects. Pharmacists should be aware of efficacy and safety considerations of these implants relative to available topical treatments for ocular hypertension or open angle glaucoma.</p>","PeriodicalId":16796,"journal":{"name":"Journal of Pharmacy Technology","volume":" ","pages":"87551225251313707"},"PeriodicalIF":1.1,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11791955/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143255927","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of 12- to 24-Hour Versus 72-Hour Intravenous Terlipressin in Patients With Acute Esophageal Variceal Bleeding: A Systematic Review and Meta-analysis.","authors":"Mohammad Al Hayek, Bisher Sawaf, Shahem Abbarh, Sudheer Dhoop, Abdallah Khashan, Ahmed Hassan, Alhasan Saleh Alzubi, Abdelrahman F Abdelwahed, Abdussalam I A Alzein, Mohamedhen Vall Nounou, Yaseen Alastal, Muhammed Elhadi","doi":"10.1177/87551225241311444","DOIUrl":"10.1177/87551225241311444","url":null,"abstract":"<p><p><b>Objective:</b> To compare the efficacy and safety of 12-24 hours versus 72 hours of intravenous terlipressin therapy in patients with acute esophageal variceal bleeding (AVB). <b>Data sources:</b> A systematic search was conducted using PubMed, Scopus, Cochrane Library, Google Scholar, Web of Science, VHL, and ClinicalTrials.gov for studies published up to February 24, 2024. The search terms included \"terlipressin,\" \"variceal bleeding,\" \"short-course,\" and \"72-hour treatment.\" <b>Study selection and data extraction:</b> Randomized controlled trials (RCTs) comparing 12 to 24 hours with 72 hours of terlipressin therapy in patients with AVB were included. Studies not meeting these criteria or focusing on unrelated outcomes were excluded. Two authors conducted data extraction and bias assessment independently, with discrepancies resolved by a third reviewer. Baseline characteristics and outcomes (rebleeding and mortality within 5 days) were recorded. <b>Results:</b> Four RCTs with 469 patients were included in the analysis. There were no significant differences observed in 5-day rebleeding rates (OR = 0.943; 95% CI [0.384, 2.317]; <i>P</i> = 0.898) or mortality rates (OR = 0.386; 95% CI [0.066, 2.260]; <i>P</i> = 0.291) between terlipressin treatment durations of 12 to 24 hours and 72 hours within the first 5 days posttreatment. In addition, no heterogeneity was found in both variables (<i>P</i> > 0.1). <b>Conclusion:</b> This meta-analysis indicates that there is no significant difference in rebleeding rates or mortality between 12 to 24 hours and 72 hours of terlipressin therapy for AVB within 5 days posttreatment. Shorter treatment durations may offer advantages in terms of resource utilization and adverse event risk but require further validation through studies involving larger patient populations.</p>","PeriodicalId":16796,"journal":{"name":"Journal of Pharmacy Technology","volume":" ","pages":"87551225241311444"},"PeriodicalIF":1.1,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11758437/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143047049","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"State Variation in Uptake of Pharmacy-Based CLIA-Waived Testing: Impact of Laws and Regulations.","authors":"Alex J Adams, Donald G Klepser, Michael E Klepser","doi":"10.1177/87551225241306678","DOIUrl":"10.1177/87551225241306678","url":null,"abstract":"<p><p><b>Background:</b> Community pharmacies have grown to be an increasingly important provider of CLIA-waived tests, just second to physician offices as the venue with the most waivers. Yet, individual variation is still observed across states with respect to the percentage of pharmacies holding a CLIA-waiver, with a reported range of 10.7% in Massachusetts to 87.9% in Delaware. <b>Objective:</b> To identify how state laws can either impede or enhance access to POCT services by pharmacies by comparing the percentage of pharmacies in each state holding a CLIA-waiver to the legal model for POCT services in each state. <b>Methods:</b> Data from the U.S. Centers for Disease Control and Prevention CLIA Laboratory Search website reported on December 4, 2023, were used to determine the number of pharmacies holding CLIA-waivers in each state. This was then divided by the number of community pharmacies in each state, as reported in the 2023 National Community Pharmacy Association Digest, and then compared with 2 public reports on pharmacy CLIA laws. <b>Results:</b> States categorized as allowing pharmacists to independently perform CLIA-waived tests in public reports actually had a lower percentage of pharmacies with a CLIA-waiver (49.60%) than those categorized as <i>not</i> allowing CLIA-waived tests (60.19%). As many as 10 241 pharmacies hold a CLIA-waiver in states that did not affirmatively report that pharmacists ordering lab tests was allowed. <b>Conclusion:</b> The paradoxical finding is likely a result of the underreporting of pharmacist CLIA-waived testing authority given the complexity of pharmacy law relative to other professions. Simplifying pharmacy law through adoption of a \"standard of care\" regulatory approach may enhance patient access to POCT services moving forward.</p>","PeriodicalId":16796,"journal":{"name":"Journal of Pharmacy Technology","volume":" ","pages":"87551225241306678"},"PeriodicalIF":1.1,"publicationDate":"2024-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11669126/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142895378","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Persistence After Switching From Adalimumab Biosimilar MSB11022 to Adalimumab Biosimilar GP2017 in Patients With Chronic Inflammatory Rheumatic Diseases.","authors":"Joaquín Borrás-Blasco, Alejandro Valcuende-Rosique, Silvia Cornejo, Celia Aparicio-Rubio, Marta Aguilar-Zamora, Marta Garijo-Bufort, Karla Romelia Arévalo-Ruales","doi":"10.1177/87551225241306675","DOIUrl":"10.1177/87551225241306675","url":null,"abstract":"<p><p><b>Objective:</b> Provide real-world data on switching from adalimumab biosimilar MSB11022 to GP2017 related to persistence, adherence, and safety in adult patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA). <b>Methods:</b> Retrospective cohort study that used registries and medical records from a single hospital (June 2022 to April 2024). Adult patients with RA, PsA, and axSpA treated with adalimumab biosimilar MSB11022 who switched to biosimilar GP2017 were identified and followed up until April 2024, or disenrollment. Baseline demographic and clinical characteristics studied included sex, age, diagnosis, and previous treatment. Adherence was measured using medication possession ratio (MPR); patients with MPR ≥85% were considered adherent. Persistence, cause of discontinuation, safety, and dosage regimen were collected. <b>Results:</b> A total of 63 patients with chronic inflammatory rheumatic diseases, of whom 36 (57.1%) were women, with an average age of 53.9 years were included. In total, 24 had axSpA, 21 had RA, and 18 had PsA. A total of 58 patients (92.1%) were biologic-naïve, and 27 (42.3%) received methotrexate. A total of 63 patients switched from adalimumab biosimilar MSB11022 to GP2017. After 12 months, 53 (84.1%) continued; 9 (14.3%) discontinued due to lack of effectiveness, side effects, or change of health department. The total persistence of patients who switched from MSB11022 to GP2017 was 12.4 ± 3.1 months. Non-naïve patients had a persistence of 13.7 ± 0.5 months, and naïve patients had 9.5 ± 3.0 months, with no significant differences. The retention rate at 12 months was 84%, with an adherence rate of 88.2%. <b>Conclusions:</b> Switching from adalimumab biosimilar MSB11022 to biosimilar GP2017 in patients with chronic inflammatory rheumatic diseases did not lead to signs of safety or loss of efficacy over 12 months other than those already known in the literature for the class of drugs.</p>","PeriodicalId":16796,"journal":{"name":"Journal of Pharmacy Technology","volume":" ","pages":"87551225241306675"},"PeriodicalIF":1.1,"publicationDate":"2024-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11669125/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142895374","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Risk of Tendon Injury in Patients Treated With Fluoroquinolone (FQ) Vs Non-Fluoroquinolone Antibiotics for Urinary Tract Infection (UTI).","authors":"Virginia H Fleming, Jianing Xu, Xianyan Chen, Daniel Hall, Robin L Southwood","doi":"10.1177/87551225241303848","DOIUrl":"10.1177/87551225241303848","url":null,"abstract":"<p><strong>Background: </strong>Fluoroquinolones (FQs) are associated with potential tendon injury but comparative risk versus other antibiotic (non-FQ) options for the same indication has rarely been evaluated.</p><p><strong>Objective: </strong>Describe the incidence (relative risk) of any tendon injury in patients receiving FQs compared with other (non-FQ) antibiotics for treatment of urinary tract infections (UTIs).</p><p><strong>Methods: </strong>A retrospective propensity score-weighted cohort study was performed to evaluate the association between FQ antibiotics and tendon injury at two time points (within one month and within six months of use) compared with non-FQ regimens for treatment of UTI. The evaluation was performed using the Merative™ MarketScan^® Research Databases from 2014 to 2020. Adult patients with International Classification of Diseases (ICD)-9/10 coding for UTI were included. Patients with a history of tendon injury or those who received both FQ and non-FQ regimens during the study period were excluded. Propensity score weighting was used to adjust for selection bias due to contributing risk factors, including demographics (age, sex), comorbidities (diabetes mellitus, chronic kidney disease), and concurrent medications (corticosteroids).</p><p><strong>Results: </strong>Both the 1-month and 6-month cohorts were predominately female and less than 50 years of age. At one month, the incidence of tendon injury was 0.2% in the FQ group and 0.1% in the non-FQ group, and the odds of tendon injury were not estimated to be significantly different between groups (odds ratio [OR] = 1.03, 95% confidence interval [CI] 0.93, 1.32). Odds of tendon injury were also not estimated to be significantly different in the 6-month cohort (OR = 0.98, 95% CI 0.84, 1.05).</p><p><strong>Conclusion and relevance: </strong>In this population of predominantly young female patients without high incidence of potentially contributing comorbidities, increased risk of tendon injury was not associated with FQ use. Future research is needed to determine whether demographic differences between this and other previously studied populations account for this discordant result.</p>","PeriodicalId":16796,"journal":{"name":"Journal of Pharmacy Technology","volume":" ","pages":"87551225241303848"},"PeriodicalIF":1.1,"publicationDate":"2024-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11664555/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142885844","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of Nonmedical Switches From Reference Infliximab to Biosimilars on Disease Control Within a Rheumatology Practice.","authors":"Marta Jankowska, Krista Dessureault, Julie MacDougall, Matthew Sowers, Morgan Merchand, Amanda G Kennedy","doi":"10.1177/87551225241308475","DOIUrl":"10.1177/87551225241308475","url":null,"abstract":"<p><p><b>Background:</b> Infliximab is an anti-tumor necrosis factor agent used to treat rheumatologic disease. Evidence on the safety of switching to biosimilars and the associated risk factors for flares/loss of disease control within rheumatology is limited. <b>Objective:</b> The primary objective is to evaluate nonmedical switches from reference infliximab to biosimilars in rheumatology on risks and level of disease control. <b>Methods:</b> This retrospective analysis of data was conducted on all adult patients at our institution's rheumatology clinics with a rheumatologic diagnosis who were stable on reference infliximab and switched to the formulary biosimilars infliximab-dyyb or infliximab-abda, during the study period. Patient demographics as well as concomitant rheumatologic medications, markers of disease control, and hospitalization data were collected. <b>Results:</b> Of the 317 patients screened, 48 patients met inclusion criteria. A total of 29 patients (60.4%) were on reference infliximab and 19 patients (39.6%) were switched to biosimilar. Eight patients (42.1%) flared after a switch to biosimilar. Of the biosimilar patients, all patients were on infliximab-dyyb and were mandated to switch by insurance. Two patients who flared after switch to biosimilar (25%) had a delay in treatment due to attempts to receive prior authorization for reference infliximab. <b>Conclusions:</b> In the patients who switched to biosimilar, almost half experienced a flare. Two of these eight patients (25%) had a delay in treatment after the switch, which may be a risk factor for flaring/loss of disease control. Pharmacists should be following patients who switch to biosimilar closely during the transition period, to monitor for signs of flares/loss of disease control.</p>","PeriodicalId":16796,"journal":{"name":"Journal of Pharmacy Technology","volume":" ","pages":"87551225241308475"},"PeriodicalIF":1.1,"publicationDate":"2024-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11663279/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142882160","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effectiveness and Safety of Sodium-Glucose Cotransporter-2 Inhibitor Continuation in Patients With Type 2 Diabetes and Late-Stage Chronic Kidney Disease.","authors":"Olivia Denny, Nicole P Albanese, Calvin J Meaney, Nicole E Siwarski, Scott V Monte","doi":"10.1177/87551225241302731","DOIUrl":"10.1177/87551225241302731","url":null,"abstract":"<p><p><b>Background:</b> Expansion of sodium-glucose cotransporter-2 inhibitor (SGLT2i) use in chronic kidney disease (CKD) prompted a pragmatic study of their safety and effectiveness in patients with type 2 diabetes mellitus (T2DM) and late-stage CKD. <b>Objective:</b> The primary clinical endpoint was change in HbA_1c. Secondary clinical endpoints included change in body weight and blood pressure. Safety endpoints included kidney function indices, mycotic or urinary tract infection, acute kidney injury, dehydration, and ketoacidosis. <b>Methods:</b> Adult patients with T2DM and late-stage CKD prescribed an SGLT2i between June 1, 2018 and June 1, 2023 were included in this retrospective cohort study. Late-stage CKD was defined as CKD stage G3b, G4, or G5, including requiring dialysis or kidney transplantation. Endpoints were compared between patients who continued an SGLT2i versus those who discontinued. <b>Results:</b> Fifty-nine patients were included. Short-term follow-up over 4.2 ± 1.7 months revealed no difference in HbA_1c between groups. Extended follow-up in a truncated sample over 10.4 ± 2.6 months showed modest, yet significantly lower HbA_1c with continuation (median: -0.3 vs 0.1%; <i>P</i> = 0.04). Weight loss was greater when treatment continued (median: -1.8 vs 0.2 kg; <i>P</i> = 0.01), whereas blood pressure did not differ. No differences in safety endpoints were observed. Kidney function mildly, but significantly worsened with continuation (median estimated glomerular filtration rate [eGFR]: -2.7 vs 0 mL/min/1.73 m²; <i>P</i> = 0.03). <b>Conclusions:</b> Patients with T2DM and late-stage CKD had similar glucose control and safety profiles irrespective of SGLT2i continuation or discontinuation. This may favor clinical decision-making toward benefits of SGLT2i reduction in weight, cardiovascular events, CKD progression, and hospitalizations over potential safety concerns in these patients.</p>","PeriodicalId":16796,"journal":{"name":"Journal of Pharmacy Technology","volume":" ","pages":"87551225241302731"},"PeriodicalIF":1.1,"publicationDate":"2024-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11660099/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142876467","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}