The Annals of pharmacotherapy最新文献

{"title":"Transdermal Opioids and the Quality of Life of the Cancer Patient: A Systematic Literature Review.","authors":"Patricia Santos Reis, D. Kraychete, Emilie de Magalhães Pedreira, Eduardo Silva Reis Barreto, César Romero Antunes Júnior, Vinicius Borges Alencar, Anna Karla do Nascimento Souza, Liliane Elze Falcão Lins-Kusterer, Liana Maria Torres de Araujo Azi","doi":"10.1177/10600280241247363","DOIUrl":"https://doi.org/10.1177/10600280241247363","url":null,"abstract":"OBJECTIVE\u0000This systematic literature review aims to evaluate the effectiveness of transdermal opioids in managing cancer pain and their impact on the quality of life (QoL) of patients.\u0000\u0000\u0000DATA SOURCES\u0000A systematic literature review conducted following the PRISMA protocol, focusing on randomized clinical trials found in the Lilacs, Embase, PubMed, and SciELO databases over the last 20 years.\u0000\u0000\u0000STUDY SELECTION AND DATA EXTRACTION\u0000We included randomized clinical trials, published in English, Portuguese, or Spanish, which assessed the impact of transdermal opioids on the QoL. Data extraction was facilitated using the Rayyan app.\u0000\u0000\u0000DATA SYNTHESIS\u0000Six articles meeting the inclusion and exclusion criteria were analyzed. These studies covered a population ranging from 24 to 422 cancer patients experiencing moderate to severe pain. The risk of bias was assessed in each study, generally being categorized as uncertain or high.\u0000\u0000\u0000RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE\u0000The findings indicate that the analgesic effectiveness and side effects of transdermal formulations (specifically buprenorphine and fentanyl) for managing moderate to severe cancer pain are comparable to, or in some cases superior to, those of oral opioids traditionally employed.\u0000\u0000\u0000CONCLUSIONS\u0000Transdermal therapy was suggested to have several advantages over oral opioid therapy in enhancing cancer patients' QoL. These benefits span various dimensions, including pain management, physical functioning, mental health, vitality, overall patient improvement, anger/aversion, strength/activity, general QoL, cognitive and emotional functions, fatigue, and insomnia.","PeriodicalId":512049,"journal":{"name":"The Annals of pharmacotherapy","volume":"53 1","pages":"10600280241247363"},"PeriodicalIF":0.0,"publicationDate":"2024-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140664776","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Nirsevimab: Expansion of Respiratory Syncytial Virus Prevention Options in Neonates, Infants, and At-Risk Young Children.","authors":"J. H. Fly, Lea S. Eiland, Jeremy S. Stultz","doi":"10.1177/10600280241243357","DOIUrl":"https://doi.org/10.1177/10600280241243357","url":null,"abstract":"OBJECTIVE\u0000Review available data from clinical trials of nirsevimab for efficacy and safety in the setting of respiratory syncytial virus (RSV) prophylaxis in infants and children, while exploring nirsevimab's role in clinical practice and highlighting continuing questions.\u0000\u0000\u0000DATA SOURCES\u0000A literature search of PubMed was conducted utilizing the phrases \"nirsevimab\" and \"medi8897.\" Additional references were identified through found references. Organizational guidelines, medication labeling, and regulatory organization presentations were utilized.\u0000\u0000\u0000STUDY SELECTION AND DATA EXTRACTION\u0000Relevant clinical trials investigating nirsevimab in infants and children were included as well as other references on pharmacology, pharmacokinetics, and pharmacoeconomics.\u0000\u0000\u0000DATA SYNTHESIS\u0000Nirsevimab, a once-a-season monoclonal antibody, demonstrated a 79.5% (95% CI, 65.9-87.7; P < 0.00001) lower incidence of RSV-associated medically attended lower respiratory tract infections (MA RSV-associated LRTI) and 77.3% (95% CI, 50.3-89.7; P = 0.0002) reduction in hospitalizations for RSV-associated MA-LRTI across 2 placebo-controlled studies. Nirsevimab demonstrated comparable safety to placebo with minor dermatologic reactions being the most common adverse event (0.9% vs 0.6%).\u0000\u0000\u0000RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE IN COMPARISON WITH EXISTING AGENTS\u0000Nirsevimab was approved by the US Food and Drug Administration, and recommended by the Advisory Committee on Immunization Practices and American Academy of Pediatrics for broad administration to infants entering their first RSV season and at risk patients during their second RSV season. Questions remain over efficacy in infants born < 29-week gestation and other economical considerations.\u0000\u0000\u0000CONCLUSIONS\u0000Nirsevimab demonstrated clinical efficacy in reducing RSV-associated MA-LRTI and RSV-associated hospitalizations in infants and was well tolerated.","PeriodicalId":512049,"journal":{"name":"The Annals of pharmacotherapy","volume":"20 1","pages":"10600280241243357"},"PeriodicalIF":0.0,"publicationDate":"2024-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140671258","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Eptacog Beta for Bleeding Treatment and Prevention in Congenital Hemophilia A and B With Inhibitors: A Review of Clinical Data and Implications for Clinical Practice.","authors":"Alana M Ciolek,&nbsp;Justin Arnall,&nbsp;Donald C Moore,&nbsp;Surabhi Palkimas,&nbsp;Julie Der-Nigoghossian,&nbsp;Kathryn Dane","doi":"10.1177/10600280211049394","DOIUrl":"https://doi.org/10.1177/10600280211049394","url":null,"abstract":"<p><strong>Objective: </strong>To review the pharmacology, dosing and administration, safety, clinical efficacy, and role of eptacog beta in the treatment of congenital hemophilia with inhibitors.</p><p><strong>Data sources: </strong>A literature search of PubMed (1966 to August 2021) was conducted using the keywords <i>eptacog beta</i>, <i>recombinant FVII</i>, and <i>hemophilia</i>.</p><p><strong>Study selection and data extraction: </strong>All relevant published articles and prescribing information on eptacog beta for the treatment of congenital hemophilia with inhibitors were reviewed.</p><p><strong>Data synthesis: </strong>Eptacog beta is a novel recombinant activated factor VII (rVIIa) product that demonstrated efficacy in controlling bleeding and associated pain in patients with hemophilia A or B with inhibitors. Eptacog beta has limited Food and Drug Administration-approved and off-label indications compared with other bypassing agents (BPAs; activated prothrombin complex concentrates [aPCC; eptacog alfa]). Eptacog beta costs less than eptacog alfa, but still more than aPCCs.</p><p><strong>Relevance to patient care and clinical practice: </strong>This review provides insight into the role of eptacog beta for treatment of congenital hemophilia with inhibitors and reviews important health system formulary considerations for available BPAs.</p><p><strong>Conclusions: </strong>Eptacog beta is more cost-effective than eptacog alfa and, as such, may become the preferred rVIIa formulary product. However, eptacog alfa availability remains necessary for the treatment of disorders where eptacog beta has limited data. aPCC should remain the first-line BPA for the treatment of bleeding in patients with inhibitors with no contraindications to use because of its equivocal efficacy and safety and in light of the magnitude of cost savings associated with this strategy.</p>","PeriodicalId":512049,"journal":{"name":"The Annals of pharmacotherapy","volume":" ","pages":"831-838"},"PeriodicalIF":2.9,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39475239","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Peripherally Infused Norepinephrine to Avoid Central Venous Catheter Placement in a Medical Intensive Care Unit: A Pilot Study.","authors":"Lara M Groetzinger,&nbsp;Julia Williams,&nbsp;Susan Svec,&nbsp;Michael P Donahoe,&nbsp;Phillip E Lamberty,&nbsp;Ian J Barbash","doi":"10.1177/10600280211053318","DOIUrl":"https://doi.org/10.1177/10600280211053318","url":null,"abstract":"<p><strong>Background: </strong>Reducing central venous catheter (CVC) utilization can reduce complications in the intensive care unit (ICU). While norepinephrine (NE) is traditionally administered via a CVC, lower concentrations may be safely administered via peripheral intravenous (PIV) lines.</p><p><strong>Objective: </strong>We aimed to describe the implementation of a pilot protocol utilizing PIVs to administer a low-dose and lower-concentration NE, review the number of CVCs avoided, and evaluate any adverse events.</p><p><strong>Methods: </strong>In a quaternary medical intensive care unit (MICU), from March 1, 2019, to February 29, 2020, we reviewed charts for CVC placement and adverse events from the pNE infusion. We also measured unit-level CVC utilization in all MICU patients and assessed the change in utilization associated with the peripheral norepinephrine (pNE) protocol.</p><p><strong>Results: </strong>Over a 1-year period, 87 patients received a pNE infusion. Overall, 44 patients (51%) never required CVC placement during their MICU stay. Three patients (3%) experienced adverse events, none of which were documented as serious and or required antidote for treatment. Implementation of the protocol was associated with a decrease in the number of patients at the unit level who received CVCs, even if they did not receive pNE.</p><p><strong>Conclusion and relevance: </strong>In this small pilot study, we pragmatically demonstrated that pNE is safe and may reduce the need for CVC placement. This information can be used to aid in pNE protocol development and implementation at other institutions, but further research should be done to confirm the safety of routine use of pNE in clinical practice.</p>","PeriodicalId":512049,"journal":{"name":"The Annals of pharmacotherapy","volume":" ","pages":"773-781"},"PeriodicalIF":2.9,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39537894","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development of Patient Education Material for Proton Pump Inhibitor Deprescribing: A Mixed-Methods Study.","authors":"Jérôme Nguyen-Soenen,&nbsp;Maud Jourdain,&nbsp;Jean-Pascal Fournier","doi":"10.1177/10600280211046630","DOIUrl":"https://doi.org/10.1177/10600280211046630","url":null,"abstract":"<p><strong>Background: </strong>Proton pump inhibitor (PPI) deprescribing is recommended in case of inappropriate use. Patient education materials are key elements in the deprescribing process.</p><p><strong>Objective: </strong>The study objective was to develop patient education material for PPI deprescribing in primary care in France.</p><p><strong>Methods: </strong>This was a mixed-methods study involving (1) a literature review of the existing patient education materials on PPI deprescribing to identify key points to optimize the layout and content of the document; (2) development of a first version of the brochure by a pluri-professional steering group, following the national reference methodology of the French National Authority for Health (Haute Autorité de Santé) and iterative modifications of the patient brochure; (3) assessment of the content and understandability of the brochure by questionnaires followed by semistructured interviews with target patients; and (4) iterative brochure readability assessment with the Flesch reading ease tool.</p><p><strong>Results: </strong>The final patient education material is a double-sided A3 brochure-that is, 4 A4 pages. The first round of user testing by questionnaire (n = 14 patients) led to modifications to improve the document understandability, validated in the second round of user testing by questionnaire (n = 10 patients). The semistructured interviews (n = 10 patients) highlighted an adequate comprehension, whereas actionability required some minor modifications. The readability test score of the final education brochure was 59.4.</p><p><strong>Conclusion and relevance: </strong>This patient education brochure for PPI deprescribing is targeted to patients in primary care. Its impact on PPI deprescribing will be assessed in a population-based pragmatic trial in primary care.</p>","PeriodicalId":512049,"journal":{"name":"The Annals of pharmacotherapy","volume":" ","pages":"800-808"},"PeriodicalIF":2.9,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39441252","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Erroneous Computerized Interpretation of QTc and Changes to Patient Drug Therapy: Cautionary Example for Pharmacists.","authors":"Doson Chua,&nbsp;Tanveer Brar","doi":"10.1177/10600280211049469","DOIUrl":"https://doi.org/10.1177/10600280211049469","url":null,"abstract":"A prolonged QT interval (&gt;500 ms) combined with individual patient risk factors increases the risk of ventricular arrhythmias and torsades de pointes.1 Pharmacists play a critical role in identifying pharmacodynamic and pharmacokinetic drug-drug interactions that may result in QT prolongation. Most 12-lead electrocardiograms (ECGs) provide a corrected QT interval (QTc); however, this value is computer generated and may be miscalculated. We present a case where a computer-calculated QTc was incorrect and would have led to inappropriate withdrawal of drug therapy. A 64-year-old woman with a past medical history of heart failure with reduced ejection fraction, atrial fibrillation, anxiety, and chronic kidney disease was admitted with urosepsis, initially treated with piperacillin/tazobactam. Her medications consisted of amiodarone 200 mg twice daily, bisoprolol 5 mg once daily, spironolactone 25 mg once daily, furosemide 80 mg twice daily, mirtazapine 30 mg at bedtime, venlafaxine 150 mg once daily, and apixaban 2.5 mg twice daily. Her baseline creatinine was 2.6 mg/dL, potassium, 2.9 mEq/L, and magnesium, 1.7 mg/dL. Her baseline ECG (Figure 1) showed sinus rhythm, heart rate of 75 beats per minute, biphasic p waves with T-wave inversion, and a computer calculated QTc of 465 ms. On day 2 of her admission, urine cultures grew Escherichia coli, which was sensitive to ciprofloxacin, piperacillin/tazobactam, and meropenem. Because an oral antibiotic was desired, piperacillin/tazobactam was changed to ciprofloxacin 500 mg twice daily. Given the concern of prolonged QTc with ciprofloxacin and the patient’s other risk factors, including other QT-prolonging drugs (amiodarone, venlafaxine), the pharmacist ordered potassium replacement therapy and a repeat ECG on day 5 to assess the QT interval. The repeat ECG on day 5 showed sinus rhythm, heart rate of 93 beats per minute, and a computer-calculated QTc of 684 ms (Figure 2). The patient’s creatinine was 2.7 mEq/L and potassium 4.2 mEq/L on day 5. Based on the significantly increased QTc, there were significant drug-drug interaction concerns. However, on visual assessment of this ECG by the pharmacist (and later confirmed by a cardiologist), the QT on the inferior leads is 360 ms, and QTc (Bazett equation) is calculated to 448 ms. The computer incorrectly calculated the QTc by interpreting the biphasic p waves as part of the QT interval, thus resulting in a significantly elevated QT and QTc. Based on manual assessment of this ECG and the QTc being similar to baseline, the patient’s drug therapy was not modified. The patient completed her course of oral ciprofloxacin and was safely discharged. A third ECG done at the completion of ciprofloxacin showed a similar pattern of biphasic p waves, T-wave inversion, heart rate 83 beats per minute, and a computer-calculated QTc of 468 ms. This case highlights that computer calculation of QT interval may not always be accurate, in particular, the challenge of recognizing ","PeriodicalId":512049,"journal":{"name":"The Annals of pharmacotherapy","volume":" ","pages":"850-852"},"PeriodicalIF":2.9,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39522794","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prior Authorization Burden on the Use of LCP-Tacrolimus in Abdominal Solid Organ Transplant Recipients.","authors":"David K Choi,&nbsp;Shree Patel,&nbsp;Cassie Muran,&nbsp;Nehrin Khamo,&nbsp;Ruchik Patel,&nbsp;Nida Fayyaz,&nbsp;Patricia West-Thielke","doi":"10.1177/10600280211050641","DOIUrl":"https://doi.org/10.1177/10600280211050641","url":null,"abstract":"","PeriodicalId":512049,"journal":{"name":"The Annals of pharmacotherapy","volume":" ","pages":"856-857"},"PeriodicalIF":2.9,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39488565","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Hemodynamic Effects of Ketamine Compared With Propofol or Dexmedetomidine as Continuous ICU Sedation.","authors":"Evan Atchley,&nbsp;Eljim Tesoro,&nbsp;Robert Meyer,&nbsp;Alexia Bauer,&nbsp;Mark Pulver,&nbsp;Scott Benken","doi":"10.1177/10600280211051028","DOIUrl":"https://doi.org/10.1177/10600280211051028","url":null,"abstract":"<p><strong>Background: </strong>Ketamine has seen increased use for sedation in the intensive care unit. In contrast to propofol or dexmedetomidine, ketamine may provide a positive effect on hemodynamics.</p><p><strong>Objective: </strong>The objective of this study was to compare the development of clinically significant hypotension or bradycardia (ie, negative hemodynamic event) between critically ill adults receiving sedation with ketamine and either propofol or dexmedetomidine.</p><p><strong>Methods: </strong>This was a retrospective cohort study of adults admitted to an intensive care unit at an academic medical center between January 2016 and January 2021.</p><p><strong>Results: </strong>Patients in the ketamine group (n = 78) had significantly less clinically significant hypotension or bradycardia compared with those receiving propofol or dexmedetomidine (n = 156) (34.6% vs 63.5%; <i>P</i> < 0.001). Patients receiving ketamine also experienced smaller degree of hypotension observed by percent decrease in mean arterial pressure (25.3% [17.4] vs 33.8% [14.5]; <i>P</i> < 0.001) and absolute reduction in systolic blood pressure (26.5 [23.8] vs 42.0 [37.8] mm Hg; <i>P</i> < 0.001) and bradycardia (15.5 [24.3] vs 32.0 [23.0] reduction in beats per minute; <i>P</i> < 0.001). In multivariate logistic regression modeling, receipt of propofol or dexmedetomidine was the only independent predictor of a negative hemodynamic event (odds ratio [OR]: 3.3, 95% confidence interval [CI], 1.7 to 6.1; <i>P</i> < 0.001).</p><p><strong>Conclusion and relevance: </strong>Ketamine was associated with less clinically relevant hypotension or bradycardia when compared with propofol or dexmedetomidine, in addition to a smaller absolute decrease in hemodynamic parameters. The clinical significance of these findings requires further investigation.</p>","PeriodicalId":512049,"journal":{"name":"The Annals of pharmacotherapy","volume":" ","pages":"764-772"},"PeriodicalIF":2.9,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39534154","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Response to Tyrosine Kinase Inhibitors in Real-World Patients With Chronic Myeloid Leukemia.","authors":"Andy H Szeto,&nbsp;Tyler Bucci,&nbsp;Allison Deal,&nbsp;Anqi Zhu,&nbsp;Majd Ahmad,&nbsp;Amanda S Cass,&nbsp;Margaret R Sketch,&nbsp;Ryan Kemper,&nbsp;Joshua F Zeidner,&nbsp;Matthew C Foster,&nbsp;Benyam Muluneh,&nbsp;Daniel J Crona","doi":"10.1177/10600280211044160","DOIUrl":"https://doi.org/10.1177/10600280211044160","url":null,"abstract":"<p><strong>Background: </strong>Tyrosine kinase inhibitors (TKIs) are the front-line therapy for chronic myeloid leukemia (CML), where phase 3 clinical trials have demonstrated their safety and efficacy. However, trial patients may not be representative of real-world patients (RWPs).</p><p><strong>Objective: </strong>To evaluate RWP clinical factors associated with effectiveness and safety in CML patients treated with TKIs.</p><p><strong>Methods: </strong>Patients with CML treated with at least 30 days of imatinib, dasatinib, nilotinib, or bosutinib between 2014 and 2018 were included. Patients were stratified into categories based on the number of factors that would have precluded enrollment into pivotal TKI phase 3 trials (0, 1, ≥2). End points included complete hematologic response (CHR), early molecular response (EMR), major molecular response (MMR), adverse event (AE)-induced dose decreases, treatment interruptions, and treatment discontinuations.</p><p><strong>Results: </strong>Final analyses included 174 patients. Patients with ≥2 factors had a higher risk of dose decreases (relative risk = 1.54; 95% CI = 1.02-2.34; <i>P</i> = 0.02) and a shorter time to dose decrease (hazard ratio = 2.43; 95% CI = 1.23-4.97; <i>P</i> = 0.006) compared with patients with 0 factors. Significant differences were observed in CHR at 1 month and MMR at 3 months between patients with 0 and ≥2 factors (<i>P</i> = 0.03 and <i>P</i> = 0.04, respectively).</p><p><strong>Conclusion and relevance: </strong>Approximately 60% of our RWPs would have been excluded from the pivotal phase 3 TKI trials. These data suggest that RWPs require more precise dosing to achieve CML clinical milestones and to mitigate AEs, but findings should be validated prospectively.</p>","PeriodicalId":512049,"journal":{"name":"The Annals of pharmacotherapy","volume":" ","pages":"753-763"},"PeriodicalIF":2.9,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39431821","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Risk of Gastrointestinal Bleeding on Treatment With Statin Alone or With Concomitant Administration of Warfarin: A Systematic Review and Meta-analysis of 5.3 Million Participants.","authors":"Akshaya Srikanth Bhagavathula,&nbsp;Kota Vidyasaga,&nbsp;Eyob Alemayehu Gebreyohannes,&nbsp;Wubshet Tesfaye","doi":"10.1177/10600280211049727","DOIUrl":"https://doi.org/10.1177/10600280211049727","url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to comprehensively evaluate the risk of gastrointestinal bleeding (GIB) with statin monotherapy or with concomitant warfarin use.</p><p><strong>Data sources: </strong>PubMed, Web of Science, and EMBASE (via Scopus) were searched for observational studies that reported the risk of GIB in adults on statin therapy or with concomitant warfarin use until August 28, 2021.</p><p><strong>Study selection and data extraction: </strong>Observational studies evaluating the risk of GIB in adults (age >18 years) on statin medication or concomitant use with warfarin were included.</p><p><strong>Data synthesis: </strong>In all, 14 studies with a total of 5 235 123 participants, reporting 48 677 GIB events (43 734 from statin users and 4943 from users of statin combined with warfarin), were included in the analyses. The pooled analysis revealed no difference in the risk of GIB with statin monotherapy (relative risk [RR]: 0.65; 95% CI: 0.42-1.02) or concomitant statin + warfarin use (RR: 0.97; 95% CI: 0.91-1.02). Prior use of statin was not associated with GIB risk (RR: 0.88; 95% CI: 0.63-1.22), whereas a shorter duration of statin use (<5 years) was associated with a lower risk of GIB (RR: 0.42; 95% CI: 0.18-0.97).</p><p><strong>Relevance to patient care and clinical practice: </strong>This analysis provides strong evidence on the association between statin use (with/without warfarin) and risk of GIB.</p><p><strong>Conclusion: </strong>Statin alone or combined with warfarin was not significantly associated with either an increased or decreased risk of GIB. The GIB risk was significantly lower when statins were used for a short duration (<5 years). The putative relationship between statins and GIB in warfarin users warrant further investigation.</p>","PeriodicalId":512049,"journal":{"name":"The Annals of pharmacotherapy","volume":" ","pages":"820-830"},"PeriodicalIF":2.9,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39475238","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}