Annals of Pharmacotherapy最新文献

{"title":"Philosophical and Ethical Underpinnings of the Medical Decision-Making Process: A Focus on Patient Values and Preferences.","authors":"Brian L Erstad","doi":"10.1177/10600280241289133","DOIUrl":"https://doi.org/10.1177/10600280241289133","url":null,"abstract":"<p><p>Current clinical practice is based on the principles of evidence-based medicine (EBM) with clinical practice guidelines (CPGs) often serving as a source of information for the medical decision-making process. There are philosophical and ethical tenets underlying this process including those pertaining to patient values and preferences. Despite their importance, these tenets may receive less attention than the empirically derived recommendations in CPGs based on the principles of EBM. The purpose of this article is to provide an overview of the philosophical and ethical underpinnings of the medical decision-making process with a focus on patient values and preferences so pharmacists and other clinicians can appreciate the interplay between science, philosophy and ethics when providing patient- or person-centered care. Appreciation of these discussions should help practitioners to recognize the limitations and challenges when attempting to incorporate population-based evidence into a patient-specific medical decision-making process that often necessitates reconciliation and negotiation between the clinician and patient when striving to provide optimal care.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280241289133"},"PeriodicalIF":2.3,"publicationDate":"2024-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142612184","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Bolus Dosing of Alteplase in Hemodynamically Unstable Acute Pulmonary Embolism.","authors":"Christine Eisenhower, Evan Cano, Madison Smith, Ryan Virgin, Margaret M Charpentier","doi":"10.1177/10600280241288601","DOIUrl":"https://doi.org/10.1177/10600280241288601","url":null,"abstract":"","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280241288601"},"PeriodicalIF":2.3,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142602566","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Angiotensin-Converting Enzyme Inhibitor Washout Period Prior to Angiotensin Receptor/Neprilysin Inhibitor Initiation in the Inpatient Setting.","authors":"Kaanan Shah, Stella Mabhugu, Jessica Obioma, Quang Nguyen, Jessica Schillig, Brittany P Torres, Meredith Howard, Bryn Lindley","doi":"10.1177/10600280241282324","DOIUrl":"10.1177/10600280241282324","url":null,"abstract":"<p><strong>Background: </strong>The 2022 AHA-ACC HFSA Guideline for Management of Heart Failure recommend initiating an angiotensin receptor/neprilysin inhibitor (ARNI) in patients with heart failure with reduced ejection fraction (HFrEF) who can tolerate an angiotensin-converting enzyme inhibitor (ACEi). The manufacturer recommends initiating a 36-hour washout period when switching from ACEi to ARNI due to an increased risk of adverse effects, including angioedema. This study investigated the adherence to the washout period when transitioning from ACEi to ARNI at a community hospital.</p><p><strong>Objectives: </strong>The primary objective was to assess the rate of adherence to the 36-hour washout when transitioning patients from ACEi to ARNI. Secondary outcomes included heart failure exacerbation readmission rates within 90 days and the rate of adverse effects (angioedema, hypotension, acute kidney injury, and hyperkalemia).</p><p><strong>Methods: </strong>This was a retrospective cohort study including patients with HFrEF who were transitioned from ACEi to ARNI during their hospital stay between March 1, 2016 and December 31, 2022. Patients were excluded if they did not receive an ACEi or ARNI during their admission or if they had an ejection fraction >40%. Pearson chi-square was used to analyze categorical data.</p><p><strong>Results: </strong>Of 33 patients included in this study, 67% received the full 36-hour washout period when transitioning from ACEi to ARNI. There were no significant differences between the rates of hospital readmissions or adverse effects between the groups. No patients experienced hyperkalemia or angioedema.</p><p><strong>Conclusion and relevance: </strong>This is the first study to our knowledge to describe real-world prescribing practices when transitioning patients from ACEi to ARNI for the treatment of HFrEF. Larger, multicenter studies are needed to provide more data on prescribing practices outside this single center. Future research should also include pharmacist's role in adhering to the recommended washout.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"10600280241282324"},"PeriodicalIF":2.3,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142574800","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Eye Drop Quality Issues: Can the FDA See This One Through?","authors":"Lyla R White, C Michael White","doi":"10.1177/10600280241233255","DOIUrl":"10.1177/10600280241233255","url":null,"abstract":"<p><p>The Food and Drug Administration (FDA) has long suffered from a lack of resources limiting their inspection capacity. They have fallen behind on proactive surveillance inspections of foreign manufacturing sites, relying instead on for-cause inspections after a problem has been discovered. Over-the-counter (OTC) products are especially vulnerable because the FDA considers them lower priority. This issue recently made big news after improperly manufactured OTC eye drops harmed users across the country, in some cases causing blindness. To prevent future harm to Americans, it is imperative that the FDA receives enough resources to keep up with their routine inspections.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"1149-1152"},"PeriodicalIF":2.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139911906","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy of Fluvoxamine in Outpatients With COVID-19: Understanding Conflicting Conclusions From 2 Recent Meta-Analyses of the Same Clinical Trials.","authors":"Marina Sánchez-Rico, Katayoun Rezaei, Eric J Lenze, Frédéric Limosin, Nicolas Hoertel","doi":"10.1177/10600280231211304","DOIUrl":"10.1177/10600280231211304","url":null,"abstract":"","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"1153-1155"},"PeriodicalIF":2.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138443584","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety Profile of Selective Serotonin Reuptake Inhibitors in Real-World Settings: A Pharmacovigilance Study Based on FDA Adverse Event Reporting System.","authors":"Yi Zhao, Yuzhou Zhang, Lin Yang, Kanghuai Zhang, Sha Li","doi":"10.1177/10600280241231116","DOIUrl":"10.1177/10600280241231116","url":null,"abstract":"<p><strong>Background: </strong>Selective serotonin reuptake inhibitors (SSRIs) are the most frequently prescribed agents to treat depression. Considering the growth in antidepressant prescription rates, SSRI-induced adverse events (AEs) need to be comprehensively clarified.</p><p><strong>Objective: </strong>This study was to investigate safety profiles and potential AEs associated with SSRIs using the Food and Drug Administration Adverse Event Reporting System (FAERS).</p><p><strong>Methods: </strong>A retrospective pharmacovigilance analysis was conducted using the FAERS database, with Open Vigil 2.1 used for data extraction. The study included cases from the marketing date of each SSRI (ie, citalopram, escitalopram, fluoxetine, paroxetine, fluvoxamine, and sertraline) to April 30, 2023. We employed the reporting odds ratio and Bayesian confidence propagation neural network as analytical tools to assess the association between SSRIs and AEs. The Medical Dictionary for Regulatory Activities was used to standardize the definition of AEs. AE classification was achieved using system organ classes (SOCs).</p><p><strong>Results: </strong>Overall, 427 655 AE reports were identified for the 6 SSRIs, primarily associated with 25 SOCs, including psychiatric, nervous system, congenital, familial, genetic, cardiac, and reproductive disorders. Notably, sertraline (<i>n</i> = 967) and fluvoxamine (<i>n</i> = 169) exhibited the highest and lowest signal frequencies, respectively. All SSRIs had relatively strong signals related to congenital, psychiatric, and nervous disorders.</p><p><strong>Conclusions and relevance: </strong>Most of our findings are consistent with those reported previously, but some AEs were not previously identified. However, AEs attributed to SSRIs remain ambiguous, warranting further validation. Applying data-mining methods to the FAERS database can provide additional insights that can assist in appropriately utilizing SSRIs.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"1105-1116"},"PeriodicalIF":2.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139970730","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mirikizumab: A New Therapeutic Option for the Treatment of Ulcerative Colitis.","authors":"David Choi, Hilary Sheridan, Shubha Bhat","doi":"10.1177/10600280241229742","DOIUrl":"10.1177/10600280241229742","url":null,"abstract":"<p><strong>Objective: </strong>To review the pharmacologic and clinical profile of mirikizumab in the treatment of moderate to severe ulcerative colitis (UC).</p><p><strong>Data sources: </strong>A PubMed search was performed from inception to December 2023 using keywords <i>mirikizumab, interleukin-23 inhibitor</i>, and <i>UC</i>. Information was also obtained from package inserts as well as published abstracts.</p><p><strong>Study selection and data extraction: </strong>Phase 3 studies plus relevant literature on mirikizumab pharmacologic and clinical profile were reviewed.</p><p><strong>Data synthesis: </strong>Mirikizumab approval was based on LUCENT-1 and LUCENT-2. In the phase 3 studies involving patients with moderate to severe UC, mirikizumab, when compared to placebo, resulted in clinical remission in a significantly higher proportion of patients in both the induction and maintenance phase. In addition, mirikizumab met the secondary endpoints of alternate definition of clinical remission, endoscopic remission, glucocorticoid-free clinical remission, histologic-endoscopic mucosal remission, and improvement in bowel urgency status, bowel-urgency remission, and maintenance of clinical remission. Common adverse events noted include infection (15.1%), injection-site reaction (8.7%), nasopharyngitis (7.2%), and headache (3.3%).</p><p><strong>Relevance to patient care and clinical practice in comparison to existing agents: </strong>Mirikizumab is the first selective interleukin 23 (IL-23) inhibitor approved for UC. Additional studies are required to determine how to position mirikizumab in both biologic-naïve and biologic-experienced patients with moderate to severe UC.</p><p><strong>Conclusion: </strong>Mirikizumab provides a novel mechanism of action for the treatment of moderate to severe UC and is another welcomed treatment advance in the treatment arsenal, providing a more selective mechanism of action while maintaining a comparable safety profile.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"1134-1139"},"PeriodicalIF":2.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139721309","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exploring Safety in Gender-Affirming Hormonal Treatments: An Observational Study on Adverse Drug Events Using the Food and Drug Administration Adverse Event Reporting System Database.","authors":"Ainhoa Gomez-Lumbreras, Lorenzo Villa-Zapata","doi":"10.1177/10600280241231612","DOIUrl":"10.1177/10600280241231612","url":null,"abstract":"<p><strong>Background: </strong>People with gender dysphoria are treated with hormone therapy for gender reassignment. The indication of this therapy was initially for the opposite sex, and information on potential adverse drug reaction (ADR) is lacking.</p><p><strong>Objective: </strong>To describe ADR associated with gender transition medication in transgender individuals reported to the US Food and Drug Administration Adverse Event Reporting System (FAERS) database.</p><p><strong>Methods: </strong>Data from the FAERS database up to June 2023 were examined, focusing on reports of gender transition medication use in the context of gender dysphoria. The ADRs were categorized using the Medical Dictionary for Regulatory Activities at both Preferred Term and System Organ Class (SOC) levels. Descriptive statistics summarized report counts, medication types, indications, and ADR severity.</p><p><strong>Results: </strong>For individuals assigned female at birth undergoing gender transition to male (transgender men), 82 reports (230 ADRs) were analyzed, with an average age of 29.5 years. Transgender hormonal therapy was cited in 72% of reports, predominantly from the United States (67.1%). A striking 88% were categorized as serious ADRs, primarily SOC injury, poisoning, and procedural complications (26.5%), followed by psychiatric disorders (14.8%) and nervous system disorders (12.2%). Among those assigned sex male at birth transitioning to female (transgender women) (81 reports, 237 ADRs), mean age was 33.3 years, with 58% indicating use for gender dysphoria. A significant proportion (53.6%) were serious ADRs, primarily SOC: injury, poisoning, and procedural complications (26.6%).</p><p><strong>Conclusions and relevance: </strong>The FAERS data reveal significant ADRs in transgender individuals using hormone therapy, sometimes unintended for their recipient gender. Population-level studies are crucial to enhance transgender health care. Spontaneous surveillance databases like FAERS illuminate off-label ADRs, urging health care providers to approach hormone therapies with informed caution.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"1089-1098"},"PeriodicalIF":2.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139721308","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Preoperative Amiodarone and Primary Graft Dysfunction in Heart Transplantation.","authors":"Abigail Servais, Scott Lundgren, Stephanie Bowman, Douglas Stoller, Adam Burdorf, Marshall Hyden, Brian Lowes, Ronald Zolty, Don Klepser, Heidi Brink","doi":"10.1177/10600280241232032","DOIUrl":"10.1177/10600280241232032","url":null,"abstract":"<p><strong>Background: </strong>Preoperative amiodarone effects on postorthotopic heart transplant (OHT) outcomes remain controversial.</p><p><strong>Objective: </strong>The purpose of this study was to determine the effect of cumulative pre-OHT amiodarone exposure on severe primary graft dysfunction (PGD).</p><p><strong>Methods: </strong>We retrospectively reviewed adult OHT recipients between August 2012 and June 2018. Primary outcome was severe PGD in patients receiving amiodarone at 3, 6, and 12 months prior to OHT compared with those not receiving amiodarone. Secondary outcomes included intensive care unit (ICU) and hospital length of stay, duration of mechanical ventilation, early graft failure (EGF), mortality at 3, 6, and 12 months post-OHT, and 30-day incidence of postoperative tachyarrhythmias, bradycardia, permanent pacemaker implantation, and rejection.</p><p><strong>Results: </strong>Incidence of severe PGD was 12.5% in those who received amiodarone compared to 6.8% in those who did not (14 vs 6, <i>P</i> = 0.18). Cumulative preoperative amiodarone significantly increased the odds of severe PGD at 3 months (odds ratio [OR]: 1.03; 95% confidence interval [CI]: 1.001-1.06; <i>P</i> = 0.044) and 6 months (OR: 1.02, 95% CI: 1.003-1.044; <i>P</i> = 0.024) in a multivariate logistic regression. Patients on amiodarone had significantly higher rates of postoperative bradycardia (13.4% vs 4.5%, <i>P</i> = 0.03).</p><p><strong>Conclusion and relevance: </strong>A trend toward increased PGD was present in patients receiving preoperative amiodarone. This finding combined with the regression showing significantly increased odds of PGD with increasing 3 and 6 month cumulative amiodarone dose is clinically concerning. Escalation of care with pacemaker implantation was required more frequently in patients on pre-OHT amiodarone.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"1099-1104"},"PeriodicalIF":2.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139740129","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Rozanolixizumab: A New Therapy in the Treatment of Myasthenia Gravis.","authors":"Emily M Hitt","doi":"10.1177/10600280241239048","DOIUrl":"10.1177/10600280241239048","url":null,"abstract":"<p><strong>Objective: </strong>The aims of this article are to review the clinical aspects of rozanolixizumab, to describe clinical trial results that led to the drug's approval, and to examine the impact on patient care to aid clinical decision making.</p><p><strong>Data sources: </strong>A PubMed search was conducted using the terms <i>Rystiggo</i>™, <i>rozanolixizumab</i>, <i>rozanolixizumab therapy</i>, and <i>myasthenia gravis</i>. The most recent prescribing information was also used for information relating to the drug and for identification of pertinent studies.</p><p><strong>Study selection/data extraction: </strong>Phase I, II, and III randomized controlled trials were all eligible for inclusion. Meeting abstracts and articles focusing on the use of rozanolixizumab or any indication other than generalized myasthenia gravis were excluded from this article.</p><p><strong>Data synthesis: </strong>Food and Drug Administration approval of rozanolixizumab is based on the phase III MycarinG study in patients with generalized myasthenia gravis. A phase II trial explored initial clinical efficacy and safety pertaining to the dose and frequency of rozanolixizumab across 2 treatment periods in patients with moderate to severe myasthenia gravis.</p><p><strong>Relevance to patient care and clinical practice in comparison to existing agents: </strong>Rozanolixizumab is the first therapy approved to treat patients positive for both types of antibodies, anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase, in generalized myasthenia gravis.</p><p><strong>Conclusion/relevance: </strong>The approval of rozanolixizumab represents an advancement in therapy for generalized myasthenia gravis. The provision of individualized, targeted, and well-tolerated treatment is valuable for the patients whose myasthenia gravis is not well controlled and who are seeking a medication with a rapid onset of action to improve their symptoms and overall quality of life.</p>","PeriodicalId":7933,"journal":{"name":"Annals of Pharmacotherapy","volume":" ","pages":"1140-1148"},"PeriodicalIF":2.3,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140292554","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}