PharmacotherapyPub Date : 2024-10-01Epub Date: 2024-10-18DOI: 10.1002/phar.4614
Andrew D Mosholder, Hector S Izurieta, Rongmei Zhang, Shanlai Shangguan, Yun Lu, Sandia Akhtar, Michael Wernecke, Jiwei He, Yoganand Chillarige, Yuhui Feng, Armen Avagyan, Kira Leishear, Richard A Forshee, Thomas E MaCurdy, Jeffrey A Kelman, David J Graham
{"title":"Use of proton pump inhibitors and risk of severe COVID-19: A case-control study in United States Medicare beneficiaries.","authors":"Andrew D Mosholder, Hector S Izurieta, Rongmei Zhang, Shanlai Shangguan, Yun Lu, Sandia Akhtar, Michael Wernecke, Jiwei He, Yoganand Chillarige, Yuhui Feng, Armen Avagyan, Kira Leishear, Richard A Forshee, Thomas E MaCurdy, Jeffrey A Kelman, David J Graham","doi":"10.1002/phar.4614","DOIUrl":"10.1002/phar.4614","url":null,"abstract":"<p><strong>Background: </strong>Concerns have been raised regarding proton pump inhibitor (PPI) use and risk of severe coronavirus disease 2019 (COVID-19). Observational studies have yielded heterogeneous results and were subject to important methodological limitations.</p><p><strong>Aims: </strong>To examine the association between the receipt of PPIs and risk of COVID-19 hospitalizations and severe in-hospital outcomes or death.</p><p><strong>Methods: </strong>Case-control study among Medicare fee-for-service beneficiaries 66+ years old with gastroesophageal reflux disorder (GERD). Within this population, we identified cases by an incident hospital discharge diagnosis of COVID-19 from April 1 to December 11, 2020, using the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) U07.1, and randomly selected up to 10 controls per case, matched on date and neighborhood. We defined PPI use as a prescription providing ≥15 days of supply in the 30 days before admission, with H2-receptor antagonist (H2RA) use as the reference to account for indication. We analyzed uncomplicated hospitalizations and hospitalizations with severe outcomes (intensive/coronary care unit admission, invasive mechanical ventilation, or death), estimating odds ratios (ORs), and 95% confidence intervals (CIs) with multinomial conditional logistic regression adjusted for demographics, comorbidities, chronic medications, and health care utilization.</p><p><strong>Results: </strong>We matched 25,867 uncomplicated and 12,954 severe hospitalized COVID-19 cases to 146,972 and 73,104 controls, respectively. Cases tended to be older and have more comorbidities. Relative to H2RA use, we found no association of PPI use with uncomplicated COVID-19 hospitalization (OR 0.99, 95% CI 0.93-1.06) or severe COVID-19 hospitalization (OR 1.00, 95% CI 0.91-1.10).</p><p><strong>Conclusions: </strong>Relative to H2RA use, PPI use was not associated with uncomplicated or severe COVID-19 hospitalizations among Medicare beneficiaries with GERD.</p>","PeriodicalId":20013,"journal":{"name":"Pharmacotherapy","volume":" ","pages":"803-810"},"PeriodicalIF":2.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142472342","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
PharmacotherapyPub Date : 2024-10-01Epub Date: 2024-10-05DOI: 10.1002/phar.4612
Atif Siddiqui
{"title":"Intravenous ketamine successfully treats treatment-resistant catatonia in schizophrenia: A case report.","authors":"Atif Siddiqui","doi":"10.1002/phar.4612","DOIUrl":"10.1002/phar.4612","url":null,"abstract":"<p><strong>Background: </strong>Benzodiazepines and electroconvulsive therapy (ECT) are mainstay treatments for catatonia, a potentially life-threatening psychomotor syndrome characterized by a range of symptoms, including immobility, mutism, stupor, posturing, and sometimes even agitation. It can be a manifestation of various underlying psychiatric or medical conditions, such as schizophrenia, mood disorders, or neurological disorders. When conventional treatments fail to alleviate symptoms, ketamine, a dissociative anesthetic, has emerged as a potential therapeutic option for catatonia. However, its precise mechanism of action in treating catatonia remains to be fully elucidated. The use of ketamine in treating treatment-resistant catatonia in patients with schizophrenia has not been described.</p><p><strong>Methods: </strong>We describe a unique case of a 77-year-old female with schizophrenia for 15 years who presented with hallucinations, generalized weakness, immobility, stupor, and mutism consistent with severe catatonia. The electroencephalogram did not show seizures, and brain imaging was negative for stroke. Her catatonia was resistant to treatment with benzodiazepines and haloperidol. However, ECT was unavailable due to the COVID-19 pandemic. She was successfully treated with a single intravenous infusion of ketamine administered at a dose of 0.5 mg/kg over 40 min with complete rapid recovery and remained stable as an outpatient.</p><p><strong>Results: </strong>Intravenous ketamine single infusion may be a safe and feasible option in schizophrenia patients with drug-resistant catatonia, particularly in patients for whom standard therapies are ineffective. However, its use should be approached cautiously due to the risk of exacerbation of psychosis in patients with schizophrenia.</p><p><strong>Conclusions: </strong>Further research is warranted to better understand the role of ketamine in the management of catatonia in this patient population.</p>","PeriodicalId":20013,"journal":{"name":"Pharmacotherapy","volume":" ","pages":"822-824"},"PeriodicalIF":2.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142375744","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
PharmacotherapyPub Date : 2024-10-01Epub Date: 2024-09-25DOI: 10.1002/phar.4611
Paweł Moćko, Magdalena Koperny, Katarzyna Śladowska, Przemysław Holko, Iwona Kowalska-Bobko, Paweł Kawalec
{"title":"Efficacy and safety of mirikizumab compared with currently approved biologic drugs for the treatment of ulcerative colitis: A systematic review and network meta-analysis.","authors":"Paweł Moćko, Magdalena Koperny, Katarzyna Śladowska, Przemysław Holko, Iwona Kowalska-Bobko, Paweł Kawalec","doi":"10.1002/phar.4611","DOIUrl":"10.1002/phar.4611","url":null,"abstract":"<p><p>Ulcerative colitis (UC) is a serious health problem that requires a constant need to identify new effective drugs. The aim of this study was to assess the efficacy and safety of mirikizumab compared with other biologic drugs approved for the treatment of moderately to severely active UC. This systematic review with frequentist network meta-analysis (NMA) included randomized controlled trials (RCTs) that evaluated the use of adalimumab, golimumab, infliximab, mirikizumab, vedolizumab, and ustekinumab compared with placebo or with another approved biologic drug. The NMA was conducted using the netmeta R software package. The P score was used to determine the treatment ranking. A total of 14 RCTs were included in the analysis. No significant differences were observed in the incidence of clinical response and remission between mirikizumab and other drugs. Mirikizumab was superior to placebo for clinical response (induction: odds ratio [OR] = 2.38; 95% confidence interval [CI]: 1.63-3.48; maintenance: OR = 3.31, 95% CI: 1.59-6.89) and remission (induction: OR = 2.09, 95% CI: 1.20-3.63; maintenance: OR = 2.96; 95% CI: 1.62-5.40). The probability plot indicated that infliximab might be the most effective option in terms of both clinical response and remission (P score, 0.8971 and 0.8814, respectively) in induction phase. No significant differences were noted between the studied drugs in any adverse events (AEs), serious AEs (SAEs) and infections for the induction phase, and in any AEs, infections and serious infections for the maintenance phase. The drugs differed in terms of discontinuation due to AEs (induction and maintenance phases) as well as SAEs and serious infections (maintenance phase). Mirikizumab did not differ from other biologics in terms of clinical response and remission for both induction and maintenance phases in patients with UC. Mirikizumab during the induction phases achieved rank 3 for clinical response and rank 5 for clinical remission. Therefore, it represents a valuable treatment option. The lack of significant differences in the risk of AEs and SAEs suggests that mirikizumab has a similar safety profile to the other drugs.</p>","PeriodicalId":20013,"journal":{"name":"Pharmacotherapy","volume":" ","pages":"811-821"},"PeriodicalIF":2.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142351910","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ashna Talwar, Satabdi Chatterjee, Susan Abughosh, Michael Johnson, Jeffrey Sherer, Rajender R. Aparasu
{"title":"Delirium event and associated treatment modifications among older adults with Alzheimer's disease: An interrupted time‐series analysis of Medicare data","authors":"Ashna Talwar, Satabdi Chatterjee, Susan Abughosh, Michael Johnson, Jeffrey Sherer, Rajender R. Aparasu","doi":"10.1002/phar.4610","DOIUrl":"https://doi.org/10.1002/phar.4610","url":null,"abstract":"BackgroundBoth Alzheimer's disease (AD) and deliriogenic medications increase the risk of delirium in older adults. This study examined the association between delirium and the subsequent monthly use of anticholinergic, sedative, and opioid medications in the 1 year after delirium in older adults with AD.MethodsThis comparative interrupted time series analysis involved adults (aged 65 years and older) with a diagnosis of AD initiating on cholinesterase inhibitors (ChEIs) based on 2013–2017 Medicare data. Separate patient‐level segmented regression models were used for each outcome to evaluate changes in the cumulative anticholinergic burden (CAB), sedative load, and opioid load after the delirium/index event using a 12‐month baseline and follow‐up period among patients who had a delirium event and those without delirium (control group). Propensity score‐based stabilized weights were utilized to balance baseline factors in the delirium and control groups.ResultsThe study included 80,019 older adults with AD with incident ChEI use; 17.11% had delirium. There was an immediate decline in monthly CAB after the delirium event (mean estimate −0.86, <jats:italic>p</jats:italic>‐value: 0.01) compared to the control group. A similar decline was observed when examining the sedative load (−0.06, <jats:italic>p</jats:italic>‐value: 0.002) after the delirium event. However, there was no decline in opioid load (−0.50, <jats:italic>p</jats:italic>‐value: 0.18). In the long term, CAB (0.13; <jats:italic>p</jats:italic>‐value: <0.0001), sedative load (0.01; <jats:italic>p</jats:italic>‐value: <0.001), and opioid load (0.07; <jats:italic>p</jats:italic>‐value: 0.006) increased over the 1‐year post‐delirium period in the delirium group compared to those without delirium.ConclusionThis study found the burden of deliriogenic medications over the 1‐year follow‐up showed increasing trends in older adults with AD, even though there was some level shift in CAB and sedative load after the delirium event.","PeriodicalId":20013,"journal":{"name":"Pharmacotherapy","volume":"1 1","pages":""},"PeriodicalIF":4.1,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142248752","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The gray area of scientific adequacy.","authors":"C Lindsay DeVane","doi":"10.1002/phar.4606","DOIUrl":"https://doi.org/10.1002/phar.4606","url":null,"abstract":"","PeriodicalId":20013,"journal":{"name":"Pharmacotherapy","volume":"44 9","pages":"696-697"},"PeriodicalIF":2.9,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142584046","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
PharmacotherapyPub Date : 2024-09-01Epub Date: 2024-05-15DOI: 10.1002/phar.2927
{"title":"Correction to \"Pharmacokinetics/pharmacodynamics analysis and establishment of optimal dosing regimens using unbound cefmetazole concentration for patients infected with Extended-Spectrum β-lactamase producing Enterobacterales (ESBL-E)\".","authors":"","doi":"10.1002/phar.2927","DOIUrl":"10.1002/phar.2927","url":null,"abstract":"","PeriodicalId":20013,"journal":{"name":"Pharmacotherapy","volume":" ","pages":"760-765"},"PeriodicalIF":2.9,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140945591","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
PharmacotherapyPub Date : 2024-09-01Epub Date: 2024-09-03DOI: 10.1002/phar.4607
Ibrahim S Alhomoud, Azita H Talasaz, Preethi Chandrasekaran, Roy Brown, Anurag Mehta, Dave L Dixon
{"title":"Incretin hormone agonists: Current and emerging pharmacotherapy for obesity management.","authors":"Ibrahim S Alhomoud, Azita H Talasaz, Preethi Chandrasekaran, Roy Brown, Anurag Mehta, Dave L Dixon","doi":"10.1002/phar.4607","DOIUrl":"10.1002/phar.4607","url":null,"abstract":"<p><p>Obesity continues to be a significant global health challenge, affecting over 800 million individuals worldwide. Traditional management strategies, including dietary, exercise, and behavioral interventions, often result in insufficient and unsustainable weight loss. Lifestyle modification remains the cornerstone of obesity management, providing the foundation for other strategies. While options such as bariatric surgery remain an effective intervention for severe obesity, it is associated with its own set of risks and is typically reserved for patients who have not achieved the desired results with pharmacotherapy and lifestyle interventions. Incretin hormone agonists represent a significant advancement in the pharmacotherapy of obesity, offering substantial weight reduction and cardiometabolic benefits. Agents like liraglutide, semaglutide, and tirzepatide supported by key clinical trials such as Satiety and Clinical Adipose Liraglutide Evidence (SCALE), Semaglutide Treatment Effect in People with Obesity (STEP) program trials, and Tirzepatide Once Weekly for the Treatment of Obesity (SURMOUNT-1) have demonstrated remarkable efficacy in promoting weight loss and improving metabolic outcomes. Additionally, novel therapies, including dual and triple incretin agonists, are under investigation and hold the potential for further advancements in obesity treatment. These novel therapies can be categorized by their mechanisms of action and route of administration into oral glucagon-like peptide-1 (GLP-1) receptor agonists, triple agonists (targeting GLP-1, glucose-dependent insulinotropic polypeptide [GIP], and glucagon receptors), and glucagon receptor-GLP-1 receptor co-agonists. Other innovative approaches include oral GIP-GLP-1 receptor co-agonists, and the combination of long-acting amylin receptor agonists with GLP-1 receptor agonists. The ongoing development of incretin-based therapies and the expanding availability of currently available agents are expected to enhance clinical outcomes further and reduce the burden of obesity-related health complications. This review aims to discuss the mechanisms and efficacy of current and emerging incretin hormone agonists for obesity management.</p>","PeriodicalId":20013,"journal":{"name":"Pharmacotherapy","volume":" ","pages":"738-752"},"PeriodicalIF":2.9,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142120432","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
PharmacotherapyPub Date : 2024-09-01Epub Date: 2024-01-11DOI: 10.1002/phar.2905
{"title":"Correction to \"International consensus recommendations for the use of prolonged-infusion beta-lactam antibiotics: Endorsed by the American College of Clinical Pharmacy, British Society for Antimicrobial Chemotherapy, Cystic Fibrosis Foundation, European Society of Clinical Microbiology and Infectious Diseases, Infectious Diseases Society of America, Society of Critical Care Medicine, and Society of Infectious Diseases Pharmacists\".","authors":"","doi":"10.1002/phar.2905","DOIUrl":"10.1002/phar.2905","url":null,"abstract":"","PeriodicalId":20013,"journal":{"name":"Pharmacotherapy","volume":" ","pages":"755-759"},"PeriodicalIF":2.9,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139417782","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Physiologically based pharmacokinetic models for predicting lamotrigine exposure and dose optimization in pediatric patients receiving combination therapy with carbamazepine or valproic acid.","authors":"Zhiwei Liu, Wenxin Shao, Xingwen Wang, Kuo Geng, Wenhui Wang, Yiming Li, Youjun Chen, Haitang Xie","doi":"10.1002/phar.4603","DOIUrl":"10.1002/phar.4603","url":null,"abstract":"<p><strong>Introduction: </strong>Lamotrigine (LTG) is an antiepileptic drug that has been used in pediatric epilepsy as a combination therapy or monotherapy after stabilization in recent years. However, there are significant drug-drug interactions (DDI) between LTG and combined drugs such as carbamazepine (CBZ) and valproic acid (VPA). It is particularly important to consider the risk of DDI in combination therapy for intractable epilepsy in pediatric patients. Therefore, it is necessary to adjust the dosage of LTG accordingly. The aim of this study was to establish and validate a pediatric physiologically based pharmacokinetic (PBPK) model for predicting LTG exposure. The model is designed to explore the potential for quantifying pharmacokinetic (PK) DDI of LTG when administered concurrently with CBZ or VPA in pediatric patients.</p><p><strong>Method: </strong>Adult and pediatric PBPK models for LTG and VPA were developed using PK-Sim® software in combination with physiological information and drug-specific parameters, and a DDI model was developed in combination with the published CBZ model. The models were validated against available PK data.</p><p><strong>Results: </strong>Predictive and observational results in adults, children, and the DDI model were in good agreement. The recommended doses of LTG for preschool children (2-6 years) and school-aged children (6-12 years) in the absence of drug interactions were 1.47 and 1.2 times higher than those for adults, respectively; 3.1 and 2.6 times higher than those for adults in combination with CBZ; and 0.67 and 0.57 times lower than those for adults in combination with VPA. In addition, plasma exposures in adolescents (12-18 years) were similar to those in adults at the same doses.</p><p><strong>Conclusion: </strong>We have successfully developed PBPK models and DDI models for LTG in adults and children, which provide a reference for rational drug use in the pediatric population.</p>","PeriodicalId":20013,"journal":{"name":"Pharmacotherapy","volume":" ","pages":"711-721"},"PeriodicalIF":2.9,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142117052","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
PharmacotherapyPub Date : 2024-09-01Epub Date: 2024-07-02DOI: 10.1002/phar.2951
{"title":"Correction to \"Risk of incident antidepressant-treated depression associated with use of 5α-reductase inhibitors compared with use of α-blockers in men with benign prostatic hyperplasia: A population-based study using the Clinical Practice Research Datalink\".","authors":"","doi":"10.1002/phar.2951","DOIUrl":"10.1002/phar.2951","url":null,"abstract":"","PeriodicalId":20013,"journal":{"name":"Pharmacotherapy","volume":" ","pages":"766"},"PeriodicalIF":2.9,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141477214","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}