Clinical Controversy in Transplantation: Tacrolimus Versus Cyclosporine in Statin Drug Interactions

2019 ◽  
Vol 54 (2) ◽  
pp. 171-177 ◽  
Author(s):  
Daniel R. Migliozzi ◽  
Nicole J. Asal

Objective: To review the available literature that provides evidence for the absence of statin interactions with tacrolimus compared with cyclosporine. Data Sources: A literature search of PubMed was performed (1990 to June 2019) using the following search terms: calcineurin inhibitors, tacrolimus, cyclosporine, statins, atorvastatin, simvastatin, and drug interactions. Clinical practice guidelines, article bibliographies, drug interaction database references, and product monographs were also reviewed. Study Selection and Data Extraction: Relevant English-language studies describing the mechanism of interaction, the magnitude of pharmacokinetic alterations, and safety were evaluated. In vitro data and studies conducted in adult humans were considered. Data Synthesis: Studies demonstrate pharmacokinetic differences between cyclosporine and tacrolimus, particularly with regard to inhibition of 2 hepatic transporters: P-glycoprotein and organic anion transporting polypeptide (OATP). Compared with cyclosporine, tacrolimus does not affect these transporters, does not enhance statin exposure, and does not increase statin-associated safety events. Relevance to Patient Care and Clinical Practice: Clinical practice guidelines allude to the need to reduce statin doses in the setting of tacrolimus. Some providers have adopted this practice, and doing so may prevent transplant recipients from attaining cardiovascular benefit, especially when increased or high-intensity doses are required. The pharmacokinetic differences between tacrolimus and cyclosporine highlight different interaction potential with statins. Conclusions: Clinicians need to be aware that tacrolimus and cyclosporine are not the same with regard to causing drug interactions with statins. Tacrolimus can be used with statins without the need for dose adjustments because of lack of an interaction.

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e050912
Author(s):  
Mia Bierbaum ◽  
Frances Rapport ◽  
Gaston Arnolda ◽  
Yvonne Tran ◽  
Bróna Nic Giolla Easpaig ◽  
...  

IntroductionClinical practice guidelines (CPGs) synthesise the latest evidence to support clinical and patient decision-making. CPG adherent care is associated with improved patient survival outcomes; however, adherence rates are low across some cancer streams in Australia. Greater understanding of specific barriers to cancer treatment CPG adherence is warranted to inform future implementation strategies.This paper presents the protocol for a systematic review that aims to determine cancer treatment CPG adherence rates in Australia across a variety of common cancers, and to identify any factors associated with adherence to those CPGs, as well as any associations between CPG adherence and patient outcomes.Methods and analysisFive databases will be searched, Ovid Medline, PsychInfo, Embase, Scopus and Web of Science, for eligible studies evaluating adherence rates to cancer treatment CPGs in Australia. A team of reviewers will screen the abstracts in pairs according to predetermined inclusion criteria and then review the full text of eligible studies. All included studies will be assessed for quality and risk of bias. Data will be extracted using a predefined data extraction template. The frequency or rate of adherence to CPGs, factors associated with adherence to those CPGs and any reported patient outcome rates (eg, relative risk ratios or 5-year survival rates) associated with adherence to CPGs will be described. If applicable, a pooled estimate of the rate of adherence will be calculated by conducting a random-effects meta-analysis. The systematic review will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.Ethics and disseminationEthics approval will not be required, as this review will present anonymised data from other published studies. Results from this study will form part of a doctoral dissertation (MB), will be published in a journal, presented at conferences, and other academic presentations.PROSPERO registration numberCRD42020222962.


2021 ◽  
Vol 8 (1) ◽  
pp. e000592
Author(s):  
Martijn P D Haring ◽  
Frans J C Cuperus ◽  
Evelien W Duiker ◽  
Robbert J de Haas ◽  
Vincent E de Meijer

ObjectiveBenign liver tumours (BLT) are increasingly diagnosed as incidentalomas. Clinical implications and management vary across and within the different types of BLT. High-quality clinical practice guidelines are needed, because of the many nuances in tumour types, diagnostic modalities, and conservative and invasive management strategies. Yet, available observational evidence is subject to interpretation which may lead to practice variation. Therefore, we aimed to systematically search for available clinical practice guidelines on BLT, to critically appraise them, and to compare management recommendations.DesignA scoping review was performed within MEDLINE, EMBASE, and Web of Science. All BLT guidelines published in peer-reviewed, and English language journals were eligible for inclusion. Clinical practice guidelines on BLT were analysed, compared, and critically appraised using the Appraisal of Guidelines, Research and Evaluation (AGREE II) checklist regarding hepatic haemangioma, focal nodular hyperplasia (FNH), and hepatocellular adenoma (HCA). Preferred Reporting Items for Systematic Reviews and Meta-Analyses recommendations (PRISMA) for scoping reviews were adhered to.ResultsThe literature search yielded unique 367 papers, 348 were excluded after screening of title/abstract, and 16 after full-text screening. Three guidelines were included: the American College of Gastroenterology (ACG; 2014), Brazilian Society of Hepatology (SBH; 2015), and European Association for the Study of the Liver (EASL; 2016). There was no uniformity in the assessment methods for grading and gravity of recommendations between guidelines. Among observed differences were: (1) indications for biopsy in all three tumours; (2) advices on contraceptive pills and follow-up in FNH and HCA; (3) use of an individualised approach to HCA; (4) absence of recommendations for treatment of HCA in men; and (5) approaches to HCA subtype identification on magnetic resonance imaging.ConclusionRecognising differences in recommendations can assist in harmonisation of practice standards and identify unmet needs in research. This may ultimately contribute to improved global patient care.


Healthcare ◽  
2020 ◽  
Vol 8 (4) ◽  
pp. 564
Author(s):  
Saja H. Almazrou ◽  
Sarah I. Alfaifi ◽  
Sumayyah H. Alfaifi ◽  
Lamees E. Hakami ◽  
Sinaa A. Al-Aqeel

The current review aims to investigate the barriers to and facilitators of the adherence to clinical practice guidelines (CPGs) in the Middle East and North Africa (MENA) region. English language studies published between January 2010 and May 2019 were searched on PubMed, Embase, and EBSCO. The barriers were categorized as clinician-related factors, such as lack of awareness of familiarity with the CPGs, and external factors, such as patients, guidelines, and environmental factors. The search identified 295 titles, out of which 15 were included. Environmental factors, specifically lack of time, resources, incentives, availability, and costs of treatment or diagnostic tests, training, and dissemination plans were the most commonly identified barriers. The familiarity with or awareness of healthcare professionals about the guideline, guideline characteristics, lack of agreement with the guidelines and preference in clinical judgment, physician self-efficacy, and motivation were reported to a lesser extent. Few studies reported on the compliance of facilitators with the guidelines including disseminating and advertising guideline materials, education and training on the guidelines, regulatory and financial incentives, and support from institutions. The review highlights that the studies on barriers to and facilitators of compliance with CPGs in the MENA region are limited in number and quality.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yali Liu ◽  
Yuan Zhang ◽  
Shu Wang ◽  
Ling Liu ◽  
Gang Che ◽  
...  

Abstract Background There is a lack of a comprehensive evaluation for pediatric clinical practice guidelines (CPGs) published in recent years. Here, we assessed the quality of pediatric CPGs, considering factors that might affect their quality. The aim of the study is to promote a more coherent development and application of CPGs. Methods Pediatric CPGs published in PubMed, MedLive, Guidelines International Network, National Institute for Health and Care Excellence, and World Health Organization between 2017 and 2019 were searched and collected. Paired researchers conducted screening, data extraction, and quality assessment using the Appraisal of Guidelines for Research and Evaluation II (AGREE II). Linear regression analysis determined the factors affecting CPGs’ quality. Results The study included a total of 216 CPGs, which achieved a mean score of 4.26 out of 7 points (60.86%) in the AGREE II assessment. Only 6.48% of the CPGs reached the “recommend” level. The remaining 69.91% should have been modified before recommendation, while the other 23.61% did not reach the recommended level at all. The overall quality of recent pediatric CPGs was higher than previously, and the proportion of CPGs with low-quality decreased over time. However, there were still too few CPGs that reached a high-quality level. The “applicability” and “rigor of development” domains had generally low scores. CPGs formulated by developing countries or regions, those that are not under an organizations or groups responsibility, and those that used non-evidence-based methods were found to be associated with poorer quality in different domains as independent or combinational factors. Conclusions The quality of pediatric CPGs still needs to be improved. Specifically, a quality control before applying new CPGs should be essential to ensure their quality and applicability.


2015 ◽  
Vol 38 (6) ◽  
pp. 305 ◽  
Author(s):  
Eyal Kraut ◽  
Pendar Farahani

Purpose: Patients with hypothyroidism are increasingly enquiring about the benefit of using combination therapy of levothyroxine (LT4) and liothyronine (LT3) as a potential treatment for hypothyroidism. Combination therapy, however, remains controversial. The purpose of this study was to systematically review available hypothyroidism treatment recommendations from clinical practice guidelines from around the world to identify the consensus regarding combination therapy. Source: Clinical practice guidelines were obtained from searches of PubMed, EMBASE, and MEDLINE, using several combinations of MeSH terms. The search was limited to clinical guidelines in English-language publications, published between January 1, 1990 and May 1, 2015. A quantitative approach was utilized for data synthesis. Principal Findings: Thirteen guidelines were identified, including three regarding pregnancy, two regarding pediatric populations and eight regarding adult populations. There were six guidelines from North America, four guidelines from Europe and three guidelines from South America. Twelve of the guidelines were published after 2010. Nine guidelines addressed combination therapy of LT4 plus LT3, and all nine concluded that LT4 therapy alone is the standard of care, with insufficient evidence to recommend widespread combination therapy. Only the 2012 ETA Guidelines and the 2015 BTA Guidelines concluded that combination therapy could be used, although only in certain circumstances and as an experimental treatment. Conclusion: This systematic review illustrates that clinical practice guidelines worldwide do not recommend and do not support routine use of combination LT4 and LT3 therapy to treat hypothyroidism.


2019 ◽  
Vol 31 (10) ◽  
pp. G139-G145
Author(s):  
Sho Sasaki ◽  
Haruki Imura ◽  
Kyoko Sakai ◽  
Yoshihito Goto ◽  
Kyoko Kitazawa ◽  
...  

Abstract Purpose To examine the update status of clinical practice guidelines (CPGs) for 24 main diseases in Japan, and to clarify the quality of and issues pertaining to the most recent versions of CPGs for each disease. Data sources CPGs were searched in two Japanese guideline databases. Study selection All relevant Japanese CPGs published between January 1999 and July 2016 were selected. Data extraction The developer and issue date were extracted for all target CPGs. The most recent CPGs were assessed using the Appraisal of Guidelines for Research and Evaluation—II (AGREE II) instrument. Results of data synthesis Among 106 target CPGs, 24 most recent CPGs were subjected to assessment using the AGREE II instrument. CPGs for 11 diseases (46%) had a mean time interval for update of ≥5 years. Among the 24 CPGs subjected to AGREE II assessment, median domain scores were 74% for “Domain 1: Scope and Purpose,” 43% for “Domain 2: Stakeholder Involvement,” 46% for “Domain 3: Rigor of Development,” 69% for “Domain 4: Clarity of Presentation,” 24% for “Domain 5: Applicability” and 27% for “Domain 6: Editorial Independence.” Conclusions The systematic assessment of CPGs for 24 major diseases in Japan revealed a trend for a delay in timing of update for many CPGs. Moreover, the 24 most recent CPGs had low domain scores for domains 2, 3, 5 and 6. In the future, concrete measures will need to be considered in order to improve the quality of CPGs.


2021 ◽  
Vol 12 ◽  
pp. 204209862098568
Author(s):  
Fenella Barlow-Pay ◽  
Thura Win Htut ◽  
Mina Khezrian ◽  
Phyo Kyaw Myint

Aims: Individuals taking immunosuppressants are at increased susceptibility to viral infections in general. However, due to the novel nature of the COVID-19, there is a lack of evidence about the specific risks of the disease in this patient group. This systematic review aims to summarize the current international clinical guidelines to highlight areas where research is needed through critical appraisal of the evidence base of these guidelines. Methods: We conducted a systematic review of clinical practice guidelines about the usage of immunosuppressants during the COVID-19 pandemic. Electronic databases including MEDLINE and the websites of relevant professional bodies were searched for English language guidelines that were published or updated between March 2020 and May 2020 in this area. We assessed the quality and consistency of guidelines. The evidence base underpinning these guidelines was critically appraised using GRADE criteria. Results: Twenty-three guidelines were included. Most guidelines ( n = 15, 65.2%) informed and updated evidence based on expert opinion. The methodological quality of the guidelines varied, ranging from ‘very low’ to ‘moderate’. Guidelines consistently recommended that high-risk patients, including those who are taking high doses of steroids for more than a month, or a combination of two or more immunosuppressants, should be shielding during the outbreak. Most guidelines stated that steroids usage should not be stopped abruptly and advised on individualized risk–benefit analysis considering the risk of the effect of COVID-19 infection and the relapse of the autoimmune condition in patients. Discussion: Clinical practice guidelines on taking immunosuppressants during the COVID-19 outbreak vary in quality. The level of evidence informing the available guidelines was generally low. Given the novel nature of COVID-19, the guidelines draw on existing knowledge and data, refer to the use of immunosuppressants and risks of serious infections of other aetiologies and have extrapolated these to form their evidence base.


2018 ◽  
Vol 52 (4) ◽  
pp. 320-327 ◽  
Author(s):  
Nina M Molenaar ◽  
Astrid M Kamperman ◽  
Philip Boyce ◽  
Veerle Bergink

Objective: Several countries have developed Clinical Practice Guidelines regarding treatment of perinatal depressive symptoms and perinatal use of antidepressant. We aimed to compare guidelines to guide clinicians in best clinical practice. Methods: An extensive search in guideline databases, MEDLINE and PsycINFO was performed. When no guidelines were (publicly) available online, we contacted psychiatric-, obstetric-, perinatal- and mood disorder societies of all first world countries and the five largest second world countries. Only Clinical Practice Guidelines adhering to quality criteria of the Appraisal of Guidelines for Research and Evaluation instrument and including a systematic review of evidence were included. Data extraction focussed on recommendations regarding continuation or withdrawal of antidepressants and preferred treatment in newly depressed patients. Results: Our initial search resulted in 1094 articles. After first screening, 40 full-text articles were screened. Of these, 24 were excluded for not being an official Clinical Practice Guidelines. In total, 16 Clinical Practice Guidelines were included originating from 12 countries. Eight guidelines were perinatal specific and eight were general guidelines. Conclusion: During pregnancy, four guidelines advise to continue antidepressants, while there is a lack of evidence supporting this recommendation. Five guidelines do not specifically advise or discourage continuation. For new episodes, guidelines agree on psychotherapy (especially cognitive behavioural therapy) as initial treatment for mild to moderate depression and antidepressants for severe depression, with a preference for sertraline. Paroxetine is not preferred treatment for new episodes but switching antidepressants for ongoing treatment is discouraged (three guidelines). If mothers use antidepressants, observation of the neonate is generally recommended and breastfeeding encouraged.


2019 ◽  
Vol 78 (7) ◽  
pp. 546-562 ◽  
Author(s):  
Maria G Grammatikopoulou ◽  
Xenophon Theodoridis ◽  
Konstantinos Gkiouras ◽  
Maria Lampropoulou ◽  
Arianna Petalidou ◽  
...  

Abstract Context Ensuring a healthy pregnancy and achieving optimal gestational weight gain (GWG) are important for maternal and child health. Nevertheless, the nutritional advice provided during pregnancy is often conflicting, suggesting limited adherence to clinical practice guidelines (CPGs). Objective The aim of this review was to identify all CPGs on maternal nutrition and GWG and to critically appraise their methodological quality. Data Sources The MEDLINE/PubMed, Cochrane, Guidelines International Network, and BMJ Best Practice databases, along with gray literature, were searched from inception until February 2019 for CPGs and consensus, position, and practice papers. Study Selection Clinical practice guidelines published in English and containing advice on maternal nutrition or GWG were eligible. Data Extraction Two authors independently extracted data on items pertaining to maternal nutrition or GWG, and CPGs were appraised using the AGREE II instrument. Results Twenty-two CPGs were included. All scored adequately in the “scope” domain, but most were considered inadequate with regard to stakeholder involvement, rigor of development, applicability, and editorial independence. Many CPGs lacked patient or dietician involvement, and more than half did not disclose funding sources or conflicts of interest. Guidance on GWG was based mostly on Institute of Medicine thresholds, while nutrition recommendations appeared scattered and heterogeneous. Conclusion Despite the importance of maternal nutrition and the plethora of advising bodies publishing relevant guidance, there is room for substantial improvement in terms of development standards and content of nutritional recommendations. Systematic review registration PROSPERO registration number CRD42019120898.


2020 ◽  
Vol 5 (4) ◽  
pp. 1006-1010
Author(s):  
Jennifer Raminick ◽  
Hema Desai

Purpose Infants hospitalized for an acute respiratory illness often require the use of noninvasive respiratory support during the initial stage to improve their breathing. High flow oxygen therapy (HFOT) is becoming a more popular means of noninvasive respiratory support, often used to treat respiratory syncytial virus/bronchiolitis. These infants present with tachypnea and coughing, resulting in difficulties in coordinating sucking and swallowing. However, they are often allowed to feed orally despite having high respiratory rate, increased work of breathing and on HFOT, placing them at risk for aspiration. Feeding therapists who work with these infants have raised concerns that HFOT creates an additional risk factor for swallowing dysfunction, especially with infants who have compromised airways or other comorbidities. There is emerging literature concluding changes in pharyngeal pressures with HFOT, as well as aspiration in preterm neonates who are on nasal continuous positive airway pressure. However, there is no existing research exploring the effect of HFOT on swallowing in infants with acute respiratory illness. This discussion will present findings from literature on HFOT, oral feeding in the acutely ill infant population, and present clinical practice guidelines for safe feeding during critical care admission for acute respiratory illness. Conclusion Guidelines for safety of oral feeds for infants with acute respiratory illness on HFOT do not exist. However, providers and parents continue to want to provide oral feeds despite clinical signs of respiratory distress and coughing. To address this challenge, we initiated a process change to use clinical bedside evaluation and a “cross-systems approach” to provide recommendations for safer oral feeds while on HFOT as the infant is recovering from illness. Use of standardized feeding evaluation and protocol have improved consistency of practice within our department. However, further research is still necessary to develop clinical practice guidelines for safe oral feeding for infants on HFOT.


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