Creatinine Assessment in Non–Steady-State Conditions: A Critical Review

2021 ◽  
pp. 106002802199964
Author(s):  
David E. Nix ◽  
Brian L. Erstad

Objectives: To discuss methods for the assessment of creatinine clearance (Clcr) when serum creatinine (SCr) is not at steady state in order to estimate kidney function and apply the estimate to kidney function staging for clinical assessment or drug dosing. Data Sources: A PubMed search was conducted from 1976 to mid-January 2021 with other articles identified through review of bibliographies of retrieved articles and citations in Scopus. Study Selection and Data Extraction: Articles assessing Clcr under non–steady-state conditions and studies evaluating predictive equations were selected. Data Synthesis: When SCr is systematically changing (ie, trending up or down), kinetic methods to estimate Clcr are appropriate. Estimates from kinetic methods should be individual based and not indexed to body surface area, and careful monitoring is required to confirm predictions as the situation evolves. Standard methods intended for steady-state conditions should not be used to estimate Clcr in patients with unstable SCr. Relevance to Patient Care and Clinical Practice: Creatinine continues to be a monitoring parameter of choice and is an important variable in all the commonly used equations for estimating Clcr and most important for estimating glomerular filtration rate. However, standard methods of estimating Clcr for medication dosing are not accurate under non–steady-state conditions. Conclusion: The methods for kinetic clearance estimation and standards methods for clearance estimation, such as the Cockcroft-Gault equation, are mutually exclusive. There are no benefits of using the kinetic method in patients with stable SCr concentrations, and standard equations are not appropriate with unstable SCr concentrations.

2021 ◽  
pp. 106002802110233
Author(s):  
C. Michael White

Objective Assess the current daily interim reference level of lead and the amount contained in current mineral and multivitamin-multimineral (MVM) products. Data Sources PubMed search from 1980 to May 15, 2021, limited to the English language, via the search strategy ((mineral OR multivitamin OR calcium OR iron OR magnesium OR copper OR zinc OR chromium OR selenium) AND (heavy metals OR Pb OR lead)). Study Selection and Data Extraction Narrative review of studies assessing lead content in mineral or MVM products. Data Synthesis Products containing different calcium forms (dolomite, bone meal, natural carbonate) have historically had higher lead levels than others (refined carbonate, lactate, gluconate, acetate, sevelamer), but the gap has closed considerably since the year 2000. Although only limited assessments of magnesium and zinc supplements have been conducted, no alarming average lead amounts were found. MVM products assessed since 2007 had low median or mean lead concentrations. However, large interproduct differences exist, with many products having very little lead and some products having concerning amounts. Relevance to Patient Care and Clinical Practice It is difficult for pharmacists and consumers to know the amount of lead in an actual product unless it is tested in an independent third-party lab. The United States Pharmacopeia and NSF International will provide a seal on the products stating that the products have a low level of lead, but even so, children could receive more lead than the Food and Drug Administration’s Interim Reference Level. Conclusions The threat from lead exposure in mineral and MVM products have diminsihed considerably over time but some products can still have excessive amounts. Without third-party testing, it is difficult for clinicians and consumers to know which outlier products to avoid.


2019 ◽  
Vol 34 (9) ◽  
pp. 580-594
Author(s):  
Jelena Lewis ◽  
Laressa Bethishou ◽  
Laura V. Tsu

OBJECTIVE: To provide an up-to-date review of current guidelines, previous trials, and new trials regarding aspirin use in primary prevention of cardiovascular (CV) disease in the elderly population. DATA SOURCES: A PubMed search of articles published through April 2019 was performed using a combination of the following words: aspirin, bleeding, cardiovascular, elderly, hemorrhage, myocardial infarction, primary prevention, stroke. STUDY SELECTION/DATA EXTRACTION: Relevant randomized controlled trials, meta-analyses, and guidelines were assessed for the use of aspirin in primary prevention of CV disease in older patients. References from the above literature were also evaluated. Articles were selected for inclusion based on relevance to the topic, detailed methods, and complete results. DATA SYNTHESIS: The role of aspirin for primary prevention of CV disease in older adults is not well defined. As a result, the guideline recommendations for the use of aspirin in this setting are inconsistent. In 2018, the ARRIVE, ASCEND, and ASPREE studies were published. These studies tried to address some of the inconsistencies regarding the use of aspirin in primary prevention of CV disease. This article reviews the current recommendations along with previous and recent studies for aspirin use for primary prevention in older adults. CONCLUSION: The role of aspirin for primary prevention of CV disease in older adults should be individualized based on patient's risk factors, including risk of CV disease and likelihood of bleeding. Updated evidence provides more guidance regarding which patient populations will benefit from therapy.


2017 ◽  
Vol 51 (12) ◽  
pp. 1112-1121 ◽  
Author(s):  
G. Christopher Wood ◽  
Joseph M. Swanson

Objective: A significant percentage of patients with hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP) have poor outcomes with intravenous antibiotics. It is not clear if adding aerosolized antibiotics improves treatment. This review is an update on using aerosolized antibiotics for treating HAP/VAP in adults. Data Sources: PubMed search using the terms “aerosolized antibiotics pneumonia,” “nebulized antibiotics pneumonia,” and “inhaled antibiotics pneumonia.” Reference lists from identified articles were also searched. Study Selection and Data Extraction: Clinical studies of aerosolized antibiotics for treating HAP/VAP in adults from July 2010 to March 2017. This article updates a previous review on this topic written in mid-2010. Data Synthesis: The size and quality of studies have improved dramatically in the recent time period compared to previous studies. However, there still are not large randomized controlled trials available. Colistin and aminoglycosides were the most commonly studied agents, and the most common pathogens were Pseudomonas and Acinetobacter. The clinical efficacy of adding aerosolized antibiotics was mixed. Approximately half of the studies showed better outcomes, and none showed worse outcomes. Aerosolized antibiotics appear to be relatively safe, though pulmonary adverse events can occur. Attention to proper administration technique in mechanically ventilated patients is required, including the use of vibrating plate nebulizers. Conclusions: Adding aerosolized antibiotics to intravenous antibiotics may improve the outcomes of adult patients with HAP/VAP in some settings. It seems reasonable to add aerosolized antibiotics in patients with multidrug-resistant organisms or who appear to be failing therapy. Clinicians should pay attention to potential adverse events and proper administration technique.


2020 ◽  
Vol 55 (1) ◽  
pp. 80-88
Author(s):  
Brian L. Erstad ◽  
David E. Nix

Objectives: To discuss the evidence and caveats associated with estimated and measured creatinine clearance (eClCr and mClCr) and glomerular filtration rate (eGFR and mGFR) assessments of kidney function in patients with more extreme forms of obesity. Data Sources: PubMed (1976 to mid-May 2020) was used, with bibliographies of retrieved articles searched for additional articles. Study Selection and Data Extraction: Articles using gold standard mGFR to evaluate eClCr, mClCr, and eGFR assessments of kidney function in patients with more extreme forms of obesity were included. Data Synthesis: The overestimation of GFR by mClCr is well established, but mClCr is an alternative to mGFR assessments for determining medication dosing in patients with extremes of body size or muscle mass, or in patients receiving narrow therapeutic index medications when eGFR is likely to be inaccurate. The vast majority of studies comparing eGFR assessments with gold standard indicators of kidney function were attempts to validate eGFR equations for diagnosing and staging chronic kidney disease (CKD). Relevance to Patient Care and Clinical Practice: For dosing medications in patients with stable kidney function and extreme obesity, a deindexed 4-variable Modification of Diet in Renal Disease or CKD Epidemiology Collaboration equation is an alternative to Cockcroft-Gault. Consistent use of the same equation by provider and between providers within any given setting is of paramount importance. Conclusions: In patients with extreme obesity and stable kidney function, eClCr or eGFR using deindexed values provides estimates of function for dosing adjustments of medications with elimination by the kidneys, but more research is needed with respect to the best size descriptor to use with estimating equations.


2012 ◽  
Vol 46 (10) ◽  
pp. 1419-1424 ◽  
Author(s):  
Laura M Godfrey ◽  
John Erramouspe ◽  
Kevin W Cleveland

Objective: To evaluate the teratogenic potential of statins in women of child-bearing age. Data Sources: A PubMed search (1980-September 2012) was performed using the search terms statin and pregnancy, then repealed using statin and teratogenicity. Results were limited to articles published in English reporting on use of statins in humans. Study Selection and Data Extraction: All articles presenting data on pregnancy outcomes after statin use during any trimester of pregnancy were included. Three case reports, 2 case series, 2 systematic reviews, 2 registry-based studies, and 1 prospective observational cohort study were reviewed. Data Synthesis: Since initial premarketing studies of lovastatin in animals, terato-genesis has been assumed to be a classwide function of statins' mechanism of action. Data from human exposure during pregnancy have been gathered and analyzed in a variety of study formats to formulate useable conclusions on statins' actual teratogenic risk and pattern of associated birth defects. Although the current trend is that actual risk is lower than once thought, the available literature is limited by potential reporting bias, contains overlap in the data, and frequently lacks numbers of total exposures to statins during pregnancy with reported malformations. Additionally, no human studies included data on the 2 newest statins (rosuvastatin, pitavastatin); the more lipophilic statins (lovastatin, simvastatin) have the most experience and thus have more evidence related to teratogenic potential. Conclusions: Human teratogenic risk has not been proven nor has it been ruled out by the available data on statin use in pregnancy. Possible differences in risk between individual statins require further evaluation. Additional data, including prospective observational cohorts with inadvertent maternal exposure to statins during early weeks of gestation, should further help to clarify appropriate recommendations for statin use in this population.


2021 ◽  
Vol 36 (11) ◽  
pp. 556-567
Author(s):  
Hindu Rao ◽  
Neeloufar Fakourfar ◽  
Caroline Sun ◽  
Jelena Lewis

Objective To review current guidelines and literature regarding continuous glucose monitoring (CGM) use in the management of type 2 diabetes mellitus (T2DM) in older people. Data Sources A PubMed search of articles published through August 2020 using a combination of the following: older people, T2DM, continuous glucose monitoring, hypoglycemia, and hyperglycemia. Study Selection/Data Extraction Relevant randomized control trials, meta-analyses, and guidelines were assessed for the use of CGM in older patients with T2DM. Articles were included based on relevance to the topic, detailed methods, and complete results. Data Synthesis CGM use in T2DM management in older people is not well defined. CGM may be a valuable technology in older people who face unique challenges, such as hypoglycemia, decline in cognitive function, and variable glucose levels. This article provides a review of recommendations for glucose monitoring in T2DM and discusses the role of specific CGM products. Conclusion CGM is a viable option for older people with T2DM to help improve overall diabetes control. Pharmacists can play an important role in educating patients about this technology.


2019 ◽  
Vol 34 (9) ◽  
pp. 580-594
Author(s):  
Jelena Lewis ◽  
Laressa Bethishou ◽  
Laura V. Tsu

OBJECTIVE: To provide an up-to-date review of current guidelines, previous trials, and new trials regarding aspirin use in primary prevention of cardiovascular (CV) disease in the elderly population. DATA SOURCES: A PubMed search of articles published through April 2019 was performed using a combination of the following words: aspirin, bleeding, cardiovascular, elderly, hemorrhage, myocardial infarction, primary prevention, stroke. STUDY SELECTION/DATA EXTRACTION: Relevant randomized controlled trials, meta-analyses, and guidelines were assessed for the use of aspirin in primary prevention of CV disease in older patients. References from the above literature were also evaluated. Articles were selected for inclusion based on relevance to the topic, detailed methods, and complete results. DATA SYNTHESIS: The role of aspirin for primary prevention of CV disease in older adults is not well defined. As a result, the guideline recommendations for the use of aspirin in this setting are inconsistent. In 2018, the ARRIVE, ASCEND, and ASPREE studies were published. These studies tried to address some of the inconsistencies regarding the use of aspirin in primary prevention of CV disease. This article reviews the current recommendations along with previous and recent studies for aspirin use for primary prevention in older adults. CONCLUSION: The role of aspirin for primary prevention of CV disease in older adults should be individualized based on patient's risk factors, including risk of CV disease and likelihood of bleeding. Updated evidence provides more guidance regarding which patient populations will benefit from therapy.


2019 ◽  
Vol 35 (3) ◽  
pp. 110-118
Author(s):  
Young Ran Lee ◽  
Caitlin Elizabeth Burton ◽  
Kolton Rucks Bevel

Objective: To review the microbiological activity, safety, and efficacy of the new fluoroquinolone delafloxacin for the treatment of acute bacterial skin and skin structure infections (ABSSSIs). Data Sources: A PubMed search from 1945 to September 2018 was done using the terms delafloxacin, acute bacterial skin and skin structure infections, skin and soft tissue infections, and fluoroquinolone. Additional sources include the Food and Drug Administration website, ClinicalTrials.gov, and the Melinta Therapeutics website. Study Selection and Data Extraction: The literature search was limited to those published in the English language and included in vitro and human studies that evaluated microbiological coverage, pharmacokinetics, pharmacodynamics, safety, and/or efficacy. Data Synthesis: Delafloxacin is a new fluoroquinolone with a unique structure for its class that covers both methicillin-resistant Staphylococcus aureus (MRSA) and Pseudomonas. This new antibiotic has demonstrated noninferiority to vancomycin plus aztreonam for the treatment of ABSSSIs in both an intravenous-only regimen and an intravenous to an oral regimen. Relevance to Patient Care and Clinical Practice: ABSSSIs are infections that are most often caused by Staphylococcus and represent one of the most common types of hospital infections. MRSA represents about half of all staphylococcal skin infections, and along with gram-negative infections, increase the rates of patient morbidity and health care costs. Delafloxacin is an additional treatment option that covers both of these types of microorganisms. Conclusions: Delafloxacin is a safe and effective treatment option for ABSSSIs, particularly in those with polymicrobial infections and those with MRSA.


2019 ◽  
Vol 53 (12) ◽  
pp. 1220-1226 ◽  
Author(s):  
Caitlin E. Reardon ◽  
Sandra L. Kane-Gill ◽  
Pamela L. Smithburger ◽  
Joseph F. Dasta

Objective: The purpose of this article is to review the safety and efficacy of sufentanil sublingual tablet (SST) and suggest its place in therapy for managing acute pain in patients requiring intravenous (IV) opioids. Data Sources: A MEDLINE/PubMed search was performed (2010 to April 2019) using the following keywords: sufentanil sublingual tablet, sufentanil, opioid, moderate to severe acute pain. Study Selection and Data Extraction Quantification: We included English language articles evaluating SST pharmacology, pharmacokinetics, efficacy, and safety in humans for the treatment of acute pain. Data Synthesis: SST is Food and Drug Administration approved and considered safe and effective for the treatment of acute pain in Risk Evaluation and Mitigation Strategy–certified and medically supervised health care settings. Phase III clinical trials showed a statistically significant decrease in summed pain intensity score when SST was compared with placebo. Relevance to Patient Care and Clinical Practice: SST can be a useful option in patients requiring a parenteral opioid who do not have IV access, or it may be unnecessary or difficult to obtain. Because of its quick onset and sustained analgesia, SST may also be useful for procedural pain in the critically ill, to expedite discharges for outpatient procedures, in emergency departments (EDs), and in the battlefield. Conclusions: SST can satisfy an unmet need in patients with acute pain, who require parenteral opioids, and either have no IV access or require prolonged time to achieve IV access such as patients in outpatient surgical centers, EDs, and the battlefield. During periods of parenteral opioid shortage, SST may provide another option for adequate analgesia.


2020 ◽  
pp. 875512252096404
Author(s):  
Arya Sathyan ◽  
Reshma Scaria ◽  
Pavithra Arunachalam ◽  
Mohanapriya Ramasamy ◽  
Dithu Thekkekkara ◽  
...  

Objective: To evaluate enuresis-induced antiepileptic drugs in children. Data Sources: A PubMed search (1917 to July 2020) was performed using the following keywords and associated medical subject headings: antiepileptic drugs, enuresis, pediatric population, drug-induced enuresis, and epilepsy. Study Selection and Data Extraction: The search was conducted to find the role of antiepileptic drugs–induced enuresis in children in studies published in English. Data Synthesis: Enuresis or bedwetting is an underreported adverse drug reaction of antiepileptic drugs. Owing to that fact, it is a condition that is outgrown with age and also could cause embarrassment. As antiepileptic drugs sometimes need to be taken for a long duration until epilepsy relapses, the occurrence of enuresis in this situation can be troublesome for both the child and the caretaker. Even though enuresis is proposed to have a significant effect on the child’s psychology, it is still considered to be a condition that is outgrown with age. This article includes a review of antiepileptic drugs reported to have caused enuresis in children. Conclusions: If a child develops enuresis as an adverse drug reaction, this adds further challenges to their life. A better understanding of this potential adverse effect may help prevent unwanted stress. Though the exact mechanisms are not known, the hypothesis generated is from the occurred cases, most of which relapsed when the drug was withdrawn. Considering the gravity of epilepsy in children, more detailed studies need to be conducted on this adverse effect to ensure a safe and effective treatment in children.


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