Evolution of Equations for Estimating Renal Function and Their Application to the Dosing of New Antimicrobials

2019 ◽  
Vol 54 (5) ◽  
pp. 496-503
Author(s):  
Alison K. Lew ◽  
Ryan L. Crass ◽  
Gregory Eschenauer
Keyword(s):  
Dose Adjustment ◽  
English Language ◽  
Antimicrobial Agents ◽  
Data Extraction ◽  
New Era ◽  
Mdrd Equation ◽  
Language Studies ◽  
Fda Approval ◽  
Literature Searches ◽  
Study Selection

Objective: To address the background and rationale for the recent introduction of the Modification of Diet in Renal Disease (MDRD) equation for renal dose adjustment of antimicrobials and to provide recommendations for pharmacists dosing new antimicrobial agents. Data Sources: Comprehensive MEDLINE and EMBASE literature searches (from August 2018 to October 2019) were performed. Search terms included creatinine clearance, Cockcroft-Gault, MDRD, and glomerular filtration rate and a subsequent search included the preceding terms AND antimicrobials OR antibiotics. Study Selection and Data Extraction: Available English-language studies on the derivation and/or use of the Cockcroft-Gault (CG) and MDRD study equation were evaluated as well as those that specifically discussed their use for dosing antimicrobial agents. Data Synthesis: The US Food and Drug Administration (FDA) approval of delafloxacin and meropenem-vaborbactam in 2017 ushered in a new era in renal dosing of antibiotics, in that both agents are recommended to be dosed by the MDRD equation. Studies demonstrate that the CG and MDRD equations can result in discrepant dosing recommendations. Relevance to Patient Care and Clinical Practice: The renal estimation equation recommended in a new antibiotic label should dictate the dosing of that medication. It is noteworthy that these equations are not interchangeable. Conclusion: Recently approved antimicrobials utilizing the MDRD equation for renal dose adjustment will be interspersed with old and new antimicrobials utilizing the CG equation because of lack of singular guidance by the FDA. This requires pharmacists to be vigilant in evaluating drug labels to determine which equation is recommended and to understand the differences, strengths, and limitations of each equation.

Intranasal Glucagon: A New Way to Treat Hypoglycemic Emergencies

2020 ◽  
Vol 54 (8) ◽  
pp. 780-787
Author(s):  
Rachel N. Lowe ◽  
Jennifer M. Trujillo
Keyword(s):  
Adverse Events ◽  
English Language ◽  
Data Extraction ◽  
Severe Hypoglycemia ◽  
Data Synthesis ◽  
Language Studies ◽  
Study Selection ◽  
Free Treatment ◽  
Patients With Diabetes ◽  
Data Source

Objective: To review the safety, efficacy, and administration of intranasal (IN) glucagon for the management of hypoglycemia. Data Source: A literature search of PubMed/MEDLINE (1995 to November 2019) using the terms intranasal glucagon, nasal glucagon, glucagon, hypoglycemia treatment, and hypoglycemia management was completed. Study Selection and Data Extraction: English-language studies evaluating IN glucagon were evaluated. Data Synthesis: IN glucagon is a newly approved product for the treatment of hypoglycemia in patients with diabetes, 4 years and older. Administered as a 3-mg dose, it was shown to be noninferior to intramuscular (IM) glucagon. In comparison trials, more than 98% of hypoglycemic events were treated successfully with IN glucagon in both pediatric and adult patients. In simulated and real-world studies, IN glucagon was administered in less than a minute for the majority of scenarios. IM glucagon took longer to administer, ranging from 1 to 4 minutes, and often, patients did not receive the intended full dose. Nausea and vomiting, known adverse events for glucagon, as well as local adverse events were most commonly reported with IN glucagon. Relevance to Patient Care and Clinical Practice: IN glucagon is safe, effective, easy to use, and does not require reconstitution prior to use, which can lead to faster delivery in a severe hypoglycemic event. It does not require age- or weight-based dosing. This delivery method offers an option for someone who fears needles or is uncomfortable with injections. Conclusion: IN glucagon is a safe, effective, easy to use, needle-free treatment option for severe hypoglycemia.

scholarly journals Cobicistat Versus Ritonavir: Similar Pharmacokinetic Enhancers But Some Important Differences

2017 ◽  
Vol 51 (11) ◽  
pp. 1008-1022 ◽  
Author(s):  
Alice Tseng ◽  
Christine A. Hughes ◽  
Janet Wu ◽  
Jason Seet ◽  
Elizabeth J. Phillips
Keyword(s):  
English Language ◽  
Data Extraction ◽  
Therapeutic Index ◽  
Search Terms ◽  
Language Studies ◽  
Study Selection ◽  
Pharmacokinetic Properties ◽  
Medication Dose ◽  
Concomitant Medications ◽  
Potential Interactions

Objective: To describe properties of cobicistat and ritonavir; compare boosting data with atazanavir, darunavir, and elvitegravir; and summarize antiretroviral and comedication interaction studies, with a focus on similarities and differences between ritonavir and cobicistat. Considerations when switching from one booster to another are discussed. Data Sources: A literature search of MEDLINE was performed (1985 to April 2017) using the following search terms: cobicistat, ritonavir, pharmacokinetic, drug interactions, booster, pharmacokinetic enhancer, HIV, antiretrovirals. Abstracts from conferences, article bibliographies, and product monographs were reviewed. Study Selection and Data Extraction: Relevant English-language studies or those conducted in humans were considered. Data Synthesis: Similar exposures of elvitegravir, darunavir, and atazanavir are achieved when combined with cobicistat or ritonavir. Cobicistat may not be as potent a CYP3A4 inhibitor as ritonavir in the presence of a concomitant inducer. Ritonavir induces CYP1A2, 2B6, 2C9, 2C19, and uridine 5′-diphospho-glucuronosyltransferase, whereas cobicistat does not. Therefore, recommendations for cobicistat with comedications that are extrapolated from studies using ritonavir may not be valid. Pharmacokinetic properties of the boosted antiretroviral can also affect interaction outcome with comedications. Problems can arise when switching patients from ritonavir to cobicistat regimens, particularly with medications that have a narrow therapeutic index such as warfarin. Conclusions: When assessing and managing potential interactions with ritonavir- or cobicistat-based regimens, clinicians need to be aware of important differences and distinctions between these agents. This is especially important for patients with multiple comorbidities and concomitant medications. Additional monitoring or medication dose adjustments may be needed when switching from one booster to another.

Ervebo (Ebola Zaire Vaccine, Live/rVSVΔG-ZEBOV-GP): The First Licensed Vaccine for the Prevention of Ebola Virus Disease

2020 ◽  
Vol 36 (6) ◽  
pp. 243-250 ◽  
Author(s):  
Christopher R. Piszczatoski ◽  
John G. Gums
Keyword(s):  
English Language ◽  
Ebola Virus ◽  
Virus Disease ◽  
Data Extraction ◽  
Ebola Virus Disease ◽  
Cochrane Library ◽  
Effective Vaccine ◽  
Fda Approval ◽  
Study Selection ◽  
Disease Relevance

Objective: To review the clinical data regarding the safety and efficacy of the Ervebo (Ebola Zaire vaccine, live/rVSVΔG-ZEBOV-GP) vaccine for the prevention of the Ebola virus disease. Data Sources: A literature search through PubMed, MEDLINE, and Cochrane Library was conducted for clinical trials published between January 2014 and June 2020 in the English language using the keywords Ervebo, rVSVΔG-ZEBOV, rVSVΔG-ZEBOV-GP, Ebola Zaire, and vaccine. Study Selection and Data Extraction: Articles were selected if they were related to the Food and Drug Administration (FDA) approval of Ervebo (Ebola Zaire vaccine, live/rVSVΔG-ZEBOV-GP) or provided novel data regarding this entity. Twelve articles noted in the FDA approval were chosen, along with 2 additional articles identified as providing novel information. Data Synthesis: The findings of the review show that Ervebo (Ebola Zaire vaccine, live/rVSVΔG-ZEBOV-GP) is a safe, immunogenic, and likely effective vaccine for the prevention of Ebola virus disease. Relevance to Patient Care and Clinical Practice: Ebola virus disease is highly infectious and often fatal. There have been multiple large outbreaks in the past 5 years, with no licensed treatments or vaccines. An effective vaccine could largely curtail current outbreaks and prevent further ones. Conclusion: The recent FDA approval of Ervebo (Ebola Zaire vaccine, live/rVSVΔG-ZEBOV-GP) offers the first approved vaccine for the prevention of Ebola virus disease. It has been shown to be safe, immunogenic, and likely effective for use in real-world applications for those at risk of contracting the disease.

Lasmiditan: Acute Migraine Treatment Without Vasoconstriction. A Review

2021 ◽  
pp. 875512252110246
Author(s):  
Juliana K Beauchene ◽  
Terri L Levien
Keyword(s):  
Cardiovascular Risk ◽  
English Language ◽  
Data Extraction ◽  
Common Side Effect ◽  
Migraine Treatment ◽  
Acute Migraine ◽  
Oral Tablet ◽  
Language Studies ◽  
Study Selection ◽  
Acute Migraine Treatment

Objective: To review the efficacy and safety of the newly Food and Drug Administration approved drug lasmiditan, and its place in therapy in the treatment of acute migraine attacks. Data Sources: A literature search of Web of Science, PubMed, and Google Scholar was preformed (September 1999 to May 2021) using the following search terms: acute migraine treatment, triptans, lasmiditan, Reyvow, Rimegepant, Nurtec, Ubrogepant, Ubrelvy, migraine, vasoconstriction, and cardiovascular risk. Product labeling, https://www.clinicaltriasl.gov , and product monographs were also reviewed. Study Selection and Data Extraction: Relevant English-language studies were considered. Data Synthesis: Lasmiditan is the first in its class approved for acute migraine treatment. Lasmiditan exerts its therapeutic effect through agonism at the 5-HT1F receptor, which has been shown to produce no vasoconstriction in preclinical models. Relevance to Patient Care and Clinical Practice: It is both scientifically and clinically relevant to review lasmiditan and determine the value of an acute migraine drug that does not induce vasoconstriction. Patients with preexisting cardiovascular conditions for which current migraine therapy is contraindicated may benefit from therapeutic use of lasmiditan. However, the potential cardiovascular benefit needs to be weighed against the increased central nervous system risks observed with lasmiditan. Conclusions: Lasmiditan is an oral tablet drug that is used for acute migraine abortive treatment and data suggest that it does not induce vasoconstriction, a common side effect often observed with the current first-line abortive migraine treatment drug class, triptans. This is especially important in acute migraine patients with cardiovascular risk factors in which triptan use is contraindicated.

Review of the Efficacy and Safety of Lemborexant, a Dual Receptor Orexin Antagonist (DORA), in the Treatment of Adults With Insomnia Disorder

2021 ◽  
pp. 106002802110084
Author(s):  
Kristin Waters
Keyword(s):  
Adverse Effects ◽  
Pharmacological Treatment ◽  
English Language ◽  
Data Extraction ◽  
Treatment Options ◽  
Efficacy And Safety ◽  
Phase 3 ◽  
Language Studies ◽  
Insomnia Disorder ◽  
Study Selection

Objective To provide an overview of the efficacy and safety of lemborexant in the treatment of insomnia disorder by assessing the currently available literature. Data Sources A literature search of PubMed was performed (2010 to March 2021) using the following search terms: lemborexant, sleep, orexin Study Selection and Data Extraction All relevant English-language studies were reviewed and considered, with a focus on phase 3 trials. Data Synthesis The efficacy and safety of lemborexant in the treatment of insomnia disorder in adults was demonstrated in 2 phase 3 trials. Lemborexant significantly reduced latency to persistent sleep compared with placebo. The first study also demonstrated a significant reduction compared with the active control zolpidem ER. Somnolence and headache were relatively common, but the marked adverse effects associated with other medications commonly used to treat insomnia, such as cognitive and psychomotor impairment and complex sleep-related behaviors, were not observed. Relevance to Patient Care and Clinical Practice Although nonpharmacological therapy is considered first-line treatment for insomnia disorder, pharmacological treatment is most commonly utilized. Lemborexant is a viable pharmacological treatment option for patients who are unable to tolerate the adverse effects associated with the most commonly prescribed medications for insomnia, such as benzodiazepines and sedative-hypnotics (Z drugs). This is especially true for geriatric patients, who may be more sensitive to these adverse effects. Conclusion Lemborexant can be recommended to treat insomnia disorder when pharmacological treatment is warranted. It has demonstrated efficacy in clinical trials and is likely better tolerated than most currently available treatment options.

Clarithromycin: Review of a New Macrolide Antibiotic with Improved Microbiologic Spectrum and Favorable Pharmacokinetic and Adverse Effect Profiles

1992 ◽  
Vol 26 (9) ◽  
pp. 1099-1108 ◽  
Author(s):  
Marc G. Sturgill ◽  
Robert P. Rapp
Keyword(s):  
Clinical Trials ◽  
English Language ◽  
Antimicrobial Agents ◽  
Macrolide Antibiotic ◽  
Data Extraction ◽  
Specific Information ◽  
Study Selection ◽  
Stated Purpose

OBJECTIVE: To compare the new macrolide antibiotic clarithromycin with erythromycin in terms of in vitro activity, pharmacokinetics, pharmacodynamics, clinical efficacy, and toxicity. DATA IDENTIFICATION: An English-language literature search employing MEDLINE (1987–91), Index Medicus (1987–91), Program and Abstracts of the 30th Interscience Conference on Antimicrobial Agents and Chemotherapy (1990), Program and Abstracts of the 31st Interscience Conference on Antimicrobial Agents and Chemotherapy (1991), and bibliographic reviews of related textbooks and review articles. STUDY SELECTION: Eighty-five articles were selected. Clinical trials with clarithromycin have been limited, and emphasis was placed on trials reported in the Program and Abstracts of the 30th Interscience Conference on Antimicrobial Agents and Chemotherapy and Program and Abstracts of the 31st Interscience Conference on Antimicrobial Agents and Chemotherapy. DATA EXTRACTION: Articles were assessed for study quality and specific information addressing the stated purpose. In articles reporting the results of clinical trials, emphasis was placed on comparative efficacy and toxicity. RESULTS OF DATA ANALYSIS: A review of 24 human trials suggests that clarithromycin is equally effective as erythromycin, penicillin VK, ampicillin, or amoxicillin for treatment of a variety of upper and lower respiratory tract or skin infections. Clarithromycin also appears to be better tolerated than these agents, with a lower incidence of gastrointestinal adverse effects. Limited clinical studies in patients with Mycobacterium leprae or Mycobacterium aviumintracellulare complex (MAI) suggest that clarithromycin may prove to be efficacious and well tolerated in the treatment of these infections. CONCLUSIONS: Clarithromycin is as effective in vivo as erythromycin, with less gastrointestinal irritation. Additionally, clarithromycin appears to expand the traditional spectrum of macrolide antibiotics, with promising activity against M. leprae and MAI.

Brexanolone (Zulresso): Finally, an FDA-Approved Treatment for Postpartum Depression

2019 ◽  
Vol 54 (2) ◽  
pp. 157-163 ◽  
Author(s):  
Jason G Powell ◽  
Scott Garland ◽  
Kayla Preston ◽  
Chris Piszczatoski
Keyword(s):  
Postpartum Depression ◽  
English Language ◽  
Data Extraction ◽  
Clinical Information ◽  
Rapid Onset ◽  
Depression Symptoms ◽  
Onset Of Action ◽  
Fda Approval ◽  
Study Selection

Objective: To review the safety and efficacy of brexanolone for the treatment of moderate to severe postpartum depression (PPD). Data Sources: A literature search through PubMed was conducted (January 2012 to July 2019) using the keyword brexanolone for clinical trials published in the English language. Study Selection and Data Extraction: Articles were selected if they were related to the Food and Drug Administration (FDA) approval of brexanolone or provided novel clinical information regarding this drug entity. Data Synthesis: The findings of the review show that brexanolone administered via IV infusion is both an effective and a fairly safe option for the treatment of PPD. Relevance to Patient Care and Clinical Practice: There are several antidepressants currently used to treat PPD; however, this is the first with FDA approval for this indication. The rapid onset of action of brexanolone may offer a quicker relief of these symptoms and may possibly lead to improved quality of life for both the mother and the child. Conclusion and Relevance: The recent FDA approval of brexanolone may offer an effective treatment of moderate to severe PPD and has been shown to rapidly decrease depression symptoms.

Novel Use of Ranolazine as an Antiarrhythmic Agent in Atrial Fibrillation

2016 ◽  
Vol 51 (3) ◽  
pp. 245-252 ◽  
Author(s):  
C. Michael White ◽  
Elaine Nguyen
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trials ◽  
Standard Therapy ◽  
English Language ◽  
Antiarrhythmic Drugs ◽  
Data Extraction ◽  
Artery Bypass ◽  
Language Studies ◽  
Study Selection ◽  
Intravenous Amiodarone

Objective: To review the limitations of current antiarrhythmic drugs in atrial fibrillation (AF) and discuss the rationale and clinical trials supporting the use of ranolazine in AF. Data Sources: MEDLINE was searched from 1980 to September 2016 using the terms ranolazine, atrial fibrillation, coronary artery bypass grafting, and valve surgery. Study Selection and Data Extraction: English-language studies and reviews assessing antiarrhythmic drugs, including ranolazine, were incorporated. Data Synthesis: The use of ranolazine monotherapy has been evaluated in 2 clinical trials. In the RAFFAELLO trial, higher doses of ranolazine showed a trend toward lower AF recurrence versus placebo ( P = 0.053), but further evidence is needed to support its use as a sole therapeutic agent. Ranolazine has shown utility in a limited number of studies as an adjunctive agent, which is critical for those in whom standard therapy is inadequate or the adverse event profile precludes optimized standard therapy. In the HARMONY trial, ranolazine 750 mg and dronedarone 225 mg twice daily reduced the AF burden by 59.1% from baseline ( P = 0.008 vs placebo). In a trial by Koskinas and colleagues, patients receiving ranolazine 1500 mg once and intravenous amiodarone had a higher conversion rate than those receiving amiodarone alone ( P = 0.024). There are also promising studies for the prevention and treatment of post–cardiothoracic surgery AF, which require further investigation. Conclusions: Ranolazine’s pharmacological properties and available evidence suggest potential for its use in AF.

Bioidentical Oral 17β-Estradiol and Progesterone for the Treatment of Moderate to Severe Vasomotor Symptoms of Menopause

2020 ◽  
pp. 106002802098261
Author(s):  
C. Brock Woodis ◽  
Emily Ghassemi ◽  
Amber N. McLendon
Keyword(s):  
English Language ◽  
Data Extraction ◽  
Menopausal Symptoms ◽  
Vasomotor Symptoms ◽  
Literature Searches ◽  
Study Selection ◽  
Intact Uterus ◽  
Study Population ◽  
17Β Estradiol ◽  
Bioidentical Hormones

Objective To review the efficacy, safety, and available literature regarding the novel combination bioidentical product Bijuva, or 17β-estradiol/progesterone (17β-E/P), for the treatment of moderate to severe menopausal symptoms in cisgender females with an intact uterus. Data Sources Literature searches of both PubMed (1966 to October 2020) and Google Scholar were conducted using search terms including bioidentical, estradiol, progesterone, menopause, E2/P4, TX-001HR, and Bijuva. Study Selection and Data Extraction All articles with studies conducted in cisgender human females and in the English language were considered for review; 18 publications were included. Data Synthesis In 1 phase 3 clinical study, 17β-E/P was proven to be effective at reducing the frequency and severity of vasomotor symptoms (VMS) at 12 weeks compared with placebo, and no cases of endometrial hyperplasia were observed over the 52-week safety study period. Menopausal women with an intact uterus were included in the study population. Relevance to Patient Care and Practice Concerns over content and safety of compounded bioidentical hormones have been raised by several professional societies. As women experience VMS of menopause, a desire for a Food and Drug Administration–regulated bioidentical combination product for the treatment of moderate to severe menopausal symptoms may be desirable. Given as a once-daily oral capsule at the dose of 1 mg estradiol/100 mg progesterone, 17β-E/P is approved for the treatment of VMS associated with menopause. Conclusions 17β-E/P is a novel bioidentical product that is the first of its kind in the treatment of moderate to severe menopausal symptoms.

A Review of β-Lactam–Associated Neutropenia and Implications for Cross-reactivity

2020 ◽  
pp. 106002802097564
Author(s):  
Christo Cimino ◽  
Ban M. Allos ◽  
Elizabeth J. Phillips
Keyword(s):  
English Language ◽  
Data Extraction ◽  
Alternative Therapy ◽  
Cross Reactivity ◽  
Drug Induced ◽  
Disease States ◽  
Language Studies ◽  
Study Selection ◽  
Frequency Of Use ◽  
Direct Substitution

Objective: To review the incidence, management, and current understanding of the pathophysiology of β-lactam–induced neutropenia and to critically evaluate the practicality and safety of direct substitution to an alternative β-lactam in the setting of this reaction. Data Sources: A literature analysis using the PubMed and Ovid search engines (July 1968 to October 2020) was performed using the search terms neutropenia, leukopenia, β-lactam, nonchemotherapy, agranulocytosis, and G-CSF (granulocyte colony-stimulating factor). Study Selection and Data Extraction: The included English-language studies evaluated the incidence, mechanism, and/or management of β-lactam–induced neutropenia in pediatric or adult patients. Data Synthesis: Drug-induced neutropenia is a well-documented adverse reaction of β-lactam antibiotics, with an incidence of approximately 10% following at least 2 weeks of intravenous therapy. However, multiple gaps in knowledge remain in the mechanism of pathophysiology and optimal management of this reaction. Both direct toxic and immune-mediated mechanisms have been implicated. Although the cornerstone of management includes cessation of the offending agent, controversy exists on the appropriateness of direct substitution or future use of an alternative β-lactam. Relevance to Patient Care and Clinical Practice: Given the frequency of use and superiority of β-lactams over alternative therapy for several infectious disease states, practical recommendations are needed on the management and safe use of β-lactams following β-lactam–induced neutropenia. Conclusion: Future use of β-lactams with differing R1 side chains, particularly those from a separate class, should not be deemed contraindicated following β-lactam–induced neutropenia and may be considered when indicated, with close laboratory monitoring.

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