scholarly journals Review of Ceftazidime-Avibactam, Meropenem-Vaborbactam, and Imipenem/Cilastatin-Relebactam to Target Klebsiella pneumoniae Carbapenemase-Producing Enterobacterales

2020 ◽  
Vol 36 (5) ◽  
pp. 202-210
Author(s):  
Dillon A. Hayden ◽  
Bryan P. White ◽  
Kiya K. Bennett
Keyword(s):  
Klebsiella Pneumoniae ◽  
English Language ◽  
Antimicrobial Agents ◽  
Product Information ◽  
Data Extraction ◽  
Global Scale ◽  
Current Data ◽  
Klebsiella Pneumoniae Carbapenemase ◽  
Ovid Medline ◽  
Study Selection

Objective: To provide a review of 3 novel antimicrobial agents—ceftazidime-avibactam, meropenem-vaborbactam, and imipenem/cilastatin-relebactam—regarding treatment of Klebsiella pneumoniae carbapenemase-producing Enterobacterales (KPC). Data Sources: A literature search of PubMed and OVID (MEDLINE) was performed up to March 2020 using the following search terms: Vabomere, meropenem-vaborbactam, vaborbactam, RPX7009, Klebsiella pneumoniae carbapenemase, KPC, carbapenem-resistant Enterobacteriaceae, CRE, relebactam, imipenem-relebactam, MK-7655, ceftazidime-avibactam. Abstracts from conferences, article bibliographies, and product information were also reviewed. Study Selection and Data Extraction: Articles were first screened by English language, then title, then abstract, and finally by review of the full article. Fifty-five clinical and preclinical studies were included. Data Synthesis: These 3 novel β-lactam/β-lactamase inhibitor combinations have shown considerable improvement in safety and efficacy as compared with traditional polymyxin-based combination therapy for the treatment of KPC infections. While meropenem-vaborbactam has not shown improved activity against Pseudomonas aeruginosa, it has shown decreased rates of resistance to KPC versus ceftazidime-avibactam. Conclusions: With increasing incidence of KPC infections on a global scale, pharmacists should be aware of the notable similarities and differences between these 3 agents, and the current data supporting their use. Pharmacists may want to consider meropenem-vaborbactam over ceftazidime-avibactam for KPC infections due to decreased likelihood of resistance.

Role of Topical Oxymetazoline for Management of Erythematotelangiectatic Rosacea

2017 ◽  
Vol 52 (3) ◽  
pp. 263-267 ◽  
Author(s):  
Rebecca M. Hoover ◽  
John Erramouspe
Keyword(s):  
English Language ◽  
Human Subjects ◽  
Data Extraction ◽  
Drug Approval ◽  
Current Data ◽  
Patient Response ◽  
Study Selection ◽  
Cochrane Database ◽  
Drug Approval Process ◽  
Individual Patient Response

Objective: To review and summarize topical oxymetazoline’s pharmacology, pharmacokinetics, efficacy, safety, cost, and place in therapy for persistent redness associated with erythematotelangiectatic rosacea. Data Sources: Literature searches of MEDLINE (1975 to September 2017), International Pharmaceutical Abstracts (1975 to September 2017), and Cochrane Database (publications through September 2017) using the terms rosacea, persistent redness, α -agonist, and oxymetazoline. Study Selection and Data Extraction: Results were limited to studies of human subjects, English-language publications, and topical use of oxymetazoline. Relevant materials from government sources, industry, and reviews were also included. Data Synthesis: Data support the efficacy of oxymetazoline for persistent facial redness. Little study beyond clinical trials cited in the drug approval process has been conducted. Current data suggest that oxymetazoline is similar in safety and efficacy to brimonidine. Head-to-head comparisons of topical α-agonists for erythema caused by rosacea are needed. Conclusion: The topical α-agonist, oxymetazoline, is safe and effective for reducing persistent facial redness associated with erythematotelangiectatic subtype of rosacea. Health care practitioners selecting among treatments should consider not only the subtype of rosacea but also individual patient response, preference, and cost.

Meropenem/Vaborbactam, the First Carbapenem/β-Lactamase Inhibitor Combination

2018 ◽  
Vol 52 (8) ◽  
pp. 769-779 ◽  
Author(s):  
Jonathan C. Cho ◽  
Monika T. Zmarlicka ◽  
Kristy M. Shaeer ◽  
Joe Pardo
Keyword(s):  
English Language ◽  
Clinical Success ◽  
Data Extraction ◽  
Phase Iii ◽  
Klebsiella Pneumoniae Carbapenemase ◽  
Preclinical Phase ◽  
Study Selection ◽  
Tract Infections ◽  
Lactamase Inhibitor

Objective: To review the pharmacology, spectrum of activity, pharmacokinetics, pharmacodynamics, safety, efficacy, administration, and considerations for clinical use of meropenem/vaborbactam (M/V). Data Sources: A literature search using PubMed and clinicaltrials.gov (June 2013 to December 2017) was conducted using the search terms meropenem, vaborbactam, RPX7009, biapenem, RPX2003, and carbavance. References from relevant articles and conference abstracts were also reviewed. Study Selection and Data Extraction: Preclinical, phase I studies, and phase III studies written in the English language were evaluated. Data Synthesis: M/V is a novel carbapenem/β-lactamase inhibitor antimicrobial with in vitro activity against nearly 99% of Klebsiella pneumoniae carbapenemase–producing Enterobacteriaceae. M/V is approved for the treatment of adults with complicated urinary tract infections (cUTIs), including pyelonephritis. In a phase III cUTI trial (TANGO I), 98.4% of patients treated with M/V experienced overall clinical success compared with 94% of patients treated with piperacillin/tazobactam (95% CI = 0.7 to 9.1). When compared with best available therapy for carbapenem-resistant Enterobacteriaceae (CRE) infections in TANGO II, patients receiving M/V were more likely to achieve clinical cure at both the end of therapy (64.3% vs 33.3%, P = 0.04) as well as at the test of cure (57.1% vs 26.7%, P = 0.04). The most common adverse effects associated with M/V were headache, infusion-site reactions, and diarrhea. Conclusion: M/V has a valuable role in the treatment of CRE and should be used judiciously to preserve its use for resistant infections.

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.

Use of Fish Oil to Prevent Coronary Angioplasty Restenosis

1992 ◽  
Vol 26 (12) ◽  
pp. 1541-1545 ◽  
Author(s):  
Vincent F. Mauro ◽  
Lawrence A. Frazee
Keyword(s):  
Eicosapentaenoic Acid ◽  
Fish Oil ◽  
English Language ◽  
Data Extraction ◽  
Current Data ◽  
Study Selection ◽  
Number Of Patients ◽  
Bibliographic Search ◽  
Definition Of ◽  
Key Terms

OBJECTIVE: To review the literature investigating the use of fish oil in preventing restenosis postangioplasty (RPA). DATA SOURCES: An Index Medicus and bibliographic search of the English-language literature pertaining to the use of fish oil in preventing RPA. The key terms used were fish oil, angioplasty, and eicosapentaenoic acid. STUDY SELECTION AND DATA EXTRACTION: The results of all trials, including abstracts, that were obtained are reviewed and critiqued. DATA SYNTHESIS: Restenosis of a coronary vessel at the site of angioplasty occurs 30–40 percent of the time. Because fish oil has been theorized to prevent atherosclerosis and because atherosclerotic-like processes are theorized to be involved in RPA restenosis, fish oil has been studied to determine whether it can prevent RPA. Results of such trials have been mixed. Some have observed a reduction in the number of patients with angiographic or clinical evidence of restenosis. Two trials have failed to observe such an effect. Reasons for the differences are unknown. Possible explanations include differences in study design, endpoint parameters, definition of restenosis, and dosing methods of the fish oil. Bleeding was not of significant concern in any of the trials, even when fish oil was combined with antiplatelet therapy. CONCLUSIONS: Fish oil may be considered for use in patients to prevent RPA. It probably should be continued for only six months following the procedure. Current data suggest that at least 3 g/d of eicosapentaenoic acid and 1 g/d of docosahexaenoic acid should be used. If possible, therapy should be started as soon as it is known that angioplasty will be performed or at least as soon as possible following the procedure. Many patients may not be able to tolerate fish oil because of its gastrointestinal effects.

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.

Critical Review of Double-Carbapenem Therapy for the Treatment of Carbapenemase-Producing Klebsiella pneumoniae

2018 ◽  
Vol 53 (1) ◽  
pp. 70-81 ◽  
Author(s):  
Ola Mashni ◽  
Lama Nazer ◽  
Jennifer Le
Keyword(s):  
Klebsiella Pneumoniae ◽  
Clinical Studies ◽  
Case Reports ◽  
Therapeutic Option ◽  
Data Extraction ◽  
Gastrointestinal Symptoms ◽  
Current Data ◽  
Study Selection

Objective: To review the clinical data on the effectiveness and safety of double carbapenem therapy (DCT) in patients infected with carbapenemase-producing Klebsiella pneumoniae (CP-Kp). Data Sources: A literature search was performed utilizing PubMed and EMBASE (from 1966 to May 2018); bibliographies of the retrieved articles were also searched. Study Selection and Data Extraction: Articles were included if they evaluated patients with infections caused by CP-Kp and were treated with DCT. Meeting abstracts, editorials, and animal and in vitro studies were excluded. Data Synthesis: The search strategy revealed 8 case reports and 6 clinical studies (total of 171 patients) that evaluated the administration of ertapenem followed by prolonged infusions of meropenem or doripenem. Most patients were critically ill and commonly had infections in the blood, lungs, and urine. Clinical and microbiological success were reported in 70% of the patients and mortality in 24%. Adverse events, which included mostly seizures, sodium disorders, and gastrointestinal symptoms, were reported in 16 patients; none required interruption of treatment. Relevance to Patient Care and Clinical Practice: This review evaluated the clinical experience of DCT in the treatment of CP-Kp infections, based on case reports and clinical studies, for the potential role of DCT as a therapeutic option. Conclusion: Despite the limited studies, current data suggest that DCT may be an effective and safe strategy to treat CP-Kp. However, large randomized controlled trials are necessary to clearly define the role of DCT.

Memantine for the Prevention of Primary Headache Disorders

2014 ◽  
Vol 48 (11) ◽  
pp. 1507-1511 ◽  
Author(s):  
Linda Huang ◽  
Michael Bocek ◽  
Joseph K. Jordan ◽  
Amy Heck Sheehan
Keyword(s):  
Chronic Migraine ◽  
English Language ◽  
Data Extraction ◽  
Primary Headache ◽  
Current Data ◽  
Headache Disorders ◽  
Primary Headache Disorders ◽  
Migraine Headaches ◽  
Study Selection ◽  
Refractory Chronic Migraine

Objective: To describe the current data evaluating the efficacy and safety of memantine for the prevention of primary headache disorders. Data Sources: A literature search using MEDLINE (1966-July 2014) and EMBASE (1973-July 2014) was conducted using the search terms memantine, headache, migraine, glutamate, and NMDA. References of identified articles were reviewed for additional, relevant citations. Study Selection and Data Extraction: All English-language articles dealing with the use of memantine for prevention of primary headache disorders were included. Data Synthesis: Data from several retrospective reports and 2 prospective clinical trials suggest that memantine may be a useful treatment option for the prevention of primary headache disorders. The majority of available literature focuses specifically on chronic migraine prevention in refractory patients who had failed multiple previous prophylactic therapies. In these patients, 10 to 20 mg of memantine daily reduced the frequency and intensity of migraine headaches and was generally well tolerated, with few adverse events. Data regarding the efficacy of memantine for other primary headache disorders such as chronic tension type and cluster headaches are limited. Conclusion: Although further studies evaluating the efficacy of memantine for prevention of primary headache disorders are warranted, memantine may be a reasonable option, used either as monotherapy or adjunctive therapy, in the refractory chronic migraine prophylaxis setting.

Lead in Mineral or Multivitamin-Multimineral Products

2021 ◽  
pp. 106002802110233
Author(s):  
C. Michael White
Keyword(s):  
English Language ◽  
Data Extraction ◽  
The United States ◽  
Third Party ◽  
Reference Level ◽  
Study Selection ◽  
Pubmed Search ◽  
Zinc Supplements ◽  
Average Lead ◽  
Year 2000

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.

Recent Advances: Antiinfectives

1995 ◽  
Vol 29 (10) ◽  
pp. 1035-1040 ◽  
Author(s):  
Laurie L Briceland ◽  
John D Cleary ◽  
Courtney V Fletcher ◽  
Daniel P Healy ◽  
Charles A Peloquin
Keyword(s):  
Infectious Diseases ◽  
English Language ◽  
Data Extraction ◽  
Information Service ◽  
Ulcer Disease ◽  
Additional Information ◽  
Study Selection ◽  
Enterococcus Spp ◽  
Scientific Meetings ◽  
Clinically Significant

Objective: To update readers on the significant changes in infectious diseases pharmacotherapy. Data Sources: An Index Medians and Iowa Drug Information Service search (1993–1994) of English-language literature pertaining to the selected topic areas was performed. Additional information from abstracts presented at scientific meetings were identified by the authors. Study Selection and Data Extraction: All identified studies were screened and those judged relevant to the update were evaluated. Data Synthesis: New or clinically significant data since 1992 that related to peptic ulcer disease, microbial resistance (e.g., Enterococcus spp., Streptococcus pneumoniae, Mycobacterium tuberculosis, Candida albicans), immunomodulators, and AIDS were evaluated and compared with previous data. Conclusions: There have been several exciting and significant changes in infectious diseases pharmacotherapy evident from this review.

Parenteral Histamine2-Receptor Antagonists in the Pediatric Population

1994 ◽  
Vol 10 (2) ◽  
pp. 53-57
Author(s):  
Neeta Bahal O'Mara ◽  
Milap C. Nahata
Keyword(s):  
Product Information ◽  
Pediatric Population ◽  
Data Extraction ◽  
Infants And Children ◽  
Optimal Dosage ◽  
Receptor Antagonists ◽  
Study Selection ◽  
Stability Data ◽  
Administration Methods ◽  
In Infants And Children

Objective: To provide a review of the use of parenteral histamine2 (H2)-receptor antagonists cimetidine, ranitidine, and famotidine in the pediatric population. Data Sources: Information was identified by MEDLINE and a review of journals. References cited in published articles and manufacturers' product information also were used. Study Selection: Information was selected for review if it addressed the parenteral administration of H2-receptor antagonists in the pediatric population. Data Extraction: Data were extracted from references pertaining to the topic. Data Synthesis: Despite the lack of Food and Drug Administration pediatric labeling, the H2-receptor antagonists often are used for a variety of indications in infants and children. Although these agents differ somewhat in chemical structure, potency, and pharmacokinetics, the most important differences exist in their drug interactions and adverse effect profiles. Further, administration methods, compatibility, and stability data differ slightly among the agents. Conclusions: Parenteral H2-receptor antagonists are used for a variety of indications in infants and children. Despite their widespread use, additional studies are needed to define the optimal dosage regimens in this population.

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