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.

Meropenem: A New Carbapenem Antimicrobial

1994 ◽  
Vol 28 (9) ◽  
pp. 1045-1054 ◽  
Author(s):  
Randy D. Pryka ◽  
George M. Haig
Keyword(s):  
Clinical Trials ◽  
English Language ◽  
Antimicrobial Agents ◽  
Pharmacokinetic Analysis ◽  
Upper Respiratory Tract ◽  
Gram Positive ◽  
Scientific Publications ◽  
In Vitro Susceptibility ◽  
Study Selection

OBJECTIVE: To describe and then compare an investigational carbapenem antibiotic, meropenem, with the only currently available antibiotic in this class, imipenem/cilastatin. DATA IDENTIFICATION: An English language search using MEDLINE (1988–1993); Abstracts of the 31st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), 1991; and Abstracts of the 32nd ICAAC, 1992. STUDY SELECTION: All current scientific publications were reviewed for study design and quality. Emphasis was placed on susceptibility and pharmacokinetic analysis. Phase 3 clinical trials are now being completed and have only been published in abstract form. Hence, conclusions derived regarding efficacy were tempered. RESULTS: Meropenem is active against a broad spectrum of gram-positive and -negative pathogens including beta-lactamase producers. Meropenem appears to be two- to fourfold less active than imipenem against gram-positive organisms. Meropenem is two- to fivefold more active against enterobacteriaceae. The two compounds appear to be equally active against Pseudomonas aeruginosa. Pharmacokinetic disposition is also similar for imipenem and meropenem. Meropenem may exhibit greater tissue penetration. Meropenem is not labile to renal hydrolysis and can be administered without a competitive antagonist of dihydropeptidase, such as cilastatin. In clinical trials, meropenem appears to be as safe and effective as imipenem/cilastatin or ceftazidime in the treatment of infections involving soft tissue, urinary tract, upper respiratory tract, abdominal processes, and febrile neutropenic episodes. CONCLUSIONS: Meropenem is comparable to imipenem in terms of in vitro susceptibility pattern and pharmacokinetic disposition. Overall, meropenem seems to offer promise as the second of the carbapenem class of antibiotics. Clinical data are preliminary, and further data are needed.

Sugar Paste for Treatment of Decubital Ulcers

1996 ◽  
Vol 12 (6) ◽  
pp. 289-290 ◽  
Author(s):  
Laura Tuneu Valls ◽  
Magdalena Trullás Altisen ◽  
Ramón Plá Poblador ◽  
Angels Ciurán Alvarez ◽  
Rosa Garriga Biosca
Keyword(s):  
English Language ◽  
Case Reports ◽  
Low Cost ◽  
Data Extraction ◽  
Data Synthesis ◽  
Length Of Treatment ◽  
Study Selection ◽  
Wide Variability

Objective: To review the use of sugar paste in the treatment of decubital ulcers. Data Sources: A MEDLINE, IDIS, and current journal search of English-language articles published between 1978 and 1993 on sugar paste in the treatment of ulcers. Study Selection: Case reports, cohort, epidemiologic, in vivo, and in vitro studies were evaluated. Data Extraction: Reports using granulated sugar or derivatives in the treatment of refractory cutaneous ulcers were evaluated. Data Synthesis: All the studies show that sugar paste treatment has satisfactorily resolved decubital ulcers, although a wide variability in treatment length has been seen. Considering the likely mechanisms of action for sugar paste, this wide variability may be a result of dressing frequency. In other words, for sugar paste to be most effective it has to be applied in such a way that a continuous optimal sugar concentration in the ulcer is maintained. To achieve this, dressing frequency should not be standardized, but individualized according to ulcer type, depth, and exudate, as well as patient healing capacity. Healing could probably have been achieved earlier if dressing had been individualized. Besides effectiveness and low cost, sugar paste is also safe, with few adverse events associated with its use. Conclusions: In spite of difficulties in evaluating the use of sugar paste in treatment of decubital ulcers, it has been shown to be an effective therapy for this disorder. However, we recommend that length of treatment be individualized for each patient.

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.

scholarly journals The New Fluoroquinolones: A Critical Review

1999 ◽  
Vol 10 (3) ◽  
pp. 207-238 ◽  
Author(s):  
George G Zhanel ◽  
Andrew Walkty ◽  
Lavern Vercaigne ◽  
James A Karlowsky ◽  
John Embil ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Metal Ion ◽  
Data Extraction ◽  
Limited Data ◽  
Intravenous Antibiotics ◽  
High Incidence ◽  
Bacteriodes Fragilis ◽  
Tract Infections

OBJECTIVE: This paper reviews the literature available on the new fluoroquinolones – clinafloxacin, gatifloxacin, grepafloxacin, levofloxacin, moxifloxacin, sparfloxacin and trovafloxacin – to compare these agents with each other and contrast them with ciprofloxacin, an older fluoroquinolone.DATA SELECTION: Published papers used were obtained by searching MEDLINE for articles published between 1994 and 1998, inclusive. References of published papers were also obtained and reviewed. Abstracts from scientific proceedings were reviewed.DATA EXTRACTION: Due to the limited data available on several of the agents, criteria for study inclusion in the in vitro, pharmacokinetics and in vivo sections were not restrictive.DATA SYNTHESIS: The new fluoroquinolones offer excellent Gram-negative bacillary activity and improved Gram-positive activity (eg, againstStreptococcus pneumoniaeandStaphylococcus aureus) over ciprofloxacin. Clinafloxacin, gatifloxacin, moxifloxacin, sparfloxacin and trovafloxacin display improved activity against anaerobes (eg,Bacteriodes fragilis). All of the new fluoroquinolones have a longer serum half-life than ciprofloxacin (allowing for once daily dosing), and several are eliminated predominantly by nonrenal means. No clinical trials are available comparing the new fluoroquinolones with each other. Clinical trials comparing the new fluoroquinolones with standard therapy have demonstrated good efficacy in a variety of infections. Their adverse effect profile is similar to that of ciprofloxacin. Clinafloxacin and sparfloxacin cause a high incidence of phototoxicity (1.5% to 14% and 2% to 11.7%, respectively), grepafloxacin causes a high incidence of taste perversion (9% to 17%) and trovafloxacin causes a high incidence of dizziness (11%). They all interact with metal ion-containing drugs (eg, antacids), and clinafloxacin and grepafloxacin interact with theophylline. The new fluoroquinolones are expensive; however, their use may result in savings in situations where, because of their potent and broad spectrum of activity, they can be used orally in place of intravenous antibiotics.CONCLUSIONS: The new fluoroquinolones offer advantages over ciprofloxacin in terms of improved in vitro activity and pharmacokinetics. Whether these advantages translate into improved clinical outcomes is presently unknown. The new fluoroquinolones have the potential to emerge as important therapeutic agents in the treatment of respiratory tract and genitourinary tract infections.

A Practical Look at the Clinical Usefulness of the Beta-Lactam/Beta-Lactamase Inhibitor Combinations

1996 ◽  
Vol 30 (10) ◽  
pp. 1130-1140 ◽  
Author(s):  
Susan M. Hart ◽  
Elaine M. Bailey
Keyword(s):  
English Language ◽  
Antimicrobial Agents ◽  
In Vivo Studies ◽  
Patient Specific ◽  
Beta Lactamase ◽  
Beta Lactam ◽  
Intraabdominal Infections ◽  
Lactamase Inhibitor

OBJECTIVE: To aid clinicians in developing an approach to the use of intravenous beta-lactam/beta-lactamase inhibitors on a patient-specific basis. To achieve this, the pharmacology, in vitro activity, and clinical use of the intravenous beta-lactam/beta-lactamase inhibitor combinations in the treatment of selected infections seen in hospitalized patients are discussed. DATA IDENTIFICATION: An English-language literature search using MEDLINE (1987–1995); Index Medicus (1987–1995); program and abstracts of the 32nd (1992), 33rd (1993), 34th (1994), and 35th (1995) Interscience Conference on Antimicrobial Agents and Chemotherapy; bibliographic reviews of review articles; and package inserts. STUDY SELECTION: In vitro and in vivo studies on the pharmacokinetics, microbiology, pharmacology, and clinical effectiveness of ampicillin/sulbactam, ticarcillin/clavulanate, and piperacillin/tazobactam were evaluated. DATA SYNTHESIS: Many properties of the beta-lactam/beta-lactamase inhibitor combinations are similar. Differences in dosing, susceptibilities, and clinical applications are important considerations for clinicians. Potential roles for these agents in the clinical setting include pneumonia, intraabdominal infections, and soft tissue infections. A short discussion on susceptibility data interpretation is also presented. CONCLUSIONS: There are important differences among the available beta-lactam/beta-lactamase inhibitor combinations, such as spectra of activity, which need to be considered in choosing an agent for a patient-specific case. These products can be useful alternatives to conventional two- to three-drug regimens in mixed infections such as foot infections in patients with diabetes and hospital-acquired intraabdominal infections.

Flibanserin

2016 ◽  
Vol 30 (2) ◽  
pp. 256-260 ◽  
Author(s):  
Ximena Vallejos ◽  
Christine Wu
Keyword(s):  
Clinical Trials ◽  
Sexual Desire ◽  
English Language ◽  
Human Subjects ◽  
Data Extraction ◽  
Premenopausal Women ◽  
Relevant Information ◽  
Time Frame ◽  
Double Blind ◽  
Study Selection

Objective: To review pivotal clinical trials, pharmacology, contraindications, precautions, and key patient education points of flibanserin for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. Data Sources: A literature search of PubMed using the key words flibanserin and HSDD was conducted in September 2015. There was no time frame to exclude relevant clinical trials. All trials referenced were published between March 2012 and June 2014. Other relevant information was obtained from the Food and Drug Administration (FDA) Web site, press releases, prescribing information from the manufacturer, and ClinicalTrials.gov . Study Selection/Data Extraction: All articles in the English language and involving human subjects were reviewed. Data Synthesis: There are three 24-week, multicenter, randomized, double-blind, placebo-controlled trials that evaluated the efficacy of flibanserin in North American premenopausal women with HSDD. There was 1 trial that studied the effects of flibanserin in postmenopausal women. In all of the trials, the investigators found statistical significant improvements in Female Sexual Function Index (FSFI) desire domain score and satisfying sexual events (SSEs). The most frequently reported adverse events in all flibanserin arms of treatment were somnolence, dizziness, and nausea. Conclusion: Flibanserin, a novel, nonhormonal agent that modulates excitatory and inhibitory neurotransmitters was studied in premenopausal women and has shown efficacy in improving sexual desire and SSEs.

Telavancin: A Novel Lipoglycopeptide Antibiotic

2009 ◽  
Vol 43 (5) ◽  
pp. 928-938 ◽  
Author(s):  
Lisa Charneski ◽  
Priti N Patel ◽  
Donna Sym
Keyword(s):  
English Language ◽  
Data Extraction ◽  
Anaerobic Bacteria ◽  
Drug Application ◽  
Qtc Interval ◽  
Gram Positive ◽  
Gram Positive Bacteria ◽  
Complicated Skin

Objective To review the pharmacology, antimicrobial activity, pharmacokinetics, clinical applications, and safety of telavancin, a new lipoglycopeptide antibiotic. Data Sources Literature was obtained from MEDLINE (1966–April 2009) and International Pharmaceutical Abstracts (1971–April 2009) using the search terms telavancin and TD-6424, and also from Theravance, Inc., and Astellas Pharma US, Inc. Study Selection And Data Extraction Available English-language articles were reviewed, as well as information obtained from Theravance, Inc., and Astellas Pharma US, Inc. Data Synthesis Telavancin has rapid bactericidal activity against gram-positive aerobic and anaerobic bacteria through multiple mechanisms of action. In vitro and Phase 2 in vivo data support the efficacy of telavancin against antibiotic-resistant gram-positive organisms. On March 4, 2008, the Food and Drug Administration (FDA) accepted as complete for review Theravance's response to the October 19, 2007, New Drug Application approvable letter for telavancin to be used as treatment for complicated skin and skin structure infections (cSSSIs) caused by gram-positive bacteria. QTc interval prolongation has been reported, although the clinical impact of this has not been determined. Drug interactions have not been identified as of yet. Conclusions Telavancin is currently under review by the FDA for the treatment of cSSSIs caused by gram-positive bacteria. The completion of Phase 3 trials will determine whether telavancin will have a role in the treatment of other infections caused by resistant gram-positive bacteria.

Brexpiprazole

2016 ◽  
Vol 51 (4) ◽  
pp. 315-322 ◽  
Author(s):  
Marija Markovic ◽  
Alyssa Gallipani ◽  
Krina H. Patel ◽  
Megan Maroney
Keyword(s):  
English Language ◽  
Data Extraction ◽  
Safety Data ◽  
Clinical Trial Data ◽  
Primary Therapy ◽  
Phase 3 ◽  
Good Tolerability ◽  
Study Selection ◽  
Animal Data

Objective: To review the pharmacology and clinical data for brexpiprazole in schizophrenia and major depressive disorder (MDD). Data Sources: An English-language literature search using PubMed and MEDLINE was performed using the term brexpiprazole. All articles containing human clinical trial data published up to September 2016 were evaluated for inclusion as well as information from the manufacturer’s product labeling. Study Selection/Data Extraction: Phase 3 trials for brexpiprazole were evaluated. Key in vitro and animal data were incorporated into the pharmacology and pharmacokinetic sections where appropriate. Data Synthesis: Four phase 3 trials have evaluated the use of brexpiprazole as a primary therapy for schizophrenia or as an antidepressant adjunct for MDD. For its schizophrenia indication, brexpiprazole was studied in 2 placebo-controlled trials of approximately 1300 patients, with 4 mg of brexpiprazole consistently showing superiority over placebo. For MDD, brexpiprazole was compared with placebo as an adjunct to antidepressants in approximately 1000 patients who had failed trials of 1 to 3 prior antidepressants. The 2-mg and 3-mg dosages of brexpiprazole showed consistent superiority over placebo in the MDD trials. Common treatment emergent adverse effects included akathisia and weight gain. Conclusions: Brexpiprazole showed efficacy for the treatment of schizophrenia in the range of 2 to 4 mg/d and as an adjunct to antidepressant therapy in MDD when dosed at 2 to 3 mg/d. Advantages of this drug include once-daily dosing, good tolerability, and lack of effect on sexual function. Disadvantages include the lack of long-term safety data and potentially high cost.

scholarly journals Yosprala: Coordinated Delivery of a Proton Pump Inhibitor and Aspirin

2019 ◽  
Vol 36 (2) ◽  
pp. 78-83
Author(s):  
Courtney A. Ingram ◽  
Gracie Giang ◽  
Katie McCrory ◽  
Terri M. Wensel
Keyword(s):  
Clinical Trials ◽  
Secondary Prevention ◽  
Cardiovascular Events ◽  
English Language ◽  
Data Extraction ◽  
Immediate Release ◽  
Study Selection ◽  
Effective Option ◽  
Enteric Coated Aspirin ◽  
Enteric Coated

Objective: Review the pharmacology, pharmacokinetics, efficacy, and safety of Yosprala (aspirin and omeprazole). Data Sources: A literature search was conducted using PubMed with the terms “Yosprala,” “PA8140,” and “PA32540” from the initial year through May, 2019. Additional sources were gathered through bibliographies. Aralez Pharmaceuticals Inc was contacted for manufacturer information. Study Selection and Data Extraction: The sources were narrowed to studies done in English language between 1990 and 2019. All viable clinical trials for the use of Yosprala in the secondary prevention of cardiovascular events were included. Data Synthesis: Yosprala is a coordinated delivery system of immediate-release omeprazole 40 mg and enteric-coated aspirin (325 mg or 81 mg). In 2016, the Food and Drug Administration approved Yosprala for the secondary prevention of cardiovascular or cerebrovascular events (ie, stroke or myocardial infarction). While it is recommended that patients take low-dose aspirin for secondary prevention of these events, many patients cannot tolerate the gastrointestinal (GI) adverse effect profile of the drug. Phase 3 clinical trials have proven that Yosprala significantly lowers the occurrence of GI bleeds and ulcers versus aspirin alone (3.2% and 8.6%, respectively; P ≤ .001). The most common adverse effects include infection, diarrhea, and dyspepsia. Conclusion: Yosprala significantly reduces the occurrence of GI ulcers and seems to be a safe and effective option for the secondary prevention of cardiovascular events.

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