Delafloxacin for the Treatment of Acute Bacterial Skin and Skin Structure Infections

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.

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Lead in Mineral or Multivitamin-Multimineral Products

Annals of Pharmacotherapy ◽

10.1177/10600280211023328 ◽

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.

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

Annals of Pharmacotherapy ◽

10.1177/1060028018763288 ◽

2018 ◽

Vol 52 (8) ◽

pp. 769-779 ◽

Cited By ~ 16

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.

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Brexpiprazole

Annals of Pharmacotherapy ◽

10.1177/1060028016678262 ◽

2016 ◽

Vol 51 (4) ◽

pp. 315-322 ◽

Cited By ~ 6

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.

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

Annals of Pharmacotherapy ◽

10.1177/106002809202600912 ◽

1992 ◽

Vol 26 (9) ◽

pp. 1099-1108 ◽

Cited By ~ 49

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.

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Sufentanil Sublingual Tablet: A New Option for Acute Pain Management

Annals of Pharmacotherapy ◽

10.1177/1060028019863144 ◽

2019 ◽

Vol 53 (12) ◽

pp. 1220-1226 ◽

Cited By ~ 3

Author(s):

Caitlin E. Reardon ◽

Sandra L. Kane-Gill ◽

Pamela L. Smithburger ◽

Joseph F. Dasta

Keyword(s):

Acute Pain ◽

English Language ◽

Data Extraction ◽

Unmet Need ◽

Phase Iii ◽

Pain Intensity Score ◽

Sublingual Tablet ◽

Phase Iii Clinical Trials ◽

Study Selection ◽

Pubmed Search

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.

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Sugar Paste for Treatment of Decubital Ulcers

Journal of Pharmacy Technology ◽

10.1177/875512259601200612 ◽

1996 ◽

Vol 12 (6) ◽

pp. 289-290 ◽

Cited By ~ 1

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.

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Eravacycline: The Tetracyclines Strike Back

Annals of Pharmacotherapy ◽

10.1177/1060028019850173 ◽

2019 ◽

Vol 53 (11) ◽

pp. 1124-1135 ◽

Cited By ~ 10

Author(s):

Maria Heaney ◽

Monica V. Mahoney ◽

Jason C. Gallagher

Keyword(s):

English Language ◽

Adverse Drug Events ◽

Data Extraction ◽

Multidrug Resistant ◽

Phase Iii ◽

Language Studies ◽

Mesh Terms ◽

Multidrug Resistant Organisms ◽

Pubmed Search

Objective: To review the pharmacology, pharmacokinetics, efficacy, safety, and place in therapy of eravacycline, a novel fluorocycline antibiotic from the tetracycline family. Data Sources: A PubMed search was conducted for data between 1946 and March 2019 using MeSH terms eravacycline and TP-434. An internet search was conducted for unpublished clinical research. Study Selection and Data Extraction: The literature search was limited to English-language studies that described clinical efficacy, safety, and pharmacokinetics in humans and animals. Abstracts featuring prepublished data were also evaluated for inclusion. Data Synthesis: Eravacycline has in vitro activity against multidrug-resistant organisms, including methicillin-resistant Staphylococcus aureus and vancomycin-resistant Enterococcus, extended-spectrum β-lactamase-producing and carbapenem-resistant Enterobacteriaceae, and Acinetobacter. It was approved for the treatment of complicated intra-abdominal infections (cIAIs) in adults following favorable results of 2 phase III trials, IGNITE 1 and IGNITE 4, compared with ertapenem and meropenem, respectively. The most common adverse drug events associated with eravacycline were infusion site reactions (7.7%), nausea (6.5%), vomiting (3.7%), and diarrhea (2.3%). Relevance to Patient Care and Clinical Practice: Eravacycline will likely be most useful for resistant infections when lack of tolerability, resistant phenotypes, or allergies prevent the use of β-lactams. Conclusions: Eravacycline is a new tetracycline antibiotic with a broad spectrum of activity that has demonstrated efficacy in the treatment of cIAIs. Although it has activity against multidrug-resistant organisms, data are limited for other indications.

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Rifabutin: A New Rifamycin for the Prevention of Atypical Mycobacterial Infection

Journal of Pharmacy Technology ◽

10.1177/875512259401000503 ◽

1994 ◽

Vol 10 (5) ◽

pp. 197-203

Author(s):

David E. Martin ◽

Ralph H. Raasch

Keyword(s):

English Language ◽

Data Extraction ◽

Case Series ◽

Mycobacterial Infection ◽

Aids Patients ◽

Double Blind ◽

Study Selection ◽

Atypical Mycobacterial Infection ◽

Cd4 Lymphocyte

Objective: To discuss the chemistry, mechanism of action, in vitro activity, pharmacology, clinical efficacy, and toxicity of rifabutin, a new rifamycin, in the prevention and treatment of disseminated mycobacterial infection in patients with AIDS. Data Sources: The English-language literature was searched from 1980 through October 1993 using MEDLINE, International Pharmaceutical Abstracts (IPA), Index Medicus, and bibliographic reviews of relevant textbooks and review articles. Study Selection: One published report of two identical randomized, prospective, double-blind trials of rifabutin to prevent disseminated mycobacteremia is available. Other literature reviewed included a clinical case series of patients treated with rifabutin for documented or presumed mycobacterial infection. Data Extraction: Clinical trial and case series were evaluated for study design, efficacy, and toxicity. Data Synthesis: In two trials, rifabutin has been shown to prolong the onset of mycobacteremia (caused by Mycobacterium avium-intracellulare or M. avium complex) in adult AIDS patients with CD4-lymphocyte counts <200 cells/mm3. The prolongation of time to bacteremia is significant compared with placebo as the CD4 count declines. However, overall survival is not prolonged by rifabutin prophylaxis in these patients. No blind, randomized studies are available evaluating the efficacy of rifabutin in treating documented mycobacteremia in AIDS patients, or in treating pulmonary infections caused by Mycobacterium tuberculosis. Conclusions: Rifabutin should be added to the prophylactic regimens of HIV-positive patients with CD4 counts <100 cells/mm3. Prophylactic treatment prolongs the period of time before dissemination of mycobacterial infection occurs (bacteremia), with associated delays in onset of fever and fatigue, decline in performance score, and hospitalization. Rifabutin is usually well tolerated in patients given 300 mg/d. Rifabutin is a weaker enzyme inducer than rifampin, but drug interactions with rifabutin should be monitored under circumstances of concomitant therapy with anticoagulants or anticonvulsants.

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SARS-CoV-2-associated gastrointestinal and liver diseases: what is known and what is needed to explore

Egyptian Liver Journal ◽

10.1186/s43066-021-00123-6 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Dina Sweed ◽

Eman Abdelsameea ◽

Esraa A. Khalifa ◽

Heba Abdallah ◽

Heba Moaz ◽

...

Keyword(s):

English Language ◽

Data Extraction ◽

Oral Route ◽

Main Body ◽

Disease Manifestation ◽

Gi Symptoms ◽

Septic Focus ◽

Pubmed Search ◽

Risk Patients ◽

Respiratory Droplets

Abstract Background The pandemic of COVID19 which is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was first described in China as an unexplained pneumonia transmitted by respiratory droplets. Gastrointestinal (GI) and liver injury associated with SARS-CoV-2 infection were reported as an early or sole disease manifestation, mainly outside China. The exact mechanism and incidence of GI and liver involvement are not well elucidated. Main body We conducted a PubMed search for all articles written in the English language about SARS-CoV-2 affecting the GI and liver. Following data extraction, 590 articles were selected. In addition to respiratory droplets, SARS-CoV-2 may reach the GI system through the fecal-oral route, saliva, and swallowing of nasopharyngeal fluids, while breastmilk and blood transmission were not implicated. Moreover, GI infection may act as a septic focus for viral persistence and transmission to the liver, appendix, and brain. In addition to the direct viral cytopathic effect, the mechanism of injury is multifactorial and is related to genetic and demographic variations. The most frequently reported GI symptoms are diarrhea, nausea, vomiting, abdominal pain, and bleeding. However, liver infection is generally discovered during laboratory testing or a post-mortem. Radiological imaging is the gold standard in diagnosing COVID-19 patients and contributes to understanding the mechanism of extra-thoracic involvement. Medications should be prescribed with caution, especially in chronic GI and liver patients. Conclusion GI manifestations are common in COVID-19 patients. Special care should be paid for high-risk patients, older males, and those with background liver disease.

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Brexanolone: A Novel Drug for the Treatment of Postpartum Depression

Journal of Pharmacy Practice ◽

10.1177/0897190020979627 ◽

2020 ◽

pp. 089719002097962

Author(s):

Edna Patatanian ◽

David R. Nguyen

Keyword(s):

Adverse Effects ◽

Postpartum Depression ◽

English Language ◽

Neuronal Excitability ◽

Data Extraction ◽

Background Information ◽

Pharmacologic Therapy ◽

Loss Of Consciousness ◽

Efficacy And Safety ◽

Pubmed Search

Objectives: To review the pharmacology, efficacy, and safety of Brexanolone and define its role in the treatment of postpartum depression. Date Sources: A MEDLINE/PubMed search was conducted (1980-May 2020) using the following keywords: postpartum depression, antidepressants, pharmacologic therapy, drug therapy, and brexanolone to identify relevant articles. Study Selection/Data Extraction: Literature search was limited to human studies published in the English language. Phase I, II, and III studies evaluating the pharmacology, efficacy, safety of brexanolone for postpartum depression were included. Bibliographies of relevant articles evaluating postpartum depression and treatment were reviewed for additional citations and background information. Data Synthesis: Brexanolone is a soluble, proprietary, injectable formulation of allopregnanolone, a neuroactive steroid that modulates neuronal excitability. Allopregnanolone levels increase during pregnancy and decrease substantially after birth. These fluctuations have profound effects on anxiety and depression. Three clinical trials established the efficacy and safety of brexanolone in the treatment of postpartum depression. In all 3 trials, brexanolone had an acceptable safety profile and was well tolerated. The most common adverse effects were loss of consciousness, sedation, dry mouth, headache, dizziness, and flushing. Due to sudden loss of consciousness and excessive sedation, continuous pulse oximetry is recommended. Conclusion: Brexanolone has a novel mechanism of action and appears to be safe and effective for the treatment of moderate to severe postpartum depression. At present, high cost, serious adverse effects, and restricted access may limit its use in clinical practice.

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