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

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.

Drug-Induced Restless Legs Syndrome

2018 ◽  
Vol 52 (7) ◽  
pp. 662-672 ◽  
Author(s):  
Edna Patatanian ◽  
Melanie K. Claborn
Keyword(s):  
Restless Legs Syndrome ◽  
English Language ◽  
Case Reports ◽  
Data Extraction ◽  
Case Series ◽  
Predisposing Factors ◽  
Drug Induced ◽  
Restless Legs ◽  
Drug Classes ◽  
Study Selection

Objective: To review the literature on drug-induced restless legs syndrome (DI-RLS). Data Sources: The review included a search for English-language literature from 1966 to December 2017 in the MEDLINE, PubMed, and Ovid databases using the following search terms: restless legs syndrome (RLS), periodic limb movement, adverse effects, and drug-induced. In addition, background articles on the pathophysiology, etiology, and epidemiology of RLS were retrieved. Bibliographies of relevant articles were reviewed for additional citations. Study Selection and Data Extraction: All case reports, case series, and review articles of DI-RLS were identified and analyzed. There were only a small number of controlled clinical trials, and most data were from case reports and case series. Results: Several drugs and drug classes have been implicated in DI-RLS, with antidepressants, antipsychotics, and antiepileptics having the most evidence. In addition, RLS may be linked with a number of disorders or underlying predisposing factors as well. Conclusions: The prevalence of RLS is variable and ranges from 3% to 19% in the general population. There are many predisposing factors to RLS, but an emerging body of evidence suggests that there is an association between numerous drugs and RLS.

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.

Rifabutin: A Review with Emphasis on its Role in the Prevention of Disseminated Mycobacterium Avium Complex Infection

1994 ◽  
Vol 28 (11) ◽  
pp. 1250-1254 ◽  
Author(s):  
Daniel S. Maddix ◽  
Kimberly B. Tallian ◽  
Paul S. Mead
Keyword(s):  
Clinical Trials ◽  
Adverse Effects ◽  
Mycobacterium Avium ◽  
Mycobacterium Avium Complex ◽  
Aids Patients ◽  
Double Blind ◽  
Medline Search ◽  
Cd4 Lymphocyte

OBJECTIVE: To discuss the mechanism of action, in vitro and in vivo activity, pharmacokinetics, clinical trials, adverse effects, drug interactions, and dosage guidelines of rifabutin. DATA SOURCES: Pertinent literature published between 1982 and 1993 was identified via a MEDLINE search. Published proceedings of selected conferences were also reviewed. STUDY SELECTION: Selected basic science, microbiologic, and pharmacokinetic articles were evaluated. Because only limited data regarding rifabutin were available in the literature, all clinical trials involving the use of rifabutin in the prevention of Mycobacterium avium complex (MAC) infection in AIDS patients were reviewed. DATA SYNTHESIS: Rifabutin is a rifamycin derivative that was approved recently for the prevention of disseminated MAC disease in patients with advanced HIV infection. The drug has in vitro and in vivo activity against gram-positive bacteria, gram-negative bacteria, and mycobacteria. Two prospective, randomized, double-blind, placebo-controlled, multicenter trials demonstrated that rifabutin decreased the progression to MAC bacteremia in AIDS patients by about 50 percent. Adverse effects that resulted in the discontinuation of rifabutin prophylaxis occurred in 16 percent of patients. Rifabutin induces hepatic enzymes to a lesser extent than does rifampin, but dosage adjustment of drugs that are known to interact with rifampin may be required. CONCLUSIONS: Rifabutin is the only drug shown to be effective in the prevention of MAC bacteremia in AIDS patients; therefore, it should be made available as a formulary agent. It may be reasonable to delay initiation of rifabutin prophylaxis until CD4 lymphocyte counts are less than 75–50/mm3.

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.

Rifaximin: A New Treatment for Travelers' Diarrhea

2005 ◽  
Vol 39 (2) ◽  
pp. 284-289 ◽  
Author(s):  
Amy L Pakyz
Keyword(s):  
Adverse Effects ◽  
Drug Interactions ◽  
English Language ◽  
Data Extraction ◽  
Cross Resistance ◽  
Double Blind ◽  
Data Synthesis ◽  
Medline Search ◽  
Study Selection ◽  
New Treatment

OBJECTIVE: To review the pharmacology, pharmacokinetics, clinical efficacy, adverse effects, drug interactions and precautions, and dosing recommendations of rifaximin, a new nonabsorbed antimicrobial agent for travelers' diarrhea. DATA SOURCES: A MEDLINE search (1966–July 2004) was conducted to extract human and animal research data in the English language on rifaximin. STUDY SELECTION AND DATA EXTRACTION: Randomized, double-blind, placebo-controlled trials were reviewed and included to evaluate the efficacy of rifaximin in the treatment of travelers' diarrhea. DATA SYNTHESIS: Rifaximin is approved for the treatment of travelers' diarrhea in patients ≥12 years of age with diarrhea caused by noninvasive strains of Escherichia coli. Rifaximin was superior to placebo and trimethoprim/sulfamethoxazole and equivalent to ciprofloxacin in the primary clinical endpoint of the time to the last unformed stool passed. CONCLUSIONS: Rifaximin is a viable alternative to ciprofloxacin for the treatment of travelers' diarrhea. As rifaximin is not systemically absorbed, it offers the advantage of leading to the development of less resistance compared with systemically absorbed antibiotics, in addition to fewer systemic adverse effects and drug interactions. However, the potential for cross-resistance between rifaximin and rifampin, as well as with other classes of antibiotics, is of concern and needs to be elucidated.

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.

Desloratadine: A Nonsedating Antihistamine

2003 ◽  
Vol 37 (2) ◽  
pp. 237-246 ◽  
Author(s):  
Lynn Limon ◽  
Denise R Kockler
Keyword(s):  
Allergic Rhinitis ◽  
English Language ◽  
Additional Data ◽  
Data Extraction ◽  
Double Blind ◽  
Data Synthesis ◽  
Once Daily ◽  
Medline Search ◽  
Study Selection ◽  
Unpublished Information

OBJECTIVE: To review information on desloratadine, a nonsedating antihistamine. DATA SOURCES: An English-language MEDLINE search was conducted (1966–July 2002). References of identified articles were subsequently reviewed for additional data. Schering Corporation provided unpublished information. STUDY SELECTION/DATA EXTRACTION: Articles and abstracts pertaining to desloratadine were considered for inclusion, with emphasis on randomized, placebo-controlled, double-blind trials. DATA SYNTHESIS: Desloratadine is approved for the treatment of symptoms associated with seasonal allergic rhinitis (SAR), perennial allergic rhinitis (PAR), and chronic idiopathic urticaria (CIU) in patients aged ≥12 years. In placebo-controlled trials, desloratadine demonstrated superior efficacy as a once-daily treatment of SAR, PAR, and CIU. Data suggest that desloratadine has antiinflammatory and decongestant activity. CONCLUSIONS: Desloratadine appears to be a “me-too” agent, with no major differences compared with other second-generation antihistamines.

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.

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

2019 ◽  
Vol 35 (3) ◽  
pp. 110-118
Author(s):  
Young Ran Lee ◽  
Caitlin Elizabeth Burton ◽  
Kolton Rucks Bevel
Keyword(s):  
Treatment Option ◽  
English Language ◽  
Data Extraction ◽  
Additional Treatment ◽  
Effective Treatment Option ◽  
Skin Structure ◽  
Patient Morbidity ◽  
Study Selection ◽  
Pubmed Search

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.

Fluoxetine in the Treatment of Premenstrual Dysphoric Disorder

2002 ◽  
Vol 36 (4) ◽  
pp. 713-717
Author(s):  
Roxane R Carr ◽  
Mary HH Ensom
Keyword(s):  
English Language ◽  
Meta Analysis ◽  
Case Series ◽  
Premenstrual Dysphoric Disorder ◽  
Small Sample ◽  
Open Label ◽  
Double Blind ◽  
Late Luteal Phase ◽  
Study Selection ◽  
Small Sample Sizes

OBJECTIVE: To examine the role of fluoxetine in the treatment of premenstrual dysphoric disorder (PMDD). DATA SOURCES: Search strategy included MEDLINE (1966–February 2002), Embase (1988–February 2002), HealthStar (1975–December 2000), Current Contents (1996–November 2001), and Copernic (November 2001). Search terms included fluoxetine, premenstrual dysphoric disorder, PMDD, late luteal-phase dysphoric disorder, and severe premenstrual syndrome. STUDY SELECTION: English-language human studies were selected and evaluated based on quality of evidence. DATA SYNTHESIS: Eight prospective trials (3 double-blind, placebo-controlled, crossover; 3 double-blind, randomized, controlled; 2 open-label), 1 case series, and 1 meta-analysis were identified. Although 6 of the studies involved small sample sizes (n < 50), all found fluoxetine to be effective in the treatment of PMDD. CONCLUSIONS: Despite limited data, fluoxetine 20 mg/d appears to be effective in the treatment of PMDD. However, adverse effects, particularly headaches and sexual dysfunction, are possible. Given the long half-life of fluoxetine and the short duration of PMDD symptoms per cycle, larger, well-designed clinical trials evaluating intermittent dosing for only 1 week or a few doses need to be performed.

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