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.

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.

Insulin Detemir—A New Basal Insulin Analog

2005 ◽  
Vol 39 (3) ◽  
pp. 502-507 ◽  
Author(s):  
Jennifer D Goldman-Levine ◽  
Karen W Lee
Keyword(s):  
Type 2 Diabetes ◽  
Basal Insulin ◽  
Insulin Detemir ◽  
Data Extraction ◽  
Safety Data ◽  
Clinical Trial Data ◽  
Insulin Analog ◽  
Study Selection

OBJECTIVE: To review the pharmacology, pharmacokinetics, clinical trial data, adverse effects, and role in therapy of insulin detemir. DATA SOURCES: Articles and meeting abstracts were identified through searches of MEDLINE (1996–June 2004), EMBASE (1980–June 2004), and International Pharmaceutical Abstracts (1970–June 2004) databases, and unpublished information was provided by the manufacturer. STUDY SELECTION AND DATA EXTRACTION: All available studies relating to insulin detemir's pharmacology were selected. Only human studies were used for pharmacokinetic, drug interaction, efficacy, and safety data. DATA SYNTHESIS: Insulin detemir is a basal insulin analog that has been shown to improve glycemic control in patients with type 1 and type 2 diabetes. CONCLUSIONS: Insulin detemir offers some benefits over NPH for use as basal insulin in patients with type 1 and type 2 diabetes.

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

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

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

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

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

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

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.

Oral Superabsorbent Hydrogel (Plenity) for Weight Management

2020 ◽  
pp. 106002802098304
Author(s):  
Alexa Pass ◽  
Damian Bialonczyk ◽  
Elaine Chiquette ◽  
Jennifer D. Goldman
Keyword(s):  
Weight Management ◽  
Safety Profile ◽  
Data Extraction ◽  
Safety Data ◽  
Clinical Trial Data ◽  
Superabsorbent Hydrogel ◽  
Study Selection ◽  
Significant Difference ◽  
Favorable Safety ◽  
Comorbidity Status

Objective To describe the mechanism, clinical trial data, adverse effects, and potential role in therapy of an oral superabsorbent hydrogel (OSH) for weight management. Data Sources A literature search was completed using MEDLINE and Google Scholar using the following search terms: oral superabsorbent hydrogel, Plenity, and Gelesis100 (September 1999 to July 2020). Abstracts and posters were identified from relevant scientific congress archives and published supplements. Study Selection and Data Extraction All available studies were considered. Only human studies were used for drug interaction, efficacy, and safety data. Data Synthesis OSH is a first-in-class, nonsystemic agent for weight management. It is indicated for use in patients with a body mass index (BMI) of 25 to 40 kg/m2 regardless of comorbidity status. OSH functions primarily through space occupancy in the stomach and small intestine. Studies have demonstrated that OSH has modest weight loss efficacy and a favorable safety profile, with no significant difference in overall adverse events compared with placebo. Relevance to Patient Care and Clinical Practice OSH is one of the only prescription antiobesity therapeutics (AOTs) that can be utilized in overweight patients with BMI equal to 25 to 30 kg/m2, regardless of comorbidity status. Given its nonsystemic mechanism of action and safety profile, OSH may help shift the focus of weight management toward patients with a lower BMI. Conclusions OSH offers a nonsystemic approach to weight management for patients who are diagnosed with overweight or obesity. As an alternative option to current pharmacological AOTs, OSH may address an existing clinical gap in weight management.

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.

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.

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.

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