Novel Use of Ranolazine as an Antiarrhythmic Agent in Atrial Fibrillation

2016 ◽  
Vol 51 (3) ◽  
pp. 245-252 ◽  
Author(s):  
C. Michael White ◽  
Elaine Nguyen
Keyword(s):  
Atrial Fibrillation ◽  
Clinical Trials ◽  
Standard Therapy ◽  
English Language ◽  
Antiarrhythmic Drugs ◽  
Data Extraction ◽  
Artery Bypass ◽  
Language Studies ◽  
Study Selection ◽  
Intravenous Amiodarone

Objective: To review the limitations of current antiarrhythmic drugs in atrial fibrillation (AF) and discuss the rationale and clinical trials supporting the use of ranolazine in AF. Data Sources: MEDLINE was searched from 1980 to September 2016 using the terms ranolazine, atrial fibrillation, coronary artery bypass grafting, and valve surgery. Study Selection and Data Extraction: English-language studies and reviews assessing antiarrhythmic drugs, including ranolazine, were incorporated. Data Synthesis: The use of ranolazine monotherapy has been evaluated in 2 clinical trials. In the RAFFAELLO trial, higher doses of ranolazine showed a trend toward lower AF recurrence versus placebo ( P = 0.053), but further evidence is needed to support its use as a sole therapeutic agent. Ranolazine has shown utility in a limited number of studies as an adjunctive agent, which is critical for those in whom standard therapy is inadequate or the adverse event profile precludes optimized standard therapy. In the HARMONY trial, ranolazine 750 mg and dronedarone 225 mg twice daily reduced the AF burden by 59.1% from baseline ( P = 0.008 vs placebo). In a trial by Koskinas and colleagues, patients receiving ranolazine 1500 mg once and intravenous amiodarone had a higher conversion rate than those receiving amiodarone alone ( P = 0.024). There are also promising studies for the prevention and treatment of post–cardiothoracic surgery AF, which require further investigation. Conclusions: Ranolazine’s pharmacological properties and available evidence suggest potential for its use in AF.

Ticlopidine and Antiplatelet Therapy

1993 ◽  
Vol 27 (9) ◽  
pp. 1090-1098 ◽  
Author(s):  
Patricia Flores-Runk ◽  
Ralph H. Raasch
Keyword(s):  
Clinical Trials ◽  
English Language ◽  
Data Extraction ◽  
Artery Bypass ◽  
Antiplatelet Agent ◽  
Antiplatelet Agents ◽  
Graft Patency ◽  
Diabetic Microangiopathy ◽  
Severe Reaction ◽  
English Language Journal

OBJECTIVE: To review the pharmacology, pharmacokinetics, clinical efficacy, and toxicity of ticlopidine. Comparisons with other antiplatelet agents are presented, with an emphasis on efficacy, and a recommendation is provided regarding ticlopidine's place in therapy. DATA SOURCES: A MEDLINE literature retrieval of English-language journal articles from 1987 to January 1993 and references identified from bibliographies of review articles and clinical trials. STUDY SELECTION: Randomized, blind, controlled studies of ticlopidine and other antiplatelet agents were preferentially selected. DATA EXTRACTION: Clinical trials were reviewed in terms of study design, efficacy results, and toxicity. DATA SYNTHESIS: Ticlopidine is a new antiplatelet agent with a distinct mechanism of action. In the largest trial of the drug for the prevention of stroke, it was found to be more effective than aspirin in reducing the risk of stroke or death. Clinical trials have also shown ticlopidine to decrease the rate of vascular death and myocardial infarction in patients with unstable angina, and to maintain venous graft patency after coronary artery bypass grafting. The use of ticlopidine in diabetic microangiopathy and peripheral vascular disease appears promising, but further studies are needed. Adverse reactions most commonly reported with ticlopidine are gastrointestinal complaints; the most severe reaction is transient neutropenia, which is seen in approximately 2.3 percent of patients and is severe in nearly 1 percent. CONCLUSIONS: Ticlopidine is a reasonable alternative for use in preventing stroke among patients unable to take aspirin or those who do not benefit from aspirin therapy. Its use as first-line therapy is limited by its high cost and the occurrence of hematologic adverse effects.

Intranasal Glucagon: A New Way to Treat Hypoglycemic Emergencies

2020 ◽  
Vol 54 (8) ◽  
pp. 780-787
Author(s):  
Rachel N. Lowe ◽  
Jennifer M. Trujillo
Keyword(s):  
Adverse Events ◽  
English Language ◽  
Data Extraction ◽  
Severe Hypoglycemia ◽  
Data Synthesis ◽  
Language Studies ◽  
Study Selection ◽  
Free Treatment ◽  
Patients With Diabetes ◽  
Data Source

Objective: To review the safety, efficacy, and administration of intranasal (IN) glucagon for the management of hypoglycemia. Data Source: A literature search of PubMed/MEDLINE (1995 to November 2019) using the terms intranasal glucagon, nasal glucagon, glucagon, hypoglycemia treatment, and hypoglycemia management was completed. Study Selection and Data Extraction: English-language studies evaluating IN glucagon were evaluated. Data Synthesis: IN glucagon is a newly approved product for the treatment of hypoglycemia in patients with diabetes, 4 years and older. Administered as a 3-mg dose, it was shown to be noninferior to intramuscular (IM) glucagon. In comparison trials, more than 98% of hypoglycemic events were treated successfully with IN glucagon in both pediatric and adult patients. In simulated and real-world studies, IN glucagon was administered in less than a minute for the majority of scenarios. IM glucagon took longer to administer, ranging from 1 to 4 minutes, and often, patients did not receive the intended full dose. Nausea and vomiting, known adverse events for glucagon, as well as local adverse events were most commonly reported with IN glucagon. Relevance to Patient Care and Clinical Practice: IN glucagon is safe, effective, easy to use, and does not require reconstitution prior to use, which can lead to faster delivery in a severe hypoglycemic event. It does not require age- or weight-based dosing. This delivery method offers an option for someone who fears needles or is uncomfortable with injections. Conclusion: IN glucagon is a safe, effective, easy to use, needle-free treatment option for severe hypoglycemia.

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 Cobicistat Versus Ritonavir: Similar Pharmacokinetic Enhancers But Some Important Differences

2017 ◽  
Vol 51 (11) ◽  
pp. 1008-1022 ◽  
Author(s):  
Alice Tseng ◽  
Christine A. Hughes ◽  
Janet Wu ◽  
Jason Seet ◽  
Elizabeth J. Phillips
Keyword(s):  
English Language ◽  
Data Extraction ◽  
Therapeutic Index ◽  
Search Terms ◽  
Language Studies ◽  
Study Selection ◽  
Pharmacokinetic Properties ◽  
Medication Dose ◽  
Concomitant Medications ◽  
Potential Interactions

Objective: To describe properties of cobicistat and ritonavir; compare boosting data with atazanavir, darunavir, and elvitegravir; and summarize antiretroviral and comedication interaction studies, with a focus on similarities and differences between ritonavir and cobicistat. Considerations when switching from one booster to another are discussed. Data Sources: A literature search of MEDLINE was performed (1985 to April 2017) using the following search terms: cobicistat, ritonavir, pharmacokinetic, drug interactions, booster, pharmacokinetic enhancer, HIV, antiretrovirals. Abstracts from conferences, article bibliographies, and product monographs were reviewed. Study Selection and Data Extraction: Relevant English-language studies or those conducted in humans were considered. Data Synthesis: Similar exposures of elvitegravir, darunavir, and atazanavir are achieved when combined with cobicistat or ritonavir. Cobicistat may not be as potent a CYP3A4 inhibitor as ritonavir in the presence of a concomitant inducer. Ritonavir induces CYP1A2, 2B6, 2C9, 2C19, and uridine 5′-diphospho-glucuronosyltransferase, whereas cobicistat does not. Therefore, recommendations for cobicistat with comedications that are extrapolated from studies using ritonavir may not be valid. Pharmacokinetic properties of the boosted antiretroviral can also affect interaction outcome with comedications. Problems can arise when switching patients from ritonavir to cobicistat regimens, particularly with medications that have a narrow therapeutic index such as warfarin. Conclusions: When assessing and managing potential interactions with ritonavir- or cobicistat-based regimens, clinicians need to be aware of important differences and distinctions between these agents. This is especially important for patients with multiple comorbidities and concomitant medications. Additional monitoring or medication dose adjustments may be needed when switching from one booster to another.

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.

Lasmiditan: Acute Migraine Treatment Without Vasoconstriction. A Review

2021 ◽  
pp. 875512252110246
Author(s):  
Juliana K Beauchene ◽  
Terri L Levien
Keyword(s):  
Cardiovascular Risk ◽  
English Language ◽  
Data Extraction ◽  
Common Side Effect ◽  
Migraine Treatment ◽  
Acute Migraine ◽  
Oral Tablet ◽  
Language Studies ◽  
Study Selection ◽  
Acute Migraine Treatment

Objective: To review the efficacy and safety of the newly Food and Drug Administration approved drug lasmiditan, and its place in therapy in the treatment of acute migraine attacks. Data Sources: A literature search of Web of Science, PubMed, and Google Scholar was preformed (September 1999 to May 2021) using the following search terms: acute migraine treatment, triptans, lasmiditan, Reyvow, Rimegepant, Nurtec, Ubrogepant, Ubrelvy, migraine, vasoconstriction, and cardiovascular risk. Product labeling, https://www.clinicaltriasl.gov , and product monographs were also reviewed. Study Selection and Data Extraction: Relevant English-language studies were considered. Data Synthesis: Lasmiditan is the first in its class approved for acute migraine treatment. Lasmiditan exerts its therapeutic effect through agonism at the 5-HT1F receptor, which has been shown to produce no vasoconstriction in preclinical models. Relevance to Patient Care and Clinical Practice: It is both scientifically and clinically relevant to review lasmiditan and determine the value of an acute migraine drug that does not induce vasoconstriction. Patients with preexisting cardiovascular conditions for which current migraine therapy is contraindicated may benefit from therapeutic use of lasmiditan. However, the potential cardiovascular benefit needs to be weighed against the increased central nervous system risks observed with lasmiditan. Conclusions: Lasmiditan is an oral tablet drug that is used for acute migraine abortive treatment and data suggest that it does not induce vasoconstriction, a common side effect often observed with the current first-line abortive migraine treatment drug class, triptans. This is especially important in acute migraine patients with cardiovascular risk factors in which triptan use is contraindicated.

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 Crisaborole: A Novel Nonsteroidal Topical Treatment for Atopic Dermatitis

2019 ◽  
Vol 35 (4) ◽  
pp. 172-178
Author(s):  
Lena McDowell ◽  
Bernie Olin
Keyword(s):  
Clinical Trials ◽  
Atopic Dermatitis ◽  
English Language ◽  
Data Extraction ◽  
Calcineurin Inhibitors ◽  
Severity Index ◽  
Systemic Absorption ◽  
Second Line ◽  
Topical Calcineurin Inhibitors ◽  
Language Studies

Objective: To review the efficacy and safety of crisaborole and its place in therapy for the management of mild to moderate atopic dermatitis (AD). Data Sources: A literature search of PubMed (data inception to February 2019) was performed using the search terms crisaborole and atopic dermatitis. Supplementary sources included the Journal of the American Academy of Dermatology Guidelines of Care for the Management of Atopic Dermatitis, clinicaltrials.gov data, manufacturer prescribing information, and article bibliographies. Study Selection and Data Extraction: Relevant English-language studies and those conducted in humans were considered and reviewed. Abstracts from clinical trials and drug reviews were reviewed. Phases I, II, III, and long-term safety studies were included. Data Synthesis: Data from multiple clinical trials have demonstrated the effectiveness and safety of crisaborole topical ointment. Patients treated with crisaborole experienced improvement in AD symptoms based on improvement in the Investigator’s Static Global Assessment and the AD Severity Index scores. Crisaborole has a limited adverse event profile and low systemic absorption. Relevance to Patient Care and Clinical Practice: Crisaborole is the first topical phosphodiesterase 4 inhibitor indicated for the treatment of mild to moderate AD. Its place in therapy is along with topical calcineurin inhibitors as a second-line option for patients who are recalcitrant to or unable to use topical corticosteroids. Conclusions: Crisaborole is a safe and efficacious second-line option for the treatment of mild to moderate AD in patients 2 years of age and older.

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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