Clinical drug investigation
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Erenumab is the first migraine-specific preventive therapy approved by Health Canada since the approval of onabotulinumtoxinA 10 years ago. It is one of four calcitonin gene-related peptide antagonist monoclonal antibodies that have been commercialized worldwide for use in the headache pipeline. The objective of our study was to determine real-life efficacy of monthly erenumab for the prevention of migraine in a small case series of difficult-to-treat patients followed at a tertiary headache clinic from the Canadian province of Québec. ⋯ This study supports the efficacy of erenumab in a case series of therapy-resistant migraine patients from the region of Québec. A high rate of previously failed preventive oral agents and medication overuse did not predict response in our patient cohort. In the presence of real-world complexity factors, such as psychological distress, regular opioid consumption and concomitant chronic pain conditions, a longer therapy trial may be warranted in obtaining optimal response.
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Review
Can mRNA Vaccines Turn the Tables During the COVID-19 Pandemic? Current Status and Challenges.
The COVID-19 pandemic continues to affect millions of people across the world. The current global statistics for the disease are 111 million cases and 2.45 million deaths, with new cases emerging each day. Although several drugs including remdesivir have been approved for emergency use, they remain ineffective in bringing the infection under control. ⋯ Moreover, Pfizer-BioNTech and Moderna Therapeutics have announced that their vaccines are effective even against the new strains (B.1.17 and B.1.351) of the virus. Both companies are now scaling up the production of the vaccines to meet the global demand. Although the long-term efficacy, safety, and immunogenicity of these vaccines is uncertain, there is hope that they can turn the tables against COVID-19 in this current pandemic situation.
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BACKGROUND AND Omadacycline is an aminomethylcycline antibiotic approved in the USA as once-daily intravenous/oral monotherapy for adults with community-acquired bacterial pneumonia (CABP). Omadacycline demonstrated noninferiority to the fluoroquinolone moxifloxacin in a phase III CABP trial; adverse-event rates were similar between treatment groups except for Clostridioides difficile infection (CDI), which occurred in 2% of moxifloxacin-treated patients and 0% of patients on omadacycline. Conceptual healthcare-decision analytic models were developed to better understand the economic implications of antibiotic selection and CDI risk in acute-care facilities.
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The results of randomised clinical trials (RCTs) on direct oral anticoagulants (DOACs) for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF) can mostly be applied to primary prevention in relatively young patients, since only a minority of patients included in these trials were receiving DOACs for secondary prevention. The real-life secondary prevention subgroup, comprising mostly elderly and high-risk patients, remains a point of interest where further exploration is needed. Our objective was to explore the effectiveness and safety of DOACs for secondary prevention in the real-life conditions. ⋯ Our real-life data study suggests that secondary stroke prevention with DOACs is as effective and safe as primary prevention, both in standard and reduced doses, in a typical group of patients who are older than patients included in RCTs.
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Cefiderocol (Fetroja®) is a siderophore cephalosporin and has demonstrated potent activity against extended-spectrum beta-lactamases producing Enterobacteriaceae, carbapenem-resistant Enterobacteriaceae, and nonfermenting Gram-negative bacilli, including Pseudomonas aeruginosa, Stenotrophomonas maltophilia, and Acinetobacter baumannii, Burkholderia cepacia, and Klebsiella pneumoniae. However, cefiderocol has limited activity against Gram-positive bacteria and anaerobes like Bacterodies fragilis. In the APEKS-cUTI study, 183 (73%) of 252 patients in the cefiderocol group versus 65 (55%) of 119 patients in the imipenem-cilastatin group achieved the composite outcome of clinical and microbiological eradication of Gram-negative bacteria (treatment difference of 18.58%; 95% CI 8.23-28.92, p = 0.0004) in complicated urinary tract infections (cUTIs). ⋯ The most common adverse events with cefiderocol were gastrointestinal symptoms such as diarrhea, constipation, nausea, vomiting, or upper abdominal pain. Two phase III clinical trials, the CREDIBLE-CR study and the APEKS-NP study, investigated the efficacy and safety of cefiderocol for the treatment of pneumonia or cUTI, and both studies showed higher all-cause mortality associated with cefiderocol. Therefore, the use of cefiderocol should be limited only to the treatment of cUTIs from Gram-negative bacteria, especially in patients who have limited or no alternative treatment options.