Year : 2018 | Volume
: 16 | Issue : 4 | Page : 164--165
Drug Dialogues – Medication news and new medications
|How to cite this article:|
. Drug Dialogues – Medication news and new medications.Curr Med Issues 2018;16:164-165
|How to cite this URL:|
. Drug Dialogues – Medication news and new medications. Curr Med Issues [serial online] 2018 [cited 2022 Dec 6 ];16:164-165
Available from: https://www.cmijournal.org/text.asp?2018/16/4/164/256321
Source: CMC Pharmacy Bulletin, a publication of the Pharmacy Service (DISH), CMC, Vellore.
New Long-Acting Anticholinergic Inhaler for Chronic Obstructive Pulmonary Disease
Revefenacin is a long-acting muscarinic antagonist (LAMA) which has been approved by the US Food and Drug Administration (FDA) for the treatment of chronic obstructive pulmonary disease (COPD) recently. Revefenacin is an inhalation solution that is administered once daily via standard jet nebulizer. The efficacy and safety of revefenacin were demonstrated in two 12-week randomized controlled studies in which 395 COPD patients (moderate to very severe), mostly Caucasians with a mean age of 64 years, were treated with the recommended dose of 175 mcg once daily. The drug was also found effective in another 52-week open-label study against tiotropium, which included 1055 patients with COPD. As with other inhaled medicines, revefenacin can cause paradoxical bronchospasm in which case the patient should discontinue use. In addition, the drug should be used with caution in patients with glaucoma. The most common adverse reactions include cough, nasopharyngitis, upper respiratory tract infection, headache, and back pain. The drug should not be administered along with other drugs that inhibit OATP1B1 and OATP1B3 (e.g., rifampicin and cyclosporine), as it may lead to increase in active metabolite exposure. Revefenacin does not need dosage adjustment in geriatric population or in patients with hepatic/renal impairment.
Source: Drugs@FDA: FDA Approved Drug Products[Internet]. [cited 2018 Nov 10]. https://www.uptodate.com/contents/role-of-anticholinergic-therapy-in-copd
New Anti-Influenza Drug With Novel Mechanism Approved
The first new influenza antiviral drug for almost two decades has been approved for use in the US. Baloxavir marboxil is being made available for the treatment of acute uncomplicated influenza in patients aged over 12 years who have had symptoms for up to 48 h, following approval by the US FDA. The FDA is still recommending immunization as the first course of action, but said that the new drug was effective in reducing influenza symptoms and length of illness if taken within 48 h of becoming unwell. The marketing approval for baloxavir marboxil follows the results of two randomized controlled trials of 1832 patients where participants received baloxavir marboxil, a placebo, or another antiviral influenza treatment within 48 h of experiencing flu symptoms. In both trials, patients treated with baloxavir marboxil found their symptoms disappeared more quickly compared with patients who took the placebo. In the second trial, the pace of recovery was no different between those who received baloxavir marboxil and those who received the other influenza treatment. Baloxavir marboxil was fast-tracked by the FDA and given priority review status on the grounds that it could significantly improve the safety or effectiveness of treating, diagnosing, or preventing a serious condition.
Source: The Pharmaceutical Journal, online, 26 OCT 2018. <https://www.pharmaceutical-journal.com/news-and-analysis/news-in-brief/fda-approves-first-new-flu-drug-in-nearly-20-years/20205654.article?firstPass=false>
Rifamycin: the New Antibiotic to Treat Traveler's Diarrhea
Rifamycin is the very recently FDA-approved antibiotic indicated for the treatment of adult patients with traveler's diarrhea caused by noninvasive strains of Escherichia coli, not complicated by fever or blood in the stool.
The efficacy of rifamycin was demonstrated in a randomized, placebo-controlled trial of 264 adults with traveler's diarrhea in Guatemala and Mexico. The drug significantly reduced traveler's diarrhea when compared with placebo. However, the drug is not shown to be effective in patients with diarrhea complicated by fever, bloody stool, or diarrhea due to pathogens other than noninvasive strains of E. coli and is not recommended for use in such patients. In addition, the drug should not be used in patients with known hypersensitivity to other rifamycin class drugs (e.g., rifaximin and rifampicin).
Source: Commissioner O of the. Press Announcements - FDA approves new drug to treat travelers' diarrhea [Internet]. [cited 2018 Nov 17] https://www.empr.com/home/news/fda-approves-new-treatment-for-travelers-diarrhea/
New Antibiotic Against Gram-Negative Urinary Tract Infections
A new antibiotic designed to overcome multidrug resistance is at least as effective as the current standard of care in complicated urinary tract infection (UTI), according to trial results published in The Lancet Infectious Diseases (October 25, 2018).
The trial randomly assigned 303 people to an intravenous infusion of the new antibiotic cefiderocol and 149 to the standard of care imipenem-cilastatin three times daily for 7–14 days.
Among those who tested positive for a Gram-negative uropathogen at baseline, 73% in the cefiderocol group and 55% in the imipenem-cilastatin group were considered cured after treatment, indicating the noninferiority of cefiderocol. There were also fewer adverse events in the cefiderocol group compared with those of standard care.
Cefiderocol is a cephalosporin antibiotic that contains a siderophore side chain. This component helps the antibiotic overcome the resistance mechanisms evolved by Gram-negative bacteria to the existing antibiotics by hijacking the bacteria's iron transport mechanism to gain entry into the cell.
Source: Portsmouth S, van Veenhuyzen D, Echols R, Machida M, Ferreira JCA, Ariyasu M, et al. Cefiderocol versus imipenem-cilastatin for the treatment of complicated urinary tract infections caused by Gram-negative uropathogens: A phase 2, randomised, double-blind, non-inferiority trial.The Lancet Infectious Diseases. 2018; DEC1;18(12):1319-28.
Single-Dose Tafenoquine Prevents the Relapse of Plasmodium Vivax Malaria
Tafenoquine is a single-dose 8-aminoquinoline that has recently been registered for the radical cure of Plasmodium vivax.
In a recent multicentric, double-blind, placebo-controlled trial conducted in six countries, 522 patients with microscopically confirmed P. vivax infection and normal glucose-6-phosphate dehydrogenase (G6PD) were given a 3-day course of chloroquine. In addition, the patients were assigned to receive a single 300-mg dose of tafenoquine on day 1 or 2 (260 patients), placebo (133 patients), or a 15-mg dose of primaquine once daily for 14 days (129 patients). At 6 months, 62.4% in the tafenoquine group (95% confidence interval [CI], 54.9–69.0), 27.7% in the placebo group (95% CI, 19.6–36.6), and 69.6% in the primaquine group (95% CI, 60.2–77.1) were free from recurrence. The hazard ratio for the risk of recurrence was 0.30 with tafenoquine as compared with placebo and 0.26 with primaquine as compared with placebo.
Though effective treatment options are available, this study is perceived to be important because tafenoquine treatment comprises only a single dose.
Ref: Lacerda MVG, Llanos-Cuentas A, Krudsood S, Lon C, Saunders DL, Mohammed R, et al. Single-Dose Tafenoquine to Prevent Relapse of Plasmodium vivax Malaria. N Engl J Med. 2019 Jan 17;380(3):215–28.