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Drug News

doi: 10.1097/01.NURSE.0000553287.87331.8e
Department: DRUG NEWS
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Novel oral antibiotic shows promise for patients with gonorrhea...new treatment for rare blood disorder...flu vaccination protects patients with chronic obstructive pulmonary disease...calcium channel blocker found to reverse coronary “slow flow”

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DRUG-RESISTANT GONORRHEA

Novel oral antibiotic shows promise

Neisseria gonorrhoeae, the pathogen that causes gonorrhea, has developed resistance to every class of antibiotic recommended for treatment, spurring the search for new therapies. A single oral dose of zoliflodacin, an investigational antibiotic that inhibits DNA biosynthesis, successfully treated most cases of uncomplicated urogenital and rectal gonorrhea in a recent randomized multicenter phase 2 trial.

Men and women eligible for enrollment had uncomplicated or untreated urogenital gonorrhea or had had sexual contact with a person who had gonorrhea in the preceding 14 days. Participants (n = 141) received one of three treatments: a single 2 g oral dose of zoliflodacin, a single 3 g oral dose of zoliflodacin, or a single 500 mg I.M. dose of ceftriaxone, currently the standard treatment for gonorrhea.

The results: Microbiologic cure at urogenital sites was documented in 96% of participants who received either 2 g or 3 g of zoliflodacin and in 100% of those who received ceftriaxone. All rectal infections were cured in all three treatment groups. However, zoliflodacin cured pharyngeal infections in only 50% (2 g) and 82% (3 g) of patients with pharyngeal infections; in comparison, all pharyngeal infections were cured in patients receiving ceftriaxone.

“Reports of multidrug-resistant N. gonorrhoeae and the possibility of untreatable gonorrhea underscore the need for the development of new antimicrobial agents,” the authors write. Because of this urgency, the FDA has granted zoliflodacin fast track status; Phase 3 trials are scheduled for this year.

Sources: Taylor SN, Marrazzo J, Batteiger BE, et al. Single-dose zoliflodacin (ETX0914) for treatment of urogenital gonorrhea. N Engl J Med. 2018;379(19):1835-1845. Thompson D. New antibiotic offers hope against “super gonorrhea.” HealthDay News. November 7, 2018.

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RAVULIZUMAB

New treatment for rare blood disorder

A rare, life-threatening blood disorder, paroxysmal nocturnal hemoglobinuria is characterized by sudden, recurring episodes of hemolysis. Signs and symptoms include severe anemia, profound fatigue, shortness of breath, intermittent episodes of dark-colored urine, kidney disease, and pain. Indicated for adults and administered once every 8 weeks, ravulizumab (Ultomiris) injection is a long-acting complement inhibitor that prevents hemolysis. In clinical trials, headache and upper respiratory infection were common adverse reactions.

The prescribing information includes a Boxed Warning about the risk of life-threatening meningococcal infections and sepsis. Healthcare providers are advised to follow the current Advisory Committee on Immunization Practices recommendations for meningococcal vaccination in patients with complement deficiencies. Patients should be immunized with meningococcal vaccines at least 2 weeks before receiving the first dose of ravulizumab unless the risks of delaying treatment outweigh the risks of developing a meningococcal infection.

Teach patients to recognize and immediately report early signs and symptoms of meningococcal infection, such as sudden onset of fever, nausea, headache, and myalgia. Ravulizumab is available only through a restricted program under a Risk Evaluation and Mitigation Strategy.

Sources: US Food & Drug Administration. FDA approves new treatment for adult patients with rare, life-threatening blood disease. News release. December 21, 2018. Apicella M. Clinical manifestations of meningococcal infection. UpToDate. 2018. www.uptodate.com.

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INFLUENZA

Vaccination protects patients with COPD

Influenza vaccination is “suboptimal” in patients with chronic obstructive pulmonary disease (COPD), researchers say, and influenza-related hospitalizations among patients with COPD is not well described. To investigate whether influenza vaccination helps to keep these patients out of the hospital, Canadian researchers analyzed data from a national, prospective, multicenter cohort study including patients with COPD hospitalized with any acute respiratory illness or exacerbation between 2011 and 2015. All patients underwent nasopharyngeal swab screening with polymerase chain reaction testing for influenza. The primary outcome was an influenza-related hospitalization.

In all, 4,755 patients with COPD were hospitalized and data on 4,198 (88%) patients with known vaccination status were analyzed. The adjusted analysis showed a 38% reduction in influenza-related hospitalizations in vaccinated versus unvaccinated patients. Compared with influenza-negative patients, patients positive for influenza had a significantly greater risk for mortality and critical illness. Risk factors for mortality included age over 75, cardiac comorbidity, residence in long-term care, and home oxygen use.

Researchers concluded that “initiatives to increase vaccination uptake and early use of antiviral agents among patients with COPD could reduce influenza-related hospitalization and critical illness and improve healthcare costs in this vulnerable population.”

Source: Mulpuru S, Li L, Ye L, et al., on behalf of the Serious Outcomes Surveillance (SOS) Network of the Canadian Immunization Research Network (CIRN). Effectiveness of influenza vaccination on hospitalizations and risk factors for severe outcomes in hospitalized patients with COPD. Chest. 2019;155(1):69-78.

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CALCIUM CHANNEL BLOCKER

Nicardipine reverses coronary “slow flow”

A poorly understood cause of chest pain, coronary slow-flow (CSF) is characterized by delayed coronary blood flow in the absence of coronary artery disease (CAD). On angiography, CSF resembles no-reflow during percutaneous coronary intervention, a condition thought to be caused by microvascular spasms. No-reflow responds well to calcium channel blockers, and researchers wondered if CSF would do the same.

To test the hypothesis, they studied 30 patients with angiographic evidence of CSF, defined as spontaneously delayed flow during diagnostic coronary angiography in the absence of obstructive epicardial CAD or other conditions associated with impaired flow. Patients were treated with 200 mcg of nicardipine via intracoronary bolus. Coronary blood flow was measured before and after nicardipine administration according to thrombolysis in myocardial infarction (TIMI) flow grade, a 4-point scale ranging from 0 (no perfusion) to 3 (complete perfusion), and corrected TIMI frame count (TFC) assessments.

At baseline, TIMI below 3 was observed in 49 coronary vessels and TFC was prolonged in 68 out of 90 vessels. After treatment with nicardipine, coronary filling “markedly accelerated,” the authors found, with all vessels demonstrating TIMI 3 flow and improved TFC. No adverse reactions were reported. Concluding that nicardipine was “highly effective in reversing spontaneous CSF,” the authors say their findings implicate microvascular spasm as a cause of CSF and recommend investigating the effectiveness of oral calcium channel blockers for long-term CSF management.

Source: Mehta HH, Morris M, Fischman DL, et al. The spontaneous coronary slow-flow phenomenon: reversal by intracoronary nicardipine. J Invasive Cardiol. [e-pub December 15, 2018.]

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