Condoliase Offers Less Invasive Treatment for Patients With Lumbar Disc Herniation
Lumbar disc herniation (LDH) is a spinal condition that causes nerve root compression, leading to radicular leg pain and affecting quality of life. Although many cases resolve with conservative treatments, approximately 10% of patients require more intensive interventions. Consequently, alternative treatments like condoliase, are being explored.
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Condoliase is a glycosaminoglycan-degrading enzyme that reduces moisture retention and pressure within the intervertebral disc, alleviating nerve root compression, which is a key contributor to pain in LDH. A phase 3, multicenter, randomized, double-blind, sham-controlled trial focused on evaluating the safety and efficacy of condoliase in the United States.
The study involved 352 participants ages 30 to 70 with radicular leg pain from LDH. Participants were randomized to receive either a single intradiscal injection (1.25 units) of condoliase or a sham injection. The primary endpoint was the change in worst leg pain score from baseline to Week 13, while secondary endpoints included changes in disability, herniation volume, and neurologic status. Results showed that the condoliase group had higher responder rates (50% or more reduction in pain) compared to the sham group. The condoliase group also showed improvements in disability and greater improvements in neurologic tests, such as the straight leg raise test, at Week 13.
Although adverse events were reported more frequently in the condoliase group, including back pain and hypersensitivity reactions, no participants required discontinuation due to adverse events. Additionally, condoliase was associated with a lower rate of posttreatment surgery compared to the sham group, which is a promising result for patients looking for less invasive alternatives to surgery.
This phase 3 trial supports condoliase as an effective treatment for radicular leg pain due to LDH, with improvements in pain relief and lower rates of surgery compared to sham treatment. Even though the drug was associated with some mild side effects, it provides a promising less-invasive option for patients who don't respond to conservative treatments. (Kim, K. D., et al. [2024]. A phase 3, randomized, double-blind, sham-controlled trial of SI-6603 [condoliase] in patients with radicular leg pain associated with lumbar disc herniation. The Spine Journal, 24[12], 2285–2296. Retrieved January 2025 from https://www.thespinejournalonline.com/article/S1529-9430(24)00936-7/fulltext)
Released: February 2025
Nursing Drug Handbook
© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.
Promising Treatment Combination for Cystic Fibrosis
Cystic fibrosis (CF) is a genetic disorder that's caused by mutations in the CFTR gene. The disease can manifest in early life, with symptoms such as pancreatic insufficiency and elevated chloride levels in sweat. Chronic respiratory infections and progressive lung damage are common, and poor nutrition exacerbates these issues, contributing to the overall decline in health.
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CFTR modulators are a therapeutic class designed to restore normal CFTR function, as individuals with healthy CFTR don't experience CF-related symptoms. Sweat chloride testing is a key diagnostic tool for CF, with elevated chloride levels indicating CFTR dysfunction. CFTR modulators, like vanzacaftor/tezacaftor/deutivacaftor, a new combination regimen, aim to normalize chloride transport and improve overall CFTR function.
In a phase 3 trial for children ages 6 to 11 years, this combination was tested with 78 participants over a 24-week treatment period for safety, pharmacokinetics, and efficacy. In the trial, participants taking the combination therapy showed stable lung function, with no significant decline in forced expiratory volume in 1 second, a key measure of lung capacity. The treatment also led to a decrease in sweat chloride concentrations, with most children achieving sweat chloride levels below the 60 mmol/L threshold, a marker of improved CFTR function. Additionally, the Cystic Fibrosis Questionnaire-Revised respiratory domain scores improved, suggesting better respiratory health. As far as safety, the regimen was found to be well tolerated, with few serious adverse events.
Overall, the 24-week trial demonstrated that vanzacaftor/tezacaftor/deutivacaftor treatment improves CFTR function in children ages 6 to 11, with a favorable safety profile. This next-generation CFTR modulator regimen offers hope for reducing the clinical burden of CF, potentially improving both quality of life and long-term health outcomes. (Hoppe, J. E., et al. [2025]. Vanzacaftor/tezacaftor/deutivacaftor for children aged 6–11 years with cystic fibrosis [RIDGELINE trial VX21-121-105]: An analysis from a single-arm, phase 3 trial. The Lancet Respiratory Medicine. Advance online publication. Retrieved January 2025 from https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(24)00407-7/fulltext)
Released: February 2025
Nursing Drug Handbook
© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.
Updated Guidelines for Tuberculosis Treatment
Updated guidelines from the American Thoracic Society, the Centers for Disease Control and Prevention, the European Respiratory Society, and the Infectious Diseases Society of America now recommend shorter, fully oral treatment regimens for tuberculosis (TB) in both adults and children.
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The push for shorter treatments comes after years of limited drug development. Recent studies have enabled the reduction of treatment durations to 4 months for drug-susceptible TB and 6 months for drug-resistant TB, providing a more efficient approach to managing the disease. However, not all patients qualify for these shortened regimens, and the existing recommendations for some patients from previous guidelines remain in place. The updated guidelines make the following suggestions:
- Children ages 3 months to 16 years old with nonsevere TB should receive a 4-month regimen of isoniazid, rifampin, pyrazinamide, and ethambutol for 2 months, followed by isoniazid and rifampin for the remaining 2 months.
- Patients age 12 and older with drug-susceptible TB should consider a 4-month regimen of isoniazid, rifapentine, moxifloxacin, and pyrazinamide.
- Patients age 14 and older with rifampin-resistant pulmonary TB and resistance to fluoroquinolones; and in cases of multidrug-resistant but fluoroquinolone-susceptible disease, a 6-month regimen of bedaquiline, pretomanid, linezolid, and moxifloxacin is recommended.
Certain pediatric cases that don't meet the criteria for the shortened regimen should continue with the standard 6-month treatment, while children with severe TB forms may require alternative regimens. Some children may also be eligible for the 4-month rifapentine-moxifloxacin regimen. The guidelines stress that drug-susceptibility testing and close monitoring for safety and effectiveness remain essential, especially to prevent the emergence of drug resistance.
The updated guidelines were largely adapted from the 2022 World Health Organization TB treatment recommendations, with a panel of 25 international experts contributing to the consensus. No new clinical trial data has emerged since the World Health Organization guidelines were published, and the U.S. guidelines align closely with the global recommendations. (Saukkonen, J. J., et al. [2025]. Updates on the treatment of drug-susceptible and drug-resistant tuberculosis: An official ATS/CDC/ERS/IDSA Clinical Practice Guideline. American Journal of Respiratory and Critical Care Medicine, 211[1], 15–33. Retrieved January 2025 from https://www.atsjournals.org/doi/full/10.1164/rccm.202410-2096ST)
Released: February 2025
Nursing Drug Handbook
© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.
Combination Metronomic Capecitabine and Aromatase Inhibitor as First-Line Treatment for Hormone Receptor-Positive, HER2-Negative Breast Cancer
Treating hormone receptor-positive, HER2-negative metastatic breast cancer (MBC) is challenging, especially as resistance to endocrine therapy develops in most patients over time. Metronomic chemotherapy, which uses lower doses of chemotherapy agents at more frequent intervals, offers potential as a less toxic alternative to traditional chemotherapy.
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Capecitabine, an oral chemotherapy agent, is one such drug used in metronomic chemotherapy. The MECCA trial explored combining metronomic capecitabine with endocrine therapy, specifically an aromatase inhibitor (AI), as a first-line treatment for hormone receptor-positive, HER2-negative MBC. This phase 3 trial in China involved 254 patients and compared the combination of capecitabine and AI with AI alone in terms of progression-free survival (PFS) and other clinical outcomes.
The primary endpoint was PFS, while secondary endpoints included overall survival (OS), objective response rate, disease control rate, and safety. Patients were randomly assigned to either the capecitabine (500 mg three times daily) plus AI group or the AI-only group. The study continued until disease progression, intolerable side effects, or patient withdrawal.
After a median follow-up of 50.7 months, the combination group showed a meaningful improvement in PFS (20.9 months) compared to the AI-only group (11.9 months). The combination group also had an OS advantage, with a median OS not yet reached compared to 45.1 months in the AI-only group. The objective response and disease control rates were higher in the combination group as well, at 37.3% and 88.1%, respectively, compared to 25.0% and 75.8% for the AI-only group.
In terms of safety, the combination therapy was generally well tolerated. Although adverse events like palmar-plantar erythrodysesthesia were more common in the capecitabine plus AI group, most side effects were mild to moderate.
The MECCA trial supports metronomic capecitabine combined with AI as an effective first-line treatment for hormone receptor-positive, HER2-negative MBC, offering improvements in PFS and OS with manageable toxicity. Further research is needed to investigate its role alongside other therapies, including CDK4/6 inhibitors and targeted therapies. (Hong, R.-X., et al. [2025]. Metronomic capecitabine plus aromatase inhibitor as initial therapy in patients with hormone receptor–positive, human epidermal growth factor receptor 2–negative metastatic breast cancer. The phase III MECCA trial. Journal of Clinical Oncology. Advance online publication. Retrieved January 2025 from https://ascopubs.org/doi/10.1200/JCO.24.00938)
Released: February 2025
Nursing Drug Handbook
© 2025 Wolters Kluwer N.V., its subsidiaries and/or its licensors. All rights reserved.