3.9 Article

Randomized, Comparative, Double-Blind, Double-Dummy, Multicenter Trial of Miconazole Buccal Tablet and Clotrimazole Troches for the Treatment of Oropharyngeal Candidiasis: Study of Miconazole Lauriad® Efficacy and Safety (SMiLES)

期刊

HIV CLINICAL TRIALS
卷 11, 期 4, 页码 186-196

出版社

TAYLOR & FRANCIS LTD
DOI: 10.1310/hct1104-186

关键词

antifungal agents; clotrimazole; HIV-related opportunistic infections; miconazole; oral candidiasis

向作者/读者索取更多资源

Background: Oropharyngeal candidiasis (OPC) is the most common opportunistic infection among persons infected with human immunodeficiency virus (HIV). Once-daily miconazole 50 mg buccal tablet (MBT) is a novel delivery system using an extended-spectrum azole with potent in vitro activity against many Candida species, including some that may be resistant to other azoles. Methods: This phase 3, double-blind, double-dummy, multicenter trial evaluated 578 randomized patients with HIV infection and OPC. The study compared the efficacy and safety of MBT once daily with clotrimazole 10 mg troches (CT) 5 times daily for 14 days. The co-primary efficacy endpoints were clinical cure at test of cure (TOG) visit (days 17-22) in the intent-to-treat (ITT) and per protocol (PP) populations. Results: Clinical cure rate at TOG visit for MBT-treated patients was statistically noninferior to CT-treated patients in both the ITT (61% vs 65%) and PP (68% vs 74%) populations. Secondary endpoints, safety, and tolerability were similar between treatment groups. Conclusions: In this large trial, once-daily MBT was shown to be noninferior to CT 5 times daily in the treatment of OPC in HIV-positive patients. MBT offers an effective, safe, and well-tolerated topical treatment option for OPC administered as a convenient once-daily dose.

作者

我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。

评论

主要评分

3.9
评分不足

次要评分

新颖性
-
重要性
-
科学严谨性
-
评价这篇论文

推荐

Article Otorhinolaryngology

Epidemiologic factors in patients with advanced head and neck cancer treated with radiation therapy

Michael T. Brennan, Nathaniel S. Treister, Thomas P. Sollecito, Brian L. Schmidt, Lauren L. Patton, Yi Yang, Alexander Lin, Linda S. Elting, James S. Hodges, Rajesh V. Lalla

Summary: Demographic factors, insurance status, cancer type/location, and dental disease are associated with advanced head and neck cancer at diagnosis, suggesting potentially modifiable factors or factors to be considered in the screening process.

HEAD AND NECK-JOURNAL FOR THE SCIENCES AND SPECIALTIES OF THE HEAD AND NECK (2021)

Editorial Material Dentistry, Oral Surgery & Medicine

Including vaccinations in the scope of dental practice The time has come

Alessandro Villa, Milda Chmieliauskaite, Lauren L. Patton

JOURNAL OF THE AMERICAN DENTAL ASSOCIATION (2021)

Editorial Material Dentistry, Oral Surgery & Medicine

Remaking the face: Pushing the boundaries of allotransplantation to the craniofacial region

Lauren L. Patton

ORAL SURGERY ORAL MEDICINE ORAL PATHOLOGY ORAL RADIOLOGY (2021)

Editorial Material Dentistry, Oral Surgery & Medicine

Viral pandemics and oral health: Lessons learned from HIV to SARS-CoV-2

Lauren L. Patton

ORAL SURGERY ORAL MEDICINE ORAL PATHOLOGY ORAL RADIOLOGY (2021)

Article Dentistry, Oral Surgery & Medicine

World Workshop on Oral Medicine VII: Bleeding control interventions for invasive dental procedures in patients with inherited functional platelet disorders: A systematic review

Jumana Karasneh, Janina Christoforou, Jennifer S. Walker, Pedro Diz Dios, Peter B. Lockhart, Lauren L. Patton

Summary: This study aims to determine bleeding control interventions (BCIs) that effectively control postoperative bleeding in patients with inherited functional platelet disorders (IFPDs) undergoing invasive dental procedures. The results of the study show that local measures and antifibrinolytics are effective, while platelet transfusion should be based on the patient's medical history and the clinician's judgment.

ORAL SURGERY ORAL MEDICINE ORAL PATHOLOGY ORAL RADIOLOGY (2022)

Article Oncology

Exposed bone in patients with head and neck cancer treated with radiation therapy: An analysis of the Observational Study of Dental Outcomes in Head and Neck Cancer Patients (OraRad)

Nathaniel S. Treister, Michael T. Brennan, Thomas P. Sollecito, Brian L. Schmidt, Lauren L. Patton, Rebecca Mitchell, Robert Haddad, Roy B. Tishler, Alexander Lin, Ryann Shadick, James S. Hodges, Rajesh Lalla

Summary: This report describes the incidence and clinical course of exposed bone in head and neck cancer patients treated with radiation therapy in the multicenter observational study OraRad. The results showed that the average maximum radiation dose to the affected area of exposed bone was 5456 cGy, with the majority of cases occurring in the mandible. The incidence of confirmed osteoradionecrosis was 3.1%, with risk factors including pre-RT extractions, higher radiation dose, and tobacco use.

CANCER (2022)

Article Oncology

Tooth Failure Post-Radiotherapy in Head and Neck Cancer: Primary Report of the Clinical Registry of Dental Outcomes in Head and Neck Cancer Patients (OraRad) Study

Michael T. Brennan, Nathaniel S. Treister, Thomas P. Sollecito, Brian L. Schmidt, Lauren L. Patton, Alexander Lin, Linda S. Elting, James S. Hodges, Rajesh Lalla

Summary: This study aimed to investigate tooth failure in head and neck cancer patients after radiation therapy (RT). The results demonstrated that tooth failure occurred within 2 years after RT, and factors such as baseline tooth count, reduction in salivary flow rate, and noncompliance with oral hygiene were associated with a higher risk of tooth failure.

INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS (2022)

Article Dentistry, Oral Surgery & Medicine

Radiation therapy for head and neck cancer leads to gingival recession associated with dental caries

Rajesh Lalla, Nathaniel S. Treister, Thomas P. Sollecito, Brian L. Schmidt, Lauren L. Patton, Erika S. Helgeson, Alexander Lin, Cynthia Rybczyk, Robert Dowsett, Upendra Hegde, Timothy S. Boyd, Thomas G. Duplinsky, Michael T. Brennan

Summary: This study aimed to examine the effects of radiation therapy for head and neck cancer on periodontal disease and its relationship to caries. The results showed that radiation therapy leads to gingival recession in the mandible, which may contribute to an increased risk of cervical caries in these patients.

ORAL SURGERY ORAL MEDICINE ORAL PATHOLOGY ORAL RADIOLOGY (2022)

Editorial Material Dentistry, Oral Surgery & Medicine

Long-COVID and the practice of oral medicine

Lauren L. Patton

ORAL SURGERY ORAL MEDICINE ORAL PATHOLOGY ORAL RADIOLOGY (2022)

Article Oncology

The impact of head and neck radiotherapy on salivary flow and quality of life: Results of the ORARAD study

Alexander Lin, Erika S. Helgeson, Nathaniel S. Treister, Brian L. Schmidt, Lauren L. Patton, Linda S. Elting, Rajesh Lalla, Michael T. Brennan, Thomas P. Sollecito

Summary: The OraRad study analyzed the impact of radiotherapy on salivary flow and patient-reported outcomes in a cohort of 572 patients receiving head and neck radiotherapy. The study found that the dose of radiotherapy was associated with changes in salivary flow and patient-reported outcomes. Salivary flow decreased to 37% of baseline at 6 months post-radiotherapy, but partially recovered to 59% at 18 months. Significant improvements in swallowing, mouth opening, dry mouth, and sticky saliva were observed between 6 and 18 months post-radiotherapy.

ORAL ONCOLOGY (2022)

Editorial Material Dentistry, Oral Surgery & Medicine

The aftermath of the COVID-19 pandemic on oral medicine practice

Lauren L. Patton

ORAL SURGERY ORAL MEDICINE ORAL PATHOLOGY ORAL RADIOLOGY (2022)

Article Dentistry, Oral Surgery & Medicine

Dental Caries Postradiotherapy in Head and Neck Cancer

M. T. Brennan, N. S. Treister, T. P. Sollecito, B. L. Schmidt, L. L. Patton, A. Lin, L. S. Elting, E. S. Helgeson, R. V. Lalla

Summary: The prevalence of dental caries increases significantly after radiotherapy in HNC patients. Daily fluoride use, good oral hygiene practices, dental insurance, and higher education level are strongly associated with caries increment. Therefore, intensifying oral hygiene measures and improving accessibility to dental care can reduce the caries burden after radiotherapy in HNC patients.

JDR CLINICAL & TRANSLATIONAL RESEARCH (2023)

Review Dentistry, Oral Surgery & Medicine

Effect of preradiation dental intervention on incidence of osteoradionecrosis in patients with head and neck cancer A systematic review and meta-analysis

Olivia Urquhart, Hillary R. DeLong, Kathleen M. Ziegler, Lauren Pilcher, Sarah Pahlke, Malavika P. Tampi, Kelly K. O'Brien, Lauren L. Patton, Nishant Agrawal, Theresa M. Hofstede, Deepak Kademani, Mark W. Lingen, Nathaniel S. Treister, Jillian Tsai, Alonso Carrasco-Labra, Ruth D. Lipman

Summary: This systematic review examines whether dental intervention is associated with a lower risk of osteoradionecrosis of the jaw (ORNJ) in patients with head and neck cancer. The results suggest that patients undergoing pre-RT extractions may have an increased risk of ORNJ. Limited evidence is available for other pre-RT procedures manipulating bone or tissue.

JOURNAL OF THE AMERICAN DENTAL ASSOCIATION (2022)

Article Dentistry, Oral Surgery & Medicine

Tooth-level predictors of tooth loss and exposed bone after radiation therapy for head and neck cancer

Rajesh Lalla, James S. Hodges, Nathaniel S. Treister, Thomas P. Sollecito, Brian L. Schmidt, Lauren L. Patton, Alexander Lin, Michael T. Brennan

Summary: This study identified tooth-level risk factors for tooth failure and exposed bone after radiation therapy for head and neck cancer. Untreated caries, periodontal pocket depth, recession, furcation score, and tooth mobility predicted tooth failure. Hopeless teeth not extracted and pocket depth predicted exposed bone occurrence.

JOURNAL OF THE AMERICAN DENTAL ASSOCIATION (2023)

Article Oncology

Oral health-related quality of life after radiation therapy for head and neck cancer: the OraRad study

Lauren L. Patton, Erika S. Helgeson, Michael T. Brennan, Nathaniel S. Treister, Thomas P. Sollecito, Brian L. Schmidt, Alexander Lin, Bhishamjit S. Chera, Rajesh V. Lalla

Summary: This study evaluated the changes in oral health-related quality of life (OH-QOL) up to 2 years after radiation therapy (RT) for head and neck cancer (HNC) patients and identified the factors associated with these changes. The results showed that dry mouth, sticky saliva, and senses problems were the most persistently impacted OH-QOL variables at 24 months. Oropharyngeal tumor site, chemotherapy, ethnicity, age, and RT dose were found to have significant impacts on OH-QOL.

SUPPORTIVE CARE IN CANCER (2023)

暂无数据