Libtayo® (Cemiplimab-rwlc) Injection for Intravenous Use.

Libtayo® (cemiplimab-rwlc) injection for intravenous use was recently approved by the US Food and Drug Administration (FDA) for locally advanced basal cell carcinoma (laBCC) and metastatic basal cell carcinoma (mBCC), both being the advanced stages of BCC. In the past, it was approved by the FDA for the treatment of metastatic cutaneous squamous cell carcinoma (mCSCC) and locally advanced cutaneous squamous cell carcinoma (laCSCC), both being the advanced stages of CSCC. Cemiplimab is a monoclonal antibody that works by blocking the programmed death-1 pathway. In two open-label, single-arm, phase 2 studies, cemiplimab was investigated for the treatment of advanced stages of BCC (study 1620, NCT03132636) and advanced stages of CSCC (study 1540, NCT02760498). The primary endpoint was objec-tive response rate (ORR) per independent central review. In the study 1620, both mBCC and laBCC received cemiplimab 350 mg every 3 weeks. ORR was 21% (6/28) and 31% (26/84) in the mBCC and laBCC groups, respectively. In the study 1520, mCSCC was divided into two groups: one receiving cemiplimab 350 mg every 3 weeks (Q3W) and another receiving 3-mg/kg cemiplimab every 2 weeks (Q2W); the third group, laCSCC, received cemiplimab 3 mg/kg every 2 weeks. ORR was 41% (23/56) in the Q3W group, 49% (29/59) in the Q2W group, and 44% (34/78) in the laCSCC group. An acceptable safety profile and antitumor activity was discovered in patients treated with cemiplimab. The recommended dosage for cemiplimab to treat advanced stages of BCC and CSCC is 350 mg every 3 weeks administered intravenously over 30 min.

Comparison of therapeutic agents' short-term effects on facial and scalp actinic keratosis: A network meta-analysis.

BACKGROUND: Care for actinic keratosis (AK) can be improved with more knowledge on the relative of effect of indicated therapies. OBJECTIVES: Using network meta-analyses, we quantitatively determined the comparative "short-term" effects of interventions in adults with facial and scalp AK. METHODS: On February 28, 2023, evidence from the peer-reviewed literature was systematically obtained from OVID, the Cochrane Central Register of Controlled Trials and ClinicalTrials.gov. We analyzed data from studies published in English, of a trial design, and investigating the effect of an actinic keratosis monotherapy. Patient complete clearance, patient partial clearance or lesion-specific clearance across adults were analyzed at 8-12 weeks after therapy. Patient complete clearance pertained to proportion of participants who experienced complete clearance of actinic keratosis lesions; patient partial clearance corresponded to percentage of subjects who achieved at least 75% clearance of actinic keratosis lesions; lesion-specific clearance represented the percentage of all lesions that were cleared. In the main (i.e., base) analyses, nodes were analyzed only at the level of the agent. RESULTS: Data from a total of 84 studies were used-across which 22 active agents were identified. Estimates of interventions' surface under the cumulative ranking curve rankings and (pairwise) relative effects were estimated. Across the three outcomes, fluorouracil 5% was ranked the most effective. CONCLUSIONS: Our work is the first to provide information on covariate-adjusted relative effects of actinic keratosis therapies- including the more recently reported treatments-for the face and scalp; this knowledge may help physicians and patients make more informed decisions.

Effect of the Intralesional Forms of Methylprednisolone Acetate and Methotrexate on Psoriatic Nails.

Individuals with psoriatic nails often have a lower quality of life relative to their counterparts with healthy nails. Methotrexate (MTX), an anti-neoplastic agent, is a longstanding treatment option for nail psoriasis. In the current study, we compared the effects of MTX to that of a corticosteroid, namely, methylprednisolone acetate (i.e., Depo-Medrol®) across individuals with nail psoriasis. We used a cohort study design, and both agents were administered intralesionally. Outcome variables were based on the Nail Psoriasis Severity Index (NAPSI). We quantified the effect in terms of change in NAPSI, complete cure at week 16, and cure between 32 and 36 weeks. Our regressions demonstrated that reduced NAPSI scores with Depo-Medrol were, on average, greater than that with MTX by 2.27 (n = 48, P = 0.000255) at week 16. Similarly, the odds of complete cure at week 16 was greater with Depo-Medrol® than with MTX (odds ratio = 18.6, P < 0.0001). In terms of both complete cure and change in NAPSI, Depo-Medrol® was significantly more effective than MTX at a follow-up period of 32-36 weeks. Our study established that intralesional Depo-Medrol® is more effective than intralesional methotrexate for treating nail psoriasis.

A meta-analysis study on the association between smoking and male pattern hair loss.

BACKGROUND: Smoking-which often refers to recreational consumption of the nicotine-containing tobacco-is deemed a risk factor for both the development of and worsening of androgenetic alopecia (AGA). However, there is no published meta-analysis study on the effect of smoking on AGA; so, we quantitatively synthesized the evidence base pertaining to the recreational activity and this form of hair loss in men. METHODS: We systematically searched PubMed and Scopus to identify published studies with suitable data, and pairwise meta-analyses were conducted. RESULTS: Our search identified eight studies-and the data thereof were used across four meta-analyses. We found that ever smokers are significantly (p < 0.05) more likely, than never smokers, to develop AGA (pooled odds ratio (OR) = 1.82, 95% confidence interval (CI): 1.55-2.14). Our results showed that the odds of developing AGA are significantly (p < 0.05) higher in men who smoke at least 10 cigarettes per day, than in their counterparts who smoke up to 10 cigarettes per day (pooled OR = 1.96, 95% CI: 1.17-3.29). For men with AGA, the odds of disease progression are significantly (p < 0.05) higher among ever smokers than in never smokers (pooled OR = 1.27, 95% CI: 1.01-1.60). We found no significant (p ≥ 0.05) association between smoking intensity and disease progression. CONCLUSIONS: Findings from the current study-which is the first meta-analysis to our knowledge reviewing the association between AGA and the extent of smoking, can guide further research and update clinical practice guidelines.

Concepts, Terminology, and Innovations in Follicular Unit Excision Hair Restoration Surgery.

Follicular unit excision (FUE) has emerged as the preferred method for hair transplants. Standardized terms and definitions established by members of the International Society of Hair Restoration Surgery and prominent hair restoration surgeons have become the standard, enabling effective knowledge sharing. This chapter provides an overview of the terminology relating to the field.The historical evolution of FUE and its pivotal role in modern hair transplantation is summarized. Anatomical terminology and graft-related definitions follow, providing insights into the scalp's complex structures and graft characteristics. The subsequent sections detail the terminology associated with graft excision and extraction, shedding light on the precise techniques and procedures employed. An exploration of various FUE techniques and the evolving landscape of FUE devices underscores the continual refinement of hair restoration practices. The chapter proceeds to discuss the "safe'" scalp donor zones, donor assessment terminology, and elements in identifying the optimal donor area for a successful FUE procedure. Additionally, punch dynamics and technique characteristics are examined, emphasizing their pivotal role in achieving superior FUE outcomes. The chapter concludes by discussing the classification of punches and graft evaluation terms, offering insights into the tools, and criteria used to assess graft quality and viability.

LITFULOTM (Ritlecitinib) Capsules: A Janus Kinase 3 Inhibitor for the Treatment of Severe Alopecia Areata.

LITFULOTM (ritlecitinib) capsules were recently approved for the treatment of severe alopecia areata in adolescents and adults, aged ≥12 years. Ritlecitinib is the active ingredient and a dual inhibitor of Janus kinase 3 and the tyrosine kinase expressed in hepatocellular carcinoma kinase family. It prevents immune attack on the hair follicles that leads to hair loss. In a phase 2b-3 dose-dependant study, five doses of oral ritlecitinib and placebo administered once daily (QD) were investigated. Ritlecitinib demonstrated efficacy in achieving the primary outcome, Severity of Alopecia Tool (SALT) score of ≤20, at week 24 (31% [38/124] 200-mg ritlecitinib QD for 4 weeks, then 50 mg QD for 20 weeks; 22% [27/121] 200-mg ritlecitinib QD for 4 weeks, then 30 mg QD for 20 weeks; 23% [29/124] 50-mg ritlecitinib QD; 14% [17/119] 30-mg ritlecitinib QD; 2% [1/59] 10-mg ritlecitinib QD; and 2% [2/130] placebo). Mild to moderate common adverse effects were observed, which included headache, nasopharyngitis, and upper respiratory tract infection. The recommended regimen of ritlecitinib capsules is 50 mg QD with without food and swallowed whole.

The treatment of plantar warts using microwave-A review of 85 consecutive cases in the United States.

BACKGROUND: Plantar warts (verrucae plantaris) are a common source of pain for patients and are often refractory to treatment. Previous work has shown a high clearance rate of verrucae using a surface-based microwave device (Swift®). AIMS: To assess the efficacy, defined as the complete visible clearance of warts, in patients with verrucae plantaris receiving microwave treatment. PATIENTS: We undertook a retrospective review and identified records of 85 patients who underwent a course of microwave treatment at a single US-based podiatry centre. Efficacy was analyzed on the basis on intention-to-treat. RESULTS: In patients who received ≥1 session there was a complete clearance rate of 60.0% (51/85) (intention-to-treat; 59 patients completed treatment, 26 lost to follow-up) and 86.4% (51/59) per treatment completion; no significant differences in clearance rates of children and adults were observed (61.0% [25/41] vs. 59.1% [26/44]). There were 31 patients who received three sessions of microwave therapy with a clearance rate of 71.0% (22/31) as per intention-to-treat (27 patients completed treatment, 4 lost to follow-up). An average of 2.3 sessions (SD: 1.1; range: 1-6) was required for the complete clearance of plantar warts. Complete clearance was also observed in some patients with recalcitrant warts following additional treatment sessions (42.9% [3/7]). A significant reduction in wart related pain was reported for all patients undergoing treatment. Some patients continued to report a reduced amount of pain post-therapy compared with pretherapy. CONCLUSIONS: Microwave treatment of verrucae plantaris appears to be a safe and effective procedure.

Epsolay™ (Microencapsulated Benzoyl Peroxide 5%) Cream for the Topical Treatment of Rosacea.

EpsolayTM cream is a novel topical treatment that utilizes microencapsulated benzoyl peroxide to treat moderate to severe papulopustular rosacea. It is effective at decreasing, and for some patients clearing, the papules, pustules, and telangiectasias associated with rosacea. It is well-tolerated with minimal adverse effects and has demonstrated efficacy comparable to other topical agents that are used for the condition.

Factors Associated With Musculoskeletal Pain Among Hair Transplant Surgeons: Analyses of Survey Data and Review of the Literature.

BACKGROUND: The prevalence of work-related musculoskeletal disorders (WRMD) is increasing among all surgical specialties. OBJECTIVE: Results of a cross-sectional survey of hair transplant surgeons were analyzed, with the aims to (1) determine the prevalence of WRMD, (2) assess risk factors associated with musculoskeletal (MSK) symptoms, and (3) identify mitigation measures. MATERIALS AND METHODS: A survey pertaining to demographics, MSK-related symptoms and its impacts, and pain mitigation measures taken, if any, were distributed to 834 hair transplant surgeons. Risk factors associated with pain severity were assessed using linear regression. RESULTS: Overall, 78.5% (73 of 93) respondents had experienced pain when performing surgery. Musculoskeletal symptoms were most severe in the neck, followed by upper/lower back, and extremities. Number of grafts performed per session of follicular unit extraction positively correlated with pain severity; female surgeons and surgeons aged >71 years were at higher risk. A majority expressed concern that WRMD may limit their career and agreed to a need for improved workplace education. Strength training and ergonomic improvements of surgical procedure were not commonly adopted. CONCLUSION: In sum, WRMD can be debilitating in health care professionals. Workplace ergonomic adjustments and physical exercise programs may be warranted to better mitigate MSK symptoms.

How Effective Are Devices in the Management of Onychomycosis?: A Systematic Review.

Onychomycosis is the most common nail disorder, with a global prevalence of approximately 5.5%. It is difficult to cure on both short-term and long-term bases. The most common treatments include the use of oral or topical antifungals. Recurrent infections are common, and the use of systemic oral antifungals raises concerns of hepatotoxicity and drug-drug interactions, particularly in patients with polypharmacy. A number of device-based treatments have been developed for onychomycosis treatment, to either directly treat fungal infection or act as adjuvants to increase the efficacy of topical and oral agents. These device-based treatments have been increasing in popularity over the past several years, and include photodynamic therapy, iontophoresis, plasma, microwaves, ultrasound, nail drilling, and lasers. Some, such as photodynamic therapy, provide more direct treatment, whereas others, such as ultrasound and nail drilling, aid the uptake of traditional antifungals. We conducted a systematic literature search investigating the efficacy of these device-based treatment methods. From an initial result of 841 studies, 26 were deemed relevant to the use of device-based treatments of onychomycosis. This review examines these methods and provides insight into the state of clinical research for each. Many device-based treatments show promising results, but require more research to assess their true impact on onychomycosis.

The March Against Onychomycosis: A Systematic Review of the Sanitization Methods for Shoes, Socks, and Textiles.

Drug-based treatment of superficial fungal infections, such as onychomycosis, is not the only defense. Sanitization of footwear such as shoes, socks/stockings, and other textiles is integral to the prevention of recurrence and reduction of spread for superficial fungal mycoses. The goal of this review was to examine the available methods of sanitization for footwear and textiles against superficial fungal infections. A systematic literature search of various sanitization devices and methods that could be applied to footwear and textiles using PubMed, Scopus, and MEDLINE was performed. Fifty-four studies were found relevant to the different methodologies, devices, and techniques of sanitization as they pertain to superficial fungal infections of the feet. These included topics of basic sanitization, antifungal and antimicrobial materials, sanitization chemicals and powder, laundering, ultraviolet, ozone, nonthermal plasma, microwave radiation, essential oils, and natural plant extracts. In the management of onychomycosis, it is necessary to think beyond treatment of the nail, as infections enter through the skin. Those prone to onychomycosis should examine their environment, including surfaces, shoes, and socks, and ensure that proper sanitization is implemented.

Outcome and Determinants of Neutropenic Enterocolitis in Pediatric Cancer Patients.

BACKGROUND: Neutropenic enterocolitis (NEC) is a dreaded complication of chemotherapy. There is scant literature regarding incidence, clinical features, and determinants. The understanding of gut dysbiosis in NEC and pediatric cancer is evolving. METHODS: Pediatric cancer patients with neutropenia and gastrointestinal symptoms were evaluated for NEC with contrast-enhanced computed tomography abdomen. Clinical, imaging, and laboratory features were analyzed. Fecal samples were analyzed for fecal calprotectin by sandwich enzyme-linked immunoassay and gut microbiota by conventional culture and compared with healthy controls and children without NEC. RESULTS: NEC was diagnosed in 44 children based on clinical and imaging features with incidence of 7.4% (4 had recurrent episodes). Common manifestations included fever (98%), pain abdomen (88%), and diarrhea (83%). Hypoalbuminemia was observed in 78% of patients. Large bowel involvement (94%) with diffuse bowel involvement (63%) and pancolitis (64%) were common. Fecal calprotectin was significantly elevated in NEC group than non-NEC group and healthy controls (median: 87, 53, and 42 µg/g, respectively). A higher degree of gut dysbiosis was observed in children with NEC with higher isolation of Bacteroides and infrequent isolation of Lactobacilli. Mortality rate of 23% was observed. Only the presence of free fluid predicted higher mortality. Though levels of fecal calprotectin and gut dysbiosis were higher in NEC, they did not increase mortality. Isolation of Bacteroides and absence of Lactobacilli predicted a longer duration of intravenous alimentation. CONCLUSIONS: NEC caused significant morbidity and mortality in pediatric cancer patients. Gut dysbiosis was significantly higher in NEC group suggesting a role in pathogenesis and influencing outcome. This highlights the role of targeted interventions towards gut dysbiosis like prebiotics and probiotics.

Onychomycosis in Older Adults: Prevalence, Diagnosis, and Management.

The risk of having onychomycosis increases with age. Data suggest that the prevalence of onychomycosis may be ≥ 20% in subjects aged ≥ 60 years and ≥ 50% in those aged ≥ 70 years. Older males are 2.1 times more prone to onychomycosis than are females. Although most nail dystrophies (approximately 50%) are caused by onychomycosis, proper clinical assessment followed by mycological examination is recommended to exclude other conditions such as nail trauma, lichen planus, and psoriasis. The US FDA-approved onychomycosis treatments are systemic antifungals (terbinafine and itraconazole) for severe onychomycosis and topical antifungals (ciclopirox 8%, efinaconazole 10%, and tavaborole 5%) for mild-to-moderate onychomycosis. Oral fluconazole is used off-label, and itraconazole may be considered for non-dermatophyte onychomycosis. Recently, fosravuconazole was approved in Japan for onychomycosis treatment. Although the treatment options and durations are the same for older patients as for other age groups, a clinical decision should take into account various age-related factors such as comorbidities, polypharmacy, hepatic and renal insufficiency, and noncompliance. Clinicians should also consider possible drug interactions and side effects when choosing a particular antifungal. Since the recurrence rate of onychomycosis is high, older patients should practice sanitization techniques, consider lifestyle changes, and perhaps consider using a topical antifungal as long-term maintenance therapy one to three times per week to prevent the recurrence of onychomycosis or to treat early disease.

Efficacy and Safety of Olanzapine in Children Receiving Highly Emetogenic Chemotherapy: A Randomized, Double-blind Placebo-controlled Phase 3 Trial.

BACKGROUND: In this trial, we evaluated the safety and efficacy of olanzapine in children receiving highly emetogenic chemotherapy. MATERIALS AND METHODS: In this study, patients aged 3 to 18 years were randomly assigned to either the olanzapine group or the placebo group. All patients received intravenous ondansetron and dexamethasone 30 minutes before highly emetogenic chemotherapy, followed by oral ondansetron for 48 hours. Participants in the olanzapine group received olanzapine once daily on days 1 and 2, while those in the control group received a placebo in the same dosage and schedule. The primary objective was: (a) to compare the complete control rates of vomiting in the delayed phase and (b) to compare the complete control rates of vomiting in acute and overall phases. The secondary objective was to evaluate the safety of olanzapine and the need for rescue medications. RESULTS: A total of 128 patients were randomly assigned either to the olanzapine group (n=63) or the control group (n=65). Complete control of vomiting between olanzapine and placebo group was 73% versus 48% ( P =0.005) in the delayed phase, 60% versus 54% ( P =0.46) in the acute phase, and 48% versus 34% ( P =0.117) in the overall phase, respectively. Grades 1 and 2 sedation was greater in the olanzapine group (46% vs. 14%; P <0.001). A significantly higher proportion of patients in the placebo group required rescue medications for vomiting compared with in the olanzapine group ( P =0.025). CONCLUSIONS: Olanzapine significantly improved complete control of vomiting in the delayed phase. A considerably lesser proportion of patients in the olanzapine group needed rescue medications.

Malignant Melanoma in Children and Adolescents Treated in Pediatric Oncology Centers: An Australian and New Zealand Children's Oncology Group (ANZCHOG) Study.

OBJECTIVES: Unlike adults, malignant melanoma in children and adolescents is rare. In adult melanoma, significant progress in understanding tumor biology and new treatments, including targeted therapies and immunotherapy have markedly improved overall survival. In sharp contrast, there is a paucity of data on the biology and clinical behavior of pediatric melanoma. We report a national case series of all pediatric and adolescent malignant melanoma presenting to ANZCHOG Childhood Cancer Centers in Australia and New Zealand. METHODS: A retrospective, descriptive, multi-center study was undertaken to identify patients less than 18 years of age treated for cutaneous malignant melanoma over a twenty-year period (1994 to 2014). Data on clinical characteristics, histopathology, and extent of disease, treatment and follow-up are described. RESULTS: A total of 37 cases of malignant melanoma were identified from all of the Australasian tertiary Childhood Cancer Centers. The median age was 10 years (range 1 month - 17 years). Clinically, the most common type of lesion was pigmented, occurring in sixteen (57%) patients, whilst amelanotic was seen in 7 patients (25%). In 11 (27.9%) the Breslow thickness was greater than 4mm. A total of 11 (29.7%) patients relapsed and 90% of these died of disease. Five-year event free survival (EFS) and overall survival were 63.2 (95% CI: 40.6 - 79.1) and 67.7% (95% CI: 45.1 - 82.6) respectively. CONCLUSION: Our data confirms that melanoma is a rare presentation of cancer to tertiary Australasian Childhood Cancer Centers with only 37 cases identified over two decades. Notably, melanoma managed in Childhood Cancer Centers is frequently at an advanced stage, with a high percentage of patients relapsing and the majority of these patients who relapsed died of disease. This study confirms previous clinical and prognostic information to support the early multidisciplinary management in Childhood Cancer Centers, in conjunction with expert adult melanoma centers, of this rare and challenging patient group.

Low-dose isotretinoin versus minocycline in the treatment of rosacea.

Rosacea is a common inflammatory facial skin condition affecting the adult population. Its papulopustular subtype is mainly treated pharmacologically by topical and oral antibiotics. For severe or antibiotics-recalcitrant disease, daily low-dose isotretinoin has also been reported to be effective. However, no previous study has assessed the efficacy of once-weekly administered isotretinoin for papulopustular rosacea. For this purpose, a retrospective comparative study was conducted. For severe rosacea, 40 mg/week isotretinoin (24 patients) was administered. For mild to moderate rosacea, once-weekly 20 mg/week isotretinoin (28 patients) was compared with 100 mg/day minocycline (24 patients). Treatment courses lasted 4 to 7 months. Forty milligrams per week isotretinoin was highly effective for severe rosacea, achieving complete response (over 90% improvement) in 62.5% of patients and partial response (50%-90% improvement) in additional 29.2% of patients. Twenty milligrams per week isotretinoin and hundred milligrams per day minocycline showed comparable efficacy for mild to moderate rosacea (complete response of 10.7% vs 8.3% and partial response of 28.6% vs 33.3%, respectively). This study demonstrates that that the use of a weekly low-dose isotretinoin is an effective treatment for papulopustular rosacea, including among patients with severe disease.

The shifting preferences of patients and physicians in nonsurgical hair loss treatment.

BACKGROUND: There are multiple etiologies for hair thinning and loss, including genetic, hormonal, immune, scaring, and infectious. Hair loss treatment involves both surgical intervention and nonsurgical therapies such as pharmaceuticals, haircare products, vitamins, and low-level laser therapy (LLLT). While pharmaceuticals have been extensively researched, the efficacy of other therapies remains inconclusive. With so many available treatments, consumers often research their options using search engines such as Google and/or seek help from hair restoration physicians. AIMS: To identify and analyze changing trends in international consumer and physician interest in nonsurgical hair loss therapies. METHODS: Worldwide trends in Google searches of hair loss products (2004-2020) were compared with product prescription frequency surveys from members of the International Society of Hair Restoration Surgery (2004-2019, ~29% response rate). RESULTS: Minoxidil and finasteride were the most prescribed hair loss treatments, while "minoxidil" was the most "Googled" term. Generic products were searched more often than their brand counterparts. Nutritionals and haircare prescriptions increased over time. LLLT was also increasingly prescribed, with Internet searches increasing following government regulation announcements. The COVID-19 pandemic initially negatively affected hair loss treatment searches, which have since returned to, and surpassed, pre-pandemic levels. CONCLUSION: Regulations and social media have influence on consumer interest in hair loss products. A weak economy and coronavirus fears may persuade consumers to turn to cheaper hair loss treatment alternatives. Hair restoration specialists need to keep abreast of online trends to communicate effectively with their patients. Patients should be cognizant of the safety and efficacy of hair restoration treatments.

Follicular Unit Excision Punches and Devices.

BACKGROUND: Follicular unit excision (FUE) is used to harvest follicular units for hair transplantation using trephine punches. The characteristics of FUE punches can impact the success of this technique; thus, many innovative punch designs and devices have been developed. With many options available, it can be difficult for the hair restoration surgeon to know which punch best suits the needs of their patients. OBJECTIVE: To provide a comprehensive review of punch shapes and devices available. METHODS: Search of PubMed, reference mining of relevant publications, and hand searching trade publications. RESULTS: We examined FUE punches and devices and consolidated descriptive information for each to create textual and visual guides. No single punch shape or device may suit all cases; thus, it is important to know the best uses and limitations of each. CONCLUSION: The surgeon should have a comprehensive knowledge base of available punch shapes and devices and understand the advantages and disadvantages of each. It is also beneficial to have an in-depth knowledge of skin properties and follicular unit structure. Ultimately, understanding the dynamics behind punch excision will enhance the FUE technique.

Finasteride Use Is Associated with Higher Odds of Obstructive Sleep Apnea: Results from the US Food and Drug Administration Adverse Events Reporting System.

Finasteride is a 5-α reductase inhibitor indicated for the treatment of androgenetic alopecia and benign prostatic hyperplasia (BPH). Finasteride has been associated with various adverse events, such as erectile dysfunction, fatigue, cognitive impairment, sleep disturbances, including insomnia, depression, and suicidal behavior. These symptoms are sometimes considered features of the "post-finasteride syndrome" (PFS) and are also encountered in obstructive sleep apnea (OSA). The overlapping clinical features of PFS and OSA suggest that OSA could possibly play a mediating role in some of the PFS-related symptoms. There are no reported studies of the association of finasteride use and OSA. The objective of this study was to determine whether finasteride use is associated with a potential safety signal of OSA compared to a baseline potential safety signal for all other drugs in the US Food and Drugs Administration Adverse Event Reporting System (FAERS) database. A case by non-case disproportionality approach was used, whereby a reporting odds ratio (ROR) with 95% confidence interval (CI) was calculated. Cases of finasteride-associated OSA were compared to a reference potential safety signal of OSA with all other drugs in the database. A similar calculation was carried out for finasteride-associated insomnia to confirm previous reports of a greater than expected reporting of insomnia with finasteride use. A significant disproportionality (ROR = 5.65 [95% CI 4.83-6.62, z = 21.56, P < 0.0001]) in reporting of OSA with the use of finasteride was observed. The potential safety signal for OSA with finasteride remained significantly higher when finasteride use for hair loss and BPH was examined separately. Finasteride use was associated with a greater than expected reporting of insomnia (ROR = 1.93 [95% CI 1.77-2.09, z = 15.958, P < 0.0001]). A limitation of this study is that selection bias is inherent in FAERS and adverse events could be underreported. Finasteride use may be associated with a potential safety signal for OSA. Patients complaining of PFS-related symptoms may benefit from a further sleep evaluation to rule out underlying OSA.

Outcomes of Febrile Neutropenia in Children With Cancer Managed on an Outpatient Basis: A Report From Tertiary Care Hospital From a Resource-limited Setting.

In low-risk febrile neutropenia (FN) patients, outpatient management is now an accepted treatment, but there is a scarcity of data on high-risk patients. The aim of our study was to describe the outcome of FN treated primarily in an outpatient setting on the basis of the severity of illness at presentation, irrespective of the intensity of chemotherapy, and absolute neutrophil count. In this prospective study, not severely ill (NSI) patients were treated with empiric antibiotics at the daycare center (outpatient) and were admitted subsequently if there was persistent fever or any complication arose. Severely ill (SI) children were admitted to the hospital upfront. A total of 118 FN episodes among children with cancer on chemotherapy 18 years of age and younger were studied. Among NSI patients managed as outpatients (n=103), 89 patients (86%) recovered with outpatient treatment, and 14 patients required hospitalization after the median duration of 5 days (interquartile range: 4 to 6 d) of antibiotic therapy. The main indication for hospital admission in the SI group was hypotension (n=5), and in the NSI group, it was persistent fever (n=11). Overall, 5% of patients (6/118) died, and 2 of these were in the NSI group. The results of this study suggest that carefully selected NSI patients could be successfully treated at outpatient management in resource-poor settings and subsequent admission if warranted.