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BACKGROUND ATX-101 is approved for submental fat reduction. OBJECTIVE To characterize the histological effect of ATX-101 injection into subcutaneous fat. METHODS This Phase 1 open-label study enrolled 14 adults to receive injections of ATX-101 into abdominal fat at varying concentrations (0.5%, 1.0%, 2.0%, or 4.0%), volumes (0.2 or 0.4 mL), spacing (0.7, 1.0, or 1.5 cm), and time points before scheduled abdominoplasty (1, 3, 7, or 28 days). During abdominoplasty, tissue was excised and preserved for histology. RESULTS All injection paradigms resulted in histological changes confined to the subcutaneous layer, which were more prominent at higher concentrations and independent of volume and spacing. Key features at Day 1 after injection were adipocytolysis, blood vessel injury, neutrophilic inflammation, and lysis of locally present neutrophils. At Day 3, inflammation was reduced versus Day 1, and hemorrhage and lipid lake formation (at higher concentrations) were observed. Day 7 samples exhibited prominent adipocytolysis, mild inflammation, lipid-laden macrophages in the septae, and repair of vascular injury. At Day 28, inflammation was largely resolved and prominent features were septal thickening, neovascularization, and atrophy of fat lobules. CONCLUSION Subcutaneous injection of ATX-101 induces adipocytolysis and local inflammation with septal thickening and resolution of inflammation by 28 days after injection. [ABSTRACT FROM AUTHOR]

Examines the experience of the University of Rochester in managed care. Information about The School-Based Health Center (SBHC); Criteria for membership; Services provided; Evaluation of the program; Problems faced in implementing the program; Status of the program; Future plans.

Discusses the development of bone marrow transplantation as a possible treatment for leukemia. Demands placed by the procedure upon nursing staff; Characteristics of transplant candidates; Infusion procedure; Precautions designed to counteract the toxic effects of the chemotherapeutic agent Cytoxan.

BACKGROUND ATX-101, an injectable form of deoxycholic acid, is approved in the United States and Canada for submental fat (SMF) reduction. OBJECTIVE To report results of REFINE-1, a randomized, double-blind, placebo-controlled, Phase 3 trial investigating the efficacy and safety of ATX-101. METHODS Subjects dissatisfied with their moderate or severe SMF received ATX-101 (2 mg/cm2) or placebo. Coprimary outcome measures were composite ≥1-grade and ≥2-grade improvements in clinician-assessed and subject-assessed SMF severity using validated scales at 12 weeks after last treatment. Magnetic resonance imaging (MRI) provided an objective measure of submental volume reduction. Patient-reported outcomes were assessed. RESULTS Among 256 ATX-101-treated and 250 placebo-treated subjects, a ≥1-grade composite response was achieved in 70.0% and 18.6%, and a ≥2-grade composite response in 13.4% and 0%, respectively (p < .001 for both). The proportion of MRI responders was more than 8 times higher with ATX-101 than placebo (46.3% vs 5.3%; p < .001). ATX-101-treated subjects reported improvement in the psychological impact of SMF and satisfaction with treatment (p < .001 for all assessments vs placebo). Of note, 55% and 75% of ATX-101-treated subjects reported 1-grade improvement in clinician-assessed SMF after 2 and 4 treatments, respectively. Adverse events (primarily localized to the injection site) were mostly mild or moderate, and transient. Marginal mandibular nerve paresis reported in 4.3% of ATX-101-treated subjects (1.0% of all ATX-101 treatment sessions) was mostly mild, transient, and resolved without sequelae. CONCLUSION ATX-101 is a safe and efficacious, first-in-class, injectable drug for SMF reduction. [ABSTRACT FROM AUTHOR]

BACKGROUND Validated aesthetic rating scales for the perioral area provide objective evaluations for clinical trials and practice. OBJECTIVE To confirm the reliability of 3 scales for evaluating dermal filler and neurotoxin treatments of the perioral area. MATERIALS AND METHODS Three lip-specific photographic scales were developed from standardized 2-dimensional images to evaluate Perioral Lines at Rest (POL), Oral Commissures (OCS), and Perioral Lines at Maximum Contraction (POLM) severity scales. Each 4-grade scale (none to severe) had 3 representative images per grade. Physician validators rated volunteers on each scale (2 rounds of live review). Volunteers provided 2 series of self-assessments. Physician and subject intrarater reliability were based on the comparison of round 1 and round 2 scores (mean weighted kappa coefficient). Other measures were physician interrater agreement (intraclass correlation) and subject/physician interrater agreement (Pearson correlation). RESULTS Physician intrarater agreement was almost perfect or substantial (POL, 0.725; OCS, 0.789; POLM, 0.826). Overall, physician interrater agreement was almost perfect for all 3 scales and ranged from moderate to substantial by grade. Subject intrarater agreement and subject/physician interrater agreement were substantial. CONCLUSION All scales demonstrated a high degree of intrarater and interrater reliability during the validation process. Physician concordance was good; subject ratings were reliable and comparable to physician assessments. [ABSTRACT FROM AUTHOR]

Describes a day in the practice lives of nurse practitioners and certified nurse midwives in the U.S. using survey results of advanced practice nurses (APN). Effects of changes in the health care delivery system; Kinds of information from which inferences can be made about the quality of care; Ethnicity of patients; List of common and difficult clinical problems.

BACKGROUND A new family of next-generation non-animal hyaluronic acid (HA) dermal fillers was approved by the FDA in June 2006. Compared with other HA fillers available in the United States at the time of writing, these new fillers have a higher concentration of HA, higher concentration of cross-linked HA, and a smooth consistency—which should promote long-lasting corrections and a smooth, natural look and feel postinjection. OBJECTIVE The objective was to compare the effectiveness and safety of these smooth-gel HA dermal fillers with bovine collagen for nasolabial fold (NLF) correction. METHODS AND MATERIALS A total of 439 subjects with moderate or severe NLFs received one of three types of smooth-gel HA dermal filler (in one NLF) and cross-linked bovine collagen (in the other NLF) and were evaluated for ≤24 weeks. RESULTS All three HA dermal fillers achieved considerably longer-lasting clinical correction than bovine collagen; 81% to 90% of HA dermal filler–treated NLFs maintained a clinically significant improvement from baseline for ≥6 months. Up to 88% of subjects preferred the HA dermal fillers over bovine collagen. All fillers were similarly well tolerated. CONCLUSION The smooth-gel HA dermal fillers offer longer-lasting correction than bovine collagen—which may lessen the frequency that repeat treatments are needed. Also, they were preferred by the vast majority of subjects—which should promote patient satisfaction. [ABSTRACT FROM AUTHOR]