Split-face Evaluation of a Multi-ingredient Brightening Foam Versus a Reference Control in Women with Photodamaged Facial Skin.

Background: The gold standard for the treatment of hyperpigmentation is hydroquinone (HQ), which has been available as a skin lightener for more than 50 years. Numerous clinical studies have proven its efficacy in various topical formulations. In the United States, HQ is available as a nonprescription product in 2% formulations and as a 4% prescription product. Objective: This study compared the safety and efficacy of a 2% hydroquinone multi-ingredient foam with a standard 4% hydroquinone cream on photodamaged facial skin. Methods: A 12-week, investigator-blinded, randomized trial with a split-face design was conducted in women with moderate photodamaged facial skin. Results: Both products improved the appearance of photodamaged facial skin and were well-tolerated. No statistically significant changes were seen between treatments during the efficacy or tolerability evaluations. Conclusion: Both treatments (2% HQ Brighten and 4% HQ) improved the appearance of photodamaged facial skin and were well-tolerated and results well-perceived by subjects over the 12-week treatment period, compared with baseline grading scores.

Efficacy and Tolerability of an Acne Treatment Regimen with Antiaging Benefits in Adult Women: A Pilot Study.

Objective: The objective of this study was to assess clinical safety and efficacy of a novel acne treatment regimen in adult women. Methods: Participants in the study included an ethnically diverse group of adult women (n=24) with mild-to-moderate acne who were treated twice daily with a topical regimen (cleanser, acne cream, and rebalancing gel) for eight weeks. Following baseline assessments, subjects returned to clinic at Weeks 2, 4, and 8 for clinical assessments and self-assessment questionnaires. Results: Twenty-one of the 24 enrolled women completed the eight-week clinical trial. Statistically significant clinical improvements were seen in both acne and aging parameters over time. The product regimen was well tolerated without adverse reactions commonly seen with topical acne products. Conclusion: The regimen demonstrated efficacy and tolerability in adult women with acne and signs of skin aging.

Topical Treatment of Aging Hands: Brief Report.

Rejuvenation of aging hands is becoming increasingly important to physicians and their patients. While a variety of invasive treatments are available, topical products that improve manifestations of aging hands are needed. In this brief report, the efficacy of a topical product containing urea, lipids, sodium copper chlorophyllin complex, antioxidants, and humectants was assessed in subjects with moderate-to-severe photodamage of the hands.

Ability of sodium copper chlorophyllin complex to repair photoaged skin by stimulation of biomarkers in human extracellular matrix.

PURPOSE: To examine the effect of sodium copper chlorophyllin complex on the expression of biomarkers of photoaged dermal extracellular matrix indicative of skin repair. PATIENTS AND METHODS: Following a previously published 12-day clinical assessment model, skin biopsy samples from the forearms of four healthy females with signs of photoaged skin were obtained and samples were analyzed by immunohistochemistry for key biomarkers of aging skin after each subject was treated with a test material consisting of a gel containing a liposomal dispersion of sodium copper chlorophyllin complex 0.05%, a positive control of tretinoin cream 0.025%, and an untreated negative control. RESULTS: There was a statistically significantly greater amount of fibrillin/amyloid P and epidermal mucins found for skin treated with the test material containing 0.05% sodium copper chlorophyllin complex and the reference control tretinoin 0.025% cream compared to the negative control (untreated site). Expression of procollagen 1 and dermal mucin also showed a greater presence in the samples treated with the test material and the reference control compared to the negative control, though the differences were not statistically significant. No adverse events were observed or reported by the subjects during the course of the study. CONCLUSION: The results of this human biopsy study suggest that both retinoids and sodium copper chlorophyllin complex have beneficial effects on biomarkers of photoaged skin. Products containing both sodium copper chlorophyllin complex and retinols may provide a dual approach to reversing age-related decreases in hyaluronic acid (HA) in the skin: inhibition of the breakdown of HA via sodium copper chlorophyllin complex by inhibition of hyaluronidase, and stimulation of HA synthases by retinol.

Clinical efficacy and safety of a multimodality skin brightener composition compared with 4% hydroquinone.

There are numerous common skin disorders involving hyperpigmentation, including solar lentigines, postinflammatory hyperpigmentation, melasma, freckles, and dyschromia from photoaging. While these conditions are of an aesthetic nature, there is great interest in newer, safer, and more effective treatment modalities. Topical hydroquinone (HQ) has been the gold standard of skin lighteners for many years. However, regulatory authorities around the world are now questioning its safety. A randomized, double-blind, half-face study was conducted in females with moderate to severe facial hyperpigmentation to assess the efficacy and tolerability of 3 new skin brightener formulations containing SMA-432, a prostaglandin E2 inhibitor, compared with 4% HQ. Each subject was assigned 2 of the 4 test materials and was instructed to apply the product on the assigned side of the face twice daily for 12 weeks. Evaluation visits were conducted at baseline and at 4, 8, and 12 weeks. At each visit, subjects were evaluated by a blinded investigator for clinical efficacy and tolerability using grading scales. Standardized digital photography and Chroma Meter assessments were also taken. Self-assessment questionnaires were completed at weeks 4, 8, and 12. Sixty-eight Caucasian subjects (136 half faces) completed the study. All test materials significantly reduced Overall Hyperpigmentation and improved the Investigator's Global Hyperpigmentation Improvement rating at weeks 4, 8, and 12 compared with baseline. SMA-432 exhibited a dose-dependent improvement in hyperpigmentation. There were no major tolerability issues with any of the test materials. Self-assessments were generally favorable for all test materials. At the completion of the trial, subjects rated one of the tested multimodality brightener compositions as the most favorable product and 4% HQ as the least favorable. This study demonstrated that the new non-HQ-containing skin brightener formulations were as effective and equally well tolerated as the gold standard, 4% HQ, in females with facial hyperpigmentation.

Clinical efficacy and safety of a multimodality skin brightener composition compared with 4% hydroquinone.

There are numerous common skin disorders involving hyperpigmentation, including solar lentigines, postinflammatory hyperpigmentation, melasma, freckles, and dyschromia from photoaging. While these conditions are of an aesthetic nature, there is great interest in newer, safer, and more effective treatment modalities. Topical hydroquinone (HQ) has been the gold standard of skin lighteners for many years. However, regulatory authorities around the world are now questioning its safety. A randomized, double-blind, half-face study was conducted in females having moderate to severe facial hyperpigmentation to assess the efficacy and tolerability of 3 new skin brightener formulations containing SMA-432, a prostaglandin E2 inhibitor, compared with 4% HQ. Each subject was assigned 2 of the 4 test materials and was instructed to apply the product on the assigned side of the face twice daily for 12 weeks. Evaluation visits were conducted at baseline and at 4, 8, and 12 weeks. At each visit, subjects were evaluated by a blinded investigator for clinical efficacy and tolerability using grading scales. Standardized digital photography and Chroma Meter assessments were also taken. Self-assessment questionnaires were completed at weeks 4, 8, and 12. Sixty-eight Caucasian subjects (136 half faces) completed the study. All test materials significantly reduced overall hyperpigmentation and improved the Investigator's Global Hyperpigmentation Improvement rating at weeks 4, 8, and 12 compared with baseline. SMA-432 exhibited a dose-dependent improvement in hyperpigmentation. There were no major tolerability issues with any of the test materials. Self-assessments were generally favorable for all test materials. At the completion of the trial, subjects rated one of the tested multimodality brightener compositions as the most favorable product and 4% HQ as the least favorable. This study demonstrated that the new non-HQ-containing skin brightener formulations were as effective and equally well tolerated as the gold standard, 4% HQ, in females with facial hyperpigmentation.

A randomized, double-blind, controlled comparative trial of the anti-aging properties of non-prescription tri-retinol 1.1% vs. prescription tretinoin 0.025%.

Vitamin A and its derivatives (commonly termed retinoids) are widely used in topical anti-aging products. Certain retinoids such as retinol and its esters are available without a prescription, while others such as tretinoin are available only via prescription. A randomized, double-blind, controlled clinical study was conducted to compare the efficacy and tolerability of a tri-retinol 1.1% gradual release cream vs. tretinoin 0.025% cream in females with mild-to-moderate facial photodamage. Subjects applied the test product to the entire face in the evening after cleansing in a progressively increasing frequency starting twice weekly for the first week, followed by three times weekly during the second week and then daily as tolerated for the third week and beyond. Treatment was continued for a total of three months. Clinical evaluations and standardized digital photographs were performed at baseline and after four, eight, and 12 weeks of treatment. Self-assessment questionnaires were completed by the subjects at four, eight, and 12 weeks to assess perceived efficacy of the test products. Thirty-four subjects (16: tri-retinol and 18: tretinoin) completed the study. Both test products significantly improved signs of photodamage, including fine and coarse periocular wrinkles, skin firmness, skin tone, mottled pigmentation, tactile roughness, overall photodamage and global photodamage improvement. There were no significant differences in efficacy between the two products for these assessments. The adverse effects (which were graded as mild or less) were those typically seen with topical retinoids. Subjects reported >93 percent overall satisfaction with both products at weeks 8 and 12.

The importance of vehicle properties to patients with atopic dermatitis.

The properties of vehicle formulations may influence drug delivery, efficacy, and tolerance profiles of topical medications. Patient preferences vary and the importance of certain aesthetic attributes depend on the disease state, the site of application, and the length and extent of treatment, among other factors. Formulations that offer aesthetic advantages over traditional vehicles may improve patients' willingness to apply therapy as directed and therefore may affect the outcome of treatment. A participant preference study was conducted to determine if an aqueous gel (hydrogel) formulation of desonide would appeal to patients with atopic dermatitis (AD). Before treatment adult participants with AD completed a questionnaire to assess their AD history and prior topical treatments and to rate the importance of topical vehicle attributes. Each participant then applied desonide hydrogel 0.05% to affected areas twice daily for 4 weeks. At the end of the treatment, participants were queried on the attributes of desonide hydrogel and how it compared with other vehicles previously used. Twenty-two participants with mild to moderate AD completed the study; 100% (22/22) of participants found desonide hydrogel to be easy to apply/use/spread, easy to use on hair-bearing skin, comfortable to use under makeup and/or cosmetics, suitable for use on multiple body areas, and stain free. Most participants reported that the product was soothing (82% [18/22]), did not dry the skin (96% [21/22]), disappeared quickly (82% [18/22]), was comfortable to wear under clothes (91% [20/22]), and was not greasy or shiny on skin (96% [21/22]).

Self-reported participant experience with desonide hydrogel in the treatment of mild to moderate atopic dermatitis.

The objective of this study was to evaluate patients' real-world experiences with desonide hydrogel for the treatment of mild to moderate atopic dermatitis (AD). Physicians who participated in this patient-experience program identified eligible participants (age range, < 3 months to 91 years) for treatment with desonide hydrogel 0.05%. The medication was prescribed by each participant's physician according to his/her practice guidelines and was provided to the participant at no charge. Patients (or their parents/guardians) voluntarily participated by providing consent and completing 2 surveys: one at baseline (pretreatment) and the other approximately 3 weeks after initiation of desonide hydrogel treatment (posttreatment). The pretreatment survey included questions about prior topical medication use for AD and satisfaction with prior treatments. The second survey assessed compliance with desonide hydrogel, satisfaction with treatment, characteristics of desonide hydrogel, intent to continue treatment, and willingness to recommend desonide hydrogel to others. A total of 1185 participants completed both the pretreatment and posttreatment surveys. Participant satisfaction with desonide hydrogel was 95% greater than satisfaction with prior topical medications for AD (P < .01). Adherence to treatment with desonide hydrogel was more than 80% based on reports from participants. Eighty-nine percent of participants reported that they would continue to use the medication for their condition if needed and 85% would recommend desonide hydrogel to others. Prescribing physicians received individual summaries of survey responses reported by each of his/her participating patients, which provided valuable feedback regarding participants' perceptions of treatment. Participants reported favorable experiences after treatment with desonide hydrogel compared with prior topical therapies. Desonide is widely prescribed for the treatment of AD.

Moisturizing advantages of desonide hydrogel in treating atopic dermatitis.

The stratum corneum typically is compromised in patients with atopic dermatitis (AD). Beneficial AD treatments should provide moisture to the skin as well as restore impaired barrier function. Traditional treatments involve ointments or creams. A clinical study was conducted to determine if desonide in a hydrogel vehicle (HGV) could improve the moisture content and barrier function of the stratum corneum in adults with mild to moderate AD. Participants applied desonide hydrogel 0.05% twice daily for 4 weeks to areas of both lesional and nonlesional skin. Corneometry and transepidermal water loss (TEWL) were measured at baseline and weeks 1, 2, and 4. Statistically significant improvements in corneometry and TEWL measurements on lesional skin were observed at all study visits compared with baseline (all P < or = .002 and P < or = .04, respectively).

Combination of physiologically balanced growth factors with antioxidants for reversal of facial photodamage.

A 3-month, open-label, single-center study was conducted to determine whether a uniquely formulated and physiologically balanced topical treatment serum containing multiple growth factors, cytokines, peptides, antioxidants and depigmenting agents could improve the visible signs of facial photodamage. Thirty-seven females, aged 32-55 years, with mild to severe, fine and coarse peri-ocular wrinkles were enrolled and completed the study. Subjects applied the treatment serum to the face twice daily for 3 months in conjunction with a basic skincare regimen. Clinical evaluations of photodamage were performed at baseline and months 1, 2 and 3. Cutometer measurements and subject self-assessment questionnaires were also conducted during the study. Clinical evaluations showed statistically significant reductions in fine wrinkles and coarse wrinkles and improvements in skin texture, tone and radiance starting at month 1 with continued improvements at months 2 and 3. Cutometer readings showed decreased skin extensibility and increased resiliency. Subject self-assessments confirmed that the beneficial effects of the treatment serum were readily observed by the users. The treatment serum was well-tolerated with no treatment-related adverse events reported during the 3-month study. Use of this novel treatment serum produced significant improvements in the visible signs of facial photodamage.

Clinical assessment of a combination lip treatment to restore moisturization and fullness.

Objective. To evaluate the efficacy and tolerance of a topical lip-care treatment. Step one of the two-step treatment is a lip-renewal formulation containing human growth factors, hyaluronic acid and marine filling spheres, emollients, and a tripeptide palmitoyl-glycyl-histidyl-lysine complex. Step two is a lip-plumper formulation containing niacin, emollients, and essential fatty acids. Design. Four-week, single-center, open-label, clinical study with clinical assessments at Baseline, Week 2, and Week 4. Treatment. Subjects wore the lip products at least eight hours every day with a minimum of three applications per day. Participants. Thirty-two women ages 22 to 40 years with mild-to-moderate lip dryness and average size lips completed the study. Measurements. Visual grading of the condition of the lips, rating of subjective irritation, corneometry, digital caliper measurements of lower lip, and digital photography. A self-assessment questionnaire was also employed to assess patient satisfaction. Results. Clinical assessments showed statistically significant improvements (P<0.001) in key lip condition parameters after both two and four weeks of use. Key parameters included lip scaling, cupping, cracking/fissuring, fine lines due to dryness, lip texture/visual roughness, lip color/rosiness, lip definition/contour, and overall lip condition. Significant increases (P<0.001) were observed in both corneometer measurements, which confirm the moisturizing benefits, and in digital caliper measurements, which confirm the lip-plumping benefits. Self-assessment questionnaires showed a 97-percent overall satisfaction rating. No adverse events were reported during the course of the study. Conclusion. The results from this clinical study demonstrate that this two-part lip-care treatment product was well tolerated and effective in restoring moisture and fullness to the lips of female subjects with mild-to-moderate lip dryness.

Immediate and Long-term Clinical Benefits of a Topical Treatment for Facial Lines and Wrinkles.

OBJECTIVE: To evaluate the efficacy and tolerance of a novel line treatment for periocular and perioral wrinkles. The line treatment was formulated with multiple growth factors, antioxidants, and a collagen-building peptide-ingredients that have been shown to increase collagen levels and provide long-term aesthetic benefits. To help provide immediate smoothing effects, hyaluronic acid filling spheres and a muscle contraction-inhibiting peptide were also included in the formulation. DESIGN: Three-month, single-center, open-label, clinical study with clinical assessments at Baseline, Minutes (within 15 minutes of initial application), Month 1, and Month 3. TREATMENT: Subjects treated periocular and perioral wrinkles twice daily for three months with the line treatment. PARTICIPANTS: Thirty-seven females, 33 to 45 years of age, with mild-to-moderate, fine and coarse periocular and perioral wrinkles, were enrolled in the study. MEASUREMENTS: Investigator assessments of fine and coarse periocular and perioral wrinkles, digital photography, and tolerance assessments were conducted at all visits. Subject self-assessment questionnaires were conducted within 15 minutes of initial application and at Month 3. RESULTS: Investigator assessments of both periocular and perioral wrinkles showed statistically significant improvements over Baseline within minutes of initial application; these positive findings continued to improve through Months 1 and 3 (all P

Comparison of characteristics of treated and non-treated patients with Hepatitis C infection.

OBJECTIVES: This study compares the characteristics of treated and non-treated patients with Hepatitis C (HCV) infection. METHODS: Information on patient demographics, clinical data, and treatment regimens were collected from a retrospective medical record review of 998 patients diagnosed with HCV, representing a diverse geographic sample of 200 U.S. physicians including 130 gastroenterologists, 50 infectious disease physicians, and 20 hepatologists. A total of 551 patients were randomly selected and 447 were provided as an augmented sample in an intent-to-treat analysis based on treatment decisions. Pretreatment factors examined included age, gender, race, weight, HCV genotype, HCV viral load, serum ALT levels, liver biopsy results, cirrhosis, HIV co-infection, HBV co-infection, IV drug use, and insurance status. Univariate analyses were performed using Chi-squared or ANOVA tests. Factors that were significant in univariate analyses were entered into a multivariate logistic regression model with HCV treatment as the outcome variable. RESULTS: Of the 998 patients reviewed, 778 were treated for HCV and 220 were not treated. In univariate analyses, non-treated patients were more likely to be African American, HBV co-infected, HIV co-infected, IDUs, alcoholics, Medicaid insured, and were less likely to have had biopsies. The multivariate regression analysis demonstrated that performance of a liver biopsy, treatment with psychiatric medications (antidepressants and anxiolytics), and patient weight were independently associated with treatment, while Medicaid insurance and HIV co-infection were independently associated with a decreased likelihood of receiving HCV therapy. CONCLUSION: This study suggests that it is not the clinical stage of HCV infection but the patient's demographic characteristics and co-morbid conditions that impact the decision to initiate HCV therapy.

Use of amphotericin B lipid complex in elderly patients.

OBJECTIVES: The safety and effectiveness of amphotericin B lipid complex (ABLC) treatment in elderly patients was investigated using a large multicenter database. METHODS: Data analysis was conducted on retrospectively collected patient data from 572 patients >65 years of age and 2930 patients < or =65 years of age treated for fungal infections at 160 North American hospitals. RESULTS: Patients were typically treated with ABLC for Candidiasis, multiple fungal pathogen infections and Aspergillosis, or were treated empirically. The median cumulative dose of ABLC in patients >65 years of age and those 65 years of age was similar (3000 and 3258 mg, respectively, P=0.127). Despite higher median pretreatment serum creatinine (S-Cr) among patients >65 years of age (1.7 mg/dl vs. 1.4 mg/dl, respectively), both groups showed only a 0.1mg/dl median S-Cr change from baseline by the end of therapy (P=0.525). Clinical response was 56 and 51%, respectively, in patients >65 years of age and patients 65 years of age or younger (P=0.049). CONCLUSIONS: This study suggests that ABLC can be safely and effectively used in the treatment of invasive fungal disease in elderly patients.

Mycophenolate mofetil vs. azathioprine is associated with decreased acute rejection, late acute rejection, and risk for cardiovascular death in renal transplant recipients with pre-transplant diabetes.

Outcomes specifically in mycophenolate mofetil (MMF)-treated diabetic renal transplant patients have not been previously reported. This study compared acute rejection (AR), late acute rejection (LAR), patient survival [and specifically death from cardiovascular (CV), infectious and malignant causes], incidence of post-transplant malignancies, and graft loss in MMF- or azathioprine (AZA)-treated renal transplant patients with pre-transplant diabetes. Outcomes were compared between MMF- (n = 14 144) and AZA- (n = 3001) treated diabetic patients using the Scientific Registry of Transplant Recipients data on all U.S. adult renal transplants performed between 1995 and 2002. Statistical analyses included Kaplan-Meier survival analysis, Cox multivariable regression and chi-square tests. MMF patients had less AR compared with AZA-treated patients (23.5% vs. 28.3%, p < 0.001) and less risk for LAR over 4 yr [hazard ratio (HR): 0.64, 95% CI 0.44, 0.92; p = 0.02]. While time to any-cause death did not differ between the groups, MMF treatment was associated with a 20% decreased risk of CV death (HR: 0.80, 95% CI 0.67, 0.97; p = 0.020) compared with AZA treatment. MMF patients also had a lower incidence of malignancies than AZA patients (2.2% vs. 3.7%, p < 0.001). These results suggest treatment with MMF compared with treatment with AZA in diabetic transplant patients is associated with less AR, less risk of LAR, a decreased risk of CV death, and a lower incidence of malignancies.

Clinical experience with nonstandard doses ofinterferon alfa-2b and ribavirin in the treatment of chronic hepatitis C infection: A retrospective analysis.

BACKGROUND: Hepatitis C virus (HCV) infection is the most common blood-borne virus in the United States. Several mono- and combination therapies have been approved by the US Food and Drug Administration for the treatment of HCV, but their routes of administration, dosing approaches, eras of introduction, and actual use in clinical practice and resulting effectiveness have not yet been reported. OBJECTIVES: The aim of this article was to characterize clinical use and virologic response (VR) of the HCV treatments interferon alfa-2b plus ribavirin (IFN + RBV) and peginterferon alfa-2b plus ribavirin (peg-IFN + RBV). METHODS: This retrospective chart review of office-based practices in theUnited States was conducted at 200 physicians' offices across the United States. We collected data concerning dosing patterns, VR (HCV RNA load, ≤1000 IU/mL or "negative" on polymerase chain reaction qualitative analysis), and adverse events (AEs) from the medical records of a geographically diverse sample of patients receiving treatment for chronic HCV infection in the United States from July 2001 to June 2002. For efficacy assessment, factors that were statistically different at baseline were adjusted using logistic regression. Providers also reviewed the medical records for symptoms or signs consistent with HCV treatment-related AEs. RESULTS: Data from the records of 675 patients (423 men, 252 women; mean [SD] age of 45.5 [8.2] years; mean [SD] body weight, 80.8 [19.4] kg) were analyzed. At baseline, the IFN + RBV treatment group (330 patients) had significantly higher percentages of black patients (22.1% vs 15.7%; P = 0.032) and patients with hepatic disease based on clinician-reported cirrhosis and liver dysfunction (18.8% vs 9.9%; P < 0.001), and a significantly lower percentage of white patients (60.3% vs 69.6%; P = 0.012) compared with the peg-IFN + RBV treatment group (345 patients). The difference in log-transformed baseline HCV RNA loads between the 2 treatment groups in this study was <1 log unit. A significantly higher percentage of IFN + RBV-treated patients compared with peg-IFN + RBV-treated patients were prescribed HCV therapy on diagnosis (37.3% vs 29.9%; P = 0.041), and the mean (SD) duration of treatment was significantly different between the 2 treatment groups (52.5 [37.0] vs 27.5 [15.0] weeks; P < 0.001). Peg-IFN + RBV was associated with a higher rate of VR compared with IFN + RBV on univariate analysis (28.5% vs 17.5%; P = 0.018). Recommended doses of peg-IFN and higher-than-recommended doses of RBV were associated with an increased likelihood of VR. Higher-than-recommended doses of peg-IFN without a concomitant increase in RBV was not associated with an increased likelihood of VR. The incidences of the 3 most commonly reported AEs in the IFN + RSV group were significantly higher compared with those in the peg-IFN + RSV group: fatigue, 217 (65.8%) versus 185 (53.6%) patients (P = 0.001); depression, 147 (44.5%) versus 120 (34.8%) (P = 0.009); and anxiety, 87 (26.4%) versus 64 (18.6%) (P = 0.014). Nausea, however, was reported in a significantly higher number of patients in the peg-IFN group compared with the IFN + RBV group (74 [21.4%] vs 51 [15.5%]; P = 0.045). The frequencies of dose modification and treatment discontinuation due to AEs were similar between the 2 treatments and were similar to or less than those reported in other studies. CONCLUSIONS: In this retrospective data analysis of US office-based practicesconcerning HCV treatment, clinicians were observed to prescribe IFN + RBV at doses that differ from recommendations in the product information (PI), as well as prescribe the RBV component of peg-IFN + RBV at doses that differed from PI recommendations. Although patients treated with peg-IFN + RBV appeared to achieve higher VR compared with those treated with IFN + RBV in our analysis of data from clinical practice, peg-IFN + RBV was associated with lower VR rates compared with those reported in clinical studies.

Retrospective study of the renal effects of amphotericin B lipid complex when used at higher-than-recommended dosages and longer durations compared with lower dosages and shorter durations in patients with systemic fungal infections.

BACKGROUND: Patients with fungal infections who are treated with amphotericin B lipid complex (ABLC) often receive dosages less than that recommended in the product information (5 mg/kg.d). This occurs despite the described safety and increased efficacy in select patients treated with higher ABLC dosages. OBJECTIVE: The purpose of this study was to compare the renal effects of high-dosage/long-duration (HDos/LDur) ABLC therapy (>5 mg/kg.d for >12 days) with those of low-dosage/short-duration (LDos/SDur) ABLC therapy (or=4 ABLC doses according to a large, multicenter patient database, the Collaborative Exchange of Antifungal Research (CLEAR) registry. The safety profile of each dosage was evaluated using serum creatinine concentration (S-Cr) and calculated creatinine clearance (CCcr). RESULTS: A total of 1726 patients were studied. The HDos/LDur group included 309 patients and theLDos/SDur group included 1417 patients. The median ages of the HDos/LDur and LDos/SDur groups were 42 and 48 years, respectively (ranges, <1 to 83 and <1 to 95 years; P < 0.001); females comprised 51% and 42% of the 2 populations (P = 0.004); and 6% and 12% had solid tumors (P = 0.002). The HDos/LDur group was more likely than the LDos/SDur group to have been treated for multiple systemic fungal pathogen infections (16% and 9%, respectively) and for mold infections (28% and 12%, respectively) (both, P < 0.001). The median change in S-Cr from baseline was 0.1 mg/dL in both groups (range, -4.9 to 5 mg/dL in the HDos/LDur group and -3.96 to 4.7 mg/dL in the LDos/SDur group). No increased risk for renal dysfunction, as reflected in the median change from baseline in CCcr, was observed in either cohort (-3 mL/min [range, -118.65 to 69.03 mL/min] in the HDos/LDur group; -2.17 mL/min [range, -107.48 to 104.45 mL/min] in the LDos/SDur group). CONCLUSION: These data suggest that higher ABLC dosages appear to be as well tolerated as lower dosages, warranting further study of ABLC dosages >5 mg/kg.d for >12 days in the treatment of systemic fungal infections.

Mycophenolate mofetil vs azathioprine in a large population of elderly renal transplant patients.

BACKGROUND: Mycophenolate mofetil (MMF) has been shown to decrease acute rejection episodes after kidney transplantation, and has been associated with better graft and patient survival vs azathioprine (AZA). Previous studies reported a higher risk of death due to infection in elderly recipients treated with MMF-based immunosuppression. METHODS: We analysed 5069 elderly ( > 65 years of age) primary renal allograft recipients treated with either MMF or AZA reported to the Scientific Registry of Transplant Recipients between 1988 and 2000, and compared rates of acute rejection, late acute rejection, graft survival, death-censored graft survival, patient survival and death with a functioning graft. RESULTS: In Cox proportional hazard models, MMF was associated with lower rates of late acute rejection with 12 (RR = 0.72, P = 0.11) and 24 months (RR = 0.50, P = 0.028) of continuous therapy. In univariate analysis (Kaplan-Meier), MMF was associated with improved patient (P = 0.0003) and graft (P<0.0001) survival vs AZA, and trends toward improved patient and graft survival in multivariate analyses. CONCLUSIONS: These findings demonstrate the efficacy of MMF-based immunosuppression in elderly transplant recipients and do not suggest an increased risk of death compared to treatment with AZA.