The Doctor's Channel - Dermatology

Sunscreen

2010-02-18T21:08:13+00:00

Vincent A. DeLeo, MD, Chairman, Department of Dermatology, St. Luke’s-Roosevelt Hospital Center, New York, New York, and Beth Israel Medical Center, New York, discusses the US Food and Drug Administration’s Proposed Rule on sunscreen drug products for over-the-counter human use. The document addresses the proper development, testing, and labeling of sunscreen products. Dermatologists will be at the forefront of educating and helping consumers understand the meaning of the new labeling.

The original editorials were featured in Cutis®, which provided an overview and discussion of the Proposed Rule.

Resources:
DeLeo VA. Proposed FDA rule on sunscreens, part 1: a new label [editorial].Cutis. 2008;81:460-462.

DeLeo VA. Proposed FDA rule on sunscreens, part 2: UVA [editorial]. Cutis. 2008;82:17-19.

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Skin manifestations of psoriatic arthritis respond best to twice weekly etanercept

2010-02-12T20:20:15+00:00

NEW YORK (Reuters Health) - In patients with psoriatic arthritis, once weekly etanercept (Enbrel) is suitable for joint symptoms but twice weekly dosing is needed to best address skin lesions, according to a report in the February 9th Online First issue of BMJ

"Inflammation in the skin seems to be more pronounced than in joints of psoriasis patients, and thus requires a higher dosing, particularly in the induction phase of treatment," lead author Dr. Wolfram Sterry, from Charite University Medicine, Berlin, told Reuters Health by email.

According to Dr. Sterry, the trial was the first to compare "two different dosing regimens of etanercept in patients with psoriasis, suffering both from moderate to severe skin involvement as well as marked arthritis."

The 98-center PRESTA study, conducted in Europe, Latin America, and the Asia Pacific region, featured 752 outpatients. During the first phase, patients were randomized to receive etanercept 50 mg once or twice weekly (by subcutaneous injection) for 12 weeks. During the second phase, all subjects received the drug once weekly for 12 more weeks.

At 12 weeks, based on physician's global assessment, lesions had cleared or almost cleared in 46% of subjects in the twice-weekly group compared to only 32% in the once-weekly group (p < 0.001).

Twice weekly etanercept patients also showed greater mean reductions in the psoriasis area and severity index at week 12 than did once weekly etanercept patients (71% vs. 62%, p < 0.001). By week 24, however, the difference was no longer statistically significant (78% vs. 74%).

In terms of patients achieving arthritis response criteria, by contrast, once weekly etanercept performed just as well as twice weekly (76% vs. 77%). Likewise, joint and tendon manifestations improved to a similar extent in both groups.

Side effects with etanercept were consistent with previous reports on the drug. The most common adverse events were upper respiratory tract infection, injection site reaction, pharyngitis, and headache. There was no significant difference in side effects between groups.

The take-home message, Dr. Sterry said, is that the "skin and joints of patients suffering from psoriasis respond excellently to etanercept treatment, with skin involvement requiring higher dosing" than joint symptoms.

"It might be interesting to see whether other treatments also show this differential effect, and what could be the mechanisms behind it," he added.

The study was sponsored by Wyeth Pharmaceuticals, which markets etanercept as Enbrel and employs five of the nine authors.

Reference:
BMJ 2010.

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Chlorhexidine-alcohol tops povidone-iodine for surgical site antisepsis

2010-01-08T16:20:12+00:00

NEW YORK (Reuters Health) – Prepping a patient’s skin with chlorhexidine-alcohol rather than with povidone-iodine reduces both superficial and deep incisional infections after clean-contaminated surgery, according to a report in The New England Journal of Medicine for January 7.

“No published randomized studies have examined the effect of one antiseptic preparation as compared with another on the incidence of surgical-site infection,” Dr. Rabih O. Darouiche, from Baylor College of Medicine, Houston, and colleagues note. Moreover, the Centers for Disease Control and Prevention have not recommended one agent over another for preventing such infections.

In the current study, the authors assessed 30-day surgical-site infection rates in patients who were randomized to receive preoperative skin preparation with chlorhexidine-alcohol scrub or povidone-iodine scrub and paint. The intention-to-treat analysis featured 849 subjects, while the per-protocol analysis included 813 patients who remained in the study throughout the 30-day follow-up period.

On the intention-to-treat analysis, the overall surgical site infection rate was significantly lower in the chlorhexidine-alcohol group than in the povidone-iodine group: 9.5% vs. 16.1% (p = 0.004). Further analysis showed that this held true for superficial (4.2% vs. 8.6%, p = 0.008) and deep (1% vs. 3%, p = 0.05) incisional infections, but not for organ-space infections (4.4% vs. 4.5%). Similar findings were seen in the per-protocol analysis.

The authors estimate that 17 surgical patients would need to receive chlorhexidine-alcohol instead of povidone-iodine to prevent one case of surgical site infection.

In a second study published in the same issue, a separate group of researchers examined the impact of Staphylococcus aureus nasal carriage on the risk of surgical-site infection and then looked at how decolonization of nasal and extranasal sites affected the risk.

Of 6771 patients who were screened with a real-time PCR assay, 1251 tested positive for S. aureus nasal carriage. Of these patients, 808 underwent a surgical procedure and were randomized to receive mupirocin nasal ointment and chlorhexidine soap or placebo ointment and soap starting at hospital admission and continuing for 5 days.

The healthcare-associated S. aureus infection rate was significantly lower in the chlorhexidine-mupirocin group than in controls: 3.4% vs. 7.7% (RR, 0.42). Deep surgical site infections were the most common type and here the difference between the groups was particularly evident: 0.9% vs. 4.4% (RR, 0.21).

“The weight of evidence suggests that chlorhexidine-alcohol should replace povidone-iodine as the standard for preoperative surgical scrubs,” Dr. Richard P. Wenzel, from Commonwealth University, Richmond, comments in a related editorial.

As for intranasal mupirocin and chlorhexidine baths for carriers of S. aureus, he continues, these “could be reserved primarily for patients who are undergoing cardiac surgery, all patients receiving an implant, and all immunosuppressed surgical candidates.”

N Engl J Med 2010;362:9-17,18-26,75-77.

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Antiretroviral therapy start-up linked to genital ulcers in women

2010-01-07T13:24:06+00:00

NEW YORK (Reuters Health) - Genital ulcers are common in HIV-infected women when antiretroviral therapy (ART) begins, particularly when CD4 counts are low or when women have had these ulcers in the past, according to prospective data from Kenya.

“The most surprising finding was that this increased risk was limited to the first month,” lead author Dr. Susan M. Graham from the University of Washington, Seattle told Reuters Health. “An earlier study…had indicated that the risk of immune reconstitution-related genital ulcer disease was increased during the first 6 months of therapy.”

The current study followed HIV-infected women prospectively, so the results provide a more accurate estimate of the risk after ART, she added.

In the December 15th Journal of Acquired Immune Deficiency Syndromes, Dr. Graham and her colleagues note that genital ulcer disease is of particular concern during HIV infection, since mucosal breakdown and local inflammation increase viral shedding at the ulcer site, thereby increasing the risk of transmission.

The researchers performed exams at baseline and then monthly on 134 Kenyan women who were starting ART with either stavudine or zidovudine combined with lamivudine and nevirapine. The median baseline CD4 cell count was 127, and 82 women had a documented history of GUD.

During the first 6 months of ART (85 visits), 54 women (40.3%) had genital ulcers. The prevalence of the ulcers rose from 9.7% at baseline to 16.7% one month after ART was initiated (adjusted odds ratio 1.9, p = 0.04), and then fell to 6.4% by month 6.

“Immune reconstitution inflammatory syndrome (IRIS) is a term used to describe the paradoxical worsening of preexisting infectious processes following ART initiation,” Dr. Graham explained. “Chronic infections such as genital herpes simplex virus type 2 (HSV-2) may flare when the host regains the capacity to mount an inflammatory response, but is still unable to control the infection completely.”

Ulcers were more frequent in women with a history of genital ulcer disease (13.9% vs 3.9%, p < 0.001). In multivariate analysis, a baseline CD4 cell count below 100 and a history of genital ulcers were independent predictors of risk after initiation of antiretroviral therapy.

Dr. Graham recommends that for women with known HSV-2 infection, suppression with acyclovir may help prevent genital ulcer recurrence, promote ulcer healing, and decrease HIV-1 shedding.

When serologic tests for herpesvirus are not available, “suppressive therapy with acyclovir at ART initiation and for up to 6 months thereafter could be considered” for women with a history of recurrent genital ulcers, she added.

The researchers emphasize that women with a history of genital ulcers should be counseled about the potential for increased transmission risk during the first few months of ART.

Reference:
J Acquir Immune Defic Syndr 2009;52:600-603.

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Drug combo not recommended for metastatic melanoma

2009-12-07T15:17:50+00:00

NEW YORK (Reuters Health) – In treating patients with metastatic melanoma, thalidomide plus temozolomide is no better than temozolomide or dacarbazine alone, according to a report in the November 13th online issue of Cancer.

“Despite a lack of prospective confirmation, the (thalidomide plus temozolomide) combination regimen became a community standard for patients with unresectable metastatic melanoma,” lead author Dr. Joseph I. Clark and co-researchers note. “Our intent was to expand on these results to better define the tolerability and efficacy of a set dose and schedule of the combination…in the cooperative group setting.”

In a Southwest Oncology Group trial, Dr. Clark, from Loyola University Medical Center, Maywood, Illinois, and associates assessed response rates and survival in 62 patients who were treated with thalidomide plus temozolomide. The eligibility criteria included stage IV disease, no active brain metastases, Zubrod performance score of 0 or 1, adequate organ function, and up to 1 prior systemic therapy excluding the study drugs and dacarbazine.

For patients younger than 70 years, thalidomide was given at a dose of 200 mg/d escalated to 400 mg/d, while for older patients, the drug was started at 100 mg/d and increased to 250 mg/d. Temozolomide was given at a dose of 75 mg/meters-squared per day for 6 weeks, followed by 2 weeks of rest, repeated until progression or toxicity.

The treatment response rate was 13%, and all of the responses were partial. This outcome, the authors note, is comparable to what would be expected with temozolomide or dacarbazine alone.

Progression-free survival at 6 months was 15%, and the estimated 1-year overall survival was 35%. The median overall survival was 8 months. No link was noted between progression-free or overall survival and a variety of biomarkers (e.g., interleukins, tumor necrosis factor).

One treatment-related death, due to MI, occurred, the report indicates. Other serious adverse events included one case each of pulmonary embolism, neutropenia, and central nervous system ischemia.

“On the basis of these results, use of this combination regimen is not recommended nor is further evaluation in a phase 3 trial appropriate,” the authors conclude.

Reference:
Cancer 2009.

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Adverse events common with low- to medium-dose glucocorticoids

2009-12-01T14:42:25+00:00

NEW YORK (Reuters Health) - In patients receiving glucocorticoids for inflammatory diseases, adverse events are very common, even at low to medium doses, according to a meta-analysis by researchers in the Netherlands.

In fact, they report in the December Annals of the Rheumatic Diseases, the overall adverse event rate was 150 per 100 patient-years. In studies that focused only on patients with inflammatory bowel disease, the adverse event rate was 555 per 100 patient-years.

When lead author Dr. J. N. Hoes and associates at the University Medical Center Utrecht applied their selection criteria in their literature search, they identified 28 studies involving 2382 subjects, including patients with rheumatoid arthritis (RA, n=796), polymyalgia rheumatica (PMR, n=167), and inflammatory bowel diseases (IBD, n = 1419). All patients had received either low-dose (0 to 7.5 mg prednisolone equivalent per day) or medium-dose (> 7.5 to 30 mg) regimens.

Mean daily doses were 7.5 mg in the RA group, 8.6 mg in the PMR group, and 13.9 mg in the IBD group.

Among the patients with RA and PMR, adverse event rates per 100 patient-years -- 43 and 80, respectively -- were much lower than in the IBD group.

Adverse events in RA patients consisted primarily of psychological and behavioral disturbances, followed by dermatological and cardiovascular effects. PMR was primarily associated with gastrointestinal, endocrine and metabolic, cardiovascular and infectious events. IBD patients most often reported gastrointestinal and neurological events.

Dr. Hoes and associates note that “the study design blocks direct comparison of glucocorticoid-related adverse event rates in patients with different diseases.” Rates were strongly affected by the type of disease, duration of the study, co-medication, and frequency of documenting adverse events. In most of the efficacy studies, adverse events were not systematically recorded, the researchers complain.

“The risk-benefit ratio of glucocorticoids is an important issue for future studies and could help to create new targets for drug development” such as selective glucocorticoid receptor agonists, the authors conclude.

Reference:
Ann Rheum Dis 2009;68:1833-1838.

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Atrophoderma Vermiculatum

2009-10-27T17:52:06+00:00

Theresa Conologue, DO, Staff Dermatologist, Geisinger Medical Center, Danville, Pennsylvania, discusses atrophoderma vermiculatum (AV), a rare follicular disorder primarily affecting children with reticular or honeycomb atrophy of the cheeks and forehead. Along with keratosis pilaris atrophicans faciei and keratosis follicularis spinulosa decalvans, AV falls within the broader spectrum of keratosis pilaris atrophicans. Although these 3 variants have unique presentations and associations, they can all be frustratingly difficult to treat.

The original article was featured in Cutis®, which provided an overview of atrophoderma vermiculatum and treatment options.

Resource:
Luria RB, Conologue T. Atrophoderma vermiculatum: a case report and review of the literature on keratosis pilaris atrophicans.
Cutis. 2009;83:83-86.

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Ultrasonography not a reliable replacement for sentinel lymph node biopsy

2009-10-01T16:34:23+01:00

NEW YORK (Reuters Health) - For patients with primary cutaneous melanoma, targeted high-resolution ultrasound should not be used as a substitute for excisional sentinal lymph node biopsy, new research indicates.

However, “ultrasound is of value in preoperative sentinel lymph node assessment and postoperative monitoring,” Dr. John F. Thomson at the Melanoma Institute Australia in N. Sydney, New South Wales, and co-investigators report in the September 28th online issue of the Journal of Clinical Oncology.

The team identified and removed sentinel lymph node biopsies from 871 lymph node fields in 716 patients. Histologically positive nodes were identified in 144 lymph node fields (16.5%) in 125 patients (17.5%).

Ultrasound was true positive for metastases in 28 patients and 35 node fields. The sensitivity of ultrasound for all lymph node fields was 24.3%, and specificity was 96.8%, the authors report. Positive predictive value was 60.3%, and negative predictive value was 86.6%.

“The great number of false negative results indicates that ultrasound cannot be used reliably as an alternative to sentinel lymph node biopsy,” Dr. Thomson’s team maintains.

On the other hand, sensitivity improved with greater Breslow thickness of melanoma. The median histologic cross-sectional area of the sentinal lymph node metastatic deposits was 0.39 mm2 (12.75 mm2 for ultrasound true-positive results and 0.22 mm2 for false-negative results). Ultrasound-detected deposits were more likely to be spherical in cross-section than the typical ovoid shape of lymph nodes.

“Ultrasound also has a role in closely monitoring patients who elect not to have a sentinel lymph node biopsy or who have a contraindication to surgery and who undergo regular imaging of their identified sentinel lymph node instead,” the authors conclude.

Reference:
J Clin Oncol 2009.

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Lupus anticoagulant greatly ups thrombosis risk in young women

2009-10-01T16:29:05+01:00

NEW YORK (Reuters Health) - In young women, the presence of lupus anticoagulant is associated with a more than 40-fold increased risk of stroke and 5-fold increased risk of myocardial infarction compared with the general population of young adult women, according to a study from the Netherlands.

“Lupus anticoagulant is one of the most important acquired risk factors for thrombotic complications and the detection of the presence of lupus anticoagulant indicates a more intense anticoagulant treatment,” study investigator Dr. Philip G. de Groot, from University Medical Centre Utrecht, told Reuters Health.

“The simultaneous presence of other risk factors (smoking and oral contraceptives) increases the risk of stroke even further -- two risk factors that can be avoided,” he added.

Although the presence of antiphospholipid antibodies in individuals who have a thrombotic event is a prerequisite for the diagnosis of the antiphospholipid syndrome, less is known about the risk of arterial thrombosis associated with antiphospholipid antibodies in the general population, Dr. de Groot and colleagues explain in the November edition of the Lancet Neurology, published online today.

To investigate, they analyzed data on 1006 young adult women enrolled in the RATIO study – the Risk of Arterial Thrombosis In relation to Oral contraceptives study. The analysis focused on 175 women with a first ischemic stroke, 203 with a first MI and 628 healthy control women.

The researchers used questionnaires to assess the prevalence of various cardiovascular risk factors, and blood samples were taken to measure various phospholipid antibodies.

Lupus anticoagulant was detected in the blood of 30 women with ischemic stroke (17%), 6 with MI (3%) and only 4 healthy control women (0.7%).

The presence of lupus anticoagulant increased the risk of stroke 43-fold compared with healthy controls; in women with lupus anticoagulant who smoked, the risk was increased 87-fold, whereas women with lupus anticoagulant who used oral contraceptives had a greater than 200-fold increased risk of stroke, the researchers report.

In addition, the presence of lupus anticoagulant increased with risk of MI 5-fold compared with healthy controls; in women who smoked, the presence of lupus anticoagulant increased the risk 34-fold, whereas lupus anticoagulant plus oral contraceptive use increased the risk 22-fold.

Increased concentrations of anti-beta2-glycoprotein I antibodies were associated with a greater than 2-fold increased risk of ischemic stroke, but neither anticardiolipin nor antiprothrombin antibodies alone increased the risk of MI.

In an accompanying Reflection and Reaction article, Dr. Kathryn Kirchoff-Torres and Dr. Steven R Levine, of the Stroke Center, Mount Sinai School of Medicine in New York City say this study “provides important evidence for a prothrombotic synergistic effect between oral contraceptives, cigarette smoking and lupus anticoagulant in young women.”

“Most importantly,” they add, “young women with antiphospholipid antibodies should be informed about the serious risks of cigarette smoking and use of oral contraceptives,” they wrote.

Reference:
Lancet Neurology, online September 28, 2009.

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Pentoxifylline/vitamin E combo may prevent some radiation side effects

2009-09-18T13:00:52+01:00

NEW YORK (Reuters Health) – The combination of pentoxifylline and vitamin E prevented radiation-induced lymphedema among breast cancer patients in a phase II trial in Sweden.

The finding builds on previous research indicating that pentoxifylline and vitamin E can reverse radiation-induced fibrosis.

In the current study, Dr. Maria Magnusson from Lund University Hospital and colleagues assessed the preventive effects of pentoxifylline added to standard vitamin E therapy on a range of radiation-induced side effects in women with breast cancer treated with surgery followed by radiotherapy.

Starting 1 to 3 months after the end of radiotherapy, the 83 participants added either pentoxifylline (400 mg three times daily) or placebo to a 12-month course of vitamin E (100 mg three times daily).

According to a report in the September issue of the European Journal of Cancer, there was no between-group difference in the primary endpoint -- passive abduction of the shoulder, which improved significantly in both groups, by a median of 3.7 degrees in the pentoxifylline arm and 9.4 degrees in the placebo arm.

The authors do point out that Visual Analogue Score (VAS) for stiffness in the skin, which “may be a harbinger of reduced abduction of the shoulder,” fell with pentoxifylline (p = 0.0003) but not with placebo (p = 0.97).

The secondary end-point, difference in arm volume, increased over time in the placebo group (1.04%) but not in the pentoxifylline group (0.50%); with a significant difference in favor of pentoxifylline.

Although the study was not designed to show differences in safety, the researchers note that safety was similar in the two groups. Nausea, a well-known transient side-effect of pentoxifylline, was common in pentoxifylline users but had only a small impact in this study; two patients using the drug discontinued it and one reduced the dose due to nausea.

Dr. Magnusson and colleagues conclude that pentoxifylline plus vitamin E can be used “to prevent some radiation-induced side-effects such as the development of increased arm-volume after a post-operative irradiation.”

Reference:
Euro J Cancer 2009;45:2488-2495.

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