Risk-Benefit Ratio

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Dietrich Abeck - One of the best experts on this subject based on the ideXlab platform.

  • improved risk benefit Ratio for topical triamcinolone acetonide in transfersome in comparison with equipotent cream and ointment a randomized controlled trial
    British Journal of Dermatology, 2003
    Co-Authors: H Fesq, J Lehmann, A Kontny, I Erdmann, K Theiling, M Rother, J Ring, G Cevc, Dietrich Abeck
    Abstract:

    Summary Background  Transfersome® is a drug delivery technology based on highly deformable, ultraflexible lipid vesicles which penetrate the skin when applied non-occlusively. Objectives  To assess the advantages of this carrier-based formulation in humans, the efficacy and the atrophogenic potential of triamcinolone acetonide (TAC) in Transfersome® was compared with commercially available TAC-containing cream and ointment. Methods  Healthy volunteers were enrolled in double-blind, placebo-controlled clinical trials with random study medication assignment to the test areas. Results  A 10-fold lower dose of TAC in Transfersome® (2·5 µg cm−2) was bioequivalent to 25 µg cm−2 TAC in conventional formulations as measured by erythema suppression (cream: P = 0·01, ointment: P < 0·001). A skin blanching assay revealed different kinetics of the formulations, with a delayed onset of action of the Transfersome® and ointment prepaRations. Ultrasonic measurements revealed a significantly reduced atrophogenic potential. There was a 12·1% reduction in skin thickness given by TAC in Transfersome® compared with a 21·1% reduction given by a bioequivalent dose in TAC cream after a 6-week treatment period (P = 0·007). Conclusions  Transfersome® may significantly improve the risk–benefit Ratio of topically applied glucocorticosteroids.

  • Improved risk–benefit Ratio for topical triamcinolone acetonide in Transfersome® in comparison with equipotent cream and ointment: a randomized controlled trial
    The British journal of dermatology, 2003
    Co-Authors: H Fesq, J Lehmann, A Kontny, I Erdmann, K Theiling, M Rother, J Ring, G Cevc, Dietrich Abeck
    Abstract:

    Summary Background  Transfersome® is a drug delivery technology based on highly deformable, ultraflexible lipid vesicles which penetrate the skin when applied non-occlusively. Objectives  To assess the advantages of this carrier-based formulation in humans, the efficacy and the atrophogenic potential of triamcinolone acetonide (TAC) in Transfersome® was compared with commercially available TAC-containing cream and ointment. Methods  Healthy volunteers were enrolled in double-blind, placebo-controlled clinical trials with random study medication assignment to the test areas. Results  A 10-fold lower dose of TAC in Transfersome® (2·5 µg cm−2) was bioequivalent to 25 µg cm−2 TAC in conventional formulations as measured by erythema suppression (cream: P = 0·01, ointment: P 

Olivier Baud - One of the best experts on this subject based on the ideXlab platform.

  • Postnatal steroid treatment in preterm infants: risk/benefit Ratio
    Journal de gynecologie obstetrique et biologie de la reproduction, 2005
    Co-Authors: Olivier Baud
    Abstract:

    This review examines the risk/benefit Ratio of postnatal steroid treatment in preterm infants and correlates epidemiological data with special emphasis on experimental evidence concening the impact of steroid on brain development. With all regimens, steroid treatment consistently reduced the need for assisted ventilation at 28 days of postnatal age or at term. However, neither oxygen at term nor neonatal mortality has been decreased by this treatment. Conversely, respiratory benefits should be weighed against several adverse effects: hyperglycemia, hypertension, gastrointestinal bleeding or perfoRation, increased risk of cerebral palsy. The impact of dexamethasone on brain development and risk factors of white matter damage could be involved in the association between postnatal steroid treatment and neurological impairment in treated infants. Injectable prepaRations of dexamethasone contain sulphiting preservatives which could account for the alteRations in neuronal matuRation observed in animal models. Early use of dexamethasone should especially be avoided for postnatal steroid treatment in premature infants. Other glucocorticoids as alternatives to dexamethasone need to be evaluated in appropriate and large controlled trials with long term follow up.

  • Postnatal steroid treatment and brain development
    Archives of Disease in Childhood-fetal and Neonatal Edition, 2004
    Co-Authors: Olivier Baud
    Abstract:

    This review examines the risk/benefit Ratio of postnatal steroid treatment in preterm infants and correlates epidemiological data with experimental evidence on the effect of glucocorticosteroids on brain development.

David P. Skoner - One of the best experts on this subject based on the ideXlab platform.

  • Addressing steroid phobia: improving the Risk-Benefit Ratio with new agents.
    Allergy and asthma proceedings, 2008
    Co-Authors: Jonathan D. Skoner, T. Schaffner, C. Schad, Anessa Ye Kyung Antionette Kwon, David P. Skoner
    Abstract:

    Inhaled corticosteroids (ICSs) are the preferred first-line preventative therapy for asthma of all severity levels. Although these drugs have been proven efficacious, concerns of adverse systemic affects due to both long- and short-term use continue to limit patient compliance with dosing regimens. Deficits in bone growth, bone density, and hypothalamic-pituitary-adrenal axis function, in addition to cataract formation and elevated intraocular pressure/glaucoma, have been associated with ICS use in some studies. Although some of these studies were flawed, featured drugs that are less commonly prescribed today, or both, adverse effects from chronic ICSs use are still a cause of concern today. Current therapies are designed to be efficacious at minimal doses, limiting potential side effects, increasing adherence, and improving asthma control.

E Hollander - One of the best experts on this subject based on the ideXlab platform.

  • Pharmacotherapy of obsessive-compulsive disorder: experience with the selective serotonin reuptake inhibitors.
    International clinical psychopharmacology, 2000
    Co-Authors: B Vythilingum, C Cartwright, E Hollander
    Abstract:

    Since the introduction of the selective serotonin reuptake inhibitors (SSRIs) a decade ago, they have become first-line agents in the treatment of obsessive-compulsive disorder (OCD). Numerous clinical trials have confirmed their efficacy, and established their superior Risk-Benefit Ratio in comparison with clomipramine, a non-selective serotonin reuptake inhibitor. Relatively higher doses and longer duRation of treatment may be necessary to effect a response in OCD, with long-term treatment being required to maintain therapeutic gains. Despite the advances represented by the SSRIs, treatment resistance remains a problem. While no one solution exists, various strategies, including pharmacotherapy augmentation, look promising.

H Fesq - One of the best experts on this subject based on the ideXlab platform.

  • improved risk benefit Ratio for topical triamcinolone acetonide in transfersome in comparison with equipotent cream and ointment a randomized controlled trial
    British Journal of Dermatology, 2003
    Co-Authors: H Fesq, J Lehmann, A Kontny, I Erdmann, K Theiling, M Rother, J Ring, G Cevc, Dietrich Abeck
    Abstract:

    Summary Background  Transfersome® is a drug delivery technology based on highly deformable, ultraflexible lipid vesicles which penetrate the skin when applied non-occlusively. Objectives  To assess the advantages of this carrier-based formulation in humans, the efficacy and the atrophogenic potential of triamcinolone acetonide (TAC) in Transfersome® was compared with commercially available TAC-containing cream and ointment. Methods  Healthy volunteers were enrolled in double-blind, placebo-controlled clinical trials with random study medication assignment to the test areas. Results  A 10-fold lower dose of TAC in Transfersome® (2·5 µg cm−2) was bioequivalent to 25 µg cm−2 TAC in conventional formulations as measured by erythema suppression (cream: P = 0·01, ointment: P < 0·001). A skin blanching assay revealed different kinetics of the formulations, with a delayed onset of action of the Transfersome® and ointment prepaRations. Ultrasonic measurements revealed a significantly reduced atrophogenic potential. There was a 12·1% reduction in skin thickness given by TAC in Transfersome® compared with a 21·1% reduction given by a bioequivalent dose in TAC cream after a 6-week treatment period (P = 0·007). Conclusions  Transfersome® may significantly improve the risk–benefit Ratio of topically applied glucocorticosteroids.

  • Improved risk–benefit Ratio for topical triamcinolone acetonide in Transfersome® in comparison with equipotent cream and ointment: a randomized controlled trial
    The British journal of dermatology, 2003
    Co-Authors: H Fesq, J Lehmann, A Kontny, I Erdmann, K Theiling, M Rother, J Ring, G Cevc, Dietrich Abeck
    Abstract:

    Summary Background  Transfersome® is a drug delivery technology based on highly deformable, ultraflexible lipid vesicles which penetrate the skin when applied non-occlusively. Objectives  To assess the advantages of this carrier-based formulation in humans, the efficacy and the atrophogenic potential of triamcinolone acetonide (TAC) in Transfersome® was compared with commercially available TAC-containing cream and ointment. Methods  Healthy volunteers were enrolled in double-blind, placebo-controlled clinical trials with random study medication assignment to the test areas. Results  A 10-fold lower dose of TAC in Transfersome® (2·5 µg cm−2) was bioequivalent to 25 µg cm−2 TAC in conventional formulations as measured by erythema suppression (cream: P = 0·01, ointment: P