|
NOVIEMBRE 2.003
NOVEMBER 2.003
PSORIASIS, PIMECROLIMUS (ELIDEL),
TALADAFIL (CIALIS), SILDENAFIL (VIAGRA), VARDENAFIL (LEVITRA), VITILIGO.
1.)
An experimental ointment formulation of pimecrolimus is effective in psoriasis
without occlusion.
2.)
Occlusive treatment of chronic hand dermatitis with pimecrolimus cream 1%
results in low systemic exposure, is well tolerated, safe, and effective. An
open study.
3.) Topical pimecrolimus in the
treatment of seborrheic dermatitis.
4.)
Review of tadalafil in the treatment of erectile dysfunction.
5.) Tadalafil, a further innovation in the treatment of sexual dysfunction.
6.) Acute
electroretinographic changes during sildenafil (Viagra) treatment for erectile
dysfunction.
7.) Sexual psychophysiology and effects of sildenafil
citrate in oestrogenised women with acquired genital arousal disorder and
impaired orgasm: a randomised controlled trial.
8.) Vardenafil: a review of its use in erectile
dysfunction.
9.) Safety and efficacy of vardenafil for the treatment of men with erectile
dysfunction after radical retropubic prostatectomy.
10.) [Clinical observation on treatment of vitiligo with xiaobai mixture].
1.) An experimental ointment formulation of
pimecrolimus is effective in psoriasis without occlusion. (ELIDEL)
Acta Derm Venereol. 2003;83(5):351-3.
Mrowietz U, Wustlich S, Hoexter G, Graeber M, Brautigam M, Luger T.
Department of Dermatology, University of Schleswig-Holstein, Campus Kiel,
Germany. [email protected]
Pimecrolimus (Elidel, SDZ ASM 981), a new macrolactam ascomycin derivative, was
highly effective in treating plaque-type psoriasis when applied under Finn-chamber
occlusion. A two-centre, randomized, double-blind, vehicle- and positive-controlled
within-patient study was therefore conducted in 23 adult psoriasis patients.
Pimecrolimus 1% was applied, twice daily, in an experimental ointment
formulation, along with the corresponding vehicle, 0.005% calcipotriol ointment
and 0.05% clobetasol-17-propionate ointment to test sites without occlusion for
21 days. Erythema, induration and scaling (score: 0 [absent] to 4 [severe]) were
evaluated. The total sign score was defined as the sum of the erythema,
induration and scaling scores (range 0-12). Pimecrolimus 1% ointment was
significantly (p = 0.03) more effective than the corresponding vehicle, with an
improvement in total sign score of 51.4% compared with 36.7% for the
corresponding vehicle. Improvements with calcipotriol and clobetasol-17-propionate
were 71.5% and 88.3%, respectively. No local or systemic drug-related side
effects were observed in the study. We conclude that pimecrolimus 1% in the
experimental ointment formulation was significantly more effective than its
corresponding vehicle, but less effective than calcipotriol and clobetasol
ointment. This is the first study reporting a significant therapeutic effect of
pimecrolimus in an ointment formulation applied without occlusion to psoriatic
plaques.
2.) Occlusive treatment of chronic hand dermatitis with
pimecrolimus cream 1% results in low systemic exposure, is well tolerated, safe,
and effective. An open study. (ELIDEL)
Dermatology. 2003;207(1):37-42.
Thaci D, Steinmeyer K, Ebelin ME, Scott G, Kaufmann R.
Department of Dermatology and Venereology, J.-W. Goethe University School of
Medicine, Frankfurt, Germany. [email protected]
BACKGROUND: Pimecrolimus cream 1% (Elidel, SDZ ASM 981) is a novel, non-steroid
inflammatory cytokine inhibitor, effective in the treatment of atopic
dermatitis. Here, we evaluate the treatment of chronic hand dermatitis with
pimecrolimus cream 1%. OBJECTIVES: To determine pimecrolimus blood
concentrations, and evaluate the safety, tolerability and efficacy following
application of pimecrolimus cream 1% to subjects with chronic hand dermatitis.
METHOD: In this open-label, multiple-topical-dose, non-controlled,
pharmacokinetic study, pimecrolimus cream 1% was applied twice daily to dorsal
and palmar areas (affected and unaffected) of both hands. Evening applications (except
day 8) were immediately followed by overnight occlusion (> or =6 h). Full
pharmacokinetic profile (days 1, 8 and 22), trough concentrations (days 3 and
15), physical examinations, laboratory measurements and adverse events were
recorded. Efficacy was assessed via Investigators' Global Assessment (IGA),
total key signs and symptoms and the subject's overall self-assessment. RESULTS:
Twelve patients completed the study. The majority of pimecrolimus blood
concentrations (73.6%) remained below the limit of quantitation (0.1 ng/ml). The
maximum concentration observed was 0.91 ng/ml and the maximum area under the
concentration-time curve from 0-12 h post dose was 7.6 ng.h/ml. Treatment was
well tolerated locally and systemically. No serious adverse events occurred;
4/13 subjects showed a total of 6 adverse events at the application site:
burning (n=4), and pruritus (n=2). No clinically relevant or drug-related
changes were observed. Clear efficacy of the treatment was shown by all 3
assessment methods. Disease state at day 22 had improved in 11 (85%) subjects
compared with baseline (IGA). CONCLUSION: Twice daily topical treatment of
moderate to severe chronic hand dermatitis with pimecrolimus cream 1% results in
low pimecrolimus blood levels, is well tolerated, safe, and effective. Copyright
2003 S. Karger AG, Basel
3.) Topical pimecrolimus in the treatment of seborrheic
dermatitis.(ELIDEL)
Dermatol Online J. 2003 Aug;9(3):13.
Brownell I, Quan LT, Hsu S.
Department of Dermatology, Baylor College of Medicine, Houston, TX, USA.
Seborrheic dermatitis is a chronic inflammatory disease that mainly affects
seborrheic areas of skin. An inflammatory response to the yeast Pityrosporum
ovale has been thought to be important in the etiology of the condition.
Therefore, topical antifungals and corticosteroids have been the mainstay of
treatment. The recent development of topical macrolactam immunomodulators has
offered a useful, safe alternative to corticosteroids in the treatment of
various inflammatory skin disorders. We report successful treatment of
seborrheic dermatitis with pimecrolimus.
4.) Review of tadalafil in the treatment of
erectile dysfunction.(CIALIS)
Expert Opin Pharmacother. 2003 Nov;4(11):2049-56.
Meuleman EJ.
University Medical Center St Radboud, Department of Urology, PO Box 9101, 6500
HB Nijmegen, The Netherlands. [email protected]
Approximately 150 million men worldwide experience erectile dysfunction (ED)
whereby they are unable to achieve and maintain an erection adequate for
satisfactory sexual performance. ED has a considerable impact on quality of life.
Tadalafil (Cialis( trade mark ), Eli Lilly & Co./ICOS) is a novel effective and
safe phosphodiesterase type 5 inhibitor, a secondary messenger for the smooth
muscle relaxing effects of nitric oxide, which plays a central role in the
vasodilation of erectile tissues. It has a longer half-life than sildenafil. As
head-to-head comparative trials are lacking, it is not clear what tadalafil
offers over sildenafil. In terms of marketing, much is made of the 'spontaneity'
achievable because of the (relatively) longer half-life of tadalafil.
5.) Tadalafil, a further innovation in the treatment of sexual dysfunction. (CIALIS)
Drugs Today (Barc). 2003 Feb;39(2):103-13.
Pomerol JM, Rabasseda X.
Fundacio Puigvert, Barcelona, Spain.
In recognition of the large number of sufferers of sexual dysfunction worldwide,
and the variety of etiologies of the condition, investigation into effective
pharmacological agents has been expanded. One method of intervention is
inhibition of the phosphodiesterase type 5 (PDE5) enzyme, which has already been
exploited with a considerable degree--though not complete--success. A number of
new agents that inhibit PDE5 are under development. Notable among these is
tadalafil, which has demonstrated a high level of selectivity for PDE5 over the
other phosphodiesterases and has shown efficacy in improving erectile function
and sexual satisfaction in phase III trials. Throughout the clinical development
program for tadalafil, the drug has been well tolerated and without serious side
effects. The manufacturer, Lilly ICOS, received an approvable letter from the US
Food and Drug Administration for use of the drug as a treatment for erectile
dysfunction on April 30, 2002. Lilly ICOS hopes to market tadalafil, with the
trade name Cialis, in the USA in 2003. Copyright 2003 Prous Science. All rights
reserved.
6.) Acute electroretinographic changes during sildenafil (Viagra)
treatment for erectile dysfunction.
Doc Ophthalmol. 2003 Sep;107(2):111-4.
Balacco Gabrieli C, Regine F, Vingolo EM, Rispoli E, Isidori A.
Department of Ophthalmology, University of Rome La Sapienza, Rome, Italy.
[email protected]
The authors describe their findings on 12 subjects who were treated with 50 mg
of sildenafil (Viagra) and underwent ERG measurements prior to and 1 hour after
ingestion. The Naka-Rushton equation was used to describe the b-wave luminance-response
function of the scotopic ERG. Statistically significant differences were noted
in the Vmax and K values. Sildenafil ingestion resulted in an increase in Vmax (higher
rod response to light stimuli) and a decrease in K (higher sensitivity).
7.) Sexual psychophysiology and effects of sildenafil
citrate in oestrogenised women with acquired genital arousal disorder and
impaired orgasm: a randomised controlled trial. (VIAGRA)
BJOG. 2003 Nov;110(11):1014-24.
Basson R, Brotto LA.
B.C. Center for Sexual Medicine, Vancouver Hospital, Canada.
OBJECTIVE: Some postmenopausal women lose genital sexual responsivity despite
preserved subjective sexual arousal from non-genital stimuli. When oestrogen
replacement is without benefit, both the underlying pathophysiology and
management of this acquired genital female sexual arousal disorder are unclear.
We aimed to study the effect of sildenafil on sexual arousal and orgasmic
functioning of such women. Secondly, we aimed to explore the concordance between
a detailed historical assessment of genital response in real life, with
laboratory vaginal photoplethysmographic assessment of genital vasocongestion.
DESIGN: Session one consisted of a semi-structured clinical interview to assess
real life sexual arousal. Session two employed vaginal pulse amplitude and self-report
questionnaire assessment of erotica-induced sexual arousal. Sessions three and
four were a randomised, double-blind, placebo-controlled crossover
administration of sildenafil on orgasm latency, intensity, perception of genital
congestion and subjective arousal to erotica plus clitoral vibrostimulation.
SETTING: University associated Sexual Medicine Clinic and Psychophysiology
Laboratory. SAMPLE: Volunteer sample of 34 oestrogenised postmenopausal women
with acquired genital female sexual arousal disorder and impaired orgasm.
METHODS: Sildenafil (50 mg) or placebo administered over two laboratory sessions.
MAIN OUTCOME MEASURES: Orgasm latency and intensity during drug sessions;
subjective and psychophysiological sexual arousal during photoplethysmography
session. RESULTS: The erotic video significantly increased subjective sexual
arousal in all women. Vaginal pulse amplitude responses varied from robust to
absent. Although across all women, sildenafil improved neither arousal nor
orgasm, subsequent analyses comparing high versus low vaginal pulse amplitude
responders revealed significantly reduced latency to orgasm, and increased
subjective sexual arousal and perception of genital arousal in the latter group
of women. CONCLUSION: The data suggest that oestrogenised postmenopausal women
with genital female sexual arousal disorder and orgasmic impairment based only
on clinical assessment do not benefit from sildenafil. However, the
photoplethysmograph had predictive value-those women showing low vaginal pulse
amplitude response benefited from sildenafil compared with women with a higher
response. Thus, oestrogenised women diagnosed with acquired genital female
sexual arousal disorder may be a heterogeneous group and the photoplethysmograph
might be useful in their further characterisation.
8.) Vardenafil: a review of its use in erectile dysfunction. (LEVITRA)
Drugs. 2003;63(23):2673-703.
Keating GM, Scott LJ.
Adis International Limited, Auckland, New Zealand. [email protected]
Vardenafil (Levitra) is a potent and highly selective oral phosphodiesterase
type 5 (PDE5) inhibitor. Vardenafil improved erectile function in men with mild
to severe erectile dysfunction (ED) of varying aetiology in two randomised,
double-blind, multicentre, fixed-dose studies of 12 or 26 weeks' duration. Men
receiving vardenafil 10 or 20 mg had significantly greater improvements in
International Index of Erectile Function (IIEF) questionnaire erectile function
domain scores than placebo recipients. Moreover, improvements in penetration and
maintenance of erection (assessed using IIEF or Sexual Encounter Profile [SEP]
questions) were significantly greater with vardenafil 5-20 mg than with placebo.
Improvements in IIEF intercourse satisfaction and orgasmic function domain
scores were significantly greater with vardenafil 10 or 20 mg than with placebo
and the proportion of patients with a positive response to a Global Assessment
Question (GAQ) concerning improvement in erections after 12 or 26 weeks' therapy
was significantly higher with vardenafil 5-20 mg than with placebo. Vardenafil
improved erectile function in men with ED associated with diabetes mellitus or
ED following unilateral or bilateral nerve-sparing radical retropubic
prostatectomy in two randomised, double-blind, multicentre, fixed-dose, 3-month
studies. In both studies, improvements from baseline in the erectile function
domain score of the IIEF and in positive responses to SEP questions were
significantly greater with vardenafil 10 or 20 mg than with placebo. In addition,
a significantly higher proportion of vardenafil 10 or 20 mg recipients than
placebo recipients had positive GAQ responses. Vardenafil was generally well
tolerated in men with ED; treatment-emergent adverse events were of mild to
moderate intensity and transient in nature. The most commonly reported adverse
events (typical of those seen with PDE5 inhibitors) in vardenafil 5-20 mg
recipients included headache, flushing, rhinitis, dyspepsia and sinusitis. There
were no reports of abnormal colour vision in men with ED taking vardenafil at
clinically recommended doses (5-20 mg). CONCLUSION: Vardenafil is a potent and
highly selective oral PDE5 inhibitor. It is effective and generally well
tolerated in men with mild to severe ED of varying aetiology, as well as in men
with ED associated with diabetes mellitus or ED after radical prostatectomy.
Vardenafil should be considered a first-line treatment option in men with ED who
are suitable candidates for oral PDE5 inhibitor therapy.
9.)
Safety and efficacy of vardenafil for the treatment of men
with erectile dysfunction after radical retropubic prostatectomy. (LEVITRA)
J Urol. 2003 Oct;170(4 Pt 1):1278-83.
Brock G, Nehra A, Lipshultz LI, Karlin GS, Gleave M, Seger M, Padma-Nathan H.
St. Joseph's Medical Center, Lawson Research Institute, London, Ontario, Canada.
[email protected]
PURPOSE: More than one-third of men may experience erectile dysfunction (ED)
after nerve sparing radical retropubic prostatectomy. The efficacy and safety of
vardenafil, a potent, selective, phosphodiesterase 5 inhibitor, was assessed for
the treatment of ED after radical prostatectomy. MATERIALS AND METHODS: In this
double-blind study 440 men with ED after nerve sparing radical prostatectomy
were randomized to take placebo, or 10 or 20 mg vardenafil. Efficacy was
measured after 12 weeks using the erectile function domain of the International
Index of Erectile Function, diary questions measuring vaginal penetration and
intercourse success rates, and a global assessment question (GAQ) on erection.
RESULTS: Of the intent to treat population 70% had severe ED (erectile function
less than 11) at baseline. After 12 weeks both vardenafil doses were
significantly superior to placebo (p <0.0001) for all efficacy variables.
Improved erections (based on GAQ) were reported by 65.2% and 59.4% of patients
on 20 and 10 mg vardenafil, respectively, and by only 12.5% of patients on
placebo (p <0.0001). Among men with bilateral neurovascular bundle sparing,
positive GAQ responses were reported by 71.1% and 59.7% of patients on 20 and 10
mg vardenafil, respectively, versus 11.5% of those on placebo (p <0.0001). The
average intercourse success rate per patient receiving 20 mg vardenafil was 74%
in men with mild to moderate ED and 28% in men with severe ED, compared to 49%
and 4% for placebo, respectively. Few adverse events were observed. They were
generally mild to moderate headache, flushing and rhinitis. CONCLUSIONS: In men
with severe ED after nerve sparing radical retropubic prostatectomy, vardenafil
significantly improved key indices of erectile function.
10.) [Clinical observation on treatment of vitiligo with
xiaobai mixture]
Zhongguo Zhong Xi Yi Jie He Za Zhi. 2003 Aug;23(8):596-8.
[Article in Chinese]
Liu ZJ, Xiang YP.
Department of Dermatology, First Affiliated Hospital, Nanhua University, Hunan
421001. [email protected]
OBJECTIVE: To observe the therapeutic effect of Xiaobai Mixture (XBM) in
treating vitiligo. METHODS: Seventy-four patients with vitiligo were randomly
divided into the XBM group treated with XBM and the control group treated with
8-MOP. The therapeutic effect, nail-fold microcirculation, plasma endothelin-1,
serum immunoglobulin were observed and compared. RESULTS: The therapeutic effect
of XBM was better than that of 8-MOP (P < 0.05). XBM could also obviously improve the nail-fold microcirculation, elevate the plasma endothelin-1 level
and lower the serum IgG (P < 0.01). CONCLUSION: XBM has superiority in treating
vitiligo.
=======================================================================
DATA-MEDICOS/DERMAGIC-EXPRESS /NOVEMBER JOURNAL 2.003/ DR. JOSE
LAPENTA R.
=======================================================================
|
