Content
Volume 3, 2000
A comparison of fusidic acid tablets and flucloxacillin capsules in skin and
soft tissue infection
CDE Morris, DT Talbot
Pages 1-14 ¦ Abstract ¦
Fusidic acid and erythromycin in the treatment of skin and soft tissue infection: a
double blind study
ARJ Wall, AP Menday
Pages 15-28 ¦ Abstract ¦
Initiating Concerta™ (OROS® methylphenidate HCl) qd in children with attention-deficit hyperactivity disorder
J Swanson, L Greenhill, W Pelham, T Wilens, M Wolraich, H Abikoff, M Atkins,
G August, J Biederman, O Bukstein, CK Conners, L Efron, K Fiebelkorn, J Fried,
M Hoffman, L Lambrecht, M Lerner, B Leventhal, K McBurnett, E Morse, D Palumbo,
L Pfiffner, M Stein, S Wigal, E Winans
Pages 59-76 ¦ Abstract ¦
Efficacy and safety of Efficort® cream versus Diprosone® cream and Advantan® cream in the treatment of eczema
E Grosshans, JF Stalder, J Bazex, JP Escande, C Pernin, M Poncet, A Clucas
Pages 93-100 ¦ Abstract ¦
Morris CDE, Talbot DT
A comparison of fusidic acid tablets and flucloxacillin capsules in skin and
soft tissue infection
J Clin Res 2000; 3: 1-14
This multicentre, randomised, double blind, parallel group study compared fusidic
acid (250 mg, bid) and flucloxacillin (250 mg qds) in patients with skin and soft
tissue infections. Treatment was taken for five days by all patients and for a
further five days if the condition remained uncured. In patients cured at the
end of treatment, a follow-up assessment was carried out 14 days later.
Both treatments were effective. At the end of treatment the physician rated the
condition as “cured/improved” for 182 (76%) of the 240 patients who took fusidic
acid and for 189 (81%) of the 233 patients who took flucloxacillin (intention
to treat population; p=0.16). Cure was maintained at the follow-up assessment
for 94% (138 of 147) and 91% (139 of 153) in the fusidic acid and flucloxacillin
groups, respectively. Bacteriological efficacy was rated as a success for 94%
(64 of 68) who received fusidic acid and 97% (55 of 57) who took flucloxacillin.
Cost effectiveness of flucloxacillin appeared greater in the intention to treat
population, whilst fusidic acid appeared more cost effective in patients with
a bacteriologically proven infection. Both treatments were well tolerated. Approximately
30% of patients in each group had adverse events. Diarrhoea was the most commonly
reported adverse drug reaction (fusidic acid 6%, flucloxacillin 5%).
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Wall ARJ, Menday AP
Fusidic acid and erythromycin in the treatment of skin and soft tissue infection: a
double blind study
J Clin Res 2000; 3: 15-28
This multicentre, randomised, double blind, parallel group study compared fusidic
acid (250 mg, bid) and erythromycin (1.0 g, bid) as treatment for patients with
skin and soft tissue infections. Treatment was taken for five days by all patients
and for a further five days if the condition remained uncured. In patients cured
at the end of treatment, a follow-up assessment was carried out 14 days later.
Both treatments were effective. At the end of treatment the physician rated the
condition as “cured/improved” for 192 (85%) of the 225 patients who took fusidic
acid and for 200 (87%)of the 229 patients who took erythromycin (intention to
treat population; p=0.52). Cure was maintained at the follow-up assessment for
95% (151 of 159) and 97% (172 of 177) in the fusidic acid and erythromycin groups,
respectively. Bacteriological efficacy was rated as a success for 96% (50 of 52)
who received fusidic acid and 97% (56 of 58) who took erythromycin.The cost effectiveness
of the treatments was similar in the intention to treat population, whilst fusidic
acid appeared more cost effective in patients with a bacteriologically proven
infection. The number of patients reporting adverse events was similar for each
group (fusidic acid 30%; erythromycin 32%). More events were reported for erythromycin
(120 vs 95). Nausea was the most commonly reported adverse drug reaction (fusidic
acid 7%, erythromycin 12%).
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Swanson J, Greenhill L, Pelham W et al
Initiating Concerta™ (OROS® methylphenidate HCl) qd in children with attention-deficit hyperactivity disorder
J Clin Res 2000; 3: 59-76
The objective of this study was to determine a tolerable method of initiating
Concerta™ (OROS® methylphenidate HCl) treatment in children with attentiondeficit hyperactivity
disorder (ADHD) not currently receiving methylphenidate (MPH) treatment. A group
of 99 children with ADHD (all subtypes, ages 6-12 years old) were evaluated in
an open-label, dose-ranging, 1- to 4-week stepwise titration trial. Patients were
initiated on Concerta™ 18 mg given once-daily (qd), advancing to 36 mg qd and
to 54 mg qd if they did not respond adequately to the previous dose. Each patient
was treated at the lowest dose for 1 week and evaluated for tolerability and effectiveness.
Patients proceeded to the subsequent higher dose only if the lower dose produced
no unacceptable side effects and, in the investigator’s opinion, there was potential
clinical benefit at the higher dose. Initiation was successfully completed once
patients received a tolerable and effective dose, as judged by the investigator,
based on the weekly symptom and safety assessments by parents/caregivers and teachers.
Clinicians judged that 95 patients (96.0%) were successfully dose titrated (final
Concerta™ dose: 18 mg, n = 18; 36 mg, n = 52; 54 mg, n=25). Of the unsuccessfully
titrated patients, one found treatment ineffective at the maximum dose and four
discontinued treatment prematurely. The data showed a marked improvement in patients’
behavior and attention at the final treatment dose compared to baseline. Once-daily
Concerta™ treatment, implemented using this openlabel, stepwise, dose-titration
protocol, was well tolerated in children with ADHD not currently receiving MPH
treatment. Children were initiated tolerably and effectively on once-daily Concerta™
treatment without prior titration on immediate-release MPH.
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Grosshans E, Stalder JF, Bazex J et al
Efficacy and safety of Efficort® cream versus Diprosone® cream and Advantan® cream in the treatment of eczema
J Clin Res 2000; 3: 93-100
In this multicentre, randomised, open, controlled study, conducted in three parallel
groups, 79 patients presenting with eczema were treated for 21 days either by
0.127% hydrocortisone aceponate (Efficort® hydrophilic cream), 0.05% betamethasone dipropionate (Diprosone® cream) or 0.1% methylprednisolone aceponate (Advantan® cream).
These patients (36 males and 43 females) presented with eczema classified as
atopic dermatitis in 27 cases (34%) and contact eczema in 52 cases (66%). 32 patients
were treated with Efficort®, 24 with Diprosone® and 23 with Advantan®.
At the end of treatment, efficacy was assessed in terms of the percentage reduction
of the total lesion score, showing a significant difference (p = 0.037) in favour
of Efficort® (87.3%) compared to Advantan® (72.6%) and a tendency in favour of Efficort® compared to Diprosone® (83.5%).
The investigator’s assessment of overall improvement of eczema was also significantly
superior for Efficort® than for Advantan® and numerically superior to Diprosone®.
The local tolerance of Efficort® was globally considered to be excellent and significantly better than that of
Advantan®.
In conclusion, it could be stated that Efficort® containing hydrocortisone aceponate, a nonfluorinated molecule, possesses a
comparable pharmacological activity to that of betamethasone dipropionate®.
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