| 1. |
- Baran, R., et al.
(författare)
-
A multicentre, randomized, controlled study of the efficacy, safety and cost-effectiveness of a combination therapy with amorolfine nail lacquer and oral terbinafine compared with oral terbinafine alone for the treatment of onychomycosis with matrix involvement
- 2007
-
Ingår i: Br J Dermatol. ; 157:1, s. 149-57
-
Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Onychomycosis is common, accounting for up to 50% of all nail disorders. Toenail onychomycosis can cause nail deformity, embarrassment, pain and walking difficulties. Some populations, such as individuals with diabetes, are at higher risk for developing secondary complications such as infections. Treatment takes many months and therapeutic choices can increase clinical effectiveness, lower toxicity and minimize healthcare costs. OBJECTIVES: Based on the results of a previous pilot study, the objective of the present study was to show, in a larger population, the enhanced efficacy of a combination of amorolfine nail lacquer and oral terbinafine in the treatment of onychomycosis with matrix involvement. In addition, a cost-effectiveness analysis was performed. METHODS: In this multicentre, randomized, open-label, parallel group study, patients were randomized to receive either a combination of amorolfine hydrochloride 5% nail lacquer once weekly for 12 months plus terbinafine 250 mg once daily for 3 months (AT group) or terbinafine alone once daily for 3 months (T group). The study duration was 18 months including a 6-month treatment-free phase following the 12-month active treatment phase for the AT group and a 15-month treatment-free phase following the 3-month active treatment phase for the T group. The primary efficacy criterion was overall response, dichotomized into success or failure, success being the combination of clinical cure and negative mycology at month 18. This criterion was used as the effectiveness measure in the pharmacoeconomic analysis, conducted from a payer perspective. RESULTS: In total, 249 patients were included into the study: 120 in the AT group and 129 in the T group. A significantly higher success rate was observed for patients in the AT group relative to those in the T group at 18 months (59.2% vs. 45.0%; P = 0.03). Both treatment regimens were safe and well tolerated. Treatment cost per cured patient was lower for the combination than for terbinafine alone in all countries. CONCLUSIONS: Study results confirmed that, in the treatment of dermatophytic toenail onychomycosis with matrix involvement, amorolfine nail lacquer in combination with oral terbinafine enhances clinical efficacy and is more cost-effective than terbinafine alone.
|
|
| 2. |
- Dréno, B, et al.
(författare)
-
Combination therapy with adapalene-benzoyl peroxide and oral lymecycline in the treatment of moderate to severe acne vulgaris : a multicentre, randomized, double-blind controlled study
- 2011
-
Ingår i: British Journal of Dermatology. - : Oxford University Press (OUP). - 0007-0963 .- 1365-2133. ; 165:2, s. 383-390
-
Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND:Oral antibiotics in association with a topical retinoid with or without benzoyl peroxide (BPO) are the recommended first-line option in the treatment of moderate to severe acne vulgaris.OBJECTIVES:To evaluate the efficacy and safety of oral lymecycline 300 mg with adapalene 0·1%-BPO 2·5% (A/BPO) fixed-dose gel in comparison with oral lymecycline 300 mg with a vehicle gel in subjects with moderate to severe acne vulgaris.METHODS:A total of 378 subjects were randomized in a double-blind, controlled trial to receive once-daily lymecycline with either A/BPO or vehicle for 12 weeks. Evaluations included percentage changes from baseline in lesion counts, success rate (subjects 'clear' or 'almost clear'), skin tolerability, adverse events and patients' satisfaction.RESULTS:The median percentage reduction from baseline in total lesion counts at week 12 was significantly higher (P < 0·001) in the lymecycline with A/BPO group (-74·1%) than in the lymecycline with vehicle group (-56·8%). The success rate was significantly higher (47·6% vs. 33·7%, P = 0·002) in subjects treated with lymecycline and A/BPO. Both inflammatory and noninflammatory lesions were significantly reduced at week 12 (both P < 0·001) with a rapid onset of action from week 2 for noninflammatory lesions (P < 0·001) and week 4 for inflammatory lesions (P = 0·005). The A/BPO and lymecycline combination was well tolerated. The proportion of satisfied and very satisfied subjects was similar in both groups, but the number in the A/BPO group who were 'very satisfied' was significantly greater (P = 0·031).CONCLUSION:These results demonstrate the clinical benefit of combining A/BPO with lymecycline in the treatment of moderate to severe acne vulgaris.
|
|
| 3. |
- Papp, K., et al.
(författare)
-
Cost-effectiveness evaluation of clobetasol propionate shampoo (CPS) maintenance in patients with moderate scalp psoriasis : A Pan-European analysis
- 2012
-
Ingår i: Journal of the European Academy of Dermatology and Venereology. - : Wiley. - 0926-9959 .- 1468-3083. ; 26:11, s. 1407-1414
-
Tidskriftsartikel (refereegranskat)abstract
- Background Scalp psoriasis is a difficult to treat and usually chronic manifestation of psoriasis. The CalePso study showed that CPS (Clobex ® Shampoo) in maintenance therapy of scalp psoriasis (twice weekly) significantly increases the probability of keeping patient under remission during 6 months, compared with vehicle (40.3% relapses vs. 11.6% relapses, ITT). Objective The objective of the study was to assess the cost-effectiveness of a maintenance therapy with CPS vs. its vehicle in nine European countries. Methods A 24-week decision tree model was developed with 4-weekly time steps. The considered population has moderate scalp psoriasis successfully treated with a daily application of CPS up to 4 weeks. Data were taken from the CalePso study and from national experts' recommendations for alternative treatment choices, with their probabilities of success taken from literature to develop country-specific models. Health benefits are measured in disease-free days (DFD). The economic analysis includes drug and physician costs. A probabilistic sensitivity analysis (PrSA) assesses the uncertainty of the model. Results Depending on the country, the mean total number of DFDs per patient is 21-42% higher with CPS compared with vehicle, and the mean total cost is 11-31% lower. The mean costs per DFD are 30-46% lower with CPS compared with the vehicle. The PrSA showed in 1000 simulations that CPS is more effective vs. vehicle in 100% of the cases and less expensive than its vehicle in 80-99% of the cases. Conclusion This model suggests that CPS is cost-effective in maintaining the success achieved in moderate scalp psoriasis patients.
|
|
| 4. |
- Tan, J., et al.
(författare)
-
Prevalence of rosacea in the general population of Germany and Russia : The RISE study
- 2016
-
Ingår i: Journal of the European Academy of Dermatology and Venereology. - : Wiley. - 0926-9959 .- 1468-3083. ; 30:3, s. 428-434
-
Tidskriftsartikel (refereegranskat)abstract
- BackgroundThere is an unmet need for general population-based epidemiological data on rosacea based on contemporary diagnostic criteria and validated population survey methodology. ObjectiveTo evaluate the prevalence of rosacea in the general population of Germany and Russia. MethodsGeneral population screening was conducted in 9-10 cities per country to ensure adequate geographic representation. In Part I of this two-phase study, screening of a representative sample of the general population (every fifth person or every fifth door using a fixed-step procedure on a random route sample) was expedited with use of a questionnaire and algorithm based on current diagnostic criteria for rosacea. Of the subjects that screened positive in the initial phase, a randomly selected sample (every third subject) t`hen underwent diagnostic confirmation by a dermatologist in Part II. ResultsA total of 3052 and 3013 subjects (aged 18-65years) were screened in Germany and Russia respectively. Rosacea prevalence was 12.3% [95%CI, 10.2-14.4] in Germany and 5.0% [95%CI, 2.8-7.2] in Russia. The profile of subjects with rosacea (75% women; mean age of 40years; mainly skin phototype II or III, majority of subjects with sensitive facial skin) and subtype distribution were similar. Overall, 18% of subjects diagnosed with rosacea were aged 18-30years. Over 80% were not previously diagnosed. Within the previous year, 47.5% of subjects had received no rosacea care and 23.7% had received topical and/or systemic drugs. Over one-third (35% Germany, 43% Russia) of rosacea subjects reported a moderate to severe adverse impact on quality of life. ConclusionRosacea is highly prevalent in Germany (12.3%) and Russia (5.0%). The demographic profile of rosacea subjects was similar between countries and the majority were previously undiagnosed.
|
|
