Twice-weekly treatment with tacrolimus 0.03% ointment in children with atopic dermatitis: clinical efficacy and economic impact over 12 months.

BACKGROUND: Rational healthcare decision-making based on clinical and economic evidence is essential to provide the best possible care for patients with atopic dermatitis (AD). OBJECTIVE: To evaluate treatment outcomes, resource use and cost associated with twice-weekly tacrolimus 0.03% ointment treatment vs. standard flare-only therapy in children with moderate-to-severe AD. METHODS: In a pan-European, Phase III multicentre randomized clinical trial, children with mild-to-severe AD were randomized to 0.03% tacrolimus ointment or vehicle twice weekly for 12 months. Disease flares were treated using open-label tacrolimus 0.03% ointment twice daily. Clinical efficacy data were evaluated in a subgroup of 153 children with moderate-to-severe AD, with resource use data--collected prospectively using caregiver questionnaires--available from 146 children. Pooled costs of resource use were determined using German unit cost data. Direct and indirect costs were considered from third-party payer, patient and caregiver, and societal perspectives. RESULTS: Twice-weekly tacrolimus ointment reduced the number of flares compared with standard therapy (P < 0.001) and prolonged time to first flare (146 vs. 17 days, P < 0.001). Mean +/- SD annual costs per patient for standard and twice-weekly therapy respectively were 2002 euro +/- 2315 vs. 1571 euro+/- 1122 for severe AD and 1136 euro +/- 1494 vs. 1233 euro +/- 1507 for moderate AD. CONCLUSIONS: In children with AD, twice-weekly treatment with tacrolimus 0.03% ointment reduces the number of flares and prolongs time spent free from flares with no additional cost in children with moderate AD, and may be cost-saving in those with severe AD.

Economic evaluation of maintenance treatment with tacrolimus 0.1% ointment in adults with moderate to severe atopic dermatitis.

BACKGROUND: Rational health care decision-making based on outcomes and economic evidence is essential to provide the best possible care for individual patients with atopic dermatitis (AD). OBJECTIVES: To describe treatment outcomes and to evaluate resource utilization and associated cost of maintenance use of tacrolimus ointment (MU) vs. standard use of tacrolimus ointment (SU) in adults with AD. METHODS: A pan-European, phase III multicentre randomized clinical trial was conducted. Patients with mild to severe AD were randomized to tacrolimus 0.1% ointment (MU) or vehicle (SU) twice per week for 12 months. Disease exacerbations were treated by using open-label tacrolimus 0.1% ointment twice daily. Resource utilization data were collected prospectively alongside the clinical trial. Costs of pooled resource data were determined using German unit cost data. Direct and indirect costs were considered from third party payer, patient and societal perspectives. RESULTS: All patients with moderate and severe AD were included in a subanalysis, 75 patients in the MU arm (57% moderately affected) and 59 patients in the SU arm (59% moderately affected). In patients with moderate AD, the number of disease exacerbations in the MU arm was 2.4 vs. 5.5 in the SU arm (P<0.001); in patients with severe AD corresponding figures were 2.3 vs. 7.4 (P<0.001), respectively. Mean+/-SD total annual cost per patient was euro1525+/-1081 (MU) vs. euro1729+/-1209 (SU) in patients with moderate AD and euro2045+/-2013 (MU) vs. euro2904+/-1510 (SU) in patients with severe AD. CONCLUSIONS: Maintenance treatment with 0.1% tacrolimus ointment is more effective and leads to cost savings and improved health-related quality of life in comparison with standard use of 0.1% tacrolimus ointment, especially in patients with severe AD.

The use of conventional radiography and computer-assisted tomography as instruments for demonstration of gross pathological lesions in the cranium and cerebrum in the crested breed of the domestic duck (Anas platyrhynchos f.dom.).

According to literature reports, the crested breed of the domestic duck (Anas platyrhynchos f. dom.) is described as a variety with high pre- and post-natal mortalities, malformations in skull and brain anatomy, and various central nervous deficiencies in affected birds. A detailed examination as to the cause and pathogenesis of these neurologic disorders has not yet been conducted, nor has an explanation concerning the inheritance of the feather crest been found. By using two non-invasive radiographic techniques, conventional radiography and computer-assisted tomography, living ducks were examined. Our studies have demonstrated that brain and skull anatomy of ducks of various breeds (Crested, Abacot Ranger, and German Pekin) can be well visualized using computer-assisted tomography. The Crested ducks investigated in this study showed abnormal fatty tissue deposits in the tentorium cerebelli, cranial malformations, and variable bone formations in the thickened hypodermis of the crest. In comparison with computer-assisted tomography, only parts of the skull changes were detected with conventional radiography; in no case could fat bodies be seen with this imaging method. An increase of the cranial capacity in the Crested ducks compared with other breeds examined (Abacot Ranger, German Pekin ducks) was found in morphometric studies carried out by computerassisted tomography. This increase of cranial capacity in Crested ducks results from an increase of the tentorial fatty depot during craniogenesis, as an enlargement of the fat body can influence cranium growth as long as the cranial bones are not yet fused. Thus, in comparison with other phenotypically similar domesticated birds like the crested chicken, the expression of the feather crest in domestic ducks demonstrates symptomatologic differences.

Specific high-performance liquid chromatographic assay for nitroglycerin in dosage forms.

A specific assay for nitroglycerin dosage forms using high-performance liquid chromatography was developed. Sublingual nitroglycerin tablets are dissolved in 25 ml of water and injected directly into the chromatograph. Chromatographic conditions are: mobile phase, 60% methanol in water; flow rate, 2 ml/min; column, microparticulate reversed phase; and detection, 200 nm. The glyceryl mononitrate and dinitrate degradation products of nitroglycerin are separated from nitroglycerin and can be identified by altering the mobile phase composition of methanol.

[Vaccinations in recurrent urinary tract infections--an observation study relating to health economy]. / Impfungen bei rezidivierenden bakteriellen Harnwegsinfektionen--eine Beobachtungsstudie mit gesundheitsökonomischen Aspekten.

BACKGROUND AND PURPOSE: Urinary tract infection (UTI) is one of the most common bacterial infections in women. Despite the need for therapy alter-natives only the conventional treatment using antibiotics is investigated in the literature. A vaccination, however, can be a useful medical and economic alternative for the treatment of recurrent urinary tract infections. MATERIALS AND METHODS: An open, prospective, not-randomised, multicentric observation study was carried out to determine the costs and effects of a vaccination in 842 patients with recurrent urinary tract infections. The data for efficacy, safety and costs of recurrent urinary tract infections were collected via patient documentation and a standardised documentation of the physicians. RESULTS: The efficacy was rated as good to very good by 82.7 % of the physicians and 82.1 % of the patients. The values for safety show even better results. They were rated as good to very good by 92.4 % of the physicians and 90.9 % of the patients. The total costs amounted to 433 euro per patient in the six months before vaccination and decreased significantly to 238 euro in the six months after vaccination (p < 0.0001). CONCLUSIONS: The results of this observation study show a clinically relevant reduction of recurrent urinary tract infections with acceptable side effects in the six months after vaccination. As the treatment costs are reduced from a mean of 238 euro to 91 euro per patient. The healthcare insurances can also benefit from the vaccination against recurrent urinary tract infections.

Stability of stabilized nitroglycerin tablets in typical distribution and administration systems.

A study was undertaken to determine whether or not the present extreme restrictions on the packaging of nitroglycerin tablets are indeed necessary when dispensing the newer stabilized tablets. Baseline tests were conducted on two molded and two compressed sublingual nitroglycerin tablets to determine weight variation, content uniformity, average potency and friability. Stability tests included: (1) use test designed to simulate patient use from a single bottle of 100 tablets over a one-month period; (2) an open plate study wherein tablets were exposed to the atmosphere for 100 days; (3) strip packaging of tablets using foil-foil or foil-cello systems; (4) placement of tablets in medication cups for a seven-day period; (5) repackaging 30-tablet batches in a variety of common prescription containers. All brands of tablets retained potency during normal use when dispensed and stored in their original containers. However, one brand was superior to all others when placed under stress conditions such as open plate exposure. These tablets also retained labeled potency when exposed in a medication cup for a seven-day period, or when repackaged in either foil-foil or foil-cello strips, or when dispensed in a number of ordinary prescription containers. The study indicated that this brand of nitroglycerin tablets might be handled like any other solid dosage form in hospital distribution systems without endangering patient care. However, exceptions to present packaging restrictions must be cleared with the Food and Drug Administration.

Stability of nitroglycerin tablets in a unit of use pendant-type container.

A stainless steel pendant (Life-Link) designed to carry emergency quantities of nitroglycerin tablets was examined for compliance with FDA packaging restrictions for nitroglycerin. The results of the study indicate that the pendant is equal or superior to screw-capped glass containers presently required for packaging of nitroglycerin tablets. Tablets stored for up to 3 months retain potency and physical integrity. The pendant provides a simple, tight, convenient, and unbreakable container for carrying nitroglycerin tablets on a 24-hour basis.