Vitamin K antagonist treatment in patients with atrial fibrillation and time in therapeutic range in four European countries.

Purpose: Patients with atrial fibrillation are at increased risk for stroke and thus require anticoagulant prophylaxis with vitamin K antagonists. However, many such patients fail to achieve target coagulation status. The objective of this study was to evaluate time in the therapeutic range and its relationship to clinical outcomes in patients with nonvalvular atrial fibrillation prescribed a vitamin K antagonist in everyday clinical practice in 4 European countries (France, Germany, Italy and the United Kingdom).

A systematic review and mixed-treatment comparison of dapagliflozin with existing anti-diabetes treatments for those with type 2 diabetes mellitus inadequately controlled by sulfonylurea monotherapy.

Background: To compare the first-in-class sodium glucose co-transporter 2 (SGLT2) inhibitor, dapagliflozin, with existing type 2 diabetes mellitus (T2DM) treatment options available within the European Union (EU) for add-on therapy to sulfonylureas (SUs).

Methods: A systematic review was conducted to identify randomised controlled trials (RCTs) in T2DM patients inadequately controlled by SU monotherapy. Direct meta-analysis, Bucher indirect comparisons and Bayesian network meta-analysis (NMA) were conducted on studies meeting predefined inclusion criteria.

Cost effectiveness of saxagliptin and metformin versus sulfonylurea and metformin in the treatment of type 2 diabetes mellitus in Germany: a Cardiff diabetes model analysis.

Background: The lack of adequate glycaemic control for patients with type 2 diabetes mellitus (T2DM), especially with existing second-line therapies, represents an unmet medical need. Of the newer therapies, the incretin-based medicines, such as saxagliptin, look promising to consolidate second-line pharmacotherapy.

Objective: This study evaluates the long-term economic consequences of saxagliptin versus sulfonylurea (glipizide) as second-line therapy when used in combination with metformin after failure of monotherapy treatment with metformin, in patients with T2DM in Germany.

The cost-effectiveness of saxagliptin versus NPH insulin when used in combination with other oral antidiabetes agents in the treatment of type 2 diabetes mellitus in Poland.

Background: This study compared the health and economic benefits of saxagliptin versus insulin as second-line therapy with either metformin (MET) or sulfonylurea (SU) after failure of the respective monotherapies for patients with type 2 diabetes in Poland.

Methods: The cost-effectiveness was assessed using a previously published diabetes model. Disease progression, utilities, and effects of changes in glycosylated hemoglobin (HbA1c), weight, and hypoglycemic events were taken from published studies, and Polish sources were used where possible.

A comparative review of health-related quality-of-life measures for use in HIV/AIDS clinical trials.

With the advent of highly active antiretroviral therapy (HAART), HIV-infected patients are living longer and are concerned not only with a treatment's ability to extend their life but also with the quality of the life they are able to lead. Regulatory authorities are also paying closer attention to the use of health-related quality-of-life (HR-QOL) measures in clinical trials and to the subsequent claims that are made based on the results. This paper reviews existing HR-QOL measures reported in the HIV/AIDS literature since 1990 and identifies those most worthy of consideration for use in future clinical trials.

An economic evaluation of sequential i.v./po moxifloxacin therapy compared to i.v./po co-amoxiclav with or without clarithromycin in the treatment of community-acquired pneumonia.

Study Objective: To evaluate costs, clinical consequences, and cost-effectiveness from a German and French health-care system perspective of sequential i.v./po moxifloxacin monotherapy compared to co-amoxiclav with or without clarithromycin (AMC +/- CLA) in patients with community-acquired pneumonia (CAP) who required parenteral treatment.

Validity of the St George's respiratory questionnaire at acute exacerbation of chronic bronchitis: comparison with the Nottingham health profile.

The purpose of the study is to compare a generic and a specific quality of life (QoL) instrument in the assessment of QoL in chronic bronchitis. Data from 320 patients were collected at acute exacerbation of chronic bronchitis (AECB), and from 230 patients during a subsequent stable phase (non-AECB), utilising both the specific St George's respiratory questionnaire (SGRQ) and the generic Nottingham health profile (NHP). Patients (maximum n = 200) reported significantly poorer QoL at AECB than at non-AECB for all domains except the SGRQ symptom domain (SRM = 0.

The community-acquired pneumonia symptom questionnaire: a new, patient-based outcome measure to evaluate symptoms in patients with community-acquired pneumonia.

Study Objective: s: To develop and validate a patient-based outcome measure to evaluate symptoms in patients with community-acquired pneumonia (CAP).

Design: A psychometric study within an international, prospective, randomized, double-blind study. The CAP-symptom questionnaire (CAP-Sym) is a new, 18-item, patient-reported outcome measure that evaluates the bothersomeness of CAP-related symptoms during the past 24 h using a 6-point Likert scale.