IntroductionThe aim of this study was to investigate whether the efficacy of liraglutide observed in randomized controlled trials translates into therapeutic benefits in the French population during routine clinical practice.MethodsThis observational, prospective, multicenter study included 3152 adults with type 2 diabetes who had recently started or were about to start liraglutide treatment. During 2 years of follow-up, an evaluation of the reasons for prescribing liraglutide, maintenance dose of liraglutide, changes in combined antidiabetic treatments, level of glycemic control, change in body weight and body mass index (BMI), patient satisfaction with diabetes treatment and safety of liraglutide were investigated. The primary study endpoint was the proportion of patients still receiving liraglutide and presenting with HbA1c <7.0% after 2 years of follow-up.ResultsAt the end of the study, 29.5% of patients maintained liraglutide treatment and reached the HbA1c target. Mean (±SD) HbA1c, fasting plasma glucose concentration, body weight and BMI were significantly reduced from baseline [8.46% (±1.46) to 7.44% (±1.20); 180 (±60) to 146 (±44) mg/dL; 95.2 (±20.0) to 91.1 (±19.6) kg; 34.0 (±7.2) to 32.5 (±6.9) kg/m2; respectively, all P < 0.0001]. Patient treatment satisfaction increased, with the mean diabetes treatment satisfaction questionnaire status version score increasing from 22.17 (±7.64) to 28.55 (±5.79), P < 0.0001. The main adverse event type was gastrointestinal, with a frequency of 10.9%, and the percentage of patients suffering ≥1 hypoglycemic episode decreased from 6.9% to 4.4%.ConclusionThe results of the EVIDENCE study suggest that the effectiveness of liraglutide in real-world clinical practice is similar to that observed in randomized controlled trials.FundingNovo Nordisk A/S.Trial RegistrationClinicalTrials.gov identifier, NCT01226966.Electronic supplementary materialThe online version of this article (doi:10.1007/s12325-015-0245-x) contains supplementary material, which is available to authorized users.
Purpose-Health-related quality of life (HRQoL) is impaired in women treated for postmenopausal osteoporosis (PMO). The objective of this study was to examine the relationship Methods-Baseline data were obtained and combined from two large and similar multinational observational studies: Prospective Observational Scientific Study Investigating Bone Loss Experience in Europe (POSSIBLE EU ® )and in the US (POSSIBLE US™) including postmenopausal women in primary care settings initiating, switching or who had been on bone loss treatment for some time. HRQoL measured by health utility scores (EQ-5D™) were available for 7,897 women (94% of study participants). The relationship between HRQoL and baseline clinical characteristics, medical history and patient demographics was assessed using parsimonious, multivariable, mixed-model analyses.
Europe PMC Funders GroupResults-Median health utility score was 0.80 (interquartile range 0.69-1.00). In multivariable analyses, young age, low body mass index, previous vertebral fracture, increased number of comorbidities, high fear of falling and depression were associated with reduced HRQoL. Regression-based model estimates showed that previous vertebral fracture was associated with lower health utility scores by 0.08 (10.3%) and demonstrated the impact of multiple comorbidities and of fear of falling on HRQoL.Conclusions-In this large observational study of women with PMO, there was substantial inter-individual variability in HRQoL. An increased number of comorbidities, fear of falling and previous vertebral fracture were associated with significant reductions in HRQoL.
This elicitation study shed light into GPs' beliefs regarding prescribing. Factors that are not common in the usual European setting were revealed, such as the influence of the patients' family and special situations during prescribing. Thus, various issues were highlighted that should inform the development of items for inclusion in a forthcoming TPB-based questionnaire. The results of this study revealed also certain issues that can affect the design of policies aiming at the rationalization of prescribing.
Patient information leaflets given by the physician during the consultation significantly modify the patient's behavior and knowledge of the disease, compared with patients not receiving the leaflets, for the conditions studied.
Background: Although insulin therapy is well-accepted by symptomatic diabetic patients, it is still often delayed in less severe patients, in whom injectable insulin remains under-used. A better understanding of patients' perception of insulin would eventually help physicians to adopt the most appropriate dialogue when having to motivate patients to initiate or to intensify insulin injection.
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