Real-life Conditions In Germany Research Articles

Impact of Parallel Topical Treatment with Nadifloxacin and Adapalene on Acne Vulgaris Severity and Quality of Life: A Prospective, Uncontrolled, Multicentric, Noninterventional Study

Introduction: Daily parallel application of adapalene and nadifloxacin has been determined to be effective and well tolerated in patients with acne vulgaris in randomized, controlled clinical studies. Here, the authors report the results from a large, prospective, uncontrolled, multicentric, noninterventional study under real-life conditions in Germany. The effect of treatment on acne severity, safety, and, for the first time, health-related quality of life (HRQoL) was investigated. Methods: Of the 292 patients (safety collective: 231 adults, 61 adolescents) who had at least grade 4 acne vulgaris on the face as per the Leeds Revised Acne Grading (LRAG), 273 (efficacy collective: 213 adults, 60 adolescents) were treated with adapalene 0.1% cream or gel and nadifloxacin 1% cream for the defined minimum of 28 days. Patients were evaluated for acne severity, acne-related facial symptoms, HRQoL, overall assessment of therapy, and safety. Results: After the median treatment duration of 37 and 38 days (adults and adolescents, respectively), 93.4% and 85.0% of adults and adolescents, respectively, exhibited a sustained decrease in acne severity. The LRAG decreased by at least 3 scores in 29.1% and 24.6% of female and male adults, respectively. HRQoL improved in 67.9% and 63.5% of adults and adolescents, respectively (median improvement in the Dermatology Life Quality Index scores per patient of 3.0 [female adults], 1.0 [male adults], and 2.0 for all adolescents in the Children’s Dermatology Life Quality Index). Female adults were more impaired in terms of HRQoL compared to male adults. The 2 best overall efficacy ratings were provided by physicians in 79.3% and 69.5% and by patients in 68.5% and 58.3% of adult and adolescent cases, respectively. The treatment was well tolerated, as reflected in the low number of 9 mild adverse events (AEs), all of which resolved without treatment. However, 4 patients terminated the study prematurely due to AEs. Conclusion: In this study, the parallel use of adapalene and nadifloxacin for at least 5 weeks resulted in a rapid improvement in acne severity, an increase in HRQoL, and a good safety profile. Therefore, it represents a promising treatment option that offers the possibility of flexible therapy adjustment.

Management and Outcomes of Patients with Superficial Vein Thrombosis under Real-life Conditions in Germany (INSIGHTS-SVT)

Management and Outcomes of Patients with Superficial Vein Thrombosis under Real-life Conditions in Germany (INSIGHTS-SVT)

Salvage therapy after failure from anti-PD-1 single agent treatment: A Study by the German ADOReg melanoma registry.

9505 Background: In melanoma, potential benefits of therapies after PD-1 inhibitor failure, including those BRAF positive patients who have already received combined BRAF-/MEK inhibitors before anti PD-1 are poorly defined. We therefore analyzed the treatment patterns and outcome of systemic therapies for patients after anti-PD-1 failure. Methods: From the ADOReg registry, patients fulfilling the following inclusion criteria were consecutively included until a number of 200 cases was reached. 1) Ipilimumab naive patients with unresectable metastatic cutaneous or mucosal melanoma. 2) Failure from treatment with a single agent anti PD-1 antibody. 3) Known BRAF status and, in case of BRAF-V600 mutation, BRAF-/MEK-inhibitor treatment prior to anti PD-1 treatment. 4) Consecutive systemic treatment started within a maximum of 6 months after anti PD-1 failure. Objectives: Rate of objective remissions (ORR), disease control (DCR), survival (OS), tolerability and disease patterns correlated to the use of different treatments after PD-1 treatment failure in real-life conditions in Germany. Results: In total 23.5 % of the patients received ipilimumab single agent, 38.5 % received the combination of ipilimumab and nivolumab (Ipi/Nivo), and the remaining various regimens. (Table) Ipi/Nivo resulted in an ORR significantly higher than for Ipi alone (p=0.02). In 18 patients receiving BRAF-/MEK inhibitor re-challenge, ORR was comparable to Ipi/Nivo. Conventional Chemotherapy was still in frequent use (dacarbazine n =33; other n=17), but response rates were low (ORR 6%). Some remission were also achieved by use of talimogene laherparepvec (n=2 out of 4). Conclusions: Treatment patterns of patients after anti-PD-1 failure differ remarkably. Although lower than reported in treatment naive patients, the combination of Ipilimumab and Nivolumab appeared favorable as compared to all other regimens, except for BRAF-/MEK inhibitor re-challenge which produced similar remission rates. Still, chemotherapies including dacarbazine are in clinical practice, though giving only poor outcome. [Table: see text]

ACT-FASTER, a Prospective Cohort Study Exploring Treatment Patterns with Fulvestrant and Exemestane in Postmenopausal Patients with Advanced Hormone Receptor-Positive Breast Cancer under Real-Life Conditions in Germany

Background: Endocrine therapy is recommended for the treatment of postmenopausal women with hormone receptor-positive (HR+) advanced breast cancer (ABC). Methods: ACT-FASTER was a German prospective non-interventional cohort study in postmenopausal women with HR+ ABC receiving fulvestrant 500 mg as first line (1 L), second line (2 L) or third line (3 L), or exemestane (any line) in the real-world palliative setting. Primary study objectives included the effectiveness of fulvestrant according to line of palliative treatment measured by time to progression (TTP), and real-life data on the epidemiology and management of these patients. Results: Of 498 evaluable patients (mean age 67.5 years), 99% were estrogen receptor-positive. On study, 86.7% of patients received fulvestrant 500 mg and 13.3% exemestane. Median TTP was 9.7 months in patients receiving fulvestrant 1 L; 6.8 months for 2 L; and 6.7 months for 3 L. The comparison between fulvestrant 1 L palliative treatment and 2 L or 3 L showed that early initiation of treatment prolonged TTP (hazard ratio 1.26; 95% confidence interval 1.08-1.48). Treatments were well tolerated. Conclusion: Fulvestrant 500 mg was administered successfully to patients under daily practice conditions, and both medications were well tolerated. TTP was longest in patients treated with fulvestrant 500 mg 1 L compared with 2 L and 3 L in the palliative care setting.

Patient-reported outcomes with golimumab in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: non-interventional study GO-NICE in Germany

The TNF inhibitor golimumab (GLM) is a treatment option in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS). The GO-NICE study assessed patient-reported outcomes (PRO) in patients newly treated with monthly GLM 50 mg subcutaneously (SC) under real-life conditions in Germany. A prospective non-interventional study with 24-month observation per patient was conducted at 158 sites. Available for analysis were 1,458 patients, 474 with rheumatoid arthritis (RA: 54.9 ± 13.4 years, 72.8% females, 60.4% biologic-naïve), 501 with psoriatic arthritis (PsA: 50.5 ± 12.1 years, 54.1% females; 47.5% biologic-naïve), and 483 with ankylosing spondylitis (AS: 43.6 ± 12.3 years, 66.5% males; 58.4% biologic-naïve). A total of 664 patients completed follow-up to month 24. An improvement of QoL by EuroQoL EQ-5D-3L was seen after 6 months and was maintained over 24 months. The patients’ health state today (EQ visual analog scale) improved statistically significantly (p < 0.0001 vs. BL) from 51.0 at baseline (BL) to 63.4 (RA), from 48.4 to 64.3 (PsA) and from 46.8 to 66.5 (AS). Functional ability (FFbH) improved significantly (p < 0.003 vs. BL) from BL 68.2 to 76.1 points (RA), from 69.0 to 76.8 points (PsA), and from 69.0 to 78.5 points (AS). The mean FACIT-Fatigue score increased significantly (p < 0.0001 vs. BL) from BL 32.4 to 38.3 points (RA), from 30.0 to 35.9 points (PsA), and from 29.9 to 37.9 points after 24 months (AS); p < 0.0001 vs. BL each. On treatment with GLM SC once monthly, significant improvements in patient-reported QoL parameters were noted in a very similar manner in all three diseases.Trial registration ClinTrials.gov Identifier: NCT01313858. Registered March 14, 2011; https://clinicaltrials.gov/ct2/show/record/NCT01313858.

Atrial fibrillation in Germany: A prospective cost of illness study

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia in clinical practice and associated with a high risk of stroke, heart failure and hospitalization. This study examines the indication-specific costs of illness of AF patients in Germany. The study was conducted nationwide with 54 general practitioners and internists, as well as 12 practicing cardiologists. The observational period per patient was one year. Costs were calculated from the perspective of the German statutory health insurance. The study collected the annual direct indication-specific costs and additional patient relevant outcomes. Indication-specific services of 361 patients (age: 75, male: 55%) documented by general practitioners and internists cause average costs of 582 € per patient. The highest cost are caused by hospitalization (289 €), followed by outpatient treatment costs (151 €) and costs of anticoagulation with 52 € per patient. Additional consulting of a cardiologist (115 patients) causes average costs of 81 €. Assuming that a patient with AF is treated once a year by a resident cardiologist, the average annual cost amounted to 664 €. The results of this prospectively cost of illness analysis for AF patients under real life conditions in Germany indicate a high socio-economic burden of AF.

P0777 : Sofosbuvir-based treatment under real life conditions in Germany (The sofger trial)

P0777 : Sofosbuvir-based treatment under real life conditions in Germany (The sofger trial)

Baseline results from ACT-FASTER, a prospective cohort study exploring treatment patterns with fulvestrant and exemestane in postmenopausal patients with advanced hormone-receptor positive breast cancer under real-life conditions in Germany

Zielsetzung: Fulvestrant (FUL) ist ein selektiver Östrogenrezeptorantagonist zur Behandlung postmenopausaler (PMP) Frauen mit Östrogenrezeptor-positivem (HR+), fortgeschrittenem Mammakarzinom (ABC) nach endokriner Vorbehandlung (ET) mit Antiöstrogen (Tamoxifen). Derzeit liegen keine eindeutigen Empfehlungen zur endokrinen Therapiesequenz postmenopausaler Frauen mit HR+ ABC vor. ACT-FASTER liefert Daten aus dem Therapiealltag in Deutschland zu FUL 500 mg und Exemestan (EXE) in unterschiedlichen Therapielinien.

Predictors for the initiation of a basal supported oral therapy (BOT) in type 2 diabetic patients under real-life conditions in Germany

ObjectiveTo assess the predictors for the initiation of a basal supported oral therapy (BOT) in type 2 diabetic patients under real-life conditions in Germany. Research design and methodsA historical cohort study based on representative German real life data (IMS® Disease Analyzer) was performed. The study included patients with type 2 diabetes who started an oral antidiabetic drug (OAD) treatment between 01/1995 and 12/2011. Patients with consecutive treatment data for at least 12 months before the initiation of an OAD treatment were eligible for the analysis. The time-dependent rate of patients starting an insulin therapy with a long-acting insulin was calculated by use of the Kaplan–Meier method. Multivariate Cox regression analyses were applied to identify associated factors. ResultsThe study included 194,967 patients with type 2 diabetes mellitus being on OAD therapy. 24,964 patients were switched to BOT during the observational period. The probability of switching to insulin therapy was associated with three main predictors such as (1) poor metabolic control, (2) midlife age and (3) number and type of the OAD before insulinization. The variation of the HbA1c threshold to HbA1c≥7.5 leads to comparable outcomes with significant HR. ConclusionThe highest probability of initiating a basal supported oral therapy (BOT) under real life conditions was found for patients with poor metabolic control, midlife age and pre-treatment with specific OADs such as SU, GLI or AGI before initiation of insulin therapy.

Amputation rate and risk factors in type 2 patients with diabetic foot syndrome under real-life conditions in Germany

AimsTo determine the risk of amputation and the influencing factors for amputation for patients with type 2 diabetes with diabetic foot syndrome. MethodsLongitudinal data from general practices in Germany (Disease Analyzer database, IMS Health) were analyzed. 3892 type 2 diabetes patients (mean age: 66.0 (SD: 10.9years), 39.1% female) with a first-time diagnosis of diabetic foot syndrome between 01/200 and 12/2004 and at least 5year follow-up documentation in the practices were included. The analyses of amputation-free survival were carried out using Kaplan–Meier curves and log-rank tests. A multivariate Cox regression model was fitted with the incident of diabetes-associated amputations as the dependent variable and adjusted for clinical and demographic characteristics. ResultThe cumulative incidence of diabetes-associated lower limb amputations was 18.2%. Amputations are independently associated with higher age, male gender, higher HbA1c value and longer diabetes duration but also some other diabetes complications. DiscussionThe diabetic foot syndrome can but must not lead to a lower limb amputation. Due to the great medical and economic burden on the health system caused by diabetic complications, early therapeutic intervention is essential for patients with diabetic foot syndrome.

PDB7 PREDICTORS FOR THE INITIATION OF A BASAL SUPPORTED ORAL THERAPY (BOT) IN TYPE 2 DIABETIC PATIENTS UNDER REAL-LIFE CONDITIONS IN GERMANY

a b s t r a c t Objective: To assess the predictors for the initiation of a basal supported oral therapy (BOT) in type 2 diabetic patients under real-life conditions in Germany. Research design and methods: A historical cohort study based on representative German real life data (IMS® Disease Analyzer) was performed. The study included patients with type 2 diabetes who started an oral antidiabetic drug (OAD) treatment between 01/1995 and 12/2011. Patients with consecutive treatment data for at least 12 months before the initiation of an OAD treatment were eligible for the analysis. The time-dependent rate of patients starting an insulin therapy with a long-acting insulin was calculated by use of the Kaplan–Meier method. Multivariate Cox regression analyses were applied to identify associated factors. Results: The study included 194,967 patients with type 2 diabetes mellitus being on OAD therapy. 24,964 patients were switched to BOT during the observational period. The probability of switching to insulin therapy was associated with three main predictors such as (1) poor metabolic control, (2) midlife age and (3) number and type of the OAD before insulinization. The variation of the HbA1c threshold to HbA1c ≥ 7.5 leads to comparable outcomes with significant HR. Conclusion: The highest probability of initiating a basal supported oral therapy (BOT) under real life conditions was found for patients with poor metabolic control, midlife age and pre-treatment with specific OADs such as SU, GLI or AGI before initiation of insulin therapy.

Different persistence on initial basal supported oral therapy in Type 2 diabetics is associated with unequal distributions of insulin treatment regimens under real-life conditions in Germany

Results from a representative German database and from two German health services research studies revealed an unequal distribution between basal supported oral therapy (BOT) and basal-bolus therapy (ICT) regimens in Type 2 diabetics treated with either insulin glargine (GLA) or human insulin (Neutral Protamine Hagedorn; NPH). This study assesses whether this unequal distribution could be caused by a different persistence on the initial BOT regimen. A Markov model was developed simulating the transition from BOT to ICT during a treatment course of 10 years. Data on persistence with BOT were obtained from the IMS® Disease Analyzer database. The model cohort consisted of German statutorily insured Type 2 diabetics starting a BOT either with insulin glargine or NPH insulin at a ratio of 1 : 1. The number of Type 2 diabetics who switched from BOT to ICT differed between the two groups: After 2 years, 53% of glargine-treated patients and 31% of NPH-treated patients continued the BOT. After 6.5 years, all NPH-treated patients had switched to ICT. However, complete transition to ICT of glargine-treated patients occurred 1.75 years later. In the first quarter of Year 3, the model simulation resulted in BOT : ICT ratios comparable to those found in the real-world settings for GLA- and NPH-treated patients. The simulation indicates that the persistence on the initial basal supported oral therapy is associated with the resulting BOT : ICT ratio. Therefore, the unequal distribution between BOT and ICT of Type 2 diabetics treated with either insulin glargine or NPH insulin might be caused by different persistence on the initial BOT regimen.