Real-life treatment patterns, compliance, persistence, and medication costs in patients with hypertension in Germany.

OBJECTIVE: This retrospective patient data analysis was initiated to describe current treatment patterns of patients in Germany with arterial hypertension, with a special focus on compliance, persistence, and medication costs of fixed-dose and unfixed combinations of angiotensin receptor blockers (ARBs), amlodipine (AML) and hydrochlorothiazide (HCT) in Germany. METHODS: The study analyzed prescription data collected by general practitioners, using the IMS Disease Analyzer database. The database was searched for patients with the diagnosis hypertension (ICD-10 code I10) and treatment data in the period 09/2009 to 08/2010. Compliance was measured indirectly based on the medication possession ratio (MPR), and persistence was defined as the duration of time from initiation to discontinuation of therapy. Medication costs were assessed from the statutory health insurance perspective in Germany. RESULTS: In the IMS DA 406,888 observable patients in Germany were encoded with the diagnosis I10 essential hypertension. In total, 88,716 patients received prescriptions including ARBs, monotherapy (18.6%) or unfixed combinations with other anti-hypertensives (19.3%). The compliance with fixed-dose combinations of ARB with HCT, either dual or with one other anti-hypertensive drug, was significantly better, compared to unfixed combinations (mean compliance 78.1% for fixed-dose vs 71.5% for unfixed combinations of ARB with HCT, p < 0.0001; mean compliance 79.4% vs 72.0%, p < 0.0001 if an additional anti-hypertensive medication was added). Fixed-dose combinations of ARB with HCT, ARB with AML, dual only or prescribed with another anti-hypertensive medication resulted in a substantial increase of persistence, especially for patients on fixed-dose dual combinations (225.7 vs 163.6 days for ARB with HCT; 232.9 vs 178.4 days for ARB with AML, respectively). Fixed-dose combinations (varying from €1.38 to €2.20 per patient and day) were on average cheaper than unfixed combinations. LIMITATIONS: Persistence and compliance could be under- or over-estimated because their assessment was based on prescription information. For two thirds of 69,060 patients, data on compliance and persistence was missing. CONCLUSION: The study shows considerable variations in ARB treatment patterns among patients, with the majority of patients treated with fixed-dose or semi-fixed combination therapy. Fixed-dose combinations of ARBs with HCT and/or AML seem to result in better compliance and persistence compared to unfixed regimes of these drug classes, leading to reduction in all-cause hospitalizations, emphasizing the benefit and potential cost-savings of using fixed-dose regimes in a real-life general practice setting in Germany.

Economic impact of compliance to treatment with antidiabetes medication in type 2 diabetes mellitus: a review paper.

OBJECTIVES: Suboptimal compliance and failure to persist with antidiabetes therapies are of potential economic significance. The present research aims to describe the impact of poor compliance and persistence with antidiabetes medications on the cost of healthcare or its components for patients with type 2 diabetes mellitus (T2DM). METHODS: Literature search was conducted in PubMed for relevant articles published in the period between 1 January 2000 and 30 April 2009. Thus, it is possible that relevant articles not listed in PubMed, but available in other databases are not included in the current review. Studies describing economic consequence of compliance and/or persistence with pharmaceutical antidiabetes treatment were identified. The variability in the studies reviewed was high, making it extremely difficult to make a comparison between them. RESULTS: Of 449 articles corresponding to the primary search algorithm, 12 studies (all conducted in USA) fulfilled the inclusion criteria regarding the economic impact of compliance and/or persistence with treatment on the overall cost of T2DM care or its components. Compliance was assessed via medication possession ratio (MPR) in ten studies, where it ranged from 0.52 to 0.93 depending on regimen. Persistence was assessed in one study. Mean total annual costs per T2DM patient varied between the studies, ranging from $4570 to $17338. In seven studies, medication compliance was inversely associated with total healthcare costs, while in four other studies inverse associations between medication compliance and hospitalisation costs were reported. In one study increased adherence did not change overall healthcare costs. CONCLUSIONS: Improved compliance may lead to reductions of the total healthcare costs in T2DM, Further research is needed in countries other than the US to assess impact of compliance and persistence to pharmacotherapy on T2DM costs in country-specific settings.

Direct costs and health-related resource utilisation in the 6 months after insulin initiation in German patients with type 2 diabetes mellitus in 2006: INSTIGATE study.

OBJECTIVE: To assess direct costs and describe resource utilisation associated with the first 6 months of insulin therapy in German patients with type 2 diabetes mellitus (DM). RESEARCH DESIGN AND METHODS: This is an ongoing pan-European, non-interventional, prospective study observing the normal course of diabetes therapy of adult patients with type 2 DM in a diabetologic practice setting, and initiating insulin therapy in 2006. Diabetes therapy 6 months prior to initiation of insulin therapy was assessed retrospectively. For German patients (n = 256), direct costs associated with health-care resource utilisation prior to and after the insulin initiation were assessed and compared from the German statutory health insurance perspective. RESULTS: The percentage of patients using blood glucose monitoring increased from 76.4 to 99.6%; 42.1% of patients remained on oral anti-diabetic medication, with metformin used most frequently (36.5%). Total average cost of resource use related to diabetes care per patient for the 6-month period prior to and 6 months after insulin initiation increased from Euro 579 to Euro 961. Mean total costs of diabetes care during 6 months after insulin initiation in the subgroup of obese patients with worse prognosis at baseline (HbA(1c)> or = 7.5% and BMI > or = 30 kg/m(2)) were Euro 1047 [95% CI 965; 1128] vs. Euro 903 [95% CI 840; 965] in other patients. CONCLUSIONS: Resource utilisation and costs related to diabetes increased in the 6 months following insulin initiation, mainly driven by specialist care resource use, insulin, and blood glucose monitoring. Total direct costs of diabetes care of the patients with a less favourable profile of BMI and HbA(1c) at baseline are higher compared to other patients.

Cross-sectional analysis of adult diabetes type 1 and type 2 patients with diabetic microvascular complications from a German retrospective observational study.

OBJECTIVE: To obtain epidemiological data on the prevalence of predefined stages of diabetic microvascular complications from a representative cross-section of patients with existing microvascular complications of type 1 or type 2 diabetes in Germany. RESEARCH DESIGN AND METHODS: A cross-sectional, retrospective study of medical records of 705 type 1 and 1910 type 2 adult diabetic patients with a diagnosis of retinopathy and/or peripheral neuropathy and/or nephropathy before 2002 and treated in 2002 in Germany. RESULTS: Of 376 patients with type 1 diabetes having retinopathy, 59.3% had mild or moderate non-proliferative retinopathy without macular oedema, 27.1% had macular oedema, and 13.6% had severe retinopathy without macular oedema. In 862 patients with type 2 diabetes, the distribution of retinopathy/maculopathy classes was 56.8%, 35.5%, and 7.7%, respectively. Of 381 type 1 diabetes patients with observed peripheral neuropathy, 81.4% had sensorimotor neuropathy, 8.9% had diabetic foot conditions, and 9.7% had lower extremity amputations because of diabetes. In 1005 patients with type 2 diabetes, the distribution of neuropathy classes was 78.2%, 12.1%, and 9.7%, respectively. The proportions of patients with renal insufficiency in type 1 and type 2 diabetes groups were 15.3% versus 13.5%, respectively. CONCLUSIONS: The study suggests that there are considerable proportions of patients with progressive stages of microvascular complications related to type 1 and type 2 diabetes in Germany. This underlines the importance of improvement of optimal quality of care and frequent screening for preventing late diabetic microvascular complications and the necessity of effective intervention strategies to tackle this major public health problem.

Cytogenetic response to prior treatment with interferon-alpha is predictive for survival after allogeneic hematopoietic stem cell transplantation in chronic myeloid leukemia.

We investigated the impact of a cytogenetic response (CyR) to IFN prior to and at the time of allogeneic hematopoietic stem cell transplantation (HSCT) on transplant-related mortality (TRM), relapse rate and survival probability after HSCT in 162 transplanted patients with chronic myeloid leukemia. One-hundred-one patients (62.3%) achieved a CyR prior to HSCT. Survival probabilities were higher in patients, who achieved any CyR prior to HSCT than in patients without CyR (63.6 vs 49.2%: P = 0.019). Survival probabilities in patients, who achieved a major CyR were better than in patients with minimal and minor CyR or in patients with no CyR (69.4 vs 58.8% vs 49.2%: P = 0.040). TRM and survival of chronic phase patients without CyR at the time of HSCT were similar to that of patients transplanted in advanced phase. Both groups combined had an outcome inferior to patients with at least minimal CyR (TRM, Gray test: P = 0.016, survival, log-rank test: P = 0.002). Univariate and multivariate analyses identified CyR prior to or at HSCT as a strong and independently favorable prognostic factor. We therefore conclude that allogeneic HSCT in CyR should be investigated prospectively as an alternative treatment option in defined patient groups.