Health care utilization and excess costs after pelvic fractures among older people in Germany.

Our study demonstrates a strong increase in utilization of inpatient health care and clear excess costs in older people in the first year after pelvic fracture, the latter even after adjustment for several confounders. Excess costs were particularly high in the first few months and mainly attributable to inpatient treatment. INTRODUCTION: We aimed to estimate health care utilization and excess costs in patients aged minimum 60 years up to 1 year after pelvic fracture compared to a population without pelvic fracture. METHODS: In this retrospective population-based observational study, we used routine data from a large statutory health insurance (SHI) in Germany. Patients with a first pelvic fracture between 2008 and 2010 (n=5685, 82% female, mean age 80±9 years) were frequency matched with controls (n=193,159) by sex, age at index date, and index month. We estimated health care utilization and mean total direct costs (SHI perspective) with 95% confidence intervals (CIs) using BCA bootstrap procedures for 52 weeks before and after the index date. We calculated cost ratios (CRs) in 4-week intervals after the index date by fitting mixed two-part models including adjustment for possible confounders and repeated measurement. All analyses were further stratified for men/women, in-/outpatient-treated, and major/minor pelvic fractures. RESULTS: Health care utilization and mean costs in the year after the index date were higher for cases than for controls, with inpatient treatment being particularly pronounced. CRs (95% CIs) decreased from 10.7 (10.2-11.1) within the first 4 weeks to 1.3 (1.2-1.4) within week 49-52. Excess costs were higher for inpatient than for outpatient-treated persons (CRs of 13.4 (12.9-13.9) and 2.3 (2.0-2.6) in week 1-4). In the first few months, high excess costs were detected for both persons with major and minor pelvic fracture. CONCLUSION: Pelvic fractures come along with high excess costs and should be considered when planning and allocating health care resources.

Time spent on self-management by people with diabetes: results from the population-based KORA survey in Germany.

AIMS: Time needed for health-related activities in people with diabetes is assumed to be substantial, yet available data are limited. Time spent on self-management and associated factors was analysed using cross-sectional data from people with diagnosed diabetes enrolled in a population-based study. METHODS: Mean total time spent on self-management activities was estimated using a questionnaire for all participants with diagnosed diabetes in the KORA FF4 study (n = 227, 57% men, mean age 69.7, sd 9.9 years). Multiple two-part regression models were fitted to evaluate associated factors. Multiple imputation was performed to adjust for bias due to missing values. RESULTS: Some 86% of participants reported spending time on self-management activities during the past week. Over the entire sample, a mean of 149 (sd 241) min/week were spent on self-management-activities. People with insulin or oral anti-hyperglycaemic drug treatment, better diabetes education, HbA1c 48 to < 58 mmol/mol (6.5% to < 7.5%) or lower quality of life, spent more time on self-management activities. For example, people without anti-hyperglycaemic medication invested 66 min/week in self-management, whereas those taking insulin and oral anti-hyperglycaemic drugs invested 269 min/week (adjusted ratio 4.34, 95% confidence interval 1.85-10.18). CONCLUSIONS: Time spent on self-management activities by people with diabetes was substantial and varied with an individual's characteristics. Because of the small sample size and missing values, the results should be interpreted in an explorative manner. Nevertheless, time needed for self-management activities should be routinely considered because it may affect diabetes self-care and quality of life.

The Boehringer Ingelheim employee study (Part 2): 10-year cardiovascular diseases risk estimation.

BACKGROUND: Cardiovascular disease (CVD) may cause an economic burden to companies, but CVD risk estimations specific to working populations are lacking. AIMS: To estimate the 10-year CVD risk in the Boehringer Ingelheim (BI) employee cohort and analyse the potential effect of hypothetical risk reduction interventions. METHODS: We estimated CVD risk using the Framingham (FRS), PROCAM (PRS) and Reynolds (RRS) risk scores, using cross-sectional baseline data on BI Pharma employees collected from 2005 to 2011. Results were compared using Fisher's exact and Wilcoxon tests. The predictive ability of the score estimates was assessed using receiver-operating characteristics analyses. RESULTS: Among the 4005 study subjects, we estimated 10-year CVD risks of 35% (FRS), 9% (PRS) and 6% (RRS) for men and 10% (FRS), 4% (PRS) and 1% (RRS) for women. One hundred and thirty-four (6%) men and 111 (6%) women employees had current CVD. The best predictors of prevalent CVD were the FRS and the RRS for men [area-under-the-curve 0.62 (0.57-0.67) for both]. A hypothetical intervention that would improve systolic blood pressure, HbA1c (for diabetes), C-reactive protein, triglycerides and total and high-density lipoprotein cholesterol by 10% each would potentially reduce expected CVD cases by 36-41% in men and 30-45% in women, and if smoking cessation is incorporated, by 39-45% and 30-55%, respectively, depending on the pre-intervention risk score. CONCLUSIONS: There was a substantial risk of developing CVD in this working cohort. Occupational health programmes with lifestyle interventions for high-risk individuals may be an effective risk reduction measure.

[Effect of Evidence-Based Risk Information on "Informed Choice" in Colorectal Cancer Screening: Randomised Controlled Trial]. / Effekt einer evidenzbasierten Verbraucherinformation zur Entscheidungsfindung beim kolorektalen Screening.

Evidence-based information is a prerequisite for informed choice. We compared the effect of evidence-based information on colorectal cancer screening with standard information in a randomised controlled trial. The primary endpoint was informed choice. We randomised 1,577 people insured by a large German statutory health insurance scheme, the Gmünder Ersatzkasse (GEK). The evidence-based information significantly increased informed choices: 44.0% vs. 12.8%; (difference 31.2%, 99% CI 25.7-36.7%; P<0.001).

[Prevention of Type 2 Diabetes: Evidence-Based Patient Information--A Randomised Controlled Trial]. / Effekt einer evidenzbasierten Patienteninformation zur Prävention von Typ 2-Diabetes.

The aim of this study was to compare the effect of our newly developed online evidence-based patient information (EBPI) vs. standard patient information about subthreshold elevated blood glucose levels and primary prevention of diabetes on informed patient decision-making. EBPI significantly improved knowledge about elevated glucose levels, but also increased decisional conflict and critical attitudes to screening and treatment options. The intention to undergo metabolic screening decreased as a result.

Effectiveness of a comprehensive support program for families with parental cancer (Family-SCOUT): results of a multicenter non-randomized controlled trial.

BACKGROUND: Cancer patients with minor children but also their families suffer from significant psychological distress and comorbidity. Protective factors predicting successful coping are well known. Corresponding systematic interventions are rare and limited by access barriers. We developed a comprehensive family-centered intervention for cancer patients with at least one dependent minor. PATIENTS AND METHODS: Family-SCOUT represents a multicentric, prospective, interventional, and controlled study for families with parental cancer and their minor children. In the intervention group (IG), all family members were addressed using a care and case management approach for nine months. Families in the control group (CG) received standard of care. Participating parents were asked to complete the Hospital-Anxiety-Depression-Scale (HADS) questionnaire at enrolment (T0) and after 9 months (T2). The primary outcome was a clinically relevant reduction of distress in at least one parent per family, measured as minimal important difference (MID) of ≥1.6 in the HADS total score. The percentage of families achieving MID is compared between the IG and CG by exact Fisher's test, followed by multivariate confounder analyses. RESULTS: T0-questionnaire of at least one parent was available for 424 of 472 participating families, T2-questionnaire after 9 months was available for 331 families (IG n = 175, CG n = 156). At baseline, both parents showed high levels of distress (HADS total: sick parents IG: 18.7 ± 8.1; CG: 16.0 ± 7.2; healthy partners: IG: 19.1 ± 7.9; CG: 15.2 ± 7.7). The intervention was associated with a significant reduction in parental distress in the IG (MID 70.4% in at least one parent) compared with the CG (MID 55.8%; P = 0.008). Adjustment for group differences from specific confounders retained significance (P = 0.047). Bias from other confounders cannot be excluded. CONCLUSIONS: Parental cancer leads to a high psychosocial burden in affected families. Significant distress reduction can be achieved through an optimized and structured care approach directed at the family level such as family-SCOUT.

Diabetes incidence does not differ between subjects with and without high depressive symptoms--5-year follow-up results of the Heinz Nixdorf Recall Study.

AIMS: Cross-sectional studies have consistently reported evidence for an association between diabetes and depressive disorders. However, only limited prospective studies have examined this association, reporting conflicting results. In a population-based cohort study, we compared cumulative incidences of diabetes between participants with and without high depressive symptoms. METHOD: We analysed the 5-year follow-up data from the German Heinz Nixdorf Recall study of 3547 participants without diabetes at baseline [mean age 58.8 (sd 7.6) years, 47.5% male]. Depressive symptoms were defined using the Centre for Epidemiologic Studies Depression scale (cut point ≥ 17). Diabetes (diagnosed or previously undetected) was identified by self-reported physician-diagnosed diabetes, medication and high blood glucose levels. We estimated 5-year cumulative incidences with 95% confidence intervals and fitted multiple logistic regression models to calculate the odds ratios, adjusted for age, sex, physical activity, smoking, living with or without partner, and educational level. RESULTS: The cumulative incidence of diabetes was 9.2% (95% CI 6.3-12.8) in participants with high depressive symptoms at baseline and 9.0% (95% CI 8.0-10.0) in participants without these symptoms. The age- and sex-adjusted odds ratio of diabetes in participants with depressive symptoms compared with those without was 1.13 [95% CI 0.77-1.68; fully adjusted 1.11 (95% CI 0.74-1.65)]. These results did not substantially change in several additional sensitivity analyses. CONCLUSION: Our study did not show a significantly increased risk of developing diabetes in individuals with high depressive symptoms compared with those without high depressive symptoms during a 5-year follow-up period.

Blood glucose testing and primary prevention of Type 2 diabetes-evaluation of the effect of evidence-based patient information: a randomized controlled trial.

AIMS: To compare the effect of our newly developed online evidence-based patient information vs. standard patient information about sub-threshold elevated blood glucose levels and primary prevention of diabetes on informed patient decision making. METHODS: We invited visitors to the cooperating health insurance company, Techniker Krankenkasse, and the German Diabetes Center websites to take part in a web-based randomized controlled trial. The population after randomization comprised 1120 individuals aged between 40 and 70 years without known diabetes, of whom 558 individuals were randomly assigned to the intervention group receiving evidence-based patient information, and 562 individuals were randomly assigned to the control group receiving standard information from the Internet. The primary endpoint was acquired knowledge of elevated blood glucose level issues and the secondary outcomes were attitude to metabolic testing, intention to undergo metabolic testing, decisional conflict and satisfaction with the information. RESULTS: Overall, knowledge of elevated glucose level issues and the intention to undergo metabolic testing were high in both groups. Participants who had received evidence-based patient information, however, had significantly higher knowledge scores. The secondary outcomes in the evidence-based patient information subgroup that completed the 2-week follow-up period yielded significantly lower intention to undergo metabolic testing, significantly more critical attitude towards metabolic testing and significantly higher decisional conflict than the control subgroup (n=466). Satisfaction with the information was not significantly different between both groups. CONCLUSIONS: Evidence-based patient information significantly increased knowledge about elevated glucose levels, but also increased decisional conflict and critical attitude to screening and treatment options. The intention to undergo metabolic screening decreased. Future studies are warranted to assess uptake of metabolic testing and satisfaction with this decision in a broader population of patients with unknown diabetes.

Impact of earlier HAART initiation on the immune status and clinical course of treated patients on the basis of cohort data of the German Competence Network for HIV/AIDS.

PURPOSE: Hitherto, studies on highly active antiretroviral therapy (HAART) initiation have shown partly inconsistent results. Our study investigated the clinical course and course of immune status after HAART initiation at CD4-cell-count/µl of treated patients between 250 and 349 (group 1), compared to 350-449 (group 2), on the basis of the cohort of the Competence Network for HIV/AIDS (KompNet cohort). METHODS: Patients had to be HAART-naïve. Medication had to start at the earliest in 1996, being at least triple combination therapy. The primary endpoints of death, first AIDS-defining illness and first drop of CD4-cell-count/µl below 200 were evaluated as censored event times between the initiation of HAART (t (0)) and the date of the first event/date of last observation. Probabilities of event-free intervals since t (0) were calculated by Kaplan-Meier estimation, compared by logrank tests. The results were adjusted for confounders using Cox regression. Additionally, incidences were estimated. RESULTS: A total of 822 patients met the inclusion criteria (group 1: 526, group 2: 296), covering 4,133 patient years (py) overall. In group 1, 0.64 death cases/100 py were found, with the corresponding vale being 0.17 in group 2. In group 1, 1.38 AIDS-defining events/100 py occurred, whereas it was 0.78 in group 2. In group 1, 2.64 events of first drop of CD4-cell-count/µl below 200 occurred per 100 py, compared to 0.77 in group 2. Kaplan-Meier estimations showed borderline significant differences regarding death (p = 0.063), no differences regarding first AIDS-defining illness (p = 0.148) and distinct differences regarding the first drop of CD4-cell-count/µl below 200 (p = 0.0004). CONCLUSIONS: The results gave a strong hint for a therapy initiation at higher CD4-cell-count/µl regarding the outcome of death in treated patients. A distinct benefit was shown regarding the first decline of CD4-cell-count/µl below 200.

Clinical relevance of dietary salt intake on aldosterone and the aldosterone-to-renin ratio as screening parameters for primary aldosteronism.

AIMS: The recommendations for screening for primary aldosteronism (PA) are determination and interpretation of both plasma aldosterone and the aldosterone-renin ratio (ARR). Although it is known that oral sodium chloride intake has an important impact on plasma aldosterone and ARR, more detailed data of this impact are sparse. We evaluated the relevance of natriuresis as a parameter of oral sodium intake, as well as patient age and antihypertensive medication on the PA screening parameters in our hypertensive patient population. METHOD: Our cross-sectional, single-center study investigated the impact of natriuresis, patient age, body mass index, Ca-antagonists, beta-blockers, ACE inhibitors and/or AT1 blockers on aldosterone and ARR in 777 hypertensive patients (393 men, 384 women) with a mean age (± SD) of 49.5 ± 15.7 years and an endogenous creatinine clearance of at least 80 ml/min. A total of 401 patients (51.6%) were on antihypertensive therapy. The mean natriuresis of the total population was 206.7 ± 97.0 mmol/day. The potential impact factors on plasma aldosterone and ARR were analyzed in two separate univariate, bivariate, and multiple regression analyses, respectively, with natriuresis as the main impact factor. RESULTS: Natriuresis as well as patient age had a significant impact on both plasma aldosterone and ARR. In addition, beta-blockers, ACE inhibitors and/or AT1 blockers had a significant impact on ARR (p < 0.05). CONCLUSIONS: In addition to antihypertensive medication, natriuresis as well as patient age seem to need further consideration in the process of PA screening and interpretation of its results. Additional experimental studies are warranted to confirm and generalize our results.

B-type natriuretic peptide and severe heart failure at baseline predict overall mortality in incident dialysis patients.

AIMS: The B-type natriuretic peptide (BNP) has become increasingly important as a diagnostic and prognostic method for cardiovascular disease or death. To our knowledge no prospective studies exist to evaluate the value of baseline BNP and baseline heart failure as predictors of overall death in incident rather than prevalent hemodialysis patients with end-stage renal disease (ESRD). METHODS: 255 ESRD patients were included in our observational study with a median observation period of 1.11 years. A Kaplan-Meier survival curve was stratified by BNP concentration (< 340 pg/ml and > or = 340 pg/ml) to estimate the impact on the overall mortality rate. Univariate and multiple Cox regression models were fitted for a variety of covariables including severe heart failure (graded according to the New York Heart Association) to evaluate the independent predictors of death. Association between BNP and four explanatory variables was described in a multiple linear regression model. RESULTS: Survival analysis demonstrated a significantly higher mortality rate in patients with higher BNP values at baseline. The independent predictive value of high BNP concentration at baseline could be statistically confirmed by multiple Cox regression analysis. However, when including the covariates hemoglobin and severe heart failure, significantly associated with BNP, in the same model, severe heart failure rather than BNP becomes a significant predictor of overall death. CONCLUSIONS: A higher BNP level at baseline may be confirmed as an independent predictor of death in the incident dialysis population. However, severe heart failure may affect the impact of BNP on the overall survival rate and thus be a stronger predictor of death than BNP.

The metabolic syndrome sensitizes leukocytes for glucose-induced immune gene expression.

Definitions of the metabolic syndrome (MetS) include obesity, dyslipidemia, elevated levels of fasting blood glucose, and blood pressure as criteria, but it is also known that the MetS is associated with chronic, subclinical inflammation. Hyperglycemia (fasting and postprandial) may be important in exacerbating this proinflammatory state. We aimed to assess the impact of oral glucose challenge and in vitro glucose-stimulation on gene expression and secretion of inflammatory parameters in peripheral blood leukocytes and to investigate whether presence of the MetS could "prime" leukocytes to up-regulate proinflammatory markers in response to glucose. Using quantitative real-time PCR, we could show that the expression of intercellular adhesion molecule 1 (ICAM-1), tumor necrosis factor alpha (TNF-alpha), and interleukin 6 (IL-6) significantly increased in peripheral blood leukocytes from "MetS" subjects (n=39) compared to "no MetS" subjects (n=35) 2 h after an oral glucose tolerance test (ICAM-1 +52%, TNF-alpha +107%, and IL-6 +38%) and also in vitro after 72 h cultivation in high-glucose medium (ICAM-1 +74%, TNF-alpha +71%, and IL-6 +44%). Using ELISA and Luminex technique, we further observed a trend towards increased immune mediator concentrations in the corresponding cell culture supernatants from MetS patients (ICAM-1 +21%, TNF-alpha +31%, and IL-6 +175%). Thus, the MetS may support peripheral inflammation by sensitizing leukocytes to up-regulate proinflammatory markers in response to glucose, which in turn increases the risk for type-2 diabetes mellitus and cardiovascular disease.

Impact of age, body mass index, insulin resistance and proteinuria on the kidney function in obese patients with Type 2 diabetes and renal insufficiency.

AIMS: To date, several different equations to predict the glomerular filtration rate (GFR) in patients with renal insufficiency have been developed for different patients groups. Our aim was to determine the prognostic factors of GFR in our homogenous patient group of obese, water-loaded patients with Type 2 diabetes and renal insufficiency, since we assumed that the endogenous creatinine clearance (ECC) alone may not be an accurate method to predict GFR. METHOD: We recruited 46 obese patients (37 men) with Type 2 diabetes and renal insufficiency in our nephrology center in Mettmann (Germany). However, two male patients were excluded from the analysis due to an outlying insulin level or low inulin clearance. The inulin clearance as a measure of renal function performed by the single shot method was compared with the GFR estimated by ECC, Cystatin C, and MDRD formula. Several multiple regression models were built to test the impact of the prognostic factors age, sex, body mass index (BMI), insulin resistance according to the homeostasis model assessment (HOMA), body water (TBW), brain natriuretic peptide (BNP), and proteinuria on the inulin clearance. In the main regression model to predict the inulin clearance by ECC, only the statistically significant prognostic factors of these models were selected, as well as the interaction between GFR predicted by ECC (GFR_ECC) and BMI. RESULTS: The prognostic factors GFR_ECC, age, BMI, HOMA and proteinuria had a statistically significant impact on the inulin clearance (the gold standard of the GFR) in our patient population (p < 0.05). However, the interaction of GFR_ECC and BMI was not significant (p = 0.06) in our model. The model was validated and considered well-fitted with a coefficient of determination (R2) of 0.69. CONCLUSIONS: The independent prognostic factors to determine GFR in obese, water-loaded diabetic patients are GFR_ECC, age, BMI, HOMA and proteinuria. However, our model should be revalidated and tested in a larger sample size to probably detect an interaction between GFR_ECC and BMI as an additional prognostic factor.

[PROtocol-based MObilizaTION on intensive care units : Design of a cluster randomized pilot study]. / PROtokollbasierte MObilisierung auf IntensivstaTIONen : Design einer clusterrandomisierten Pilotstudie.

BACKGROUND: Despite convincing evidence for early mobilization of patients on intensive care units (ICU), implementation in practice is limited. Protocols for early mobilization, including in- and exclusion criteria, assessments, safety criteria, and step schemes may increase the rate of implementation and mobilization. HYPOTHESIS: Patients (population) on ICUs with a protocol for early mobilization (intervention), compared to patients on ICUs without protocol (control), will be more frequently mobilized (outcome). METHODS: A multicenter, stepped-wedge, cluster-randomized pilot study is presented. Five ICUs will receive an adapted, interprofessional protocol for early mobilization in randomized order. Before and after implementation, mobilization of ICU patients will be evaluated by randomized monthly one-day point prevalence surveys. Primary outcome is the percentage of patients mobilized out of bed, operationalized as a score of ≥3 on the ICU Mobility Scale. Secondary outcome parameters will be presence and/or length of mechanical ventilation, delirium, stay on ICU and in hospital, barriers to early mobilization, adverse events, and process parameters as identified barriers, used strategies, and adaptions to local conditions. EXPECTED RESULTS: Exploratory evaluation of study feasibility and estimation of effect sizes as the basis for a future explanatory study.

Prescription of insulin glargine in primary care practices in Germany.

BACKGROUND: New classes of antidiabetic medications have been introduced, but details of their use are not well known. The aim was to assess prescription patterns and dosing for insulin glargine (market launch: 6/2000) in primary care patients. METHODS: Computerized data on prescriptions (Disease Analyzer, 6/1999 to 8/2003) from 277 general and internal medicine practices throughout Germany were analysed (67,402 diabetic patients; 340 incident glargine (age: 67+/-12 years) and 378 incident NPH users (66+/-11 years). RESULTS: Diabetes prevalence in the practices increased over the three-year period (5.1% to 6.2%). The highest increase was observed for insulin treated patients (+29%), followed by diet (+21%) and oral antidiabetics (+19%). Premixed insulin (short-acting insulin and NPH) remained constant as largest insulin group. A continuous increase of short-acting insulin analogues was found (+70%). Long-acting insulin analogues (glargine) increased threefold. Glargine was more often prescribed in combination with oral antidiabetics than NPH (76% vs 49%; p<0.05). Only about a quarter received short-acting insulin (NPH: 61%; p<0.05). The cumulative annual dose was higher among NPH users (geometric mean; NPH: 7971 IU; glargine: 5719 IU) (p<0.01), which persisted after adjusting for age, sex, and morbidity (p<0.01). CONCLUSIONS: Diabetes prevalence continuously increased in German primary care practices from 1999 to 2003. The largest increase was found for insulin treatment, in particular, for short and long-acting insulin analogues. Insulin glargine was more often prescribed in combination with oral agents, whereas NPH insulin was more frequently prescribed with short-acting insulin, indicating different prescription patterns in primary care.

The prognostic value of the C-reactive protein levels in HD patients with death risk from infection.

AIMS: Infection is considered the second leading cause of death in dialysis patients with end-stage renal disease (ESRD). However, infection prevalence as primary cause of death still seems to be underreported in the literature. We investigated the role of C-reactive protein (CRP) levels shortly before death as predictor of dying from an infection as primary cause of death in this patient group. METHOD: Between January 1997 through March 2006, we defined the primary causes of death in 231 of the 481 incident patients in our single-center study, who died during this time and assessed the overall prevalence of infection at different predefined CRP cutpoints (between 2 and 300 mg/l). By means of an adjusted multiple logistic regression model, we calculated the odds ratio of (log) CRP for death in 346 survivors and non-survivors with available CRP levels within 5 days of death. In the 96 non-survivors (i.e. cases) of this group, the association of (log) CRP and causes of death was determined by the multiple linear regression model. RESULTS: Infection as a primary cause of death was initially diagnosed in 42% of the 231 non-survivors by standard parameters and clinically. However, the rate of patients possibly dying from this disease increased accordingly when also including cases without any clinical infection signs but with CRP values higher than a given cutpoint (between 2 and 300 mg/l), e.g. when including all cases with CRP cutpoints higher than 100 mg/l, overall prevalence of infection as cause of death increases to 57% (95% CI = 51-64%). Infection was significantly associated with higher CRP levels compared with cardiac death (p < 0.001), with an odds ratio of log CRP for death of 5.4 (95% CI = 3.8-7.7). CONCLUSIONS: Prevalence of infection as primary cause of death in ESRD patients may be even higher than currently stated in the literature. Therefore, to reduce mortality, infections should be further avoided and controlled in the future.

Cost comparison analysis: pentaerythrithyl tetranitrate (PETN) and isosorbide dinitrate (ISDN) prescribed to diabetic patients in primary care practices in Germany.

INTRODUCTION: Both pentaerythrithyltetranitrate (Pentalong, PETN) and isosorbide dinitrate (ISDN) are commonly used in the therapy of ischemic heart disease (IHD). However, little is known about the therapeutic patterns in diabetic patients and no comparative data are available regarding the prescription costs of these two substances. Thus, the aim of this investigation was to compare the costs for PETN and ISDN therapy in diabetic patients in primary care. MATERIAL AND METHODS: All continuously treated patients aged > or = 40 years with diabetes (anti-diabetic agents) and IHD or angina pectoris (ICD codes) and newly started on PETN or ISDN therapy (index date) in the period 2000-2005 were selected from a database containing data from 400 practices throughout Germany (Disease Analyzer, IMS Health). Prescriptions costs for PETN and ISDN, as well as costs for cardiovascular comedication, were determined for the period 183 days before and after the index date, and that changes in costs after the index date were calculated. Differences in costs between the two groups were evaluated using multivariate regression, adjusting for age, sex and comorbidity. Patients in Eastern (n = 137, age 71 +/- 10 years, 55% male) and Western Germany (n = 212, age 73 +/- 9 years, 50% male) were analyzed separately since there is a longer history of PETN use in Eastern Germany. RESULTS: Significantly more patients were treated with PETN in Eastern Germany (61 vs. 11%, p < 0.05). The patient groups treated with PETN and ISDN differed with respect to sex and comorbidity. PETN therapy was more expensive than ISDN therapy in both German regions (adjusted cost differences were 10 and 17 Euro). However, when comedication was taken into account, a smaller cost increase after the index date was observed in the PETN group than in the ISDN group (non-significant cost savings of 43 and 52 Euro after adjustment for Western and Eastern Germany, respectively). CONCLUSION: PETN therapy tends to produce a saving in costs compared to ISDN therapy in diabetic patients when costs for comedication are taken into account and after adjustment for age and comorbidity. The prescription patterns in Eastern and Western Germany and the patient characteristics of those receiving PETN and ISDN differed, indicating differences in patients selection and prescribing by physicians in the two regions.

Incremental prescription and drug costs during the years preceding diabetes diagnosis in primary care practices in Germany.

INTRODUCTION: To evaluate incremental drug prescription costs before diabetes diagnosis in primary care patients in Germany. MATERIAL AND METHODS: Based on 400 primary care practices throughout Germany (Disease Analyzer, IMS Health, Frankfurt, Germany), we selected only patients receiving continuous treatment (age >or= 40 years) and ascertained drug prescriptions and costs up to 6 years before diabetes was diagnosed. For control, we selected age- and sex-matched nondiabetics (n = 6,294 pairs, age 65.5 +/- 10.5 years, 44 % male). We evaluated incremental prescriptions and costs by calculating differences and ratios between patients with and without a diabetes diagnosis. We also evaluated predictors of cost differences using multivariate regression models. The data used for the evaluation was taken from the period 1993 to 2002. RESULTS: The mean number of prescriptions in the year preceding diagnosis in men and women increased 15 % and 19 %, respectively (p < 0.001). Prescription costs were 21 % (men) and 28 % (women) higher in subjects who were destined to receive a diabetes diagnosis (269 and 264 Euros per person) compared to controls (p < 0.001). Incremental prescriptions and costs were already present six years preceding diagnosis. Cardiovascular drugs had the largest impact, accounting for about two-thirds of incremental prescriptions and costs. Women had higher numbers of prescriptions and costs, however, differences and ratios were comparable to men. Incremental costs were higher in patients with private compared to statutory health insurance, and in Western compared to Eastern Germany. DISCUSSION: Numbers of prescriptions and costs in primary care patients with future diabetes diagnosis in Germany were already increased six years before clinical detection, reflecting increased cardiovascular risk even before clinical diabetes diagnosis.