Institute of Biometrics and Epidemiology

Düsseldorf, Germany

Institute of Biometrics and Epidemiology

Düsseldorf, Germany
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Kostev K.,IMS Health | Rathmann W.,Institute of Biometrics and Epidemiology
Primary Care Diabetes | Year: 2013

Aims To study whether the time to insulin therapy in type 2 diabetic patients in primary care in Germany and UK has increased (2005-2010). Methods Longitudinal data from general practices in Germany and UK (Disease Analyser) from 1995 to 2010 were analyzed. Patients who started their insulin treatment from 2005 to 2010 were analyzed regarding the time from the first diabetes diagnosis in the practices (index date) and the first insulin prescription, including 6368 patients (age: 68 (SD: 12) years) in Germany and 1998 patients (age: 64 (12) yrs) in UK. Results Median (interquartile range) time to insulin therapy in the practices increased from 943 (214-1994) days in 2005 to 1549 (957-2533) days in 2010 (p < 0.001). In UK, time to onset of insulin treatment increased from 1700 (649-2521) days in 2005 to 2061 (1309-2686) days in 2010 (p < 0.001). The last HbA1c values before insulin initiation were high and slightly increased during the study period (Germany: 2005: 8.2%, 2010: 8.4%; UK: 2005: 9.5%, 2010: 9.8%; both p < 0.001). Conclusions This real world data shows that the time to insulin therapy has increased in type 2 diabetes patients from 2005 to 2010 (Germany, UK). The average HbA1c values before insulin therapy also slightly increased during this period. © 2013 Primary Care Diabetes Europe.


Kostev K.,IMS Health | Rathmann W.,Institute of Biometrics and Epidemiology
Primary Care Diabetes | Year: 2013

Aim: To investigate if micro- and macrovascular co-morbidity has an influence on the time to insulin initiation in type 2 diabetes patients. Methods: Longitudinal data from general practices in Germany, France and UK (Disease Analyzer) from 1995 to 2009 were analyzed, including 44,440 patients in Germany, 10,148 patients in France, and 25,499 patients in UK with newly diagnosed diabetes (index date). Cox regression was used to investigate the association of newly diagnosed micro- and macrovascular complications (ICD-10) on the time to insulin initiation adjusting for age, sex, antidiabetic therapy, and co-morbidity (hypertension, lipid disorders). Results: Insulin treatment was started in 9747 (22%) patients in Germany within 10 years after index date (France: n = 702, 7%; UK: 3936, 14%). In all three countries, occurrence of microvascular complications was significantly associated with a higher likelihood to have insulin initiated (hazard ratio (HR), 95%CI: neuropathy: Germany 1.6; 1.5-1.8; France: 2.1; 1.1-3.9; UK: 1.5; 1.3-1.9; nephropathy: Germany 1.4; 1.3-1.6; France: 2.7; 1.4-3.8; UK: 1.2; 1.1-1.3). Among macrovascular complications, only coronary heart disease was related to insulin initiation in all three countries (Germany 1.2; 1.1-1.3; France: 1.5; 1.2-2.0; UK: 1.5; 1.3-1.7). Conclusions: A more rapid progression to insulin therapy was found in patients with microvascular complications. © 2013 Primary Care Diabetes Europe.


Kowall B.,University of Duisburg - Essen | Kowall B.,Institute of Biometrics and Epidemiology | Stang A.,University of Duisburg - Essen | Stang A.,Boston University | And 2 more authors.
Pharmacoepidemiology and Drug Safety | Year: 2015

Background: In observational studies, a lower cancer risk was reported for patients with diabetes using metformin. However, many of these studies had shortcomings like time-related biases. We aimed to compare the incidence rate of any cancer and some selected cancer sites in metformin, sulfonylurea, and insulin users and to reduce some major biases common in observational studies. Methods: In a retrospective database study, we used patient data from general practices throughout Germany and the UK. Eighty thousand two hundred and sixty-three patients aged 30-89years at diagnosis of diabetes were observed for a mean follow-up of 4.8years after the first antidiabetes medication. In Cox regression models adjusted for age, sex, country, metabolic factors, diabetes duration, medication, and comorbidity, patients who started using metformin were compared with those who started using sulfonylurea (or insulin) (intention-to-treat type analysis), and, additionally, patients with metformin monotherapy were compared with those with sulfonylurea (or insulin) monotherapy. The initial 12months of follow-up after the first antidiabetes prescription were excluded. Results: Four thousand seven hundred seventy-nine (6.0%) incident cases of cancer were identified. Throughout all analyses, hazard ratios were close to the null for comparisons of metformin use with sulfonylurea and insulin use. For example, in intention-to-treat analyses comparing metformin with sulfonylurea use, hazard ratios were 1.05 (95%CI: 0.99-1.12) for any cancer, 1.05 (0.85-1.30) for colorectal, 1.04 (0.82-1.31) for lung, 1.03 (0.81-1.30) for breast, and 0.89 (0.73-1.08) for prostate cancer. Conclusion: This study provides evidence that metformin has no protective effect on the incidence of cancer in persons with diabetes. © 2015 John Wiley & Sons, Ltd.


Kostev K.,IMS Health | Dippel F.-W.,University of Leipzig | Rathmann W.,Institute of Biometrics and Epidemiology
Primary Care Diabetes | Year: 2014

Aims To investigate the frequency and predictors (diabetes care and treatment, comorbidity) of documented hypoglycaemia in primary care patients with insulin-treated type 2 diabetes. Methods Data from 32,545 patients (mean age: 70 (SD 11) years, 50.3% males) from 1072 practices were retrospectively analyzed (Disease Analyzer database Germany: 09/2011-08/2012). Logistic regression (≥1 documented hypoglyemia) was used to adjust for confounders (age, sex, practice characteristics, diabetes treatment regimen). Results The prevalence of patients (12 months) with at least one reported hypoglycaemia was 2.2% (95% CI: 2.0-2.4%). The adjusted odds of having hypoglycemia were increased for renal failure (OR; 95% CI: 1.26; 1.16-1.37), autonomic neuropathy (1.34; 1.20-1.49), and adrenocortical insufficiency (3.08; 1.35-7.05). Patients with mental disorders including dementia (1.49; 1.31-1.69), depression (1.24; 1.13-1.35), anxiety (1.18; 1.01-1.37), and affective disorders (1.80; 1.36-2.38) also showed an increased odds of having hypoglycemia. Location of the practice in an urban area was associated with a lower odds ratio (0.74; 0.68-0.80). Conclusions Both individual patient characteristics (e.g. comorbidity) and regional factors (practice location) have a substantial impact on hypoglycaemia in primary care patients with insulin therapy. © 2013 Primary Care Diabetes Europe.


Kostev K.,IMS Health | Rathmann W.,Institute of Biometrics and Epidemiology
Diabetologia | Year: 2013

Aims/hypothesis: The aim of this study was to estimate the prevalence of and risk factors for diabetic retinopathy in newly diagnosed type 2 diabetes in general practices in the UK. Methods: The Disease Analyzer Database (UK) assembles longitudinal data on diagnoses, prescriptions and laboratory values reported from 674 office-based physicians (97 general practices). Patients with newly diagnosed type 2 diabetes (between 2005 and 2009) were identified and the presence of retinopathy was defined based on the International Classification of Diseases code (E11.3) or on the original diagnosis text. The time period between first diabetes diagnosis and first retinopathy diagnosis was calculated. Logistic regression was used to examine associations of potential risk factors with prevalent diabetic retinopathy. Results: There were 12,524 patients with newly diagnosed type 2 diabetes mellitus in the general practices. The mean age was 65 years with slightly more male patients (56%). The prevalence of diagnosed retinopathy was 19.0% (95% CI 18.3%, 19.7%). The median time to first retinopathy diagnosis was 309 (interquartile range 50-693) days. Factors independently associated with retinopathy in multivariate logistic regression were age (OR 1.02 [95% CI 1.01, 1.03] per year of age), male sex (OR 1.11 [95% CI 1.01, 1.22]), HbA1c (OR 1.12 [95% CI 1.02, 1.22] per 1% [11 mmol/mol] increase), systolic blood pressure (OR 1.03 [95% CI 1.01, 1.05] per 10 units) and antihypertensive drugs. No significant relationships were observed for obesity and diastolic blood pressure. Conclusions/interpretation: Diabetic retinopathy was diagnosed in about one out of five patients with type 2 diabetes during the first year after diabetes diagnosis in UK general practices. Age, male sex, hyperglycaemia and hypertension were identified as risk factors of early retinopathy in type 2 diabetes. © 2012 Springer-Verlag Berlin Heidelberg.


Kostev K.,IMS Health | Dippel F.W.,Sanofi S.A. | Rathmann W.,Institute of Biometrics and Epidemiology
Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy | Year: 2015

Background: When target glycated hemoglobin (HbA1c) levels are not reached, basal insulin therapy should be considered in type 2 diabetes. The objective of this report was to describe the predictors of glycemic control (strict criterion: HbA1c ≤6.5%) during the first year after initiating basal insulin therapy in primary care.Methods: The study applied a retrospective approach using a nationwide database in Germany (Disease Analyzer, IMS Health, January 2008 to December 2011, including 1,024 general and internal medicine practices). Potential predictors of glycemic control considered were age, sex, duration of diabetes, type of basal insulin, comedication with short-acting insulin, baseline HbA1c, previous oral antidiabetic drugs, diabetologist care, private health insurance, macrovascular and microvascular comorbidity, and concomitant medication. Multivariable logistic regression models were fitted with glycemic control as the dependent variable.Results: A total of 4,062 type 2 diabetes patients started basal insulin (mean age 66 years, males 53%, diabetes duration 4.8 years, mean HbA1c 8.8%), of whom 295 (7.2%) achieved an HbA1c ≤6.5% during the one-year follow-up. Factors positively associated with HbA1c ≤6.5% in logistic regression were male sex (odds ratio 1.59, 95% confidence interval 1.23–2.04), insulin glargine (reference neutral protamine Hagedorn; odds ratio 1.43, 95% confidence interval 1.09–1.88), short-acting insulin (odds ratio 1.33, 95% confidence interval 1.01–1.76), and prior treatment with metformin, dipeptidyl peptidase-4 inhibitors, and diuretics. Lipid-lowering drugs were associated with a lower odds of reaching the glycemic target.Conclusion: Few type 2 diabetes patients (7%) reached the glycemic target (HbA1c ≤6.5%) after one year of basal insulin therapy. Achievement of the glycemic target was associated with type of basal insulin, additional short-acting insulins, previous antidiabetic medication, and other comedication, eg, diuretics or lipid-lowering drugs. © 2015 Kostev et al.


Rathmann W.,Institute of Biometrics and Epidemiology | Kostev K.,IMS Health | Gruenberger J.B.,Novartis | Dworak M.,Novartis | And 2 more authors.
Diabetes, Obesity and Metabolism | Year: 2013

Aims: To investigate therapy persistence, frequency of hypoglycaemia and macrovascular outcomes among type 2 diabetes patients with dipeptidyl peptidase-4 (DPP-4) inhibitors (DPP-4) and sulphonylureas (SU). Methods: Data from 19 184 DPP-4 (mean age: 64years; 56% males) and 31 110 SU users (69years; 51%) with new prescriptions (index date), without additional antidiabetics except metformin, in 1201 general practises in Germany were analysed. Therapy discontinuation (prescription gap >90days), hypoglycaemia [International Classification of Diseases (ICD-10)] and macrovascular outcomes (ICD-10) (2-year follow-up) were compared adjusting for age, sex, diabetes duration, metformin, previous hypoglycaemia, health insurance, hypertension, hyperlipidaemia, antihypertensives, lipid-lowering and antithrombotic drugs, microvascular complications and Charlson co-morbidity score using logistic or Cox regression models. Results: Two years after index date, DDP-4 (non-persistence: 39%) were associated with a lower risk of discontinuation compared to SU (49%) [adjusted hazard ratio (HR): 0.74; 95% confidence interval (CI): 0.71-0.76]. Hypoglycaemias (≥1) were documented in 0.18% patients with DPP-4 and in 1.00% with SU [odds ratio (OR): 0.21; 95%CI: 0.08-0.57]. Hypoglycaemias were significantly associated with incident macrovascular complications (HR: 1.6; 95% CI: 1.1-2.2). Risk of macrovascular events was 26% lower in DPP-4 than in SU users. Conclusions: Lack of persistence with antidiabetic therapy is frequently found in primary care patients. DPP-4 was associated with lower therapy discontinuation and a fivefold reduced frequency of patients with hypoglycaemia compared to SU. The low absolute numbers of hypoglycaemias are most likely due to the fact that only severe events were documented. DPP-4 treatment was associated with reduced incidence of macrovascular events relative to SU in type 2 diabetes patients in primary care practises. © 2012 Blackwell Publishing Ltd.


Kostev K.,IMS Health | Jockwig A.,Fresenius University of Applied Sciences | Hallwachs A.,Praxis for Internal Medicine and Nephrology | Rathmann W.,Institute of Biometrics and Epidemiology
Primary Care Diabetes | Year: 2014

Aims To estimate the prevalence and risk factors of diabetic neuropathy in newly diagnosed type 2 diabetes in general practices. Methods Longitudinal data from nationwide general practices in Germany (n = 630) and UK (n = 100) (Disease Analyzer) were analyzed. Patients with newly diagnosed (<1 year) type 2 diabetes (2008-2012) were identified including 45,633 patients (age: 66, SD: 12 years) in Germany and 14,205 patients (age: 63, SD: 13 years) in UK. Neuropathy was identified by ICD code (E11.4) or the original diagnosis. Associations of potential risk factors with neuropathy were investigated using logistic regression. Results The prevalence of diagnosed neuropathy was 5.7% (95% CI: 5.5-5.9%) in Germany and 2.4% (1.9-2.9%) in UK. In Germany, factors independently associated with neuropathy in stepwise logistic regression were age (>70 years: OR; 95% CI 2.1; 1.6-2.8), retinopathy (3.0; 2.1-4.2), peripheral artery disease (PAD: 1.9; 1.4-2.5), insulin treatment (4.6; 3.5-6.2) and oral antidiabetic drugs (OAD: 1.6; 1.2-2.0). In UK, male sex (1.4; 1.01-1.9), nephropathy (1.7; 1.2-2.5), PAD (1.5; 1.1-2.1), antihypertensives (1.7; 1.1-2.5), insulin (2.1; 1.1-3.8) and OAD (1.4; 1.01-1.8) were identified. Conclusions The prevalence of diabetic neuropathy at time of type 2 diabetes diagnosis was low in primary care (Germany, UK). Neuropathy was associated with age, PAD and microvacular complications. © 2014 Primary Care Diabetes Europe.


Aims: Insulin aspart has a higher ability to treat postprandial glucose than regular human insulin, which may have favourable cardiovascular effects. The aim was to collect and compare the incidence of recorded macro- and microvascular events in patients with type 2 diabetes with insulin aspart or regular human insulin in general practices. Methods: Computerized data from 3154 aspart and 3154 regular insulin users throughout Germany (Disease Analyzer, January 2000 to July 2011) were analysed after matching for age (60±10years), sex (men: 57%), health insurance (private: 5.8%) and diabetes treatment period in practice (2.2±2.5years). Hazard ratios (HR; Cox regression) for macro- or microvascular outcomes (follow-up: 3.5years) were further adjusted for diabetologist care, practice region, hypertension, hyperlipidaemia, co-medication (basal insulin, oral antidiabetics, antihypertensives, lipid-lowering agents and antithrombotic drugs), previous treatment with rapid-acting insulins, hypoglycaemia and the Charlson co-morbidity score. Furthermore, adjustment was carried out for baseline microvascular complications when analysing macrovascular outcomes and vice versa. Results: Overall, the risk of combined macrovascular outcomes was 15% lower for insulin aspart users (p=0.01). For insulin aspart there was also a decreased risk incident stroke [HR: 0.58; 95% confidence interval (CI): 0.45-0.74], myocardial infarction (HR: 0.69; 95% CI: 0.54-0.88) and peripheral vascular disease (HR: 0.80; 95% CI: 0.69-0.93). For microvascular complications (retinopathy, neuropathy and nephropathy), no significant differences were observed (HR: 0.96; 95% CI: 0.87-1.06). Conclusion: Use of the rapid-acting insulin analogue aspart was associated with a reduced incidence of macrovascular outcomes in type 2 diabetes in general practices. It is important to confirm this finding in a randomized controlled trial. © 2012 Blackwell Publishing Ltd.


Kress S.,Vinzentius Krankenhaus | Kostev K.,IMS Health | Dippel F.W.,Sanofi S.A. | Giani G.,Institute of Biometrics and Epidemiology | Rathmann W.,Institute of Biometrics and Epidemiology
International Journal of Clinical Pharmacology and Therapeutics | Year: 2012

Objective: Insulin glulisine has a higher efficacy in reducing postprandial glucose excursions and in restoring normal postprandial microcirculation than rapid human insulin. The aim was to compare the incidence of macro- and microvascular outcomes in Type 2 diabetic patients treated with insulin glulisine or regular human insulin. Materials: Computerized data from 952 glulisine (age: 61 ± 11 y) and 11,157 regular insulin (65 ± 11 y) users in general practices throughout Germany (Disease Analyzer, 11/2004 to 3/2010) were analyzed. Methods: Hazard ratios (HR; Cox regression) for 3.5-year-risk of macro- or microvascular outcomes were adjusted for age, sex, diabetes duration, diabetologist care, hypertension, hyperlipidemia, depression, and comedication (basal insulin, oral antidiabetics). Furthermore, adjustment was carried out for baseline microvascular complications when analyzing macrovascular outcomes and vice versa. Results: Overall, risk for macro- or microvascular outcomes was 20% lower for insulin glulisine users (p < 0.05). There was a decreased risk for coronary heart disease (HR; 95%CI: 0.78; 0.62-0.99), and an indication for a lower risk for incident myocardial infarction (HR: 0.66; 0.43-1.02). Also for microvascular complications, the adjusted hazard ratios for retinopathy, nephropathy and neuropathy were below 1.0, indicating a lower risk for the insulin glulisine group, however, which was significant for neuropathy only (HR: 0.74; 0.58-0.93). Conclusions: Evidence has been presented which indicates that prescription of the rapidly-acting insulin analog glulisine is associated with a reduced incidence of macro- and microvascular outcomes in Type 2 diabetes patients under real-life conditions. Given that this was a retrospective database analysis, where data on patient history, glycemic control and duration of the disease were limited, it is important to confirm this finding in a randomized controlled trial. ©2012 Dustri-Verlag Dr. K. Feistle.

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