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1.
Cardiovasc Diabetol ; 12: 47, 2013 Mar 20.
Article in English | MEDLINE | ID: mdl-23510200

ABSTRACT

BACKGROUND: Type-2 diabetes mellitus has a major impact on health related quality of life (HRQoL). We aimed to identify patient and treatment related variables having a major impact. METHODS: DiaRegis is a prospective diabetes registry. The EQ-5D was used to describe differences in HRQoL at baseline. Odds ratios (OR) with 95% confidence intervals (CI) were determined from univariable regression analysis. For the identification of independent predictors of a low score on the EQ-5D, multivariable unconditional logistic regression analysis was performed. RESULTS: A total of 2,760 patients were available for the present analysis (46.7% female, median age 66.2 years). Patients had considerable co-morbidity (18.3% coronary artery disease, 10.6% heart failure, 5.9% PAD and 5.0% stroke/TIA). Baseline HbA1c was 7.4%, fasting- and postprandial plasma glucose 139 mg/dl and 183 mg/dl.The median EQ-5D was 0.9 (interquartile range [IQR] 0.8-1.0). Independent predictors for a low EQ-5D were age > 66 years (OR 1.49; 95%CI 1.08-2.06), female gender (2.11; 1.55-2.86), hypertension (1.73; 1.03-2.93), peripheral neuropathy (1.62; 0.93-2.84) and clinically relevant depression (11.01; 3.97-30.50). There was no influence of dysglycaemia on the EQ-5D score. CONCLUSION: The present study suggests, that co-morbidity but not average glycaemic control reduces health related quality of life in type 2 diabetes mellitus.


Subject(s)
Cardiovascular Diseases/drug therapy , Cardiovascular Diseases/epidemiology , Diabetes Mellitus, Type 2/drug therapy , Diabetes Mellitus, Type 2/epidemiology , Hypoglycemic Agents/administration & dosage , Quality of Life , Administration, Oral , Aged , Cardiovascular Diseases/psychology , Comorbidity , Diabetes Mellitus, Type 2/psychology , Drug Therapy, Combination , Female , Humans , Male , Middle Aged , Prospective Studies , Quality of Life/psychology , Registries , Treatment Outcome
2.
Cardiovasc Diabetol ; 11: 122, 2012 Oct 06.
Article in English | MEDLINE | ID: mdl-23039216

ABSTRACT

BACKGROUND: We aimed at identifying variables predicting hypoglycemia in elderly type 2 diabetic patients and the relation to HbA1c values achieved. DESIGN: Prospective, observational registry in 3810 patients in primary care. Comparison of patients in different age tertiles: with an age < 60 (young, n=1,253), age 60 to < 70 (middle aged, n=1,184) to those ≥ 70 years (elderly, n=1,373). Odds Ratios (OR) with 95% confidence intervals (CI) were determined from univariable and multivariable regression analyses. RESULTS: Elderly patients had a later diabetes diagnosis, a longer diabetes duration, better glucose control and more frequent co-morbid disease conditions. Overall 10.7% of patients experienced any severity hypoglycemia within the last 12 months prior to inclusion. Higher rates of hypoglycemia were observed in the elderly than in the young after adjusting for differences in HbA1c, fasting and post-prandial blood glucose (OR 1.68; 95%CI 1.16-2.45). This was particularly true for hypoglycemic episodes without specific symptoms (OR 1.74; 95%CI 1.05-2.89). In a multivariate model stroke / transitory ischemic attack, the presence of heart failure, clinically relevant depression, sulfonylurea use and blood glucose self-measurement were associated with hypoglycemic events. CONCLUSION: Elderly patients are at an increased risk of hypoglycemia even at comparable glycemic control. Therefore identified variables associated with hypoglycemia in the elderly such as heart failure, clinically relevant depression, the use of sulfonylurea help to optimize the balance between glucose control and low levels of hypoglycemia. Asymptomatic hypoglycemia should not be disregarded as irrelevant but considered as a sign of possible hypoglycemia associated autonomic failure.


Subject(s)
Blood Glucose/drug effects , Diabetes Mellitus, Type 2/drug therapy , Hypoglycemia/chemically induced , Hypoglycemic Agents/administration & dosage , Hypoglycemic Agents/adverse effects , Administration, Oral , Age Factors , Aged , Biomarkers/analysis , Blood Glucose/metabolism , Comorbidity , Diabetes Mellitus, Type 2/blood , Diabetes Mellitus, Type 2/epidemiology , Female , Germany/epidemiology , Glycated Hemoglobin/metabolism , Humans , Hypoglycemia/blood , Logistic Models , Male , Middle Aged , Multivariate Analysis , Odds Ratio , Prospective Studies , Registries , Risk Assessment , Risk Factors , Treatment Outcome
3.
BMC Endocr Disord ; 12: 23, 2012 Oct 17.
Article in English | MEDLINE | ID: mdl-23075070

ABSTRACT

BACKGROUND: Hypoglycaemia is a serious adverse effect of antidiabetic drug therapy. We aimed to determine incidence rates of hypoglycaemia in type-2 diabetic patients and identify predictors of hypoglycaemia when treatment is intensified. METHODS: DiaRegis is a prospective German registry that follows 3810 patients with type-2 diabetes referred for treatment intensification because of insufficient glycaemic control on one or two oral antidiabetic drugs. RESULTS: Out of a total of 3347 patients with data available for the present analysis 473 (14.1%) presented any severity hypoglycaemia over a follow-up of 12 months. 0.4% were hospitalized (mean of 1.3±0.6 episodes), 0.1% needed medical assistance (1.0±0.0), 0.8% needed any help (1.1±0.5) and 10.1% no help (3.4±3.7), and 8.0% had no specific symptoms (3.6±3.5). Patients with incident hypoglycaemia had longer diabetes duration, higher HbA1c and a more frequent smoking history; more had co-morbid disease conditions such as coronary artery disease, peripheral arterial disease, amputation, heart failure, peripheral neuropathy, diabetic retinopathy and clinically relevant depression at baseline. Multivariable adjusted positive predictors of incident hypoglycaemia over the follow-up were prior anamnestic hypoglycaemia, retinopathy, depression, insulin use and blood glucose self-measurement, but not sulfonylurea use as previously reported for anamnestic or recalled hypogylcaemia. On the contrary, glitazones, DPP-4 inhibitors and GLP-1 analogues were associated with a reduced risk of hypoglycaemia. CONCLUSIONS: Hypoglycaemia is a frequent adverse effect in ambulatory patients when antidiabetic treatment is intensified. Particular attention is warranted in patients with prior episodes of hypoglycaemia, microvascular disease such as retinopathy and in patients receiving insulin. On the other hand glitazones, DPP-4 inhibitors and GLP-1 analogues are associated with a reduced risk.

4.
Eur J Prev Cardiol ; 19(4): 765-72, 2012 Aug.
Article in English | MEDLINE | ID: mdl-21628353

ABSTRACT

BACKGROUND: Patients with type-2 diabetes are at risk for treatment- and disease-related complications. Little is known about the interrelation of hypoglycaemia and co-morbid vascular disease (VD), defined as coronary heart disease, stroke and peripheral arterial disease. HYPOTHESIS: Hypoglycaemia is associated with co-morbid VD in diabetic patients. METHODS: DiaRegis is a prospective registry that included patients with type-2 diabetes in 2009/2010. Metric variables are displayed as median and quartiles. For the comparison of patients with or without VD Odds Ratios (OR) were determined from univariate analyses and adjusted for differences in patient characteristics (multivariable analysis). RESULTS: Data on hypoglycaemia and VD within the last 12 months were available for 3741 patients (98.2%) with a median (IQR) age of 65.9 (57.6-72.9) years; 46.7% were female. VD patients (n = 909; 24.3%) were older (70.7 vs 63.9 years; p < 0.0001), less often female (33.6% vs 50.9%; p < 0.0001) and had had diabetes for a longer duration (6.4 vs 5.4 years; p < 0.0001). Mean cholesterol (total, HDL and LDL) was also slightly lower (p < 0.0001). Glycaemic control (HbA1c, fasting and postprandial glucose) was comparable. VD patients received less metformin (80.7 vs 85.2%; p < 0.01) and more sulfonylureas (31.8 vs 27.6%; p < 0.05). There was an increased incidence of symptomatic hypoglycaemia with or without requiring help and with a need for medical assistance. After adjusting a number of baseline variables the rates of symptomatic hypoglycaemias with help remained significantly increased (OR 3.73 (95% CI 1.31-10.65) in patients with VD. CONCLUSIONS: As hypothesized there is a strong association between the incidence of hypoglycaemia and vascular disease at comparable glycaemic control, which confirms prior randomized controlled trial data suggesting an interrelationship between hypoglycaemia and vascular disease.


Subject(s)
Diabetes Mellitus, Type 2/drug therapy , Hypoglycemia/chemically induced , Hypoglycemic Agents/adverse effects , Vascular Diseases/epidemiology , Administration, Oral , Aged , Chi-Square Distribution , Comorbidity , Coronary Disease/epidemiology , Cross-Sectional Studies , Diabetes Mellitus, Type 2/epidemiology , Female , Germany/epidemiology , Humans , Hypoglycemia/epidemiology , Hypoglycemic Agents/administration & dosage , Incidence , Logistic Models , Male , Middle Aged , Multivariate Analysis , Odds Ratio , Peripheral Arterial Disease/epidemiology , Prospective Studies , Registries , Risk Assessment , Risk Factors , Stroke/epidemiology , Time Factors , Treatment Outcome
5.
Cardiovasc Diabetol ; 10: 66, 2011 Jul 14.
Article in English | MEDLINE | ID: mdl-21756359

ABSTRACT

BACKGROUND: We aimed to identify predictors of anamnestic hypoglycaemia in type-2 diabetic patients on oral mono- or dual oral combination antidiabetic pharmacotherapy. METHODS: DiaRegis is a prospective registry in type-2 diabetic patients in primary care. Odds ratios (OR) with 95% confidence intervals were determined from univariate logistic regression. Using multivariate logistic regression analysis with stepwise backward selection at an alpha of 0.05 independent predictors of hypoglycaemia were determined. RESULTS: 3,808 patients had data on hypoglycaemia available (median age 65.9 years, 46.6% female). 10.8% had at least one anamnestic hypoglycaemic episode within the previous 12 months. Patients with hypoglycaemia received more sulfonylureas (OR 2.16; 95%CI 1.75-2.67) and less metformin (OR 0.64; 95%CI 0.50-0.82). On top of metformin, patients with thiazolidine (OR 0.50; 95%CI 0.28-0.89) and DPP-4 inhibitor use (OR 0.34; 95%CI 0.16-0.70) had a decreased risk for hypoglycaemia while it was again increased with sulfonylureas (OR 2.08; 95%CI 1.44-2.99). Age < 65 years was an independent predictor of a reduced hypoglycaemia incidence (OR 0.76; 95%CI 0.59-0.96), low HbA1c (OR 1.68; 95%CI 1.31-2.14), stroke/TIA (OR 1.72; 95%CI 1.08-2.72), heart failure (OR 1.77; 95%CI 1.28-2.45), and the use of sulfonylureas (OR 2.58; 95%CI 2.03-3.29) were independent predictors of increased risk. CONCLUSIONS: The results indicate that the risk of hypoglycaemia might be substantially reduced by carefully selecting antidiabetic pharmacotherapy in patients with type-2 diabets in primary care.


Subject(s)
Diabetes Mellitus, Type 2/drug therapy , Drug Therapy/methods , Hypoglycemia/epidemiology , Hypoglycemic Agents/adverse effects , Hypoglycemic Agents/therapeutic use , Aged , Cohort Studies , Diabetes Mellitus, Type 2/complications , Diabetes Mellitus, Type 2/metabolism , Drug Therapy, Combination , Female , Germany/epidemiology , Glycated Hemoglobin/metabolism , Heart Failure/epidemiology , Heart Failure/prevention & control , Humans , Incidence , Logistic Models , Male , Middle Aged , Prospective Studies , Registries , Retrospective Studies , Risk Factors , Stroke/epidemiology , Stroke/prevention & control
6.
Cardiovasc Diabetol ; 9: 53, 2010 Sep 16.
Article in English | MEDLINE | ID: mdl-20843379

ABSTRACT

BACKGROUND: Patients with type 2 diabetes are at an increased risk for disease and treatment related complications after the initial approach of oral mono/dual antidiabetic therapy has failed. Data from clinical practice with respect to this patient group are however scarce. Therefore we set up a registry in primary care documenting the course and outcomes of this patient group. METHODS: Diabetes Treatment Patterns and Goal Achievement in Primary Diabetes Care (DiaRegis) is a prospective, observational, German, multicenter registry including patients with type-2 diabetes in which oral mono/dual antidiabetic therapy has failed. Data were recorded at baseline and will be prospectively documented during visits at 6 ± 1, 12 ± 2 and 24 ± 2 months. The primary objective is to estimate the proportion of patients with at least 1 episode of severe hypoglycemia within one year. RESULTS: 313 primary care offices included 4,048 patients between June 2009 and March 2010 of which 3,810 patients fulfilled the in- and exclusion criteria. 46.7% of patients were female; patients had a median diabetes duration of 5.5 years and most were obese with respect to BMI or waist circumference. HbA1c at baseline was 7.4%, fasting plasma glucose 142 mg/dl and postprandial glucose 185 mg/dl. Co-morbidity in this patient population was substantial with 17.9% having coronary artery disease, 14.4% peripheral neuropathy, 9.9% heart failure and 6.0% peripheral arterial disease. 68.6% of patients received oral monotherapy, 31.4% dual oral combination therapy. The most frequent antidiabetic agent used as monotherapy was metformin (79.0%) followed by sulfonylureas (14.8%). CONCLUSIONS: DiaRegis is a large, prospective registry in primary diabetes care to document the course and outcomes of patients with type-2 diabetes in which the initial approach of oral mono/dual antidiabetic therapy has failed. The two year follow-up will allow for a prospective evaluation of these patients during multiple adjustments of therapy.


Subject(s)
Diabetes Mellitus, Type 2/drug therapy , Diabetes Mellitus, Type 2/epidemiology , Hypoglycemic Agents/administration & dosage , Metformin/administration & dosage , Primary Health Care/statistics & numerical data , Registries/statistics & numerical data , Adult , Comorbidity , Diabetes Complications/epidemiology , Diabetes Complications/therapy , Female , Follow-Up Studies , Geographic Information Systems , Germany , Humans , Hypoglycemia/chemically induced , Hypoglycemia/epidemiology , Hypoglycemic Agents/adverse effects , Male , Metformin/adverse effects , Risk Factors , Sulfonylurea Compounds/administration & dosage , Sulfonylurea Compounds/adverse effects
7.
Clin Res Cardiol ; 98(4): 249-56, 2009 Apr.
Article in English | MEDLINE | ID: mdl-19221687

ABSTRACT

AIMS: Peripheral arterial disease (PAD) and coronary artery disease (CAD) are manifestations of the same underlying condition, atherothrombosis. We compared patients with PAD only with those having PAD and concomitant documented CAD in terms of characteristics, risk factors, treatment and prognosis. METHODS AND RESULTS: This is a subgroup analysis of the German cohort of the Reduction of Atherothrombosis for Continued Health (REACH) Registry. It includes 483 patients with PAD only, and 479 patients with PAD plus CAD. Patients with concomitant cerebrovascular disease were excluded. Symptomatic PAD was defined as intermittent claudication (IC), confirmed by ankle brachial index <0.9, or PAD-related intervention. Patients in the total cohort were predominantly elderly (mean age 67.3 +/- 8.9 years), males (72.3%), current or previous smokers (80.18%), and had often abdominal obesity (49.6%). Atherosclerotic risk factors and comorbidities were highly prevalent. Patients with PAD + CAD compared to those with PAD only were significantly more intensively treated with regards to antihrombotic agents (97.1% vs. 88.8%), statins (80.2% vs. 51.6%), or ACE inhibitors/ARB (75.6% vs. 61.1%). After two-year follow-up, no significant differences between subgroups were noted for total mortality (4.6% vs. 5.5%), cardiovascular mortality (3.7% vs. 3.9%), non-fatal myocardial infarction (1.9% vs. 2.7%) but for non-fatal stroke (4.4% vs. 2.0%, P < 0.05). CONCLUSION: Peripheral arterial disease patients carry a high burden of risk factors and co-morbidities, and are at high risk of death and cardiovascular events. If documented CAD is absent, PAD patients are undertreated. Thus, in PAD patients, secondary cardiovascular prevention with stringent treatment of risk factors to the same extent as in CAD patients is mandatory, in line with current guidelines.


Subject(s)
Cardiovascular Diseases/prevention & control , Coronary Artery Disease/complications , Peripheral Vascular Diseases/physiopathology , Aged , Angiotensin II Type 1 Receptor Blockers/therapeutic use , Angiotensin-Converting Enzyme Inhibitors/therapeutic use , Cardiovascular Diseases/mortality , Coronary Artery Disease/physiopathology , Female , Fibrinolytic Agents/therapeutic use , Follow-Up Studies , Germany/epidemiology , Humans , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Intermittent Claudication/drug therapy , Intermittent Claudication/etiology , Intermittent Claudication/physiopathology , Male , Middle Aged , Peripheral Vascular Diseases/drug therapy , Peripheral Vascular Diseases/etiology , Practice Guidelines as Topic , Prognosis , Prospective Studies , Registries , Risk Factors
8.
Pathophysiol Haemost Thromb ; 32(1): 16-24, 2002.
Article in English | MEDLINE | ID: mdl-12214159

ABSTRACT

The aim of the study was to evaluate the effect of two antithrombotic therapies on platelet function and on coagulation in patients with nonvalvular atrial fibrillation (NVAF). Twenty patients with NVAF were treated with aspirin (300 mg/day) and clopidogrel (75 mg/day) for 2 weeks immediately followed by oral anticoagulation (target international normalized ratio 2.0-3.0). Parameters of platelet function and coagulation were evaluated before antithrombotic therapy, at the end of aspirin plus clopidogrel and during subsequent anticoagulation treatment. Aspirin plus clopidogrel significantly inhibited platelet aggregation, fibrinogen receptor activation and release of P-selectin and prolonged in vitro bleeding time (p < 0.01). Coagulation parameters (platelet-dependent thrombin generation, antithrombin III, thrombin-antithrombin III complex, prothrombin fragment 1 + 2) were not significantly affected. During the subsequent oral anticoagulation phase platelet function was not substantially reduced; however, coagulation parameters were significantly inhibited (p < 0.001). The results indicate that combined antiplatelet therapy is superior to aspirin monotherapy in inhibiting platelet function but does not seem to substantially modulate coagulation cascade in patients with NVAF.


Subject(s)
Anticoagulants/administration & dosage , Aspirin/administration & dosage , Atrial Fibrillation/drug therapy , Blood Coagulation/drug effects , Platelet Activation/drug effects , Ticlopidine/administration & dosage , Administration, Oral , Aged , Anticoagulants/pharmacology , Aspirin/pharmacology , Atrial Fibrillation/blood , Biomarkers/blood , Blood Platelets/drug effects , Blood Platelets/metabolism , Clopidogrel , Drug Synergism , Drug Therapy, Combination , Female , Humans , Male , Middle Aged , Platelet Function Tests , Prospective Studies , Receptors, Fibrinogen/metabolism , Thrombin/biosynthesis , Ticlopidine/analogs & derivatives , Ticlopidine/pharmacology
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