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1.
Herz ; 45(5): 483-492, 2020 Aug.
Artigo em Alemão | MEDLINE | ID: mdl-30267118

RESUMO

BACKGROUND: Cardiovascular (CV) diseases are still the most frequent cause of death in industrial nations. Employer-initiated screening of the CV risk could make an early contribution to optimization of the prevention strategies. METHODS: In a cross-sectional study the CV risk profile (e.g., dyslipidemia, hypertension, smoking, diabetes mellitus and familial disposition) of 1436 employees at the industrial park in Frankfurt Höchst was analyzed. The total risk was estimated using the PROCAM score. RESULTS: A hypercholesterolemia (low-density lipoprotein, LDL >130 mg/dl) was detected in 36% of the participants. Of the high-risk participants (myocardial infarct, apoplexy and/or diabetes) 23.7% (n = 9/38) were in the target range for LDL as defined by the European Society of Cardiology (ESC) of below 70 mg/dl, 18.4% (n = 7) had levels between 70 and 100 mg/dl and 57.9% (n = 22) had levels of more than 100 mg/dl. In addition, more than half of the subjects (53.2%) had increased blood pressure values (defined as systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg). The prevalence of diabetes (blood sugar >126 mg/dl) was very low (1.3%) as was the frequency of manifest CV diseases (1.4% myocardial infarct or apoplexy, 2.9% stabile angina pectoris or peripheral arterial occlusive disease, PAOD). CONCLUSION: The data confirm that the risk factors high blood pressure and dyslipidemia are widespread and the achievement of target values is insufficient, particularly with a high risk of CV. Behavioral therapeutic and/or pharmaceutical measures should be instigated in order to better exploit the high preventive potential for carriers of these risk factors.


Assuntos
Doenças Cardiovasculares , Dislipidemias , Estudos Transversais , Humanos , Lipídeos , Fatores de Risco
2.
Internist (Berl) ; 59(7): 744-752, 2018 07.
Artigo em Alemão | MEDLINE | ID: mdl-29946874

RESUMO

Approximately 30% of patients receiving oral anticoagulation using vitamin K antagonists (VKA) require surgery within 2 years. In this context, a clinical decision on the need and the mode of a peri-interventional bridging with heparin is needed. While a few years ago, bridging was almost considered a standard of care, recent study results triggered a discussion on which patients will need bridging at all. Revisiting the currently available recommendations and study results the conclusion can be drawn that the indications for bridging with heparin must nowadays be taken more narrowly and considering the individual patient risk of bleeding and thromboembolism. Bridging with heparin is only needed in patients with a very high risk of thromboembolism. This overview aims to give guidance for a risk-adapted peri-interventional approach to management of patients with a need for long-term anticoagulation using VKA.


Assuntos
Anticoagulantes , Tromboembolia , Vitamina K , Administração Oral , Anticoagulantes/uso terapêutico , Humanos , Assistência Perioperatória , Tromboembolia/prevenção & controle , Vitamina K/antagonistas & inibidores
3.
Eur J Neurol ; 25(11): 1326-1332, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-29924461

RESUMO

BACKGROUND AND PURPOSE: External counterpulsation improves cerebral perfusion velocity in acute stroke and may stimulate collateral artery growth. However, whether (non-acute) at-risk patients with high-grade carotid artery disease may benefit from counterpulsation needs to be validated. METHODS: Twenty-eight patients (71 ± 6.5 years, five women) with asymptomatic unilateral chronic severe internal carotid artery stenosis (>70%) or occlusion were randomized to receive 20 min active counterpulsation followed by sham treatment or vice versa. Cerebral blood flow velocity (CBFV) (measured bilaterally by transcranial middle cerebral artery Doppler), tissue oxygenation index (TOI) (measured over the bilateral prefrontal cortex by near-infrared spectroscopy) and cerebral hemodynamic parameters, such as relative pulse slope index (RPSI), were monitored. RESULTS: Ipsilateral mean CBFV (ΔVmean +3.5 ± 1.2 cm/s) and tissue oxygenation (ΔTOI +2.86 ± 0.8) increased significantly during active counterpulsation compared to baseline, whilst the sham had little effect (ΔVmean +1.13 ± 1.1 cm/s; ΔTOI +1.25 ± 0.65). On contralateral sides, neither counterpulsation nor sham control had any effect on either parameter. During counterpulsation, early dynamic changes in ΔRPSI of the ipsilateral CBFV signal predicted improved tissue oxygenation during counterpulsation (odds ratio 1.179, 95% confidence interval 1.01-1.51), whilst baseline cerebrovascular reactivity to hypercapnia failed to show an association. CONCLUSIONS: In patients with high-grade carotid disease, ipsilateral cerebral oxygenation and blood flow velocity are increased by counterpulsation. This is a necessary condition for the stimulation of regenerative collateral artery growth and thus a therapeutic concept for the prevention of cerebral ischaemia. This study provides a rationale for further clinical investigations on the long-term effects of counterpulsation on cerebral hemodynamics and collateral growth.


Assuntos
Circulação Cerebrovascular/fisiologia , Transtornos Cerebrovasculares/terapia , Contrapulsação , Idoso , Velocidade do Fluxo Sanguíneo/fisiologia , Transtornos Cerebrovasculares/diagnóstico por imagem , Transtornos Cerebrovasculares/fisiopatologia , Feminino , Hemodinâmica/fisiologia , Humanos , Masculino , Pessoa de Meia-Idade , Artéria Cerebral Média/diagnóstico por imagem , Ultrassonografia Doppler Transcraniana
4.
Anaesthesist ; 67(8): 599-606, 2018 08.
Artigo em Alemão | MEDLINE | ID: mdl-29926118

RESUMO

Approximately 30% of patients receiving oral anticoagulation using vitamin K antagonists (VKA) require surgery within 2 years. In this context, a clinical decision on the need and the mode of a peri-interventional bridging with heparin is needed. While a few years ago, bridging was almost considered a standard of care, recent study results triggered a discussion on which patients will need bridging at all. Revisiting the currently available recommendations and study results the conclusion can be drawn that the indications for bridging with heparin must nowadays be taken more narrowly and considering the individual patient risk of bleeding and thromboembolism. Bridging with heparin is only needed in patients with a very high risk of thromboembolism. This overview aims to give guidance for a risk-adapted peri-interventional approach to management of patients with a need for long-term anticoagulation using VKA.


Assuntos
Anticoagulantes/uso terapêutico , Fibrinolíticos/uso terapêutico , Heparina/uso terapêutico , Vitamina K/antagonistas & inibidores , Coagulação Sanguínea/efeitos dos fármacos , Hemorragia/induzido quimicamente , Humanos , Terapia Trombolítica/métodos
5.
Diabet Med ; 35(8): 1037-1048, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-29637608

RESUMO

AIMS: To evaluate the evidence for the novel dual sodium-glucose co-transporter-1 (SGLT1) and -2 (SGLT2) inhibitor, sotagliflozin, which may enhance the efficacy of SGLT2 inhibitors by additionally reducing intestinal glucose absorption. METHODS: The search terms 'sotagliflozin', 'LX4211', 'SGLT' and 'diabetes' were entered into PubMed. Evidence for the pharmacokinetics, pharmacodynamics, safety and efficacy of sotagliflozin in Type 1 and 2 diabetes was extracted from the retrieved literature, critically evaluated, and contextualized in relation to data on existing SGLT2 inhibitors. RESULTS: There is convincing evidence from a range of phase II and III clinical trials that sotagliflozin significantly improves glycaemic control in both Type 1 and Type 2 diabetes. Additional benefits, such as smaller postprandial plasma glucose excursions, lower insulin requirements, appetite suppression and weight loss have been documented. While this is encouraging, several safety concerns remain; a dose-dependent increase in the rate of diabetic ketoacidosis, diarrhoea and genital mycotic infection is apparent, although statistical exploration of the data regarding such events is currently lacking. Speculatively, use of a 200-mg rather than a 400-mg dose may help to limit unwanted effects. CONCLUSIONS: The current evidence for sotagliflozin in diabetes appears promising. Further studies sufficiently powered to assess present and emerging safety concerns, as well as to identify individuals for whom sotagliflozin may be of particular benefit/harm would now be informative for regulatory decision-making. Direct comparisons with existing SGLT2 inhibitors are also needed to determine relative safety/efficacy profiles for the different indications.


Assuntos
Diabetes Mellitus Tipo 1/tratamento farmacológico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Glicosídeos/uso terapêutico , Transportador 1 de Glucose-Sódio/antagonistas & inibidores , Inibidores do Transportador 2 de Sódio-Glicose/uso terapêutico , Glicemia/efeitos dos fármacos , Glicemia/metabolismo , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 2/sangue , Humanos , Hipoglicemiantes/uso terapêutico
6.
Herz ; 43(3): 246-257, 2018 May.
Artigo em Alemão | MEDLINE | ID: mdl-28341983

RESUMO

BACKGROUND: The multifactorial origin of cardiovascular diseases has led to polypharmacy in primary and secondary prophylaxis with evidence-based medications, such as statins, antihypertensive drugs and platelet aggregation inhibitors. The number of prescribed drugs correlates inversely to adherence and can lead to treatment failure. Fixed-dose combination drugs (polypills) could increase the medication adherence of patients, reduce risks and prevent cardiovascular events. METHODS: This review is based on publications that were retrieved from Medline (via PubMed) and The Cochrane Library. The clinical database ClinicalTrials.gov. was also considered. RESULTS: In the studies on primary prevention conducted to date, fixed-dose combinations showed a superior control of risk factors, e.g. hypertension and low-density lipoprotein (LDL) cholesterol compared to placebo and at least non-inferiority compared to usual care. In secondary prevention, the effect of the polypill is mostly on the reduction of blood pressure and LDL cholesterol in non-adherent patients; however, evidence that fixed-drug combinations reduce cardiovascular morbidity and mortality compared to standard therapy is lacking. CONCLUSION: The polypill can be considered as an alternative to polypharmacy after a risk-benefit assessment, especially in non-adherent patients. Ongoing studies are investigating the effect of the polypill on cardiovascular events. Current polypills are limited by the lack of sufficient dosages of the individual components to avoid overtreatment and undertreatment at the individual treatment level.


Assuntos
Fármacos Cardiovasculares , Doenças Cardiovasculares , Combinação de Medicamentos , Inibidores de Hidroximetilglutaril-CoA Redutases , Anti-Hipertensivos , Humanos , Fatores de Risco , Comprimidos
7.
Int J Cardiol ; 241: 344-350, 2017 Aug 15.
Artigo em Inglês | MEDLINE | ID: mdl-28284500

RESUMO

OBJECTIVE: Increased levels of neuro-hormonal biomarkers predict poor prognosis in patients with acute myocardial infarction (AMI) complicated by left ventricular systolic dysfunction (LVSD). The predictive value of repeated (one-month interval) brain natriuretic peptides (BNP) and big-endothelin 1 (BigET-1) measurements were investigated in patients with LVSD after AMI. METHODS: In a sub-study of the Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study (EPHESUS trial), BNP and BigET-1 were measured at baseline and at 1month in 476 patients. RESULTS: When included in the same Cox regression model, baseline BNP (p=0.0003) and BigET-1 (p=0.026) as well as the relative changes (after 1month) from baseline in BNP (p=0.049) and BigET-1 (p=0.045) were predictive of the composite of cardiovascular death or hospitalization for worsening heart failure. Adding baseline and changes in BigET-1 to baseline and changes in BNP led to a significant increase in prognostic reclassification as assessed by integrated discrimination improvement index (5.0%, p=0.01 for the primary endpoint). CONCLUSIONS: Both increased baseline and changes after one month in BigET-1 concentrations were shown to be associated with adverse clinical outcomes, independently from BNP baseline levels and one month changes, in patients after recent AMI complicated with LVSD. This novel result may be of clinical interest since such combined biomarker assessment could improve risk stratification and open new avenues for biomarker-guided targeted therapies. KEY MESSAGES: In the present study, we report for the first time in a population of patients with reduced LVEF after AMI and signs or symptoms of congestive HF, that increased baseline values of BNP and BigET-1 as well as a further rise of these markers over the first month after AMI, were independently predictive of future cardiovascular events. This approach may therefore be of clinical interest with the potential of improving risk stratification after AMI with reduced LVEF while further opening new avenues for biomarker-guided targeted therapies.


Assuntos
Endotelina-1/sangue , Insuficiência Cardíaca/sangue , Infarto do Miocárdio/sangue , Peptídeo Natriurético Encefálico/sangue , Espironolactona/análogos & derivados , Disfunção Ventricular Esquerda/sangue , Idoso , Biomarcadores/sangue , Eplerenona , Feminino , Seguimentos , Insuficiência Cardíaca/tratamento farmacológico , Insuficiência Cardíaca/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Antagonistas de Receptores de Mineralocorticoides/uso terapêutico , Infarto do Miocárdio/tratamento farmacológico , Infarto do Miocárdio/epidemiologia , Valor Preditivo dos Testes , Espironolactona/uso terapêutico , Taxa de Sobrevida/tendências , Fatores de Tempo , Resultado do Tratamento , Disfunção Ventricular Esquerda/tratamento farmacológico , Disfunção Ventricular Esquerda/epidemiologia
8.
Med Klin Intensivmed Notfmed ; 112(6): 499-509, 2017 Sep.
Artigo em Alemão | MEDLINE | ID: mdl-27807613

RESUMO

BACKGROUND: Acute pulmonary embolism (PE) is a cardiovascular emergency with high mortality in which a rapid diagnosis and the early initiation of therapy is vital. In the present study patients with acute PE hospitalized at the Clinic Lippe in Detmold were characterized and their prognosis examined. METHODS: In our department at the hospital Detmold, all patients with acute PE admitted in 2012 and 2013 were documented with respect to the severity of PE, predisposing risk factors and diagnostic and therapeutic steps. RESULTS: A total of 170 patients with acute PE were documented of which 80 patients (47 %) had low, 70 patients an intermediate (41 %) and 20 a high risk (12 %). The main diagnostic tool was thoracic computed tomography (82 %). All patients initially received unfractionated or low-molecular weight heparin; systemic intravenous fibrinolysis was carried out in 3 % of patients (intermediate risk n = 1, high risk n = 4). Nineteen percent (n = 13) of the patients at intermediate and 30 % (n = 6) of patients at high risk received local intrapulmonary fibrinolysis. Overall, the mortality rate in hospital was 10 % (low risk 2.5 %; intermediate risk 7 %; high risk 58 %). All 5 patients who received systemic emergency lysis died. One (5.3 %) of the 19 patients at intermediate risk, undergoing local intrapulmonary fibrinolysis, died. CONCLUSION: In acute PE a rapid diagnosis and the initiation of an adequate therapy remains a big challenge. Further studies are required to evaluate if aggressive treatment options might reduce mortality especially among patients at intermediate or high risk.


Assuntos
Embolia Pulmonar , Terapia Trombolítica , Tomografia Computadorizada por Raios X , Humanos , Prognóstico , Embolia Pulmonar/diagnóstico por imagem , Embolia Pulmonar/tratamento farmacológico , Fatores de Risco
9.
Dtsch Med Wochenschr ; 141(6): e53-9, 2016 Mar.
Artigo em Alemão | MEDLINE | ID: mdl-26983119

RESUMO

BACKGROUND: Chronic ischemic heart disease take the first place in cause of death in Germany. The proportion of patients aged 75 years or older amounts more than 80 %. Due to their growing part of population the medical care of older patients becomes increasingly important. In this investigation patients aged ≥ 75 years with coronary three-vessel disease were characterized and various treatment strategies were compared. PATIENTS AND METHODS: This analysis was retrospective. The data of patients aged 75 years or older with three-vessel disease diagnosed by coronary angiography at the Klinikum Lippe Detmold between 2005 and 2007 were collected. Depending on the received therapy they were parted in three groups: optimal drug therapy (OMT), interventional - (PCI) and surgical revascularization (CABG). Patient characteristics as well as survival- and MACCE-rates during follow up were ascertained. Subgroup analyzes were performed for acute coronary syndrom (ACS) and stable coronary artery disease( CAD). RESULTS: The data of 434 patients with an average age of 79 years were documented. 139 (32.0 %) were assigned to the OMT- 189 (43.6 %) to the PCI- and 106 (24.4 %) to the CABG-group. Overall there was no significant difference between the three groups regarding mortality. In the subgroup of patients wit ACS (n = 180) mortality significantly increased in the OMT-group compared to the two invasive therapies (PCI (p = 0.029), CABG (p = 0.045)). The subgroup of patients with stable CAD showed no significant differences in mortality between the three types of therapy. CONCLUSIONS: Older patients benefit from an interventional or surgical revascularization in the context of ACS. In contrast, in elderly with stable CAD optimal medical therapy provides a reasonable alternative to invasive therapy without increase in mortality.


Assuntos
Doença da Artéria Coronariana/terapia , Idoso , Idoso de 80 Anos ou mais , Procedimentos Cirúrgicos Cardíacos , Feminino , Alemanha , Humanos , Masculino , Estudos Retrospectivos
10.
Acta Diabetol ; 52(6): 1093-101, 2015 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-26239142

RESUMO

AIMS: Treatment strategies for obese patients with type 2 diabetes mellitus aim to increase physical activity, reduce body weight, and improve glucose control using weight-beneficial antidiabetic drugs. The objective of this study was to determine whether these strategies are implemented, and to identify factors predictive of glucose control and body weight management in a large, real-world patient population. METHODS: The prospective DiaRegis cohort study included 3807 patients with type 2 diabetes in whom the treating physician decided to intensify and optimize treatment because of insufficient glucose control. RESULTS: Antidiabetic treatment of overweight and obese patients was compared with that of normal-weight patients over a 2-years follow-up period, and multivariate analyses were performed to identify predictors of body weight loss. Among the 3807 participants, 92.5 % were overweight or obese. Normal-weight participants were more often treated with sulfonylureas or insulin, and overweight and obese patients with metformin or glucagon-like peptide (GLP)-1 analogues. Predictors of weight loss were body mass index (BMI) ≥30 kg/m(2) and any reported physical activity. CONCLUSIONS: DiaRegis study shows that under real-world conditions, antidiabetic drug therapy is performed dependent on body weight. This strategy results in adequate glucose control and moderate weight reductions in overweight and obese patients. Weight loss is affected by treatment with weight-beneficial drugs, but also by any reported physical activity. However, only a small subgroup of patients perform physical activity. Initiation and maintenance of a physically active lifestyle remains a significant challenge for physicians, and patients with type 2 diabetes.


Assuntos
Peso Corporal/efeitos dos fármacos , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Obesidade/tratamento farmacológico , Adulto , Idoso , Glicemia/metabolismo , Estudos de Coortes , Exercício Físico , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Sobrepeso/tratamento farmacológico , Estudos Prospectivos , Perda de Peso
11.
J Hum Hypertens ; 29(5): 316-23, 2015 May.
Artigo em Inglês | MEDLINE | ID: mdl-25273857

RESUMO

We aimed to analyze benefits and risks of aliskiren treatment in older adults (⩾ 65 years) in clinical practice. Patients (n = 14,986) were assigned to either aliskiren (ALIS), an angiotensin-converting-enzyme inhibitor or angiotensin receptor blocker (ACEi/ARB), or an agent not blocking the renin-angiotensin system (non-RAS). Older adults (n = 7396) had a longer history of hypertension (8.7 vs 4.7 years; P < 0.0001), lower mean diastolic blood pressure (DBP; 87.7 ± 11.0 vs 92.1 ± 11.0 mm Hg) and more renal (12.0 vs 5.6%; P < 0.0001) or cardiovascular disease (44.0 vs 18.9%; P < 0.0001); 4548 received aliskiren (68.8%), 1215 ACEi/ARBs (18.4%) and 850 non-RAS treatments (12.9%). Office BP at 1 year was reduced by 18.4 ± 21.5/7.2 ± 12.0 mm Hg. BP reductions were greater (19.5 ± 21.7/7.6 ± 12.1 mm Hg) in the aliskiren group than in the ACEi/ARB (15.6 ± 20.9/6.4 ± 11.9) and non-RAS groups (16.1 ± 20.7/6.5 ± 11.7 mm Hg), respectively (P<0.0001 for systolic BP (SBP) and <0.01 for DBP). After multivariable adjustment, differences in SBP reductions were clinically irrelevant and no differences were noted for DBP. Adverse effects were higher in older adults with no differences between treatment groups. In conclusion, the present analysis of a large, unselected cohort of patients in clinical practice from the 3A study, offers real-life evidence of the effectiveness and safety of aliskiren for the treatment of hypertension in older adults.


Assuntos
Amidas , Fumaratos , Hipertensão , Fatores Etários , Idoso , Amidas/administração & dosagem , Amidas/efeitos adversos , Anti-Hipertensivos/administração & dosagem , Anti-Hipertensivos/efeitos adversos , Pressão Sanguínea/efeitos dos fármacos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Feminino , Fumaratos/administração & dosagem , Fumaratos/efeitos adversos , Alemanha/epidemiologia , Humanos , Hipertensão/diagnóstico , Hipertensão/tratamento farmacológico , Hipertensão/epidemiologia , Hipertensão/metabolismo , Masculino , Pessoa de Meia-Idade , Renina/antagonistas & inibidores , Sistema Renina-Angiotensina/efeitos dos fármacos , Medição de Risco , Resultado do Tratamento
12.
Chirurg ; 85(6): 513-9, 2014 Jun.
Artigo em Alemão | MEDLINE | ID: mdl-24823997

RESUMO

BACKGROUND: The aim of the perioperative management of anticoagulation in patients with long-term oral anticoagulation is to minimize bleeding complications of surgical interventions. OBJECTIVES: We aimed to give a summary of current data and to give practical recommendations for colleagues practicing surgery. MATERIAL AND METHODS: This article gives a narrative overview of available data from 31 publications between 2000 and 2013. RESULTS: Every perioperative decision on whether to continue oral anticoagulation is preceded by an assessment of the risk of bleeding and embolism. In cases with a low risk of bleeding, oral anticoagulation can usually be continued. In contrast, for larger interventions with a moderate to high risk of bleeding, a discontinuation of phenprocoumon with temporary bridging is required. In this case it is common practice to discontinue phenprocoumon 7-9 days preoperatively and administer heparin mostly in the form of low molecular weight heparin (LMWH) depending on the international normalized ratio (INR). In contrast perioperative management of direct oral anticoagulants (DOAC) is discussed controversially. Based on the pharmacokinetics of the DAOC, the recommendations are to minimize the anticoagulation-free interval to 2-4 half-lives (HWZ) preoperatively (1-5 days) and early postoperative restart. In this case no bridging is necessary. On the other hand, an early interruption of DOAC 5 days prior to surgery to a minimum of 2 days postoperatively is favored by some surgeons to assure an adequate perioperative hemostasis. Depending on the risk of thromboembolism, bridging is required. These recommendations are justified by limited clinical experience and the absence of antagonism. CONCLUSION: The perioperative management of coagulation is still a challenge. While there are consolidated decision aids for phenprocoumon, the approach under DOAC treatment is still controversial due to limited data.


Assuntos
Anticoagulantes/administração & dosagem , Anticoagulantes/efeitos adversos , Perda Sanguínea Cirúrgica/prevenção & controle , Assistência Perioperatória/métodos , Tromboembolia/tratamento farmacológico , Administração Oral , Anticoagulantes/farmacocinética , Perda Sanguínea Cirúrgica/fisiopatologia , Relação Dose-Resposta a Droga , Meia-Vida , Humanos , Coeficiente Internacional Normatizado , Femprocumona/administração & dosagem , Femprocumona/efeitos adversos , Femprocumona/farmacocinética , Medição de Risco , Tromboembolia/sangue
13.
Diabetes Obes Metab ; 16(3): 248-54, 2014 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-24033863

RESUMO

AIMS: We aimed to identify predictors of hypoglycaemia in patients with poorly controlled type 2 diabetes treated with a single daily bolus of insulin glulisine on top of insulin glargine and oral antidiabetic drugs (basal-plus regimen). METHODS: We retrospectively analysed four large basal-plus trials including 713 patients (47% female) with type 2 diabetes, mean age of 59.9 ± 9.5 years and diabetes duration of 11 ± 7.0 years. Predictors for symptomatic, severe and nocturnal hypoglycaemia were identified by multivariate logistic regression analyses, calculation of odds ratios (ORs) and Wald 95% confidence intervals (CIs). RESULTS: Mean numbers of hypoglycaemic events per year were 4.64 ± 11.4 (symptomatic < 60 mg/dl), 0.59 ± 2.28 (nocturnal) and 0.03 ± 0.22 (severe). A total of 44.5% of patients reached the composite endpoint of glycated haemoglobin (HbA1c) <7.0% plus no severe hypoglycaemia, and 26.7% reached the composite of HbA1c <7.0% plus no symptomatic hypoglycaemia. Predictors of nocturnal and symptomatic hypoglycaemia were female gender (OR 1.82; 95% CI 1.07-3.11 and OR 1.89; 95% CI 1.31-2.78), diabetes duration >10 versus <5 years (OR 2.61; 95% CI 1.03-6.59 and OR 2.01; 95% CI 1.15-3.51) and higher basal insulin dose (per unit of increase) (OR 1.01; 95% CI 1.00-1.03 and OR 1.01; 95% CI 1.00-1.02). Conversely, a higher body mass index (BMI) (27-30 vs. <27 kg/m(2) and >30 vs. <27 kg/m(2) ) conferred a reduced risk of symptomatic hypoglycaemia with an OR of 0.53 (95% CI 0.31-0.90) and an OR of 0.61 (95% CI 0.39-0.97). CONCLUSIONS: Female gender, a long diabetes duration and higher basal insulin dose were predictors of hypoglycaemia, while protection was provided by BMI > 30. These results may help to successfully establish basal-plus insulin regimen in individual patients on their transition from basal-only to basal-bolus treatment.


Assuntos
Glicemia/metabolismo , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemia/induzido quimicamente , Insulina de Ação Prolongada/uso terapêutico , Insulina/análogos & derivados , Adulto , Idoso , Glicemia/efeitos dos fármacos , Índice de Massa Corporal , Diabetes Mellitus Tipo 2/sangue , Esquema de Medicação , Quimioterapia Combinada , Feminino , Hemoglobina A Glicada/metabolismo , Humanos , Hipoglicemia/sangue , Insulina/uso terapêutico , Insulina Glargina , Masculino , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Valor Preditivo dos Testes , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Retrospectivos , Fatores Sexuais , Fatores de Tempo , Resultado do Tratamento
14.
J Hum Hypertens ; 28(3): 193-200, 2014 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-24067349

RESUMO

The percentile distribution of blood pressure (BP) with regard to age, sex and cardiovascular risk factors is unknown. We aimed to provide epidemiological data for a comprehensive description of the BP distribution across a wide age-range. We used data from the German Metabolic and Cardiovascular Risk Project (GEMCAS), a cross-sectional study with 35 683 participants aged 18-99 years, conducted during October 2005 in 1511 randomly selected general practices in Germany. BP and waist circumference were measured, data on lifestyle, cardiovascular disease (CVD) risk factors and medication assessed. In men, we found even in the lowest percentile (5th) a gradual increase of the systolic BP from the lowest to the highest age group of 10 mm Hg, all other percentile groups an increase of 20 mm Hg. In women, this increase ranged from 15 mm Hg (5th percentile) to 40 mm Hg (95th percentile). In a subgroup of participants with no antihypertensive usage (n=22 550) and no CVD/CVD risk factors (n=13 297), we still observed a distinct age-related increase of BP readings. Our study provides detailed information on the population distribution of BP readings in both sexes and also among very old individuals. The results are useful in a public health context to plan gender- and age-specific prevention strategies.


Assuntos
Pressão Sanguínea/fisiologia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos Transversais , Feminino , Medicina Geral , Alemanha/epidemiologia , Humanos , Hipertensão/epidemiologia , Hipertensão/fisiopatologia , Estilo de Vida , Masculino , Pessoa de Meia-Idade , Fatores de Risco , Inquéritos e Questionários , Circunferência da Cintura
15.
Int J Clin Pract ; 67(10): 1005-14, 2013 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-23981060

RESUMO

BACKGROUND: DPP-4 inhibitors (DPP4-I) have been shown to provide non-inferior glycaemic control compared with sulfonylureas (SU), but result in a reduction of body weight and a significantly lower risk of hypoglycaemia in patients with type 2 diabetes. We aimed to validate these results in a large real-world sample of patients participating in the prospective DiaRegis registry and to assess prognostic implications. METHODS: DiaRegis included 3810 patients with type 2 diabetes in which antidiabetic therapy was intensified. We defined two patient subgroups, the first receiving either a DPP4-I or SU on top of prior metformin monotherapy and the second containing patients out of subgroup 1 with unaltered treatment for 1 year. RESULTS: After enrolment 884 patients with prior metformin monotherapy received a dual combination of metformin with either DPP4-I (n = 628; 71%) or SU (n = 256; 29%). Patient characteristics, blood glucose and blood pressure control as well as comorbidity burden were virtually identical. There were neither significant differences in the change of HbA1c over the 12 months treatment period nor in the reduction of body weight, but fasting (p = 0.033) and postprandial glucose levels (p = 0.01) were significantly lower in those receiving DPP4-I. Hypoglycaemia was significantly less frequent in patients receiving DPP4-I (OR 0.32; 95% CI 0.19-0.54). Qualitative changes were robust for subgroup 2 (except of fasting plasma glucose). Patients receiving DPP4-I had significantly less stroke/transitory ischaemic attack (0.2 vs. 2.0; p < 0.05) during the 1 year follow-up, whereas other vascular events (coronary artery bypass graft, percutaneous coronary intervention) were borderline significant. CONCLUSIONS: The present results confirm prior randomised controlled trial results in patients with type 2 diabetes from real world clinical practice demonstrating that DPP4-I on top of prior metformin monotherapy result in similar HbA1c reductions within 12 months but a significant reduction in hypoglycaemia compared with sulfonylurea added to metformin. The reduction in vascular events observed has to be verified in larger cohorts.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Inibidores da Dipeptidil Peptidase IV/administração & dosagem , Hipoglicemiantes/uso terapêutico , Metformina/administração & dosagem , Compostos de Sulfonilureia/administração & dosagem , Administração Oral , Idoso , Diabetes Mellitus Tipo 2/sangue , Combinação de Medicamentos , Feminino , Hemoglobina A Glicada/metabolismo , Humanos , Hipoglicemia/induzido quimicamente , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do Tratamento
16.
Dtsch Med Wochenschr ; 138(18): 934-9, 2013 May.
Artigo em Alemão | MEDLINE | ID: mdl-23613371

RESUMO

BACKGROUND: Due to the variety of affected organ systems, necessitating a multidisciplinary and interconnected approach in deciding on individual diagnostic and therapeutic strategies, a structured documentation of data for patients suffering from diabetes mellitus is steadily gaining importance. Towards this purpose, multiple quality initiatives (e. g. SWEET, QS-DPV, EUBIROD etc.) as well as several software systems (e. g. [DPV2] DIAMAX, DPV, EMIL, Qmax etc.) have been developed to capture patient-related data. This is further complicated by the necessity to exchange data with a large variety of doctor's office administration systems. METHODS: To address this complex of issues, DiabetesDE in cooperation with several societies, doctor's associations and prospective end users launched a national register platform. DIVE (Diabetes Care Evaluation) is aimed at establishing a national diabetes register to centrally capture data from diabetes patients being treated by diabetology specialists in Germany, thus making them available for quality assurance and health services research. RESULTS: Since September 2011, 142 so far participating doctors have documented data for 84,774 patients. Compared to patients treated by general practitioners, persons under specialist care show a more advanced clinical picture with substantial co-morbidity. CONCLUSION: DIVE provides a national platform which will address essential fields of activity with regard to the development of a national diabetes strategy--epidemiology, diabetes registry, health care research, quality assurance--based on usual office administration systems, thus contributing to the improvement of care and treatment for patients suffering from diabetes.


Assuntos
Diabetes Mellitus Tipo 1/tratamento farmacológico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Pesquisa sobre Serviços de Saúde , Hipoglicemiantes/uso terapêutico , Programas Nacionais de Saúde/normas , Garantia da Qualidade dos Cuidados de Saúde/normas , Sistema de Registros , Software , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Comorbidade , Comportamento Cooperativo , Estudos Transversais , Sistemas de Gerenciamento de Base de Dados/normas , Complicações do Diabetes/diagnóstico , Complicações do Diabetes/epidemiologia , Complicações do Diabetes/terapia , Diabetes Mellitus Tipo 1/diagnóstico , Diabetes Mellitus Tipo 1/epidemiologia , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/epidemiologia , Documentação/normas , Quimioterapia Combinada , Feminino , Alemanha , Humanos , Comunicação Interdisciplinar , Masculino , Sistemas Computadorizados de Registros Médicos/normas , Pessoa de Meia-Idade , Especialização , Adulto Jovem
17.
Unfallchirurg ; 116(3): 246-54, 2013 Mar.
Artigo em Alemão | MEDLINE | ID: mdl-21909736

RESUMO

BACKGROUND: The aim of this study was to compare the efficacy and tolerability of enoxaparin for preventing thromboembolism after surgery in the out-patient and in-hospital settings. MATERIALS AND METHODS: A total of 2,005 out-patient and 1,360 hospitalized patients were included in the study. Prophylaxis was carried out with 20 or 40 mg enoxaparin and follow-up examination after 4-6 weeks. RESULTS: Out-patients were younger (mean 48.4 vs. 58.5 years, p<0.01), had less cardiovascular comorbid diseases (7.1 vs. 20.8%, p<0.01) and underwent less complex interventions (arthroscopy 33.6 vs. 7.5%, p<0.01). Out-patients also received 20 instead of 40 mg enoxaparin more frequently (60.7 vs. 38.3%, p<0.01). The mean duration of thromboprophylaxis was reduced (12.6 vs. 15.3 days). For patients treated with 20 and 40 mg minor bleeding was observed in 1.8 and 3.4%, respectively (4.7 with 20 mg and 4.5% with 40 mg in hospital), major bleeding was 0.1% for both doses in out-patients and 0.0% with 20 mg and 0.3% with 40 mg in-hospital. Deep vein thrombosis (DVT) occurred in 0.4% of out-patients receiving 20 mg enoxaparin and 0.6% with 40 mg (0.0% with 20 mg and 0.9% with 40 mg in-hospital). There were no cases of pulmonary embolism (PE) in out-patients but PE was observed in 0.2% and 0.5% with 20 mg and 40 mg in-hospital patients, respectively. CONCLUSIONS: Thromboprophylaxis with enoxaparin is well tolerated under clinical conditions as well as under out-patient treatment and severe bleeding complications are rare.


Assuntos
Assistência Ambulatorial/estatística & dados numéricos , Enoxaparina/uso terapêutico , Hospitalização/estatística & dados numéricos , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/prevenção & controle , Trombose Venosa/prevenção & controle , Comorbidade , Feminino , Fibrinolíticos/uso terapêutico , Alemanha/epidemiologia , Humanos , Pacientes Internados/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Pacientes Ambulatoriais/estatística & dados numéricos , Prevalência , Medição de Risco , Resultado do Tratamento
18.
J Hum Hypertens ; 27(2): 131-7, 2013 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-22258208

RESUMO

Hypertension in the elderly is a major risk factor for cardiovascular disease. We aimed to analyze determinants of blood pressure (BP) control across different age groups. Population of a large global survey on hypertension treatment and control including 18927 patients was analyzed. A logistic regression analysis was conducted to estimate BP control rates and the prevalence of antihypertensive drug usage according to age. Systolic BP control decreased from 29.6% (95% confidence intervals (CI) 26.0;33.5) at 18-40 years to 22.4% (20.8;24.2) at >75 years (P<0.0001), and diastolic BP control increased from 31.6% (27.9;35.6) to 57.3% (55.2;59.3), respectively (P<0.0001). BP control was worse in diabetic patients, but did not differ substantially with co-morbid conditions, except for a better control in patients with myocardial infarction (MI) (P<0.05). The use of ≥ 3 antihypertensive drugs increased with age from 16.1 to 37.8% (P<0.0001) due to a more frequent use of loop diuretics (P<0.0001), thiazides (P<0.0001), angiotensin-converting enzyme (ACE) inhibitors (P<0.0001) and calcium channel blockers (P<0.0001). About one third of patients received non-guideline-recommended drug-drug combinations. BP control is largely unsuccessful with increasing age. Owing to frequent inadequacies in the combination of antihypertensive drugs, future guidelines and educational programs should devote increased attention to the choice of optimal drug-drug combinations in the elderly.


Assuntos
Anti-Hipertensivos/uso terapêutico , Pressão Sanguínea/efeitos dos fármacos , Quimioterapia Combinada/estatística & dados numéricos , Hipertensão/tratamento farmacológico , Adolescente , Adulto , Idoso , Determinação da Pressão Arterial , Feminino , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Médicos , Fatores de Risco , Adulto Jovem
20.
Herz ; 37(3): 294-300, 2012 May.
Artigo em Inglês | MEDLINE | ID: mdl-22476616

RESUMO

BACKGROUND: Patients with type 2 diabetes and heart failure are considered to be at high risk for hypoglycaemic complications. There is a considerable uncertainty with respect to the appropriate choice of antidiabetic pharmacotherapy in patients with type 2 diabetes and comorbid heart failure. Little is known about comorbidity, hypoglycaemia rates and selected pharmacotherapy in diabetic patients with heart failure in clinical practice. METHODS: DiaRegis is a prospective registry in Germany including 3,810 patients with type 2 diabetes receiving antidiabetic treatment with oral mono or oral dual combination therapy in 2009/2010. Only patients for which adjustment of pharmacotherapy (including the introduction of insulin and GLP-1 analogues) was deemed necessary were enrolled. We examined the differences in comorbidity, hypoglycaemia and choice of anti-diabetic pharmacotherapy between diabetics with and without clinical heart failure in clinical practice in Germany. RESULTS: For 3,746 patients, data on the presence of heart failure were available, median (IQR) age 65.9 (57.6-72.8) years and 46.8% were female. Patients with heart failure (n = 370; 9.9%) were older, had a higher BMI, were less physically active, and had more cardiovascular risk factors and a substantial comorbidity. Glycaemic control was comparable between groups. Of the patients with heart failure, 76.8% received metformin, 32.7% sulfonylureas, 2.2% glucosidase inhibitors, 4.3% glinides, 6.2% glitazones and 7.3% DPP-4 inhibitors at baseline before adjustment of therapy. In multivariate analyses, patients with heart failure received less metformin (odds ratio (OR) 0.58, 95% confidence interval (CI) 0.43-0.79) and sulfonylureas (OR 0.70, 95%CI 0.52-0.95) but not thiazolidinediones (OR 1.22, 95%CI 0.82-1.81) or other antidiabetic drugs. Hypoglycaemia was considerably more frequent in diabetic patients with heart failure than in those without (OR 1.96, 95%CI 1.47-2.61). CONCLUSION: Patients with type 2 diabetes and heart failure had a substantially increased comorbidity burden compared to patients without heart failure. They more often suffered from episodes of hypoglycaemia, especially those requiring medical assistance. The diagnosis of heart failure did not impact the choice of antidiabetic pharmacotherapy in patients with type 2 diabetes. There was no differential use of thiazolidinediones despite evidence discouraging their use in patients with heart failure.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/epidemiologia , Insuficiência Cardíaca/epidemiologia , Hipoglicemia/tratamento farmacológico , Hipoglicemia/epidemiologia , Hipoglicemiantes/uso terapêutico , Sistema de Registros , Idoso , Comorbidade , Feminino , Alemanha/epidemiologia , Insuficiência Cardíaca/tratamento farmacológico , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência , Medição de Risco , Fatores de Risco , Resultado do Tratamento
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