PubMed Health⌕ Search

Biomedical subjects

P T Sawicki

Publications and source records attributed to P T Sawicki.

At least 19 recordsLinked to original sources
PubMed2006

[Patient-relevant end points: present state of the discussion at the Institute for Quality and Cost-Effectiveness in Public Health].

In addition to an exact definition, correct measurement of any patient-relevant value is important. Assessing the value of medical interventions is mainly made difficult by the uncertain interpretation of a study's end points, among others caused by the use of invalid surrogate parameters, the clinically unreasonable combination of end points or the arbitrary POST HOC combination of end points as well as the premature termination of studies because of unclear evidence of superiority. As numerous errors can be made when measuring patient-relevant end points, it is the task of the Institute for Quality and Cost-Effectiveness in Health Care not only to describe patient-relevant value in general (and particular for different cases), but also to point out measurement errors in this regard, so that they can be avoided in future.

Academies and Institutes↗
PubMed2006

[Aspects of economic evaluation in health care].

Health economists use models to estimate comparative costs and usage of interventions in health care. However the concepts and methods used have inherent weaknesses, especially in the determination of relevant and exact effect sizes. Health economic methodologies do not replace sociopolitical decision making, but they can play an important role in rational decision making about necessary changes to our social and health system if the instruments themselves are neither over- nor underestimated.

Cost-Benefit Analysis↗
PubMed2005

Impact of smoking on the metabolic action of subcutaneous regular insulin in type 2 diabetic patients.

BACKGROUND AND AIMS: Smoking has repeatedly been associated with alterations in both insulin sensitivity and insulin absorption in type 2 diabetes, which should lead to differences in the pharmacokinetic (PK) and pharmacodynamic (PD) properties of regular insulin (RI). However, a direct comparison of the PK/PD-effects of RI has never been performed in these patients. Therefore, the aim of this exploratory study was to investigate the time-action profile of RI in a small group of smoking and matching non-smoking patients with type 2 diabetes using the euglycemic glucose clamp technique, which is seen as the gold standard for PD/PK investigations. MATERIAL AND METHODS: Nine smokers (more than 10 cigarettes per day) and nine non-smokers matched for gender, age, and BMI (without significant differences in HbA (1c), diabetes duration or blood pressure) were enrolled in the study. Patients' blood glucose was stabilized overnight at 7.2 mmol/l using a Biostator. Smokers were required to smoke one cigarette within ninety minutes prior to injection of 18 U RI s. c. in the morning. Glucose infusion rates (GIR) were registered for the subsequent 480 min. RESULTS: Injection of 18 U of RI resulted in significantly higher insulin concentrations in smokers compared to non-smokers, in particular in the later part of the experiment (Insulin-AUC (240-480) 10.5 +/- 2.3 (mean +/- SD) vs. 7.8 +/- 1.6 microU/ml/min, p < 0.05). This was also reflected in the PD results with a higher metabolic effect in smokers in the last four hours of the experiment (GIR-AUC (240-480) 0.9 +/- 0.4 vs. 0.6 +/- 0.3 g/kg, p < 0.05). Pharmacokinetic analyses revealed a trend towards a lower insulin clearance in smokers (1.1 +/- 0.2 vs. 1.4 +/- 0.4 l/min, p = 0.08). CONCLUSIONS: This pilot study conducted in a small group of patients with type 2 diabetes shows that regular insulin exhibits a longer-lasting rise in insulin concentrations and a higher metabolic effect four to eight hours after injection in smokers compared to non-smokers. This suggests that hyperinsulinemia in smoking type 2 diabetic patients is at least partly caused by a deterioration in insulin clearance.

Aged↗
PubMed2004

Meta-analysis of short-acting insulin analogues in adult patients with type 1 diabetes: continuous subcutaneous insulin infusion versus injection therapy.

AIMS/HYPOTHESIS: This study aimed to compare the effect of treatment with short-acting insulin (SAI) analogues versus structurally unchanged short-acting insulin (regular insulin) on glycaemic control and on the risk of hypoglycaemic episodes in type 1 diabetic patients using different insulin treatment strategies. METHODS: We performed a meta-analysis of 27 randomised controlled trials that compared the effect of SAI analogues with regular insulin in patients with type 1 diabetes mellitus. The treatments were administered either via continuous subcutaneous insulin infusion (CSII) or by conventional intensified insulin therapy (IIT) with short-acting insulin injections before meals and basal insulin administered once or twice daily in most cases. RESULTS: HbA(1)c levels were reported for 20 studies. For studies using CSII, the weighted mean difference between values obtained using SAI analogues and regular insulin was -0.19% (95% CI: -0.27 to -0.12), whereas the corresponding value for injection studies was -0.08% (95% CI: -0.15 to -0.02). For the analysis of overall hypoglycaemia, we used the results from nine studies that reported the mean frequency of hypoglycaemic episodes per patient per month. For studies using CSII, the standardised mean difference between SAI analogues and regular insulin was -0.07 (95% CI: -0.43 to 0.28), whereas for IIT studies the corresponding value was -0.04 (95% CI: -0.24 to 0.16). CONCLUSIONS/INTERPRETATION: Taking into consideration the low quality of the trials included, we can conclude that use of a short-acting insulin analogue in CSII therapy provides a small, but statistically significant improvement in glycaemic control compared with regular insulin. An even smaller effect was obtained with the use of ITT. The rate of overall hypoglycaemic episodes was not significantly reduced with short-acting insulin analogues in either injection regimen.

Adult↗
PubMed2004

Acarbose for prevention of diabetes, hypertension and cardiovascular events? A critical analysis of the STOP-NIDDM data.

INTRODUCTION: Cardiovascular morbidity and mortality is a major and still unresolved threat to patients with reduced glucose tolerance and Type 2 diabetes mellitus. In epidemiological studies, in non-diabetic subjects, post-prandial glycaemia is positively associated with the risk of diabetes, hypertension and cardiovascular events. If this epidemiological association is causal, Acarbose, which reduces post-prandial blood glucose concentrations, should result in a decrease in the risk of these events. The STOP-NIDDM trial investigated whether Acarbose reduces the risk of diabetes, hypertension and cardiovascular events. Consequently, the validity of the results of this trial is of major importance for future treatment in non-diabetic and diabetic patients. METHODS: We searched various databases and the Internet for publications of the design and the results of the STOP-NIDDM trial. A systematic review of these publications was done with respect to information about potential sources of bias and contradictory information in the articles. RESULTS: We found several serious flaws in the STOP-NIDDM study, especially selection bias, inadequate blinding, bias in data analysis and reporting, and potential sponsoring bias. CONCLUSIONS: The validity of the results of the STOP-NIDDM trial is seriously flawed. The clinical benefit of Acarbose and of the reduction of post-prandial glycaemia is unproven.

Acarbose↗
PubMed2002

Reliability of causes of death in persons with Type I diabetes.

AIMS/HYPOTHESIS: To compare causes of death assessed by a clinical review committee, the information given on death certificates, and ICD-codes provided by the State Documentation Office in deceased persons with Type 1 (insulin-dependent) diabetes mellitus. METHODS: A cohort of 3674 patients were monitored for 10+/-3 (mean +/- SD) years. Vital status and end-stage diabetic complications were documented for 97%; 251 patients had died. Causes of death were assessed by a clinical review committee and compared to the information provided by death certificates and ICD-9 codes. RESULTS: The review committee defined a leading cause of death in 94% of cases, whereas death certificates were available for 73% and ICD-codes for 79% of patients; 10% of death certificates could not be evaluated due to insufficient information. Diabetes was mentioned on 71% of death certificates, and renal disease in 75% of cases with renal replacement therapy. There was acceptable agreement between the committee, death certificates and ICD-codes only for deaths due to neoplasma, and between the committee and death certificates for deaths due to acute myocardial infarction, cerebrovascular events and accidents. In only one out of four deaths due to hypoglycaemia and in four of seven deaths due to ketoacidosis was this diagnosis mentioned on the death certificate. No death due to hypoglycaemia or ketoacidosis and 41% due to suicide were identifiable by ICD-codes. CONCLUSION/INTERPRETATION: Reliance on death certificates or ICD-codes as the only sources of information on the cause of specific mortality does not provide data of sufficient reliability for evaluation of clinical outcome in Type I diabetes.

Adult↗
PubMed2002

A time-limited, problem-orientated psychotherapeutic intervention in Type 1 diabetic patients with complications: a randomized controlled trial.

AIMS: To examine the effects of a time-limited, problem-orientated psychotherapeutic intervention on self-defined psychological problems and metabolic control in Type 1 diabetic patients with microvascular complications. DESIGN: Randomized wait-list controlled trial with a follow-up of 6 months. SETTING: Out-patient clinic of a university diabetes centre. PARTICIPANTS: Forty-six Type 1 diabetic patients with intensified insulin therapy and presence of microvascular diabetic complications. Twenty-four patients were randomly allocated to the intervention group and 22 patients to the control group. INTERVENTION: Participation in a structured, problem-orientated, time-limited psychotherapeutic intervention (IG). The control group (CG) patients received routine diabetes care in a specialized diabetes university clinic. OUTCOME MEASURES: Degree of change of three self-defined main psychological and psychosocial problems (no. 1, no. 2 and no. 3) on a 1-10 graded scale and glycosylated haemoglobin HbA1c values. RESULTS: Two patients (one in each group) died during the study period. All remaining patients were followed for 6 months. Problem scores were high at baseline in both groups: IG/CG (mean values, standard deviation in parentheses): problem no. 1, 7.8 (2.0)/8.3 (1.7); problem no. 2, 7.7 (2.3)/7.6 (1.8); and problem no. 3, 7.7 (2.3)/7.4 (2.6). At follow-up, all problems were significantly lower in the intervention group (IG) when compared with the CG: IG/CG: problem no. 1, 4.3 (2.9)/6.8 (3.0), P = 0.03; problem no. 2, 3.9 (2.4)/5.8 (2.8), P = 0.03; problem no. 3, 4.7 (2.4)/6.8 (2.4), P = 0.02. Mean HbA1c decreased in the intervention group by 0.6 (1.2)% and increased in the control group by 0.1 (0.7)%, P = 0.016. In patients with suboptimal metabolic control, i.e. HbA1c > 8%, mean HbA1c decreased by 1.0 (1.2)% in the IG and increased by 0.1 (0.7)% in the CG, P = 0.011. CONCLUSION: A time-limited, structured, problem-orientated psychotherapeutic intervention decreases the severity of psychological problems and improves metabolic control in Type 1 diabetic patients with microvascular complications and self-management of intensified insulin therapy.

Adult↗
PubMed2002

[Results of a structured hypertension teaching and treatment programme].

The benefit of good blood pressure control in patients with arterial hypertension has been repeatedly demonstrated. In high risk patients, a good blood pressure control is one of the main prerequisites for the reduction in morbidity and mortality. However, as shown in population-based studies, the quality of blood pressure control both in patients with essential hypertension and in hypertensive diabetic patients is still unsatisfactory. Only a minority of patients achieve target blood pressure values below 140/90 mm Hg. This situation has not changed within the recent years, although the prescriptions of antihypertensive drugs have continuously increased. This paper describes a structured hypertension treatment and teaching programme (HTTP) which was developed and evaluated during the last 16 years and which aims at intensification of antihypertensive therapy by active involvement of the patient in his own treatment. This programme primarily focuses on the improvement of the patients' long-term treatment compliance by means of information about non-pharmacological and pharmacological therapies and instructions to regular blood pressure self measurements. The efficacy and feasibility of the HTTP has been evaluated in several studies which unanimously show considerable benefits not only concerning blood pressure control but, most importantly, regarding reduction in the incidence and progression of hypertension associated diseases as cerebro- and cardiovascular events and diabetic nephropathy. Therefore, it seems essential to implement the HTTP in the German health care system in order to finally achieve the desired quality of care for patients with arterial hypertension.

Antihypertensive Agents↗
PubMed2001

Betablocker treatment in diabetes mellitus.

OBJECTIVES: Betablockers have been convincingly shown to reduce total and cardiovascular morbidity and mortality of hypertensive diabetic patients. In diabetic patients, after myocardial infarction, these agents confer a twice as high protective effect when compared to non-diabetic patients. However, most paradoxically, betablocking agents are used less frequently in diabetes. Control of hypertension is insufficient in most of the diabetic patients, probably because a combination of antihypertensive agents including betablockers is frequently needed to sufficiently control blood pressure but is not used in these patients. The fear of betablocker-associated side effects in diabetes may be partly responsible for the frequent antihypertensive mono-therapy and the resulting poor quality of blood pressure control among diabetic patients. DESIGN: We have performed an analysis of the literature to assess whether possible adverse metabolic effects, a higher risk of hypoglycaemia or less nephroprotective effects of beta1-selective betablocking agents could justify the reticence in prescribing these antihypertensive agents to diabetic patients. RESULTS: A thorough review of the literature does not indicate that beta1-selective betablocking agents have important adverse effects on glucose metabolism, prolong hypoglycaemia or mask hypoglycaemic symptoms. In diabetic nephropathy, betablockers are as nephroprotective as angiotensin converting enzyme inhibitors. CONCLUSIONS: The unnecessary less frequent prescription of beta1-selective betablockers in diabetes mellitus may contribute to the higher cardiovascular mortality among these patients.

Adrenergic beta-1 Receptor Antagonists↗
PubMed2001

Low prevalence of cardiac autonomic neuropathy in Type 1 diabetic patients without nephropathy.

AIM: To assess the prevalence of cardiac autonomic neuropathy (CAN) in Type 1 diabetic patients with and without nephropathy. METHODS: Sixty-six consecutive patients without nephropathy (n = 24), with incipient (n = 26) or overt nephropathy (n = 16) and a diabetes duration between 21 and 31 years were examined. Heart rate variability (HRV) as measure for CAN was investigated with short-term spectral analysis in the low-frequency (LF) band (0.06-0.15 Hz), reflecting sympathetic and vagal activity, and high-frequency (HF) band (0.15-0.50 Hz), reflecting vagal activity. HRV was expressed as spectral power (ms2, log-transformed). Normal, age-corresponding reference values were established in 184 controls. QTc intervals and dispersion were measured. RESULTS: After adjustment for age, there was no significant difference between healthy controls and patients without nephropathy. After further adjustment for diabetes duration, HbA1c, hypertension and treatment with beta-blockers, HRV in both frequency bands decreased with evidence of nephropathy. LF band (supine): patients without nephropathy 5.56 (4.89-6.21) (least squares means and 95% confidence interval (CI)), incipient nephropathy 5.72 (5.15-6.29) and overt nephropathy 4.11 (3.27-4.96). HF band (supine): without nephropathy 5.93 (5.26-6.60), incipient nephropathy 5.99 (5.41-6.57) and overt nephropathy 4.84 (4.00-5.68). Significant differences were found for patients without and with incipient nephropathy compared with those with overt nephropathy in the LF band and between patients with incipient nephropathy compared with those with overt nephropathy in the HF band. QTc intervals and QTc dispersion increased significantly with increasing nephropathy. CONCLUSIONS: Long-term Type 1 diabetes without nephropathy was not associated with impaired cardiac autonomic function in our study. However, in those with nephropathy, a loss of both vagal and sympathetic activity was present, and the severity of CAN correlated positively with more advanced nephropathy.

Adult↗
PubMed2001

Impact of diabetic nephropathy on pharmacodynamic and Pharmacokinetic properties of insulin in type 1 diabetic patients.

OBJECTIVE: To quantify pharmacokinetic and pharmacodynamic properties of regular insulin and insulin lispro in type 1 diabetic patients with and without overt diabetic nephropathy. RESEARCH DESIGN AND METHODS: In this double-blind, two-way cross-over, euglycemic (5 mmol/l) glucose clamp study, we investigated the metabolic response to subcutaneous injections of regular insulin and insulin lispro (0.2 U/kg) in 12 type 1 diabetic patients with overt diabetic nephropathy (proteinuria >500 mg/24 h and/or serum creatinine >1.5 mg/dl; NP group) and in a control group of 12 type 1 diabetic patients with normal renal function (DC group). RESULTS: Peak plasma free insulin levels with insulin lispro (359 [NP] vs. 254 pmol/l [DC]) were higher and time to maximal insulin concentrations (85 [NP] vs. 99 min [DC]) shorter than with regular insulin (213 [NP] vs. 144 pmol/l [DC]; 118 [NP] vs. 153 min [DC]) in both patient groups. Overall insulin levels for regular insulin and for insulin lispro were higher in patients with overt diabetic nephropathy compared with control patients. Time to maximal metabolic effect was shorter with insulin lispro than with regular insulin in both patient groups (102 vs. 191 min [NP]; 105 vs. 172 min [DC]). The overall metabolic effect of regular insulin but not of insulin lispro was lower in patients with diabetic nephropathy than in diabetic control patients (967 vs. 1,510 mg/kg, respectively). CONCLUSIONS: Although insulin levels are higher in patients with overt diabetic nephropathy, the metabolic response to regular insulin is reduced. Insulin lispro maintains its characteristic pharmacokinetic and pharmacodynamic properties in patients with overt diabetic nephropathy.

Adult↗
PubMed2001

[Optimized therapy for hypertension].

The benefit of good blood pressure control in patients with arterial hypertension has been repeatedly demonstrated. In high-risk patients, a good blood pressure control is one of the main prerequisites for the reduction of morbidity and mortality. However, as has been shown in population-based studies, the quality of blood pressure control both in patients with essential hypertension and in hypertensive diabetic patients is still unsatisfactory. Only a minority of patients achieve target blood pressure values below 140/90 mm Hg. This situation has not changed within the recent years, although the prescriptions of antihypertensive drugs have continuously increased. This paper describes a structured hypertension treatment and teaching program (HTTP) which was developed and evaluated during the last 16 years and which aims at intensification of antihypertensive therapy by active involvement of the patients in their own treatment. This programme primarily focuses on the improvement of the patients' long-term treatment compliance by means of information about non-pharmacological and pharmacological therapies and instructions to regular blood pressure self-measurements. The efficacy and feasibility of the HTTP has been evaluated in several studies which unanimously show considerable benefits not only concerning blood pressure control but, most importantly, regarding reduction in the incidence and progression of hypertension-associated diseases as cerebro- and cardiovascular events and diabetic nephropathy. Therefore, it seems essential to implement the HTTP in the German health care system in order to finally achieve the desired quality of care for patients with arterial hypertension.

Antihypertensive Agents↗
PubMed2000

Non-linear effects of blood pressure and glycosylated haemoglobin on progression of diabetic nephropathy.

OBJECTIVE: To describe the long-term simultaneous impacts of blood pressure and glycosylated haemoglobin values on the risk of progression of diabetic nephropathy. DESIGN: Prospective, multicentre, 6-year follow-up study. SETTING: One reference centre (university department of internal medicine) and nine general hospitals. SUBJECTS: A total of 601 type 1 diabetic patients on intensive insulin therapy with and without diabetic nephropathy. MAIN OUTCOME MEASURES: Progression of nephropathy was defined as change for the worse within five stages of nephropathy by at least one of these stages during the study period. By the use of logistic regression, the relationship between metabolic and blood pressure control and the risk of nephropathy progression was quantified. RESULTS: The main determinants of nephropathy progression were glycosylated haemoglobin and blood pressure, which were both non-linearly associated with the risk of progression. No significant threshold levels for any of the predictors of progression were identified. CONCLUSIONS: The results of this study underline the importance of optimizing metabolic and blood pressure control to arrest the progression of diabetic nephropathy without the evidence for a clinically relevant threshold effect.

Adult↗