Klaus Jeitler

Continuous subcutaneous insulin infusion versus multiple daily insulin injections in patients with diabetes mellitus: systematic review and meta-analysis

AimsWe compared the effects of continuous subcutaneous insulin infusion (CSII) with those of multiple daily insulin (MDI) injections on glycaemic control, risk of hypoglycaemic episodes, insulin requirements and adverse events in type 1 and type 2 diabetes mellitus.MethodsThe electronic databases MEDLINE, EMBASE and CENTRAL were systematically searched for randomised controlled trials up to March 2007. A systematic review and meta-analysis were performed.ResultsOverall, 22 studies were included (17 on type 1 diabetes mellitus, two on type 2 diabetes mellitus, three on children). With regard to adults with type 1 diabetes mellitus, our meta-analysis found a between-treatment difference of −0.4% HbA1c (six studies) in favour of CSII therapy. Available median rates of mild or overall hypoglycaemic events were comparable between the different interventions (1.9 [0.9–3.1] [CSII] vs 1.7 [1.1–3.3] [MDI] events per patient per week). Total daily insulin requirements were lower with CSII than with MDI therapy. In patients with type 2 diabetes mellitus, CSII and MDI treatment showed no statistically significant difference for HbA1c. The incidence of mild hypoglycaemic events was comparable between the treatment groups. In adolescents with type 1 diabetes mellitus, glycated haemoglobin and insulin requirements were significantly lower in the CSII groups; no data were available on hypoglycaemic events. The only study performed in younger children did not provide enough data for conclusive inferences. No overall conclusions were possible for severe hypoglycaemia and adverse events for any of the different patient groups due to rareness of such events, different definitions and insufficient reporting.Conclusions/interpretationCSII therapy in adults and adolescents with type 1 diabetes mellitus resulted in a greater reduction of glycated haemoglobin, in adult patients without a higher rate of hypoglycaemia. No beneficial effect of CSII therapy could be detected for patients with type 2 diabetes mellitus.

Effects of treatment in women with gestational diabetes mellitus: systematic review and meta-analysis

Objective To summarise the benefits and harms of treatments for women with gestational diabetes mellitus. Design Systematic review and meta-analysis of randomised controlled trials. Data sources Embase, Medline, AMED, BIOSIS, CCMed, CDMS, CDSR, CENTRAL, CINAHL, DARE, HTA, NHS EED, Heclinet, SciSearch, several publishers’ databases, and reference lists of relevant secondary literature up to October 2009. Review methods Included studies were randomised controlled trials of specific treatment for gestational diabetes compared with usual care or “intensified” compared with “less intensified” specific treatment. Results Five randomised controlled trials matched the inclusion criteria for specific versus usual treatment. All studies used a two step approach with a 50 g glucose challenge test or screening for risk factors, or both, and a subsequent 75 g or 100 g oral glucose tolerance test. Meta-analyses did not show significant differences for most single end points judged to be of direct clinical importance. In women specifically treated for gestational diabetes, shoulder dystocia was significantly less common (odds ratio 0.40, 95% confidence interval 0.21 to 0.75), and one randomised controlled trial reported a significant reduction of pre-eclampsia (2.5 v 5.5%, P=0.02). For the surrogate end point of large for gestational age infants, the odds ratio was 0.48 (0.38 to 0.62). In the 13 randomised controlled trials of different intensities of specific treatments, meta-analysis showed a significant reduction of shoulder dystocia in women with more intensive treatment (0.31, 0.14 to 0.70). Conclusions Treatment for gestational diabetes, consisting of treatment to lower blood glucose concentration alone or with special obstetric care, seems to lower the risk for some perinatal complications. Decisions regarding treatment should take into account that the evidence of benefit is derived from trials for which women were selected with a two step strategy (glucose challenge test/screening for risk factors and oral glucose tolerance test).

Long-term Effects of Weight-Reducing Interventions in Hypertensive Patients Systematic Review and Meta-analysis

Weight loss is recommended in all major guidelines for antihypertensive therapy. We searched for randomized controlled trials investigating the effects of weight-reducing diets, pharmacologic substances, and invasive interventions for weight reduction on patient-relevant end points and blood pressure (BP) in patients with essential hypertension. No information on the effects on patient-relevant end points was available. Patients assigned to weight loss diets, orlistat, or sibutramine reduced their body weight more effectively than did patients in the usual care/placebo groups. Reduction of BP was higher in patients treated with weight loss diets (systolic BP [SBP]: weighted mean difference [WMD], -6.3 mm Hg; diastolic BP [DBP]: WMD, -3.4 mm Hg) or orlistat (SBP: WMD, -2.5 mm Hg; DBP: WMD, -2.0 mm Hg). Systolic BP increased with sibutramine treatment (WMD, 3.2 mm Hg). In patients with essential hypertension, therapy with a weight loss diet or orlistat resulted in reductions in body weight and BP. Although sibutramine treatment reduced body weight, it did not lower BP.

Benefit assessment of salt reduction in patients with hypertension: systematic overview.

Objective We assessed the benefits and harm of reduced salt intake in patients with essential hypertension focusing on patient-relevant outcomes and blood pressure. Methods A systematic search of five electronic databases was performed to identify high-quality secondary literature based on randomized controlled trials (RCTs). An update primary literature search (RCTs) was performed for the time period up to 2010 that was not covered by secondary literature. Major outcomes were death, cardiovascular morbidity/mortality, hospital stays, terminal renal failure, quality of life, and adverse events. Change in blood pressure was defined as surrogate parameter. Results Four different systematic reviews and two RCTs met the inclusion criteria. Only one review reported limited data on patient-relevant outcomes. Over an intervention period of up to 12 months, mean SBP was reduced by 3.6–8.0 mmHg in all reviews. For the same intervention period, a statistically significant advantage with regard to mean DBP reduction ranging from 1.9 to 2.8 mmHg was found in three reviews. The fourth publication reported a nonsignificant reduction (DBP reduction of 4.7 mmHg). None of the RCTs identified in the primary literature search update reported data on patient-relevant outcomes. However, both RCTs found blood pressure improvements with salt reduction. Conclusion A benefit from a salt-reduced diet in patients with high blood pressure is not proven with regard to patient-relevant outcomes based on systematic reviews and RCTs published up to 2010. The results indicate a blood pressure-lowering effect through reduced salt intake in hypertensive patients.

Clinical effectiveness of stress-reduction techniques in patients with hypertension: systematic review and meta-analysis.

Objective: A systematic review and meta-analysis focusing on patient-relevant outcomes and blood pressure was conducted to assess the clinical effectiveness of stress-reduction techniques in adults with essential hypertension. Methods: Systematic reviews and randomized controlled trials (RCTs) were identified as part of a systematic search in six electronic databases ending September 2012. RCTs comparing stress-reduction techniques versus no such techniques with a follow-up of at least 24 weeks and published in English or German were included. Outcomes of interest were death, cardiovascular morbidity/mortality, end-stage renal disease, health-related quality of life, adverse events, changes in blood pressure, and changes in antihypertensive medication. When appropriate, meta-analyses were used to combine data. Results: Seventeen RCTs analyzing different stress-reduction techniques such as biofeedback, relaxation or combined interventions were identified. Data were not reported for most of the patient-relevant outcomes, and meta-analyses could only be used to evaluate effects on blood pressure. The data indicated a blood pressure-lowering effect, but the studies had methodological shortcomings and heterogeneity between them was high. Mean group differences for DBP ranged from −10 to 1 mmHg and for SBP from −12 to 10 mmHg. In terms of antihypertensive medication, no favorable effects of stress-reduction techniques could be identified. Conclusions: The available RCTs on stress-reduction techniques used for at least 24 weeks appeared to indicate a blood pressure-lowering effect in patients with essential hypertension, but this should be interpreted with caution because of major methodological limitations. A benefit of specific stress-reduction techniques in hypertensive patients remains unproven.

Choosing Wisely: assessment of current US top five list recommendations’ trustworthiness using a pragmatic approach

Objectives Identification of sufficiently trustworthy top 5 list recommendations from the US Choosing Wisely campaign. Setting Not applicable. Participants All top 5 list recommendations available from the American Board of Internal Medicine Foundation website. Main outcome measures/interventions Compilation of US top 5 lists and search for current German highly trustworthy (S3) guidelines. Extraction of guideline recommendations, including grade of recommendation (GoR), for suggestions comparable to top 5 list recommendations. For recommendations without guideline equivalents, the methodological quality of the top 5 list development process was assessed using criteria similar to that used to judge guidelines, and relevant meta-literature was identified in cited references. Judgement of sufficient trustworthiness of top 5 list recommendations was based either on an ‘A’ GoR of guideline equivalents or on high methodological quality and citation of relevant meta-literature. Results 412 top 5 list recommendations were identified. For 75 (18%), equivalents were found in current German S3 guidelines. 44 of these recommendations were associated with an ‘A’ GoR, or a strong recommendation based on strong evidence, and 26 had a ‘B’ or a ‘C’ GoR. No GoR was provided for 5 recommendations. 337 recommendations had no equivalent in the German S3 guidelines. The methodological quality of the development process was high and relevant meta-literature was cited for 87 top 5 list recommendations. For a further 36, either the methodological quality was high without any meta-literature citations or meta-literature citations existed but the methodological quality was lacking. For the remaining 214 recommendations, either the methodological quality was lacking and no literature was cited or the methodological quality was generally unsatisfactory. Conclusions 131 of current US top 5 list recommendations were found to be sufficiently trustworthy. For a substantial number of current US top 5 list recommendations, their trustworthiness remains unclear. Methodological requirements for developing top 5 lists are recommended.

[Health status of type 2 diabetics in Austria - perspective of a quality improvement initiative].

SummaryOBJECTIVE: To determine the prevalence of late complications in a large clinical sample of type 2 diabetic patients in Austria. METHODS: Data of all patients with type 2 diabetes entered into the database of the Forum for Quality Systems in Diabetes Care Austria (FQSD-A) between 1 January 1997 and 1 September 2007 were used for the analyses. RESULTS: Data from 23,641 persons with Type 2 Diabetes Mellitus were collected. Patients were 66.3 ± 11.5 years old, with an average diabetes duration of 8.0 ± 8.5 years. Prevalence of blindness, amputation, myocardial infarction or bypass, stroke and end stage renal failure was 0.9%, 2.3%, 12.2%, 8.7% and 0.8%, respectively. CONCLUSIONS: Prevalence of late diabetic complications in Austria is high compared with other European countries. The management of persons with Type 2 Diabetes should be further optimized to reduce the incidence of late complications of diabetes.ZusammenfassungZIELSETZUNG: Ziel dieser Arbeit ist es, die Prävalenz von diabetischen Spätkomplikationen unter österreichischen Patienten mit Diabetes Mellitus Typ 2 anhand von im Rahmen einer Qualitätssicherungs-Initiative gewonnenen Daten zu bestimmen. METHODIK: Analyse der Daten aller Personen mit diagnostiziertem Diabetes Mellitus Typ 2, die in der Datenbank des Forums für Qualitätssicherung in der Diabetologie Österreich (FQSD-Ö) zwischen 1.1.1997 und 1.9.2007 dokumentiert wurden. ERGEBNISSE: Insgesamt wurden 23.641 Patienten mit Typ-2-Diabetes dokumentiert. Die Patienten waren im Schnitt 66,3 ± 11,5 Jahre alt, mit einer Diabetesdauer von 8,0 ± 8,5 Jahren. Von Blindheit waren 0,9 %, von einer Amputation 2,3 %, von Herzinfarkt oder Bypass 12,2 %, von Schlaganfall 8,7 % und von Nierenversagen 0,8 % der Patienten betroffen. SCHLUSSFOLGERUNGEN: Die Prävalenz der diabetischen Spätkomplikationen in der ausgewerteten österreichischen Population ist hoch, jedoch vergleichbar mit anderen europäischen Ländern. Die Behandlung von Patienten mit Diabetes in Österreich muss weiterhin optimiert werden, um das Auftreten von Spätschäden zu vermindern.OBJECTIVE To determine the prevalence of late complications in a large clinical sample of type 2 diabetic patients in Austria. METHODS Data of all patients with type 2 diabetes entered into the database of the Forum for Quality Systems in Diabetes Care Austria (FQSD-A) between 1 January 1997 and 1 September 2007 were used for the analyses. RESULTS Data from 23,641 persons with Type 2 Diabetes Mellitus were collected. Patients were 66.3 +/- 11.5 years old, with an average diabetes duration of 8.0 +/- 8.5 years. Prevalence of blindness, amputation, myocardial infarction or bypass, stroke and end stage renal failure was 0.9%, 2.3%, 12.2%, 8.7% and 0.8%, respectively. CONCLUSIONS Prevalence of late diabetic complications in Austria is high compared with other European countries. The management of persons with Type 2 Diabetes should be further optimized to reduce the incidence of late complications of diabetes.

Self-management of Oral Anticoagulation

BACKGROUND Properly dosed oral anticoagulation effectively prevents thromboembolic events. It is unclear whether adult patients with an indication for long-term oral anticoagulation can benefit from self-management in terms of patient-oriented endpoints and improved coagulation values. METHOD We selectively searched the Medline database for high-quality systematic reviews based on randomized controlled trials of self-measurement or self-management of oral anticoagulation, compared to standard treatment. RESULTS We identified eight review articles based on overlapping sets of ran - domized clinical trials. In all of these systematic reviews, patients who performed self-measurement or self-management had a 40% to 50% lower rate of thromboembolic events; in six of them, the mortality was also significantly lower, by 30% to 50%. Subgroup analysis revealed that these effects were present exclusively in patients who performed self-management, and not in those who only performed self-measurement. None of the review articles revealed any difference in the frequency of severe hemorrhagic events. Quality of life and patient satisfaction were rated in five reviews, which, however, used different instruments, with the result that no clear conclusions could be drawn. All of the review articles documented an improvement in coagulation values, but information on statistical significance was mostly lacking. CONCLUSION Adults with an indication for long-term oral anticoagulation benefit from self-management, as compared to standard treatment with management of dosing by a physician. A limitation of this study is that the multiple review articles on which it is based were largely analyses of the same group of clinical trials.

β-Blockers for hypertension

Nadia Khan and Finlay McAlister[1][1] defined the primary outcome for their meta-analysis as the composite cardiovascular outcome of death, nonfatal myocardial infaraction or nonfatal stroke. Unfortunately, this definition is unclear; as a result, for some studies only cardiovascular deaths and for

Diuretics and diabetes incidence—an appeal against the reluctance to prescribe a medication that is safe and proven

Diabet. Med. 27, 130–135 (2010)