OBJECTIVETo compare the incidences of severe hypoglycemia and corresponding clinical circumstances in a German population between 2007–2010 and 1997–2000.RESEARCH DESIGN AND METHODSA screening for severe hypoglycemia was performed in the Lippe-Detmold area in Germany to sensitively detect severe hypoglycemia. This was defined as a symptomatic event requiring treatment with intravenous glucose and being confirmed by a blood glucose measurement of <50 mg/dL.RESULTSSevere hypoglycemia increased considerably from 264 events in 1997–2000 to 495 events in 2007–2010, which translated into an increase in frequency of severe hypoglycemia among all emergency admissions from 0.68 to 0.83% (P = 0.015). This was mostly related to intensification of antihyperglycemic therapy, particularly in the increasingly morbid group of hypoglycemic patients with type 2 diabetes indicated by lower HbA1c, more comedication (3.3 vs. 7.7 drugs), and more concomitant diseases (3.6 vs. 4.4) (all P values <0.001).CONCLUSIONSWithin a 10-year period, there was an intensification of antihyperglycemic therapy in increasingly comorbid subjects, leading to a considerably higher incidence of severe hypoglycemia.
In a multicenter placebo-controlled double-blind randomized clinical study, 91 patients with rheumatoid arthritis were given 28 days' treatment with recombinant interferon-gamma (50 micrograms daily for 20 days, then 50 micrograms each second day up to day 28, given by subcutaneous injection). The aim of the study was to provide a methodologically clear demonstration of the efficacy of treatment with interferon-gamma, using criteria that could be handled by statistical tests. Evaluatable documentation was available for 79 patients, of whom 40 were treated with the active compound. The principal criterion for the statistical evaluation of the therapeutic success was improvement of the Ritchie "joint pain index" or Lansbury "joint pain index" by at least 30% within 28 days. The chi-square test showed superiority of the interferon arm over the placebo arm with an error probability of alpha less than 1%. In addition, efficacy of interferon-gamma was demonstrated in respect of practically all parameters investigated. The frequency of side-effects, including febrile reactions, was the same for the active compound and the placebo. During interferon treatment the daily maximum body temperature was raised by 0.3 degrees C on average, but was below 37.2 degrees C at all times.
BackgroundIn patients with cardiomyopathy of unknown origin, endomyocardial biopsy provides the possibility of improved diagnosis and tailored treatment. Specific guidance has been developed based on cardiovascular centre of excellence experience but it is unknown if the benefits also extend into the tertiary care hospital setting.MethodsEndomyocardial biopsies was performed in patients with cardiomyopathy of unknown origin. The outcomes were mirrored against the current ESC recommendations.ResultsA total of 57 patients with cardiomyopathy of unknown origin underwent endomyocardial biopsy with a mean age of 54 years and 28 % being women. In 17 patients (30 %), viruses were detected in the biopsy material, in 6 patients (11 %) cardiac amyloidosis was found of which 3 had also a positive test for viruses. The overall mortality rate was 18 % in the mean follow up period of 30 months, with a rate of 24 % in those with virus detection (mean FU 24 months) and 15 % in those without virus detection (mean FU 31 months. Death rates were 83 % in patients with cardiac amyloidosis (mean FU 10 months).ConclusionWe conclude that, limited by uncertainty stemming from the small number of included patients, endomyocardial biopsy may not prove to have a clinical impact on treatment decisions and outcomes in a tertiary care hospital setting. We consider cardiac amyloidosis to be an exception, since the mortality rate with or without concomitant virus load was extremely high.
In an open, non-randomized clinical trial conducted at multiple centres, 49 patients with rheumatoid arthritis were treated with recombinant interferon-gamma for 20 days. The study was carried out in two sub-studies. In the first, the total daily dose of interferon-gamma was 50 micrograms; in the second, 100 micrograms. Of the 49 cases, 40 were evaluable for statistical analysis; 24 of these patients (60%) responded to therapy, according to the criteria of a successful outcome laid down in the study protocol, and were classified as responders. In responders, the clinical parameters investigated improved with both dosages. The lower dosage differed from the higher one in having a markedly lower incidence of side-effects. The results lead to the conclusion that a randomized double-blind phase-III clinical trial should be performed.
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