BackgroundThe independent prognostic impact of diabetes mellitus (DM) and prediabetes mellitus (pre‐DM) on survival outcomes in patients with chronic heart failure has been investigated in observational registries and randomized, clinical trials, but the results have been often inconclusive or conflicting. We examined the independent prognostic impact of DM and pre‐DM on survival outcomes in the GISSI‐HF (Gruppo Italiano per lo Studio della Sopravvivenza nella Insufficienza Cardiaca‐Heart Failure) trial.Methods and ResultsWe assessed the risk of all‐cause death and the composite of all‐cause death or cardiovascular hospitalization over a median follow‐up period of 3.9 years among the 6935 chronic heart failure participants of the GISSI‐HF trial, who were stratified by presence of DM (n=2852), pre‐DM (n=2013), and non‐DM (n=2070) at baseline. Compared with non‐DM patients, those with DM had remarkably higher incidence rates of all‐cause death (34.5% versus 24.6%) and the composite end point (63.6% versus 54.7%). Conversely, both event rates were similar between non‐DM patients and those with pre‐DM. Cox regression analysis showed that DM, but not pre‐DM, was associated with an increased risk of all‐cause death (adjusted hazard ratio, 1.43; 95% CI, 1.28–1.60) and of the composite end point (adjusted hazard ratio, 1.23; 95% CI, 1.13–1.32), independently of established risk factors. In the DM subgroup, higher hemoglobin A1c was also independently associated with increased risk of both study outcomes (all‐cause death: adjusted hazard ratio, 1.21; 95% CI, 1.02–1.43; and composite end point: adjusted hazard ratio, 1.14; 95% CI, 1.01–1.29, respectively).ConclusionsPresence of DM was independently associated with poor long‐term survival outcomes in patients with chronic heart failure.Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT00336336.

Objetivo: Avaliar eficácia da terapia de ondas de choque focal (f-ESWT) comparada ao placebo para dor e incapacidade em pacientes com osteoartrose de joelho (OA). Métodos: Ensaio clínico randomizado, duplo-cego, placebo controlado, pacientes com OA primária de joelhos realizaram exercícios (alongamentos de isquiotibiais e fortalecimento de quadríceps) e randomizados em f-ESWT ou placebo. Todos os pacientes foram submetidos a 4 sessões semanais de 7.000 pulsos, e no grupo f-ESWT a energia foi de até 0.15mJ/mm2. O desfecho primário foi a escala analógica visual (VAS) para dor em 1 mês. Os desfechos secundários foram WOMAC, TUG, Lequesne e índice de resposta OMERACT-OARSI em 1 e 3 meses; bem como VAS aos 3 meses e eventos adversos (EAs). O teste de Mann-Whitney U e o teste exato Fisher foram utilizados com alfa = 5% e poder = 80% em uma análise de intenção de tratar. Os desfechos contínuos foram relatados como média ± desvio padrão. Resultados: 18 pacientes (9 em cada grupo), idade de 60.6±8.7 com 33.3% homens. Não houve diferença significativa entre grupos em qualquer variável. F-ESWT não foi superior ao placebo em 1 mês: VAS = -2,97 ± 3,18 e -2,68 ± 2,33 cm, respectivamente, p = 0,96. Somente o TUG no 1º mês foi significativo: 9.09 ± 2.30 e 11.01 ± 2.85 seg, p = 0.01. Conclusão: f-ESWT não foi superior ao placebo para osteoartrose de joelhos. Este estudo foi insuficiente para detectar diferenças. Novos estudos devem usar WOMAC A (subescala dor) como desfecho primário e recrutar 92 pacientes.

The correct equivalence ratio of DFZ to MP is 1.875:1, and of DFZ to prednisolone 1.5:1. We found a relative prevalence of bone resorption compared to bone formation in the first 6 months of treatment. The trend of OPG requires further investigation.

2 cases of acute renal failure associated with diclofenac therapy are reported. In the 1st case no other risk factors but diclofenac administration were identified. Renal biopsy showed patchy interstitial infiltration of mononuclear cells and polymorphonuclear leukocytes. In the 2nd case preexisting nephropathy and heart failure were underlying illnesses. In both cases renal function returned to the basal values after stopping the drug.

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Objective: To assess the efficacy of focused extracorporeal shockwave therapy (f-ESWT) when compared to sham for pain and disability in patients with knee osteoarthritis (OA). Methods: Randomized, parallel, double-blind, sham-controlled clinical trial. Patients with primary knee OA were given a set of exercises (hamstring stretching and quadriceps strengthening) and randomized into f-ESWT or sham (sham probe). All patients were submitted to 4 weekly sessions of 7,000 pulses, and in the f-ESWT group energy was up to 0.15mJ/mm2. Primary outcome was visual analog scale (VAS) for pain at 1 month. Secondary outcomes were WOMAC, TUG, Lequesne's index and OMERACT-OARSI responder index at 1 and 3 months; as well as VAS at 3 months and adverse events (AEs). Both patients and outcome assessors were blinded. Mann-Whitney U test and Fisher's exact test were used with alpha=5% and power=80% in an intention-to-treat analysis. Continuous outcomes were reported as mean± standard deviation. Results: 18 patients were included (9 in each group), aging 60.6±8.7, with 33.3% males. There was no significant difference at baseline across groups in any variables. Active f-ESWT was not superior to sham f-ESWT at 1 month: VAS=-2.97±3.18 and-2.68±2.33cm, respectively, p=0.96. TUG at 1 month had significant differences: 9.09±2.30 and 11.01±2.85sec, p=0.01. No serious AEs were observed. Conclusions: Active f-ESWT was not superior to sham f-ESWT for knee OA. This RCT was underpowered to detect differences in this study. New RCTs should use WOMAC A (pain subscale) as primary outcome and recruit at least 92 patients.

We studied P-III-P levels along with several acute phase reactants, Beta-2-microglobulin and autoantibody synthesis in 52 rheumatoid patients. No relationship arose between P-III-P levels and immunological parameters nor with acute phase reactants. We observed a highly significant difference between P-III-P levels in patients with knee and/or hip involvement with respect to those with only polyarthritis of small joints (86.1 +/- 21.5 vs 61.2 +/- 19.1 ng/ml; p less than 0.001). In 24 consecutive patients we also observed a significant correlation (p less than 0.02) between P-III-P levels and AIMS score. We conclude that P-III-P levels are mainly related to the synovial inflammation of major joints and as such P-III-P might represent the biochemical marker of the synovial mass in rheumatoid arthritis.