This study evaluated the long-term safety and efficacy of dapagliflozin as an adjunct to adjustable insulin in patients with type 1 diabetes and inadequate glycemic control. RESEARCH DESIGN AND METHODS DEPICT-1 (Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes) was a randomized (1:1:1), double-blind, placebo-controlled phase 3 study of dapagliflozin 5 mg and 10 mg in patients with type 1 diabetes (HbA 1c 7.5-10.5% [58-91 mmol/mol]) (NCT02268214). The results of the 52-week study, consisting of the 24-week short-term and 28-week extension period, are reported here. RESULTS Of the 833 patients randomized into the study, 708 (85%) completed the 52-week study. Over 52 weeks, dapagliflozin 5 mg and 10 mg led to clinically significant reductions in HbA 1c (difference vs. placebo [95% CI] 20.
Aim: To evaluate the metacarpophalangeal (MCP) joints (MCP2 and 5) in healthy subjects by ultrasonography (US) using a high frequency transducer (18 MHz) and to verify the interobserver agreement. Material and methods: We enrolled 50 healthy volunteers (37 women, age between 30-58 years, mean age 41.7 years, divided into 3 groups according to age: 30-39, 40-49, and 50-58 years). The subjects were successively evaluated by 4 rheumatologists: 2 experienced (team A) and 2 beginners (team B) in US. Seven dorsal and palmar longitudinal scanning positions and a supplementary scan for MCP cartilage were performed. The bone surface (erosions, osteophytes), the intra-articular content (synovial thickening and vascularization, 4 grade scale), and the aspect of the metacarpal head cartilage were analyzed. The anterior palmar recess was measured. The time for examination was recorded. Results: Erosions were detected in 7% of joints by team A and 2% by team B (p<0.05, kappa agreement 0.567) in subjects over 40 years. The agreement by team A in the detection of the erosions was very good (kappa value 0.83). A moderate positive correlation was obtained between the presence of erosions and age (r= 0.401, p=0.004). Osteophytes were identified only on the dorsal scan in subjects over 50 years (in 3.5% of joints team A, 1.5% team B, p>0.05, kappa value 0.421). No grade 1 synovitis was observed by team A but 4 joints with grade 1 synovitis were identified by team B (p<0.05) from the dorsal scan. The dimensions of the palmar recess had large distribution (MCP 2 between 0.55-1.3 mm; MCP 5 between 0.6-1.2 mm). No statistical significant differences were obtained when comparing the dimensions of the two hands or the values obtained in agegroups (all p>0.05). No statistical significant correlations were obtained between the dimensions of palmar recess and the body mass index or dominant hand (all p>0.05). No pathological findings were found in the examination of the metacarpal head cartilage. Power Doppler investigation found the presence of grade 1 signal in 2.5% joints by team A and 1.5% by team B (p>0.05) only in the dorsal scans. The mean time for examination was 7.8±1.74 min in team A and 13.78±2.96 min in team B (p<0.05). Conclusions: In healthy subjects pathological findings are occasionally encountered, especially erosions and osteophytes. Using an 18 MHz transducer the aspect of grade 1 synovitis was not encountered in healthy non-inflammatory MCP joints. There is a permanent need for standardized training and examination in musculoskeletal US.
The case of a 61-year-old male with a recent total gastrectomy for a hemorrhagic gastric tumor is presented, with the important co-morbidities of type II diabetes mellitus requiring insulin, chronic hepatitis C with liver dysfunction, stage II essential hypertension, chronic stage III renal disease peripheral type II aorto-iliac disease with stage II ischemia of both legs, and chronic anemia. About one month following the gastrectomy, the patient presented with fever and acute inflammatory syndrome. Severe aortic insufficiency, aortic valvular vegetations, and positive blood cultures with Staphylococcus saprophytic were found. The diagnosis of infectious endocarditis on the aortic valve was established (positive blood cultures with echocardiographic features of vegetations, fever), and antibiotic treatment with Levofloxacin and Vancomycin was initiated. The evolution was favorable with the remission of the inflammatory syndrome and quick cessation of fever. However, the hemodynamic aspect showed progressive heart failure with acute pulmonary edema. The transesophageal echocardiographic examination confirmed the existence of severe aortic insufficiency and valvular vegetations with a left ventricular ejection fraction of 38%. The coronary angiography revealed double vessel disease. The calculated Euroscore II was 33.4%. Aortic valve replacement with porcine xenograft and double coronary artery bypass graft surgery was performed. The patient had a favorable postoperative course remaining afebrile and out of heart failure, with the markers of inflammation largely within normal limits. The left ventricular ejection fraction increased to 50%. The successful outcome of this case, represented by a rare association of cancer, endocarditis, and coronary disease, reveals the importance of the multidisciplinary teams involved in this case: gastroenterology, general surgery, cardiology, infectious diseases, cardiac surgery, and intensive care. Therefore, in such cases with high risk, complex patients, a strong collaboration between all specialties is needed to overcome all of the limitations of the patient’s co-morbidities.
We present the case of a 35-year-old woman who had a high-risk pulmonary embolism (according to ESC risk stratification for pulmonary embolism) after she had undergone a Caesarion section. Postoperatively, she presented with acute left lower limb pain, swelling and erythema. A diagnosis was made of deep vein thrombosis (DVT) of the ilio-femoral and popliteal veins. She was started on anticoagulant therapy, which proved to be inefficient, the patient developing a left calf and thigh oedema and shortness of breath. A CT scan revealed high-risk embolus located in the right atrium and through the tricuspid valve. The decision was made to refer her to a cardiovascular surgeon. During her preoperative evaluation, the patient became hemodynamically unstable and was rushed into the operating room, severely desaturated, bradycardic, without consciousness, with severe hypotension. On the basis of the severe state of the patient and the CT scan findings we performed an emergency pulmonary embolectomy, with the patient on cardio-pulmonary by-pass, without cross-clamping the aorta, using a modified Trendelenburg procedure. This case supports using open pulmonary embolectomy for patients with hemodynamic instability on the basis of clinical diagnosis.
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