BACKGROUND Guidelines recommend nonstatin lipid-lowering agents in patients at very high risk for major adverse cardiovascular events (MACE) if low-density lipoprotein cholesterol (LDL-C) remains ≥70 mg/dL on maximum tolerated statin treatment. It is uncertain if this approach benefits patients with LDL-C near 70 mg/dL. Lipoprotein(a) levels may influence residual risk. OBJECTIVES In a post hoc analysis of the ODYSSEY Outcomes (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) trial, the authors evaluated the benefit of adding the proprotein subtilisin/kexin type 9 inhibitor alirocumab to optimized statin treatment in patients with LDL-C levels near 70 mg/dL. Effects were evaluated according to concurrent lipoprotein(a) levels. METHODS ODYSSEY Outcomes compared alirocumab with placebo in 18,924 patients with recent acute coronary syndromes receiving optimized statin treatment. In 4,351 patients (23.0%), screening or randomization LDL-C was <70 mg/dL (median 69.4 mg/dL; interquartile range: 64.3–74.0 mg/dL); in 14,573 patients (77.0%), both determinations were ≥70 mg/dL (median 94.0 mg/dL; interquartile range: 83.2–111.0 mg/dL). RESULTS In the lower LDL-C subgroup, MACE rates were 4.2 and 3.1 per 100 patient-years among placebo-treated patients with baseline lipoprotein(a) greater than or less than or equal to the median (13.7 mg/dL). Corresponding adjusted treatment hazard ratios were 0.68 (95% confidence interval [Cl]: 0.52–0.90) and 1.11 (95% Cl: 0.83–1.49), with treatment-lipoprotein(a) interaction on MACE ( P interaction = 0.017). In the higher LDL-C subgroup, MACE rates were 4.7 and 3.8 per 100 patient-years among placebo-treated patients with lipoprotein(a) >13.7 mg/dL or ≤13.7 mg/dL; corresponding adjusted treatment hazard ratios were 0.82 (95% Cl: 0.72–0.92) and 0.89 (95% Cl: 0.75–1.06), with P interaction = 0.43. CONCLUSIONS In patients with recent acute coronary syndromes and LDL-C near 70 mg/dL on optimized statin therapy, proprotein subtilisin/kexin type 9 inhibition provides incremental clinical benefit only when lipoprotein(a) concentration is at least mildly elevated. (ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab; NCT01663402 )
SUMMARY Postpericardiotomy syndrome (PPS) is worsening or new formation of pericardial and/or pleural effusion mostly 1 to 6 weeks after cardiac surgery, as a result of autoimmune inflammatory reaction within pleural and pericardial space. Its incidence varies among different studies and registries (2% to 30%), as well as according to the type of cardiac surgery performed. We conducted this retrospective analysis of PPS incidence and diagnostic and treatment strategies in patients referred for cardiac surgery for revascularization, valvular and/or aortic surgery. We retrospectively analyzed 461 patients referred for an urgent or elective cardiac surgery procedure between 2009 and 2015. PPS diagnosis was established using well defined clinical criteria. Demographic and clinical characteristics were used in regression subanalysis among patients having undergone surgery of aortic valve and/or ascending aorta. Within 6 weeks after cardiac surgery, 47 (10.2%) patients had PPS. The median time from the procedure to PPS diagnosis was 14 days. The incidence of PPS was 26% after aortic valve and/or aorta surgery, and 7.9% and 8.3% after coronary bypass and mitral valve surgery, respectively. Among patients subjected to aortic valve and/or aortic surgery, regression analysis showed significant association of fever, C-reactive protein (CRP) elevation between 5 and 100 mg/L, urgent procedure and postoperative antibiotic use with PPS diagnosis, whereas younger age showed near-significant association. All patients had complete resolution of PPS, mostly after corticosteroid therapy, with only 2 cases of recurrent PPS that successfully resolved after colchicine therapy. Pleural drainage was indicated in 15 (32%) patients, whereas only one patient required pericardial drainage. In conclusion, PPS incidence in our retrospective analysis was similar to previous reports. Patients having undergone aortic valve and/or aortic surgery were most likely to develop PPS. The most relevant clinical criteria for diagnosis in these patients were fever, CRP elevation between 5 and 100 mg/L, and pericardial and/or pleural effusion formation or worsening 2 weeks after cardiac surgery.
BACKGROUND AND OBJECTIVESStudies of bone mineral density (BMD) in women with type 2 diabetes mellitus have shown conflicting results. We conducted this study to determine whether postmenopausal women with diabetes have higher BMD than non-diabetic women of similar age, and to investigate the relationship between BMD and relevant clinical characteristics in these groups of women.PATIENTS AND METHODSWe retrospectively analyzed lumbar spine, femoral neck, and radius BMD data and other relevant clinical data for 130 postmenopausal women with type 2 diabetes mellitus and 166 non-diabetic women collected during a voluntary screening for osteoporosis in postmenopausal women without a history of low bone mass or osteoporotic fractures.RESULTSWomen with type 2 diabetes mellitus had significantly higher mean lumbar spine BMD ( 0.903±0.165 vs. 0.824±0.199, respectively, P<.001) and mean femoral neck BMD (0.870±0.132 vs. 0.832±0.134, respectively, P<.05) than non-diabetic women. In both groups of women, age correlated negatively with BMD levels at all three anatomical sites. Higher body mass index was associated only with higher lumbar spine BMD in both groups. Alkaline phosphatase levels showed a negative correlation with BMD at all sites in women with type 2 diabetes mellitus.CONCLUSIONPostmenopausal women with type 2 diabetes mellitus have higher BMD levels than non-diabetic women with similar clinical characteristics, and require a more scrutinized approach in managing low bone mass.
BACKGROUND AND OBJECTIVESStudies of bone mineral density (BMD) in women with type 2 diabetes mellitus have shown conflicting results. We conducted this study to determine whether postmenopausal women with diabetes have higher BMD than non-diabetic women of similar age, and to investigate the relationship between BMD and relevant clinical characteristics in these groups of women.PATIENTS AND METHODSWe retrospectively analyzed lumbar spine, femoral neck, and radius BMD data and other relevant clinical data for 130 postmenopausal women with type 2 diabetes mellitus and 166 non-diabetic women collected during a voluntary screening for osteoporosis in postmenopausal women without a history of low bone mass or osteoporotic fractures.RESULTSWomen with type 2 diabetes mellitus had significantly higher mean lumbar spine BMD ( 0.903±0.165 vs. 0.824±0.199, respectively, P<.001) and mean femoral neck BMD (0.870±0.132 vs. 0.832±0.134, respectively, P<.05) than non-diabetic women. In both groups of women, age correlated negatively with BMD levels at all three anatomical sites. Higher body mass index was associated only with higher lumbar spine BMD in both groups. Alkaline phosphatase levels showed a negative correlation with BMD at all sites in women with type 2 diabetes mellitus.CONCLUSIONPostmenopausal women with type 2 diabetes mellitus have higher BMD levels than non-diabetic women with similar clinical characteristics, and require a more scrutinized approach in managing low bone mass.
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