A Randomized Trial of Colchicine for Acute Pericarditis Imazio, Massimo; Brucato, Antonio; Cemin, Roberto ...
New England journal of medicine/The New England journal of medicine,
10/2013, Volume:
369, Issue:
16
Journal Article
Peer reviewed
Open access
In a randomized trial, patients with acute pericarditis were assigned to either colchicine or placebo in addition to conventional antiinflammatory therapy. Colchicine significantly reduced the ...incidence of incessant or recurrent pericarditis.
Colchicine has been used for centuries to treat and prevent gouty attacks
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and more recently has been recommended to treat and prevent serositis in patients with familial Mediterranean fever and recurrent pericarditis.
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,
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Preliminary data from nonrandomized trials have also supported the use of colchicine for the treatment and prevention of acute pericarditis.
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In a single-center, open-label, randomized trial, called the Colchicine for Acute Pericarditis (COPE) study, the addition of colchicine to conventional therapy with either aspirin or glucocorticoids halved the recurrence rate after an initial attack of acute pericarditis.
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Our study, called the Investigation on Colchicine for Acute Pericarditis . . .
Summary Background Colchicine is effective for the treatment of acute pericarditis and first recurrences. However, conclusive data are lacking for the efficacy and safety of colchicine for treatment ...of multiple recurrences of pericarditis. Methods We did this multicentre, double-blind trial at four general hospitals in northern Italy. Adult patients with multiple recurrences of pericarditis (≥two) were randomly assigned (1:1) to placebo or colchicine (0·5 mg twice daily for 6 months for patients weighing more than 70 kg or 0·5 mg once daily for patients weighing 70 kg or less) in addition to conventional anti-inflammatory treatment with aspirin, ibuprofen, or indometacin. Permuted block randomisation (size four) was done with a central computer-based automated sequence. Patients and all investigators were masked to treatment allocation. The primary outcome was recurrent pericarditis in the intention-to-treat population. This trial is registered with ClinicalTrials.gov , number NCT00235079. Findings 240 patients were enrolled and 120 were assigned to each group. The proportion of patients who had recurrent pericarditis was 26 (21·6%) of 120 in the colchicine group and 51 (42·5%) of 120 in the placebo group (relative risk 0·49; 95% CI 0·24–0·65; p=0·0009; number needed to treat 5). Adverse effects and discontinuation of study drug occurred in much the same proportions in each group. The most common adverse events were gastrointestinal intolerance (nine patients in the colchicine group vs nine in the placebo group) and hepatotoxicity (three vs one). No serious adverse events were reported. Interpretation Colchicine added to conventional anti-inflammatory treatment significantly reduced the rate of subsequent recurrences of pericarditis in patients with multiple recurrences. Taken together with results from other randomised controlled trials, these findings suggest that colchicine should be probably regarded as a first-line treatment for either acute or recurrent pericarditis in the absence of contraindications or specific indications. Funding Azienda Sanitaria 3 of Torino (now ASLTO2).
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Contemporary series of postpericardiotomy syndrome (PPS) are lacking. The aim of this study was to evaluate the incidence, time course, features at presentation, risk factors, and prognosis of PPS. ...The study population consisted of 360 consecutive candidates to cardiac surgery enrolled in a prospective cohort study. PPS was diagnosed in 54 patients (15.0%; mean age 66 ± 12 years, 48.1% women): 79.6% in the first month, 13.0% in the second month, and 7.4% in the third month. Specific symptoms, signs, or features were pleuritic chest pain (55.6%), fever (53.7%), elevated markers of inflammation (74.1%), pericardial effusion (88.9%), and pleural effusion (92.6%). Cardiac tamponade was rare at presentation (1.9%). Female gender (hazard ratio 2.32, 95% confidence interval 1.22 to 4.39, p = 0.010), and pleura incision (hazard ratio 4.31, 95% confidence interval 2.22 to 8.33, p <0.001) were identified as risk factors in multivariate analysis. Patients with PPS had longer cardiac surgery stays (11.5 ± 4.6 vs 9.9 ± 4.7 days, p = 0.021) and rehabilitation stays (16.4 ± 6.7 vs 12.4 ± 6.2 days, p <0.001) and more readmissions (13.0% vs 0%, p <0.001). Adverse events after a mean follow-up period of 19.8 months were recurrences (3.7%), cardiac tamponade (<2%), but no cases of constriction. In conclusion, despite advances in cardiac surgery techniques, PPS is a common postoperative complication, generally occurring in the first 3 months after surgery. Severe complications are rare, but the syndrome is responsible for hospital stay prolongation and readmissions. Female gender and pleura incision are risk factors for PPS.
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low-density lipoprotein cholesterol (LDL-C) is a strong cardiovascular risk factor, but the methods used to correctly determine it are is still questioned. The aim of this study was to compare the ...direct determination of LDL-C levels, obtained with the Roche cobas c system, with LDL-C values calculated through Sampson's and Friedewald's equations in very high-risk patients with triglycerides concentrations of less than 2.25 mmol/L (<200 mg/dL).
in 127 consecutive patients with a recent diagnosis of acute coronary syndrome and triglycerides of less than 2.25 mmol/L, plasma LDL-C was measured directly and calculated with Sampson's and Friedewald's equations before hospital discharge, and the data were compared.
median LDL values obtained with the Friedenwald and Sampson equations and with direct determination were 2.31 (IQR 1.59-3.21), 2.36 (IQR 1.66-3.26) and 2.64 (IQR 1.97-3.65) mmol/L, respectively. Direct measurements were higher by 0.35 and 0.40 mmol/L when compared to the levels calculated with Sampson's or Friedewald's equations, respectively (
< 0.01). The correlation between the two equations was almost perfect (rho 0.997) but decreased when the directly determined data were compared to those calculated with Sampson's equation (rho 0.954) or Friedewald's method (rho 0.939).
direct determination generated higher values of LDL-C concentration through a probable systematic overestimation.
Phase III trials should be integrated by post authorisation safety studies (PASS) to confirm their conclusions in real life. In this setting, comorbidities are commonly more prevalent, decisions ...about drugs and regimens are left to the attending physicians and therapy monitoring is not usually as strict as in pivotal trials.
To evaluate real life safety and effectiveness of edoxaban and rivaroxaban, ETNA-AF Europe (ETNA-AF-Eu) and XANTUS studies were reviewed and compared. A further comparison between data collected in these studies and in the pivotal studies ENGAGE AF-TIMI 48 and ROCKET-AF was also performed.
ETNA-AF-Eu and XANTUS showed lower bleeding, stroke, cardiovascular- and all-cause mortality rates as compared to those observed in Phase 3 trials, even when including subgroups with lower comorbidities. Patients in ETNA-AF-Eu were older, with a larger proportion of octogenarians (≥85 years in 10.5%) and patients with impaired renal function as compared to patients in XANTUS (CrCl <50 ml/min in 18.2% vs 12.2%) and in ENGAGE AF-TIMI 48 and ROCKET-AF, without paying any excess tribute in terms of safety. Therapy persistence was very high in the two real life studies (91.9% in ETNA-AF-Eu and 79.9% in XANTUS), thus showing that edoxaban and rivaroxaban are well tolerated in real life.
The ETNA-AF-Eu and XANTUS confirmed the safety and effectiveness of edoxaban and rivaroxaban in real life.
•PASS should integrate Phase III trials to confirm their conclusions in real life.•PASS showed better outcomes compared to Phase III trials.•PASS, especially ETNA-AF, included older patients, with more impaired renal function.•PASS did not pay any excess tribute in terms of safety.•PASS had a very high therapy persistence (91.9% in ETNA-AF-Eu and 79.9% in XANTUS).
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Despite the proven superiority of the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) over the Cockcroft–Gault (CG) formula, current guidelines recommend the latter to assess renal ...function in patients treated with non-vitamin K antagonist oral anticoagulants (NOACs). To assess the relationship between the CG and the recommended CKD-EPI formulas, in a cohort of atrial fibrillation (AF) patients treated with NOACs, and the misclassifications introduced by the CG formula for renal function levels, we estimated renal function with three equations: CG, CKD-EPI with body surface adjustment (1.73 mL/m2, CKD-EPI) and without such adjustment (CKD-EPI_noBSA), in all consecutive AF patients discharged from NOACs from the Cardiology Division of a main city hospital between February 1st and May 31st 2018. We compared the different estimates of glomerular filtration rate and potential renal function class misclassifications. We reclassified 37/115 patients (32.1%) when switching from the CG to the CKD-EPI; and 24/115 (20.8%) switching from the CG to the CKD-EPI_noBSA formulas. Class reallocation was distributed across all levels of renal function, but mostly affected the “hyper-normal” function. In estimating consequences of such reallocation, a change in NOAC dosages would have occurred in 10/115 patients (8.7%) when switching from the CG to the CKD-EPI formula and in 10/115 patients when switching from the CG to the CKD-EPI_noBSA formula. Although the CG method has been traditionally used to calculate renal function in all NOAC studies, a renal dysfunction class reallocation occurs in a substantial fraction of hospital-admitted AF patients with the use of better estimates of renal function.
Sacubitril/valsartan (SV) has been demonstrated to reduce cardiovascular mortality, hospitalization for heart failure and to induce reverse ventricular remodeling. The present study was designed to ...confirm the effects of SV in a selected population of patients with HFrEF and to evaluate the different responses between patients with an ischemic or a non-ischemic etiology. A total of 79 patients with indication of SV were recruited prospectively during a timelapse of 4 years. SV was overall associated to a reduction of end-diastolic and end-systolic volume, of NT-proBNP levels, furosemide dosage and NYHA functional class, together with an increase in EF. These changes were more evident in patients with non-ischemic dilated cardiomyopathy, who showed a significant improvement in ventricular volumes, ejection fraction, TAPSE and blood levels of NT-proBNP. Kaplan-Meier curves confirmed a greater benefit in terms of ejection-fraction improvement in non-ischemic patients compared to the ischemic group. The results of the present study confirm the positive effect of SV on NYHA functional class, NT- proBNP, left ventricular volumes and EF in HFrEF patients, showing evidence of association of SV with ventricular remodeling in patients with dilated cardiomyopathy of non-ischemic etiology compared to the ischemic group.
Background: The aim of this study is to analyse the relation between red blood cells, platelets morphology and acute myocardial infarction (AMI), and to assess whether they could supplement the role ...of traditional cardiac biomarkers in the early identification of patients with AMI. Methods: All consecutive patients admitted to our emergency department between the 1st January and the 31st August 2009 due to chest pain of suspected cardiac origin were included in the study. All the patients underwent physical examination, a 12-lead ECG, blood sampling for determination of cardiac troponin I and a complete blood count. Results: A percentage of 6.7% of the 1971 patients had a confirmed diagnosis of AMI. Mean corpuscular volume (MCV), red blood cells distribution width (RDW) and platelets count (Plt) did not differ between patients with and without AMI. However, the mean platelet volume (MPV) was significantly higher in AMI patients (7.9 vs. 7.7 fL; p=0.0457). After stratification for gender, men with AMI displayed a lower RDW (p=0.0464) and a higher MPV (p=0.0062) as compared with those without AMI. The MCV and Plt were not significantly different. Women with AMI had a higher RDW (p=0.0079) as compared with those without AMI, while the MCV, Plt and MPV were not significantly different. Conclusions: Our study partially confirms previous data on the association between MPV or RDW and AMI. The inclusion of these parameters along with other conventional cardiac biomarkers might be a valuable perspective when evaluating patients with suspected AMI, although gender differences should be taken in account.
The natural history of postpericardiotomy syndrome (PPS), a relatively common complication of cardiac surgery, varies from mild self-limited episodes to cases with protracted courses, recurrences, ...and readmissions. Preventive strategies may be valuable to decrease morbidity and management costs. We thus aimed to conduct a comprehensive systematic review on available data for pharmacologic primary prevention of PPS. Controlled clinical studies were searched in several databases and were included provided they focused on pharmacologic primary prevention of PPS. Random-effect odds ratios (ORs) were computed for occurrence of PPS. From the initial sample of 343 citations, 4 controlled clinical trials for primary prevention of PPS were finally included (894 patients); 3 studies were double-blind randomized controlled trials (RCTs). Treatment comparisons were colchicine versus placebo (2 RCTs enrolling 471 patients), methylprednisolone versus placebo (1 RCT on 246 pediatric patients), and aspirin versus historical controls (1 nonrandomized study on 177 pediatric patients). Meta-analytic pooling showed that colchicine was associated with decreased risk of PPS (OR 0.38, 0.22 to 0.65). Data on methylprednisolone (OR 1.13, 0.57 to 2.25) or aspirin (OR 1.00, 0.16 to 6.11) were negative but inconclusive because these were based on 1 study and/or a nonrandomized design. In conclusion, clinical evidence for primary prevention of PPS is still limited to few studies of variable quality. Nevertheless, available data suggest a beneficial profile for colchicine and open a new therapeutic strategy for prevention of PPS.
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