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The Hellenic Cardiovascular Research Society, aiming to cooperate with specialists - especially young and talented doctors from the field of cardiovascular medicine and, more widely, from the field of Medicine - would like to evaluate relevant curricula vitae .

Those interested in such cooperation should send their CVs to info@cardioresearch.net until September 30th, 2014.

The candidates chosen will be invited for a personal interview.

Contact person: Maria Grammatikou,
Clinical Operations Manager
Phone number 210 6723827

July 28, 2014

Simple Pulse Measure Can Detect AF After Stroke  Simple measurement of the peripheral pulse (MPP) at the radial artery is an effective screening tool for diagnosis of atrial fibrillation (AF) in patients who have had a stroke, a new pilot study published online in Neurology Journal suggests.The study, found that health professionals, relatives, and even patients can be trained to distinguish abnormal rhythms just by measuring the pulse. For the current study, 256 patients who had sustained a recent acute ischemic stroke and their relatives were instructed on how to detect an abnormal radial pulse. Three different modalities of pulse measurement were investigated: (1) measurement by a health care professional with positive experience on cardiovascular assessment of patients, (2) measurement by a relative of the patient after successful completion of the tutorial, and (3) self-measurement by the patient after successful completion of the tutorial. All these were performed as single measurements for at least 30 seconds, with examiners blinded to the current heart rate and rhythm. There was no upper time limit for MPP. Measurements were conducted during the daytime. Patients also underwent simultaneous blinded ECG, and the results of the pulse measurements and ECG observations were compared. Results showed that 90% of the patients were able to measure their own pulse reliably. Diagnostic sensitivity was highest for pulse measurements when taken by a healthcare professional, followed by relatives. But even patients managed a diagnostic sensitivity of 54%, and the researchers point out that this was derived from a single measurement and may increase by repeated testing. Specificity was high for pulse measurement by all groups.

False-positive results were limited to 6 cases (2.7%), with a positive predictive value of 76.9% and a negative predictive value of 90.0%.

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Major infections worsened mortality rates in patients undergoing cardiac surgery  Major infections substantially increased mortality after cardiac surgery, according to a new study published in the last issue of JACC. Researchers prospectively examined the frequency of postoperative infections and associated mortality, and they identified practices that were predictive of infections within 65 days of cardiac surgery. The study enrolled 5,158 patients who underwent any type of cardiac surgery at one of 10 Cardiothoracic Surgical Trials Network sites from February 2010 to October 2010. The primary endpoint was onset of one of 10 major infections within 65 days of index cardiac surgery. The infections included: deep incisional surgery site infection at the primary incision or a secondary incision site, mediastinitis, infectious myocarditis or pericarditis, endocarditis, cardiac device infection, pneumonia, empyema, C. difficile colitis and bloodstream infection.

Nearly 5% of patients experienced major infections. The following baseline characteristics were linked to higher risk for infection: chronic lung disease (HR=1.66; 95% CI, 1.21-2.26), HF (HR=1.47; 95% CI, 1.11-1.95) and longer surgery (HR=1.31; 95% CI, 1.21-1.41). Prophylaxis with second-generation cephalosporins reduced the risk for infection (HR=0.7; 95% CI, 0.52-0.94) and high levels of hemoglobin were protective against infection (HR=0.9; 95% CI, 0.84-0.97). According to the researchers, practices and conditions associated with increased infection risk included:

  • Postoperative antibiotic duration of more than 48 hours (HR=1.92; 95% CI, 1.28-2.88). By contrast, compared with antibiotic duration of 24 to 48 hours, duration of less than 24 hours was not associated with increased infection risk (HR=1; 95% CI, 0.72-1.38)
  • Stress hyperglycemia (HR=1.32; 95% CI, 1.01-1.73)
  • Intubation time of between 24 and 48 hours (HR=1.49; 95% CI, 1.04-2.14)
  • Ventilation time of more than 48 hours (HR=2.45; 95% CI, 1.66-3.63)

Blood transfusion during surgery conferred an elevated risk for infection after all surgery types, except procedures involving left ventricular assist devices (HR=1.13; 95% CI, 1.07-1.2), according to the researchers.

Patients who contracted major infections had a much higher mortality rate compared with those who did not (infected patients, 5%; noninfected patients, 0.7%; HR=10.02; 95% CI, 6.12-16.39).

Other factors associated with an adverse effect on survival in the study population included higher creatinine (HR=1.17; 95% CI, 1.06-1.29), HF (HR=2.09; 95% CI, 1.34-3), diabetes (HR=1.65; 95% CI, 1.08-2.51) and older age (HR=1.04; 95% CI, 1.02-1.06). Men had half the mortality risk of women (HR=0.49; 95% CI, 0.33-0.72).

The 30-day readmission rate for the study population was 14%, whereas the 65-day readmission rate was 19%. Infectious accounted for 16% of readmissions, according to the study.

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Low exercise capacity increased CABG mortality risk in ischemic LV dysfunction  Among patients with ischemic left ventricular dysfunction, those with poor exercise tolerance are at elevated early and 5-year risk for mortality after CABG compared with medical therapy, according to recent findings. Conversely, patients with a higher exercise capacity have better 5-year survival outcomes with CABG, the researchers wrote. In an exploratory analysis which published online in JACC Heart Failure Journal, researchers evaluated 1,212 patients enrolled in the STICH trial, in which participants, all of whom were diagnosed with ischemic LV dysfunction and CAD, were randomly assigned to medical intervention alone or medical therapy with CABG. Before randomization, the researchers evaluated the patients' physical activity level via a quality-of-life questionnaire and their performance during a 6-minute walk test. The questionnaire sought information on physical abilities and activities, as well as the extent to which the patients felt limited by HF. Based on the participants' responses, the researchers ascribed a numeric Physical Ability Score (PAS) between 0 and 100, with 100 indicating no limitation during physical activity, to each patient. During the walking test, patients were instructed to walk around an established course for 6 minutes and attempt to cover as much ground as possible, but also to stop and rest as needed. The primary outcome of the study was all-cause mortality during a median follow-up of 56 months. Patients were able to walk 300 m during the 6-minute walk test in 682 cases, whereas 530 participants were unable to do so. PAS was >55 in 749 cases, and 433 patients had a PAS ≤55. During the study period, 462 patients died, with most deaths due to CV-related causes (80%).

Among the patients randomly assigned to CABG who walked ≥300 m during the test, the risk for mortality was lower compared with nonrecipients who walked the same distance (HR=0.77; 95% CI, 0.59-0.99). Mortality risk was also lower for CABG-allocated patients among those with a PAS >55 (HR=0.79; 95% CI, 0.62-1.01 vs. medical therapy alone), but this trend did not reach statistical significance. Mortality rate did not differ significantly according to treatment among those unable to walk 300 m during the test.

The researchers noted that patients who walked ≥300 m during the test and had a PAS >55 (n=486) were at significantly reduced mortality risk with CABG (HR=0.71; 95% CI, 0.52-0.97). No difference in mortality risk was observed according to treatment among those who did not meet both criteria.

Patients who were unable to walk 300 m during the test or who had PAS ≤55 had significantly higher 60-day mortality risk after CABG (HR=3.24; 95% CI, 1.64-6.83 vs. medical therapy).

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July 22, 2014

HPS2-THRIVE published: Niacin did not benefit patients with vascular disease  Confirming findings presented at the American College of Cardiology 2013 Scientific Sessions, the HPS2-THRIVE data published in the last issue of New England Journal of Medicine indicate that the addition of niacin to statin-based therapy did not benefit patients with vascular disease and increased risk for adverse events. In the study were randomly assigned 25,673 adults with vascular disease taking statin-based therapy to 2 g extended-release niacin and 40 mg laropiprant or placebo daily. Median follow-up was 3.9 years.

As presented previously, the primary outcome, a composite of CV death, nonfatal MI, stroke and arterial revascularization, occurred in 13.2% of the niacin-laropiprant group vs. 13.7% of the placebo group (rate ratio=0.96; 95% CI, 0.9-1.03).

Assignment to niacin-laropiprant was also associated with the following: increased serious disturbances in diabetes control (absolute excess, 3.7 percentage points; P<.001), increased incidence of diabetes diagnosis (absolute excess, 1.3 percentage points; P<.001), increased gastrointestinal serious adverse events (absolute excess, 1 percentage point; P<.001), increased musculoskeletal system serious adverse events (absolute excess, 0.7 percentage points; P<.001), increased skin-related serious adverse events (absolute excess, 0.3 percentage points; P=.003), increased infection (absolute excess, 1.4 percentage points, P<.001) and increased bleeding (absolute excess, 0.7 percentage points; P<.001).

Adverse events reported in the niacin-laropiprant group, including a 9% increase in the risk for death (number needed to harm=200; P=.08).

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New Study Finds Diabetes Risk Rises With Statin Adherence but the benefits of statins still "clearly" outweigh the risks  The risk of new-onset type 2 diabetes rises with adherence to statin therapy, providing further confirmation of the previously reported link. However, the benefits of statins still "clearly" outweigh the risks, according to a large new population-based study and analysis which published online in Diabetes Care Journal. The study, involving a healthcare utilization database of 115,709 statin-using patients with an average 6.4 years of follow-up per patient, "extends earlier findings of an increased risk of diabetes with statin therapy by providing evidence of a clear-cut association between adherence to statin therapy and risk of new-onset diabetes in a real-world setting.

In the new study, the patients had a mean age of 62 years at the time of first statin prescription. None had been diagnosed with diabetes prior to that time. During follow-up, 9.6% of the entire cohort developed diabetes, at a rate of 14.9 per 1000 person-years.

Adherence was defined by the proportion of days during which the medication was available to the patient divided by the number of days of follow-up, called the "proportion of days covered (PDC)". Adherence was very low (PDC less than 25%) in 37.1% of patients, low (25% – 49%) in 20.2%, intermediate (50% – 75%) in 18.4%, and high (> 75%) in 24.4% of the participants.

After adjustment for age (continuous), sex, first-line statin therapy, concomitant use of other drugs, history of CVD, and Charlson morbidity index score category, the hazard ratios for developing diabetes compared with the very low adherence group were 1.12 for low adherence, 1.21 for intermediate, and 1.32 for high adherence. All were statistically significant (95% confidence intervals did not include 1).

Statins used by participants included simvastatin, pravastatin, fluvastatin, atorvastatin, and rosuvastatin (Crestor, AstraZeneca): a separate analysis of high- vs low-potency statins did not show a statistically significant difference in the statin effect on diabetes risk.

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Newer DES Up Survival vs Medications Only in Stable CAD according to a new metanalysis  A new meta-analysis which published in the BMJ suggests that medical therapy plus revascularization with PCI using "newer-generation" drug-eluting stents (DES)—defined as everolimus-eluting stents and the zotarolimus-eluting stent—improves survival better than an initial strategy of optimal medical therapy (OMT) only. No such advantage was seen for PCI using either bare-metal stents or "early-generation" DES, the latter of which includes the paclitaxel-eluting, sirolimus-eluting, and zotarolimus-eluting stents.

Of the observed revascularization methods, only CABG and newer-generation DES significantly cut the risk of MI compared with an initial med-based strategy. CABG also produced the steepest decline in need for subsequent revascularization. But that end point also fell significantly with all PCI options except plain-old balloon angioplasty. In general among stent options, newer-generation DES were associated with the lowest rates of subsequent revascularization, followed by early-generation DES and then bare-metal stents.

Their meta-analysis encompassing 93 553 patients with stable or unstable CAD was published June 23, 2014. It included 100 randomized trials with at least six months of follow-up and at least 100 patients per treatment arm, who entered with asymptomatic or symptomatic stable CAD; they were published from 1980 to 2013. It used outcomes data obtained at the assessment closest to five years for a total of 262 090 patient-years of follow-up. In all, a medication-dominated treatment strategy was compared with revascularization with FDA-approved devices.

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July 07, 2014

Hypertension and lengthy Beta-Blocker Use May Provoke Psoriasis  Older women who have had hypertension or been taking beta-blockers for several years are at increased risk of developing psoriasis according the results of the large, prospective Nurses' Health Study which published online in JAMA Dermatology. Specifically, women who had hypertension for at least 6 years had a 27% higher risk of developing psoriasis than women with normal blood pressure. Moreover, women who took beta-blockers for at least 6 years had a 39% higher risk of developing psoriasis than women who never used these medications. However, other commonly used antihypertensive drugs did not confer an increased risk of the skin disease.

To investigate how hypertension is linked with new cases of psoriasis, the researchers examined prospective data from 77 728 women in the Nurses' Health Study. The women, who were around age 60 in 2008, had replied to biennial questionnaires that included questions about antihypertensive medications and psoriasis.

The authors identified 843 incident cases of physician-diagnosed psoriasis during 1996 to 2008. Using a multivariate-adjusted model, they determined that women who had hypertension for 6 years or more had a significantly higher risk of developing psoriasis than women who did not have hypertension (hazard ratio [HR] 1.27; 95% CI, 1.03–1.57). Similarly, women who had hypertension and were not taking any antihypertensive therapy had a significantly higher risk of incident psoriasis than women with normal blood pressure (HR 1.49; 95% CI, 1.15–1.92). Beta-blocker use for 6 years or longer was linked with a significantly higher risk of developing psoriasis compared with not taking these agents (HR 1.39; 95% CI, 1.11–1.73). On the other hand, thiazide diuretics, calcium channel blockers, and ACE inhibitors were not associated with an increased risk of psoriasis.

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Rivaroxaban linked to higher treatment adherence than warfarin among AF patients  Rivaroxaban was linked to significantly higher medication adherence and lower rates of discontinuation compared with warfarin among patients with nonvalvular atrial fibrillation in a recent retrospective cohort analysis published online in Current Medical Research and Opinion Journal.

Researchers searched the databases for patients with at least one medical claim related to a primary or secondary diagnosis of nonvalvular AF from 2009 to March 2013. All patients identified for analysis (n=32,886) also received at least one prescription for rivaroxaban after November 2011 or for warfarin after July 2010 (n=25,627), and had at least 6 months of continuous medical and prescription benefits before the study. Rivaroxaban recipients were matched at a 1:1 ratio with warfarin recipients via propensity score. The follow-up interval was the time from the initial prescription to inpatient death or the end of the study period or of continuous enrollment with medical and prescription benefits (mean 184 days for rivaroxaban and 408 days for warfarin).

During follow-up, patients in the rivaroxaban group had a 77.1% rate of medication persistency vs. 57.8% in the warfarin group. Rivaroxaban recipients were less likely to be nonpersistent than warfarin recipients (adjusted HR=0.63; 95% CI, 0.59-0.68). Older age, higher CHADS2 scores, chronic kidney disease and treatment with multiple medications were linked to significantly decreased risk for nonpersistence.

In an analysis of 5,659 rivaroxaban recipients and 5,957 warfarin recipients with evaluable discontinuation data, patients in the rivaroxaban group discontinued medication less frequently than warfarin recipients (20.9% of cases vs. 41.5%). Adjustment for patient characteristics revealed that treatment with rivaroxaban was linked to a 46% lower risk of discontinuation vs. warfarin (adjusted HR=0.54; 95% CI: 0.49-0.58). The risk for discontinuation was further decreased in a subset of patients who did not switch anticoagulants during the study period (adjusted HR=0.44; 95% CI, 0.4-0.48). Patient factors linked to significantly lower risk for discontinuation included older age, chronic kidney disease and receipt of more medications.

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Glycoprotein IIb/IIIa inhibitors failed to improve outcomes with early invasive strategy  Glycoprotein IIb/IIIa inhibitor use during PCI did not improve the effectiveness of an early invasive strategy post-fibrinolysis compared with standard therapy, according to results of a substudy of the TRANSFER-AMI study which published in the Heart Journal.

In the study, investigators evaluated an early invasive strategy post-fibrinolysis in relation to glycoprotein IIb/IIIa inhibitor use for safety and efficacy outcomes in a cohort of 1,059 STEMI patients. Eligible participants were assigned an early invasive strategy or standard therapy and stratified by glycoprotein IIb/IIIa inhibitor use, which was permitted during PCI at the discretion of the treating physician. A composite of death, reinfarction, recurrent ischemia, new or worsening HF or cardiogenic shock at 30 days served as the primary outcome measure. Results indicated that 695 patients (65.6%) received glycoprotein IIb/IIIa inhibitors. The researchers reported significant heterogeneity (P<.001) in the early invasive group compared with the standard group with regard to efficacy. Patients in the glycoprotein IIb/IIIa inhibitor group who underwent the invasive strategy had a 9.6% rate of the primary endpoint compared with 22.3% for standard therapy (P<.001). For patients not receiving glycoprotein IIb/IIIa inhibitors, the rates were 14.8% for the invasive group and 10.4% for standard therapy (P=0.21). Median Global Registry of Acute Coronary Events (GRACE) risk scores were 121 in the inhibitor use group and 130 for those who did not receive inhibitors (P<.001). The invasive strategy no longer demonstrated effectiveness with respect to glycoprotein IIb/IIIa use in an analysis that adjusted for the interaction between risk score and treatment assignment (P for interaction=.08), according to the results.

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July 14, 2014

ESC issues triage strategy for urgent management of cardiac tamponade  The European Society of Cardiology) Working Group on Myocardial and Pericardial Diseases has developed a stepwise scoring system to identify patients who need immediate pericardiocentesis and patients who can safely be transferred to a specialized institution. The position statement was published online in the European Heart Journal.

Prompt recognition of cardiac tamponade is critical, and once it is diagnosed, patient management can be challenging because of the lack of validated criteria for risk stratification, the authors write. Moreover, the 2004 ESC guidelines on pericardial disease, the only cardiology or medical-society guidelines about this, do not cover certain important issues. The group aimed to use evidence-based data, where possible, to determine which patients need immediate drainage of the pericardial effusion; whether echocardiography is sufficient to guide pericardiocentesis; which patients should be transferred to a specialized/tertiary institution or surgical service; and what type of medical support is needed during transportation. To diagnose cardiac tamponade, the position statement advises that "cardiac tamponade should be suspected in patients presenting with hypotension, jugular venous distension, pulsus paradoxus, tachycardia, tachypnea, and/or severe dyspnea, [and] additional signs may include low QRS voltages, electrical alternans, and enlarged cardiac silhouette on chest X ray." Echocardiography should be carried out without delay, they note. Cardiac computed tomography and cardiovascular MRI are useful to rule out cancer or aortic dissection in patients with large pericardial effusions. Constrictive pericarditis, congestive heart failure, and advanced liver disease with cirrhosis need to be ruled out. Once cardiac tamponade is diagnosed, patients may require immediate, lifesaving pericardial drainage if they are in hemodynamic shock. If the patient is hemodynamically stable, the procedure should be performed within 12 to 24 hours of diagnosis, after obtaining laboratory test results including blood counts.

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EVAR improved safety vs. open repair in treating AAA  Among patients with abdominal aortic aneurysms, endovascular aneurysm repair was associated with improved safety compared with open repair, leading researchers to conclude that adoption of the endovascular technique can improve the safety of surgical admissions.

The study, which was published online in JAMA Surgery, involved cases of abdominal aortic aneurysm (AAA) repair that were taken from the Nationwide Inpatient Sample from 2003 — when Patient Safety Indicators (PSIs) were established to monitor preventable adverse events during hospitalizations — to 2010. Researchers used Agency for Healthcare Research and Quality software (Win QI, version 4.4) to calculate PSIs.

Year, age, sex, race/ethnicity, comorbidities, rupture status, hospital teaching status and emergency status were the variables included in the unadjusted analysis. In the multivariable analysis, researchers stratified data by year for any PSI in endovascular aneurysm repair (EVAR) or open aneurysm repair. Postoperative mortality served as the control for safety.

Overall, 43,385 EVARs and 27,561 open repairs were featured in the analysis, with those undergoing EVAR being less likely to have any PSI (3% vs. 11.2%; P<.001). EVAR patients were more likely to be male, older and white, seek care at teaching hospitals and have a lower Charlson Comorbidity Index.

Data from the multivariable analysis indicated a more than 40% reduction in the risk-adjusted odds of any PSI in the EVAR group (OR=0.58; 95% CI, 0.51-0.65). Additionally, when stratified by year, the risk-adjusted odds of any PSI were less likely in the EVAR group for every year but 2007, and the likelihood of death was less in every year for those receiving EVAR. Moreover, the annual percentage of PSIs decreased from 7.4% in 2003 to 4.4% in 2010 in the EVAR group, whereas it increased in the open repair group from 41.1% in 2003 to 75.3% in 2010.

In related data, the rate of mortality was significantly higher after open repair than EVAR (10.6% vs. 1.8%; P<.001; OR=0.28; 95% CI, 0.24-0.32).

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Painful Diabetic Neuropathy Linked to 'Nondipping' BP  Painful diabetic polyneuropathy (PDPN) is associated with higher nocturnal blood pressure (BP) independent of pain-related comorbidities, a new study published online in Diabetes Care.

The trial included a total of 113 diabetes patients: 34 with PDPN, 33 with painless diabetic polyneuropathy, and 46 without DPN. The patients with PDPN had higher neuropathic symptom and sign scores than did those with painless DPN, but the 2 groups had similar results on cardiovascular autonomic reflex tests (CARTs).

Nighttime systolic BPs were higher in the PDPN group than in either of the other 2 groups, 130.4 mm Hg vs 124.2 mm Hg for those with painless DPN (P < .05) and 119.9 mm Hg for those without DPN (P < .0001).

The PDPN group also experienced less change in systolic and diastolic BP overnight compared with the group without DPN (5.5 vs 8.6 mm Hg for systolic [ P < .05] and 10.8 vs 14.2 mm Hg for diastolic [P < .05]).

There were no differences in ambulatory BP monitoring results between the painless DPN and the non-DPN groups.

"Nondipping," or the absence of the normal nocturnal decrease in BP, was seen in 8 patients (7%) and was highly correlated with PDPN status (P = .007), as well as with a higher CART score (3.0 vs 1.3; P = .020).

In stepwise regression analysis, orthostatic hypotension, high risk for obstructive sleep apnea (OSA), and results on a neuropathic pain screening tool called the Douleur Neuropathique en 4 Questions (DN4) were all independent determinants of overnight change in systolic BP (P = .0001) and in nighttime systolic BP (P < .0001).

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July 07, 2014

Hypertension and lengthy Beta-Blocker Use May Provoke Psoriasis  Older women who have had hypertension or been taking beta-blockers for several years are at increased risk of developing psoriasis according the results of the large, prospective Nurses' Health Study which published online in JAMA Dermatology. Specifically, women who had hypertension for at least 6 years had a 27% higher risk of developing psoriasis than women with normal blood pressure. Moreover, women who took beta-blockers for at least 6 years had a 39% higher risk of developing psoriasis than women who never used these medications. However, other commonly used antihypertensive drugs did not confer an increased risk of the skin disease.

To investigate how hypertension is linked with new cases of psoriasis, the researchers examined prospective data from 77 728 women in the Nurses' Health Study. The women, who were around age 60 in 2008, had replied to biennial questionnaires that included questions about antihypertensive medications and psoriasis.

The authors identified 843 incident cases of physician-diagnosed psoriasis during 1996 to 2008. Using a multivariate-adjusted model, they determined that women who had hypertension for 6 years or more had a significantly higher risk of developing psoriasis than women who did not have hypertension (hazard ratio [HR] 1.27; 95% CI, 1.03–1.57). Similarly, women who had hypertension and were not taking any antihypertensive therapy had a significantly higher risk of incident psoriasis than women with normal blood pressure (HR 1.49; 95% CI, 1.15–1.92). Beta-blocker use for 6 years or longer was linked with a significantly higher risk of developing psoriasis compared with not taking these agents (HR 1.39; 95% CI, 1.11–1.73). On the other hand, thiazide diuretics, calcium channel blockers, and ACE inhibitors were not associated with an increased risk of psoriasis.

… more More

Rivaroxaban linked to higher treatment adherence than warfarin among AF patients  Rivaroxaban was linked to significantly higher medication adherence and lower rates of discontinuation compared with warfarin among patients with nonvalvular atrial fibrillation in a recent retrospective cohort analysis published online in Current Medical Research and Opinion Journal.

Researchers searched the databases for patients with at least one medical claim related to a primary or secondary diagnosis of nonvalvular AF from 2009 to March 2013. All patients identified for analysis (n=32,886) also received at least one prescription for rivaroxaban after November 2011 or for warfarin after July 2010 (n=25,627), and had at least 6 months of continuous medical and prescription benefits before the study. Rivaroxaban recipients were matched at a 1:1 ratio with warfarin recipients via propensity score. The follow-up interval was the time from the initial prescription to inpatient death or the end of the study period or of continuous enrollment with medical and prescription benefits (mean 184 days for rivaroxaban and 408 days for warfarin).

During follow-up, patients in the rivaroxaban group had a 77.1% rate of medication persistency vs. 57.8% in the warfarin group. Rivaroxaban recipients were less likely to be nonpersistent than warfarin recipients (adjusted HR=0.63; 95% CI, 0.59-0.68). Older age, higher CHADS2 scores, chronic kidney disease and treatment with multiple medications were linked to significantly decreased risk for nonpersistence.

In an analysis of 5,659 rivaroxaban recipients and 5,957 warfarin recipients with evaluable discontinuation data, patients in the rivaroxaban group discontinued medication less frequently than warfarin recipients (20.9% of cases vs. 41.5%). Adjustment for patient characteristics revealed that treatment with rivaroxaban was linked to a 46% lower risk of discontinuation vs. warfarin (adjusted HR=0.54; 95% CI: 0.49-0.58). The risk for discontinuation was further decreased in a subset of patients who did not switch anticoagulants during the study period (adjusted HR=0.44; 95% CI, 0.4-0.48). Patient factors linked to significantly lower risk for discontinuation included older age, chronic kidney disease and receipt of more medications.

… moreMore

Glycoprotein IIb/IIIa inhibitors failed to improve outcomes with early invasive strategy  Glycoprotein IIb/IIIa inhibitor use during PCI did not improve the effectiveness of an early invasive strategy post-fibrinolysis compared with standard therapy, according to results of a substudy of the TRANSFER-AMI study which published in the Heart Journal.

In the study, investigators evaluated an early invasive strategy post-fibrinolysis in relation to glycoprotein IIb/IIIa inhibitor use for safety and efficacy outcomes in a cohort of 1,059 STEMI patients. Eligible participants were assigned an early invasive strategy or standard therapy and stratified by glycoprotein IIb/IIIa inhibitor use, which was permitted during PCI at the discretion of the treating physician. A composite of death, reinfarction, recurrent ischemia, new or worsening HF or cardiogenic shock at 30 days served as the primary outcome measure. Results indicated that 695 patients (65.6%) received glycoprotein IIb/IIIa inhibitors. The researchers reported significant heterogeneity (P<.001) in the early invasive group compared with the standard group with regard to efficacy. Patients in the glycoprotein IIb/IIIa inhibitor group who underwent the invasive strategy had a 9.6% rate of the primary endpoint compared with 22.3% for standard therapy (P<.001). For patients not receiving glycoprotein IIb/IIIa inhibitors, the rates were 14.8% for the invasive group and 10.4% for standard therapy (P=0.21). Median Global Registry of Acute Coronary Events (GRACE) risk scores were 121 in the inhibitor use group and 130 for those who did not receive inhibitors (P<.001). The invasive strategy no longer demonstrated effectiveness with respect to glycoprotein IIb/IIIa use in an analysis that adjusted for the interaction between risk score and treatment assignment (P for interaction=.08), according to the results.

… more More


June 30, 2014

CHMP Recommends Approval of Clopidogrel/Aspirin Combo  The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) is recommending the approval of a combination tablet that includes clopidogrel and aspirin for individuals at risk for atherothrombotic events who are already taking the two antiplatelet agents. Specifically, it recommends that the combination be made available for adult patients with non-ST-segment-elevation acute coronary syndrome, including patients undergoing PCI. In addition, the combination should be made available for patients with ST-segment-elevation MI eligible for thrombolytic therapy. On the overall "basis of quality, safety, and efficacy data submitted," CHMP says the positive risk-to-benefit balance favors the approval of the combination tablet. The drug would be available in two doses: clopidogrel 75 mg/aspirin 75 mg and clopidogrel 75 mg/aspirin 100 mg.

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Apixaban Recommended for DVT/PE Indications By EMA  The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) "has adopted a positive opinion" on extending the marketing authorization for apixaban to include treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), plus prevention of recurrences of these conditions in adults. A final decision on this recommendation will come after the European Commission reviews the recommendations. .

The CHMP's opinion comes on the basis of the AMPLIFY trial results and those of its extension study, AMPLIFY-EXT , in 5395 patients. In the trial, apixaban was as effective as standard enoxaparin plus warfarin in treating acute venous thromboembolism (VTE), but patients taking the newer drug saw a 69% drop in risk of major bleeding complications. In the one-year extension study, patients taking apixaban had significantly fewer recurrences of venous thromboembolism than those taking a placebo. Apixaban is an oral selective factor Xa inhibitor already approved in the EU, US, Japan, and elsewhere for the reduction of stroke and systemic embolism risk in patients with nonvalvular atrial fibrillation. It is also already approved for DVT prophylaxis in patients who have undergone elective hip or knee replacement in both the US and EU.

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FDA review of cardiovascular risks for diabetics taking hypertension drug olmesartan not conclusive; label updates required  The US Food and Drug Administration (FDA) has completed its safety review of olmesartan in diabetic patients, stating there is no clear evidence of increased cardiovascular risk associated with the angiotensin-receptor blocker (ARB). The FDA conducted the safety review based on data from a large clinical trial testing whether olmesartan could slow the progression of kidney disease in patients with type 2 diabetes. In the trial, known as Randomized Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP), investigators observed that diabetic patients taking olmesartan had an increased risk of dying from cardiovascular causes. Following on ROADMAP, the FDA also reviewed an epidemiologic study of Medicare patients and found a similar suggestion of increased risk of cardiovascular mortality among the olmesartan-treated diabetic patients. According to the agency, while the results of the Medicare study appear to support ROADMAP, it had doubts about the results. As a result, the findings of the FDA review are not conclusive and not indicative of increased cardiovascular risk. The "evidence available at this time does not support changing our recommendations for olmesartan use and does not support recommending that its use be avoided in patients with diabetes," it states. The label, however, will be amended to highlight some of the data from these studies.

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June 23, 2014

Lower than optimal systolic BP may not further reduce CV risk  Once systolic BP is less than 140 mm Hg, there may not be any further benefit in lowering it to below 120 mm Hg, according to new data from the Atherosclerosis Risk in Communities (ARIC) Study which published online in JAMA Int. Medicine. There were studied 4.480 participants from the ARIC Study with hypertension but without CVD at baseline from 1987 to 1989. They evaluated incident CV events among participants stratified into three groups: those with systolic BP ≥140 mm Hg (elevated group), those with systolic BP between 120 mm Hg and 139 mm Hg (standard group) and those with systolic BP ≤120 mm Hg (low group). Systolic BP was measured at baseline and during three triennial visits. The primary outcome was a composite of HF, ischemic stroke, MI and CHD-related death. Median follow-up was 21.8 years.

After adjustment for baseline age, sex, diabetes, BMI, cholesterol level, smoking and alcohol intake, Rodriguez and colleagues found that the elevated group developed incident CV events at a much higher rate compared with the low group (adjusted HR=1.46; 95% CI, 1.26-1.69). However, there was no difference in incident CV event-free survival between the standard group and the low group (HR=1; 95% CI, 0.85-1.17). Adjusting for BP medication use and diastolic BP did not change the results.

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Loss-of-function mutations in APOC3 gene linked to lower CV risk  Loss-of-function mutations in the APOC3 gene are associated with lower levels of triglycerides and reduced risk for CHD and ischemic CVD, according to two studies published online in The New England Journal of Medicine. In the first study, the triglycerides and HDL working group of the NHLBI’s Exome Sequencing Project found four mutations of APOC3, three of them loss-of-function mutations, associated with lower levels of plasma triglycerides and reduced risk for CHD. In the other study, a Danish research team found that APOC3 loss-of-function mutations were associated with lower levels of triglycerides and reduced risk for ischemic vascular disease and ischemic heart disease.

In the Exome Sequencing Project, researchers sequenced 18,666 genes in 3,734 people of European or African descent. They performed tests to determine whether rare mutations were associated with plasma triglyceride levels. For the mutations determined to be associated with triglyceride levels, the researchers evaluated their association with CHD in 110,970 people. The researchers found four mutations of APOC3 linked to lower plasma triglyceride levels. They found that approximately 1 in 150 participants were heterozygous carriers of at least one of the four mutations. Those who had at least one of the mutations had triglyceride levels 39% lower (P<1x10-20) and circulating levels of APOC3 46% lower (P=8x10-10) compared with those who did not, the researchers found. The 498 carriers of at least one mutation had a CHD risk 40% lower compared with the 110,472 noncarriers (OR=0.6; 95% CI, 0.47-0.75), according to the researchers.

In the Danish study, were analyzed 75,725 participants from two general-population studies. They tested whether low levels of nonfasting triglycerides were associated with reduced risk for ischemic vascular disease and ischemic heart disease. Median follow-up was 4 years.

Median follow-up was 34 years, during which 10,797 participants developed ischemic vascular disease and 7,557 of those who developed ischemic vascular disease also developed ischemic heart disease. The researchers found that those with nonfasting triglyceride levels <1 mmol/L had a lower incidence of CVD compared with those with nonfasting triglyceride levels &tr;4 mmol/L (ischemic vascular disease, HR=0.43; 95% CI, 0.35-0.54; ischemic heart disease, HR=0.4; 95% CI, 0.31-0.52). Compared with those who had no loss-of-function mutations in APOC3, those with at least one had 44% lower nonfasting triglyceride levels (P<.001), according to the researchers. Compared with those who had no loss-of-function mutations in APOC3, those with at least one had lower incidence of and risk for ischemic vascular disease (HR=0.59; 95% CI, 0.41-0.86) and ischemic heart disease (HR=0.64; 95% CI, 0.41-0.99), Jørgensen and colleagues found.

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Depression associated with CV mortality in younger women  Depressive symptoms predicted CAD presence and risk for death in women aged 55 years or younger in a recent study published online in J. Am. Heart Ass. However, depressive symptoms did not predict CAD presence or risk for death in women aged older than 55 years or in men aged 55 years or younger. The researchers analyzed 3,237 patients undergoing coronary angiography for the evaluation of CAD (mean age, 62.5 years; 34% women).

Participants were stratified by presence or absence of CAD burden. Depressive symptoms were categorized by Patient Health Questionnaire-9 (PHQ-9) score. Median follow-up was 2.9 years. After multivariable adjustment for CAD risk factors, depressive symptoms predicted the presence of CAD in women aged 55 years or younger (OR=1.07; 95% CI, 1.02-1.13 per one-point increase in PHQ-9 score). They did not find a similar relationship among men aged 55 years or younger (OR=1; 95% CI, 0.95-1.04), women aged 56 to 64 years (OR=1.05; 95% CI, 0.99-1.12) or women aged at least 65 years (OR=0.98; 95% CI, 0.93-1.03).

Depressive symptoms predicted increased risk for death in women aged 55 years and younger (adjusted HR=1.07; 95% CI, 1.02-1.14 per one-point increase in PHQ-9 score), but not in men aged 55 years or younger (adjusted HR=0.97; 95% CI, 0.91-1.03), in women aged 56 to 64 years (adjusted HR=1.1; 95% CI, 0.95-1.07) or in women aged at least 65 years (adjusted HR=1.02; 95% CI, 0.97-1.07).

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June 16, 2014

Statins reduced physical activity among older men  Statin use is associated with a moderate decrease in physical activity among older men, according to recent findings of a study published online in JAMA Int. Med. Researchers evaluated 5,994 men aged at least 65 years enrolled in the multicenter, prospective Osteoporotic Fractures in Men (MrOS) cohort study. The present study included cross-sectional and longitudinal analysis of men who underwent a baseline examination as part of the MrOS trial between March 2000 and April 2002. The patients were seen for additional follow-up clinic visits at a mean of 4.6 years and 6.9 years after baseline, through 2009. For each visit, participants were asked to bring all medications they had taken within the past month. At each clinic visit, participants completed self-administered questionnaires pertaining to demographics, self-perceived health and physician-diagnosed conditions. Participants also responded to the Physical Activity Scale for the Elderly (PASE) questionnaire, which assessed workplace, household and leisure activity for 1 week. During the third clinic visit, participants were fitted with an accelerometer that monitored physiological data, represented as metabolic equivalents (METS), every minute for 1 week. Researchers estimated patients' activity levels and the amount of time they spent sedentary per day (≤1.5 METS), as well as the duration of moderate (≤3 METS) and vigorous physical activity (≥6 METS). For cross-sectional analysis (n=4,137), patients were classified as statin users (n=989) or nonusers (n=3,148). In the longitudinal analysis (n=3,039), patients were categorized as prevalent users (those using statins at baseline and throughout the study, n=727), new users (statin use commenced during the study period, n=845) and nonusers (n=1,467; 48%). The cross-sectional analysis revealed that statin users were more likely to report a previous MI or stroke, hypertension, diabetes, lower total cholesterol and a lower self-perception of health. After adjustment for confounders, the difference in PASE baseline scores was estimated at –5.8 points among users compared with nonusers. In the longitudinal analysis, the researchers observed an overall decline in physical activity among study participants during approximately 7 years of follow-up. Among nonusers, PASE score decreased by a mean of 2.5 points per year, whereas prevalent users exhibited a mean score decrease of 2.8 points per year. Among new statin users, PASE score declined at a faster rate compared with nonusers, with a difference of 0.9 points between groups per year. However, the observed decline in PASE score among the three groups was not statistically significant.

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Processed red meat consumption may increase risk for HF  Men who consumed higher amounts of processed red meat had a significantly higher risk for HF and related mortality compared with men whose consumption was lower, according to findings from a recent prospective study published online in Circ. Heart Fail. Journal.

Researchers evaluated data from 37,035 men enrolled in the population-based, prospective Cohort of Swedish Men, which was established in 1997. The men were aged 45 to 79 years and had no history of HF, ischemic heart disease or cancer at enrollment. Consumption of processed and unprocessed meat was determined via responses to a 96-item self-administered food-frequency questionnaire in 1997. Follow-up for HF incidence and mortality was conducted from 1998 until HF diagnosis, death or Dec. 31, 2010. Pork, beef/veal and minced meat were classified as unprocessed meats; sausage, cold cuts, liver pate and blood pudding/sausages were identified as processed meats. The researchers said dishes such as hamburger or ground beef were classified as unprocessed meat because they are typically prepared without food additives in Sweden. HF developed in 2,891 men and resulted in 266 deaths during the mean 11.8 years of follow-up. Multivariate analysis indicated a significant association between higher consumption of processed meat and risk for HF (≥75 g/day vs. <25 g/day: HR=1.28; 95% CI, 1.1-1.48) and HF-related mortality (≥75 g/day vs. <25 g/day: HR=2.43; 95% CI, 1.52-3.88). No association was observed between consumption of unprocessed meat and HF incidence or related mortality. Further adjustment for history of hypertension, elevated cholesterol and diabetes did not significantly alter results. For each additional 50 g/day of processed red meat, the risk for HF increased by 8% and the risk for HF mortality increased by 38%, according to dose-response analysis.

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CoreValve Indication Expanded to Include High-Risk Patients  The US Food and Drug Administration (FDA) has expanded the indication for the CoreValve transcatheter aortic valve to include high-risk surgical patients. The approval comes following the positive results of the CoreValve High-Risk cohort, release earlier this year at the American College of Cardiology 2014 Scientific Sessions. The CoreValve was noninferior to surgical aortic-valve replacement in a randomized trial of 795 patients. In the approval of FDA, the entire CoreValve platform was approved for use in high-risk surgery patients, including the 23-mm, 26-mm, 29-mm and 31-mm size valves. All four sizes can be delivered through an 18-French catheter, which, the company press release notes, is the smallest commercially available transcatheter aortic-valve replacement (TAVR) delivery system. The CoreValve was FDA-approved in January for use in patients too frail to undergo surgical aortic-valve replacement.

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