Tag Archives: heart failure

European Medicines Agency Starts Review of Combined Use Of Drugs That Block The Renin-Angiotensin System 1

by • Heart Failure, People, Places & Events, Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , , , , ,

The European Medicines Agency said last week that it was initiating a review of the combined use of agents that block the renin-angiotensin system (RAS). The three classes of RAS-blocking drugs (ACE inhibitors, ARBs, and direct renin inhibitors) are used to treat hypertension and congestive heart failure.

The EMA said that the review was being performed to address concerns that combined RAS-blocking drugs could increase the risk for hyperkalemia, hypotension, and kidney failure when compared with a single agent.  A recent meta-analysis of 33 clinical studies published in the British Medical Journal concluded that ”although dual blockade of the renin-angiotensin system may have seemingly beneficial effects on certain surrogate endpoints, it failed to reduce mortality and was associated with an excessive risk of adverse events… The risk to benefit ratio argues against the use of dual therapy.”

Franz Messerli, senior author of the BMJ meta-analysis, applauded the EMA action and said that “as usual the FDA is dragging its feet.”

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Click here to read the full story on Forbes.

 

 

 

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Study Questions Role Of Dual-Chamber ICDs For Primary Prevention Reply

by • Heart Rhythms • Tags: , , , , ,

Dual-chamber ICDs are implanted in a majority of primary prevention patients without a pacing indication who receive an ICD. Although there are a number of theoretical advantages with dual-chamber devices, these devices are more likely to cause complications. Although CMS requires providers to justify the medical necessity of dual-chamber devices, current guidelines from the AHA/ACC and HRS do not specify a single-chamber device.

In a new study published in JAMA, Pamela Peterson and colleagues analyzed data from 32,000 primary prevention patients without a pacing indication who were enrolled in the National Cardiovascular Data Registry (NCDR). 38% received a single-chamber device and 62% received a dual-chamber device. At 1 year there wereno significant differences in mortality, all-cause hospitalization, or heart failure hospitalization between the two groups. However, patients in the dual-chamber group had a higher risk of complications, including a highly significant increase in the 90 day risk of mechanical complications requiring reoperation (1.43% in the single-chamber group versus 2.02% in the dual-chamber group, p < 0.001). A very similar pattern emerged when the investigators performed an analysis that matched patients in the two groups with a propensity model. The analysis suggested “that the choice of a dual-chamber device is relatively random with respect to patient characteristics.

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FDA Warns That Tolvaptan Can Lead To Serious Liver Injury Reply

by • Heart Failure, People, Places & Events, Policy & Ethics • Tags: , ,

The FDA has issued a drug safety communication concerning tolvaptan (Samsca, Otsuka), a selective vasopression V2-receptor antagonist used in heart failure patients to treat clinically significant hypervolemic and euvolemic hyponatremia. The FDA said tolvaptan “should not be used for longer than 30 days and should not be used in patients with underlying liver disease because it can cause liver injury, potentially leading to liver transplant or death. “

The liver injury risk was discovered in clinical trials testing tolvaptan in patients with autosomal dominant polycystic kidney disease (ADPKD). The drug label has been updated and now states that use of the drug should be limited to 30 days and that it is no longer indicated in patients with cirrhosis. The FDA recommended that tolvaptan should be discontinued in patients with liver disease who are currently taking the drug.

 

 

BLOCK HF: CRT Superior To Conventional Pacing In Heart Failure Patients With AV Block Reply

by • Heart Failure, Heart Rhythms • Tags: , , , , , ,

 

Patients with atrioventricular (AV) block generally receive right ventricular pacing; cardiac resynchronization therapy (CRT) has been restricted to patients with a low ejection fraction and a wide QRS duration. However, RV pacing may worsen LV dysfunction in AV block patients with low ejection fractions. Previous studies have raised the possibility that these patients may benefit from biventricular pacing with a CRT device.

Now, results from the Medtronic-sponsored BLOCK HF (Biventricular versus Right Ventricular Pacing in Heart Failure Patients with Atrioventricular Block) trial, published in the New England Journal of Medicine, lend more support for the expansion of CRT devices into this population. Anne Curtis and colleagues randomized 691 patients to standard RV pacing or  biventricular pacing. After 37 months of followup, a primary outcome event– death, urgent care visit for heart failure that required intravenous therapy, or a 15% or more increase in the LV end-systolic volume index– occurred in 55.6% of the RV pacing group versus 45.8% in the biventricular pacing group (HR 0.74, CI 0.60-0.90).

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Anne Curtis

 

 

 

 

Another Negative Trial With Darbepoetin Alfa 1

by • Heart Failure, Prevention, Epidemiology & Outcomes • Tags: , , ,

Once again a trial testing the erythropoiesis-stimulating agent darbepoetin alfa (Aranesp, Amgen) has produced a negative result. Results of the RED-HF (Reduction of Events by Darbepoetin Alfa in Heart Failure) trial were presented at the ACC in San Francisco and published simultaneously in the New England Journal of Medicine.

A total of 2278 patients with systolic heart failure and mild-to-moderate anemia were randomized to darbepoetin alfa (Aranesp, Amgen) or placebo. As expected, treatment with darbepoetin alfa significantly improved hemoglobin levels. However, no significant improvements in outcomes were associated with darbepoetin alfa.

Click here to read the full story on Forbes.

 

Eplerenone May Help Prevent Heart Failure In Acute STEMI Patients Reply

by • Heart Failure, MI/ACS • Tags: , , ,

A new trial presented at the ACC in San Francisco suggests that the mineralocorticoid receptor antagonist eplerenone Pfizer, Inspra) may help prevent the development of heart failure when given acutely in STEMI patients without preexisting heart failure.

In the REMINDER trial 1,012 STEMI patients were randomized to eplerenone or placebo. After 10.5 months of followup, the primary endpoint– the time to CV mortality, rehospitalization or extended initial hospital stay due to diagnosis of HF, sustained ventricular tachycardia or fibrillation, EF ≤40% after 1 month, or an elevation of BNP/NT-proBNP after 1 month– occurred in 18.4% of the eplerenone group versus 29.6% of the placebo group ((HR, 0.581; 95% CI; 0.449-0.753; P<0.0001).

Click here to read the full story in Forbes.

Study Warns Against Dual Blockade of Renin-Angiotensin System In Heart Failure And Hypertension 1

by • Heart Failure, Policy & Ethics, Prevention, Epidemiology & Outcomes • Tags: , , , ,

The enormous success of ACE inhibitors in hypertension and heart failure spurred hope that adding a second drug to block the renin-angiotensin system would yield improved outcomes. Although definitive evidence supporting dual blockade of the renin-angiotensin system has never been found, more than 200,000 patients in the US currently receive  this therapy. Now a large new meta-analysis suggests that dual blockade results in no improvement in mortality but is associated with an increase in important adverse events.

In a paper published online in BMJ, Harikrishna Makani and colleagues at Columbia University and New York University performed a meta-analysis of more than 68,000 patients who were enrolled in clinical trials comparing dual blockade of the renin-angiotensin system with monotherapy. They found no significant difference between the groups for all cause mortality or cardiovascular mortality, although dual blockade was associated with a signifcant 18% reduction in hospital admission for heart failure:

Click here to read the full article on Forbes.

 

Amgen Trial Fails To Show Benefit Of Anemia Drug In Heart Failure Patients Reply

by • Heart Failure, Policy & Ethics • Tags: , , , , , , ,

Deutsch: Amgen als Sponsor der Tour of California

 

The bad news continues for Aranesp (darbepoetin alfa), Amgen’s long-acting erythropoietin-stimulating agent. The drug is intended to stimulate red cell blood production in patients with anemia. Amgen today announced the top line results of a large phase 3 heart failure trial of the drug and said  the trial had failed to meet its primary endpoint.

 

The RED-HF (Reduction of Events With Darbepoetin Alfa in Heart Failure) Trial, which started in 2006, had randomized 2,278 patients with heart failure and anemia to receive either Aranesp or placebo.

 

Click here to read the full story on Forbes.

 

Observation Units For Heart Failure Could Reduce Unnecessary Hospitalizations 1

by • Heart Failure • Tags: , ,

Two new papers published in the Journal of the American College of Cardiology propose that most heart failure (HF) patients who present to the emergency department (ED) don’t need to be hospitalized and can be safely managed in an observation unit. Currently, the vast majority of HF patients  who show up in the ED are hospitalized….

Click here to read my complete story on Forbes.

Journal of the American College of Cardiology

 

 

Richard Lehman On ICDs In Clinical Practice And Serelaxin For HF Reply

by • Heart Failure, Heart Rhythms • Tags: , , , ,

This week in CardioExchange Richard Lehman is not quite as funny as most weeks (perhaps he’s still recovering from New Years’ celebrations?), but he has some interesting and useful comments on a JAMA study comparing real world patients in registries to patients in clinical trials and an impressive Lancet study testing the role of the novel agent serelaxin in acute heart failure.

“So after much hard work and statistical legerdemain, the study shows that the mortality of real-life heart failure patients after ICD implantation for primary prevention is the same as that in the trials, and less than that of the control patients in the trials. Which I guess is a useful thing to know.”

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 ”I don’t think that by itself it changes practice in any way, but it does show that recombinant human relaxin 2, serelaxin, is an interesting new treatment that deserves further study in heart failure.”

 

 

WARCEF: No Advantage For Warfarin Over Aspirin In Heart Failure 1

by • Heart Failure • Tags: , , ,

A new study offers “no compelling reason” to use warfarin instead of aspirin in heart failure patients who don’t have atrial fibrillation. In a paper published in the New England Journal of Medicine, Shunichi Homma and members of the Warfarin versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF) study group report the results of a trial in which 2,305 patients with left ventricular dysfunction were randomized to warfarin or placebo and followed for up to six years.

No significant differences were observed in the primary endpoint (the composite of death, ischemic stroke, or intracerebral hemorrhage) or its individual components. Warfarin was superior to aspirin in reducing the rate of ischemic stroke, but this advantage was offset by an increased incidence of major hemorrhage in the warfarin group.

  • Primary endpoint: 26.4% for warfarin versus 27.5% for aspirin, HR 0.93, CI 0.79-1.10
  • Ischemic stroke: 1.8% versus 3.5%, HR 0.55, CI 0.32-0.96)
  • Major hemorrhage: 5.8% versus 2.7%, OR2.21, CI 1.42-3.47

The authors concluded:

Given the finding that warfarin did not provide an overall benefit and was associated with an increased risk of bleeding, there is no compelling reason to use warfarin rather than aspirin in patients with a reduced LVEF who are in sinus rhythm.

In an accompanying editorial, John Eikelboom and Stuart Connolly agree with the study authors that there is no justification for the “routine clinical use of warfarin in most patients with heart failure” but write that warfarin is still “most likely to benefit” heart failure patients with atrial fibrillation or with a history of cardioembolic stroke or formation of LV thrombus. They leave open the possibility that warfarin may also benefit heart failure patients with underlying coronary artery disease, and recommend that future studies of anticoagulants in heart failure focus on this population.

Study Evaluates Losartan Efficacy in Heart Failure Reply

by • Heart Failure • Tags: , , ,

The angiotensin II-receptor blocker (ARB) losartan has labored under the perception that it is not as potent as other ARBs, and some evidence has suggested that it may not confer the same clinical benefits as other ARBs in heart failure patients. In a paper from Denmark published in JAMA, Henrik Svanström and colleagues performed a country-wide registry study in which they compared heart failure patients who were new users of losartan and candesartan.

Overall there were no significant differences in mortality between the two groups:

  • Adjusted hazard ratio (HR) for losartan: 1.10, CI 0.96-1.25

When compared with high-dose candesartan (16-32 mg), however, low-dose (12.5 mg) and medium-dose  (50 mg) losartan were linked to an increased risk for death, but this was not observed with high-dose (100 mg) losartan:

  • Low-dose losartan: HR 2.79, CI 2.19-3.55
  • Medium-dose losartan: HR 1.39, CI, 1.11-1.73
  • High-dose losartan: HR 0.71, CI, 0.50-1.00

The authors concluded that their “findings do not support the hypothesis of differential effects of specific ARBs in patients with heart failure.”
Click here to read the press release from JAMA…