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Survey: Ivabradine Set to Become ‘Gold Standard’ in Treatment of Chronic Heart Failure

Opportunities exist for therapies offering reductions in mortality and hospitalization rates

Decision Resources Group, a health-care research firm located in Burlington, Mass., finds that ivabradine — available in Europe as Procoralan (Servier) — is poised to become the clinical “gold standard” in the treatment of chronic heart failure (CHF).

In Europe, ivabradine has enjoyed moderate use in patients with CHF and stable angina, and the drug’s favorable clinical profile could prime it for a potentially successful launch in the U.S., where Amgen owns the marketing rights to Procoralan, the new report says.

Ivabradine has the potential to fulfill unmet needs related to the treatment of CHF in that it was shown to reduce mortality and rehospitalizations in a phase III clinical trial in CHF patients. However, although ivabradine is backed by comprehensive clinical data and enthusiasm from cardiologists, it will not be in an advantageous position in the treatment paradigm when introduced in the U.S. As in Europe, the therapy will likely be restricted to patients in sinus rhythm who are unable to tolerate beta blockers or to those who have been unable to achieve sufficient rate control with beta blockers alone.

Surveyed U.S. and European cardiologists agreed that a therapy’s effects on the rate of mortality and on hospitalization for worsening heart failure are the attributes that most influence their decisions regarding prescribing in CHF. Improvements in these attributes will be a crucial factor influencing the clinical differentiation and reimbursement of emerging therapies, according to the report.

The prevention of worsening renal function was highlighted by cardiologists as one of the most pertinent unmet needs related to the treatment of CHF and is an issue associated with the use of aldosterone antagonists. The new mineralocorticoid antagonist finerenone (Bayer) has the potential to capitalize on this unmet need as it is predicted to have kidney-sparing effects compared with spironolactone (Aldactone, Pfizer; and generics) and eplerenone (Inspra, Pfizer; and generics).

Surveyed cardiologists indicated that price is an overriding factor in their treatment decisions when considering certain efficacy, safety, and delivery attributes. Issues related to cost could substantially constrain the uptake of more-innovative but expensive emerging treatments, such as the gene therapy Mydicar (Celladon) and the stem cell therapy Revascor (Teva/Mesoblast).

“CHF represents a particularly tough segment for novel therapies to emerge as first-line options,” said analyst Joseph Dwyer. “The standard of care, comprised of generic ACE inhibitors, beta blockers, and oral diuretics, is accompanied by a wealth of outcomes data and a relatively small price tag. More expensive novel agents will therefore likely find use as add-on therapies.”

Source: Decision Resources; April 14, 2014.

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Decision supported by data from more than 4,000 patients