Breakthrough In Cardiovascular Medicine Treatment

FDA Sign and Building 21 at Entrance - Photo by: The U.S. Food and Drug Aadministration - Source: Flickr Creative CommonsFDA Sign and Building 21 at Entrance - Photo by: The U.S. Food and Drug Aadministration - Source: Flickr Creative Commons

In what is deemed a break through in cardiovascular medicine treatments, the FDA has approved a new drug called Corlanor (ivabradine).

Corlanor is designed to reduce hospitalization time caused by the worsening of heart failure symptoms. The FDA approved the drug only to be used for a single type of chronic heart failure caused by the lower-left part of their heart not contracting well. Patients need to understand the risks associated for this drug were evaluated for just this specific indication, and that this medication is not to be used for any other heart problems other than the one it was designed for. Patients symptoms also need to fall under a certain criteria, and heart failure needs to be under control before using this drug. In other words a normal heartbeat with a resting heart rate of at least 70 beats per minute is required. Patients also need to be taking beta blockers at the highest dose tolerable.
Heart failure is a familiar cardiovascular disease affecting about 5.1 million individuals in the United States. In this condition, the heart cannot pump enough blood to satisfy the needs of the body. Heart failure develops over time as the pumping activity of the heart grows feebler. The top reasons for heart failure are heart-damaging disorders, including high blood pressure and coronary heart disease.

“Corlanor is believed to work by reducing heart rate and signifies the first approved product in this drug category.”
Corlanor was reviewed under the FDA’s priority review system, which provides for an expedited review of drugs that are intended to take care of illness or a serious disease, and can provide an important advancement over available therapy. For products which have been designated as fast track, FDA may review parts of a marketing application on a rolling basis.

 

FDA Blind Test

The Approval of Corlanor by the FDA was based on the results of a randomized double-blind trial comparing the drug to a placebo. The security and effectiveness of Corlanor was examined in a clinical trial of 6,505 participants, and the results were astonishing. Corlanor reduced hospitalization for worsening heart failure in comparison to an inactive drug (placebo) by 35%.

 

Dosing

Corlanor is taken twice daily with meals. The starting dosage is 5 mg 2x a day, or 2.5 mg 2x a day for painted who are at a greater risk for hemodynamic compromise or a history of conduction defects. As the patient’s body adjusts to the medication, a higher dosage may become necessary. Deepening on the heart rate, if that’s under 60 bpm, an increase in dose by 2.5 2x a day is needed upwards of a max of 7.5mg 2x day. 50-60 bpm the dose stays at the highest dose of 5mg 2x a day. Under 50 bmp or if symptoms of bradycardia are present, the dose must be decreased by 2.5 mg 2x a day is required. If current therapy dose is 2.5 mg 2x a day, then discontinuation is required.

Side effects

With every medication comes side effects. The most common of side effects associated with Corlanor were:
Bradycardia on average 10% vs 2.2% in placebo
Hypertension, blood pressure increased 8.9% 7.8%
Atrial fibrillation 8.3% 6.6%

 

REFERENCES

  1. Food and Drug Administration. FDA News Release – FDA approves Corlanor to treat heart failure. 
  2. Swedberg K, Komajda M, Bohm M, et al. Ivabradine and outcomes in chronic heart failure (SHIFT): A randomised placebo-controlled study. Lancet 2010; 376:875–885. Abstract
  3. Otto MA. Ivabradine approved to reduce heart failure hospitalizations. PM 360, April 16, 2015