The results of a clinical trial for an injectable drug to lower LDL levels show promising results. The FOURNIER clinical trial results for the Amgen produced Repatha were presented at the American College of Cardiology in March 2017. The goals of the FOURNIER trial was to prove if Repatha reduced cardiovascular risk associated with high cholesterol and cardiovascular death.
High cholesterol affects millions of Americans and low density lipoprotein (LDL) is many times the culprit. LDL is frequently referred to as the “bad cholesterol.” High levels of LDL have been correlated to an increased risk of cardiovascular disease and strokes. Statins have and continue to be one of the widely prescribed drugs to combat high cholesterol. Repatha is manufactured by Amgen as an alternative to traditional statin drug therapy for high cholesterol.
What Is An Approved PCSK9 Inhibitor ?
Proprotein convertase subtilisin/kexin type 9 (PCSK9) is the gene with the function of regulating cholesterol in the blood through its’ instructions. The protein can regulate the number of LDL receptors; therefore a PCSK9 drug will inhibit the production of LDL cholesterol. Two PCSK9 inhibitors, evolocumab and alirocumab were tested in two different groups in clinical trials. The PCSK9 gene was only discovered in 2003; scientists are encouraged and hope the clinical trials will provide the data necessary for a new drug therapy to treat high cholesterol.
One of the benefits of approved PCSK9 inhibitors is the administration. The injection would be by sub-q which is better tolerated by patients and the injections would be necessary once or twice a month versus a daily pill which would be much easier for patients than a daily pill to remember.
Will PCSK9 Replace Statins?
Many patients with high cholesterol control their cholesterol by taking a class of drugs called statins. Lipitor is a very popular statin; however, many people cannot medically tolerate statins. Whether it due to genetics or the side effects, statins fail to control LDL in many patients. Statins lower the LDL by inhibiting enzymes which in turn help the liver produce cholesterol. Statins remain one of the most widely prescribed drugs and include: Lescol, Mevacor, Altocor, Pravachol, Crestor and Zocor. Due to the expiration of the patents, many statins are also available as generic drugs.
Current Clinical Trials LDL
Clinicaltrials.gov is a service provided by the U.S. National Institutes of Health. It is a wonderful and informative resource to find, monitor and participate in clinical trials. Many LDL clinical trials are currently listed and seeking volunteers. Completed trials are also listed along with the specific information of each trial and the administrator.
The results of the FOURNIER clinical trial for Repatha is available here.
Repatha: The $14,000 Cholesterol Fighting Drug – Is It Worth The Price?