Drugs Xagena
Evolocumab ( Repatha ) is a monoclonal antibody targeting proprotein convertase subtilisin/kexin type 9 ( PCSK9 ) that is administered subcutaneously at a dosage of 140 mg every 2 weeks or 420 mg once monthly.
Across 12-week phase III trials in patients with primary hypercholesterolemia or mixed dyslipidemia, Evolocumab was more effective than placebo ( treatment difference -54.8 to -76.3 % ) and/or Ezetimibe ( treatment difference -36.9 to -47.2 % ) at reducing low-density lipoprotein cholesterol ( LDL-C ) levels, including when added to statin therapy, when administered to statin-intolerant patients, when administered as monotherapy, and in patients with heterozygous familial hypercholesterolemia who were receiving statins with or without other lipid-lowering drugs.
Evolocumab also significantly lowered LDL-C levels ( treatment difference of ≈30 % vs. placebo ) in patients with homozygous familial hypercholesterolemia when added to statins with or without Ezetimibe in a 12-week phase III trial.
The efficacy of Evolocumab was maintained in the longer term, and it was well tolerated.
In conclusion, subcutaneous Evolocumab is a valuable new treatment for use in primary hypercholesterolemia or mixed dyslipidemia and homozygous familial hypercholesterolemia, particularly in patients unable to reach LDL-C goals despite treatment with statins with or without other lipid-lowering therapies and in patients who do not tolerate or are not able to receive statins. ( Xagena )
Keating GM, Am J Cardiovasc Drugs 2015; Epub ahead of print
XagenaMedicine_2015
