Monthly injections of an experimental drug from Amgen Inc slashed levels of cholesterol by up to an additional 66 percent in patients already taking statins, researchers said on Sunday, making it a potential strong rival to a similar drug being developed by Regeneron Pharmaceuticals Inc.
Amgen and Regeneron are racing to develop medicines that cut cholesterol through a new strategy, by blocking a protein called PCSK9.
In earlier studies, both drugs cut levels of “bad” LDL cholesterol by up to two thirds, although Amgen’s AMG 145 had been tested in healthy volunteers taking no other cholesterol medicines, while Regeneron’s REGN 727 was tested in patients with High cholesterol that also took statins.
Amgen on Sunday reported its first results from an early-stage trial of AMG 145 in patients with High cholesterol also taking statins, and impressive findings were seen in those getting injections every two weeks or every month.
In the 51-patient study, patients receiving monthly injections of AMG 145 and taking low to moderate doses of statins had up to a two-thirds reduction in LDL cholesterol by the eighth week of the study.
“We gave two doses four weeks apart and at the eighth week there was minimal tapering off” of the drug’s potency, Clapton Dias, Amgen’s medical services director, said in an interview. “The 66-percent reduction of LDL was maintained.”
Lower Your High LDL-Bad Cholesterol
In short, cholesterol is a group of lipids (fats) vital to cell membranes, nerve fibers and bile salts, and a necessary precursor for the sex hormones.
LDL-“bad cholesterol” carries cholesterol for cell building needs, but leaves behind any excess on artery walls and in tissues.
HDL-“good cholesterol” helps to prevent narrowing of the artery walls by removing the excess cholesterol and transporting it to the liver for excretion.
High LDL and low HDL levels indicate diets high in refined carbohydrates and/or carbohydrate sensitivity.
In patients receiving injections of AMG 145 every two weeks in combination with low to moderate doses of statins, LDL reductions of up to 75 percent were seen after six weeks, Amgen said.
Signs of Elevated Cholesterol
Fairly common on the eyelids, xanthomas are yellow, soft and slightly raised non-contagious bumps made of cholesterol deposits. They occur both in men (33 per cent) and women (40 per cent) who have elevated cholesterol levels.
Another sign of High cholesterol levels in the blood are xanthelasma - yellow patches on the eyelids, common in diabetics.
Those taking the Amgen drug every two weeks in combination with high doses of statins had LDL reductions of up to 63 percent.
Classification of Cholesterol Levels
In medicine cholesterol is measured in metric units - either:
in milligrams per deciliter of blood, abbreviated as mg/dL (used in U.S.), or
in millimoles per liter of blood, abbreviated as mmol/L (used in Canada and Europe).
A deciliter (dL) is 1/10 of a liter or about 1/4 of a pint. A mole is an amount of a substance (in this case, cholesterol) that contains a certain number of molecules or atoms. A millimole (mmol) is 1/1,000 of a mole.
Total cholesterol levels:
- less than 200 mg/dL (5.17 mmol/L) is considered desirable
- 200 mg/dL - 239 mg/dL (5.17 mmol/L - 6.18 mmol/L) - borderline-high
- 240 mg/dL and above (6.21 mmol/L and higher) is considered high.
LDL-“bad” cholesterol levels:
- less than 100 mg/dL (less than 2.6 mmol/L) is considered optimal
- 100 mg/dL - 129 mg/dL (2.6 mmol/L - 3.35 mmol/L) - near optimal or above optimal
- 130 mg/dL - 159 mg/dL (3.35 mmol/L - 4.10 mmol/L) - borderline high
- 160 mg/dL - 189 mg/dL (4.12 mmol/L - 4.88 mmol/L) - high
- 190 and above (4.90 mmol/L and greater) is considered very high.
HDL-“good” cholesterol levels:
- 60 mg/dL (1.56 mmol/L) or higher is considered desirable (it reduces the risk of heart disease, even if total or LDL cholesterol is high)
- 40 mg/dL - 60 mg/dL (1.04 mmol/L - 1.56 mmol/L) - acceptable
- below 40 mg/dL (1.04 mmol/L) is considered low (it increases the risk for coronary artery disease in people who also have high total cholesterol levels).
Data from the Phase 1 study were presented at the annual scientific sessions of the American College of Cardiology being held in Chicago.