Abbott losing the cholesterol control drug race

AIM-HIGH, a National Heart, Lung, and Blood Institute study, was created to test whether or not raising High Density Lipoprotein cholesterol levels with a combination of Niaspan and simvastatin (a form of lipid treatment) would provide an additional 25 percent reduction in cardiovascular outcomes; the study focused on patients who have a cardiovascular disease and controlled levels of Low Density Lipoprotein, who would otherwise not have been recommended for additional treatment.  

 

The study AIM-HIGH was surprisingly terminated early due to an analysis conducted in May that found the additional form of lipid treatment did not improve upon cardiovascular events; the combination of the treatments was actually linked to strokes in 1.6 percent of patients, compared with 0.7 percent in the control group. The combination did not reduce heart attacks, heart-related hospitalizations, or the need for medical procedures to reduce chest pain and reinstate significant blood flow. The final results of the AIM-HIGH  were shown to be statistically insignificant, a shocker for such a large pharmaceutical company.

 

LDL, the “bad” cholesterol, is transported in the bloodstream. As it makes it’s way through the body, LDL tends to leave behind deposits in the blood stream and the blood vessels. Over time, the deposits can accumulate into plaque. Large amounts of plaque can block blood vessels, which is why LDL cholesterol is associated with cardiovascular diseases; the blockage of a blood vessel can lead to heart attacks and strokes. While LDL is a naturally occurring fat in the body, different diets can alter the levels of LDL for better or for worse.

 

On the other hand, HDL is considered to be the “good” cholestrol. As it flows through the blood stream, the HDL acts as a maintenance crew and sweeps away LDL (and it’s respected deposits) back  to the liver.

 

The AIM-HIGH study, which tested patients with cardiovascular diseases and well controlled lipid levels, sheds light on the benefits of additional lipid treatments.

 

According to the National Cholesterol Education Program (NAEP)The primary target of lipid therapy is the “bad” cholesterol, and the secondary target is non-HDL cholesterol. Patients in the study who were at high risk for cardiovascular disease are recommended, by the NAEP to have the following ideal levels of cholesterol: 70 mg/dL or less for LDL, 100mg/dL or less for HDL, and 100mg/dL for non-HDL.

 

Though 94 percent of patients in the study had low levels of HDL cholesterol in the blood (35mg/dL), they  were shown to have LDL cholesterol levels of 71 mg/dL, non-HDL levels of 106 mg/dL, and triglyceride levels of 161 mg/dL.

 

"Niaspan remains an important treatment option to help patients reach their lipid treatment goals, many of whom require multiple medications to do so. Even when looking only at the high-risk patient group evaluated in the AIM-HIGH study, epidemiologic data tell us that in clinical practice more than three-quarters of these patients do not reach their recommended goals for lipid therapy," said John Leonard, M.D., Senior Vice President, Global Pharmaceutical Research and Development, Abbott. "Physicians should consider each patient’s cardiovascular profile and the NCEP treatment guidelines when evaluating a patient for potential additional treatment with lipid lowering medicines such as Niaspan."

 

On Novemer 9, 2011, another one of Abbotts feeble attempts at a cholesterol regulating drugs, Trilipix, was found by U.S health regulators to be ineffective in lowering the risks of stroke and heart attack.

 

Amgen, a serious competitor of Abbott, recently announced their impressive test results of a drug that reduces levels of LDL. Their drug AMG145 blocks the protein called PCSK9, thereby reducing LDL levels by nearly two thirds. Amgen’s study, however, was focused on patients who were not on any other medications. They do have plans, though, for conducting a new study on patients on medication for cholesterol control. With almost a 64 percent improvement of cholesterol in just a single dose of medicine, it is very safe to say that Amgen’s study results significantly outshine the insignificant ones of Abbott.

 

Clapton Dias, Medical Sciences Director of Clinical Pharmacology and Early Development at Amgen, commented that AMG145 ”appears to be a promising way to lower [LDL] cholesterol...”

 

U.S. biotechnology company Regeneron and their partner, the French pharmaceutical company Sanofi, will soon begin late-stage studies of their injectable product REGN727. This injection provides a potentially more effective approach to treating LDL than conventional means like Abbott’s failed avenue.. It is a fully human monoclonal antibody intended to act against PCSK9, proteins that plays an important role in regulating LDL levels. The firms presented, last week, positive Phase II data from two studies, one of which included  combining the drug with Pfizer's Lipitor (atorvastatin). These tests and studies definitely place Regeneron as a potential winner in the race.

 

Other companies conducting rival studies on anti-PCSK9 medicines include the worthy adversaries: Alnylam Pharmaceuticals, Pfizer, Merck & Co, and a partnership between Bristol-Myers Squibb and Isis Pharmaceuticals.

 

As is typical with large, competitive pharmaceutical companies, a race to create the biggest and baddest drug will continue. For the time being it appears that Abbott is getting lost in the dust struggling to keep up while other companies speed along with obvious ease.