Generic Zocor - Simvastatin

The IDEAL economic analysis assessed the cost-effectiveness of preventing cardiovascular events for patients who took intensive Lipitor therapy versus standard dose Zocor. The analysis compared the total cost per patient for 4.8 years in each treatment group by calculating medication costs, the cost of hospitalizations associated with cardiovascular events and lost work days for the U.S. and for Sweden. The cost of Lipitor was compared to the cost of generic simvastatin for Sweden. For the U.S., the cost of Lipitor was compared to Zocor in three scenarios, including:

– Lipitor compared to the current U.S. price of Zocor (simvastatin);

– Lipitor compared to a 50% reduction in the current U.S. price of Zocor;

– Lipitor compared to a 75% reduction in the current U.S. price of Zocor

“IDEAL, which is one of a limited number of head to head statin therapy trials showed that patients using intensive atorvastatin therapy compared with standard dose simvastatin suffered fewer cardiovascular events. The findings in IDEAL, along with other positive studies of intensive atorvastatin therapy against active treatment comparitors such as AVERT, PROVE-IT, REVERSAL and ALLIANCE, indicate that all statin therapy in not alike,” said Dr. Michael Koren, director of non-invasive cardiology at Memorial Hospital in Jacksonville, Florida. “Switching patients from atorvastatin to other less effective drugs could have negative health implications for patients. The IDEAL pharmacoeconomic analysis makes the case that drug cost savings from use of generic statins may be largely offset by higher patients care and indirect costs.”

The results were presented at the annual American Heart Association Quality of Care and Outcomes Research Meeting in Washington, D.C., and a summary of the data was published in the current issue of “Circulation.”

The newly announced American Heart Association (AHA) and American College of Cardiology (ACC) guidelines on secondary prevention further support LDL reduction. The new guidelines recommend that LDL-cholesterol should be less than 100 mg/dL for all patients with CHD and other forms of atherosclerosis vascular disease. In the IDEAL study, patients treated with Lipitor achieved average LDL-cholesterol levels of 81 mg/dL which was significantly lower than patients taking Zocor, who had an average LDL-cholesterol level of 104 mg/dL.

Lipitor is the most prescribed cholesterol-lowering therapy in the world, with nearly 115 million patient-years of experience. Lipitor is a prescription drug. It is used in patients with multiple risk factors for heart disease such as family history, high blood pressure, age, low HDL or smoking to reduce the risk of heart attack and stroke. When diet and exercise alone are not enough, Lipitor is used along with a low-fat diet and exercise to lower cholesterol.

Lipitor is also used in patients with type 2 diabetes and at least one other risk factor for heart disease such as high blood pressure, smoking or complications of diabetes, including eye disease and protein in urine, to reduce the risk of heart attack and stroke.

Lipitor is not for everyone. It is not for those with liver problems. And it is not for women who are nursing, pregnant or may become pregnant.

If you take Lipitor, tell your doctor if you feel any new muscle pain or weakness. This could be a sign of rare but serious muscle side effects.

Tell your doctor about all medications you take. This may help avoid serious drug interactions. Your doctor should do blood tests to check your liver function before and during treatment and may adjust your dose. The most common side effects are gas, constipation, stomach pain and heartburn.

They tend to be mild and often go away.

Pfizer Inc said today that a new economic analysis that compares outcomes for patients taking Lipitor to those taking Zocor shows that Lipitor patients had greater reductions in heart attacks, strokes and cardiovascular procedures. This provides a cost savings for payors in long-term hospitalizations and surgical costs.

The economic analysis examined the results from the IDEAL (Incremental Decrease in Endpoints Through Aggressive Lipid Lowering) trial to analyze the cost effectiveness of treatment with Lipitor and Zocor (simvastatin) in Sweden, where Zocor is available generically as simvastatin. The IDEAL patients who received Lipitor (80 mg) achieved greater reductions in heart attacks, strokes and cardiovascular procedures compared to patients taking standard dose Zocor (20-40 mg).

The results also showed that one out of every six heart attacks, strokes or cardiovascular procedures could be avoided for coronary heart disease patients treated with intensive Lipitor therapy above and beyond those treated with Zocor over 4.8 years.

These results were then applied to the U.S. health care system, with two key findings:

– Better efficacy was achieved in patients taking Lipitor, at a better overall value, compared to patients on standard Zocor therapy; and Patients taking Lipitor achieved greater reductions in cardiovascular events, and the system had overall cost savings, compared to patients taking Zocor at the current U.S. price, and even when Zocor was discounted by 50 percent.

In the U.S., cardiovascular disease remains the nation’s leading health threat, and accounts for an estimated 500,000 recurrent heart attacks and 200,000 recurrent debilitating strokes annually.

“The economic impact of heart attacks and strokes in the U.S. alone totals nearly $403 billion in medical care and lost productivity annually,” said Dr. Peter Lindgren, Stockholm Health Economics. “This analysis suggests that the cost of using Lipitor versus generic simvastatin could represent a good value for money.”

“Even if the current U.S. price of Zocor were reduced by 75 percent, Lipitor patients could still achieve better cardiovascular outcomes at an increase to payors of less than one dollar a day,” said Dr. Gregg Larson, vice president cardiovascular medical at Pfizer. “While the economic cost of a stroke can be exorbitant, often entailing years of rehabilitation and supervised care the emotional impact on patients and their families is also devastating.”

Many top-selling drugs used to treat cancer and lower cholesterol are made from organic compounds called polyketides, which are found in nature but historically difficult for chemists to alter and reproduce in large quantities.

For the first time, scientists at UC Irvine have discovered how polyketides form their ringlike shape, making it easier for chemists to manipulate them into new drugs.

The key, they found, is an enzyme called aromatase/cyclase, which forms a C-shape mold in which polyketides can form one molecule at a time. By changing this mold, chemists can control the size and shape of the polyketide, resulting in the formation of new drugs.

“Almost every polyketide has rings in its chemical structure, and if we can control ring formation, we can produce more polyketide drugs,” said Sheryl Tsai, lead author of this study and an assistant professor of molecular biology and biochemistry and chemistry at UCI. “Until now, polyketide ring formation was a mystery that hampered our efforts to produce new drugs.”

The research appears online this week in the Proceedings of the National Academy of Sciences.

Polyketide-based drugs and products account for more than $35 billion in sales annually. They include antibiotics that can cure a bacteria infection (tetracycline and erythromycin); anti-cancer drugs used in chemotherapy (doxorubicin and mithramycin); anti-oxidants that help prevent cancer and promote heart strength (EGCG and resverastrol); and drugs that lower cholesterol levels (Zocor). Green tea and red wine also contain beneficial polyketides.

Polyketides are made naturally by bacteria, fungi, plants and marine animals. Those organisms produce polyketides to kill their predators, be it another bacteria or fungi. They can produce different types of polyketides that kill different types of enemies.

“Because bacteria do not have arthritis or diabetes, they would not evolutionally select polyketides that could be used for arthritis or diabetes treatment,” Tsai said. “But we can coax the bacteria to do precisely that, if we can control the ring formation in the polyketides.”

Prior to this study, it was not known how nature controls the polyketide ring shape, which is essential for antibiotic and anti-cancer properties.

By using molecular cloning and chemical biology techniques, Tsai and her scientific team discovered that the aromatase/cyclase enzyme has a pocket that shapes the polyketide, promoting a unique ring pattern.

Said Tsai: “We hope this will lead to the development of new drugs in such areas as cancer therapeutics, obesity treatment and stem cell research.”