Combination drug

| Nov 1, 2005

Heart disease and stroke are leading causes of death in people with diabetes. As important as it is to keep blood glucose in line, maintaining a healthy lipid profile is also tantamount to healthy longevity.

Great strides have been made over the years with medications such as statins and ACE inhibitors to keep cholesterol and blood pressure at healthy levels for people with and without diabetes. With the marriage of the statin Zocor (simvastatin) and the cholesterol absorption inhibitor Zetia (ezetimibe), Merck/Schering-Plough Pharmaceuticals has a combination drug called Vytorin that does double duty at keeping your lipid profile in line.

According to Merck, Vytorin

  • Helps block the absorption of cholesterol that comes from food and 
  • Reduces the cholesterol that is already made in the body

Vytorin has been demonstrated to lower bad (LDL) and total cholesterol, while raising good (HDL) cholesterol. In addition, it lowers triglycerides, the fatty substances in the blood.

Source: Merck/Schering-Plough Pharmaceuticals

Who Should Not Take Vytorin

Do not take Vytorin

  • If you are allergic to Zocor or Zetia
  • If you have active liver disease or a blood test indicates possible liver problems
  • If you are pregnant, think you might be pregnant, are planning on becoming pregnant or if you are breastfeeding

Source: Merck/Schering-Plough Pharmaceuticals

Side Effects of Vytorin

In clinical studies, patients reported the following common side effects while taking Vytorin:

  • Headache
  • Muscle pain

In addition, patients taking Zocor or Zetia have reported the following side effects:

  • Swelling of the face, lips, tongue or throat
  • Rash
  • Liver problems
  • Inflammation of the pancreas
  • Nausea
  • Gallstones

Source: Merck/Schering-Plough Pharmaceuticals

Skip Irvine is a spokesperson for Merck/Schering Plough Pharmaceuticals

Which diabetic patient profile is appropriate for Vytorin, and why?

All patients with diabetes are potentially at increased cardiovascular risk and should be considered for lipid-modifying interventions. The presence of additional risk factors beyond diabetes itself (such as hypertension, dyslipidemia, smoking) adds to the risk and the importance of optimizing plasma lipids.

Vytorin is the first and only product approved to treat the two sources of cholesterol by inhibiting the production of cholesterol in the liver and blocking the absorption of cholesterol in the intestine, including cholesterol from food.

What future studies are planned to demonstrate Vytorin’s efficacy?

No incremental benefit of Vytorin on cardiovascular morbidity and mortality over and above that demonstrated for Zocor has been established. Merck/Schering-Plough Pharmaceuticals has announced several large-scale clinical trials for Vytorin. One of them, known as IMPROVE IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial) will directly evaluate the risk reduction provided by Vytorin 10/40 mg as compared to Zocor 40 mg for major cardiovascular events in approximately 10,000 patients presenting with acute coronary syndromes. The intent of the study is to determine whether Vytorin provides incremental reductions in cardiovascular events in these patients, as compared to Zocor alone.

Vytorin Beats Lipitor in Diabetic Study Population

According to a study featured last summer at the ADA Scientific Sessions in San Diego, California, people with diabetes taking Vytorin showed greater improvement in LDL, total and HDL cholesterol when compared to people taking Lipitor. In addition, improvements to triglyceride levels were comparable to those seen in people taking Lipitor.

In the diabetic subgroup study population of the Vytorin vs. Atorcastatin trial, 212 people taking Vytorin experienced a 56.2 percent decrease in LDL cholesterol, a 40.7 percent decrease in total cholesterol, a 26.7 decrease in triglycerides and a 6.4 increase in HDL cholesterol. The 201 people taking Lipitor experienced a 45.6 decrease in LDL cholesterol, a 34.3 decrease in total cholesterol, a 25.5 percent decrease in triglycerides and a 3.9 percent increase in HDL cholesterol.

[Abstract 962-P]

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Categories: Blood Glucose, Diabetes, Diabetes, Food, Medications

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