Heart disease and stroke are leading causes ofdeath in people with diabetes. As importantas it is to keep blood glucose in line, maintaininga healthy lipid profile is also tantamount tohealthy longevity.

Great strides have been made over the yearswith medications such as statins and ACEinhibitors to keep cholesterol and blood pressureat healthy levels for people with and withoutdiabetes. With the marriage of the statin Zocor(simvastatin) and the cholesterol absorptioninhibitor 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 lowerbad (LDL) and total cholesterol, while raisinggood (HDL) cholesterol. In addition, it lowerstriglycerides, 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 commonside effects while taking Vytorin:

  • Headache
  • Muscle pain

In addition, patients taking Zocor or Zetia have reported thefollowing 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/ScheringPlough Pharmaceuticals

Which diabetic patient profile is appropriate forVytorin, and why?

All patients with diabetes are potentially at increasedcardiovascular risk and should be considered for lipid-modifyinginterventions. The presence of additional riskfactors beyond diabetes itself (such as hypertension,dyslipidemia, smoking) adds to the risk and theimportance of optimizing plasma lipids.

Vytorin is the first and only product approved to treat thetwo sources of cholesterol by inhibiting the productionof cholesterol in the liver and blocking the absorption ofcholesterol in the intestine, including cholesterol fromfood.

What future studies are planned to demonstrateVytorin’s efficacy?

No incremental benefit of Vytorin on cardiovascularmorbidity and mortality over and above thatdemonstrated for Zocor has been established. Merck/Schering-Plough Pharmaceuticals has announcedseveral large-scale clinical trials for Vytorin. One of them,known as IMPROVE IT (Improved Reduction of Outcomes:Vytorin Efficacy International Trial) will directly evaluatethe risk reduction provided by Vytorin 10/40 mg ascompared to Zocor 40 mg for major cardiovascularevents in approximately 10,000 patients presentingwith acute coronary syndromes. The intent of the studyis to determine whether Vytorin provides incrementalreductions in cardiovascular events in these patients, ascompared to Zocor alone.

Vytorin Beats Lipitor in Diabetic Study Population

According to a study featured last summer at the ADAScientific Sessions in San Diego, California, peoplewith diabetes taking Vytorin showed greater improvementin LDL, total and HDL cholesterol when comparedto people taking Lipitor. In addition, improvementsto triglyceride levels were comparable to those seen inpeople taking Lipitor.

In the diabetic subgroup study population of theVytorin vs. Atorcastatin trial, 212 people taking Vytorinexperienced a 56.2 percent decrease in LDL cholesterol, a40.7 percent decrease in total cholesterol, a 26.7 decreasein triglycerides and a 6.4 increase in HDL cholesterol.The 201 people taking Lipitor experienced a 45.6 decreasein LDL cholesterol, a 34.3 decrease in total cholesterol,a 25.5 percent decrease in triglycerides and a 3.9 percentincrease in HDL cholesterol.

[Abstract 962-P]

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