U.S. FDA issues an early communication about ongoing data review of three Cholesterol lowering agents

<p>On January 26, 2008, the U.S. Food and Drug Administration (FDA), the American equivalent to the Saudi Food and Drug Authority (SFDA), has issued an early communication about ongoing data review for the following cholesterol-lowering agents:</p>
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<p><strong>Generic Name</strong></p></td>
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<p><strong>U.S. Trade Name</strong></p></td>
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<p><strong>Saudi Arabia Trade Name(s)</strong></p></td></tr>
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<p>Ezetimibe</p></td>
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<p>Zetia</p></td>
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<p>Ezetrol</p></td></tr>
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<p>Ezetimibe + Simvastatin</p></td>
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<p>Vytorin</p></td>
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<p>Inegy</p></td></tr>
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<p>Simvastatin</p></td>
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<p>Zocor</p></td>
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<p>Zocor, Simvagen</p></td></tr></tbody></table>
<p>Ezetimibe was approved in U.S. in October 2002 to manage high cholesterol levels. It acts by inhibiting the absorption of cholesterol from the intestine. The drug was approved in Saudi Arabia in 2004. Simvastatin is a drug that belongs to a group of drugs known as “statins”. The statins available in Saudi Arabia are: Fluvastatin (Lescol); Pravastatin (Lipostat); Rosuvastatin (Crestor); and Simvastatin (Zocor) or (Simvagen).</p>
<p>The manufacturers of both Zetia and Vytorin, Merck/Schering Plough Pharmaceuticals, reported preliminary results from the Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia (ENHANCE) trial. This trial was designed to evaluate the amount of atherosclerotic plaque in blood vessels located in the neck based on images obtained through ultrasound in patients treated with Vytorin (Ezetimibe plus Simvastatin) or Simvastatin alone. </p>
<p>Manufacturers stated that there was no significant difference between Vytorin and Simvastatin in the amount of atherosclerotic plaque in the inner walls of the carotid (neck) arteries despite greater lowering of LDL-cholesterol (bad cholesterol) with Vytorin compared to Simvastatin. Once Merck/Schering Plough completes the analysis of the unblinded data from ENHANCE, it will submit a final study report to the U.S. FDA. Once the U.S. FDA receives the final study report, FDA estimates it will take approximately 6 months to fully evaluate the data. After reviewing the data from the ENHANCE study, and considering all other available information about the link between LDL lowering and reduction of cardiovascular events, FDA will determine whether any further regulatory action is warranted with regard to Zetia and Vytorin and also whether any changes to FDA’s current approach to drugs that lower LDL cholesterol are warranted.</p>
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<p><strong>ACTIONS THAT HEALTHCARE PROFESSIONALS AND PUBLIC SHOULD FOLLOW:</strong></p>
<p>· Patients should talk to their doctors if they have further questions about the information from the ENHANCE trial.</p>
<p>· Healthcare professionals are not advised to discontinue prescribing Ezetimibe or Simvastatin until further scientific details are published.</p>
<p><strong><br />REPORT ADVERSE DRUG REACTIONS TO THE SAUDI FDA</strong> </p>
<p>The public and health professionals are encouraged to report adverse drug reactions the National Pharmacovigilance Center on the Internet at: </p>
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