New Data Show High Frequency Of Medical Claims For Gastrointestinal Events By Patients On Antiplatelet Therapy

A review of medical claims from more than 70 managed care plans showed that 6. 2 percent of patients prescribed the antiplatelet medicine clopidogrel submitted at least one insurance claim for ulcer or gastrointestinal bleeding, according to data released by Cogentus Pharmaceuticals, Inc. here at annual meeting of International Society for Pharmacoeconomics and Outcomes Research.

Clopidogrel, marketed as Plavix ( R ) , is among world's largest-selling prescription medicines and is prescribed to prevent heart attacks and strokes. The retrospective study reported tracked insurance claims for gastrointestinal adverse events among more than 368, 000 patients in the 12 months following their first prescription for clopidogrel.

" This study provides important new information about frequency of medical attention for gastrointestinal events required by an insured population on antiplatelet therapy, " said lead author Doctor Pablo Lapuerta, Chief Medical Officer and Senior Vice President for Clinical Strategy at Cogentus.

" Inhibition of normal platelet function by clopidogrel likely contributed to gastrointestinal complications, particularly in such a real-world setting in which patients often have multiple risk factors, " he said. " While it's important for patients to stay on clopidogrel to prevent progression of coronary heart disease, ulcers and bleeding can result in patients not taking their heart disease medicine. '

Experts believe that multiple factors contribute to ulcer disease and its complications. Studies have shown an increased risk of gastrointestinal bleeding among patients using antiplatelet medicines such as clopidogrel or aspirin, and an even higher risk for patients taking clopidogrel in combination with aspirin or other non-steroidal anti-inflammatory drugs ( NSAIDS ) . One study showed that treatment with clopidogrel augmented bleeding caused by NSAIDS, an effect attributed to inhibition of platelets by clopidogrel.

Increasing age is a recognized risk factor for ulcer disease, and clopidogrel is commonly prescribed for elderly patients with atherosclerosis. In the insurance claim review, 72 percent of patients were over 60 years of age. Information about concurrent aspirin use, which is common among patients with cardiovascular disease and particularly among clopidogrel users, was not available. A higher incidence of bleeding side effects was seen in women -- 7. 2 percent filed medical claims for an ulcer or gastrointestinal bleeding while 5. 4 percent of men filed claims.

" The surprisingly high frequency of these claims raises a significant public health concern, " said Dr. Byron Cryer, John C. Vanatta III Professor of Medicine and Associate Dean for Minority Affairs at Southwestern Medical School in Dallas. " Until recently, gastrointestinal side effects in patients taking antiplatelet therapy have been largely underappreciated by physicians, who are appropriately focused on preventing future heart attacks. We need to address this problem to help keep patients on their medical treatment regimens. '

Doctor Cryer is a member of the Scientific Steering Committee overseeing COGENT, the global Phase 3 clinical trial program sponsored by Cogentus. The COGENT program will evaluate efficacy and safety of Cogentus's lead product, CGT-2168, which combines clopidogrel and gastroprotectant omeprazole. CGT-2168 is designed to maintain cardiovascular benefits of antiplatelet therapy while reducing its potentially serious gastrointestinal side effects.

ABOUT COGENTUS

Cogentus Pharmaceuticals, Inc. , of Menlo Park, CA, is a privately held specialty pharmaceutical company founded in 2006. Cogentus ( http: //www. cogentus. net ) is committed to becoming a premier developer of innovative, fixed-dose combination prescription medicines serving unmet medical needs that drive significant commercial opportunities.

ABOUT COGENT

COGENT stands for Clopidogrel and Optimization of Gastrointestinal Events Trial. The program is expected to enroll more than 4, 000 patients at hundreds of sites in the United States, Canada, Europe and South America. The COGENT program is designed to measure incidence of upper gastrointestinal bleeding and ulcers in patients who take CGT-2168 and aspirin compared with patients who take clopidogrel and aspirin. The vast majority of patients who take clopidogrel also take aspirin.

Plavix ( R ) is a registered trademark of Sanofi-Aventis

Cogentus Pharmaceuticals, Inc http: //www. cogentus. net

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Zyrtec? For what?

Zyrtec: uses

Zyrtec is an antihistamine which provides relief of seasonal and perennial allergy symptoms such as watery eyes, runny nose ( rhinitis ) , itching eyes, and sneezing. It is also used for hives.

Zyrtec: how to use

Take Zyrtec by mouth once a day; or use as directed by your doctor. Zyrtec may be taken with or without food.

Don't increase your dose or take this more often than directed.

Don't take Zyrtec for several days before allergy testing since test results can be affected.

Inform your doctor if your condition persists or worsens.

Zyrtec: side effects

Drowsiness, fatigue and dry mouth may occur while use Zyrtec. In children, stomach pain and vomiting may occur while use Zyrtec. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed Zyrtec because he or she has judged that benefit to we is greater than risk of side effects. Many people using Zyrtec don't have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur:

A serious allergic reaction to Zyrtec is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include:

This isn't a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Zyrtec: precautions

Before taking Zyrtec, tell your doctor or pharmacist if you're allergic to it; or to hydroxyzine; or if we have any other allergies.

Before using Zyrtec, tell your doctor or pharmacist your medical history, especially of:

Zyrtec may make we drowsy; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages.

Caution is advised when using Zyrtec in the elderly because they may be more sensitive to the effects of drug, especially drowsiness effect.

Zyrtec should be used only when clearly needed during pregnancy. Discuss risks and benefits with your doctor.

Zyrtec passes into breast milk. Breast-feeding isn't recommended while using Zyrtec.

Zyrtec: interactions

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Don't start, stop, or change the dosage of any medicine before checking with them first.

Before using Zyrtec, tell your doctor or pharmacist of all prescription and nonprescription products we may use, especially of drugs that cause drowsiness such as:

Check labels on all your medicines ( e. g. , cough-and-cold products ) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products.

This document doesn't contain all possible interactions. Therefore, before using Zyrtec, tell your doctor or pharmacist of all products we use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Zyrtec: overdose

If overdose of Zyrtec is suspected, contact your local poison control center or emergency room immediately. US residents can call US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: severe drowsiness. In children, symptoms may include initial restlessness and irritability followed by drowsiness.

Zyrtec: notes

Don't share Zyrtec with others.

Zyrtec: missed dose

If you miss a dose Zyrtec, use it as soon as we remember. If it is near the time of next dose, skip missed dose and resume your usual dosing schedule. Don't double dose of Zyrtec to catch up.

Zyrtec: storage

Store Zyrtec at room temperature between 68-77 degrees F ( 20-25 degrees C ) away from light and moisture. Brief storage between 59-86 degrees F ( 15-30 degrees C ) is permitted. Or store in the refrigerator between 36-46 degrees F ( 2-8 degrees C ) . Don't store Zyrtec in the bathroom. Keep all medicines away from children and pets.

Properly discard Zyrtec when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Shipping options for Zyrtec