Healthcare Industry News:  sanofi-aventis 

Biopharmaceuticals

 News Release - June 20, 2006

New Data Reveals That Enoxaparin Results in Significant Cost Savings Compared to Unfractionated Heparin (UFH) in Treatment of in-Hospital Patients at Risk for Venous Thromboembolism (VTE)

Thrombosis Management Clinical Effectiveness Initiative(R) (CEI) Study Demonstrates Cost Savings of More Than $1,000 Per Discharge With Enoxaparin

BRIDGEWATER, N.J., June 20 (HSMN NewsFeed) -- A large scale study providing the first actuarial-based analysis of prophylaxis with enoxaparin compared to unfractionated heparin (UFH) in patients at risk for venous thromboembolism (VTE) was published today in Pharmacy & Therapeutics (P&T). The study, "Cost Implications of Using Unfractionated Heparin or Enoxaparin in Medical Patients At-Risk for Venous Thromboembolic Events," reveals that patients treated with enoxaparin (a low-molecular weight heparin [LMWH]) had an average savings in cost per discharge of $1,002 compared to patients treated with UFH, despite higher drug acquisition costs for enoxaparin. This four-year retrospective study (1999-2003) of more than 17,000 medical patients at risk of VTE in 15 hospitals nationwide including Brigham & Women's Hospital, Banner Good Samaritan Medical Center and Thomas Jefferson University Hospital, were part of the Thrombosis Management Clinical Effectiveness Initiative (CEI) conducted by Aon Corporation's Life Sciences Practice.

"The data support that, because of its cost-effectiveness, enoxaparin may be the preferred treatment strategy for prophylaxis in those at risk for deep-vein thrombosis and pulmonary embolism," said lead author Richard M. Weinberg, M.D. (Chief Quality Officer, Stamford Hospital, CT). "While UFH is inexpensive to purchase, the use of enoxaparin is associated with savings in several areas, including ICU charges, laboratory tests and medical-surgical supplies. This more than compensates for enoxaparin's higher acquisition cost."

In addition, data from the CEI study found that the lower total in-patient costs were not attributable to a shorter length of hospital stay, but resulted from savings achieved in several hospital cost centers including the ICU, laboratory and medical-surgical supplies. The most significant cost savings achieved by substituting enoxaparin for UFH occurred among patients with respiratory disease with a major complication or co-morbidity and unstable angina.

Research Design and Method

The CEI study included an analysis of administrative data from 89,584 medical patients at risk for VTE, hospitalized in 15 mid-to-large (< 300 beds and > 600 beds) hospitals nationwide. Based on principal diagnosis, secondary diagnosis, significant procedures, age, sex and discharge status, all discharges were categorized into severity adjusted "diagnosis related groups" (DRGs). Included in the analysis were DRGs in which at least 50% of patients had a length of hospital stay of five or more days. As a result, 10,953 patients receiving UFH and 6,246 receiving enoxaparin were compared based on the total cost of care associated with each therapy choice.

Key Findings

* The severity-adjusted total savings, summed across all 47 included diagnoses, showed that thromboprophylaxis with enoxaparin was less costly by $1,002 per discharge compared with UFH.

* In 74% of the included DRGs (n=35), lower costs were observed with enoxaparin compared with UFH.

* In 36.2% of the included DRGs (n=17), differences were statistically significant, 32% (n=15) showing lower costs with enoxaparin.

-- The largest cost-savings with the enoxaparin treatment were achieved in the diagnostic category of respiratory disease with a major complication or co-morbidity and unstable angina.

* A breakdown of costs per cost center revealed that the savings for ICU, laboratory and medical-surgery supplies comprised a large part of total savings.

* Those treated with enoxaparin had a 0.6-day longer mean length of hospital stay compared with patients taking UFH.

"The significant cost savings demonstrated by the data, combined with the overall beneficial safety and efficacy profile of enoxaparin, have important implications for hospital administrators," said Dr. Geno J. Merli, Ludwig Kind Professor of Medicine and Director Jefferson Center for Vascular Diseases, Jefferson Medical College and Thomas Jefferson University Hospital. "Hospital decision-makers should look to these results when considering cost-effective VTE prevention protocols."

The Thrombosis Management CEI was supported through a grant by sanofi-aventis U.S., the makers of LOVENOX® (enoxaparin sodium injection).

About Venous Thromboembolism (VTE)

Venous thromboembolism refers to two serious conditions: Deep-Vein Thrombosis (DVT) and pulmonary embolism. According to the American Heart Association, DVT blood clots affect up to 2 million Americans each year, and complications kill up to 200,000 people in the U.S. annually -- more than breast cancer and AIDS combined.

Treatments for DVT include early mobilization, sequential compression devices to prevent blood clotting, and anticoagulants and/or blood-thinning drugs.

About Lovenox®

Lovenox® (enoxaparin sodium injection) is a unique chemical entity in a class of antithrombotic agents known as low-molecular-weight heparins (LMWH). The No. 1 selling low-molecular-weight heparin in the world, Lovenox® is obtained by alkaline degradation of heparin benzyl ester and is about one-third the molecular size of unfractionated heparin. Numerous clinical studies have demonstrated that Lovenox® is a safe and effective way to significantly reduce the incidence of DVT in a wide range of patient populations, and is the only LMWH that is more effective than unfractionated heparin in the prophylaxis of ischemic complications of UA and NSTEMI when administered concomitantly with aspirin. This has been demonstrated by more than 15 years of use in the treatment of 130 million patients in 96 countries. With numerous national and international clinical studies demonstrating its safety and efficacy, Lovenox® is the most widely studied LMWH.

Important Safety Information

LOVENOX® (enoxaparin sodium injection) cannot be used interchangeably with other low-molecular-weight heparins or unfractionated heparin, as they differ in their manufacturing process, molecular weight distribution, anti-Xa and anti-IIa activities, units, and dosage.

When epidural/spinal anesthesia or spinal puncture is employed, patients anticoagulated or scheduled to be anticoagulated with low-molecular-weight heparins or heparinoids are at risk of developing an epidural or spinal hematoma, which can result in long-term or permanent paralysis.

The risk of these events is increased by the use of postoperative indwelling epidural catheters or by the concomitant use of drugs affecting hemostasis. Patients should be frequently monitored for signs and symptoms of neurological impairment. (See boxed WARNING -- http://products.sanofi-aventis.us/lovenox/Boxed%20Warning ).

As with other anticoagulants, use with extreme caution in patients with conditions that increase the risk of hemorrhage. Dosage adjustment is recommended in patients with severe renal impairment. Unless otherwise indicated, agents that may affect hemostasis should be discontinued prior to LOVENOX® therapy. Bleeding can occur at any site during LOVENOX® therapy. An unexplained fall in hematocrit or blood pressure should lead to a search for a bleeding site. (See WARNINGS -- http://products.sanofi-aventis.us/lovenox/Warnings and PRECAUTIONS -- http://products.sanofi-aventis.us/lovenox/Precautions).

Thrombocytopenia can occur with LOVENOX®. In patients with a history of heparin-induced thrombocytopenia, LOVENOX® should be used with extreme caution. Thrombocytopenia of any degree should be monitored closely. If the platelet count falls below 100,000/mm(3), LOVENOX® should be discontinued. Cases of heparin-induced thrombocytopenia have been observed in clinical practice. (See WARNINGS -- http://products.sanofi-aventis.us/lovenox/Warnings).

The use of LOVENOX® has not been adequately studied for thromboprophylaxis in pregnant women with mechanical prosthetic heart values. (See WARNINGS -- http://products.sanofi-aventis.us/lovenox/Warnings).

LOVENOX® is contraindicated in patients with hypersensitivity to enoxaparin sodium, heparin, or pork products, and in patients with active major bleeding.

Please see accompanying full prescribing information -- http://products.sanofi-aventis.us/lovenox/lovenox.html -- including boxed WARNING -- http://products.sanofi-aventis.us/lovenox/Boxed%20Warning.

Please visit http://www.lovenox.com for complete prescribing information, including boxed WARNING, and additional important information.

About sanofi-aventis

sanofi-aventis is the world's third largest pharmaceutical company, ranking number one in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine, and vaccines. sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY ).

Contact: Amy Ba, (908) 243-4261/Amy.ba@sanofi-aventis.com

(US.ENO.06.06.003)

Reference

Weinberg M, Richard et al. Cost Implications of Using Unfractionated Heparin or Enoxaparin in Medical Patients At-Risk for Venous Thromboembolic Events. Pharmacy & Therapeutics, June 2006.


Source: Sanofi-aventis

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