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Cancer Pain Study Shows Drug Pump Provides Better Relief With Fewer Side Effects Than Standard Treatments Alone.

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ORLANDO, Fla.--(BW HealthWire)--May 21, 2002

Data also suggest possible survival benefit in patients

with implantable Medtronic infusion system

Cancer and its treatment can cause pain so severe that standard treatments, which include pills, patches and shots containing narcotics, sometimes fail to provide adequate relief, making an already difficult situation for patients and their caregivers worse. In fact, the World Health Organization (WHO) estimates that up to 80 percent of people who die from cancer suffer uncontrolled pain during the progression of their disease. And despite the healthcare community's new focus on improving pain management, the WHO predicts that about 25 percent of cancer patients will still die in pain this year.

But according to the results of a landmark study presented here today at the 38th Annual Meeting of the American Society of Clinical Oncology (ASCO), an effective but underused delivery method for morphine can make a big difference to cancer patients with the most stubborn and debilitating pain -- and to the people who care for them. Supported by Medtronic, Inc. (NYSE:MDT), the study showed that opioids delivered through the company's implantable infusion system provided better relief from moderate to severe cancer pain with smaller doses and significantly fewer side effects, and improved quality of life for patients and caregivers. The data also suggests that the same treatment, which uses a programmable drug pump, may have helped patients live longer -- by about two months, on average.

"The power of the pump is that we only need to use tiny amounts of opioids, less than 1/300th of the amount required orally, to give even better relief from cancer pain," said Thomas Smith, M.D., chairman of Hematology and Oncology at Virginia Commonwealth University's Massey Cancer Center and the study's principal investigator. "Since the pump delivers medication directly to the spinal fluid to block pain signals before they reach the brain, patients experience significantly less pain and far fewer side effects."

In Curbing Cancer, Pain Poses Problem

According to the American Cancer Society, 1.3 million new cases of cancer will be diagnosed in 2002, and a new report published in the current issue of the journal Cancer predicts the incidence of the disease will double over the next five decades due to greater life expectancy. As a result, treating the disease and the pain associated with its progression and treatment will continue to be a challenge for patients, caregivers and clinicians.

Oral opioids are a class of painkillers that are used -- successfully, in most cases -- to treat pain associated with cancer. But many patients resist taking them because of side effects such as sedation, confusion, fatigue, constipation, nausea and vomiting. What's more, worsening pain requires that the drugs be given in escalating doses, which can increase the side effects.

"Many people with cancer do not do well on conventional pain medication because the side effects dramatically reduce their quality of life," said clinical nurse specialist Patrick J. Coyne, R.N., M.S.N., director of cancer pain management at Massey Cancer Center and a study investigator. "Some of the patients who entered this trial were heavily sedated, confused, constipated, and generally felt miserable due to their oral pain medications. But once they began to receive the opioids via the implantable pump, they suddenly felt much better. And their caregivers felt better too. It's important to remember that severe chronic pain doesn't just affect the sufferer, it affects their loved ones as well."

According to the American Cancer Society, one-third of people with cancer and two-thirds of people with metastatic, or advanced-stage, cancer experience pain. But in up to 15 percent of patients, oral opioids fail to provide adequate relief. A subset of these patients -- an estimated 50,000 Americans -- are considered candidates for intrathecal pain therapy with a programmable drug pump.

"The pain was gnawing like a toothache in my bones. But no matter how much medication I took, I couldn't stop the pain. I just kept popping more and more pills," said Doreen Russo, a breast cancer survivor who now uses intrathecal infusion therapy to manage her pain. "I was practically an invalid, but after receiving the pump I'm doing great. I no longer have terrible pain, and I'm able to do everything that I used to do like housework, shopping and gardening. My pain is under control, and I'm able to enjoy time with my family again."

Russo's experience is unique to her. Results with intrathecal pain therapy vary by patient.

Trial Sets Precedent in Study of Cancer Pain

Medtronic's cancer pain trial represents the first prospective, multicenter, randomized clinical study comparing routes of administering opioids for the treatment of cancer pain.

Worldwide, 202 patients from 21 medical centers participated in the study. The primary endpoints were pain control and drug toxicity. Researchers defined clinical success as a greater than or equal to 20 percent reduction in visual analog scale (VAS) pain scores or equal pain scores with a greater than or equal to 20 percent reduction in toxicity (side effects of pain medication).

At four weeks, the pain scores for pump patients fell 52 percent compared with a 39 percent drop in patients who only received conventional therapy (p equals 0.055). The pump reduced composite drug-related toxicity scores by 50 percent compared with a 17-percent decrease in the conventional group (p equals 0.004). Importantly, the researchers found statistically significant reductions in fatigue and depressed levels of consciousness in pump patients when compared with patients in the group receiving conventional therapy alone (p is less than 0.05).

Additionally, 54 percent of patients in the pump group were alive after six months of treatment, compared with 37 percent in the conventional therapy group (p equals 0.06). While not statistically significant, this finding warrants further study, which Medtronic intends to pursue.

During this trial, complications with the infusion system were similar to those seen in typical clinical use. Because the drug pump is surgically placed, surgical complications, such as infections, are possible. The catheter could be dislodged or blocked, or in rare cases, the pump could stop working. This could cause a reduction in or loss of pain relief.

The Medtronic SynchroMed(R) EL Infusion System, the intrathecal drug delivery system used in this study, consists of a programmable pump and a catheter that are implanted during an hour-long surgical procedure, which can be performed on an outpatient basis or may require a brief hospital stay. The pump is placed just under the skin of the abdomen and is connected to a small, flexible catheter that delivers pain medication directly to the intrathecal space.

In oncology, Medtronic infusion systems are also used to treat colorectal liver metastases and primary liver cancer by delivering chemotherapy directly to the liver.

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease. More information about Medtronic Pain Therapies can be found online at www.medtronicpain.com and by calling Medtronic Patient Services at 1-800-510-6735.

Any statements made about the company's anticipated financial results and regulatory approvals are forward-looking statements subject to risks and uncertainties such as those described in the company's Annual Report on Form 10-K for the year ended April 27, 2001. Actual results may differ materially from anticipated results.

Editor's Note: More information, as well as photography and video, related to this story is available online at http://www.medtronic.com/newsroom.
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