 July-August 2007; Issue 10
Abuse of Opioid Analgesics in Primary Care Studied
Opioids in Morning May Improve Sleep at Night
Medical Residents Negatively Biased Toward Opioid Rx
APF Voices Concerns Over AMDG Opioid Guidelines
Gabapentin + Opioid Better for Neuropathic Pain
OTFC Relieves Breakthrough Pain
Alcohol Injections Relieve Morton’s Neuroma Pain
Hypertension May Decrease Perception of Chest Pain
Understandings of Fibromyalgia Updated
Duloxetine Relieves Pain of DPN
Mind-Body Pain Interventions for Older Adults
Bullied Teens May Use Pain Relievers to Cope
Recent Drug or Device Approvals and Announcements
This edition of News/Research Updates was researched/compiled by Winnie Dawson, MA, RN, BSN [WD], and edited by Stewart B. Leavitt, MA, PhD [SBL]. Medical reviewers were: James D. Toombs, MD; Lee A. Kral, PharmD, BCPS; Steven Tucker, MD, FACP. Posting Date: August 22, 2007.
Where noted, product brand names are for informational purposes only and are registered trademarks of their respective manufacturers. In some cases, additional brands may be available for specific products.
Abuse of Opioid Analgesics in Primary Care Studied
Researchers at the University of Wisconsin studied the rate of substance-use disorders in a population of patients receiving daily opioid therapy for chronic noncancer pain prescribed by primary-care physicians. A total of 801 adults from primary care and internal medicine practices in 6 healthcare systems were recruited for interviews and urine screens; the most common diagnoses being treated were degenerative arthritis, low back pain, migraine headaches, neuropathy, and fibromyalgia.
Patients had received opioid therapy for a minimum of 3 months and the drugs most frequently prescribed were oxycodone preparations, such as OxyContin, which were prescribed to nearly 60% of participants. Hydrocodone and morphine were the next most frequently prescribed.
A major finding was that 3.7% of patients met DSM-IV clinical criteria for an opioid-use disorder, either abuse (0.6%) or dependence/addiction (3.1%). The most significant predictor of overall substance misuse was aberrant drug-use behavior, including deliberate oversedation, drug dosage increases without authorization, feeling intoxicated when using opioids, and taking opioids for reasons other than pain.
Practice Perspective: The authors conclude that, considering the potential benefit for improving the lives of patients with chronic pain, a 3.7% rate of opioid-use problems “is a small risk compared with the alternative of continuous pain and suffering.” To provide optimal pain management with the lowest risk of opioid analgesic misuse, it is important for clinicians to become familiar with the behaviors most commonly associated with substance-use disorders. Patients frequently mislead clinicians about drug misuse, so the identification of conduct that signifies an opioid-use disorder can be difficult. This is especially problematic since some behaviors that are frequently considered to be indicative of substance abuse can have other explanations such as inadequate pain treatment, untreated psychiatric illness, or situational stress.
 For further commentary on this study, see “Iatrogenic Opioid-Use Problems; What’s the Risk” in the Pain-Topics e-Briefing (Vol. 2, No. 1, 2007) available at: http://www.pain-topics.org/pdf/e-Briefing-Vol2-No1-2007.pdf. – SBL
Reference: Fleming MF, Balousek SL, Klessig CL, et al. Substance use disorders in a primary care sample receiving daily opioid therapy. The Journal of Pain. 2007;8(7):573-582.
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Opioids in Morning May Improve Sleep at Night
The pain of osteoarthritis can have a profound effect on patient quality of sleep. Researchers presented the results of a sleep study of patients taking daily pain relievers at the 2007 Associated Professional Sleep Societies Meeting in June 2007. Patients (n = 34) were carefully selected for the symptoms of moderate-to-severe arthritis pain and disturbed sleep. They participated in a single-blind placebo run-in for about 6 days and, subsequently, received morning daily dosing of 30 mg/day morphine sulfate extended release capsules for 14 days. Patients who met the criteria for incomplete pain relief at day 6 of active-drug therapy were given a dose increase to 60 mg/day and therapy was extended for 14 additional days. Polysomnographic and neurocognitive testing plus other self-reported measures of mood, sleep, and sleepiness were administered to patients while they were on their usual medication, after placebo run-in, and at the end of treatment.
REM sleep latency – the time it took patients to reach a deep sleep – decreased from 113 minutes to 62.5 minutes (p < 0.05) with morphine sulfate extended release capsules. Furthermore, total sleep time increased from 367 minutes per night to about 402 minutes (p < 0.05), an increase of more than a half hour. The most successful dose was 30 mg/day and, overall, sleep efficiency (the percentage of sleep time divided by the time in bed) increased from 76.5% to 83.8%. The medication caused no unexpected adverse effects.
Clinical Conclusion: The researchers reported that morning dosing of extended-release morphine sulfate capsules improved sleep time and efficiency and, while it seems counter-intuitive to achieve such results, morning treatment should be considered in patients who experience disturbed sleep at night due to arthritis pain. [However, this was a small study and further investigation may be warranted. – SBL]
Reference: Rosenthal M, Moore P, Groves E, et al. Sleep improvement in chronic osteoarthritis pain patients with morning dosing of once-a-day extended release morphine sulfate. Sleep. 2007;30(Abstract Supplement):A316, Abstract 0925.
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Medical Residents Negatively Biased Toward Opioid Rx
Clinician beliefs often influence their approach to pain therapy. Therefore, a study by researchers in Minnesota assessed medical residents’ beliefs and concerns about using opioids to treat pain in patients with cancer versus those with noncancer low back pain (NLBP). Resident physicians (n=72) from the Internal Medicine and Medical Pediatric departments of 2 medical centers completed a survey questionnaire.
The residents’ answers to 28 questions demonstrated a significant difference in their feelings about using opioids to treat chronic cancer pain versus NLBP. Mean scores showed that residents had concerns that opioids cause significantly more abuse and addiction in patients with NLBP than in those with cancer. Greater concerns also were expressed regarding prescribing opioids for NLBP in terms of medication side effects, criticism from faculty, and sanctioning by the state board or legal system.
Practice Implication: While the investigators acknowledged several barriers to residents’ prescribing of opioids for NLBP – eg, skills in handling potential patient abuse, documentation of noncancer prescribing, and knowledge of regulations that govern opioid use – they also stress that improved training is needed during residency that could, ultimately, reduce negative attitudes.
Reference: Roth CS, Burgess DJ, Mahowald ML. Medical residents’ beliefs and concerns about using opioids to treat chronic cancer and noncancer pain. JRRD (J Rehabil Res Dev). 2007;44(2):263-270.
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APF Voices Concerns Over AMDG Opioid Guidelines
The American Pain Foundation (APF) reports that it has been following the March 2007 initiative by the Agency Medical Directors Group (AMDG) of Washington State to establish guidelines for assisting practitioners in the safe and effective use of opioid analgesics. The APF recognizes the public health impact of prescription drug abuse and, in general, supports initiatives that aid clinicians in the treatment of chronic noncancer pain with opioids.
However, the APF published a recent position statement raising 5 major concerns relating to implementation of this Washington State guideline:
- The recommendation that patients in need of long-term opioid treatment receive evaluation by a pain management consultant raises questions about the definition of a “pain specialist.”
- Furthermore, due to the fact that reimbursement for pain management can be challenging, there is concern that an increase in pain-specialty referral will ultimately place a financial burden on the patient and/or undermine patient care where specialists are unavailable.
- The guideline sets a limit on how much morphine (or equivalent) can be prescribed by non-pain specialists. The APF believes that the proposed upper dosing limit of 120 mg/day is an “arbitrary ceiling” with no scientific data to support the concern that a higher dose is unreasonable.
- The proposed guidelines could increase provider fear that would, ultimately, lead to an even greater undertreatment of severe chronic pain.
- The guideline could increase the stigma on pain patients who may be viewed as potential drug abusers.
Clinical Implication: Founded in 1997, the APF is an independent nonprofit organization with an advisory board of distinguished practitioners in the pain management field. While the APF believes that the guideline is well-intentioned, there are concerns that it will not effectively curb abuse and diversion. Their position statement urges Washington State to amend the guideline to avoid added barriers for patients. Minimally, the APF urges the policy leaders to provide a clarification of the qualifications for “pain specialists” and to institute prospective quality monitoring programs to measure unintentional program consequences and increases in access-to-care issues.
Reference: American Pain Foundation position statement on Washington State Interagency guideline on opioid dosing for chronic non-cancer pain: an educational pilot to improve care and safety with opioid treatment. May 2007
For the full APF position statement, see: http://www.painfoundation.org/PositionStatements/WAOpioidGuideline2007.pdf
 For the AMDG guidelines (March 2007), see: http://www.agencymeddirectors.wa.gov/
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Gabapentin + Opioid Better for Neuropathic Pain
Neuropathic pain is a frequent complication of cancer pain and can present a treatment challenge because adjuvant analgesics are often required to enhance opioid therapy. Investigators in Turkey evaluated the effectiveness and safety of gabapentin (an anticonvulsant) combined with an opioid, as compared with opioid monotherapy, for neuropathic cancer pain management. Patients (n=63) who reported nociceptive pain relief, but not neuropathic, from current opioid therapy were randomized to 1 of 2 treatment protocols. One group (GO) of patients received gabapentin, titrated according to pain response, adjuvant to ongoing constant-dose opioid treatment, while the other group (OO) continued opioid monotherapy according to the World Health Organization treatment ladder approach.
Pain intensity, allodynia (pain due to a stimulus which does not normally provoke pain), and analgesic drug consumption were evaluated at days 4 and 13. Both groups reported a significant reduction in pain intensity compared with baseline; however, mean pain intensity for burning and shooting pain was significantly higher in the OO group compared with the GO group on both evaluation days (p = 0.0001). Additionally, at day 4, a significant decrease in allodynia was observed in the GO group compared with the OO group. The rate of adverse effects in the GO group was significantly lower than that in the OO group (p = 0.015).
Clinical Conclusion: The results of this study suggest that gabapentin added to an opioid can provide better neuropathic pain relief than opioid monotherapy alone in cancer patients. The researchers suggest that this combination may represent a potential first-line regimen for the management of patients who have neuropathic cancer pain.
Reference: Keskinbora K, Pekel AF, Aydinli I. Gabapentin and an opioid combination versus opioid alone for the management of neuropathic cancer pain: a randomized open trial. J Pain Symptom Manage. 2007;34(2):183-189.
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OTFC Relieves Breakthrough Pain
Breakthrough pain, a transitory flare of pain intensity that overwhelms medication taken for persistent pain, is common in patients with cancer pain. Investigators examined the effectiveness and adverse effects of opioids for breakthrough pain relief in patients with cancer. Randomized controlled trials of opioids used as rescue medication, compared with other analgesics or placebo, were identified by a systematic literature search. Four studies with a total of 393 participants already taking regularly scheduled opioids met the inclusion criteria; all used oral transmucosal fentanyl citrate (OTFC) to manage breakthrough pain. Two studies evaluated the titration of OTFC, one study compared OTFC to standard release morphine, and one study compared OTFC with placebo.
When compared with placebo and morphine, participants using OTFC reported lower pain intensity scores and higher pain relief scores at all time points. Global assessment scores also favored OTFC and the adverse effect profile of OTFC was similar to other opioids.
Clinical Conclusion: Current evidence supports OTFC, when compared with both placebo and morphine therapy, for the safe and effective treatment of breakthrough pain. However, the investigators suggested that additional clinical research is warranted due to the low number of trials reported for OTFC and the lack of comparative trials for other opioids in breakthrough pain.
Reference: Zeppetella G, Ribeiro MDC. Opioids for the management of breakthrough (episodic) pain in cancer patients. The Cochrane Database of Systematic Reviews. 2007, Issue 3. Abstract available online at: http://www.cochrane.org/reviews/en/ab004311.html.
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 Alcohol Injections Relieve Morton’s Neuroma Pain
Morton’s neuroma is a thickening of the tissue around the digital nerve leading to the toes, often between the 3rd and 4th toes, that commonly causes a sharp, burning pain. Researchers in the United Kingdom assessed the efficacy of a series of sonographically-guided alcohol injections into the lesion. The prospective study included 101 consecutive patients with Morton’s neuroma who received an average of 4 treatments per person and had follow-up images taken at a mean 21 months (range 13-34 months) after the last treatment.
Partial or total symptom improvement was reported in 94% of patients, with 84% experiencing complete pain relief. The median assessed pain score was 8 before treatment and decreased to zero post-treatment (p = 0.001) and transitory local pain occurred in about 17% of patients. Almost 30% of patients who had sonographic assessments at 6 months post-treatment showed a 30% decrease in the size of the neuroma. No major complications were reported.
Practice Pointer: Treatment was highly successful in this population and the researchers assessed the technical success rate at 100%. While custom shoe inserts can relieve the pain for some patients, in those needing more aggressive therapy alcohol injection is a less invasive alternative than the often-used surgical nerve resection.
Reference: Hughes RJ, Ali K, Jones H, et al. Treatment of Morton’s neuroma with alcohol injection under sonographic guidance: follow-up of 101 cases. AJR (Am J Roentgenol). 2007;188(6):1535-1539.
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Hypertension May Decrease Perception of Chest Pain
A Canadian study examined the relationship between blood pressure and chest pain in a prospective study of 907 men and women diagnosed with possible myocardial ischemia who underwent exercise stress-testing. The McGill Pain Questionnaire (MPQ) was administered immediately after testing and additional measurement tools were administered at rest and after exercise. Blood pressure and cardiac perfusion using SPECT (single positron emission tomography) scanning were measured before, during, and after exercise.
Systolic blood pressure values at the end of exercise were inversely related to a number of measures of pain, including the total MPQ score. Patients with high post-exercise systolic pressure had significantly less chest pain (p = 0.003), regardless of whether or not there was a demonstrated perfusion deficit. An additional measurement tool evaluating exertional chest pain during daily living showed that higher blood pressure was also significantly associated with lower angina (p = 0.001).
Clinical Concept: The inverse relationship between chest pain and blood pressure remained significant after adjustment for a range of confounding variables such as gender, medication use, or exercise duration. Reduced pain perception in patients with hypertension could put them at risk for undetected heart problems, such as silent ischemia which could be potentially fatal. Healthcare providers should be alert for atypical signs of myocardial ischemia, including reports of widespread pain. Additionally, it is important to educate patients with hypertension regarding the potential for reduced pain perception and the need for antihypertensive medication compliance.
Reference: Ditto B, D’Antono B, Dupuis G, et al. Chest pain is inversely associated with blood pressure during exercise among individuals being assessed for coronary heart disease. Psychophysiology. 2007;44(2):183-188.
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Understandings of Fibromyalgia Updated
Fibromyalgia – chronic, widespread pain in muscles and soft tissues accompanied by fatigue – is a fairly common condition that does not manifest any structural organ damage. Affecting approximately 2% of the US population, fibromyalgia is an example of a class of maladies called central sensitivity syndromes (CSS), which are based on neurochemical abnormalities and include irritable bowel syndrome, migraine, and restless leg syndrome.
Twenty-five years ago, Muhammad B. Yunus, MD, and colleagues published the first controlled study of the clinical characteristics of fibromyalgia syndrome, which led to formal recognition of this disease by the medical community. Most recently, in the June 2007 issue of Seminars in Arthritis and Rheumatism, Yunus synthesizes and interprets the extensive body of accumulated scientific literature on fibromyalgia and his own insights into the concept of CSS.
Yunus describes 13 separate conditions that are related to central sensitization (CS), where the central nervous system (spinal cord and brain) sensitizes certain parts of the body so that even mild pressure or touch causes much pain. Such hypersensitivity also may be associated with other symptoms such as poor sleep and fatigue. According to Yunus, “CSS are the most common diseases that are based on real neurochemical pathology and cause real pain and suffering. In some patients stress and depression may contribute to the symptoms but they are all based on objective changes in the central nervous system.”
In an accompanying editorial John B. Winfield, MD, comments, "Dr. Yunus, who took a more biological approach to fibromyalgia in the past, now emphasizes a biopsychosocial perspective. In my view, this is tremendously important because it is the only way to synthesize the disparate contributions of such variables as genes and adverse childhood experiences, life stress and distress, posttraumatic stress disorder, mood disorders, self-efficacy for pain control, catastrophizing, coping style, and social support into the evolving picture of central nervous system dysfunction vis-a-vis chronic pain and fatigue."
References:
Yunus MB. Fibromyalgia and overlapping disorders: The unifying concept of central sensitivity syndromes. Sem Arthritis Rheumatism. 2007;36(6).
Winfield JB. Fibromyalgia and related central sensitivity syndromes: Twenty-five years of progress [editorial]. Sem Arthritis Rheumatism. 2007;36(6).
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Duloxetine Relieves Pain of DPN
With the growing prevalence of diabetes, the challenge of managing chronic neuropathic pain could increase dramatically. An analysis published in the August issue of Pain Medicine evaluated recent studies of patients receiving duloxetine for the management of diabetic peripheral neuropathic (DPN) pain. Data from 3 double-blind, randomized, placebo-controlled 12-week therapy trials enrolling patients with a minimum of 6 months’ of daily pain symptoms were pooled.
One placebo-controlled study of 457 patients (Study 1) evaluated 3 different dosing regimens, while Studies 2 (n = 334) and 3 (n = 348) compared duloxetine 60 mg/day and 60 mg/twice-daily with placebo, respectively. The primary efficacy outcome measurement in each study was the weekly mean score of the 24-hour average pain severity; an effective treatment response was defined as a 30% reduction in pain severity.
Response rates at study completion were significantly higher among patients receiving duloxetine (60 mg/daily or 60/mg/twice-daily) compared with placebo in all 3 studies. The number of patients achieving pain relief in all treatment groups was significantly higher than the placebo groups from week 1 through the end of therapy. A significant reduction in pain severity for patients receiving duloxetine compared with those receiving placebo in the 3-study pooled data occurred at day 3. The pooled rate of treatment discontinuation due to adverse events was almost 11% among patients receiving duloxetine 60 mg/daily and 16% for those on a twice-daily regimen; nausea was the most frequent complaint.
Practice Pointer: Because diabetic peripheral neuropathy is among the most common complications of diabetes and frequently results in pain, it is important to stay abreast of the safe and effective treatment options available. In this analysis, duloxetine demonstrated an early therapeutic response and researchers reported that efficacy was sustained until the last visit of the 12-week study.
Reference: Pritchett YL, McCarberg BH, Watkin JG, et al. Duloxetine for the management of diabetic peripheral neuropathic pain: response profile. Pain Medicine. 2007;8(5):397-409.
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Mind-Body Pain Interventions for Older Adults
Studies have shown that chronic noncancer pain in older adults is frequently undertreated. A review of the literature, published in the June issue of Pain Medicine, evaluated the feasibility, safety, and evidence of 8 mind-body interventions for pain reduction in adults aged 50+ years. Of 381 articles reviewed, 20 met inclusion criteria for therapies in older adults using 1) biofeedback, 2) progressive muscle relaxation, 3) meditation, 4) guided imagery, 5) hypnosis, 6) tai chi (a self-paced martial art using movement and gentle physical exercise), 7) qi gong (the coordination of different breathing patterns with various physical postures and motions), and 8) yoga.
Tai chi, yoga, hypnosis, and progressive muscle relaxation were significantly associated with pain reduction in several studies that included older adults, but specific benefits were not analyzed by age. The results showed some support for the efficacy of progressive muscle relaxation plus guided imagery for the pain of osteoarthritis. Limited support was demonstrated for meditation and tai chi for coping or improving function in older adults with low back pain or osteoarthritis. One uncontrolled study of biofeedback showed significant reductions in pain.
Clinical Implication: The increased potential for medication adverse effects in older adults and the frequently reported prevalence of untreated pain may recommend mind-body therapies for this special population. Many mind-body treatment modalities require modifications for safety and feasibility in the older adult, and such customized programs are becoming more widely available. However, while 70% of the studies were controlled trials, the researchers noted that there was a tendency toward small numbers and a lack of comparison groups. Thus, there is insufficient evidence to determine whether these 8 mind-body interventions reduce chronic noncancer pain in older adults and future, larger trials are recommended.
Reference: Morone NE, Greco CM. Mind-body interventions for chronic pain in older adults: a structured review. Pain Medicine. 2007;8(4):359-375.
For further information on alternative therapies for pain management, see the Pain-Topics.org tab section “Non-Opioid Therapies” at: http://pain-topics.org/non_opioid_therapies/index.php.
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Bullied Teens May Use Pain Relievers to Cope
esearchers in Denmark administered an anonymous survey to adolescents – ages 11 to 16 – in order to examine the association between bullying and physical or psychological symptoms. Students (n = 5,205) answered questions on health problems, medicine use, bullying, as well as varied psychosocial conditions.
The results, published in the July 2007 issue of Pediatrics, found that about half of the students had experienced bullying within the current school term. Participants who were bullied reported an increased occurrence of headache, stomach ache, nervousness, and difficulty falling asleep. Adolescent self-report of medicine use showed that victims of bullying used drugs for pain and psychological problems more often than did adolescents who were not bullied. While the results showed that about 40% of the general population of students used headache medicines on a monthly basis, the percentage jumped to 60% among adolescents who were bullied.
Practice Pointers: In a related news story (Reuters), lead author Pernille Due, MD, stated that “our analysis showed that even after we took the bullied children’s higher prevalence of symptoms into account, they were still at a much increased risk of using medicine.” In an earlier and larger study published in the European Journal of Public Health (Due et al, 2005), responses from students (n = 123,227) in 28 countries in Europe and North America also showed that bullied adolescents had a higher incidence of headache, stomach ache, backache, dizziness, and psychological symptoms. Healthcare providers should be aware that adolescent victims of bullying are prone to excess use of medicine and preventive actions should be taken to address the issues related to bullying and medicine use.
References:
Due P, Hansen EH, Merlo J, et al. Is victimization from bullying associated with medicine us among adolescents? A nationally representative cross-sectional survey in Denmark. Pediatrics. 2007;120(1):110-117.
Due P, Holstein BE, Lynch J, et al. Bullying and symptoms among school-aged children: international comparative cross-sectional study in 28 countries. Eur J Public Health. 2005;15(2):128-132.
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Recent Drug or Device Approvals and Announcements
Following are briefs on new pain-management drug or device approvals or announcements, as well as items related to safety concerns for existing products. If the FDA news website posted a specific announcement, the link to it has been provided below. All brand names are registered trademarks of their respective manufacturers.
Additionally, the FDA Center for Drug Evaluation and Research website offers the option to search on any approved drug name or active ingredient at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm, and safety information is posted by FDA’s MedWatch at http://www.fda.gov/medwatch/safety/2006/safety06.htm.
Lyrica® (pregabalin) –Approved As Fibromyalgia Treatment
In June, the FDA approved Lyrica as the first drug indicated for the treatment of fibromyalgia. Individuals with fibromyalgia, most commonly women in early-to-middle adulthood, experience chronic pain, muscle stiffness, fatigue, and sleep problems. Two studies involving 1,800 patients with fibromyalgia demonstrated a reduction in pain after taking Lyrica, although the exact mechanism by which Lyrica reduces pain in fibromyalgia is unknown. The most common side effects, which appear to be dose related, include mild-to-moderate dizziness and sleepiness. Because Lyrica can impair motor function and cause problems with concentration and attention, the FDA advises that patients talk to their health care professional about whether the use of Lyrica may impair their ability to drive. The drug was previously approved for treating partial seizures and diabetic neuropathy.
For more information, see the FDA press release at: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01656.html (access checked 7/31/07).
The Lyrica package insert can be downloaded at: http://www.pfizer.com/pfizer/download/uspi_lyrica.pdf (access checked 7/31/07).
Zelnorm® (tegaserod maleate) – Restricted Use Permitted
The FDA has agreed to allow the restricted use of Zelnorm for qualifying patients. The July announcement states that under a treatment investigational new drug (IND) protocol, Zelnorm can be offered to women younger than 55 with no history or symptoms of cardiovascular ischemic disease. Additionally, these individuals must be suffering from irritable bowel syndrome with constipation or chronic idiopathic constipation with unsatisfactory response to other available treatments. For further details of the program's protocol, practitioners can call 866-248-1348 or 888-669-6682. Zelnorm will remain off the market for general patient use.
For more information, see the FDA press release at: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01673.html (access checked 7/31/07).
Prestige® Cervical Disc System – Approved for Degenerative Disc Disease
The July FDA approval of an artificial cervical disc for the surgical treatment of intractable pain and myelopathy, two common consequences of cervical degenerative disc disease, offers an alternative to vertebral fusion. This 2-piece metal device is attached to adjacent vertebrae with bone screws and replaces a diseased cervical disc. The device is designed to provide stability while allowing motion to provide pain relief and improve functionality. The approval was based on preclinical studies and a clinical trial in 541 patients. Medtronic Sofamor Danek, the manufacturer of Prestige, has agreed to conduct a 7-year study to evaluate long-term safety and effectiveness.
For more information, see the FDA press release at: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01668.html (access checked 8/03/07).
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