 November-December 2008; Issue 18
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; Seth I. Kaufman, MD; Edward Hesterlee, PharmD, FACA. Posting Date: December 22, 2008.
Development of these Pain Treatment Topics News/Research Updates was supported by an unrestricted educational grant from COVIDIEN/Mallinckrodt, St. Louis, MO. Any mention of product brand names is for informational purposes only and such brands are registered trademarks of their respective manufacturers. In some cases, additional product brands may be available.
 Access to all external URL links was checked prior to posting; however, some may change or become obsolete over time and will no longer function. This is beyond our control.
Accidental Opioid Overdose in Children Increasing
New research suggests that the increased availability of prescription opioids may be contributing to a surge in accidental overdose deaths and injuries among children under the age of 6. Investigators used data from poison centers participating in the Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System. Exposures in children younger than 6 years, involving buprenorphine, fentanyl, hydrocodone, hydromorphone, methadone, morphine, and oxycodone (January 2003 to June 2006) were analyzed.
The study reported that 9179 toddlers and children were involved in incidents related to opioid access during the 3.5-year period, with exposure ranging from a pill taken from a child's mouth to actual ingestion. In these incidents, 8 children died, while 43 suffered life-threatening injuries or serious disabilities, and 214 required prolonged medical attention. Of 51 patients who experienced a major effect or death, only 35 were treated with naloxone and a beneficial response was documented in 34 of them. The implicated medications belonged primarily to parents, grandparents, and other adults.
[Commentary: In a media interview (MSNBC, October 20, 2008), Richard Dart of the Rocky Mountain Poison and Drug Center noted that prescription drugs have become a primary cause of child poisonings, second only to carbon monoxide poisoning. He believes that the actual number of overdoses may be more than twice as high as what was voluntarily reported to the Center. Dart further observed that about half of the accidental prescription opioid exposures occurred in "complicated" households, which he defined as those including many adults living together or household members with a history of drug use or child neglect. The rest occurred in so-called "competent" families.
These data underscore the fact that practitioners need to consider where and how the opioid analgesics they prescribe will be used. They also need to remember to use naloxone promptly in cases of suspected opioid overdose, but judiciously.
Patients need to be educated not only on the safe use of these agents for themselves, but how to safeguard the medications from misuse, whether intentional or accidental, by other members of their households (including pets). They also need to understand how to recognize early signs of overdose and the importance of prompt action, including how naloxone serves as an effective antidote. –– SBL.]
Reference: Bailey JE, Campagna E, Dart RC, the RADARS System Poison Center Investigators. The Underrecognized Toll of Prescription Opioid Abuse on Young Children. Ann Emergency Med. Early online publication, DOI: 10.1016/j.annemergmed.2008.07.015.
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Prescription-Opioid Overdose Deaths Examined
Along with increases in prescription opioid analgesic use, rates of abuse and overdose also have risen in certain locales. Deaths from overdose are highest in rural areas, and unintentional overdoses during 1999-2004 in West Virginia represented the highest increases in the United States. An updated report by the Centers for Disease Control and other government agencies, recently published in the Journal of the American Medical Association, evaluated West Virginia 2006 data on overdose deaths, pharmaceutical diversion* rates, and related factors. [*Pharmaceutical diversion was defined as "death involving a prescription drug without a documented prescription” or “having received prescriptions for controlled substances from 5 or more clinicians (doctor shopping)."]
Data from the state medical examiner’s office was combined with records from state prescription drug monitoring programs and 8 opioid-treatment programs for analysis. The following facts were noted:
- Two thirds of the 295 opioid-associated overdose decedents in West Virginia were male.
- Prescription opioids were involved in 93% of all opioid-related deaths, but fewer than half (44%) of decedents had been personally prescribed those medications.
- Most of the deaths involved prescription-opioid diversion (63%) or doctor shopping (21%).
- Diversion was most prevalent in younger decedents aged 18-24.
- Doctor shopping was significantly more prevalent among female decedents and individuals aged 35-44.
- Multiple substances – 2 prescription drugs on average (range 1-5) – were evident in almost 80% of deaths.
- Psychotherapeutic drugs contributed to almost 49% of deaths; 79% of those were benzodiazepines.
The authors also noted that risk for opioid abuse increased with lower education and living in the poorest counties of the state. They did not evaluate sources of opioids in this study but cited data from a 2008 regional report by the National Drug Intelligence Center indicating that sources of diversion largely involved illegal sales by healthcare professionals, employee theft, forged prescriptions, and Internet purchases.
Practice Pointers: In proper context, it must be considered that these data may point toward important trends of concern but are not representative of the entire U.S. The authors reaffirm the need for healthcare practitioners to counsel patients prescribed opioids on the risks of overdose for themselves and to caution against sharing drugs. Furthermore, clinicians are again reminded to follow pain management guidelines and to contact state prescription-drug monitoring programs to help identify patients who are seeing other practitioners for scheduled drugs.
References:
Hall AJ, Logan JE, Toblin RL, et al. Patterns of abuse among unintentional pharmaceutical overdose fatalities. JAMA. 2008(Dec 10);300(22):2613-2620.
National Drug Intelligence Center. Drug Market Analysis 2008: Appalachia High Intensity Drug Trafficking Area. Washington, DC: U.S. Dept of Justice; 2008. Report 2008-R0813-001.
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Methadone Cardiotoxicity Questioned
Methadone — a potent synthetic opioid — is a cost-effective, well-tolerated analgesic for chronic pain therapy in appropriately-selected patients. However, there has been concern regarding studies showing potential cardiac-conduction risks associated with methadone therapy. While some reports suggest an increased risk of QTc-interval prolongation and the life-threatening arrhythmia torsade de pointes (TdP), other studies have not supported this finding. In light of this inconsistency, practitioner opinions differ on whether an electrocardiogram (ECG) should be performed routinely on patients receiving methadone therapy –– either for pain relief or as therapy for opioid addiction (eg, methadone maintenance therapy or MMT).
A review, published in the November 2008 issue of Journal of Pain and Symptom Management, examines evidence for cardiotoxicity associated with methadone. An analysis of 16 studies suggested that approximately 30% (range 9%-88%) of patients taking methadone could potentially experience prolongation of QTc intervals. In 2 studies, plus several case reports, incidents of TdP were mentioned. Additionally, 3 studies reported a correlation between the methadone dose and the duration of the QTc interval; 1 study showed a return to baseline QTc intervals when methadone therapy was discontinued. Much of the evidence is low-level and of limited quality, so definitive cause-effect relationships could not be determined.
Clinical Concepts: Despite the considerable evidence, the author notes that significant reasons for doubting the relationship between methadone and clinically significant cardiac conduction problems include: a) the lack of large controlled trials, b) the lack of studies reporting TdP or QTc-interval prolongation more than 40 ms above the baseline, c) the lack of evidence of clinically-significant cardiac toxicity given the high number of patients on methadone therapy. He concludes: “With the data available, it is not appropriate to either recommend ECG for all patients on methadone or to dismiss the risk for QTc prolongation/TdP.” The author suggests performing ECG testing on hospitalized patients beginning methadone treatment, plus repeat testing following dose escalation or when adding drugs that can increase a patient's risk for TdP. Additionally, patients with known risk factors for QTc-interval prolongation or TdP –– such as medical frailty, cardiac pathophysiology, or interacting comedications –– should have ECG testing. If other pain therapies are ineffective, methadone may need to be continued with appropriate monitoring even if QTc internals are significantly prolonged.
Reference: Cruciani RA. Methadone: to ECG or not to ECG…that is still the question. Review article. J Pain Symptom Manage. 2008(Nov);36(5):545-552.
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Opioids for Chronic Nonmalignant Pain Improve QoL
Pain specialists at the Cleveland Clinic in Ohio studied the long-term benefits of opioid therapy on quality of life in 67 patients with chronic nonmalignant pain of at least 6-months duration. These patients were unresponsive to other medical and interventional therapies, and some had more than one pain condition. Prior to opioid-therapy initiation, patients completed a 9-part survey to measure health-related quality of life (QoL), a visual-analog pain scale, and questions about disability status. The same information was also collected after a minimum 6 months of therapy and compared with pre-treatment responses.
After 6 months of opioid therapy, average QoL scores showed significant improvement in 8 of 9 survey parameters. Statistically significant scores were reported for improvements in physical functioning, general health, vitality, social functioning, emotional role, and mental health.
Clinical Concepts: While no significant changes were reported in pain scores, disability status, or return to work, the authors concluded that opioid therapy may provide benefits in perceived quality of life as well as specific aspects of functional abilities and activities of daily living. The authors acknowledge that this was a small study and had several limitations, including lack of a control group, varied follow-up times, a heterogeneous patient population, and a low number of patients per pain condition. Therefore, an analysis of subgroups and relative effects of different opioid regimens was not possible.
Reference: Soin A, Cheng J, Brown L, et al. Functional outcomes in patients with chronic nonmalignant pain on long-term opioid therapy. Pain Pract. 2008(Sep-Oct);8(5):379-384.
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Factors Affecting Analgesic Adherence Evaluated
Studies reporting high levels of unrelieved cancer pain motivated researchers at Oslo University College in Norway to evaluate the rates of insufficient adherence to analgesic-drug regimens. In addition to levels of adherence, the study examined the effects of several demographic and personal characteristic variables on adherence. This cross-sectional, multi-clinic study of oncology outpatients (n=174) being treated at the Oslo cancer hospital asked participants to complete a pain inventory as well as questionnaires designed to measure adherence, self-efficacy, and perceived barriers.
Results from 2 adherence questionnaires were similar, with a mean score of 2.0 (range 0 to 4). High levels of adherence were exhibited by 21% of patients (score = 4) and 46% had low adherence scores of 0 or 1. Overall, only 41% of participants actually were adhering to their analgesic regimens.
After multiple regression analysis, the strongest predictors of adherence were male gender, low self-efficacy for physical function, the use of stronger opioid analgesics, higher average pain intensity scores, and better pain relief scores. Scores from assessments of perceived barriers to pain management did not correlate with adherence.
Clinical Concepts: As might be expected, a decision to stop taking pain-relieving medication when the patient felt better, albeit temporarily, was the most common reason for nonadherence. This would indicate the need for improved patient education on pain management in this population. The authors believed that oncology practitioners could enhance compliance by doing an adherence evaluation as part of the patient's routine pain assessment. [Medication cost also can be an important factor, but was not addressed in this study. –– SBL]
Reference: Valeberg BT, Miaskowski C, Hanestad BR, et al. Prevalence rates for and predictors of self-reported adherence of oncology outpatients with analgesic medications. Clin J Pain. 2008(Sep);24(7):627-636.
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Oxycodone Enhances Gabapentin for Neuropathic Pain Relief
Patients with painful diabetic neuropathy often have significant comorbidities and suffer from residual pain, adding to the challenge of pain management. Pain experts at King's College Hospital in London conducted a double-blind, placebo-controlled study to evaluate the benefits of adding extended-release oxycodone (OxyContin®) to existing gabapentin therapy. Patients (n=338) with moderate to severe unrelieved pain from diabetic neuropathy despite receiving a maximum-tolerated dose of gabapentin were randomized to either oral ER-oxycodone or placebo, plus continuing gabapentin therapy in both groups, for up to 12 weeks. The primary endpoint was pain relief, with additional assessments for rescue medication use, sleep quality, and global pain.
In the ER-oxycodone/gabapentin group there was a 33% reduction in pain scores from baseline to study completion, and the overall treatment effect was greater with ER-oxycodone/gabapentin than with placebo/gabapentin (p = 0.007). The ER-oxycodone/gabapentin group also had significantly better pain relief than had been achieved with prior gabapentin monotherapy (p = 0.003). Additionally, patients on ER-oxycodone/gabapentin therapy used less rescue medication (p = 0.03), had fewer nights of disturbed sleep (p < 0.05), and had far fewer discontinuations due to lack of efficacy (14% vs 54% for ER-oxycodone/placebo). The adverse effects commonly reported with opioid use were not exacerbated by combining extended-release oxycodone with existing gabapentin therapy.
Clinical Concepts: Opioids are not commonly recommended as first-line treatment for neuropathic pain, but a clinically-significant improvement in pain relief was demonstrated in this study for patients who received ER-oxycodone in addition to their maximum-tolerated maintenance doses of gabapentin.
Reference: Hanna M, O'Brien C, Wilson MC. Prolonged-release oxycodone enhances the effects of existing gabapentin therapy in painful diabetic neuropathy patients. Eur J Pain. 2008(Aug);12(6):804-813.
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Early Biologic Therapy for RA Has Long-Term Benefits
Studies have shown that early aggressive treatment of rheumatoid arthritis (RA) provides better remission outcomes. Researchers at Connolly Hospital in Dublin, Ireland, randomized 40 treatment-naïve patients with very early RA to a regimen of methotrexate (MTX) 20 mg/week or a combination of MTX plus etanercept (ETN) 50 mg/week, with a discontinuation of ETN at week 24 for patients achieving remission. All patients had confirmed RA, based on American College of Rheumatology (ACR) criteria, for a duration of 6 weeks to one year. Remission was defined as a Disease Activity Score in 28 joints (DAS28) of < 2.6.
At 24 weeks, 85% of patients in the combination therapy group achieved clinical remission compared with 35% of patients treated with MTX alone. At 48 weeks, 60% of those who had taken ETN for 24 weeks and continued with MTX alone remained in remission; whereas, only 30% of patients taking MTX monotherapy for 48 weeks were in remission. Patients in the combination therapy group also showed significantly greater improvement on ACR-50 and ACR-70 response scores* at 24 and 48 weeks, compared with the MTX monotherapy group.
[*American College of Rheumatology criteria for ACR-50 and ACR-70 responses require that a patient have a 50% or 70% reduction in the number of swollen and tender joints, respectively, plus improvements in 3 additional symptom parameters.]
Clinical Concepts: In a related news story (Medpage Today), Claire Sheehy, MD, stated that this small study supports the “idea of a window of opportunity early in RA when the burden of disease is lower and the potential of remission is greater.” She added that a larger randomized trial is needed to confirm results and, while the study did not include complete cost information, this dual-therapy intervention cost $8,750 per patient for a potential 30% increase in 48-week remission over methotrexate monotherapy.
Reference: Sheehy C, Murphy E, Duffy T, et al. Remission induction with etanercept and methotrexate in very early rheumatoid arthritis with sustained remission after etanercept withdrawal. American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Scientific Meeting, San Francisco, CA. October 24-29, 2008. Meeting Abstract: 2042.
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Musculoskeletal Pain Influences Death Risk
To investigate potential increased risk of mortality in patients with pain disorders, researchers at the University of Manchester in the UK conducted a prospective cohort study of 4515 patients who had participated in a previous pain study during 1996. Patients from 3 clinical practices in 4 age groups (16-44, 45-64, 65-74, and 75+ years) were asked to complete a questionnaire to provide demographics and pain data. Participants were classified to 1 of 3 pain groups based on response criteria: no pain, regional pain, or widespread pain.
Subjects whose pain reports satisfied criteria for “widespread pain” used in the ACR classification of fibromyalgia* were also asked to indicate each pain site on a blank manikin. (* Pain must have been reported on the right and left sides of the body, above and below the waist, and in the axial skeleton.) Those subjects reporting pain who did not meet the criteria for widespread pain were categorized as “regional pain.” Participants were followed for 8 years or until their death.
Of the 4344 respondents who provided pain status information, 44% reported “no pain”, 35% had “regional pain,” and almost 17% reported “widespread pain.” Subjects reporting “widespread pain” were more likely to be female (60%) and older (average age 65). At study’s end, patients in the “no pain” group had the lowest mortality rate (27/1000 person-years), with “regional pain” and “widespread pain” having 38/1000 and 42/1000 person-years, respectively.
A weighted analysis — after adjusting for age, gender, and ethnicity — showed that subjects with “regional pain” were 20% more likely to die during the follow-up period and those with “widespread pain” had a 30% increased risk of death, when compared with subjects who reported “no pain.” Both “regional pain” and “widespread pain” were associated with a significant increase in cancer mortality but not cardiovascular disease.
Clinical Concepts: The authors noted that their previous community-based study reported in 2003 demonstrated an increased rate of death primarily due to cancer in “subjects who reported regional and widespread pain.” However, they stated that the number of specific cancer-site deaths in this presently-reported study (2009) was too small to analyze further. Potentially confounding factors, such as smoking, were acknowledged but unmeasured in this study. In an earlier study by these authors (2001), adjusting effects for socioeconomic status, smoking, and levels of psychological distress did not affect the relationship between widespread pain and cancer mortality.
[Editorial Comment: While studies such as these are of interest, the methodology does not necessarily establish cause-effect relationships between cancer and pain. Other factors, as yet undetermined, may play more vital roles; however, this could suggest that serious pain conditions may be a signal of underlying processes having potentially life-threatening consequences that should be explored by pain practitioners. ––SBL.]
References:
McBeth J, Symmons DP, Silman AJ, et al. Musculoskeletal pain is associated with a long-term increased risk of cancer and cardiovascular-related mortality. Rheumatology. 2009(Jan);48(1):74-77.
McBeth J, Silman AJ, Macfarlane GJ. Association of widespread body pain with an increased risk of cancer and reduced cancer survival: a prospective, population-based study. Arthritis Rheum. 2003;48(6):1686-1692.
Macfarlane GJ, McBeth J, Silman AJ. Widespread body pain and mortality: prospective population based study. Br Med J. 2001;323(7314):662-665.
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Depression, Anxiety Add to Chronic Pain Morbidity
Investigators at the Roudebush Veterans Administration Medical Center in Indianapolis analyzed enrollment data from the Stepped Care for Affective Disorders and Musculoskeletal Pain (SCAMP) study to identify the relationship between depression and/or anxiety and chronic pain intensity and disability. Patients (n=500) with low back, hip, or knee pain lasting 3 months or longer were included; they averaged 59 years of age, and were 55% female, 56% white, and 40% black.
Subjects were categorized as having pain only (54%), pain with depression (20%), pain with anxiety (3%), or pain with depression and anxiety (23%). The group with all 3 conditions reported significantly lower health-related quality of life (p < 0.0001), and had the greatest pain severity (p < 0.0001) and pain-related disability (p < 0.0001) scores. Also, the average number of disability days reported for the most recent 3 months were significantly greater in patients with pain-depression-anxiety (mean 43 days, p < 0.0001).
Practice Pointers: Patients with chronic pain may be candidates for depression and anxiety screening. And, if indicated, adjunctive treatment for the mental disorders may provide better outcomes in chronic pain management.
Reference: Bair MJ, Wu J, Damush TM, et al. Association of depression and anxiety alone and in combination with chronic musculoskeletal pain in primary care patients. Psychosom Med. 2008(Oct);70(8):890-897.
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Patient-Controlled Analgesia Errors Assessed
A retrospective analysis of patient-controlled analgesia (PCA) errors was conducted using Medmarx — a national voluntary medication-error reporting database — data covering a 5-year period. Quantitative analyses showed that almost 70% of errors were due to human factors. A sampling of other key results include:
- More than 9500 PCA errors were reported from nearly 500 hospitals.
- Over 60% of Medmarx subscribers reported at least one PCA error.
- Although PCA errors accounted for only 1% of all reported errors in the Medmarx database, these represented 6.5% of harmful outcomes (including 2 deaths), compared with 1.5% harmful outcomes for all other errors.
- Harmful PCA events occurred in older patients to a greater degree than other age groups.
- Incorrect dosage or total quantity of analgesic medication administered was ranked as the leading type of PCA error in this study.
- Errors due to confusion on drug names or the use of unauthorized drugs were also common.
- Equipment-related issues such as incorrect programming of PCA units also were implicated.
Clinical Concepts: The authors concluded that errors were reported during all phases of the medication-use process, and suggested that institutions need to assess their own individual weaknesses to effectively reduce PCA errors. Operator errors during programming included errors in the bolus dose, the lockout interval, and the basal rate. Reasons for these errors included distraction and inexperience, and a recommendation was made to implement a practice of routine PCA double-checking by 2 qualified staff members.
Reference: Hicks RW, Heath WM, Sikirica V, et al. Medication errors involving patient-controlled analgesia. Joint Commission Journal on Quality and Patient Safety. 2008(Dec);34(12):734-742.
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Triptans Help Differentiate Sinus Headache From Migraine
Researchers from Emory University School of Medicine in Atlanta, Georgia, enrolled 54 patients with self-described complaints of “sinus headache” (including facial pain, pressure, or localized headache), but without positive diagnostic evidence of sinusitis, in a prospective trial of empirical migraine treatment. Eletriptan 40 mg was prescribed at onset of “sinus headache” pain with instructions to repeat the dose if the symptoms were not relieved within 2 hours. Patients who did not experience relief with eletriptan were switched to sumatriptan or rizatriptan. Patients kept a headache diary and rated each episode before and after triptan use using a visual analog scale.
Of the 38 patients who completed the migraine-directed therapy and follow-up, more than 80% reported significant headache relief with triptans, pre-determined to be >50% reduction in pain. One patient reported partial improvement, assessed as 25-50% relief; 3 patients experienced headache relief with triptan therapy and lifestyle or diet changes; 7 participants required topiramate for long-term migraine management following the study.
Practice Pointers: In a related news story (ENToday), the primary author, Elina Kari, MD, stated, “this study demonstrated that the demographics of patients with self-described ‘sinus headaches’ who did not have findings of sinusitis on endoscopy and CT scan closely reflected the demographics of patients afflicted with migraines.” She added that “sinus headache appears to be overdiagnosed and overtreated.” Researchers expressed concern about the nearly one third who did not participate in follow-up, largely due to resistance to a migraine diagnosis. The authors conclude that triptan therapy may be a useful tool for the differential diagnosis of migraine.
Reference: Kari E, Delgaudio JM. Treatment of sinus headache as migraine: the diagnostic utility of triptans. Laryngoscope. 2008(Oct 22); [Early online publication prior to print].
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Better Pain Control, Communication Needed by Hospitals
Investigators from the Harvard School of Public Health in Boston, Massachusetts, conducted a national patient satisfaction survey involving patients from 40 major metropolitan-area hospitals. Perceptions of care across 6 domains were analyzed, including practitioner communication, nursing services, discharge planning, and pain management. Hospital characteristics commonly thought to enhance patients’ experiences and quality of clinical care were examined in relation to patients' evaluations of their actual experiences.
Of the 4032 hospitals reporting any quality data, 2429 also reported data on patients’ experiences. On average, 36% of the patients who were invited to participate chose to do so [however, the total number of patients involved in this study was not reported]. Overall, while results varied somewhat by region and specific domain, many hospitals received low scores in basic areas like pain management, communication, and discharge instructions.
Here are some of the findings:
- Nearly one-third of patients gave low scores for pain management.
- Almost 20% of patients reported dissatisfaction with the communication of discharge instructions.
- The quality of clinical care and patients’ experiences showed a positive relationship.
- For-profit hospitals received lower scores than their not-for-profit counterparts.
Clinical Concepts: In light of recent initiatives by the Joint Commission and other organizations, the authors reported surprise at the low scores in pain management and the communication of discharge instructions. The authors stated that the survey results offer “insights into areas that need improvement,” and they expressed hope that regular reporting of performance on patient-reported measures of quality will accelerate such improvements.
Reference: Jha AK, Orav EJ, Zheng J, et al. Patients’ perception of hospital care in the United States. NEJM. 2008(Oct 30);359(18):1921-1931.
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Dry-Needling Plus Steroids Relieve Plantar Fascitis
The painful inflammation of plantar fasciitis can be treated conservatively with rest, ice, physical therapy, and anti-inflammatory medications; or, more aggressively, with shockwave therapy. A study presented by Italian researchers at the Radiological Society of North America 2008 annual meeting involved a dry-needling treatment of 44 patients with plantar fasciitis that was unresponsive to other medical therapy. Radiologists injected local anesthetic, then guided a needle to the areas of pain using ultrasound, and completed the procedure with an injection of steroids into soft tissues around the fascia.
Within 3 weeks following treatment, symptoms disappeared in 42 patients (95%); only 2 patients appeared to have no response to therapy.
Clinical Concepts: This meeting abstract did not report on safety issues and “suggested” the use of an orthotic soft arch support following the treatment but did not specifically state that the orthotic was used in this trial. The researchers reported that the ultrasound-guided dry-needling and steroid therapy is “quicker, cheaper, and not painful if compared to shockwaves.”
Reference: Sconfienza LM, Lacelli F, Serafini G, et al. What’s new in the treatment of plantar fasciitis: a percutaneous ultrasound (US)-guided approach. Radiological Society of North America (RSNA) 94th Scientific Assembly and Annual Meeting. Chicago, IL. November 30 – December 5, 2008. Meeting Abstract:SSA13-07.
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Briefly Noted...
> One in Ten Americans Suffers Arthritis Pain
Approximately 21 million Americans – 9.5% of adults 18 and older – either visited or called a doctor for a prescription to reduce arthritis pain in 2005, according to the latest News and Numbers from the U.S. Agency for Healthcare Research and Quality (AHRQ). Some 21 million adults sought treatment, but women did so more often than men (12% vs 7%). About $32 billion was spent for arthritis treatments, including doctor visits (36%), hospital care (31%), prescription drugs (21%), home health care (12%) and emergency room visits (<1%).
Source: Arthritis: Use and Expenditures among U.S. Adult Noninstitutionalized Population, 2005. AHRQ Medical Expenditure Panel Survey (MEPS), Statistical Brief #222, September 2008.
> Rheumatoid Arthritis Increasing in American Women
After 4 decades of decline, rheumatoid arthritis (RA) is on the rise among American women. Researchers at the Mayo Clinic found that in the 4 decades leading up to 1994, the U.S. saw a decline in the incidence of RA, but in the mid-90s the incidence and the prevalence of the disease started increasing again. Their findings were based on a study that included 350 adult patients of average age 57 from Olmsted County, Minnesota.
Lead author, rheumatologists Sherine Gabriel, MD, and colleagues said they didn't know what the underlying cause was, but speculated it might be an environmental factor. In the decade leading up to 1995 the annual incidence of RA among women in the U.S. was about 36/100,000; however, this jumped to 54/100,000 in the following decade. Among men the incidence has not changed and remains at about 29/100,000. The overall proportion of the U.S. population with RA rose from 0.85 to 0.95 per cent, they added.
Sources: Presented at the annual meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals, October 25, 2008, San Francisco. Also reported by Medical News Today, October 27, 2008.
> Despite Treatment, 1 in 3 Patients Still Suffer Chronic Pain
Despite 3-months of pain treatment, a third of patients still suffer from severe chronic pain, and 3 in 5 feel depressed or anxious as a result of their pain. Furthermore, half of patients with chronic pain suffer the added burden of analgesic side effects. These are findings released last October from PainSTORY (Pain Study Tracking Ongoing Responses for Year), the first survey of its kind to provide in-depth insight into how chronic pain impacts the lives of patients during one year in 13 European countries.
PainSTORY results thus far demonstrate that both the physical and psychological aspects of patients' lives are affected by their chronic pain. About 60% of patients experience problems walking and more than half experience problems sleeping. Almost half have changed the way they work, and many find it difficult to socialize. Many patients were being prescribed suboptimal treatment for their pain. Of the 81% with moderate-to-severe pain taking prescription medication, only 13% were receiving strong opioids. More than half of patients were suffering at least one side effect as a result of their prescribed medication, including constipation, dizziness, and drowsiness, which are common symptoms for both weak and strong opioids.
Source: European Week Against Pain, October 20-25, 2008, Cambridge. Reported via PRNewswire, October 21, 2008.
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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. All brand names are registered trademarks of their respective manufacturers.
Tapentadol Hydrochloride – Approved for Moderate to Severe Pain Relief
In November 2008, the FDA granted approval of tapentadol hydrochloride — a centrally-acting synthetic analgesic — in 3 immediate-release tablet strengths: 50 mg, 75 mg, and 100 mg. This new analgesic option for adults combines two mechanisms of action, mu-opioid receptor agonism and inhibition of norepinephrine reuptake. The approval was based on the results of 3 clinical trials of more than 2100 patients that demonstrated significant pain relief compared with placebo. Adverse effects and drug contraindications are consistent with other opioid medications. Johnson & Johnson Pharmaceutical Research & Development reported that tapentadol has not been given a trade name, and the product cannot be sold until it receives a controlled substance classification.
Fentanyl Transdermal System — FDA Approval for Teva Pharmaceutical Industries Ltd.
In October 2008, the FDA approved the manufacture and marketing of another generic version of the fentanyl transdermal patch. This product has been approved as the generic equivalent of Duragesic® for continuous management of moderate to severe chronic pain that cannot be managed by other pain relievers; similar approvals have been previously granted to other manufacturers. This product uses the Aveva Drug Delivery System — a proprietary matrix “drug in adhesive” design — and will be available in 25, 50, 75, and 100 mcg/hour strengths.
 Warning: The FDA has issued warnings concerning the dangers of using patches inappropriately. The fentanyl transdermal system should ONLY be used in patients who are already receiving opioid therapy, who have demonstrated opioid tolerance, and who require a total daily dose at least equivalent to 25 mcg/hour.
TNF-Blockers – FDA Asks Makers to Strengthen Warnings of Increased Infection Risk
A September 2008 press release reported that the FDA has instructed manufacturers of 4 tumor necrosis factor (TNF) alpha blockers — prescribed for a variety of health conditions including arthritis, ankylosing spondylitis, and Crohn’s disease — to strengthen their existing warnings of risks for developing opportunistic fungal infections. TNF-blockers (Humira®, Cimzia®, Enbrel®, and Remicade®) suppress the immune system and, according to FDA reviewers, healthcare professionals are failing to consistently recognize serious fungal infections, resulting in delayed treatment of those infections. The FDA specifically reported 21 cases of belated identification of histoplasmosis in patients treated with Enbrel, Humira, or Remicade living in the Ohio River and Mississippi River valleys. The delay in treatment for infection may have contributed to the deaths of 12 patients. The FDA asked manufacturers to submit warning revisions to product safety labeling within 30 days and provide prescriber education regarding the risks.
Ionsys™ Transdermal System – Johnson & Johnson Company Issues 11-Country Recall
A needleless, three-part advanced fentanyl patch system used in 11 European countries has been recalled after some units self-activated. The credit-card-sized Ionsys fentanyl iontophoretic transdermal system uses a low-intensity electrical field to move fentanyl into the patient's skin and, subsequently, the bloodstream. The activation defect, which could create a risk of opioid overdose, was identified in the factory and there were no reports of patient events. The product was approved in the United States in May 2006 but was never marketed because a change in the manufacturing process required an FDA resubmission; the new application was rejected in August 2008. Johnson & Johnson’s Ortho McNeil unit plans to re-submit the application in 2009.
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