Relationship of American Spinal Injury Association Impairment Scale Grade to Post-injury Hospitalization and Costs in Thoracic Spinal Cord Injury.

BACKGROUND: The lifetime economic burden of thoracic spinal cord injury (SCI) is known to be high, but evidence of variability of costs in relation to the American Spinal Injury Association Impairment Scale (AIS) grade is limited. OBJECTIVE: To estimate lifetime economic costs of hospitalization by AIS grade in thoracic SCI. METHODS: Using SCI Model Systems data from January 2000 to March 2016 from the National Spinal Cord Injury Statistical Center, we estimated mean total annual days of all-cause hospitalization by AIS grade among persons with thoracic SCI, based on assessments 1, 5, and 10 yr post-injury. We combined this information with secondary cost data and projections of life expectancy to estimate lifetime economic costs of hospitalization by AIS grade in persons aged 35 yr at time of thoracic SCI. Future costs were discounted to present value at 3% annually. RESULTS: One year post-injury, mean total annual days of hospitalization ranged from 2.1 for persons with AIS-D injuries to 5.9 for those who were AIS-A. Similar differences were noted 5 and 10 yr post-SCI. The estimated net present value of expected lifetime costs of hospitalization following thoracic SCI at age 35 yr was $321 534, $249 514, $188 989, and $68 120 (2015 US$) for AIS-A, AIS-B, AIS-C, and AIS-D injuries, respectively. CONCLUSION: Persons with less severe thoracic SCI, as reflected in AIS grade, spend fewer days in hospital over their lifetimes, leading to lower costs of inpatient care. Therapies improving AIS grade following thoracic SCI may provide cost savings in addition to addressing substantial unmet need.

Clinical characteristics and patterns of healthcare utilization in patients with painful neuropathic disorders in UK general practice: a retrospective cohort study.

BACKGROUND: Clinical characteristics and patterns of healthcare utilization in patients with painful neuropathic disorders (PNDs) who are under the care of general practitioners (GPs) in the UK are not well understood. METHODS: Using a large electronic UK database, we identified all adults (age ≥ 18 years) with any GP encounters between 1 January 2006-31 December 2006 at which a diagnosis of PND was noted ("PND patients"). An age-and gender-matched comparison group also was constituted consisting of randomly selected patients with one or more GP encounters-but no mention of PNDs-during this period. Characteristics and patterns of healthcare utilization of patients in the two groups were then examined over the one-year study period. RESULTS: The study sample consisted of 31,688 patients with mention of PNDs and an equal number of matched comparators; mean age was 56 years, and 62% were women. The prevalence of various comorbidities was higher among patients in the PND group, including digestive disorders (31% vs. 17% for comparison group), circulatory disorders (29% vs. 22%), and depression (4% vs. 3%) (all p < 0.01). Receipt of prescriptions for pain-related pharmacotherapy also was higher among PND patients, including nonsteroidal anti-inflammatory drugs (56% of PND patients had one or more such prescriptions vs. only 22% in the comparison group), opioids (49% vs. 12%), tricyclic antidepressants (20% vs. 1%), and antiepileptics (12% vs. 1%) (all p < 0.01). PND patients also averaged significantly more GP visits (22.8 vs. 14.2) and referrals to specialists (2.8 vs. 1.4) over one year (both comparisons p < 0.01). CONCLUSIONS: Patients with PNDs under the care of GPs in the UK have relatively high levels of use of healthcare services and pain-related pharmacotherapy.

Patterns of healthcare utilization and cost in patients with newly diagnosed fibromyalgia.

OBJECTIVES: To compare healthcare utilization and costs in the year preceding and following initial diagnosis of fibromyalgia (FM). METHODS: Using a large US health insurance claims database, we identified all persons with newly diagnosed FM (International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis code 729.1) between January 1, 2003, and December 31, 2005 ("FM patients"). Each patient's first-noted claim with a diagnosis of FM was designated the "index date," and all pharmacy, outpatient, and inpatient claims were compiled over the 12-month periods preceding and following this date ("prediagnosis" and "postdiagnosis," respectively). Patients with incomplete pre- or postdiagnosis data were excluded. Healthcare utilization and costs were compared between the 2 periods. RESULTS: A total of 1803 patients met all study inclusion criteria; mean (SD) age was 50.4 (9.4) years; 91% were women. Comorbidities were common, including arthritis (21% of study subjects), back pain (20%), and painful neuropathic disorders (16%). The percentage of study subjects receiving various pain-related medications increased from pre- to postdiagnosis, including opioids (51.3% vs 55.9%), antiepileptics (22.6% vs 28.6%), and tricyclic antidepressants (15.5% vs 21.2%) (all P <.01). Mean total healthcare costs also increased by $1725 between these periods (mean [95% confidence interval]: $9324 [$8655, $10,092] vs $11,049 [$10,245, $11,973], respectively; P <.01). CONCLUSIONS: Patients with FM are often seen for other medical problems prior to initial diagnosis. Levels of healthcare utilization and costs are high during both the pre- and postdiagnosis periods.

How do changes in pain severity levels correspond to changes in health status and function in patients with painful diabetic peripheral neuropathy?

The current analysis compares changes in pain with changes in function and health status in individuals with painful diabetic peripheral neuropathy (DPN). The post hoc analysis is based on a 12week, multinational, placebo-controlled trial of pregabalin in which 401 patients were randomized to treatment. Study measures included the Brief Pain Inventory short-form (BPI-sf), EQ-5D and other patient-reported outcomes. Cutpoints were derived on the BPI-sf 0-10 average pain numeric rating scale [NRS] to classify pain grades of "mild" (1-3), moderate (4-6) and severe (7-10), adjusting for geographical regions where data were collected. Two different metrics were used to classify the importance of change in pain severity from baseline to 12weeks: changes in pain severity grades (defined by cutpoint categories) and percent reduction in the NRS (categories ranging from 0-9% to 50%). An improvement in one pain grade or a 30% reduction in the NRS served as determinants of a clinically important difference. Patients with a one-grade reduction in pain severity, either from "severe-to-moderate" or "moderate-to-mild," had a 3-point improvement the BPI-sf Pain Interference Index (PII; a composite measure of function); a reduction from "severe-to-mild" pain corresponded to a 6-point improvement in the PII. Similarly, a reduction in the NRS of 30% and 50% corresponded to a 3-point and a 5-point improvement in the PII, respectively. Changes in pain were also associated with changes in health status. Results suggest that patients whose pain is not reduced to a mild level of severity can still experience clinically important changes in function and health status.

Cost-effectiveness of pregabalin versus venlafaxine in the treatment of generalized anxiety disorder: findings from a Spanish perspective.

The objective of the present study was to describe a new model of the cost-effectiveness of treatment of generalized anxiety disorder (GAD) and its application to a comparison of pregabalin versus venlafaxine extended-release (XR) from a Spanish healthcare perspective. Microsimulation techniques, including Hamilton Anxiety Scale (HAM-A) score, number of weeks with minimal or no anxiety (HAM-A

Magnitude of potentially inappropriate prescribing in Germany among older patients with generalized anxiety disorder.

BACKGROUND: Several medications commonly used to treat generalized anxiety disorder (GAD) have been designated "potentially inappropriate" for use in patients aged > or =65 years because their risks may outweigh their potential benefits. The actual extent of use of these agents in clinical practice is unknown, however. METHODS: Using a database with information from encounters with general practitioners (GP) in Germany, we identified all patients, aged > or =65 years, with any GP office visits or dispensed prescriptions with a diagnosis of GAD (ICD-10 diagnosis code F41.1) between 10/1/2003 and 9/30/2004 ("GAD patients"). Among GAD-related medications (including benzodiazepines, tricyclic antidepressants [TCAs], selective serotonin reuptake inhibitors, venlafaxine, hydroxyzine, buspirone, pregabalin, and trifluoperazine), long-acting benzodiazepines, selected short-acting benzodiazepines at relatively high dosages, selected TCAs, and hydroxyzine were designated "potentially inappropriate" for use in patients aged > or = 65 years, based on published criteria. RESULTS: A total of 975 elderly patients with GAD were identified. Mean age was 75 years, and 72% were women; 29% had diagnoses of comorbid depression. Forty percent of study subjects received potentially inappropriate agents - most commonly, bromazepam (10% of all subjects), diazepam (9%), doxepin (7%), amitriptyline (5%), and lorazepam (5%). Twenty-three percent of study subjects received long-acting benzodiazepines, 10% received short-acting benzodiazepines at relatively high doses, and 12% received TCAs designated as potentially inappropriate. CONCLUSION: GPs in Germany often prescribe medications that have been designated as potentially inappropriate to their elderly patients with GAD - especially those with comorbid depressive disorders. Further research is needed to ascertain whether there are specific subgoups of elderly patients with GAD for whom the benefits of these medications outweigh their risks.

Patterns of healthcare utilization in patients with generalized anxiety disorder in general practice in Germany

Background and Objectives: To describe patterns of healthcare utilization among patients with generalized anxiety disorder (GAD) in general practitioner (GP) settings in Germany. Methods: Using a large computerized database with information from GP practices across Germany, we identified all patients, aged > 18 years, with diagnoses of, or prescriptions for, GAD (ICD-10 diagnosis code F41.1) between October 1, 2003 and September 30, 2004 («GAD patients»). We also constituted an age- and sex-matched comparison group, consisting of randomly selected patients without any GP encounters or prescriptions for anxiety or depression (a common comorbidity in GAD) during the same period. GAD patients were then compared to those in the matched comparison group over the one-year study period. Results: The study sample consisted of 3340 GAD patients and an equal number of matched comparators. Mean age was 53.2 years; 66.3% were women. Over the 12-month study period, GAD patients were more likely than matched comparators to have encounters for various comorbidities, including sleep disorders (odds ratio [OR] = 6.75 [95% CI = 5.31, 8.57]), substance abuse disorders (3.91 [2.89, 5.28]), and digestive system disorders (2.62 [2.36, 2.91]) (all p < 0.01). GAD patients averaged 5.6 more GP encounters (10.5 [SD = 8.8] vs 4.9 [5.7] for comparison group) and 1.4 more specialist referrals (2.3 [2.9] vs 0.9 [1.7]) (both p < 0.01). Only 58.3% of GAD patients received some type of psychotropic medication (i.e., benzodiazepines, antidepressants, and/or sedatives/hypnotics). Conclusions: Patients with GAD in GP practices in Germany have more clinically recognized comorbidities and higher levels of healthcare utilization than patients without anxiety or depression (AU)

Reliability of a 1-week recall period for the Medical Outcomes Study Sleep Scale (MOS-SS) in patients with fibromyalgia.

OBJECTIVE: To evaluate the reliability of a one-week versus a four-week recall period of the Medical Outcomes Study Sleep Scale (MOS-SS) in patients with fibromyalgia (FM). METHODS: The MOS-SS was administered by mail to patients with a confirmed diagnosis of FM and a current pain rating of > 2 (0-10 point numerical rating scale) recruited through newspapers, support groups, and the Internet. Reliability of MOS-SS subscale domains was evaluated using test-retest methodology separated by a 1-3 day interval for the 4-week recall period and a 7-day interval for the 1-week recall period. Patient Impression of Change was evaluated for sleep, and for patients with no change, the intraclass correlation coefficient (ICC) and the Pearson correlation coefficient was calculated for MOS-SS subscales. RESULTS: Of 129 patients enrolled, 91.3% were female, mean age was 49.4 +/- 11.0 years; self-rated FM severity was moderate-to-severe in 88.1% of patients. MOS-SS subscale scores were similar for both recall periods with little variation between test-retest. The 9-item Sleep Problems Index scores ranged from 57.2 +/- 14.5 to 61.9 +/- 15.8 across all assessments and demonstrated high reliability which was similar for the 1-week (ICC 0.81) and 4-week (ICC 0.89) recall periods. For the other MOS-SS subscales, the 1-week recall period also showed good reliability, which was consistent for the ICC and Pearson correlation coefficients. CONCLUSION: A 1-week recall period is adequately reliable for use of the MOS-SS in studies evaluating sleep disturbance in patients with FM.

The economic burden of fibromyalgia: comparative analysis with rheumatoid arthritis.

OBJECTIVE: To quantify and compare direct costs, utilization, and the rate of comorbidities in a sample of patients with fibromyalgia (FM), a poorly understood illness associated with chronic widespread pain that is commonly treated by rheumatologists, to patients with rheumatoid arthritis (RA), a well studied rheumatologic illness associated with inflammatory joint pain. Patients with both illnesses were isolated and reported as a third group. A secondary analysis of work loss was performed for an employed subset of these patients. RESEARCH DESIGN AND METHODS: Retrospective cohort analysis of Thomson Reuters MarketScan administrative healthcare claims and employer-collected absence and disability data for adult patients with a diagnosis of FM (ICD-9-CM 729.1) and/or RA (ICD-9-CM 714.0x,-714.3x) on at least one inpatient or two outpatient claims during 2001-2004. MAIN OUTCOME MEASURES: The 12-month healthcare utilization, expenditures, and rates of comorbidities were quantified for all study-eligible patients; absence and short-term disability days and costs were quantified for an employed subset. RESULTS: The sample included 14034 FM, 7965 RA, and 331 FM+RA patients. Patients with FM had a higher prevalence of several comorbidities and greater emergency department (ED) utilization than those with RA. Mean annual expenditures for FM patients were $10911 (SD=$16075). RA patient annual expenditures were similar to FM: $10716 (SD= $16860). Annual expenditures were almost double in patients with FM+RA ($19395, SD= $25440). A greater proportion of patients with FM had any short-term disability days than those with RA (20 vs. 15%); and a greater proportion of patients with RA had any absence days (65 vs. 80%). Mean costs for absence from work and short-term disability in the FM and RA groups were substantial and similar. The FM+RA group was of insufficient sample size to report on work loss. LIMITATIONS: The availability of newer and more expensive FDA-approved medications since 2004 is not reflected in our findings. This analysis was restricted to commercially insured patients and therefore may not be generalizable to the entire U.S. population. CONCLUSIONS: The burden of illness in FM is substantial and comparable to RA. Patients with FM incurred direct costs approximately equal to RA patients. Patients with FM had more ED, physician, and physical therapy visits than RA patients. Patients in both groups had several comorbidities. Patients with FM+RA incurred direct costs almost double those of the patients with either diagnosis alone. FM and RA patients incurred similar overall absence and short-term disability costs.

Measurement properties of the Medical Outcomes Study Sleep Scale in patients with fibromyalgia.

OBJECTIVE: Sleep problems are a common symptom of fibromyalgia (FM). The objective of this study was to evaluate the Medical Outcomes Study (MOS) Sleep Scale as a measure of FM-related sleep problems. METHODS: Analyses were based on data from the 1056 and 1077 studies, two randomized, double-blind, placebo-controlled trials of pregabalin for adults with FM. MOS Sleep Scale scores of study patients were compared with United States normative scores using a one-sample Z test. Subscale structure of the MOS was evaluated by confirmatory factor analyses, internal consistency was evaluated using Cronbach's alpha reliability coefficients. Estimated clinically important differences (CID) in MOS Sleep Disturbance subscale scores were evaluated using mixed-effects models of change in subscale scores as a function of the Patient Global Impression of Change (PGIC). RESULTS: 1056 and 1077 included 748 and 745 patients, respectively. Most patients were female (1056: 94.4%, 1077: 94.5%) and white (1056: 90.2%, 1077: 91.0%). Mean ages were 48.8 years (1056) and 50.1 years (1077). Baseline MOS Sleep Scale scores were statistically (P<0.001) and substantially poorer than general population values. The MOS subscale structure was confirmed in both studies at each assessment except at baseline in the 1056 study. Cronbach's alpha coefficients were acceptable, at least 0.70, for all multi-item scales at baseline and end-of-study assessments in both studies, with the exception of the Sleep Adequacy subscale at baseline. The estimated CID for the MOS Sleep Disturbance subscale was 7.9. CONCLUSIONS: The MOS Sleep Scale is an appropriate measure of FM-related sleep problems. These analyses provide the foundation for further use and evaluation of the MOS Sleep Scale in FM patients.

Clinical and economic characteristics of patients with painful neuropathic disorders in Germany.

Using a large database with information from general practitioners (GP) throughout Germany, we identified all adults (age > or = 18 years) with encounters for painful neuropathic disorders (PNDs) between August 1, 2005 and July 31, 2006 (PND patients). We also constituted an age- and sex-matched comparison group, consisting of randomly selected patients without any GP encounters for PNDs during the same period. Selected characteristics were then compared between PND patients and those in the comparison group over the 1-year study period. The study sample consisted of 275,685 PND patients and a similar number in the matched comparison group; mean age was 53.7 years, and 57% were women. PND patients were more likely than matched comparators to have encounters for various comorbidities, including circulatory system disorders (47% vs. 20%, respectively), depression (9% vs. 2%), and anxiety (4% vs. 1%) (all P < 0.01). They also were more likely to have received pain-related medications (57% vs. 13% for comparison group; P < 0.01)--most commonly, nonsteroidal anti-inflammatory drugs, benzodiazepines, and opioids, and less often, tricyclic antidepressants and anti-epileptics. PND patients averaged 7.3 more GP visits during the year (mean [95% CI] = 9.9 [9.9, 9.9] vs. 2.6 [2.6, 2.7] for comparison group); they also had significantly more specialist referrals and physician-excused absences from work (all P < 0.01). Patients with PNDs under the care of GPs in Germany have comparatively more comorbidities and higher levels of use of healthcare services. The pain-related medications that these patients receive raise concerns that PNDs may not be optimally treated in these settings.

Use of pregabalin in patients with painful neuropathic disorders under the care of general practitioners in the U.K.

PURPOSE: To examine the use of pregabalin in patients with painful neuropathic disorders under the care of general practitioners (GPs) in the U.K. MATERIALS AND METHODS: Using a large U.K. database of GP encounters, we identified all persons aged > or = 18 years with at least one GP encounter with a diagnosis of a painful neuropathic disorder (eg, postherpetic neuralgia, diabetic peripheral neuropathy) between January 1, 2004 and July 31, 2006. Among these patients, we then identified those who initiated therapy with pregabalin; the date of initial receipt of pregabalin was designated the "index date." We then examined use of pregabalin over the 6-month period following this date ("follow-up"), as well as changes in the use of other pain-related medications (eg, opioids, tricyclic antidepressants [TCAs], other antiepileptics [AEDs]) between the 6-month period preceding the index date ("pretreatment") and follow-up. Patients with less than 6 months of pretreatment and follow-up data were excluded, as were those without any encounters during pretreatment for a painful neuropathic disorder. RESULTS: A total of 1,400 patients (1.4% of all identified patients with painful neuropathic disorders) initiated therapy with pregabalin and met all other entry criteria; mean age was 62 years, and 58% were women. During pretreatment, most (54%) patients received three or more different types of pain-related medications. During follow-up, patients averaged four prescriptions for pregabalin, totaling 93 therapy days. Compared with pretreatment, fewer patients received other pain-related medications during follow-up, including TCAs (37% during pretreatment vs. 27% during follow-up), opioids (64% vs. 55%), and AEDs other than pregabalin (36% vs. 16%) (all P < 0.01). CONCLUSIONS: In the U.K., many patients prescribed pregabalin by their GPs may have been refractory to other pain-related medications. Use of these medications declined following initiation of pregabalin therapy.

Conceptual adequacy of the neuropathic pain symptom inventory in six countries.

BACKGROUND: Neuropathic pain results from a nerve lesion or nerve damage. Because it is a subjective experience, patient-reported outcomes may measure both the symptoms and impact on the patient's life. The purpose of this study was to determine whether the Neuropathic Pain Symptom Inventory (NPSI) adequately assesses neuropathic pain symptoms in patients with diabetic peripheral neuropathy, post-herpetic neuralgia, trigeminal neuralgia, and sciatica across multiple cultures. METHODS: From data collected from 132 subjects in 6 countries, qualitative research methods identified their most important symptoms (and verbal descriptions) associated with neuropathic pain. A core set of commonly described symptoms spanning multiple cultures was also described. Moderators using a semi-structured discussion guide conducted focus groups consisting of patients in the U.S., Brazil, Japan, China, Finland, and Spain to elicit concepts that were most important and relevant (concept elicitation phase). Study subjects ranked the importance of each neuropathic pain symptom, completed the NPSI, and commented on its ability to capture key symptoms (face and content validation phase). RESULTS: Descriptive terms for sensations of neuropathic pain were similar in all countries; burning, electric shocks, and pins and needles were among the most-common sensations. Individuals with neuropathic pain experienced all sensations that were included in the NPSI. They also tended to describe pins and needles and numbness interchangeably, perhaps reflecting the relative number of DPN subjects on study. CONCLUSION: Based on data from these focus groups, the NPSI is an acceptable instrument for assessing neuropathic pain.

Characteristics and patterns of healthcare utilization of patients with fibromyalgia in general practitioner settings in Germany.

OBJECTIVE: To examine characteristics and patterns of healthcare utilization of patients with fibromyalgia (FM) under the care of general practitioners (GPs) in Germany. RESEARCH DESIGN AND METHODS: Retrospective cohort study, using a large electronic database with information on GP encounters in Germany (IMS MediPlus). We identified all patients, aged > or =18 years, with any encounters for FM (ICD-10 diagnosis code M79.7) between February 1, 2004 and January 31, 2007. We also constituted a comparison group consisting of randomly selected patients with one or more GP encounters - but none for FM - during this period, who we matched to FM patients based on age and sex. Characteristics and healthcare utilization of patients in the FM and comparison groups were then examined over the 1-year period, February 1, 2006-January 31, 2007. MAIN OUTCOME MEASURES: Prevalence of co-morbidities; use of pain-related pharmacotherapy; number of GP office visits; number of specialist referrals; and number of sick notes (physician-excused absences from work). RESULTS: The study sample consisted of 4983 FM patients and an identical number in the comparison group. Mean age was 58 years; 87% were women. The prevalence of various co-morbidities was greater among FM patients, including painful neuropathies (33% vs. 18% for comparison group) and depression (20% vs. 5%) (both p<0.01); more FM patients also received pain-related pharmacotherapy (67% vs. 28%; p<0.01). Compared with patients in the comparison group, FM patients averaged approximately twice as many GP visits (11.4 [SD=10.1] vs. 5.8 [7.5]), referrals (4.5 [5.2] vs. 2.2 [3.6]), and sick notes (0.6 [1.8] vs. 0.3 [1.1]) (all p<0.01). LIMITATIONS: Information in the study database is limited to GP encounters, and the sensitivity and specificity of our case-finding methods are unknown. CONCLUSIONS: Patients with FM under the care of GPs in Germany have comparatively more co-morbidities and higher levels of healthcare utilization.

Human and economic burden of generalized anxiety disorder.

The goal of the current work is to provide a comprehensive review and interpretation of the literature on the human and economic burden of generalized anxiety disorder (GAD) and how it compares with that of other mental disorders. The term "human burden" is used to describe quantified impairments in role functioning and quality of life (QOL). "Economic burden" describes costs related to health care resource utilization and lost work. A review of 34 studies reporting original quantitative data on associations between GAD and role functioning, QOL, and/or economic costs was undertaken. GAD was defined by DMS-III-R, DSM-IV, or ICD-10 DCR. Persons with GAD (both with and without a comorbid mental disorder) described significant impairments due to both physical and emotional problems. Studies typically showed that role and QOL impairments of GAD were at least comparable in magnitude to those of other anxiety disorders, somatoform disorders, and physical conditions, and greater than those of substance use disorders. Large representative studies showed that role impairments of pure GAD were similar in magnitude to those of pure MDD. Studies of DSM-IV disorders showed that QOL impairments of GAD were at least comparable in magnitude to those of MDD; studies of DSM-III-R disorders showed the opposite pattern. GAD was associated with considerable economic costs owing to lost work productivity and high medical resource use. Quality of care initiatives that have been implemented to increase recognition and improve treatment outcomes for persons with MDD should be extended to the effective management of GAD.

Use of tricyclic antidepressants in older patients with diabetic peripheral neuropathy.

PURPOSE: To describe patterns of use of tricyclic antidepressants (TCAs) (eg, amitriptyline, nortriptyline) among older patients with diabetic peripheral neuropathy (DPN). MATERIALS AND METHODS: Using a large, integrated, US health-insurance claims database, we identified all patients who received TCAs between January 1, 1999 and June 30, 2001 ("study period"). Among these persons, we then selected those who: (1) were aged >or=65 years as of the date of first receipt of a TCA during the study period; and (2) had one or more healthcare encounters with a diagnosis of DPN in the 30-day period immediately preceding date of first receipt of a TCA. We then examined the prevalence of selected comorbidities and concurrent use of medications which might render inappropriate the prescribing of TCAs, based on a listing of contraindications, warnings, and precautions found in the package inserts for these medications. Patterns of TCA prescribing were examined, based on information on paid claims. RESULTS: There were 349 DPN patients, aged >or=65 years, who received TCAs. Mean age was 73.8 years, 55.9% were women, and 17.9% had diagnoses of depression. Most patients (84.0%) began therapy with amitriptyline. Almost one-half of study patients had indicators of potentially inappropriate TCA use, primarily cardiovascular comorbidities. Mean TCA dose among patients with and without these indicators was 23.3 (+/-13.4) mg and 25.4 (+/-15.3) mg, respectively (P=0.42). CONCLUSIONS: The high prevalence of contraindications, warnings, or precautions and the low level of TCA exposure suggest that many older patients with DPN who receive TCAs may be inappropriately treated.

Clinical characteristics and pain management among patients with painful peripheral neuropathic disorders in general practice settings.

Alleviating chronic pain is a global healthcare priority. Understanding the medical profile and current treatment patterns in patients with painful neuropathic disorders (PNDs) is crucial to the development of effective pain management strategies. Thus, our objective was to describe the demographic and clinical characteristics of persons with PNDs and their use of pain medications. Using the general practice research database, we categorized PNDs in two ways: Pure PNDs (which include diabetic neuropathy, postherpetic neuralgia, etc.; N=16,690) and Mixed PNDs (which include back/neck pain with neuropathic involvement; N=14,309). On average, PND patients were 55 years old (Pure, 55.4 [SD=16.9] years; Mixed, 54.3 [SD=16.4] years). Over a third had other chronic pain-related (Pure, 37.5%; Mixed, 37.1%) and nearly a quarter had non-pain related (Pure, 28.1%; Mixed, 24.1%) comorbidities. Use of medications with clinically demonstrated efficacy in PNDs was higher among patients with Pure PNDs (tricyclic antidepressants [Pure, 16.6%; Mixed, 10.1%]; 2nd generation antidepressants [Pure, 11.0%; Mixed, 9.7%]; and antiepileptics [Pure, 12.2%; Mixed, 2.6%]), whereas use of NSAIDs (Pure, 43.1%; Mixed, 65.2%) and opioids (Pure, 8.5%; Mixed, 14.3%) was higher among patients with Mixed PNDs. Average daily doses of select neuropathic pain-related medications among PND patients (Pure and Mixed) were lower than those recommended for neuropathic pain. Among both Pure and Mixed PND patients, use and doses of evidenced-based neuropathic pain-related medications was low, and lower than the use of NSAIDs (a medication class with no proven efficacy for PNDs) in each group, suggesting possible sub-optimal neuropathic pain management among these patients.

Patient burden of trigeminal neuralgia: results from a cross-sectional survey of health state impairment and treatment patterns in six European countries.

Trigeminal neuralgia (TN) is an uncommon neuropathic condition associated with excruciating facial pain. It is important to determine the effect of TN pain on patient functioning and to characterize relevant pharmacologic treatment patterns and health resource utilization in general practice. Eighty-two patients with TN were identified in a general practice setting during an observational survey of broad neuropathic pain syndromes in six European countries. Patients answered a questionnaire that included pain severity and interference items from the modified Short Form Brief Pain Inventory (mBPI-SF), the EuroQol Survey of functioning and well-being (EQ-5D), and questions related to current treatment, health status, and resource utilization. Physicians provided information on medications prescribed for TN pain and pain-related comorbidities (anxiety, depression, and sleep disturbance). The mean patient age was 62.7 +/- 15.8 years, 46% were > or =65 years, and 66% of patients had TN >1 year of duration. The mean Pain Severity Index was 4.2 (range 0-10), reflecting moderate pain despite 94% of patients taking prescription medications for their TN pain. Prescription medications included carbamazepine (mean daily dose 534.1 +/- 269.8 mg), the recommended first-line pharmacologic therapy for TN. Pain severity was significantly associated with reduced EQ-5D health state valuation (P < 0.001) and greater pain interference (mBPI-SF) (P < 0.001). These findings demonstrate that TN pain presents a substantial patient burden expressed as interference with daily functioning and reduced health status associated with pain severity. This burden may result from both suboptimal management strategies and the frequent resistance of this neuropathic condition to treatment, and suggests a need for more effective pain management strategies.

Prevalence of contraindicated medical conditions and use of precluded medications in patients with painful neuropathic disorders prescribed amitriptyline.

Amitriptyline is a tricyclic antidepressant that is historically indicated and used to manage depression. More recently, due to clinical evidence demonstrating efficacy, it is often prescribed in the management of painful neuropathic disorders (PNDs). However, the amitriptyline label contains numerous preclusions (contraindications, warnings/precautions, drug interactions). Our objective was to measure the frequency of amitriptyline prescriptions in PND patients using the U.K. General Practice Research Database and assess whether any prescriptions were given to patients with preclusions listed in the product label. We identified a total of 13,546 patients (mean age 59 +/- 16.2 years; 66.7% female) who had a diagnosis of a PND and received > or =1 prescription for amitriptyline between July 1998 and June 2001. Nearly half (46.7%) of PND patients prescribed amitriptyline had > or =1 preclusion for its use; 3.5% had > or =1 contraindication; 22% had > or =1 warning/precaution; and 33% received > or =1 medication with a potential for drug interactions with amitriptyline. Preclusions were more likely in women than in men (48.3% vs. 43.4%, P < 0.0001); their incidence increased with age (42.8%, 50.4%, 55.1%, and 52.3% among those ages <65, 65-74, 75-84, and 85+ years, P < 0.0001), and the number of patients with preclusions was the highest in the phantom limb pain group (67.4%) and lowest in the atypical facial pain group (42.9%), P < 0.001. The average daily amitriptyline doses (starting: 33.6 +/- 32.4 mg; maintenance: 42.1 +/- 39.9 mg) were low compared to those used for the treatment of depression. Results indicate that, in a significant number of cases, the existence of preclusions did not prevent the prescribing of amitriptyline. Our findings raise a potential concern about the way this medication is being used. However, the clinical significance of these data is, as yet, unclear. Although, in theory, adverse outcomes may have been associated with this practice, we could not confirm this with this database analysis.

Use of tricyclic antidepressants in older patients with painful neuropathies.

OBJECTIVE: To describe patterns of use of tricyclic antidepressants (TCAs) (e.g., amitriptyline, nortriptyline) in older patients with painful neuropathies. RESEARCH DESIGN AND METHODS: Using a large US health insurance claims database, we identified all persons who: (1) received a TCA between 1 January 1999 and 30 June 2001, (2) were aged > or =65 years as of the date of their first prescription for a TCA during this period, and (3) had one or more health care encounters for the treatment of a painful neuropathy in the 30-day period immediately preceding their initial receipt of a TCA. We then examined the prevalence of selected comorbidities and/or concurrent use of medications that might render the prescribing of a TCA inappropriate, based on a listing of contraindications, warnings, and precautions found in the package inserts for these agents. Patterns of TCA use also were examined, based on information on paid claims. RESULTS: A total of 1,732 patients met all inclusion and exclusion criteria for the study. Their mean age was 74.6 years; 60.3% were women. Amitriptyline was the most frequently prescribed TCA (79.4% of patients). Forty-one percent of study subjects receiving TCAs had conditions--primarily cardiovascular--that render the use of such agents potentially inappropriate. The mean daily dose of TCAs was universally low (about 23 mg). CONCLUSIONS: The high prevalence of conditions rendering the use of TCAs potentially inappropriate, along with relatively low daily dosages, suggest that many older patients with painful neuropathies who are prescribed these agents may be suboptimally treated.