Therapy switching, augmentation, and discontinuation in patients with osteoarthritis and chronic low back pain.

BACKGROUND: Recommended pain treatments for osteoarthritis (OA) and chronic low back pain (CLBP) are suboptimal, and limited information is available regarding patterns of pharmacotherapy among patients with these conditions. AIMS: Evaluate patterns of therapy switching, augmentation, and discontinuation after treatment initiation with select pain medications in patients with OA and CLBP. METHODS: Using the U.K. The Health Improvement Network (THIN) database, OA and CLBP patients newly prescribed (index-event) nonselective nonsteroidal anti-inflammatory drugs (NS-NSAIDs), cyclooxygenase-2 inhibitors (Cox-2s), acetaminophen, tramadol and weak or strong opioids were selected. Descriptive statistics, Kaplan-Meier analyses, and COX proportional hazards models were used to evaluate patterns of changes in pharmacotherapy during the 12-month postindex period. RESULTS: Rates of therapy switching, augmentation, and discontinuation, respectively, were significantly different (all P values<0.0001) across the evaluated medication cohorts for both OA and CLBP patients. Discontinuation rates in OA patients were 91.9% (NS-NSAIDs), 86.9% (Cox-2s), 91.4% (acetaminophen), 89.7% (tramadol), 93.2% (weak opioids), and 84.3% (strong opioids); and in CLBP patients were 97.2% (NS-NSAIDs), 94.0% (Cox-2s), 95.0% (acetaminophen), 92.8% (tramadol), 97.0% (weak opioids), and 86.8% (strong opioids). The rates of switching (range 30.0% to 59.6%) and augmentation (range 7.5% to 15.2%) were lower. Estimated probability evaluations suggested that two-thirds of patients who switched, augmented, or discontinued therapy did so within the first couple of months, and a majority did so within 6-months of treatment initiation. CONCLUSIONS: This study demonstrates that therapy switching and discontinuation of select pain medications were common among OA and CLBP patients in the U.K. and may result from inadequate pain relief or undesirable side effects.

Use and costs of prescription medications and alternative treatments in patients with osteoarthritis and chronic low back pain in community-based settings.

OBJECTIVE: To evaluate the use and direct medical costs of pharmacologic and alternative treatments for patients with osteoarthritis (OA) and chronic low back pain (CLBP). METHODS: The LifeLink™ Health Plan Claims Database was used to identify patients ≥18 years old, diagnosed with OA (N = 112,951) or CLBP (N = 101,294). Of these patients, 64,085 with OA and 47,386 with CLBP received pain-related treatments during CY2008 and were selected for inclusion. For patients in both cohorts, pharmacologic and alternative treatments, and direct medical costs were examined during CY2008. RESULTS: Opioids were the most frequently prescribed medication (>70%) in both groups, followed by nonselective nonsteroidal anti-inflammatory drugs (>50%). Over 30% received antidepressants, >20% received benzodiazepines, and 15% in each group received sedative hypnotics. Use of alternative treatments was as follows: chiropractor, OA 11%, CLBP 34%; physical therapy, 20% in both groups; transcutaneous electrical nerve stimulations (TENS), OA 14%, CLBP 22%; acupuncture, hydrotherapy, massage therapy, and biofeedback, <3% in both groups. Mean (SD) total healthcare costs among these patients were, OA: $15,638 ($22,595); CLBP: $11,829 ($20,035). Pharmacologic therapies accounted for approximately 20% of these costs, whereas alternative treatments accounted for only 3% to 4% of the total costs. CONCLUSIONS: Patients with OA and CLBP used a variety of pain-related and adjunctive medications. Although, alternative treatments are widely recommended, we found limited use of several of these in clinical practice, potentially due to the source of our data (commercial claims). Further research is needed to ascertain the extent to which such therapies contribute to the total costs of OA and CLBP management.

Retrospective evaluation of clinical characteristics, pharmacotherapy and healthcare resource use among patients prescribed pregabalin or duloxetine for diabetic peripheral neuropathy in usual care.

OBJECTIVE: To evaluate treatment patterns and costs among patients with painful diabetic peripheral neuropathy (pDPN) newly prescribed pregabalin or duloxetine in usual care settings. METHODS: Using the PharMetrics® Database, patients with pDPN (ICD-9-CM codes 357.2 or 250.6x) newly prescribed pregabalin or duloxetine were identified. Patients initiated on duloxetine (n=713; mean age 55.4 ± 9.5 years) were propensity score-matched with patients initiated on pregabalin (n=713; mean age 56.3 ± 9.3 years). Prevalence of comorbidities, pain-related pharmacotherapy and healthcare resource use/costs (pharmacy, outpatient, inpatient, total) were examined during the 12 months preceding (pre-index) and following (follow-up) the date of the first pregabalin or duloxetine prescription. RESULTS: Both cohorts had multiple comorbidities and a substantial pain medication burden. Among pregabalin patients, use of other anticonvulsants (35.6% vs. 24.7%) and tricyclic antidepressants significantly decreased (18.2% vs. 13.7%) and serotonin-norepinephrine reuptake inhibitors (SNRIs) increased (7.9 % vs. 12.9%) in the follow-up period; all P values <0.05. Among duloxetine patients, use of other SNRIs (8.7% vs. 5.2%) and selective serotonin reuptake inhibitors decreased significantly (32.1% vs. 18.9%) in the follow-up period, but there were increases for anticonvulsants (42.1% vs. 48.4%), benzodiazepines (25.5% vs. 32%), and sedative/hypnotics (22.6% vs. 25.8%); all P values <0.05. Among pregabalin and duloxetine patients there were increases (P<0.05) in pharmacy, outpatient, and total healthcare costs from the pre-index to the follow-up period. Total medication costs in the follow-up period were significantly higher for duloxetine (median $6,763 [IQR $3,970-$10,914]) relative to pregabalin (median $6,059 [IQR $3,277-$9,865]); P=0.0017. CONCLUSIONS: Patients with pDPN prescribed pregabalin and duloxetine were characterized by a substantial comorbidity and pain medication burden. Although there were no differences in total healthcare costs, medication costs were significantly higher in the duloxetine cohort relative to the pregabalin cohort.

Clinical characteristics, pharmacotherapy, and healthcare resource use among patients with diabetic neuropathy newly prescribed pregabalin or gabapentin.

OBJECTIVE: To characterize comorbidities, pain-related pharmacotherapy, and healthcare resource use among patients with painful diabetic peripheral neuropathy (pDPN) newly prescribed pregabalin or gabapentin in clinical practice. METHODS: Using the LifeLink(™) Health Plan Claims Database, patients with pDPN (ICD-9-CM codes 357.2 or 250.6) newly prescribed (index event) gabapentin (n = 1,178; 56.9 ± 10.3 years old) were identified and propensity score-matched with patients initiated on pregabalin (n = 1,178; 56.4 ± 9.8 years old). Comorbidities, pain-related pharmacotherapy, and healthcare resource use/costs were examined during the 12-month pre-index and follow-up periods. RESULTS: Both cohorts were characterized by multiple comorbidities and substantial use of pain-related and adjunctive medications. In the pregabalin cohort, the use of tricyclic antidepressants significantly decreased (16.0% vs. 13.2%) and nonsteroidal anti-inflammatory drugs (30.8% vs. 34.8%), muscle relaxants (19.2% vs. 22.9%), anticonvulsants (14.4% vs. 18.1%), benzodiazepines (22.3% vs. 25.0%), and topical agents (7.0% vs. 9.8%) increased (P < 0.05) in the follow-up period. In the gabapentin cohort, there were significant increases (P < 0.05) in the use of short-acting (55.4% vs. 61.2%) and long-acting (9.4% to 12.8%) opioids, serotonin-norepinephrine re-uptake inhibitors (14.2% vs. 16.7%), anticonvulsants (7.1% vs. 19.2%), benzodiazepines (19.1% vs. 24.3%), sedative/hypnotics (14.9% vs. 18.0%), and tramadol (13.3% vs. 16.8%). There were significant increases (P < 0.05) in pharmacy, outpatient, and total costs in both cohorts and in costs of physician office visits in the gabapentin cohort. There was no difference in postindex median total costs between the pregabalin and gabapentin cohorts ($16,137 vs. $15,766). CONCLUSIONS: Patients with pDPN prescribed pregabalin and gabapentin had a substantial comorbidity and pain medication burden. Although healthcare costs increased in both groups, the increase in pain medication burden was higher in the gabapentin group. Direct medical costs were similar for both groups. Given the human and economic burden of pDPN, future research may benefit from a focus on efficacy parameters to further differentiate treatment options.

Healthcare utilization and costs associated with treatment for opioid dependence.

OBJECTIVE: Opioid use disorder (OUD) can be managed with medication assisted therapy (MAT) (methadone [MET], buprenorphine [BUP], or extended-release naltrexone [XR-NTX]) or counseling alone (non-pharmacological therapy [NPT]). The objective of this study was to evaluate healthcare resource utilization and costs associated with XR-NTX compared with alternative treatments for opioid dependence. METHODS: Adults with a diagnosis of opioid dependence who initiated treatment with XR-NTX, BUP, MET, or NPT between January 1, 2011 and December 31, 2014 were identified in the Truven Health MarketScan Commercial administrative claims database. Healthcare resource utilization, costs (inpatient [IP], emergency department [ED], outpatient [OP], and pharmacy) and adherence were evaluated for each cohort during 12-month baseline and follow-up periods. RESULTS: A total of 29,235 patients were included in the analysis; 1,041, 20,566, 745, and 6,883 received XR-NTX, BUP, MET, and NPT, respectively. Patients in the XR-NTX cohort were significantly younger and had more comorbidities compared with the other cohorts. Patients in the XR-NTX group had the largest percentage decrease in IP and ED utilization and costs from baseline to follow-up. OP and pharmacy costs increased significantly from baseline to follow-up for all cohorts. Overall, there was no significant change in total healthcare costs for the XR-NTX group, whereas the costs increased significantly for other groups (BUP = +43%, MET = +47.7%, NPT = +38.8%). CONCLUSIONS: Healthcare resource utilization and costs increased from baseline to follow-up in BUP, MET, and NPT patients, whereas patients receiving XR-NTX experienced no such increase. This analysis suggests there may be economic value in the use of XR-NTX for OUD.

A retrospective evaluation of the use of gabapentin and pregabalin in patients with postherpetic neuralgia in usual-care settings.

BACKGROUND: Both gabapentin and pregabalin are approved for the management of postherpetic neuralgia (PHN), although dosing and pharmacokinetic differences between these medications may affect their use in actual practice. OBJECTIVES: This study was conducted to characterize the use of gabapentin and pregabalin in the management of PHN in clinical practice, with a specific focus on the doses actually prescribed and changes in the use of other neuropathic pain-related medications after the initiation of gabapentin or pregabalin. METHODS: The PharMetrics Patient-Centric Database was used to identify patients with PHN who were newly prescribed gabapentin or pregabalin between September 1, 2005, and March 31, 2006. The out-comes of interest were the prevalence of comorbidities, exposure to neuropathic pain-related medications (ie, the proportions of patients receiving >or=1 prescription for these medications in the 6-month periods before and after the date of the first gabapentin or pregabalin prescription), and attainment of therapeutic dose levels (gabapentin, >or=1800 mg/d; pregabalin, >or=150 mg/d). RESULTS: The database search identified 151 patients with PHN who were newly prescribed gabapentin (57.0% female; mean [SD] age, 55.8 [11.3] years) and 100 patients who were newly prescribed pregabalin (62.0% female; mean age, 52.8 [9.4] years). The prevalence of comorbidities did not differ significantly between recipients of prescriptions for gabapentin or pregabalin, with the exception of hyperlipidemia, which was more prevalent in those prescribed gabapentin (33.8% vs 22.0%, respectively; P = 0.044), and depression, which was more prevalent in those prescribed pregabalin (12.0% vs 4.6%, respectively; P = 0.031). In the pretreatment period, those who were prescribed pregabalin had significantly greater use of long-acting opioids (P = 0.005), anticonvulsants (P < 0.001), selective norepinephrine reuptake inhibitors (P < 0.001), and the lidocaine 5% patch (P = 0.005) compared with those prescribed gabapentin. Use of any opioid increased from pretreatment to follow-up in those prescribed gabapentin, significantly so in those who received >or=2 opioid prescriptions (P = 0.016). Use of any opioid decreased significantly from pre-treatment to follow-up in those prescribed pregabalin (P = 0.005), particularly in those who received >or=2 opioid prescriptions (P = 0.004). Tramadol use decreased significantly in those prescribed gabapentin (P = 0.045), and anticonvulsant use decreased significantly in those prescribed pregabalin (P = 0.004). Among patients prescribed gabapentin or pregabalin who received 1 prescription, 2 consecutive prescriptions, and >or=3 consecutive prescriptions, a greater proportion of those prescribed pregabalin attained therapeutic dose levels by their first, second, and third consecutive prescriptions compared with those prescribed gabapentin (69.0% vs 3.5%, respectively [P < 0.001]; 71.4% vs 21.7% [P < 0.001]; and 89.3% vs 46.2% [P < 0.001], respectively). CONCLUSIONS: In these patients with PHN in the usual-care setting, opioid use increased after the initiation of gabapentin and decreased after the initiation of pregabalin. Few of those prescribed gabapentin received a prescription for a therapeutic dose, whereas a greater proportion of patients who were prescribed pregabalin received a prescription for a therapeutic dose.

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.

Burden of illness in painful diabetic peripheral neuropathy: the patients' perspectives.

UNLABELLED: Our goal was to assess the patient-level burden among subjects with painful diabetic peripheral neuropathy (DPN). Community-based physicians recruited patients with painful DPN (N = 255) between April and October 2003. Patients completed a survey on pain experience (Brief Pain Inventory-DPN [BPI-DPN]), health status (EuroQoL [EQ-5D]), healthcare utilization (consults, prescription [Rx], and over-the-counter [OTC] medications), and work productivity/functioning. Patients were 61 +/- 12.8 years old and had diabetes for 12 +/- 10.3 years and painful DPN for 6.4 +/- 6.4 years; 25.5 and 62.7% had other neuropathic and musculoskeletal pain conditions. Average and worst pain scores (BPI-DPN, 0-10 scales) were 5.0 +/- 2.5 and 5.6 +/- 2.8. The mean EQ-5D utility was .5 +/- .3 (range = -.594-1). A majority (87.4%) took pain medications (Rx/OTC) in the preceding week: an average of 3.8 +/- 3.9 Rx and 2.1 +/- 1.3 OTC medications. Nearly half (46.7%) received NSAIDs. Other frequently reported medications were short/long-acting opioids (43.1%), anticonvulsants (27.1%), selective serotonin reuptake inhibitors/selective norepinephrine reuptake inhibitors (18%), and tricyclic antidepressants (11.4%). During the preceding 3 months, 59.6% had >or=2 health professional consults; 59% reported decreased home productivity; 85.5% reported activity limitations; and 64.4% of patients who worked (N = 73) reported missing work/decreased work productivity due to painful DPN. Our results underscore a substantial patient-level burden among subjects with painful DPN. PERSPECTIVE: Information on the patient-level burden among painful DPN sufferers in the U.S. was previously lacking. Our results suggest that this burden is significant, evidenced by moderate-to-high pain levels, polypharmacy, health resource use, and work/activity limitations. Results also suggest suboptimal pain management and low levels of satisfaction with treatments.

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.

Validation of a modified version of the brief pain inventory for painful diabetic peripheral neuropathy.

Neuropathic pain is the focus of current clinical research, clinical identification, and treatment. It is unique from nociceptive pain and requires evaluation of the relevance and utility of common pain measures created for other painful conditions. This study evaluated the psychometric properties of a modified Brief Pain Inventory (BPI) for patients with painful diabetic peripheral neuropathy (BPI-DPN). Participants were patients with painful DPN (n=255) enrolled in a DPN Burden of Illness survey referred through 17 outpatient settings (primary care physicians, endocrinologists, neurologists, and anesthesiologists). Patients completed the BPI-DPN, and self-report measures of health-related quality of life, mood sleep, and healthcare utilization. Construct, criterion and discriminant validity, and internal consistency reliability were evaluated. Principal axis factoring with oblimin rotation revealed two interpretable factors (eigenvalues>1.0), consistent with most published BPI validation studies; a severity scale comprising the four BPI Severity items and an interference scale comprising the seven Interference items, which satisfied criteria for interpretability and model fit. Cronbach's alpha was high (0.94) for both scales. Mean pain Severity was highly correlated with Bodily Pain from the Medical Outcomes Study Short Form-12, version 2 (rs=0.63, P < 0.001), the Pain/Discomfort item in the Euro-QoL (rs=0.58, P < 0.001), and a verbal rating scale measure of pain severity (rs=0.74, P < 0.001). Individual BPI-DPN Interference domains were moderately correlated (rs's >0.5, P < 0.001) with analogous measures, and the Sleep Interference item had a high, significant association with the three primary Medical Outcome Study-Sleep scale subscales (rs's=0.66-71, P < 0.001). Worst Pain and Interference ratings were significantly associated with hospital utilization and outpatient visits due to DPN. These results replicate, in a pure peripheral neuropathic pain condition, the BPI psychometric characteristics documented in populations with nociceptive or mixed pain conditions. The BPI-DPN is a promising instrument in the evaluation of painful DPN.

Pain severity in diabetic peripheral neuropathy is associated with patient functioning, symptom levels of anxiety and depression, and sleep.

Our goal was to evaluate pain severity, pain-related interference with function, sleep impairment, symptom levels of anxiety and depression, and quality of life among patients with painful diabetic peripheral neuropathy (DPN). Participants in a burden of illness survey (n = 255) completed the modified Brief Pain Inventory-DPN (BPI-DPN), MOS Sleep Scale, Hospital Anxiety and Depression Scale (HADS), Short Form Health Survey-12v2 (SF-12v2), and the EuroQoL (EQ-5D). Patients were 61 +/- 12.8 years old (51.4% female), had diabetes for 12 +/- 10.3 years and painful DPN for 6.4 +/- 6.4 years. Average and Worst Pain scores (BPI-DPN, 0-10 scales) were 5.0 +/- 2.5 and 5.6 +/- 2.8. Pain substantially interfered (>or=4 on 0-10 scales) with walking ability, normal work, sleep, enjoyment of life, mood, and general activity. Moderate to severe symptom levels of anxiety and depression (HADS-A and HADS-D scores >or=11 on 0-21 scales) occurred in 35% and 28% of patients, respectively. Patients reported greater sleep problems compared with the general U.S. population and significant impairment in both physical and mental functioning (SF-12v2) compared with subjects with diabetes. The mean EQ-5D utility score was 0.5 +/- 0.3. Greater pain levels in DPN (mild to moderate to severe) corresponded with higher symptom levels of anxiety and depression, more sleep problems, and lower utility ratings and physical and mental functioning, (all Ps < 0.01). Painful DPN is associated with decrements in many aspects of patients' lives: physical and emotional functioning, affective symptoms, and sleep problems. The negative impact is higher in patients with greater pain severity.

Validation of a modified version of the Brief Pain Inventory for painful diabetic peripheral neuropathy.

Neuropathic pain is the focus of current clinical research, clinical identification, and treatment. It is unique from nociceptive pain and requires evaluation of the relevance and utility of common pain measures created for other painful conditions. This study evaluated the psychometric properties of a modified Brief Pain Inventory (BPI) for patients with painful diabetic peripheral neuropathy (BPI-DPN). Participants were patients with painful DPN (n = 255) enrolled in a DPN Burden of Illness survey referred through 17 outpatient settings (primary care physicians, endocrinologists, neurologists, and anesthesiologists). Patients completed the BPI-DPN and self-report measures of health-related quality of life, mood sleep, and health care use. Construct, criterion and discriminant validity, and internal consistency reliability were evaluated. Principal axis factoring with oblimin rotation revealed two interpretable factors (eigenvalues > 1.0), consistent with most published BPI validation studies: a severity scale comprising the four BPI Severity items and an interference scale comprising the seven Interference items, which satisfied criteria for interpretability and model fit. Cronbach's alpha was high (0.94) for both scales. Mean pain Severity was highly correlated with Bodily Pain from the Medical Outcomes Study Short Form-12, version 2 (r(s) = 0.63, P < .001), the Pain/Discomfort item in the Euro-QoL (r(s) = 0.58, P < .001), and a verbal rating scale measure of pain severity (r(s) = 0.74, P < .001). Individual BPI-DPN Interference domains were moderately correlated (r(s)'s > 0.5, P < .001) with analogous measures, and the Sleep Interference item had a high, significant association with the three primary Medical Outcome Study-Sleep scale subscales (r(s)'s = 0.66-71, P < .001). Worst Pain and Interference ratings were significantly associated with hospital use and outpatient visits because of DPN. These results replicate, in a pure peripheral neuropathic pain condition, the BPI psychometric characteristics documented in populations with nociceptive or mixed pain conditions. The BPI-DPN is a promising instrument in the evaluation of painful DPN.

The burden of chronic low back pain: clinical comorbidities, treatment patterns, and health care costs in usual care settings.

STUDY DESIGN: Retrospective analysis of an insurance claims database. OBJECTIVE: To examine the comorbidities, treatment patterns, health care resource utilization, and direct medical costs of patients with chronic low back pain (CLBP) in clinical practice. SUMMARY OF BACKGROUND DATA: Although the socioeconomic impact of CLBP is substantial, characterization of comorbidities, pain-related pharmacotherapy, and health care resource use/costs of patients with CLBP relative to non-CLBP controls have been infrequently documented. METHODS: Using the LifeLink Health Plan Claims Database (IMS Health Inc., Watertown, MA), patients with CLBP, defined using the International Classification of Diseases, Ninth Revision, Clinical Modification, were identified and matched (age, sex, and region) with non-CLBP individuals. Comorbidities, pain-related pharmacotherapy, and health care service use/costs (pharmacy, outpatient, inpatient, total) were compared for the 2 groups during 2008. RESULTS: A total of 101,294 patients with CLBP and controls were identified (55% women; mean age was 47.2 ± 11.6 years). Relative to controls, patients with CLBP had a greater comorbidity burden including a significantly higher (P < 0.0001) frequency of musculoskeletal and neuropathic pain conditions and common sequelae of pain such as depression (13.0% vs. 6.1%), anxiety (8.0% vs. 3.4%), and sleep disorders (10.0% vs. 3.4%). Pain-related pharmacotherapy was significantly greater (P < 0.0001) among patients with CLBP including opioids (37.0% vs. 14.8%; P < 0.0001), nonsteroidal anti-inflammatory drugs (26.2% vs. 9.6%; P < 0.0001), and tramadol (8.2% vs. 1.2%; P < 0.0001). Prescribing of "adjunctive" medications for treating conditions associated with pain (i.e., depression, anxiety, and insomnia) was also significantly greater (P < 0.0001) among patients with CLBP; 36.3% of patients received combination therapy. Health care costs were significantly higher in the CLBP cohort (P < 0.0001), reflecting greater resource utilization. Total direct medical costs were estimated at $8386 ± $17,507 in the CLBP group and $3607 ± $10,845 in the control group; P < 0.0001). CONCLUSION: Patients with CLBP are characterized by greater comorbidity and economic burdens compared with those without CLBP. This economic burden can be attributed to greater prescribing of pain-related medications and increased health resource utilization.

Clinical characteristics, pharmacotherapy, and healthcare resource use among patients with fibromyalgia newly prescribed pregabalin or tricyclic antidepressants.

OBJECTIVE: To examine treatment patterns and costs among patients with fibromyalgia prescribed pregabalin or tricyclic antidepressants (TCAs). METHODS: Using the LifeLink™ Health Plan Claims Database, patients with fibromyalgia (International Classification of Diseases, Ninth Revision, Clinical Modification code 729.1X) newly prescribed (index date) TCAs (n = 898) were identified and propensity score-matched (PSM) with patients newly prescribed pregabalin (n = 898). Pain-related pharmacotherapy, comorbidities, and healthcare resource use/costs were examined during the 12 months, pre-index, and follow-up periods. RESULTS: Both patient groups reported multiple comorbidities and received pain medications in the pre-index and follow-up periods. Among patients prescribed pregabalin, use of non-selective non-steroidal anti-inflammatory drugs (43.3% vs 39.8%), other anticonvulsants (28.6% vs 23.3%), and tetracyclic/miscellaneous antidepressants (28.5% vs 25.8%) significantly decreased, and cyclooxygenase 2 (COX-2) inhibitors (7.7% vs 10.4%), TCAs (4.8% vs 7.9%), and topical agents (10.8% vs 15.1%) increased in the follow-up period (p < 0.05). Among patients prescribed TCAs, there were significant decreases in muscle relaxants (42.0% vs 38.4%) and sedative hypnotics (27.4% vs 23.9%), and increases in COX-2 inhibitors (5.8% vs 7.9%) and anticonvulsants (25.1% vs 33.7%; p < 0.05). There were increases (p < 0.0001) in pharmacy costs in both cohorts and total healthcare costs in the pregabalin cohort from pre-index to follow-up. Median total costs were higher (p < 0.05) in the pregabalin group vs TCAs in the pre-index ($9935 vs $8771) and follow-up ($10,689 vs $8379) periods. LIMITATIONS: Despite attempts to address bias through PSM, the higher pre-index costs in the pregabalin cohort suggest a channeling of patients with more severe fibromyalgia to pregabalin. CONCLUSIONS: Patients with fibromyalgia prescribed pregabalin or TCAs had multiple comorbidities and a sizeable pain medication burden, which increased in the follow-up period for both cohorts. Only 5% of pregabalin initiators had been treated with concomitant TCAs at baseline, suggesting that TCAs were inappropriate for these patients owing to their contraindications.

Clinical comorbidities, treatment patterns, and healthcare costs among patients with fibromyalgia newly prescribed pregabalin or duloxetine in usual care.

OBJECTIVE: To assess comorbidities, pain-related pharmacotherapy, and healthcare resource use among patients with fibromyalgia (FM) newly prescribed pregabalin or duloxetine (index event) in usual care settings. METHODS: Using the LifeLink™ Health Plan Claims Database, patients with FM (International Classification of Diseases, Ninth Revision, Clinical Modification code 729.1X) were identified. Patients initiated on duloxetine were propensity score-matched with patients initiated on pregabalin (n = 826; mean age [standard deviation] of 48.3 [9.3] years for both groups). Prevalence of comorbidities, pain-related pharmacotherapy, and healthcare resource use/costs were examined during the 12-month pre-index and follow-up periods. RESULTS: Both patient groups had multiple comorbidities and a substantial pain-related and adjuvant medication burden. In the pregabalin group, use of other anticonvulsants decreased significantly (31.6% vs 24.9%), whereas use of serotonin-norepinephrine reuptake inhibitors (SNRIs; 16.5% vs 22.5%) and topical agents (10.1% vs 13.2%) increased in the follow-up period (p < 0.01). In the duloxetine group, there were significant decreases in the use of other SNRIs (13.0% vs 5.7%), selective serotonin reuptake inhibitors (41.3% vs 21.7%), and tricyclic antidepressants (18.8% vs 13.2%), and an increase in the use of anticonvulsants (28.6% vs 40.1%; p < 0.0001). There were significant increases (p < 0.0001) in pharmacy and total healthcare costs in both cohorts, and a significant increase in outpatient costs (p = 0.0084) in the duloxetine cohort from pre-index to follow-up. There were no significant differences in median total healthcare costs between the pregabalin and duloxetine groups in both the pre-index ($10,159 vs $9,556) and follow-up ($11,390 vs $11,746) periods. LIMITATIONS: Limitations of this study are typical of those associated with retrospective database analyses. CONCLUSIONS: Patients with FM prescribed pregabalin or duloxetine were characterized by a significant comorbidity and pain/adjuvant medication burden. Although healthcare costs increased in both groups, there were no statistically significant differences in direct healthcare costs between the two groups.

Patterns of therapy switching, augmentation, and discontinuation after initiation of treatment with select medications in patients with osteoarthritis.

BACKGROUND: Osteoarthritis (OA) is a debilitating condition characterized by chronic pain. Several pain medications are recommended, and patients frequently alternate among these medications. OBJECTIVES: The purpose of this study was to examine the use of pain medications in clinical practice with respect to recommended guidelines. This objective was accomplished by evaluating patterns of switching, augmentation, and discontinuation after treatment initiation with select medications in patients with OA. METHODS: The LifeLink Health Plan Claims Database was used to select patients with OA (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] code 715.XX) who were newly prescribed (index event) nonsteroidal antiinflammatory drugs (NSAIDs), cyclooxygenase (COX)-2 inhibitors, acetaminophen, tramadol, weak opioids, and strong opioids. Descriptive statistics, Kaplan-Meier analyses, and the COX proportional hazards model were used to assess therapy switching, augmentation, and discontinuation during the 12-month postindex period. Patterns of intraarticular injections and joint replacement surgeries among the cohorts were also evaluated. RESULTS: Substantial proportions of OA patients switched, augmented, or discontinued therapy during the postindex period. Rates of therapy switching, augmentation, and discontinuation, respectively, were significantly different (all P < 0.0001 for overall effects using log-rank tests) across the evaluated medication cohorts: NSAIDs, 22.3%, 6.7%, 93.2%; COX-2 inhibitors, 27.5%, 10%, 87.4%; acetaminophen, 46.0%, 6.5%, 98.7%; tramadol, 44.5%, 8.4%, 95.6%; weak opioids, 27.2%, 4.1%, 98.3%; and strong opioids, 41.1%, 3.3%, 97%. Therapy switching, augmentation, and discontinuation occurred within 2 months after treatment initiation in two thirds of patients and within 6 months in >90% of patients. The patterns of intraarticular injections were significantly different across treatment cohorts, as were the patterns of joint replacement surgeries (both P < 0.0001 for overall effects using log-rank tests), with average times to surgery that appeared longer with acetaminophen, NSAIDs, and COX-2 inhibitor initiators (416-447 days) than with tramadol and opioids (354-385 days). CONCLUSIONS: Results indicate that therapy switching and discontinuation were frequent among OA patients initiating treatment with the currently recommended medication classes and might suggest suboptimal pain relief or potentially intolerable therapy-related side effects.

Clinical comorbidities, treatment patterns, and direct medical costs of patients with osteoarthritis in usual care: a retrospective claims database analysis.

OBJECTIVE: Comorbidities and resource utilization among patients with osteoarthritis (OA) in clinical practice have been infrequently characterized. The purpose of this study was to examine comorbidities, pain-related pharmacotherapy, and direct medical costs of patients with OA in clinical practice. METHOD: This retrospective cohort analysis used medical and pharmacy claims data from the LifeLink™ Database. OA patients (ICD-9-CM codes 715.XX) were matched (age, gender, and region) with individuals without OA. Comorbidities, pain-related pharmacotherapy, and direct medical costs (pharmacy, outpatient, inpatient, total) were examined for the calendar year 2008. RESULTS: The sample consisted of 112,951 OA patients and 112,951 controls (mean age: 56.9 [SD=9.5] years; 62% female). Relative to controls, OA patients were significantly more likely (p<0.0001) to have comorbidities, including musculoskeletal (84.3 vs. 37.1%) and neuropathic pain (22.0 vs. 6.1%) conditions, depression (12.4 vs. 6.4%), anxiety (6.6 vs. 3.5%), and sleep disorders (11.9 vs. 4.2%). OA patients were significantly more likely (p<0.0001) to receive pain-related medications, including opioids (40.7 vs. 17.1%), NSAIDs (37.1 vs. 11.5%), tramadol (9.8 vs. 1.8%), and adjunctive medications for treating depression, anxiety, and insomnia. Mean [SD] total direct medical costs were more than two times higher among OA patients ($12,905 [$21,884] vs. $5099 [$13,855]; p<0.001) and median costs were more than three times higher ($6188 vs. $1879; p<0.0001). Study limitations include potential errors in coding and recording; overestimation of the comorbidity burden; inability to link condition of interest, OA, with prescribed medications; and possible underestimation of the true costs of OA, because indirect costs were not considered and the direct costs were from a third party payer (commercial insurance) perspective. CONCLUSION: The patient burden of OA was characterized by a high prevalence of comorbidities. The payer burden was also substantial, with significantly greater use of pain-related and adjunctive medications, and higher direct medical costs.