Direct and indirect costs of pain therapy for osteoarthritis in an insured population in the United States.

OBJECTIVE: To assess the health care utilization and cost of illness for osteoarthritis (OA) patients taking pain medications. Specifically, the goals were to estimate the direct health care and indirect costs of OA. METHODS: A claims database of privately insured patients was used to identify OA patients. Prescription drug pain treatments included tramadol, cyclooxygenase-II inhibitors, and nonsteroidal anti-inflammatory drugs. Mean annual per patient costs were calculated from an employer's perspective. RESULTS: OA patients were prescribed multiple drugs simultaneously and/or sequentially to manage pain. OA patients had a number of prevalent comorbid conditions. Average annual direct medical, drug, and indirect work loss costs were $8601, $2941, and $4603, respectively. CONCLUSIONS: There was a substantial payer burden associated with OA resulting from the drug, medical, and disability costs and OA-related comorbidities and high concomitant medication utilization.

Pain relief and pain-related sleep disturbance with extended-release tramadol in patients with osteoarthritis.

OBJECTIVE: This analysis evaluated changes in pain and pain-related sleep disturbance with extended-release tramadol (tramadol ER) in patients with moderate, chronic osteoarthritis pain, and the influence of pain reduction on pain-related sleep disturbance. METHODS: Data were obtained from a 12-week, randomized, double-blind, placebo-controlled, fixed-dose study of tramadol ER 100 mg, 200 mg, 300 mg, or 400 mg once daily. Subjects reported osteoarthritis pain intensity with a 100-mm visual analog scale (VAS; 0 = no pain, 100 = extreme pain). A Sleep Problems Index score from 0 to 100 mm (0 = never, 100 = always) was determined from the mean of three subject-reported scores of pain-related sleep disturbance. RESULTS: A total of 815 subjects received tramadol ER (all doses combined) and 205 received placebo. Mean pain reduction at 12 weeks was -30.4 mm and -21.5 mm for tramadol ER and placebo, respectively (p < 0.001). Tramadol ER-treated subjects were nearly twice as likely as placebo subjects to have clinically meaningful pain reduction at 12 weeks, defined as 30 mm or greater reduction (odds ratio [OR] = 1.84, P < 0.001) or 30% or greater reduction (OR = 1.95, P < 0.001) in pain. Clinically meaningful reduction of pain-related sleep disturbance at 12 weeks, defined as 16 mm or greater improvement on the Sleep Problems Index, was more common for tramadol ER than placebo (51% vs. 42%, respectively, p = 0.022). Pain reduction was associated with reduced pain-related sleep disturbance (R = 0.51). Study treatment was generally well tolerated. Possible limitations included homogeneity of pain scores at baseline and the effect of adverse events on sleep analyses. CONCLUSIONS: In patients with chronic osteoarthritis pain, pain reduction is associated with decreased pain-related sleep disturbance.

Psychometric testing and validation of the Chronic Pain Sleep Inventory.

BACKGROUND: Patients with chronic pain often experience significant disruptions in sleep. A potential benefit of treatment aimed at pain relief is improved quality of sleep in patients with chronic pain. OBJECTIVE: The goal of this study was to evaluate the psychometric properties of the Chronic Pain Sleep Inventory (CPSI) and provide preliminary evidence of its construct validity in assessing sleep problems among patients with chronic pain. METHODS: Data came from four 12-week, multi-center, double-blind, randomized, placebo-controlled clinical trials of chronic low back pain and osteo-arthritis of the hip or knee. CPSI data were collected at baseline and 12 weeks. The 5 CPSI items measured trouble falling asleep (CPSI1), needing sleep medication (CPSI2), awakened by pain during the night (CPSI3) and in the morning (CPSI4), and overall quality of sleep (CPSI5) on a 100-mm visual analog scale. Exploratory and confirmatory factor analyses were conducted to evaluate the underlying dimensionality and structure of the CPSI scales. The known-groups method was used to assess validity by comparing CPSI item scores across groups of patients known to differ in the presence and severity of sleep problems as measured by the Physical Dependence Questionnaire. RESULTS: A total of 2674 patients were included in the study (mean age, 57.6 years; 61.0% female; 80.2% white). The majority of the patients were treated for chronic pain related to osteoarthritis of the hip or knee (n=2294). Findings revealed a single sleep problems index can be scored from 3 of the 5 CPSI items (CPSI1, CPSI3, and CPSI4). All 3 items attributed sleep problems to pain, with high factor loadings (>0.80) and a high internal consistency (>0.90). Moderate to high correlations (r >or= 0.50) between CPSI items demonstrated convergent validity, and weak correlations (r<0.50) with other health-related scales (the Western Ontario and McMaster Universities Osteo-arthritis Index and the 36-item Short-Form Health Survey) demonstrated discriminant validity. All CPSI items showed greater ability to discriminate and respond to changes in the presence and severity of sleep problems than the other health-related scales. CONCLUSIONS: CPSI items showed good construct validity, and the results support the scoring of a reliable single index from 3 of the 5 CPSI items that all attributed sleep problems to pain.

Extended-release tramadol in the treatment of osteoarthritis: a multicenter, randomized, double-blind, placebo-controlled clinical trial.

OBJECTIVE: This study evaluated the efficacy and safety of tramadol extended-release (tramadol ER) tablets once daily in subjects with osteoarthritis pain. METHODS: This 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial included 1020 adults with osteoarthritis of the knee or hip and baseline pain intensity >or= 40 on a 100-mm pain visual analog scale (0 = no pain, 100 = extreme pain). Subjects took placebo or were titrated to a target dose of tramadol ER 100, 200, 300, or 400 mg once daily. MAIN OUTCOME MEASURES: The co-primary efficacy variables were pain and physical function subscales of the WOMAC Osteoarthritis Index and subject global assessment of disease activity. RESULTS: Mean changes in WOMAC Osteoarthritis Index pain and physical function subscales were significantly different between tramadol ER and placebo, overall (p

Health-related quality of life in patients with schizophrenia during treatment with long-acting, injectable risperidone.

BACKGROUND: We investigated the impact of treatment with long-acting, injectable risperidone versus placebo on health-related quality of life (HRQoL) in patients with schizophrenia. Results are discussed in the context of HRQoL in the general U.S. population. METHOD: Patients with DSM-IV schizophrenia entered a randomized, double-blind, placebo-controlled trial. After screening, previous antipsychotics were discontinued, and oral risperidone was titrated up to a dose of 4 mg/day over 1 week. Patients were then randomly assigned to receive placebo [N = 92] or long-acting risperidone (25 [N = 93], 50 [N = 97], or 75 mg [N = 87] every 2 weeks) for 12 weeks. HRQoL was measured using the Medical Outcomes Study Short-Form 36-item questionnaire (SF-36). RESULTS: At week 12, patients receiving long-acting risperidone had improved significantly (p <.05) in 5 domains of the SF-36 (bodily pain, general health, social functioning, role-emotional, and mental health) compared with patients receiving placebo. The effect was greatest for the 25-mg group, with significant improvement versus placebo in 6 domains (p <.05). At baseline, all SF-36 domain scores except bodily pain were significantly lower (p <.05) than normal values in all groups. With placebo, scores in all 8 domains remained below normal values after 12 weeks, while patients receiving long-acting risperidone showed improvement in HRQoL toward normal levels, with clinically meaningful improvements in all mental-health domains. In the 25-mg group, scores in 7 domains were not statistically different from normal values after 12 weeks. CONCLUSIONS: Long-acting, injectable risperidone improved HRQoL toward normal levels. After 12 weeks, HRQoL of patients receiving 25 mg was not significantly different from normal.

Risperidone versus Conventional Antipsychotics for Schizophrenia and Schizoaffective Disorder : Symptoms, Quality of Life and Resource Use under Customary Clinical Care.

OBJECTIVE: To prospectively compare risperidone with conventional antipsychotic agents among schizophrenia patients treated under usual practice conditions. DESIGN: One-year, multicentre, open-label, randomised trial carried out in 21 centres in 17 states of the US. PATIENTS: 684 patients were followed from 1995 to 1997, and must have experienced a symptom relapse at study start. INTERVENTIONS: Patients were randomly assigned to risperidone therapy or their physician's 'best choice' of any one of the 13 conventional antipsychotic medications approved in the US. MAIN OUTCOME MEASURES AND RESULTS: Outcomes measured were changes in psychiatric symptoms, side effects, satisfaction with drug therapy, quality of life (including health-related quality of life [HRQOL]) and resource utilisation. A subgroup analysis of the non-switchers was also conducted. Irrespective of treatment group, treatment switching and days with no drug therapy were observed. Compared with patients on conventional antipsychotics, those in the risperidone group achieved statistically superior scores on the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [PANSS total score improved from 83.32 to 61.80 vs 81.42 to 66.99 in the risperidone and conventional groups, respectively), Barnes Akathisia Scale (scores improved from 0.89 to 0.55 vs 0.87 to 0.81 in the risperidone and conventional groups, respectively), and 36-Item Short Form Health Survey (SF-36) scale (scores improved from 32.83 to 39.92 vs 32.55 to 37.22 in the risperidone and conventional groups, respectively) during the 1-year treatment period. A significantly higher percentage of risperidone- treated patients had a 60% improvement in PANSS scores at 12 months (20.9% of patients compared with 10.7% in the risperidone and conventional groups, respectively). There was no statistically significant difference in resource utilisation between the two groups. Among non-switchers, patients in the risperidone group had lower total costs and more clinical benefits. CONCLUSIONS: Conditions of usual practice resulted in a high degree of non-treatment, treatment changing and multi-antipsychotic drug therapy. Patients in the risperidone group had better clinical outcomes (e.g. reduced psychiatric symptoms and side effects) and improved HRQOL. There were no significant differences in healthcare utilisation between the two study groups.