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Health-related quality of life among patients treated with lurasidone: results from a switch trial in patients with schizophrenia.

ABSTRACT: Patients with schizophrenia frequently switch between antipsychotics, underscoring the need to achieve and maintain important treatment outcomes such as health-related quality of life (HRQoL) following the switch. This analysis evaluated HRQoL changes among patients with schizophrenia switched from their current antipsychotic to lurasidone.Stable but symptomatic outpatients with schizophrenia were switched from their current antipsychotic to lurasidone in a six-week, open-label trial. HRQoL was assessed using two validated patient-reported measures, the Personal Evaluation of Transitions in Treatment (PETiT) scale and the Short-Form 12 (SF-12). Total and domain scores (psychosocial function and adherence-related attitude) were assessed using the PETiT scale; patients' mental and physical component summary scores (MCS and PCS) were assessed using the SF-12. Changes in HRQoL from baseline to study endpoint were compared using ANCOVA, with baseline score, treatment, and pooled site as covariates. Changes were assessed among all patients and those switched from specific antipsychotics to lurasidone.The analysis included 235 patients with data on the PETiT and SF-12 who had received ? 1 dose of lurasidone. Statistically significant improvements were observed from baseline to study endpoint on the PETiT total (mean change [SD]: 3.2 [8.5]) and psychosocial functioning (2.5 [6.9]) and adherence-related attitude (0.7 [2.6]) domain scores (all p ? 0.002). When examined by preswitch antipsychotic, significant improvements in PETiT total scores were observed in patients switched from quetiapine, risperidone, aripiprazole, and ziprasidone (all p < 0.03) but not olanzapine (p = 0.893). Improvements on the SF-12 MCS score were observed for all patients (mean change [SD]: 3.7 [11.5], p < 0.001) and for those switched from quetiapine or aripiprazole (both p < 0.03). The SF-12 PCS scores remained comparable to those at baseline in all patient groups.These findings indicate that patients switching from other antipsychotics to lurasidone experienced statistically significant improvement of HRQoL, based on PETiT scores, within six weeks of treatment. Patient health status remained stable with respect to the SF-12 physical component and showed improvement on the mental component. Changes in HRQoL varied based on the antipsychotic used before switching to lurasidone.NCT01143077.

SUBMITTER: Awad G

PROVIDER: S-EPMC3936838 | biostudies-literature | 2014 Feb

REPOSITORIES: biostudies-literature

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Health-related quality of life among patients treated with lurasidone: results from a switch trial in patients with schizophrenia.

Awad George G Hassan Mariam M Loebel Antony A Hsu Jay J Pikalov Andrei A Rajagopalan Krithika K

BMC psychiatry 20140223

<h4>Background</h4>Patients with schizophrenia frequently switch between antipsychotics, underscoring the need to achieve and maintain important treatment outcomes such as health-related quality of life (HRQoL) following the switch. This analysis evaluated HRQoL changes among patients with schizophrenia switched from their current antipsychotic to lurasidone.<h4>Methods</h4>Stable but symptomatic outpatients with schizophrenia were switched from their current antipsychotic to lurasidone in a six ...[more]

PMID: 24559217

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Project description:BackgroundLong-term improvement of health-related quality of life (HRQoL) in schizophrenia may improve adherence and reduce relapse and rehospitalization. This analysis examines long-term changes in HRQoL among patients with schizophrenia switched to lurasidone from other antipsychotics.MethodsPatients who completed an open-label 6-week switch study continued on lurasidone for an additional 24-weeks. HRQoL was measured using the self-reported Personal Evaluation of Transitions in Treatment (PETiT) scale and Short-Form 12 (SF-12) questionnaire. The PETiT assessed HRQoL via total and domain scores (adherence-related attitude and psychosocial functioning). The SF-12 assessed patients' mental and physical component summary scores (MCS and PCS). Mean changes from the initial baseline were calculated at extension baseline and extension endpoint using analysis of covariance models. Analyses were further stratified by prior antipsychotic medication and responder status; responders were defined as having a ≥20 % improvement in Positive and Negative Syndrome Scale during the first 6-weeks of treatment.ResultsThe analysis included 144 patients with PETIT or SF-12 data who received ≥1 dose of lurasidone. Mean (standard deviation) PETiT total score improved significantly from 34.9 (9.3) at baseline to 39.5 (8.9) at extension baseline and 39.1 (9.0) at extension endpoint, representing improvements of 4.5 (7.9) and 5.1 (7.2) points, respectively (both p < 0.001). Significant improvements in adherence-related attitude and psychosocial functioning were observed at extension baseline and extension endpoint (all p < 0.001). Improvement in SF-12 MCS score was observed at extension baseline and endpoint, and PCS score at extension endpoint (all p < 0.01). Patients who switched from quetiapine and aripiprazole showed significant improvement of PETiT total score and adherence-related attitude at extension baseline and extension endpoint. In addition, patients who switched from quetiapine, risperidone, aripiprazole, or ziprasidone showed significant improvement in MCS scores from baseline to extension endpoint. Responders to lurasidone demonstrated greater improvement in PETiT total, psychosocial functioning, and MCS scores at extension baseline than nonresponders.ConclusionsAfter switching to lurasidone, patients with schizophrenia experienced HRQoL improvements that were sustained for an additional 24 weeks of treatment. Further study is warranted to understand the implications of these improvements in terms of employment, adherence, relapse, and rehospitalization.Trial registrationClinical trials.gov identifier NCT01143090 (June 10th, 2010).

Project description:Depressive symptoms associated with bipolar disorder negatively impact health-related quality of life (HRQoL). The efficacy of lurasidone in reducing depressive symptoms has been previously demonstrated. The objective of this study was to examine the direct and indirect effect (mediated through improvement in depression symptoms) of lurasidone in improving patient HRQoL.A secondary analysis of data was conducted of two 6-week, double-blind, placebo-controlled trials assessing the effect of lurasidone (lurasidone monotherapy [20-60 mg/day or 80-120 mg/day]; lurasidone adjunctive to lithium or valproate [20-120 mg/day]) in patients with bipolar depression. Patient HRQoL was measured using the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q SF). Depression symptoms were measured using the Montgomery-Asberg Depression Rating Scale (MADRS). Analysis of covariance (ANCOVA) was used to estimate the effect of lurasidone on improvement in the Q-LES-Q SF percentage maximum score from baseline to 6 weeks. Path analysis was used to evaluate the total effect (?1), as well as the indirect (?2*?3) and direct (?4) effect of lurasidone on Q-LES-Q SF change through improvements in MADRS.A total of 340 and 485 patients from the monotherapy and adjunctive therapy, respectively, were included in the analysis. At 6-weeks, ANCOVA analyses demonstrated that lurasidone provided significant improvement in adjusted mean Q-LES-Q SF scores in comparison to placebo for monotherapy (22.9 and 22.7 vs. 15.2, both p?<?0.01) and adjunctive therapy (23.1 vs. 17.9, p?=?0.01). Path analyses indicated that lurasidone treatment predicted MADRS improvement (monotherapy: ?2?=?-0.44, p?<?0.001; adjunctive therapy: ?2?=?-0.34, p?=?0.003), which subsequently predicted improvement in Q-LES-Q SF (monotherapy: ?3?=?-0.73, p?<?0.001; adjunctive therapy: ?3?=?-0.75, p?<?0.001); however, the effect of lurasidone on improvement in Q-LES-Q SF was largely mediated by change in MADRS (monotherapy: ?4?=?0.11, p?=?0.13; adjunctive therapy: ?4?=?0.02, p?=?0.77).Lurasidone as a monotherapy and adjunctive to lithium or valproate is an effective treatment for improving HRQoL in patients with bipolar depression. However, improvement in HRQoL was not independent of improvement in depression, indicating that the effect of lurasidone on improving patient HRQoL may act through a reduction in depressive symptoms associated with bipolar disorder.Clinicaltrials.gov identifiers: NCT00868699 and NCT00868452 (both registered March 23, 2009).

Project description:ObjectiveTo evaluate the effects of elagolix on clinically meaningful improvements in health-related quality of life (HRQOL) measured by the EHP-30 (Endometriosis Health Profile-30).MethodsData from two phase III trials of elagolix for moderate to severe pain associated with endometriosis were pooled and analyzed as three groups: placebo, elagolix 150 mg once daily, or elagolix 200 mg twice daily. Patients were administered the EHP-30 questionnaire at baseline, and at months 1, 3, and 6 of treatment. Previously established responder definitions were applied to determine percentages of patients with clinically meaningful EHP-30 improvements. The probability of meeting EHP-30 responder definitions with elagolix compared with placebo at months 3 and 6 was determined by Poisson regression analysis, controlling for baseline scores.ResultsAt month 6, the probabilities of meeting EHP-30 subscale responder definitions for pain, control and powerlessness, self-image, social support, emotional well-being, and sexual intercourse were 169% (adjusted relative risk [aRR]: 2.69, 95% CI 2.26-3.21), 129% (aRR 2.29, 95% CI 1.96-2.67), 80% (aRR 1.80, 95% CI 1.54-2.11), 70% (aRR 1.70, 95% CI 1.47-1.97), 67% (aRR 1.67, 95% CI 1.45-1.92), and 62% (aRR 1.62, 95% CI 1.36-1.92) greater, respectively (all P<.001), in the 200-mg group than in the placebo group. Although lower in magnitude than the 200-mg group, the 150-mg group also had greater probabilities of meeting responder definitions than the placebo group for all subscales except sexual intercourse. The probabilities of meeting responder definitions for pain, control and powerlessness, self-image, social support, and emotional well-being were 75% (aRR 1.75, 95% CI 1.44-2.14), 50% (aRR 1.50, 95% CI 1.25-1.80), 22% (aRR 1.22, 95% CI 1.01-1.47), 30% (aRR 1.30, 95% CI 1.09-1.53), and 35% (aRR 1.35, 95% CI 1.16-1.57) greater, respectively (all P<.05), in the 150-mg group than in the placebo group.ConclusionPatients with moderate to severe pain associated with endometriosis and were treated with elagolix experienced clinically meaningful HRQOL improvements.Clinical trial registrationClinicalTrials.gov, NCT01620528 and NCT01931670.Funding sourceAbbVie Inc.

Project description:Health-related quality of life (HRQOL) is often reduced with glaucoma, but associated factors are poorly understood.To determine factors associated with reduced HRQOL in medically and surgically treated patients with glaucoma.Prospective cohort study at a tertiary referral glaucoma practice, with 160 consecutive, prospectively enrolled medically or surgically treated adult patients with glaucoma.All patients completed 2 HRQOL questionnaires (the 25-item National Eye Institute Visual Function Questionnaire and the Adult Strabismus-20 questionnaire [AS-20]). Thirty-six patients had undergone glaucoma drainage device surgery, 51 underwent trabeculectomy, and 73 were medically treated. Factors considered for association with HRQOL in multiple regression analyses were age, sex, best-eye and worst-eye mean deviation on Humphrey visual fields, treatment modality, best-eye and worst-eye visual acuity, and diplopia.The mean (SD) age of participants was 69 (13) years, 63% were female, 97% were white, 93% were not Hispanic, and the mean deviation (SD) was -13 (10) dB. Reduced HRQOL was associated with worse diplopia (Diplopia Questionnaire score) on 6 subscales (range of partial r2 [rp2], 0.207-0.069). Reduced HRQOL was associated with lower best-eye mean deviation on 5 of 6 subscales (rp2 range, 0.379-0.027), lower worst-eye mean deviation on 4 of 6 (rp2 range, 0.242-0.046), treatment group on 3 of 6 (rp2 range, 0.190-0.025), lower worst-eye visual acuity on 5 of 6 (rp2 range, 0.063-0.025), lower best-eye visual acuity on 2 of 6 (rp2 range, 0.032-0.017), and younger age on 2 of 6 (rp2 range, 0.021-0.014). In adjusted analyses, glaucoma drainage device was associated with worse HRQOL in 3 AS-20 subscales compared with trabeculectomy and 2 AS-20 subscales compared with medical. Differences ranged from -14.7 to -7.4, with half the absolute magnitude of the full range of the 95% CI ranging from 9.2 to 5.7.Our findings support the assertion that reduced HRQOL is common in surgically and medically treated patients with glaucoma. Overall, poor HRQOL in patients with glaucoma is moderately associated with worse diplopia, lower mean deviation on visual field testing in either eye, poorer visual acuity in either eye, treatment type, and younger age. Previous glaucoma drainage device surgery was specifically associated with poorer HRQOL compared with trabeculectomy or medical treatment. Psychosocial effects of glaucoma drainage device should be considered when counseling patients with glaucoma.

Project description:Abstract Background: Several atypical antipsychotics are approved to treat adolescent patients with schizophrenia. However, risk for antipsychotic-associated weight gain and metabolic dysfunction underscores the need to identify additional evidence-based treatments that are both efficacious and well tolerated in this vulnerable patient population. Lurasidone is an atypical antipsychotic agent that has demonstrated efficacy in the treatment of adults with schizophrenia in the dose range of 40–160?mg/d. The objective of this randomized, double-blind, placebo-controlled study was to evaluate the efficacy and safety of lurasidone in adolescent patients with schizophrenia. Methods: Adolescent patients (13–17 years old) who met DSM-IV-TR criteria for schizophrenia were randomized to 6 weeks of double-blind treatment with fixed-dose lurasidone 40?mg/d, 80?mg/d, or placebo. An MMRM analysis was performed to assess change from baseline to Week 6 on the primary (PANSS total score) outcome measure. An ANCOVA using an LOCF approach was performed to assess change from baseline on secondary endpoints: Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) and Children’s Global Assessment Scale (CGAS). Safety and tolerability assessments included adverse event reporting, weight, and laboratory measures. Results: A total of 327 patients (mean age = 15.4 years old) were randomized to receive lurasidone 40?mg/d (N = 108), 80?mg/d (N = 106) or placebo (N = 113). Performance on the PANSS total score at Week 6 demonstrated a placebo-adjusted LS mean improvement of ?8.0 (P < .001) for the 40?mg/d group and ?7.7 (P < .001) for the 80?mg/d group. Placebo-adjusted LS mean improvement at Week 6 on the PQ-LES-Q was 5.3 (P = .001) and 5.8 (P < .001) for the 40?mg/d and 80?mg/d groups, respectively; and, on the CGAS was 4.6 (P = .002) and 4.9 (P < .001) for the 40?mg/d and 80?mg/d groups, respectively. Study discontinuation due to adverse events was 8.0% in the placebo group and 3.7% in lurasidone treated patients. The most common adverse events (?5% in either lurasidone group and at least twice the rate of placebo) were: nausea, somnolence, akathisia, vomiting, and sedation. LS mean change in weight at week 6 for the lurasidone 40?mg/d, 80?mg/d, and placebo groups was 0.17?kg, 0.49?kg, and 0.05?kg, respectively. Median change at Week 6 (LOCF) in total cholesterol was ?4.0?mg/dL, ?2.0?mg/dL, and ?7.0?mg/dL, respectively; in triglycerides was ?2.0?mg/dL, 7.0?mg/dL, and ?2.0?mg/dL, respectively; and in glucose was 0.0?mg/dL, 1.0?mg/dL, and 0.0?mg/dL, respectively. Conclusion: Adolescent patients with schizophrenia treated with lurasidone demonstrated significant improvement in symptoms, quality of life, and function. Lurasidone was generally well tolerated and associated with minimal changes in weight and metabolic parameters. Sponsored by Sunovion Pharmaceuticals Inc. ClinicalTrials.gov identifier: NCT01911429

Project description:BackgroundThis post hoc analysis of clinical trial data evaluated long-term, self-reported mental and physical health-related quality of life (HRQoL) scores in schizophrenia patients receiving aripiprazole lauroxil (AL), an atypical long-acting injectable (LAI) antipsychotic approved for the treatment of schizophrenia in adults.MethodsThe study population included 291 stable schizophrenia outpatients enrolled in 2 consecutive long-term safety studies of AL given every 4 weeks for up to 124 weeks. HRQoL was measured using the SF-36v2® Health Survey (SF-36v2) over the course of the follow-up. The primary outcome was change in SF-36v2 mental component summary (MCS) and physical component summary (PCS) scores from baseline to 124 weeks. To contextualize these scores, descriptive analyses were conducted to compare the scores with available scores for the general population as well as for other populations with chronic medical (ie, hypertension and type 2 diabetes) or psychiatric (ie, depression) conditions.ResultsResults from this post hoc analysis indicated that the mean MCS score for patients continuing AL improved significantly from baseline over 124 weeks (P < .05, all timepoints), while mean PCS score showed little change over 124 weeks. At baseline, patients had lower (worse) MCS scores than the normed general population, but by week 124, patients had MCS scores comparable to those in the general population. This pattern of change was not observed with PCS scores. Comparison of study MCS scores with those associated with other diseases showed that this schizophrenia cohort had lower scores than those with chronic medical conditions but higher scores than those with depression. PCS scores were higher in the study population than published scores for all reference populations at baseline and week 124.ConclusionsIn this post hoc analysis, outpatients with schizophrenia who continued the LAI antipsychotic AL showed gradual and sustained improvement in self-reported mental HRQoL over several years of follow-up, whereas self-reported physical HRQoL did not change. By the end of follow-up, mental health scores of study patients with schizophrenia were comparable to those of the general population and better than those of patients with depression.Trial registrationClinicalTrials.gov (NCT01626456 [trial registration date: June 15, 2012] and NCT01895452 [trial registration date: July 5, 2013]).

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Health-related quality of life among patients treated with lurasidone: results from a switch trial in patients with schizophrenia.

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Health-related quality of life among patients treated with lurasidone: results from a switch trial in patients with schizophrenia.

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