scholarly journals Dosing patterns and medication adherence in bipolar disorder patients treated with lurasidone: a US retrospective claims database analysis

2016 ◽  
Vol 6 (6) ◽  
pp. 355-368 ◽  
Author(s):  
Martha Sajatovic ◽  
Daisy Ng-Mak ◽  
Caitlyn T. Solem ◽  
Fang-Ju Lin ◽  
Krithika Rajagopalan ◽  
...  

Background: The aim of this study was to describe dosing patterns and medication adherence among bipolar patients who initiated lurasidone in a real-world setting. Methods: Adult bipolar patients who initiated lurasidone between 1 November 2010 and 31 December 2012 (index period) with 6-month pre- and post-index continuous enrollment were identified from the IMS RWD Adjudicated Claims US database. Patients were grouped by starting lurasidone daily dose: 20 mg (7.1%), 40 mg (62.2%), 60–80 mg (28.7%), and 120–160 mg (2.1%). Patient characteristics were compared across doses using Cochran–Armitage trend tests. Multivariable ordinal logistic regression assessed the association between initial lurasidone dose and patient characteristics. Medication adherence was measured using medication possession ratio (MPR). Results: Of 1114 adult bipolar patients (mean age 40.6 years, 70.6% female), 90% initiated lurasidone at 40 mg or 80 mg/day (mean 51.9 mg/day). Of these, 16.2% initiated lurasidone as monotherapy. Mean lurasidone maintenance dose was 55.2 mg/day and mean MPR was 0.53 [standard deviation (SD) = 0.34] over the 6-month follow up. Substance use, hyperglycemia, obesity, and prior antipsychotic use were associated with higher initial lurasidone doses ( p < 0.05). Odds of a 20 mg/day increase in initial lurasidone dose was 1.6-times higher for patients with substance use [95% confidence interval (CI): 1.16−2.24], 2.6-times higher with hyperglycemia problems (95% CI: 1.15−5.83), 1.7-times higher with obesity (95% CI: 1.05−2.60), and 1.3 (95% CI: 1.01−1.78) and 1.8-times higher (95% CI: 1.17−2.86) with prior use of second- and first-generation antipsychotics, respectively. Conclusions: This real-world analysis of bipolar patients indicated that 40 mg or 80 mg/day were the most common starting doses of lurasidone. A majority of patients used concomitant psychiatric medications (polypharmacy). Higher doses of lurasidone were prescribed to patients with comorbidities or prior antipsychotic use. Adherence to lurasidone was comparable to or better than antipsychotic adherence reported in bipolar disorder literature.

2021 ◽  
Vol 10 (7) ◽  
pp. 1527
Author(s):  
Jamie Duckers ◽  
Beth Lesher ◽  
Teja Thorat ◽  
Eleanor Lucas ◽  
Lisa J. McGarry ◽  
...  

Cystic fibrosis (CF) is a rare, progressive, multi-organ genetic disease. Ivacaftor, a small-molecule CF transmembrane conductance regulator modulator, was the first medication to treat the underlying cause of CF. Since its approval, real-world clinical experience on the use of ivacaftor has been documented in large registries and smaller studies. Here, we systematically review data from real-world observational studies of ivacaftor treatment in people with CF (pwCF). Searches of MEDLINE and Embase identified 368 publications reporting real-world studies that enrolled six or more pwCF treated with ivacaftor published between January 2012 and September 2019. Overall, 75 publications providing data from 57 unique studies met inclusion criteria and were reviewed. Studies reporting within-group change for pwCF treated with ivacaftor consistently showed improvements in lung function, nutritional parameters, and patient-reported respiratory and sino-nasal symptoms. Benefits were evident as early as 1 month following ivacaftor initiation and were sustained over long-term follow-up. Decreases in pulmonary exacerbations, Pseudomonas aeruginosa prevalence, and healthcare resource utilization also were reported for up to 66 months following ivacaftor initiation. In studies comparing ivacaftor treatment to modulator untreated comparator groups, clinical benefits similarly were reported as were decreases in mortality, organ-transplantation, and CF-related complications. The safety profile of ivacaftor observed in these real-world studies was consistent with the well-established safety profile based on clinical trial data. Our systematic review of real-world studies shows ivacaftor treatment in pwCF results in highly consistent and sustained clinical benefit in both pulmonary and non-pulmonary outcomes across various geographies, study designs, patient characteristics, and follow-up durations, confirming and expanding upon evidence from clinical trials.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 8561-8561
Author(s):  
Eric S. Nadler ◽  
Anupama Vasudevan ◽  
Kalatu Davies ◽  
Yunfei Wang ◽  
Ann Johnson ◽  
...  

8561 Background: Atezolizumab plus chemotherapy was the first CIT combination regimen approved for 1L treatment of ES-SCLC in 2019. This study investigated patient characteristics and treatment patterns for patients with ES-SCLC receiving this regimen in the real-world community oncology setting. Methods: This was a retrospective study including adult patients diagnosed with ES-SCLC between 01-Oct-2018 (after IMpower 133 publication in NEJM Sep-2018) and 31-Dec-2019, with follow-up through 31-March-2020 using The US Oncology Network electronic health records data. Descriptive analyses of patient characteristics and treatment patterns were conducted, with Kaplan-Meier (K-M) methods used to assess time to treatment discontinuation (TTD) and time to next treatment/death (TTNT). Results: Of the 408 patients included in this study, 267 (71.4%) received atezo+carboplatin+etoposide (Atezo+Chemo), 80 (21.4%) received carboplatin+etoposide (Chemo only) and the rest received other regimens. The Atezo+Chemo patients in the real-world cohort compared with the IMpower 133 trial (n = 201) were older (median age 68 vs. 64 years) and included fewer males (45% vs. 64%), fewer white race (73% vs. 81%), more patients with brain metastases at baseline (23% vs. 9%), and more patients with worse ECOG (2/3) performance-status score (24% vs. 0%). The median follow-up, TTD, and TTNT in months (mo) for the real-world cohort are presented in the table alongside the best comparable measures reported for the trial. Conclusions: Most patients in this real-world ES-SCLC cohort received the Atezo+Chemo regimen in the 1L setting. While the follow-up was much shorter and patients had worse baseline characteristics (age, brain metastases, ECOG) in the real-world setting compared to the IMpower 133 trial, the real-world median TTD in this descriptive analysis was found to be in line with the median duration of treatment in the trial. Further research with longer follow-up comparing the real-world effectiveness of the CIT and chemo regimens is needed.[Table: see text]


2020 ◽  
Vol 11 ◽  
Author(s):  
Ulrich W. Preuss ◽  
M. N. Hesselbrock ◽  
V. M. Hesselbrock

Objective: Comorbidity of alcohol use disorders in bipolar subjects is high as indicated by epidemiological and clinical studies. Though a more severe course of bipolar disorder in subjects with comorbid alcohol dependence has been reported, fewer studies considered the longitudinal course of alcohol dependence in bipolar subjects and the prospective course of comorbid bipolar II subjects. Beside baseline analysis, longitudinal data of the COGA (Collaborative Study on Genetics in Alcoholism) were used to evaluate the course of bipolar I and II disordered subjects with and without comorbid alcohol dependence over more than 5 years of follow-up.Methods: Characteristics of bipolar disorder, alcohol dependence and comorbid psychiatric disorders were assessed using semi-structured interviews (SSAGA) at baseline and at a 5-year follow-up. Two hundred twenty-eight bipolar I and II patients were subdivided into groups with and without comorbid alcohol dependence.Results: Of the 152 bipolar I and 76 bipolar II patients, 172 (75, 4%) had a comorbid diagnosis of alcohol dependence. Bipolar I patients with alcohol dependence, in particular women, had a more severe course of bipolar disorder, worse social functioning and more suicidal behavior than all other groups of subjects during the 5-year follow-up. In contrast, alcohol dependence improved significantly in both comorbid bipolar I and II individuals during this time.Conclusions: A 5-year prospective evaluation of bipolar patients with and without alcohol dependence confirmed previous investigations suggesting a more severe course of bipolar disorder in comorbid bipolar I individuals, whereas bipolar II individuals were less severely impaired by comorbid alcohol use disorder. While severity of alcohol dependence improved during this time in comorbid alcohol-dependent bipolar I patients, the unfavorable outcome for these individuals might be due to the higher comorbidity with personality and other substance use disorders which, together with alcohol dependence, eventually lead to poorer symptomatic and functional clinical outcomes.


Author(s):  
David J. Miklowitz ◽  
W. Edward Craighead

Whereas pharmacological interventions remain the primary treatment for bipolar disorder, adjunctive psychosocial interventions have the potential to increase adherence to medication regimens, decrease hospitalizations and relapses, improve quality of life, and enhance mechanisms for coping with stress. Controlled studies have established that individual, family, and group psychoeducation, designed to provide information to bipolar patients and their families about the disorder, its pharmacological treatment, and the treatments’ side effects, leads to lower rates of recurrence and greater adherence to pharmacological treatment among bipolar patients. Type 1 and 2 studies have evaluated cognitive behavioral therapy (CBT) as an ancillary treatment. These studies indicate that CBT is associated with better medication adherence and significantly fewer recurrences and/or rehospitalizations. One Type 1 study has evaluated the effectiveness of IPSRT (interpersonal and social rhythm therapy) for bipolar disorder. IPSRT demonstrated its greatest symptomatic effects during a maintenance treatment period, especially if bipolar patients had been successful in stabilizing their daily and nightly routines during an acute treatment period. Finally, four Type 1 studies in adult and pediatric patients have shown that marital/ family therapy may be effectively combined with pharmacotherapy to reduce recurrences and improve medication adherence and family functioning.


BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e029862 ◽  
Author(s):  
Seung Jae Kim ◽  
Oh Deog Kwon ◽  
BeLong Cho ◽  
Seung-Won Oh ◽  
Cheol Min Lee ◽  
...  

ObjectivesWe tried to clarify, by using representative national data in a real-world setting, whether single-pill combinations (SPCs) of antihypertensives actually improve medication adherence.DesignA nationwide population-based study.SettingWe used a 2.2% cohort (n=1 048 061) of the total population (n=46 605 433) that was randomly extracted by National Health Insurance of Korea from 2008 to 2013.ParticipantsWe included patients (n=116 677) who were prescribed with the same antihypertensive drugs for at least 1 year and divided them into groups of angiotensin II receptor blocker (ARB)-only, calcium channel blocker (CCB)-only, multiple-pill combinations (MPCs) and SPCs of ARB/CCB.Primary outcome measuresMedication possession ratio (MPR), a frequently used indirect measurement method of medication adherence.ResultsAdjusted MPR was higher in combination therapy (89.7% in SPC, 87.2% in MPC) than monotherapy (81.6% in ARB, 79.7% in CCB), and MPR of SPC (89.7%, 95% CI 89.3 to 90.0) was higher than MPR of MPC (87.2%, 95% CI 86.7 to 87.7) (p<0.05). In subgroup analysis, adherence of SPC and MPC was 92.3% (95% CI 91.5 to 93.0) vs 88.1% (95% CI 87.1 to 89.0) in those aged 65–74 years and 89.3% (95% CI 88.0 to 90.7) vs 84.8% (95% CI 83.3 to 92.0) in those ≥75 years (p<0.05). According to total pill numbers, adherence of SPC and MPC was 90.9% (CI 89.8 to 92.0) vs 85.3% (95% CI 84.1 to 86.5) in seven to eight pills and 91.2% (95% CI 89.3 to 93.1) vs 82.5% (95% CI 80.6 to 84.4) in nine or more (p<0.05). The adherence difference between SPC and MPC started to increase at five to six pills and at age 50–64 years (p<0.05). When analysed according to elderly status, the adherence difference started to increase at three to four pills in the elderly (≥65 years) and at five to six in the non-elderly group (20–64 years) (p<0.05). These differences all widened further with increasing age and the total medications.ConclusionSPC regimens demonstrated higher adherence than MPC, and this tendency is more pronounced with increasing age and the total number of medications.


2017 ◽  
Vol 33 (S1) ◽  
pp. 83-83
Author(s):  
Mallik Greene ◽  
Tingjian Yan ◽  
Eunice Chang ◽  
Ann Hartry ◽  
Michael Broder

INTRODUCTION:Existing studies have not investigated the effectiveness of one long-acting injectable antipsychotic (LAI) versus another in preventing hospitalizations among patients with bipolar disorder (BD). This study was conducted to compare all-cause inpatient healthcare utilization and associated costs among BD patients who initiated LAIs.METHODS:This retrospective cohort analysis used the Truven Health Analytics MarketScan® Commercial and Medicaid claims database. Bipolar patients >18 years with at least one claim for one of the following LAIs were identified between 1 January 2013 and 30 June 2014 (identification period): aripiprazole, haloperidol, paliperidone, and risperidone. The first day of initiating an LAI was considered the index date. Logistic regression and generalized linear regression models were conducted to estimate risk of inpatient hospitalization and associated costs during the 1-year follow up.RESULTS:A total of 1,540 BD patients initiated an LAI: 14.5 percent aripiprazole, 16.3 percent risperidone, 21.0 percent haloperidol, and 48.1 percent paliperidone. With the aripiprazole cohort as the reference group, the odds of having any inpatient hospitalizations were significantly higher in haloperidol [Odds Ratio, OR (95 percent Confidence Interval, CI): 1.49 (1.01 - 2.19)] and risperidone [1.78 (1.19 - 2.66)] cohorts. The paliperidone cohort also had a higher risk of having a hospitalization than aripiprazole, but the difference was not statistically significant (p>.05). Among LAI initiators having any inpatient hospitalizations, the adjusted mean all-cause inpatient costs were lowest in the aripiprazole cohort (USD26,002), followed by risperidone (USD27,937), haloperidol (USD30,411), and paliperidone (USD33,240). However, the cost difference was not statistically significant.CONCLUSIONS:Our study findings highlight the value of aripiprazole in reducing all-cause inpatient hospitalizations and associated costs among patients with BD during the 1-year follow-up. It is worthwhile to note that bipolar diagnoses were identified from healthcare claims coded for reimbursement purposes, thus misclassification was possible. Future studies are warranted to understand the impact of LAI use in a longer period of time.


2011 ◽  
Vol 190 (2-3) ◽  
pp. 253-258 ◽  
Author(s):  
Christian J. Teter ◽  
Anthony E. Falone ◽  
Amanda M. Bakaian ◽  
Chunhao Tu ◽  
Dost Öngür ◽  
...  

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e12546-e12546 ◽  
Author(s):  
Nicole Princic ◽  
Matthew Brouillette ◽  
Derek Tang ◽  
Chinjune Lin ◽  
Brad Lanoue ◽  
...  

e12546 Background: Patient compliance, typically not captured in clinical trials, may have profound effects on treatment effectiveness. As there has been limited real-world data, the objective of this analysis was to examine compliance among HR+/HER2- mBC patients treated with everolimus as a second or later line of therapy in the US across age groups. Methods: In this retrospective cohort study, the MarketScan Commercial and Medicare Supplemental claims databases were used to select post-menopausal HR+/HER2- mBC women who initiated an everolimus-based line of therapy during 1/1/2013- 7/31/2016 study period. The first secondary malignancy diagnosis was the index date. Patients had 6 months of continuous enrollment in their health plans pre- and post- index, and were followed until the earliest of disenrollment, inpatient death, or end of study. Compliance was measured using medication possession ratio (MPR) during a second (2L), third (3L) and fourth (4L) line of therapy. MPR was defined as total days of supply of everolimus during the line of therapy divided by total duration of the line. Results: Of 645 eligible mBC patients treated with everolimus during follow-up, there were 239, 142, and 80 with a 2L, 3L, and 4L of therapy respectively. Mean age overall was 61.1 + 11.7 years and average duration of follow-up was 718.3 + 304.1 days. Across all patients the median MPR ranged during each line from 0.90-0.92 and the majority (93.8%-97.5%) were highly compliant to therapy (defined as MPR>80%). These results were consistent for patients aged <65 and 65+ years across a 2L, 3L, and 4L of therapy (Table). Conclusions: This study shows high compliance for everolimus-based therapy within a 2L, 3L, and 4L of therapy and this is consistent across ages. This real world data suggests good drug manageability and may provide valuable information for clinicians in selecting treatment for mBC. [Table: see text]


Author(s):  
Craig Coleman ◽  
Zhong Yuan ◽  
Jeffrey Schein ◽  
Concetta Crivera ◽  
Veronica Ashton ◽  
...  

Background: Medication adherence rates decline over time, especially after the first dispensing. Comparing adherence rates for medications that have been on the market for differing period of time may distort real differences in medication adherence. Other analysis factors such as minimum number of dispensing criteria and Pharmacy Quality Alliance (PQA) adherence measures can also affect adherence measurement. Objectives: To use one real world example (rivaroxaban vs apixaban) in non-valvular atrial fibrillation (NVAF) patients to quantify the impact of adjusting for imbalances in follow-up periods, minimum number of dispensing, and use of the PQA adherence measure. Methods: Using IMS Health Real-World Data Adjudicated Claims and Truven MarketScan claims databases, we included adult patients with ≥1 rivaroxaban or apixaban dispensing (index date), ≥1 year of pre-index eligibility, ≥1 AF diagnosis pre-index, newly initiated on oral anticoagulant therapy, and no valvular involvement. Adherence was evaluated using proportion of days covered (PDC) ≥0.8 for cohorts with (1) unbalanced follow-up (2) balanced follow-up (by matching on month and year of follow-up since fill-date) (3) ≥2 rivaroxaban or apixaban dispensings and a balanced follow-up, and using (4) the PQA adherence measure. Results: Rivaroxaban users had significantly longer mean (SD) follow-up than apixaban (408 [300] versus 254 [196] days, respectively). While apixaban users appeared to be more adherent in unadjusted analyses, this finding was reversed after 1) adjusting for unbalanced follow-up 2) excluding single-time users; and 3) applying the PQA-endorsed adherence measure (Figure). Similar results were found using the Truven databases. Conclusion: Comparisons of the adherence rates among medications need to account for the period of time each have been on the market, number of dispensing and PQA measures. Retrospective analyses of adherence that do not adjust for such differences could produce spurious findings.


Author(s):  
Julia-Lou Consoloni ◽  
Katia M'Bailara ◽  
Cyrille Perchec ◽  
Bruno Aouizerate ◽  
Valérie Aubin ◽  
...  

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