Satisfaction with botulinum toxin treatment: a cross-sectional survey of patients with cervical dystonia

Abstract

Objective:

Botulinum toxin is widely utilized as a first-line therapy for cervical dystonia (CD). Numerous studies have demonstrated the efficacy and safety of this treatment, but little data exist on patient satisfaction. To address this question, a structured patient survey was conducted in Germany, France, the US, and Canada (n?=?136 patients with CD).

Methods:

Specific information was collected on the patients’ current and prior botulinum toxin treatment cycles and their overall quality-of-life (including completion of the Cervical Dystonia Impact Profile-58 [CDIP-58]).

Results:

Patients rated the mean onset of action for their previous injection as 3.8 days, with peak effect at 3.6 weeks and a decline in effects at 9.5 weeks. While most patients were satisfied with their current therapy, only 50.7% were very satisfied, 42.6% were somewhat satisfied, and 6.6% not at all satisfied with their current therapy. Patient satisfaction was lowest just prior to injection and highest at the time of peak effect. Approximately 45% of patients reported that they would prefer a treatment cycle of ≤10 weeks. The mean patient rating of current state of health was above 50 on a visual analog scale from 0 (low) to 100 (high). CDIP-58 results indicated that patients continued to have symptoms on all domains.

Conclusions:

Botulinum toxin is generally very effective for the treatment of CD. However, this survey indicates that patient satisfaction typically declines prior to re-injection, and many patients may prefer an injection interval of less than the standard 12 weeks. While the survey was based on subjective patient recollections, and the degree to which patient satisfaction is attributable to the control of neurological symptoms remains unclear, prospective studies are clearly warranted to confirm the time course of patient satisfaction and to determine the optimal treatment parameters with botulinum toxins.     

Patient- and clinician-reported satisfaction with pharmacological stress agents for single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI)

Abstract

Objective:

The objective of this study was to compare clinician and patient measures of satisfaction with two pharmacological stress agents (PSA), regadenoson and dipyridamole, used in Single Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI).

Methods:

This observational study included patients who had undergone SPECT MPI with regadenoson or dipyridamole, as well as the clinician/clinical technologist who performed the test. Mean scores for individual item and domain scores of the main outcome measures were computed as well as the effect sizes (ES) of the mean difference in scores between treatment groups. Statistical significance of the mean item and domain score differences were assessed via Mann-Whitney tests.

Main outcomes measures:

Two self-report questionnaires which had beeb previously developed and validated: Patient Satisfaction/Preference Questionnaire (PSPQ) and Clinician Satisfaction/Preference Questionnaire (CSPQ).

Results:

A total of 87 patients (68 received regadenoson, 19 received dipyridamole) and nine clinicians/clinical technologists took part in the study. Patients had a mean age of 66.8?±?12.2 years, and 56.3% were male. Compared to dipyridamole, use of regadenoson was associated with greater clinician satisfaction on all items and domains of the CSPQ (p?<?0.001 for all comparisons). Among patients, regadenoson was associated with less bother and greater satisfaction than dipyridamole for all items on the PSPQ. These patients reported less stinging at the injection site (ES?=??0.66) and less nervousness during injection (ES?=??0.60). The PSPQ found that regadenoson patients were more satisfied with their PSA than dipyridamole patients in all areas.

Limitations:

This study utilized a relatively small sample size of dipyridamole patients and lacked an adenosine group. A broader sampling of professionals would also help demonstrate generalizability.

Conclusion:

Both patients and clinicians reported higher satisfaction with regadenoson compared to dipyridamole for SPECT-MPI. Clinicians were particularly satisfied with the preparation and administration aspects of the drug, while patients rated it highly on convenience and reduced incidence of side-effects.     

Attributes of nuclear imaging centers impacting physician referrals for single-photon emission computed tomography myocardial perfusion imaging tests

Aim: To evaluate nuclear imaging center attributes that cardiologists and primary care physicians (PCPs) consider when referring patients for single-photon emission computed tomography myocardial perfusion imaging (SPECT-MPI) tests, and how these attributes impact physician referral decisions in the United States.

Methods: A targeted literature review and seven one-to-one interviews with physicians and imaging center directors were conducted to identify attributes that could impact physicians’ referral decisions. The impact of the identified attributes was assessed via an online discrete choice survey among eligible PCPs and cardiologists randomly selected from a nationally representative panel, and quantified with an odds ratio (OR) scale estimated with a multivariable logistic regression.

Results: Nine two-level attributes were identified: ease of the referral process, waiting time for tests, insurance preauthorization assistance, time to receive results, conclusive test reports, patient satisfaction, a protocol for rapid conversion from an exercise to a pharmacological stress test, patient communication, and assistance with parking/wheelchair access. A total of 410 physicians, including 208 (50.7%) cardiologists and 202 (49.3%) PCPs completed the survey. Among all physicians, a protocol that allows for a rapid conversion from an exercise to a pharmacological stress test (OR?=?2.9) and preauthorization assistance (OR?=?2.6) were the most impactful attributes. Additionally, cardiologists preferred imaging centers that provide an easy referral process (OR?=?2.7), while PCPs favored centers offering a conclusive test report (OR?=?2.4).

Limitations: Some center features that might impact physician referral decision were not evaluated in this study, if they were not easily changeable from an imaging center’s perspective.

Conclusions: The availability of a protocol for rapid conversion from an exercise to a pharmacological stress test and preauthorization assistance had the most significant impact on physician referral decisions for SPECT-MPI. Additionally, cardiologists preferred centers providing an easy referral process, while PCPs favored those offering a concluding statement and actionable steps in test reports.     

Randomized,open-label study to evaluate patient-reported outcomes with fingolimod after changing from prior disease-modifying therapy for relapsing multiple sclerosis: EPOC study rationale and design

Abstract

Objective:

The study to Evaluate Patient OutComes, Safety, and Tolerability of Fingolimod (EPOC; NCT01216072) aimed to test the hypothesis that therapy change to oral Gilenya (Novartis AG, Stein, Switzerland) (fingolimod) improves patient-reported outcomes compared with standard-of-care disease-modifying therapy (DMT) in patients with relapsing multiple sclerosis; safety and tolerability were also assessed. This communication describes the study rationale and design.

Methods:

EPOC is a phase 4, open-label, multi-center study conducted in the US and Canada of patients with relapsing forms of multiple sclerosis who are candidates for therapy change. Therapy change eligibility was determined by the treating physician (US patients) or required an inadequate response to or poor tolerance for at least 1 MS therapy (Canadian patients). Patients were randomly assigned in a 3:1 ratio to 6 months of treatment with once-daily oral fingolimod 0.5?mg or standard-of-care DMTs. The primary study end-point was the change from baseline in treatment satisfaction as determined by the global satisfaction sub-scale of the Treatment Satisfaction Questionnaire for Medication. Secondary end-points included changes from baseline in perceived effectiveness and side-effects, and measures of activities of daily living, fatigue, depression, and quality-of-life. A 3-month open-label fingolimod extension was available for patients randomly assigned to the DMT group who successfully completed all study visits.

Results:

Enrollment has been completed with 1053 patients; the patient population is generally older and has a longer duration of disease compared with populations from phase 3 studies of fingolimod.

Limitations:

Inclusion criteria selected for patients with a sub-optimal experience with a previous DMT, limiting the collection of data on therapy change in patients who were satisfied with their previous DMT.

Conclusions:

Results of the EPOC study are anticipated in early 2013 and will inform treatment selection by providing patient-centered data on therapy switch to fingolimod or standard-of-care DMTs.

Trial Registration:

ClinicalTrials.gov NCT01216072.     

Development and Psychometric validation of the Diabetes Therapy-Related QOL (DTR-QOL) Questionnaire

Abstract

Objective:

We developed and evaluated the psychometric properties of the Diabetes Therapy-Related QOL (DTR-QOL) as a disease-specific, self-administered questionnaire to assess the influence of diabetes treatment on patient QOL, regardless of treatment method.

Methods:

This new questionnaire was developed and validated in a standardized manner: Item development, pilot-testing and psychometric validation. A survey was conducted using the provisional version of the questionnaire, and reliability and validity were evaluated with psychometric testing.

Results:

The provisional version of the questionnaire was generated with 29 items through literature review and pilot testing. For psychometric assessment, analyses were performed on the responses of 284 adult Japanese patients with diabetes. Factor analysis by the principal factor method with promax rotation revealed 4 factors; “burden on social activities and daily activities” (13 items), “anxiety and dissatisfaction with treatment” (8 items), “hypoglycemia” (4 items), and “satisfaction with treatment” (4 items). For reliability, the intraclass correlation was 0.92, and Cronbach’s alpha coefficient was 0.94, indicating adequate test-retest reliability and internal consistency. For known-group validity, there were significant differences in scores for following variables: age, diabetes type, HbA1c, treatment method, glycemic control, hypoglycemia, nocturnal hypoglycemia, concern about weight gain, health status (patient assessment), and degree of communication with physician.

Conclusions:

The DTR-QOL, with good reliability and validity, can assess the influence of diabetes treatment on patient QOL. The DTR-QOL can be used regardless of treatment method that patients receive, and this characteristic enables to detect a difference on patients QOL between treatment methods before and after a switch of treatment. Limitations of this study include representativeness of the patient sample. The relatively small number of patients with type 1 diabetes should be noted. Also, responsiveness of the DTR-QOL has not yet been examined.     

Prevalence and impact of constipation and bowel dysfunction induced by strong opioids: a cross-sectional survey of 520 patients with cancer pain: DYONISOS study

Abstract

Objective:

To describe the prevalence of opioid-induced constipation (OIC) in patients with cancer pain according to the Knowles-Eccersley-Scott symptom score (KESS), the different symptoms of opioid-induced bowel dysfunction (OIBD), and to assess the impact of OIBD on patient’s quality-of-life.

Methods:

A cross-sectional observational study, using the KESS questionnaire and the physician’s subjective assessment of constipation, and other questionnaires and questions on constipation, OIBD, and quality-of-life, carried out on 1 day at oncology day centres and hospitals.

Results:

Five hundred and twenty patients were enrolled at 77 centres in France; 61.7% of patients (n?=?321) showed a degree of constipation that is problematic for the patient according to KESS (between 9–39). Even more patients, 85.7% (n?=?438), were considered constipated according to the physician’s subjective assessment—despite laxative use (84.7% of patients). Quality-of-life was significantly reduced in constipated vs non-constipated patients for both PAC-QoL (p?<?0.0001 for total score and each dimension) and the SF-12 questionnaires (statistically significant for all dimensions except physical state and role physical). OIC and OIBD led to hospitalization (16% of patients), pain (75% of patients), and frequent changes in opioid and laxative treatment.

Key limitations:

This cross-sectional study, in a selected population of cancer patients, has measured prevalence and impact of OIBD. Further confirmation could be sought through the use of longitudinal studies, and larger populations, such as non-cancer pain patients treated with opioids

Conclusions:

Cancer patients taking opioids for pain are very frequently constipated, even if they are prescribed laxatives. This leads to relevant impairments of quality-of-life.     

Psychometric validation of anti-clot treatment scale and treatment satisfaction questionnaire for medication version II in Japanese patients with atrial fibrillation

Aims: The Anti-Clot Treatment Scale (ACTS) and Treatment Satisfaction Questionnaire for Medication version II (TSQM-II) are validated treatment satisfaction patient-reported outcome (PRO) instruments. The ACTS includes two domains: Burdens and Benefits; the TSQM-II includes four: Effectiveness, Side Effects, Convenience, and Global Satisfaction. Japanese-language versions of the ACTS and TSQM-II have been developed and linguistically validated. This study aimed to assess their psychometric properties in Japanese patients with atrial fibrillation (AF).

Materials and methods: ACTS and TSQM-II data from 534 patients with AF were collected in a Japanese post-marketing surveillance study of a direct oral-anticoagulant, rivaroxaban. Four key psychometric properties, in line with best practice guidelines from the US Food and Drug Administration, were examined using traditional psychometric methods: acceptability, scaling assumptions, reliability (i.e. internal consistency reliability, test-retest reliability), and construct validity (i.e. convergent validity and known groups).

Results: ACTS Burdens and Benefits and TSQM-II Effectiveness, Convenience, and Global Satisfaction scales were found to be acceptable (e.g. item-level missing data at baseline <4%), with all scales having good internal consistency (Cronbach’s alpha > 0.80). test-retest reproducibility intraclass correlation coefficients for the ACTS Burdens and Benefits were 0.59 and 0.65, respectively, and between 0.54–0.61 for the TSQM-II scales. Known-groups validity for the ACTS and TSQM-II was supported by differences in scale scores by positive and negative impact (p?<?0.05). Correlations between the ACTS and TSQM-II (convergent validity) were lower than expected (range r?=?0.09–0.48), but in line with the original ACTS development study.

Limitations: Evaluation of test-retest reproducibility was limited by assessment period, which was longer (3 months) than recommended guidelines (usually up to 2 weeks).

Conclusions: Overall, Japanese versions of ACTS and TSQM-II scales satisfied internal consistency reliability and traditional validity criteria. Our study supports the ACTS and TSQM-II as appropriate PRO instruments to measure satisfaction with anticoagulant treatment in Japanese patients with AF.

Trial registration: NCT01598051, clinicaltrials.gov; registered April 20, 2012.     

Cost effectiveness and impact on quality of life of abobotulinumtoxinA and onabotulinumtoxinA in the treatment of children with lower limb spasticity in Canada

Abstract

Background: Injectable botulinum neurotoxins are a mainstay of treatment for pediatric spasticity. AbobotulinumtoxinA and onabotulinumtoxinA are both injectable toxin therapies used to treat pediatric lower limb (PLL) spasticity in Canada. The objective of this study was to assess the cost-effectiveness of abobotulinumtoxinA vs. onabotulinumtoxinA in the treatment of PLL spasticity in Canada.

Methods: A probabilistic Markov cohort model with a 2-year time horizon was developed, with health states defined by response to therapy, as characterized by the goal attainment scale (GAS). Based on randomized controlled trial evidence, response to therapy was similar or higher for abobotulinumtoxinA relative to onabotulinumtoxinA; uncertainty was incorporated into model parameters, however, as the two therapies have not been compared head-to-head. Canadian resource use and cost data were incorporated.

Results: In the base case, abobotulinumtoxinA generated 1.48 quality-adjusted life years over the model time horizon, compared to 1.47 for onabotulinumtoxinA. AbobotulinumtoxinA was associated with cost savings of $123 CAD, reflecting lower costs in both medication acquisition and health services. The estimated improvement to quality of life and reduced costs result in an estimate of economic dominance for abobotulinumtoxinA over onabotulinumtoxinA. This dominant result persisted across probabilistic and scenario analyses.

• Key points for decision makers

• Based on a review of available clinical evidence, abobotulinumtoxinA was found to have significant and/or numerical efficacy benefits to onabotulinumtoxinA on functional outcomes (Goal Attainment Scale) and tone (Modified Ashworth Scale) and in the treatment of pediatric lower limb spasticity

• In this cost-effectiveness analysis, abobotulinumtoxinA was found to be associated with greater quality-adjusted life years and lower costs than onabotulinumtoxinA (economically dominant)

• A limitation of this analysis was the uncertainty around key parameters. Specifically, the lack of head-to-head comparison data for the two therapies, and variable data regarding likely onabotulinumtoxinA dosing in PLL in clinical practice. However, across a range of plausible scenarios, the economic dominant result remained.

     

Cost-effectiveness analysis of intra-articular injections of a high molecular weight bioengineered hyaluronic acid for the treatment of osteoarthritis knee pain

Objective:

To determine the cost-effectiveness of bioengineered hyaluronic acid (BioHA, 1% sodium hyaluronate) intra-articular injections in treating osteoarthritis knee pain in poor responders to conventional care (CC) including non-steroidal anti-inflammatory drugs (NSAIDs) and analgesics.

Methods:

Two decision analytic models compared BioHA treatment with either continuation of patient’s baseline CC with no assumption of disease progression (Model 1), or CC including escalating care costs due to disease progression (NSAIDs and analgesics, corticosteroid injections, and surgery; Model 2). Analyses were based on patients who received two courses of 3-weekly intra-articular BioHA (26-week FLEXX Trial?+?26-week Extension Study). BioHA group costs included fees for physician assessment and injection regimen, plus half of CC costs. Cost-effectiveness ratios were expressed as averages and incremental costs per QALY. One-way sensitivity analyses used the 95% confidence interval (CI) of QALYs gained in BioHA-treated patients, and ±20% of BioHA treatment and CC costs. Probabilistic sensitivity analyses were performed for Model 2.

Results:

For 214 BioHA patients, the average utility gain was 0.163 QALYs (95% CI?=??0.162 to 0.488) over 52 weeks. Model 1 treatment costs were $3469 and $4562 for the BioHA and CC groups, respectively; sensitivity analyses showed BioHA to be the dominant treatment strategy, except when at the lower end of the 95% CI. Model 2 annual treatment costs per QALY gained were $1446 and $516 for the BioHA and CC groups, respectively. Using CC as baseline strategy, the incremental cost-effectiveness ratio (ICER) of BioHA was $38,741/QALY gained, and was sensitive to response rates in either the BioHA or CC groups.

Conclusion:

BioHA is less costly and more effective than CC with NSAIDs and analgesics, and is the dominant treatment strategy. Compared with escalating CC, the $38,741/QALY ICER of BioHA remains within the $50,000 per QALY willingness-to-pay threshold to adopt a new technology.     

Quantifying the defensive medicine contribution to primary care costs

Background:

Defensive medicine represents one cause of economic losses in healthcare. Studies that measured its cost have produced conflicting results.

Objective:

To directly measure the proportion of primary care costs attributable to defensive medicine.

Research design and methods:

Six-week prospective study of primary care physicians from four outpatient practices. On 3 distinct days, participants were asked to rate each order placed the day before on the extent to which it represented defensive medicine, using a 5-point scale from 0 (not at all defensive) to 4 (entirely defensive).

Main outcome measures:

This study calculated the order defensiveness score for each order (the defensiveness/4) and the physician defensive score (the mean of all orders defensiveness scores). Each order was assigned a weighted cost by multiplying the total cost of that order (based on Medicare reimbursement rates) by the order defensiveness score. The proportion of total cost attributable to defensive medicine was calculated by dividing the weighted cost of defensive orders by the total cost of all orders.

Results:

Of 50 eligible physicians, 23 agreed to participate; 21 returned the surveys and rated 1234 individual orders on 347 patients. Physicians wrote an average of 3.6?±?1.0 orders/visit with an associated total cost of $72.60?±?18.5 per order. Across physicians, the median physician defensive score was 0.018 (IQR?=?[0.008, 0.049]) and the proportion of costs attributable to defensive medicine was 3.1% (IQR?=?[0.5%, 7.2%]). Physicians with defensive scores above vs below the median had a similar number of orders and total costs per visit. Physicians were more likely to place defensive orders if trained in community hospitals vs academic centers (OR?=?4.29; 95% CI?=?1.55–11.86; p?=?0.01).

Conclusions:

This study describes a new method to directly quantify the cost of defensive medicine. Defensive medicine appears to have minimal impact on primary care costs.     

Healthcare costs associated with bevacizumab and cetuximab in second-line treatment of metastatic colorectal cancer

Abstract

Objective:

To compare the health care costs of patients with metastatic colorectal cancer (mCRC) who received second-line treatment with Avastin (bevacizumab) versus Erbitux (cetuximab), from the third-party payer’s perspective.

Methods:

Patients with mCRC were selected from the PharMetrics claims database if they received second-line therapy containing either bevacizumab (second-line bevacizumab cohort) or cetuximab (second-line cetuximab cohort). Six-month costs following second-line therapy start date and average monthly healthcare costs while on second-line therapy (in 2009 US$) were calculated and compared between the two groups.

Results:

A total of 2188 patients with mCRC who met the eligibility criteria were included in the analysis, including 1808 patients receiving bevacizumab and 380 patients receiving cetuximab in second-line treatment. Demographic and baseline characteristics were similar between the two groups. Patients’ mean age was 61 years and 56% were males. In second-line treatment, bevacizumab was commonly used with oxaliplatin (43.5%) and irinotecan-based regimens (40.4%), whereas cetuximab was commonly used with irinotecan-based regimens (68.2%). Bevacizumab patients had significantly lower total all-cause healthcare costs than cetuximab patients (adjusted difference: –$10,231, p?=?0.020), and lower medical costs (–$10,796, p?=?0.012) during the 6 months following second-line therapy initiation. Approximately half of the difference in total all-cause healthcare costs was attributable to the lower chemotherapy and targeted therapy costs (–$5635, p?=?0.032) of bevacizumab patients than those of cetuximab patients. While on second-line therapy, bevacizumab patients also had lower average monthly all-cause healthcare costs than cetuximab patients.

Limitations:

Second-line treatment in the current study was defined based on changes in mCRC medications, not based on disease progression due to the limited clinical information available in claims.

Conclusion:

The use of bevacizumab in second-line therapy was associated with significantly lower healthcare costs in mCRC patients, compared to the use of cetuximab.     

Examining and interpreting responsiveness of the Diabetes Medication Satisfaction measure

Abstract

Objective: Treatment satisfaction (TS) is an important patient reported outcome (PRO) in diabetes as it is correlated with outcomes necessary for optimal treatment (e.g., compliance, self-management behaviour). The objective of this study was to examine the responsiveness of the DiabMedSat, a disease-specific PRO measure, assessing Overall, Burden, Efficacy and Symptom TS.

Methods: The DiabMedSat was included in an open label, observational study of the safety and efficacy of biphasic insulin aspart 30 (NovoMix 30) in routine practice with type 2 diabetes. Responsiveness analyses, examining both internal and external responsiveness, were conducted and minimally important differences (MID) assessed.

Results: In 18,817 patients, all TS scores significantly improved after 26 weeks of treatment (p<0.001). The effect sizes for these changes were above 0.5 indicating that the ability to detect change was moderate-to-large in size. Significant differences were found for all TS scores comparing patients who met their HbA_1c goal, who improved but did not meet goal and who did not improve (p<0.01), and for patients who experienced a minor hypoglycaemic event and those who did not (p<0.001). DiabMedSat scores were able to detect changes in patients’ own global rating of satisfaction (MID ranging from 5.3 to 11.7) and in physician-rated satisfaction with patients’ HbA_1c improvement (MID ranging from 5.3 to 10.2).

Conclusions: In the context of an observational study, the DiabMedSat has been shown to be highly responsive to change and can be considered as an acceptable PRO measure for TS in diabetes.     

A real-world,multi-site,observational study of infusion time and treatment satisfaction with rheumatoid arthritis patients treated with intravenous golimumab or infliximab

Objectives: To assess real-world infusion times for golimumab (GLM-IV) and infliximab (IFX) for rheumatoid arthritis (RA) patients and factors associated with treatment satisfaction.

Methods: An observational study assessed infusion time including: clinic visit duration, RA medication preparation and infusion time, and infusion process time. Satisfaction was assessed by a modified Treatment Satisfaction Questionnaire for Medication (patient) and study-specific questionnaires (patient and clinic personnel). Comparative statistical testing for patient data utilized analysis of variance for continuous measures, and Fisher’s exact or Chi-square test for categorical measures. Multivariate analysis was performed for the primary time endpoints and patient satisfaction.

Results: One hundred and fifty patients were enrolled from six US sites (72 GLM-IV, 78 IFX). The majority of patients were female (80.0%) and Caucasian (88.7%). GLM-IV required fewer vials per infusion (3.7) compared to IFX (4.9; p?=?.0001). Clinic visit duration (minutes) was shorter for GLM-IV (65.1) compared to IFX (153.1; p?<?.0001), as was total infusion time for RA medication (32.8 GLM-IV, 119.5 IFX; p?<?.0001) and infusion process times (45.8 GLM-IV, 134.1 IFX; p?<?.0001). Patients treated with GLM-IV reported higher satisfaction ratings with infusion time (p?<?.0001) and total visit time (p?=?.0003). Clinic personnel reported higher satisfaction with GLM-IV than IFX specific to medication preparation time, ease of mixing RA medication, frequency of patients requiring pre-medication, and infusion time.

Limitations: Findings may not be representative of care delivery for all RA infusion practices or RA patients.

Conclusions: Shorter overall clinic visit duration, infusion process, and RA medication infusion times were observed for GLM-IV compared to IFX. A shorter duration in infusion time was associated with higher patient and clinic personnel satisfaction ratings.     

Exenatide BID and liraglutide QD treatment patterns among type 2 diabetes patients in Germany

Abstract

Objectives:

This study evaluated patient and prescriber characteristics, treatment patterns, average daily dose (ADD), and glycemic control of patients initiating glucagon-like peptide 1 (GLP-1) receptor agonists in Germany.

Methods:

The LifeLink? EMR-EU database was searched to identify patients initiating exenatide twice daily (BID) or liraglutide once daily (QD) during the index period (January 1, 2009–April 4, 2010). Eligible patients had ≥180 days pre-index history, ≥90 days post-index follow-up, and a pre-index type 2 diabetes diagnosis. Univariate tests were conducted at α?=?0.05.

Results:

Six hundred and ninety-two patients were included (exenatide BID 292, liraglutide QD 400): mean (SD) age 59 (10) years, 59% male. Diabetologists prescribed liraglutide QD to a larger share of patients (65% vs 35% exenatide BID) than non-diabetologists (51% vs 49%). GLP-1 receptor agonist choice was not associated with age (p?=?0.282), gender (p?=?0.960), number of pre-index glucose-lowering medications (2.0 [0.9], p?=?0.159), pre-index HbA1c (8.2 [1.5%], p?=?0.231) or Charlson Comorbidity Index score (0.45 [0.78], p?=?0.547). Mean (SD) ADD was 16.7?mcg (9.2, label range 10–20?mcg) for exenatide BID and 1.4?mg (0.7, label range 0.6–1.8?mg) for liraglutide QD. Among patients with post-index HbA1c tests, mean unadjusted values did not differ between cohorts. Exenatide BID patients were more likely than liraglutide QD patients to continue pre-index glucose-lowering medications (67.1% vs 60.3%, p?=?0.027) or to start concomitant glucose-lowering medications at index (32.2% vs 25.0%, p?=?0.013); exenatide BID patients were less likely to augment treatment with another drug post-index (15.8% vs 22.5%, p?=?0.027).

Limitations:

Results may not be generalizable. Lab measures for clinical outcomes were available only for a sub-set of patients.

Conclusions:

Results suggested that some differences exist between patients initiating exenatide BID or liraglutide QD, with respect to prescribing physician specialty and pre- and post-index treatment patterns. Both GLP-1 receptor agonists showed comparable post-index HbA1c values in a sub-set of patients.     

The economic burden of advanced Parkinson’s disease: an analysis of a UK patient dataset

Abstract

Background:

To evaluate the cost burden of patients with advanced Parkinson’s disease (PD) according to the waking hours per day spent in OFF state. An analysis of resource use comprising medical services, professional care and informal care data from an observational, cross-sectional study was conducted.

Methods:

A total of 60 physicians comprising 40 neurologists and 20 geriatricians across the UK participating in the Adelphi PD Disease Specific Programme took part. There were 302 PD patients at H&Y stages 3–5. Patients were characterised according to the percentage of time per day spent in OFF state (<25%, 26–50%, 51–75%, >75%).

Results:

Average 12-monthly total costs increased according to the time spent in OFF state from £25,630 in patients spending less than 25% of their waking hours in OFF to £62,147 for patients spending more than 75% of their time in OFF. Overall, 7% of costs were attributed to direct medical care, while 93% were split between direct non-medical professional care (50%) and indirect informal care (43%).

Limitations:

Low patient numbers in the more advanced disease stages of PD led to very little or no data to directly inform some of the severe health states of the analysis. Data gaps were filled in with data derived from a regression analysis which may affect the robustness of the analysis.

Conclusion:

This study illustrates the increasing costs of advancing PD, in particular related to the time spent in OFF state, and identifies that the foremost cost burden is associated with the care needs of the patient rather than medical services.     

The economic burden of depression among adults with rheumatoid arthritis in the United States

Aims: Depression is the most frequent comorbidity reported among patients with rheumatoid arthritis (RA). Comorbid depression negatively impacts RA patients’ health-related quality-of-life, physical function, mental function, mortality, and experience of pain and symptom severity. The objective of this study was to assess healthcare utilization, expenditures, and work productivity among patients with RA with or without depression.

Materials and methods: Data from adult patients who had at least two visits each related to RA and depression over a 1-year period were extracted from the Truven Health MarketScan research databases. Outcomes comprised healthcare resource utilization, work productivity loss, and direct healthcare costs comparing patients with RA with depression (n?=?3,478) vs patients with RA without depression (n?=?43,222).

Results: Patients with RA and depression had a significantly greater relative risk of hospitalization and number of all-cause and RA-related hospitalizations, utilization of emergency services, days spent in the hospital, physician visits, and RA-related surgeries compared with RA patients without depression. Patients with RA and depression had a higher risk of and experienced more events and days of short-term disability compared with patients without depression. The incremental adjusted annual all-cause and RA-related direct costs were $8,488 (95% CI = $6,793–$10,223) and $578 (95% CI = –$98–$1,243), respectively, when comparing patients with RA and depression vs RA only.

Limitations: The current analysis is subject to the known limitations of retrospective studies based on administrative claims data.

Conclusions: This study suggested increased healthcare utilization, work productivity loss, and economic burden among RA patients due to comorbid depression. These findings emphasize the importance of managing depression and including depression as a factor when devising treatment algorithms for patients with RA.     

Hospitalization rates in patients switched from oral anti-psychotics to aripiprazole once-monthly: final efficacy analysis

Abstract

Objective:

To compare hospitalization rates in patients with schizophrenia treated prospectively with aripiprazole once-monthly 400?mg (AOM 400; an extended-release injectable suspension) vs the same patients’ retrospective rates with their prior oral anti-psychotic therapy.

Research design and methods:

Multi-center, open-label, mirror-image, naturalistic study in a community setting in North America. Patients who required a change in treatment and/or would benefit from long-acting injectable anti-psychotic therapy were treated prospectively for 6 months with AOM 400. Retrospective data on hospitalization rates were obtained.

Clinical trial registration:

ClinicalTrials.gov: NCT01432444.

Main outcome measures:

The proportion of patients with ≥1 psychiatric inpatient hospitalization with oral anti-psychotic therapy examined retrospectively (months –4 to –1 before oral conversion) and after switching to AOM 400 (months 4–6 after initiating AOM 400).

Results:

Psychiatric hospitalization rates were significantly lower when patients were treated with AOM 400 compared with oral anti-psychotic therapy both in the 3-month primary efficacy sample (2.7% [n?=?9/336] vs 27.1% [n?=?91/336], respectively; p?<?0.0001) and in the total sample (6-month prospective rate: 8.8% [n?=?38/433] vs 6-month retrospective rate: 38.1% [n?=?165/433]; p?<?0.0001). Discontinuations due to adverse events (AEs) during cross-titration were lower in patients cross-titrated on oral aripiprazole for >1 and <4 weeks (2.9% [n?=?7/239]) compared with patients cross-titrated for ≤1 week (10.4% [n?=?5/48]). The most common treatment-emergent AEs during the prospective treatment phase were insomnia (6.7% [n?=?29/431]) and akathisia (6.5% [n?=?28/431]). Patient-rated injection-site pain decreased from the first injection to the last visit.

Conclusions:

In a community setting, patients with schizophrenia demonstrated significantly lower psychiatric hospitalization rates after switching from their prior oral anti-psychotic therapy to AOM 400. Patients served as their own control, and thus an active control group was not included in this study. Confounding factors, such as insurance coverage and availability of hospital beds, were not examined here and deserve further consideration.