Prevalence and healthcare resource utilization of patients with Dravet syndrome: Retrospective linkage cohort study.

PURPOSE: Prevalence, demography, antiseizure medication (ASM) usage, healthcare resource utilization (HCRU), and mortality of Dravet syndrome (DS) in the UK were investigated using primary and secondary care data in this retrospective cohort study. METHODS: Patients with confirmed DS were anonymously identified from the UK Clinical Practice Research Datalink (CPRD) GOLD database (01/01/1987-31/10/2018) using the DS Read Codes (F25G.11 or F25G.00). Probable DS was identified using the International Classification of Diseases-10/Read Code for epilepsy plus stiripentol or potassium bromide prescription. CPRD data were linked to the Hospital Episode Statistics database and Office for National Statistics to calculate HCRU and mortality. RESULTS: The prevalence of confirmed (n = 32; 1.1/100,000) and probable (n = 22; 0.6/100,000) DS in 2017 was 1.5/100,000. Most patients with DS (confirmed, n = 22/28; probable, n = 8/14) were aged <18 years in 2017. Mean (standard deviation) ASM usage was 5.5 (2.7) in confirmed DS and 7.6 (3.8) in probable DS, over 3.4 (3.5) years and 10.0 (6.2) years of follow-up, respectively. HCRU (per patient-year) was similarly high in patients with confirmed and probable DS; mainly consisting of general practitioner consultations (mean, 4.8-7.9), outpatient visits (5.6-8.3), hospital admissions (0.9-4), and emergency department visits (0.3-2.3). Fewer than five deaths were recorded in patients with confirmed and probable DS. CONCLUSION: Using linked national healthcare databases, our study showed that the UK prevalence of DS recorded in primary care was low, and most cases were in patients aged <18 years. HCRU and ASM usage were similarly high in confirmed or probable DS.

Epidemiology of Distal Renal Tubular Acidosis: A Study Using Linked UK Primary Care and Hospital Data.

INTRODUCTION: Distal renal tubular acidosis (dRTA), or RTA type 1, a rare inherited or acquired disease, is a disorder of the distal tubule caused by impaired urinary acid secretion. Due to associated conditions and nonspecific symptoms, dRTA may go undetected. This analysis aims to estimate the prevalence of dRTA in the UK Clinical Practice Research Datalink (CPRD) databases and extrapolate it to European Union Five (EU5) populations. METHODS: A retrospective analysis was conducted using the CPRD GOLD database and linked Hospital Episode Statistics (HES) data to identify diagnosed and potentially undiagnosed or miscoded patients (suspected patients). Patients' records with at least one diagnosis code for dRTA, RTA, specific autoimmune diseases, or renal disorders recorded between January 1987 and November 2017 were obtained and analyzed. An algorithm was developed to detect potentially undiagnosed/miscoded dRTA, based on associated conditions and prescriptions. RESULTS: A total of 216 patients with diagnosis of RTA or dRTA were identified (with 98 linked to hospital data), and 447 patients were identified as having suspected dRTA. dRTA prevalence for 2017 was estimated between 0.46 (recorded cases, of which 22.1% were considered primary) and 1.60 when including suspected cases (7.6% primary) per 10,000 people. Prescription and clinical records of diagnosed patients revealed a wide range of comorbidities and a need for pharmacological treatment to manage associated symptoms. CONCLUSION: The study provides new estimates of dRTA prevalence in Europe and suggests that patients may often be unreported or miscoded, potentially confounding appropriate disease management.

Prevalence, healthcare resource utilization and mortality of Lennox-Gastaut syndrome: retrospective linkage cohort study.

PURPOSE: To retrospectively investigate the prevalence, demography, antiseizure medication (ASM) usage, healthcare resource utilization (HCRU), and mortality of patients with Lennox-Gastaut syndrome (LGS) in primary and secondary care in the UK. METHODS: Patients with confirmed LGS were anonymously identified from the UK Clinical Practice Research Datalink (CPRD) GOLD database (01/01/1987-31/1b0/2018) using the LGS Read Code (F250500). Probable LGS was identified using the International Classification of Diseases-10/Read Code for epilepsy (Hospital Episode Statistics [HES]/CPRD) plus rufinamide prescription. Period prevalence was calculated based on patients enrolled in CPRD GOLD and alive in 2017. CPRD data were linked to HES to calculate HCRU, and to the Office for National Statistics mortality registry. RESULTS: Period prevalence of LGS was 0.578/10,000 (n = 180), with 74 and 106 patients identified with confirmed (0.289/10,000) and probable LGS (0.420/10,000). Mean (max) ASM usage was ~1 (3) per year. In confirmed LGS, valproate (72%), lamotrigine (69%), and clobazam (66%) were the most commonly prescribed ASMs. HCRU (per patient-year) was similar in confirmed and probable LGS and mostly consisted of primary care general practitioner consultations (4-6), outpatient visits (5-10), inpatient admissions (1-4), and A&E visits (1). During the follow-up period, 18 patients died with crude mortality rates of 6.12 (confirmed LGS) and 4.17 (probable LGS) deaths per 1000 person-years. CONCLUSION: Prevalence of LGS appears low in the UK. The similarly high HCRU and mortality rates in confirmed and probable LGS support the validity and specificity of the probable LGS algorithm and high burden of LGS.

Real-life prescribing of asthmatic treatments in UK general practice over time using 2014 BTS/SIGN steps.

The 2014 British Thoracic Society (BTS) and Scottish Intercollegiate Guideline Network (SIGN) guidelines recommend a stepwise approach to asthma management. We investigated the management of asthma in primary care in the UK to understand how real-world practice compares with BTS/SIGN guidelines. Asthma patients were identified from the UK Clinical Practice Research Datalink from September 2006 to August 2016. Aims were to classify patients according to BTS/SIGN steps, describe the proportion of patients transitioning between steps and describe patient demographics and clinical characteristics per group. Overall, 647,308 patients with asthma were identified (40,096 aged 5-11 years; 607,212 aged 12-80 years). Most treated patients were in step 1 or 2 (88.3% of children/67.5% of adults in December 2007; 83.0% of children/67.0% of adults in June 2016). Most patients remained within their treatment step within a 6-month interval (>78% of children and adults throughout the study duration). The proportion of patients stepping up and down reduced from the beginning of the study, although stepping down to step 1 was relatively common in both adults and children. Few patients had a recorded asthma review in the year before reference date (18.8% of children and 14.8% of adults). Although prescribing patterns meant that most patients remained within their treatment step throughout the study, we cannot be sure that this was because their disease was truly stable. The small proportion of patients stepping up/down and the lack of recorded asthma review suggest that patients may not be treated in accordance with BTS/SIGN guidelines.

Treatment patterns, persistence and adherence rates in patients with type 2 diabetes mellitus in Japan: a claims-based cohort study.

OBJECTIVE: To determine real-world trends in antidiabetic drug use, and persistence and adherence, in Japanese patients with type 2 diabetes mellitus (T2DM). DESIGN: Retrospective evaluation of administrative claims data (2011-2015) using the Japan Medical Data Center (JMDC) and Medical Data Vision (MDV) databases. SETTING: Analysis of two administrative claims databases for Japanese patients with T2DM. PARTICIPANTS: Adults (aged ≥18 years) with an International Classification of Diseases, 10th Revision code of T2DM and at least one antidiabetic drug prescription. MAIN OUTCOME MEASURES: Treatment patterns in untreated (UT) or previously treated (PT) patients receiving antidiabetic therapy; persistence with treatment at 12 months; adherence to treatment at 12 months. RESULTS: 40 908 and 90 421 patients were included from the JMDC and MDV databases, respectively. The most frequently prescribed therapy at the index (first prescription) date was dipeptidyl peptidase-4 inhibitor (DPP-4i) in UT patients (JMDC: 44.0%, MDV: 54.8%) and combination therapy in PT patients (74.6%, 81.1%). Most common combinations were DPP-4i plus: biguanide (BG; 11.4%, 10.9%), sulfonylurea (SU; 8.4%, 11.0%) or BG+SU (7.8%, 9.1%). In UT or PT patients from either database whose index prescription was for any antidiabetic drug class(es) other than DPP-4i, the most frequent add-on or switch was to DPP-4i. 12-month persistence with index monotherapy was highest with DPP-4i and BG. Adherence was high (≥80%) for all monotherapy schedules, except insulin and glucagon-like peptide-1 agonist, and for the five most frequent two-drug and three-drug combinations. Persistence was greater in elderly UT patients and in those receiving ≤5 medications, but comparatively worse in UT patients with ≥3 index antidiabetic drug classes. CONCLUSIONS: The findings indicate that DPP-4i is the most commonly used antidiabetic drug class in Japanese patients with T2DM, and persistence and adherence to this antidiabetic drug class are high.

Adherence and persistence to hyperlipidemia medications in patients with atherosclerotic cardiovascular disease and those with diabetes mellitus based on administrative claims data in Japan.

BACKGROUND AND AIMS: Real-world data on treatment patterns in Japanese hyperlipidemia patients with diabetes mellitus (DM) or prior atherosclerotic cardiovascular diseases (ASCVD) are lacking. METHODS: This is a retrospective, longitudinal cohort analysis of administrative claims data (Japan Medical Data Center [JMDC] and Medical Data Vision [MDV] databases) for patients prescribed a new hyperlipidemia medication between 2014 and 2015. Patients were followed for ≥12 months. Outcomes included prescribing patterns, persistence (discontinuations), and adherence (proportion of days covered). RESULTS: Data were analyzed for 11,718 and 27,746 DM, and 4101 and 14,356 ASCVD patients from the JMDC and MDV databases, respectively. Among previously-untreated patients, index prescriptions were primarily for moderate statins in the DM (JMDC: 74.7%, MDV: 77.5%) and ASCVD (JMDC: 75.4%, MDV: 78.5%) sub-cohorts. Combinations were rarely prescribed (≤2.5%). Previously-treated patients were most frequently prescribed combinations in the DM (JMDC: 46.7%, MDV: 53.6%) and ASCVD (JMDC: 49.3%, MDV: 53.3%) sub-cohorts. Intensive statins were rarely used by previously-untreated (≤1%) or previously-treated (≤8%) patients in either sub-cohort. Approximately half of previously-untreated patients discontinued hyperlipidemia therapy within 12 months. Adherence was ≥80% across most drug classes. CONCLUSIONS: Many Japanese hyperlipidemia patients with DM or ASCVD are prescribed single-agent lipid-lowering therapy. Use of intensive therapy is lower than expected, and is suggestive of under-treatment. The low persistence rates are concerning, and warrant further study.

Impact of Hypertension on Hospitalizations for Cardiovascular Diseases in a Worksite Population: An Epidemiologic Study Using Claims Data for Workers.

BACKGROUND: Few of studies investigated the effect of antihypertensives among working population. We aimed to describe the impact of hypertension with and without antihypertensives on hospitalizations because of cardiovascular diseases (CVDs) in the Japanese working population. METHODS: This retrospective study included adults aged 40-64 years whose systolic and diastolic blood pressure (BP) readings taken between 2008 and 2015 were available in the Japanese claims database. Individuals were categorized as treated (T) or untreated (UT) depending on their hypertension treatment history. Time to first CVD-related hospitalization was compared among individuals with different BP levels using Cox models that included baseline characteristics with either baseline BP level or a time-dependent variable reflecting BP changes over time. RESULTS: Of 740,784 UT individuals (male: 61.9%, mean age: 47.9 years), 2,121 individuals were hospitalized due to a CVD over a 957.3-day average follow-up. Among 72,828 T individuals (male: 74.3%, mean age: 53.7 years), the corresponding figure was 470 individuals over an 813.4-day average follow-up. The risk of hospitalization increased with baseline hypertension severity among UT (hazard ratios [HRs] = 1.93, 2.82, and 6.32 for grade 1, grade 2, and grade 3, respectively; P < 0.0001, reference: optimal) but not among T individuals. UT individuals with hypertension at any given time had a significantly higher probability of hospitalization compared to nonhypertensive individuals (HR = 1.74, P < 0.0001). CONCLUSIONS: This study adds quantitative evidence on the impact of hypertension on the risk of CVD-related hospitalization in the Japanese working population. It suggests that antihypertensive treatment had beneficial effects in this relatively young, working population aged 40-64 years.

Comparison of persistence and adherence between fixed-dose combinations and two-pill combinations in Japanese patients with type 2 diabetes.

OBJECTIVE: To compare treatment patterns, persistence and adherence between fixed-dose combinations (FDCs) and two-pill combinations (TPCs) of oral antidiabetic drug (OAD) classes in Japanese patients with type 2 diabetes mellitus (T2DM) using administrative claims databases (Japan Medical Data Center [JMDC] and Medical Data Vision [MDV]). METHODS: This was a retrospective, longitudinal cohort analysis conducted between 2011 and 2015, in patients with T2DM receiving OADs as FDC or TPC. Outcomes included prescribing patterns, treatment persistence and adherence. RESULTS: Data from 3474 and 3066 patients receiving FDCs, and 4325 and 5192 patients receiving TPCs from the JMDC and MDV databases, respectively, was extracted. The most common OAD combination received by over half of all patients was dipeptidyl peptidase-4 inhibitor (DPP-4i) + thiazolidinediones (TZDs) (64.1% [JMDC] and 70.5% [MDV]). Overall, 12-month persistence rates were higher in patients receiving FDCs compared with TPCs (70.4 vs. 66.2% [JMDC], 75.6 vs. 55.7% [MDV]). In the JMDC population receiving FDCs or TPCs, persistence rates were highest with DPP-4i schedules (67.5-83.5%). Median time to discontinuation was significantly longer with biguanide + TZD, and DPP-4i + TZD FDC schedules (p < .05) than TPC; adherence rates were ≥80% across all antidiabetic drug classes in both database populations. CONCLUSIONS: Persistence with and adherence to OADs in Japanese patients with T2DM were greater with FDCs than with TPCs, which may suggest increased patient satisfaction due to reduced treatment burden. Further studies are warranted to investigate the impact of adherence and persistence of FDCs of OADs on glycemic control.

A retrospective study of treatment persistence and adherence to mirabegron versus antimuscarinics, for the treatment of overactive bladder in Spain.

BACKGROUND: Persistence on-treatment with antimuscarinics in patients with overactive bladder (OAB) is reported to be sub-optimal. This retrospective, longitudinal, observational cohort study assessed treatment persistence with ß3-adrenoceptor agonists (i.e. mirabegron) and antimuscarinics, both classes of OAB pharmacotherapy, in patients with OAB in Spain. METHODS: Adults who received mirabegron or an antimuscarinic in routine clinical practice (1 June-31 October 2014), were identified from anonymised prescription data within the Spanish Cegedim Electronic Medical Records database. The primary endpoint, treatment persistence (time to treatment discontinuation [TTD] and the proportion of patients remaining on-treatment after 12 months), was unadjusted for potential confounders. Multivariate Cox regression models of persistence, adjusted for baseline characteristics, were used to compare differences in treatment groups. Adjusted subgroup analyses (target OAB drug, age, treatment status and sex) and sensitivity analyses (extending the time used to define treatment discontinuation from 30 days [base-case] to 45, 60 or 90 days without prescription renewal) were also performed. RESULTS: Overall, 1798 patients received mirabegron (N = 1169) or an antimuscarinic (N = 629); the mean age was 66.42 years. Median TTD was longer for mirabegron versus antimuscarinics (90 vs 56 days) and a higher proportion of patients who received mirabegron were persistent after 12 months (20.2% vs 10.2%); multivariate analyses indicated significantly greater persistence with mirabegron versus antimuscarinics (hazard ratio [HR]: 1.52; 95% confidence interval [CI]: 1.37-1.70; p < 0.001). Significant differences were also observed in subgroup analyses of mirabegron versus individual antimuscarinics (median TTD: 90 vs [range] 28-60 days; HR range: 1.21-2.17; p ≤ 0.013) and in all other subgroups assessed (p < 0.001). Sensitivity analysis showed that the median TTD for mirabegron increased by up to 31 days, and was significantly longer versus antimuscarinics across all adjusted periods (HR range: 1.43-1.53; all p < 0.001). CONCLUSIONS: Patients with OAB in Spain who received mirabegron experienced longer persistence on-treatment than those who received antimuscarinics and the proportion of patients persistent on-treatment at 12 months with mirabegron was two-times higher versus antimuscarinics. These data may provide strategic insights for clinicians and policy makers involved in the management of OAB.

Treatment patterns in hyperlipidaemia patients based on administrative claim databases in Japan.

BACKGROUND AND AIMS: Real-world evidence on treatment of hyperlipidaemia (HLD) in Japan is limited. We aimed to describe treatment patterns, persistence with, and adherence to treatment in Japanese patients with HLD. METHODS: Retrospective analyses of adult HLD patients receiving drug therapy in 2014-2015 were conducted using the Japan Medical Data Center (JMDC) and Medical Data Vision (MDV) databases. Depending on their HLD treatment history, individuals were categorised as untreated (UT) or previously treated (PT), and were followed for at least 12 months. Outcomes of interest included prescribing patterns of HLD drug classes, persistence with treatment at 12 months, and adherence to treatment. RESULTS: Data for 49,582 and 53,865 patients from the JMDC and MDV databases, respectively, were analysed. First-line HLD prescriptions for UT patients were predominantly for moderate statins (JMDC: 75.9%, MDV: 77.0%). PT patients most commonly received combination therapy (JMDC: 43.9%, MDV: 52.6%). Approximately half of the UT patients discontinued treatment during observation. Within each cohort, persistence rates were lower in UT patients than in PT patients (JMDC: 45.0% vs. 77.5%; MDV: 51.9% vs. 85.3%). Adherence was ≥80% across almost all HLD drug classes, and was slightly lower in the JMDC cohort than MDV cohort. CONCLUSIONS: Most common prescriptions were moderate statins in UT patients and combination therapy in PT patients. The high discontinuation rate of HLD therapy in UT patients warrants further investigation and identification of methods to encourage and support long-term persistence.

Cost of Depression in Japanese Patients with Rheumatoid Arthritis: Evidence from Administrative Data.

INTRODUCTION: To determine the cost of depression comorbidity among Japanese adults with rheumatoid arthritis (RA). METHODS: A retrospective database study of 8968 patients diagnosed with RA between 2010 and 2015 and treated with any RA medication was conducted. Health care utilization characteristics were compared between patients with and without a comorbidity of depression. Propensity score matching was applied to ensure a balanced comparison between the two cohorts. RESULTS: The prevalence of a depression comorbidity was found for 5% of the total RA patients. This comorbidity was associated with 62% (56%) higher total outpatient visits and 66% (163%) higher rate of emergency room visits after 6 (12) months. CONCLUSIONS: Burden of depression among RA patients in Japan is relatively high and awareness for depression as a comorbidity of RA needs to be reinforced. FUNDING: Janssen Pharmaceutical KK.

A retrospective study of treatment persistence and adherence to α-blocker plus antimuscarinic combination therapies, in men with LUTS/BPH in the Netherlands.

BACKGROUND: To assess treatment persistence and adherence in men ≥45 years of age with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH), using prescription records from the Netherlands IMS Lifelink™ LRx database. METHODS: In this retrospective, observational cohort study, we identified men who received combination therapy with an α-blocker plus an antimuscarinic (e.g. solifenacin or tolterodine) between 1 November 2013 and 31 October 2014. Treatment could be received as a fixed-dose combination (FDC) tablet or as two drugs administered together (concomitant therapy), if both combination drugs were prescribed within 30 days. The primary objective was to assess treatment persistence, defined as the time from initiation of combination therapy until first discontinuation of the FDC or at least one of the drugs given concomitantly (i.e. ≥30 days without prescription renewal). Subgroup and sensitivity analyses were conducted to assess persistence by antimuscarinic agent, and with different gap lengths used to define discontinuation (45, 60 and 90 days), respectively. RESULTS: A total of 1891 men received an α-blocker plus an antimuscarinic (FDC, N = 665; concomitant therapy, N = 1226). Median time to discontinuation was significantly longer with FDC versus concomitant therapy (414 vs. 112 days; adjusted hazard ratio [HR] 2.04, 95% confidence interval 1.77, 2.35; p < 0.0001). Persistence at 12 months (51.3% vs. 29.9%) was also significantly greater with FDC compared with concomitant therapy. Assessment of antimuscarinic subgroups showed that median time to discontinuation was longest with solifenacin combinations (214 days) compared with other antimuscarinic combinations (range, 47-164 days; adjusted HR range, 1.27-1.77, p = 0.037). No observable impact on treatment persistence was found by adjusting the gaps used to define discontinuation. DISCUSSION: This study of real-world evidence of men with LUTS/BPH treated with α-blocker plus antimuscarinic combination therapy in the Netherlands showed that treatment persistence was significantly greater in those who received a FDC tablet compared with combination therapy given concomitantly. The study also shows that treatment persistence was extended in men who received combination therapy containing solifenacin compared with other antimuscarinics. CONCLUSIONS: Overall, these findings may be useful for prescribers, as improved persistence on-treatment may translate into improved outcomes for men with LUTS/BPH. Further study is warranted to establish the key drivers of persistence in men receiving combination therapy for LUTS/BPH.

Persistence and Adherence with Mirabegron versus Antimuscarinic Agents in Patients with Overactive Bladder: A Retrospective Observational Study in UK Clinical Practice.

BACKGROUND: Persistence with antimuscarinic therapy in overactive bladder (OAB) is poor, but may be different for mirabegron, a ß3-adrenoceptor agonist with a different adverse event profile. OBJECTIVE: To compare persistence and adherence with mirabegron versus tolterodine extended release (ER) and other antimuscarinics in routine clinical practice over a 12-mo period. DESIGN, SETTING, AND PARTICIPANTS: Retrospective, longitudinal, observational study of anonymised data from the UK Clinical Practice Research Datalink GOLD database. Eligibility: age ≥18 yr, ≥1 prescription for target OAB drug (between May 1, 2013 and June 29, 2014), and 12-mo continuous enrolment before and after the index prescription date. INTERVENTIONS: Mirabegron, darifenacin, fesoterodine, flavoxate, oxybutynin ER or immediate-release (IR), propiverine, solifenacin, tolterodine ER or IR, and trospium chloride. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was persistence (time to discontinuation). Secondary endpoints included 12-mo persistence rates and adherence (assessed using medication possession ratio, MPR). Cox proportional-hazards regression models and logistic regression models adjusted for potential confounding factors were used to compare cohorts. Analyses were repeated after 1:1 matching. RESULTS AND LIMITATIONS: The study population included 21996 eligible patients. In the unmatched analysis, the median time-to-discontinuation was significantly longer for mirabegron (169 d, interquartile range [IQR] 41-not reached) compared to tolterodine ER (56 d, IQR 28-254; adjusted hazard ratio [HR] 1.55, 95% confidence interval 1.41-1.71; p<0.0001) and other antimuscarinics (range 30-78 d; adjusted HR range 1.24-2.26, p<0.0001 for all comparisons). The 12-mo persistence rates and MPR were also significantly greater with mirabegron than with all the antimuscarinics. Limitations include the retrospective design, use of prescription records to estimate outcomes, and inability to capture reasons for discontinuation. CONCLUSIONS: Persistence and adherence were statistically significantly greater with mirabegron than with tolterodine ER and other antimuscarinics prescribed for OAB in the UK. PATIENT SUMMARY: This study assessed persistence and adherence (or compliance) with medications prescribed for OAB in a large UK population. We found that patients prescribed mirabegron remained on treatment for longer and showed greater adherence than those prescribed traditional antimuscarinics.

Subjective health status and health-related quality of life among women with Recurrent Vulvovaginal Candidosis (RVVC) in Europe and the USA.

BACKGROUND: Recurrent vulvovaginal candidosis (RVVC) is a chronic condition causing discomfort and pain. Health status and health-related quality of life (HRQoL) in RVVC were never previously described using validated questionnaires. The objective of this study is to describe subjective health status and HRQoL and estimate health state utilities among women with RVVC. METHODS: A cross-sectional online survey was conducted among women who reported having suffered four or more yeast infections over the past 12 months, in five European countries (France, Germany, Italy, Spain and the UK) and the USA. Index scores were derived from the EQ-5D, a questionnaire providing a single index value for health status. The SF-36 questionnaire was used for HRQoL assessment. Information on disease severity, treatment patterns and productivity was also collected. RESULTS: 12,834 members of online research panels were contacted. Among them, 620 women with RVVC (5%) were selected to complete the full questionnaire. The mean EQ-5D index score was 0.70 (95% confidence interval: [0.67, 0.72]) and the difference between women with a yeast infection at the time of questionnaire completion and other respondents was 0.05 (p = 0.47). The EQ-5D index score increased significantly with the time since last infection (p < 0.001). 68% of women reported depression/anxiety problems during acute episode, and 54% outside episodes, compared to less than 20% in general population (p < 0.001). All SF-36 domain scores were significantly below general population norms. Mental health domains were the most affected. The impact on productivity was estimated at 33 lost work hours per year on average, corresponding to estimated costs between €266/year and €1,130/year depending on the country. CONCLUSIONS: Subjective health status and HRQoL during and in between acute inflammatory episodes in women with RVVC are significantly worse than in the general population, despite the use of antifungal therapy. The average index score in women with RVVC is comparable to other diseases such as asthma or COPD and worse than diseases such as headache/migraine according to US and UK catalogs of index scores. The survey also revealed a significant loss of productivity associated with RVVC.

Impact of therapy escalation on ambulatory care costs among patients with type 2 diabetes in France.

BACKGROUND: This study compares annual ambulatory care expenditures per patient with type 2 diabetes mellitus (T2DM) in France according to treatment phase and renal function status. METHODS: Records from patients with T2DM were extracted from a health insurance database. Patients were classified in subgroups, by treatment phase: oral/GLP1 monotherapy, double therapy, triple therapy or insulin therapy, and according to renal function status (identified using pharmacy, lab and consultation claims). Annual ambulatory expenditures were estimated from the national insurance perspective by year (from 2005 to 2010) and subgroup. RESULTS: The number of patients ranged from 9,682 to 11,772 between 2005 and 2010. The average annual expenditure per individual in 2010 ranged from €3,017 (standard deviation: €3,829) for monotherapy to €3,609 ± €3,801 for triple therapy, and €7,398 ± €5,487 with insulin (adjusted ratio insulin therapy/monotherapy: 2.36, p < 0.001). Similar differences between treatement stages were found in previous years. Additional costs for insulin were mainly related to nursing care (multiplied by 18.42, p < 0.001), medical devices and pharmacy costs. DM-attributable drug costs were mainly related to antidiabetic drugs (28% for monotherapy to 71% for triple therapy), but also to cardiovascular system drugs (21% for monotherapy to 51% with insulin) and nervous system drugs (up to 8% with insulin). Declining renal function was associated with an increase in expenses by 12% to 53% according to treatment stage. CONCLUSIONS: Overall, ambulatory care expenditures increase with treatment escalation and declining renal function amongst patients with T2DM. Insulin therapy is associated with substantially increased costs, related to pharmacy, nursing care and medical device costs.

Antidepressant monotherapy: A claims database analysis of treatment changes and treatment duration.

BACKGROUND: The basic principles of pharmacotherapy for depression are consistent among most US and western European guidelines. All recommend ≥6 months of antidepressant therapy and propose several alternatives in cases of inappropriate response. OBJECTIVES: The aims of this analysis were to describe antidepressant treatment changes and treatment duration in patients undergoing treatment for a new episode of depression and to identify risk factors for treatment changes and treatment discontinuation. METHODS: For this claims database analysis, adults and children treated with antidepressants for a new episode of depression in the time period from 2004 to 2006 were identified using the IMS LifeLink Health Plan Database. Treatment changes (defined as switches to an antidepressant or antipsychotic; combination with an antidepressant; or augmentation with lithium, an anticonvulsant, or an atypical antipsychotic) were described. Antidepressant treatment duration was assessed and described per treatment change. Risk factors for treatment change or discontinuation were identified using multivariate logistic regression (treatment change) or Cox regression (treatment duration). RESULTS: Of 134,287 patients identified using the database (mean [SD] age, 39.1 [14.9] years; 68.1% women), 31,123 (23.2%) had a treatment change, most commonly an antidepressant switch (12,735 [9.5%]) or combination (12,214 [9.1%]). Antipsychotics were introduced in <5% of patients. The median overall treatment duration (111 days) was shorter than that recommended in the guidelines (≥ 6 months). Index antidepressant class was significantly associated with treatment change (higher for tricyclic antidepressants [TCAs] [odds ratio (OR) = 1.59 (95% CI, 1.48-1.70)]; lower for selective serotonin reuptake inhibitors [OR = 0.87 (95% CI, 0.84-0.91)]) and duration (increased risk for early discontinuation for TCAs [hazard ratio (HR) = 1.36 (95% CI, 1.30-1.44)]; lower risk for late discontinuation for serotonin-norepinephrine reuptake inhibitors [HR = 0.81 (95% CI, 0.79-0.84)]). Indicators of depression severity or complexity (prescription by a mental health specialist, previous use of psychotropics, previous psychiatric hospitalization, and presence of psychosomatic comorbidities) were associated with a higher risk for treatment change and inconsistently associated with treatment duration. Two health plans were associated with increased risk for discontinuation (Medicaid, HR = 1.35 [95% CI, 1.28-1.42]; Medicare, HR = 1.38 [95% CI, 1.12-1.71]). Combination and augmentation strategies were associated with a lower risk for treatment discontinuation (combination, HR = 0.83 [95% CI, 0.81-0.86]; augmentation, HR = 0.75 [95% CI, 0.73-0.77]). Overall treatment duration was <30 days in 31,177 patients (26.2%) and >6 months in 54,502 (37.5%). CONCLUSIONS: In this claims database analysis, changes in antidepressant treatment involved 23.2% of patients. The median overall treatment duration was shorter than recommended by guidelines due to a quarter of patients having early treatment discontinuation.

Prescription patterns of antidepressants: findings from a US claims database.

BACKGROUND: Introduction of serotonin reuptake inhibitors in the 1990s has increased the use of antidepressants and modified their prescription patterns. OBJECTIVE: To identify reasons for prescriptions of antidepressants and factors associated with absence of a labelled indication on the prescription patterns of antidepressants and healthcare costs in a claims database. METHODS: Antidepressant users with a new treatment episode with bupropion, citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline or venlafaxine in 2003 and 2004 were identified in the PharMetrics database. Any ICD-9 code for an approved or clinically-accepted diagnosis for antidepressant treatments ('diagnosis of interest') occurring within the month before or after the index claim was considered as a reason for prescription. Socio-demographic and medical characteristics were described between users with and without a diagnosis of interest and analysed using logistic regression. RESULTS: A total of 392 409 antidepressant users were identified. Diagnoses of interest were recorded for 46.7% of users, the most frequent diagnosis being depressive disorders (29% of the patients), anxiety disorders (17%) and abuse and dependence (5%). There were no major differences in patterns of diagnoses of interest between the antidepressants except for fluvoxamine and bupropion. Users without a diagnosis of interest had similar somatic comorbidities and overall baseline costs to users with a diagnosis of interest. However, they used specialised care less often (4.3 vs. 17.8%, OR = 0.50 [0.48; 0.51]), received psychotherapies less frequently (2.7 vs. 26.6%, OR = 0.12 [0.12; 0.12]), and had a shorter duration of use of antidepressants more often (36.9 vs. 28.5%, OR = 1.18 [1.17; 1.20]). CONCLUSIONS: The reason for prescribing antidepressants was often not reported in claims databases, and although antidepressant users with or without a diagnosis of interest can have similar somatic medical profiles and overall costs, they do not follow the same trajectory in the mental healthcare system. Depending on the research question to be answered, it is therefore important to specify which users are being targeted.

Healthcare expenditure in severely depressed patients treated with escitalopram, generic SSRIs or venlafaxine in the UK.

OBJECTIVE: To retrospectively compare the 12-month healthcare utilisation and direct medical costs associated with the use of escitalopram, generic SSRIs, and venlafaxine in patients with severe depression in the United Kingdom (UK). METHODS: Data for this retrospective cohort study were extracted from the GPRD, a large primary care database in the UK. Data from adults with an incident prescription of escitalopram, venlafaxine, or generic SSRI were extracted. The initial prescription had to fall within 3 months of a physician visit when severe depression according to the GPRD definition was mentioned. Frequency of antidepressant treatment, GP consultations, referrals, hospitalisations, and concomitant psychiatric medication was assessed on the 12-months after initial prescription and 2006 unit costs for healthcare services obtained from published literature were applied, and then compared between treatment cohorts using a propensity score-adjusted generalised linear model. RESULTS: The total annual healthcare expenditure per patient was similar with escitalopram and generic SSRIs (916 pounds vs. 974 pounds, adjusted p = 0.48) and significantly lower than venlafaxine (916 pounds vs. 1367 pounds, adjusted p < 0.0001), a pattern repeated when antidepressant costs were excluded from the analysis (escitalopram vs. SSRIs, 831 pounds vs. 957 pounds, adjusted p = 0.10; escitalopram vs. venlafaxine, 831 pounds vs. 1156 pounds, adjusted p = 0.006). Over the 12-month analysis period, there were significantly fewer hospitalisations per patient in the escitalopram vs. venlafaxine (0.12 vs. 0.27; adjusted p = 0.01) or generic SSRI (0.12 vs. 0.19; adjusted p = 0.046) groups. CONCLUSION: Despite some limitations associated with the system of data collection in the GPRD (need to apply proxies for severity assessment and external unit costs to resource consumption), the results of this real-life study brings additional evidence of escitalopram appearing to be a cost-effective treatment for patients suffering from severe depression as diagnosed in routine practice and could be considered for first-line treatment in these patients.