Comparison of effectiveness and safety of treatment with apixaban vs. other oral anticoagulants among elderly nonvalvular atrial fibrillation patients

Objective: To compare the risk of stroke/systemic embolism (S/SE) and major bleeding (MB) of elderly (≥65 years of age) nonvalvular atrial fibrillation (NVAF) patients initiating apixaban vs. rivaroxaban, dabigatran, or warfarin.

Methods: NVAF patients with Medicare Advantage coverage in the US initiating oral anticoagulants (OACs, index event) were identified from the Humana database (1 January 2013–30 September 2015) and grouped into cohorts depending on OAC initiated. Propensity score matching (PSM), 1:1, was conducted among patients treated with apixaban vs. each other OAC, separately. Rates of S/SE and MB were evaluated in the follow-up. Cox regressions were used to compare the risk of S/SE and MB between apixaban and each of the other OACs during the follow-up.

Results: The matched pairs of apixaban vs. rivaroxaban (n?=?13,620), apixaban vs. dabigatran (n?=?4654), and apixaban vs. warfarin (n?=?14,214) were well balanced for key patient characteristics. Adjusted risks for S/SE (hazard ratio [HR] vs. rivaroxaban: 0.72, p?=?.003; vs. warfarin: 0.65, p?p?p?p?=?.27) and MB (HR: 0.82, p?=?.23) of NVAF patients treated with apixaban vs. dabigatran trended to be lower, but did not reach statistical significance.

Conclusions: In the real-world setting after controlling for differences in patient characteristics, apixaban is associated with significantly lower risk of S/SE and MB than rivaroxaban and warfarin, and a trend towards better outcomes vs. dabigatran among elderly NVAF patients in the US.     

Effects of non-medical switching on outcomes among patients prescribed tumor necrosis factor inhibitors

Objective: To evaluate health care use and outcomes among patients who experienced a non-medical switch of their prescribed anti-tumor-necrosis-factor biological agent (anti-TNF) for cost containment reasons.

Methods: Retrospective evaluation of Humedica electronic health records of patients ≥18 years old with anti-TNF treatment for immune conditions. Using natural language processing, stable patients who experienced a non-medical switch (for cost reasons) of their anti-TNF between 2007 and 2013 were identified (NMS cohort, n?=?158) and matched to patients who did not (control cohort, n?=?4804). Rates of office visits, emergency department visits, and hospitalizations at 30, 90, and 365 days following were evaluated. Medication-related adverse events, defined as subsequent medication change due to a side effect and/or efficacy-related reason were also compared.

Results: Adjusted rates of office visits were higher among the NMS cohort than the control cohort at 30 (46.4% vs. 31.7%, p?p?p?p?=?.003), 90 (31.6% vs 9.6%, p?p?p?=?.001).

Conclusion: Non-medical switching among patients prescribed anti-TNFs was associated with increased health care use, medication-related side effects, and reports of diminished efficacy.     

Sensory profiles are comparable in patients with distal and proximal entrapment neuropathies,while the pain experience differs

Objective: Distal and proximal entrapment neuropathies such as carpal tunnel syndrome (CTS) and cervical radiculopathy (CR) share similar etiologies. Experimental models suggest that, despite comparable etiology, pathomechanisms associated with injuries of the peripheral and central axon branches are distinct. This study therefore compared self-reported and elicited sensory profiles in patients with distal and proximal entrapment neuropathies.

Methods: Patients with electrodiagnostically confirmed CTS (n?=?103) and patients with CR (n?=?23) were included in this study. A group of healthy participants served as controls (n?=?39). Symptoms and sensory profiles were evaluated using quantitative sensory testing (QST) and a self-reported neuropathic pain questionnaire (painDETECT).

Results: Both patient groups were characterized by a loss of function in thermal and mechanical detection in the main pain area and dermatome compared to healthy reference data (p?<?.001). There was no significant difference between patients with CTS and CR in pain and detection thresholds except for reduced vibration sense in the main pain area (p?<?.001) and reduced pressure pain sensitivity in the dermatome in patients with CR (p?<?.001). However, patients with CR reported higher pain intensities (p?=?.008), more severe pain attacks (p?=?.009) and evoked pain by light pressure (p?=?.002) compared to patients with CTS.

Conclusion: While QST profiles were similar between patients with CTS and CR, self-reported pain profiles differed and may suggest distinct underlying mechanisms in these patient cohorts.     

The partnership between renalase and ejection fraction as a risk factor for increased cardiac remodeling biomarkers in chronic heart failure patients

Abstract

Objective: Heart failure (HF) represents a huge socio-economic burden. It has been demonstrated, experimentally, that renalase, a newly discovered protein, prevents cardiac hypertrophy and adverse remodeling, which is seen in HF. We postulated the following aims: to investigate associations of renalase with biomarkers of cardiac remodeling: galectin-3, soluble suppression of tumorigenicity, (sST2), growth differentiation factor 15 (GDF-15) and syndecan-1, myocardial stretch (BNP) and cardio-renal axis (cystatin C) in HF patients with reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF) to determine whether renalase, in combination with left ventricular ejection fraction (LVEF), represents a risk factor for plasma elevation in biomarkers.

Methods: We classified HF patients (n?=?76) according to LVEF (preserved/reduced), applied a median plasma renalase (113?ng/mL) as a cut-off value (low/high) and created four subgroups of HF patients: HFpEF/low renalase (n?=?19), HFrEF/low renalase (n?=?19), HFrEF/high renalase (n?=?32) and HFpEF/high renalase (n?=?6). A control group (n?=?35) consisted of healthy volunteers.

Results: Plasma concentrations of evaluated biomarkers were determined using an ELISA technique and were highest in HF patients with reduced EF (p?<?.001, respectively), and renalase’s positive correlations were obtained relating to all biomarkers: galectin-3 (r?=?0.913; p?<?.001), sST2 (r?=?0.965; p?<?.001), GDF-15 (r?=?0.887; p?<?.001), syndecan-1 (r?=?0.922; p?<?.001), BNP (r?=?0.527; p?<?.001) and cystatin C (r?=?0.844; p?<?.001) and strong and negative correlation with LVEF (r?=??0.456, p?<?.001). Increased renalase, regardless of the EF (preserved/reduced), was shown to be an independent risk factor for an increase in all evaluated cardiac remodeling biomarkers, p?<?.001, respectively. However, increased renalase and reduced EF was the only independent risk factor for BNP and cystatin C elevation, p?<?.001, respectively. Results after multivariable adjustments (age/gender) were identical.

Conclusion: When elevated plasma renalase and HF are present, regardless of EF being reduced or preserved, that represents a significant risk factor for increase in cardiac remodeling biomarker plasma concentrations. However, only elevated renalase and reduced EF demonstrated significance as a risk factor for BNP and cystatin C plasma elevation. Renalase may be considered a promising molecule for the improved predictive abilities of conventional biomarkers and is worthy of further investigation.     

Enteric-coated budesonide for the induction and maintenance of remission of Crohn’s disease in children

Objective: These studies evaluated the safety and efficacy of enteric-coated budesonide for the induction and maintenance of remission of mild-to-moderate Crohn’s disease (CD) in children.

Methods: The consecutive, multicenter, open-label, non-comparative studies enrolled patients aged 6–17 years. In the induction study, patients with active CD of the ileum and/or ascending colon received budesonide 9?mg or 6?mg once daily for 8 weeks; in the maintenance study, patients in remission received budesonide 6?mg once daily for 12 weeks. The primary objective was assessment of safety, including glucocorticosteroid-related side effects and serum cortisol levels. Efficacy was assessed using the Pediatric Crohn’s Disease Activity Index (PCDAI), and health-related quality of life (HRQoL) using the IMPACT-III questionnaire.

Results: In the induction study (n?=?108), most adverse events were related to CD, commonly abdominal pain; possible glucocorticosteroid-related effects included acne and increased appetite but without significant weight gain. Subnormal morning cortisol levels were observed in 32 of 103 patients after 8 weeks. Budesonide reduced disease activity from baseline (mean?±?standard deviation, 9.1?±?8.5 vs. 19.1?±?10.1, p?p?n?=?50), mean disease activity worsened (p?=?.047) with HRQoL unchanged (p?=?.33).

Conclusions: Budesonide treatment was generally well tolerated, although the potential for adrenal suppression was noted. Budesonide was effective for induction of remission in children with mild-to-moderate CD but not for maintaining remission (ClinicalTrials.gov identifiers: NCT01444092, NCT01453946).     

Factors associated with prolonged time to treatment failure with fulvestrant 500 mg in patients with post-menopausal estrogen receptor-positive advanced breast cancer: a sub-group analysis of the JBCRG-C06 Safari study

Objective: The JBCRG-C06 Safari study showed that earlier fulvestrant 500?mg (F500) use, a longer time from diagnosis to F500 use, and no prior palliative chemotherapy were associated with significantly longer time to treatment failure (TTF) among Japanese patients with estrogen receptor-positive (ER+) advanced breast cancer (ABC). The objective of this sub-group analysis was to further examine data from the Safari study, focusing on ER?+?and human epidermal growth factor receptor-negative (HER2?) cases.

Methods: The Safari study (UMIN000015168) was a retrospective, multi-center cohort study, conducted in 1,072 patients in Japan taking F500 for ER?+?ABC. The sub-analysis included only patients administered F500 as second-line or later therapy (n?=?960). Of these, 828 patients were HER2?.

Results Multivariate analysis showed that advanced age (≥65 years; p?=?.035), longer time (≥3 years) from ABC diagnosis to F500 use (p?p?p?Conclusions: In ER+/HER2? patients receiving F500 as a second-line or later therapy, treatment line, advanced age, no prior palliative chemotherapy use, and a longer period from ABC diagnosis to F500 use were associated with longer TTF.     

Healthcare costs for allergic rhinitis patients on allergy immunotherapy: a retrospective observational study

Objective: Subcutaneous immunotherapy (SCIT) for allergic rhinitis (AR) has been shown to control symptoms for up to several years following treatment discontinuation, but the effect of SCIT on healthcare costs for commercially insured patients is unknown. The objective of this study was to compare healthcare costs and resource utilization for patients with AR who received SCIT compared with those who discontinued SCIT shortly after initiation.

Methods: This retrospective cohort study evaluated medical and pharmacy claims from the Optum Research Database from January 2009 through February 2014 for adults and pediatric patients with >7 (continuers) vs. ≤7 (discontinuers) injection visits for SCIT within 60 days of initiation.

Results: After 1:1 propensity score matching, each cohort included 6710 patients. Continuers were less likely than discontinuers to use oral corticosteroids (27.7% vs. 29.6%, p?=?.018), or to have ≥1 respiratory-related emergency room visit (5.4% vs. 6.5%, p?=?.008) and ≥1 inpatient stay (1.1% vs. 1.7%; p?=?.002). Continuers were more likely than discontinuers to have ≥1?AR-related office (98.8% vs. 94.6%, p?p?=?.002). Continuers had greater mean total AR-related costs than discontinuers ($1918 vs. $646, p?p?=?.077); when adjusted with a generalized linear model, these costs were significantly lower among continuers (p?Conclusions: Continued SCIT use is associated with decreased emergency room visits and inpatient stays, decreased oral corticosteroid use, and lower respiratory-related costs, compared with early discontinuation.     

Identity talk on dangerous consumptions down-under

Abstract

Aim: To explore participation with alcohol marketing (i.e. commenting on brand statuses) and user-created promotion on social media (i.e. photos of peers drinking) by young people in the United Kingdom (UK), and what association this has with higher-risk consumption and brand identification.

Method: Online cross-sectional survey with 11–19-year olds in the UK (n?=?3,399) (average age: 15?years old). Past-month participation was measured for five forms of alcohol marketing on social media and one form of user-created promotion (all Yes/No). Past-month awareness of nine wider alcohol marketing activities, social media apps used at least weekly, and ownership of branded merchandise were included as covariates. Outcomes included higher-risk consumption in current drinkers (≥5 AUDIT-C) and brand identification in all respondents (8 pictures with brand names removed).

Results: Over one-in-ten respondents (13.2%) had participated with at least one form of marketing on social media or participated with user-created promotion (12.2%). For both, participation was greater in current drinkers and those of legal purchasing age. A logistic regression found that participation with two or more forms of marketing on social media (AOR?=?1.96, p?AOR?=?3.46, p?SD?=?2.12) alcohol brands. A linear regression found participation with marketing on social media was not associated with brand identification (β?=?0.01, p?=?.42) but participation with user-created promotion was (β?=?0.05, p?Conclusion: Social media provides opportunities for adolescents to participate with commercial marketing and user-created promotion and this is associated with higher-risk consumption and brand identification.     

Everolimus compliance and persistence among tuberous sclerosis complex patients with renal angiomyolipoma or subependymal giant cell astrocytoma

Objective: Everolimus is the only FDA approved drug to treat renal angiomyolipoma or subependymal giant-cell astrocytoma (SEGA) in tuberous sclerosis complex (TSC). Potential differences exist between patients with commercial and Medicaid insurance on everolimus use; however, there is limited information from the real world. This study compared compliance and persistence of everolimus between commercial and Medicaid patients using US claims data.

Methods: Patients with ≥1 claim of TSC with renal angiomyolipoma or SEGA were selected from the MarketScan commercial (1 January 2009–31 August 2016) and Medicaid (1 January 2009–30 June 2015) databases. Patients were followed from index date (the earliest date of TSC, renal angiomyolipoma or SEGA diagnosis) to death or end of data. Non-persistence, defined as ≥60?day gap without everolimus, and medication possession ratio (MPR) were assessed among the subset of patients with ≥1 year of follow-up from the first everolimus claim.

Results: A total of 1497 TSC patients met the study criteria (896 renal angiomyolipoma only, 411 SEGA only and 190 both). Compared to Medicaid patients (N?=?513), commercial patients (N?=?984) had the same ages (22 years) but a shorter length of follow-up (38 vs. 48 months, p?<?.001). Medicaid and commercial patients had similar rates of being treated with everolimus (14.4% vs. 13.6%, p?=?.668), but it took Medicaid patients a longer time to start everolimus (871 vs. 704 days, p?<?.001). Although the non-persistence rate was not significantly different between commercial and Medicaid patients (42.5% vs. 35.1%, p?=?.561), the number of days from everolimus initiation to non-persistence was significantly lower for commercial patients (945 vs. 1132, p?<?.001). During the 1 year post everolimus initiation, commercial patients had a significantly higher MPR (0.81 vs. 0.74, p?<?.001) and higher percentage of patients with MPR ≥0.80 (67.8% vs. 58.1%, p?<?.001).

Conclusions: Among TSC patients with renal angiomyolipoma or SEGA and treated with everolimus, everolimus MPR was between 0.74 and 0.81. Medicaid patients had lower MPR than commercial patients but better persistence.     

Adherence to iron chelation therapy in patients who switched from deferasirox dispersible tablets to deferasirox film-coated tablets

Objective: To compare real-world adherence to and persistence with deferasirox film-coated tablets (DFX-FCT) and deferasirox dispersible tablets (DFX-DT) among patients who switched from DFX-DT to DFX-FCT, overall and by disease type (sickle cell disease [SCD], thalassemia, and myelodysplastic syndrome [MDS]).

Methods: Patients were ≥2 years old and had ≥2 DFX-FCT claims over the study period and ≥2 DFX-DT claims before the index date (first DFX-FCT claim). The DFX-DT period was defined from the first DFX-DT claim to the index date; the DFX-FCT period was defined from the index date to the end of the study period. Adherence was measured as medication possession ratio (MPR) and proportion of days covered (PDC). Persistence was defined as continuous medication use without a gap ≥30 or 60 days between refills. Comparisons were conducted using paired-sample Wilcoxon sign-rank and McNemar’s tests.

Results: In total, 606 patients were selected (SCD: 348; thalassemia: 107; MDS: 106; other: 45). Adherence and persistence in the DFX-FCT vs DFX-DT period was significantly higher across all measures: mean MPR was 0.80 vs 0.76 (p?<?.001); 60.9% vs 54.3% of patients had MPR?≥?0.8 (p?=?.009); mean 3-month PDC was 0.83 vs 0.71 (p?<?.001); 64.2% vs 45.4% of patients had 3-month PDC?≥?0.8 (p?<?.001); 87.2% vs 63.4% of patients had 3-month persistence with no gap ≥30 days and 96.1% vs 79.9% with no gap ≥60 days (p?<?.001). Adherence and persistence improved after switching across all diseases, particularly MDS.

Conclusions: Adherence and persistence improved significantly after switching from DFX-DT to DFX-FCT for all diseases, but especially MDS.     

Cost comparison of laparoscopic colectomy versus open colectomy in colon cancer

Background: Laparoscopic colectomy has been shown to be safe, oncologically comparable, and clinically beneficial over open colectomy for colon cancer, but utilization remains low.

Objectives To evaluate the cost of laparoscopic colectomy vs open colectomy for colon cancer.

Methods: The authors conducted a retrospective claims data analysis using the 2012 and 2013 Truven Health Analytics MarketScan Commercial Claims and Encounter Database. The denominator population consisted of individuals who had commercial insurance coverage in all months of 2012 and >1 month in 2013 and pharmacy coverage throughout eligibility. The study population included individuals aged 18–64 years who were identified with colon cancer in 2013 and underwent an elective inpatient open colectomy or laparoscopic colectomy between January and November 2013. The cost and re-admission rate of open vs laparoscopic colectomy were compared after risk, adjusting for comorbidities, demographics, and geographic region.

Results: During the study period, 1299 elective inpatient colon cancer colectomies were performed (open, n?=?558; laparoscopic, n?=?741). After risk adjustment, the laparoscopic vs open group was shown to have lower re-admission rates (6.61 and 10.93 per 100 cases, respectively, p?=?.0165), lower average re-admission costs ($1676 and $3151, respectively, p?=?.0309), and lower 30-day post-discharge healthcare utilization costs ($4842 and $7121, respectively, p?=?.0047). Average allowed cost for the combined inpatient and 30-day post-discharge period was lower for laparoscopic vs open colectomy cases ($36,395 and $44,226, respectively, p?Conclusions: The cost of laparoscopic colectomy was found to be statistically significantly less than that of open colectomy in patients undergoing elective surgery for colon cancer.     

Racial/ethnic subgroup differences in outcomes and acceptability of an Internet-delivered intervention for substance use disorders

ABSTRACT

The Therapeutic Education System (TES), an Internet version of the Community Reinforcement Approach plus prize-based motivational incentives, is one of few empirically supported technology-based interventions. To date, however, there has not been a study exploring differences in substance use outcomes or acceptability of TES among racial/ethnic subgroups. This study uses data from a multisite (N?=?10) effectiveness study of TES to explore whether race/ethnicity subgroups (White [n?=?267], Black/African American [n?=?112], and Hispanic/Latino [n?=?55])moderate the effect of TES. Generalized linear mixed models were used to test whether abstinence, retention, social functioning, coping, craving, or acceptability differed by racial/ethnic subgroup. Findings demonstrated that race/ethnicity did not moderate the effect of TES versus TAU on abstinence, retention, social functioning, or craving. A three-way interaction (treatment, race/ethnicity, and abstinence status at study entry) showed that TES was associated with greater coping scores among nonabstinent White participants (p?=?.008) and among abstinent Black participants (p?<?.001). Acceptability of the TES intervention, although high overall, was significantly different by race/ethnicity subgroup with White participants reporting lower acceptability of TES compared to Black (p?=?.006) and Hispanic/Latino (p?=?.008) participants. TES appears to be a good candidate treatment among a diverse population of treatment-seeking individuals with substance use disorders.     

Pelargonium sidoides preparation EPs 7630 in COPD: health-related quality-of-life and other patient-reported outcomes in adults receiving add-on therapy

Objective: Patient-reported outcomes (PRO) such as health-related quality-of-life (HRQoL) belong to the most important criteria for the evaluation of medical therapies in clinical trials or practice-based benefit assessments. This study, therefore, revisited results of an earlier published clinical trial investigating the effects of the herbal drug preparation from the roots of Pelargonium sidoides EPs 7630, administered as add-on therapy in patients suffering from chronic obstructive pulmonary disease (COPD), with respect to HRQoL and other PRO.

Methods: A total of 199 adults diagnosed with COPD stages II/III and receiving standard treatment according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) were randomly assigned to add-on therapy with EPs 7630 or placebo for 24 weeks. HRQoL (disease-specific St. George’s Respiratory Questionnaire, SGRQ; current HRQoL state according to the EuroQuol visual analog scale, EQ VAS) and PRO (Integrative Medicine Outcomes Scale, IMOS; Integrative Medicine Patient Satisfaction Scale, IMPSS; symptom severity score of cough, sputum production and sternal pain while coughing; duration of inability to work) were assessed at each study visit or documented daily by the patient in a patient diary, respectively.

Results: At week 24, all HRQoL and PRO measures showed a more pronounced improvement under EPs 7630 than under placebo (EQ VAS, p?p?p?=?.021; duration of inability to work, p?=?.004; two-sided t-test each; IMOS, p?p?Conclusions: Add-on therapy with EPs 7630 led to an improvement in HRQoL and other PRO in adult patients with COPD compared to placebo while showing a good long-term tolerability.     

Efficacy and safety of ultrasound-guided percutaneous polidocanol sclerotherapy in benign predominantly cystic thyroid nodules: a prospective study

Objective: To evaluate the efficacy and safety of percutaneous polidocanol injection (PPI) in treatment of predominantly cystic thyroid nodules.

Materials and methods: This prospective study included 111 patients with 122 benign predominantly cystic thyroid nodules inducing pressure symptoms or cosmetic problems. The nodules were randomized to a single aspiration with (n?=?61) or without (n?=?61) subsequent PPI and followed up after 1, 3, 6, and 12 months. Ten patients (12 nodules) declined to follow up after aspiration in group 2. Nodule volumes, symptoms scores, and cosmetic scores were evaluated before and after treatment. The therapeutic success rate and safety of PPI for treatment of predominantly cystic thyroid nodules were also evaluated.

Results: In the PPI group, the nodule volumes were reduced from 13.67?±?9.90 to 2.60?±?2.66 (p?50%) was obtained in 57 of 61 (93.44%) nodules in the PPI group, compared to seven of 49 (14.29%) in the aspiration group (p?p?p?p?Conclusions: US-guided PPI of benign recurrent predominantly cystic thyroid nodules is effective and safe. PPI is an important alternative to benign recurrent predominantly cystic thyroid nodules.     

Epidural fentanyl does not affect cervical dilation and progress of first stage of vaginal delivery: a randomized,double-blind study

Objective: Local anesthetics combined with opioids are commonly used in labor epidural analgesic schemes. This study investigated if the addition of fentanyl to epidural ropivacaine can affect cervical dilation and progress of vaginal delivery.

Methods: Sixty-two nulliparous parturients were randomized to receive epidurally 8?ml ropivacaine 0.2% combined with fentanyl 20?μg (F/R-group, n?=?31) or with normal saline 0.4?ml (R-group, n?=?31), every hour. Rescue doses of 5?ml ropivacaine 0.2% were also administered. Measurements were performed every 60?min until full cervical dilation. The primary end-point was the time to reach 10-cm cervical dilation. Secondary outcomes were Bishop scores, mode of delivery, total ropivacaine dose, pain, and satisfaction scores (numerical scale, 0–10).

Results: Data from 60 parturients (29 in the F/R and 31 in the R-group) were analyzed. The F/R-group had 26 vaginal deliveries (four instrumentally assisted), and three cesarean deliveries. The R-group had 27 vaginal deliveries (six instrumentally assisted) and 4 cesarean deliveries. Time to 10-cm cervical dilation did not differ between the groups (4?±?2.4?h in the F/R-group vs 4.4?±?2.1?h in the R-group, p?=?.341). The number of women remaining in the study every hour until full cervical dilation and Bishop scores for a 4-h period did not differ between the groups (p?=?.617). Total ropivacaine dose was comparable between the groups, but the F/R-group reported significantly lower pain (p?=?.01) and higher satisfaction scores (p?=?.001).

Conclusions: The addition of fentanyl to ropivacaine 0.2% solution did not affect cervical dilation and progress of the first stage of labor, but improved both analgesia and satisfaction.     

Comparison of data characterizing the clinical effectiveness of the fluocinolone intravitreal implant (ILUVIEN) in patients with diabetic macular edema from the real world,non-interventional ICE-UK study and the FAME randomized controlled trials

Objective: To compare the effectiveness and safety of the fluocinolone acetonide (FAc) intravitreal implant between the observational Iluvien Clinical Evidence study in the United Kingdom (ICE-UK) and the Fluocinolone Acetonide in Diabetic Macular Edema (FAME) randomized controlled trials (RCTs) in people with diabetic macular edema (DME). Clinical Trials Registration: NCT00344968.

Methods: This study selected patients randomized to receive 0.2?µg/day FAc insert (FAc treated eyes) or sham injection (control eyes) from the FAME RCTs, and patients’ first FAc treated eye and non-FAc treated fellow (control) eye from the ICE-UK study. Outcomes included change in visual acuity (VA), central foveal thickness (CFT), and intraocular pressure (IOP).

Results: After 12 months follow-up, mean change in VA was 5.0 letters improvement (p?<?.001) and 1.6 letters improvement (p?=?.003) in FAME FAc treated and control eyes, and 3.8 letters (p?=?.012) and –2.1 letters (p?=?.056) in ICE-UK FAc treated and control eyes, respectively. Mean change in CFT was –144?µm (p?<?.001) vs –72?µm (p?<?.001) in FAME FAc treated and control eyes and –113 µm (p?<?.001) vs –13?µm (p?<?.001) in ICE-UK FAc treated and control eyes. For eyes with a follow-up of 12 months, 77 (22.3%) and 15 (8.6%) FAME FAc treated and control eyes and 25 (18.7%) and six (4.3%) ICE-UK FAc treated and control eyes required emergent IOP-lowering therapy.

Conclusions: Statistically significant improvements in VA 12 months after FAc implantation were observed in both the real-world study and in the RCTs. The improvement in VA and CFT in the RCTs was marginally greater than in the real-world study; however, recruits in the real-world study had more severe visual morbidity at baseline. Whilst there were many changes in the care of people with DME over this time, these data all support the value of treatment with FAc intravitreal implant.     

Prescribing patterns and healthcare costs of gout

Objective/methods: The Longitudinal Health Insurance Database (LHID) 2010 was used to identify gout cases and their number of gout flares.

Results: Out of 21,376 gout patients, a total of 3561 (16.7%) had frequent gout flares (≥3 gout flares/year). Average all-cause healthcare utilization (35.9 visits vs. 30.7 visits; p?<?.001) and gout-related utilization (22.7 visits vs. 15.6 visits; p?<?.001) were higher in frequent gout flare patients than in those with infrequent gout flares. The median gout-related cost (USD $369 vs. $285; p?<?.001), but not all-cause costs (p?=?.25), were higher in frequent gout flare patients compared to the infrequent group. Over 55.8% of the flares were treated with colchicine?+?NSAIDs.

Conclusions: In conclusion, patients with frequent gout flares had higher healthcare utilization and gout-related healthcare costs. Colchicine?+?NSAIDs are commonly used therapy for gout flare.