A systematic literature review of frequency of vaso-occlusive crises in sickle cell disease.

BACKGROUND AND PURPOSE: Sickle cell disease (SCD) is a collection of rare inherited blood disorders affecting approximately 100,000 people in the U.S. and 20-25 million people globally. Individuals with SCD experience recurrent episodes of severe and unpredictable pain that are caused by vaso-occlusive crises (VOCs), a hallmark of the disease. VOCs are the primary cause of hospitalization in SCD, result in missed workdays and school days, and decrease quality of life (QoL). Although VOCs cause significant burden in the lives of individuals with SCD, there is no synthesis on the frequency of VOCs in the real world. This systematic literature review sought to identify literature describing the frequency of VOCs experienced by individuals with SCD in real-world settings. METHODS: MEDLINE and 6 congresses were searched (date range: January 1, 2000 to June 30, 2020). Studies were reviewed independently by two researchers. Studies assessing frequency or prevalence of VOCs or VOC-related outcomes were included. RESULTS: Of 1438 studies identified in the search, 52 met pre-specified inclusion and exclusion criteria. Reported frequency of VOCs varied widely ranging from a mean or median of 0 VOCs/year to 18.2 VOCs/year. The proportion of patients experiencing ≥ 3 VOCs/year ranged from 4 to 67% and the proportion of patients experiencing ≥ 5 VOCs/year ranged from 18 to 59%. Measures of VOC severity were limited, with 13 studies considering frequency of complicated VOCs and only 1 study reporting duration of VOC episodes. CONCLUSIONS: This is the first study to systematically assess published evidence pertaining to VOCs in real-world settings. Reported VOC frequency in real-world settings varied widely, with a majority of studies only considering VOCs managed in an inpatient or outpatient setting. Studies that considered VOCs managed at home reported a higher frequency of VOCs, suggesting that many studies may underestimate the frequency of VOCs. This systematic literature review (SLR) highlights the need for consistent reporting of (1) self-reported VOCs, including those managed at home, (2) definitions of VOCs, (3) complicated VOCs, and (4) duration of VOC episodes in literature.

Erratum to 'Lipid Treatment and Goal Attainment Characteristics among Persons with Atherosclerotic Cardiovascular Disease in the United States' [American Journal of Preventive Cardiology 1C (2020) 100010].

[This corrects the article DOI: 10.1016/j.ajpc.2020.100010.].

Lifetime Costs for Treated Follicular Lymphoma Patients in the US.

BACKGROUND AND OBJECTIVE: The objective of this study was to estimate the lifetime costs of patients receiving treatment for follicular lymphoma (FL) in the United States. METHODS: A Markov model was programmed in heRo3 with a 6-month cycle length, 35-year time horizon (lifetime projection), and health states for line of treatment, response, receipt of maintenance therapy among responders, transformation to diffuse large B-cell lymphoma (DLBCL), development of second primary malignancy (SPM), and death. The model was used to estimate the expected lifetime costs of FL (in 2019 USD), including costs of drug acquisition and administration, transplant procedures, radiotherapy, adverse events, follow-up, DLBCL, SPM, end-of-life care, and indirect costs. Model inputs were based on published sources. RESULTS: In the US, patients with FL receiving treatment have a life expectancy of approximately 14.5 years from initiation of treatment and expected lifetime direct and indirect costs of US$515,884. Costs of drugs for induction therapy represent the largest expenditure (US$233,174), followed by maintenance therapy costs (US$88,971) and terminal care costs (US$57,065). Despite the relatively advanced age of these patients, indirect costs (due to patient morbidity and mortality and caregiver lost work time) represent a substantial share of total costs (US$40,280). Treated FL patients spend approximately 6.9 years in the health states associated with first-line therapy. Approximately 66 and 46% continue to second- and third-line therapies, respectively. The mean (95% credible interval) of expected lifetime costs based on the probabilistic sensitivity analyses was US$559,202 (421,997-762,553). CONCLUSIONS: In the US, the expected lifetime costs of care for FL patients who receive treatment is high. The results highlight the potential economic benefits that might be achieved by treatments for FL that prevent or delay disease progression.

Statin utilization and low-density lipoprotein cholesterol in statin-treated patients with atherosclerotic cardiovascular disease: Trends from a community-based health care delivery system, 2002-2016.

BACKGROUND: A better understanding of patterns in statin utilization and low-density lipoprotein cholesterol (LDL-C) among patients with atherosclerotic cardiovascular disease (ASCVD) in a clinical practice setting is needed. OBJECTIVES: The objective of this study was to examine statin utilization and LDL-C among new statin users with ASCVD. METHODS: This retrospective study used an electronic health record database from a community-based health care system. We identified ASCVD patients ≥21 years of age with a new statin prescription during the study period (2002-2016). Outcomes included high-intensity statin therapy (HIST) prescribing at treatment initiation, medication adherence (defined as proportion of days covered ≥0.80), statin therapy titrations rates, and changes in LDL-C during follow-up. RESULTS: Among 6199 eligible patients, mean follow-up was 16.8 months. At treatment initiation, 16.6% of patients received HIST. Approximately 53% of patients were adherent to statin regimens. Mean percent reduction in LDL-c was 25% during follow-up; 18% of patients, overall, and 30% of those initiating on HIST attained LDL-C reductions >50%. Rates of statin intensity-level increases were 8.4 per 100 person-years. HIST prescribing increased over time, beginning after generic atorvastatin availability and preceded treatment guidelines by two years. Initiation on HIST, higher adherence, and treatment intensification during follow-up were independent predictors of attaining LDL-C goals of <70 mg/dL or <100 mg/dL. CONCLUSIONS: In a community-based health care system, modest LDL-C lowering for secondary ASCVD prevention is likely driven by suboptimal adherence and low HIST prescribing and treatment intensification rates. Clinician and patient education are needed to reduce clinical inertia and improve medication adherence to better manage ASCVD.

In vitro and computational modelling of drug delivery across the outer blood-retinal barrier.

The ability to produce rapid, cost-effective and human-relevant data has the potential to accelerate the development of new drug delivery systems. Intraocular drug delivery is an area undergoing rapid expansion, due to the increase in sight-threatening diseases linked to increasing age and lifestyle factors. The outer blood-retinal barrier (OBRB) is important in this area of drug delivery, as it separates the eye from the systemic blood flow. This study reports the development of complementary in vitro and in silico models to study drug transport from silicone oil across the OBRB. Monolayer cultures of a human retinal pigmented epithelium cell line, ARPE-19, were added to chambers and exposed to a controlled flow to simulate drug clearance across the OBRB. Movement of dextran molecules and release of ibuprofen from silicone oil in this model were measured. Corresponding simulations were developed using COMSOL Multiphysics computational fluid dynamics software and validated using independent in vitro datasets. Computational simulations were able to predict dextran movement and ibuprofen release, with all of the features of the experimental release profiles being observed in the simulated data. Simulated values for peak concentrations of permeated dextran and ibuprofen released from silicone oil were within 18% of the in vitro results. This model could be used as a predictive tool for drug transport across this important tissue.

Lipid treatment and goal attainment characteristics among persons with atherosclerotic cardiovascular disease in the United States.

OBJECTIVE: National estimates of atherosclerotic cardiovascular disease (ASCVD) in the United States (US) are scarce, especially for patients grouped by cardiovascular risk, lipid-lowering therapy use, and low-density lipoprotein cholesterol (LDL-C) levels. The objective of this study was to estimate the size of the ASCVD population, including the subgroup at very high risk for recurrent events as defined by the 2018 Multi-Society Cholesterol Guidelines. METHODS: Patient-level data from the Truven MarketScan Research Database were used and extrapolated to approximate national figures based on known national demographic and ASCVD prevalence numbers. Demographic and clinical characteristics, including LDL-C levels and lipid-lowering therapy use, were captured. RESULTS: The extrapolated prevalence of ASCVD in 2014 was 18.3 million, of whom 690,524 had an acute coronary syndrome event in the past year. An estimated 41.4% of patients with ASCVD had diabetes, 44.9% had polyvascular disease, and 23.8% had multiple cardiovascular events. A third of those with ASCVD were estimated to be at very high risk for subsequent events per the 2018 Multi-Society Cholesterol Guidelines. Of those with ASCVD, 74.2% were estimated to have an LDL-C level of ≥70 â€‹md/dL, and more than half of these patients were neither on statins nor ezetimibe. Only 9.2% of patients with ASCVD and LDL-C ≥70 â€‹mg/dL were on a high-intensity statin. CONCLUSIONS: The underutilization of lipid-lowering therapies in general, and in particular the relatively low usage of high-intensity statins among patients with uncontrolled LDL-C (including those at very high risk), suggests that eligible patients for proprotein convertase subtilisin/kexin type 9 inhibitor therapy may not be as numerous as previously estimated.

STREPTOZOTOCIN-INDUCED DIABETES MELLITUS - A PARADOX OF HIGH INTRINSIC PLATELET REACTIVITY AND LOW IN VITRO PLATELET AGGREGATION.

CONTEXT: Studies of platelet function in diabetics are inconsistent, some studies reporting higher platelet reactivity, while others showed no change. OBJECTIVE: We aimed to evaluate platelet indices and in vitro platelet aggregation in rats with long-lasting (28 weeks) diabetes mellitus. DESIGN: Twelve controls and 14 diabetic rats were investigated. Diabetes was induced in 11-week-old rats using streptozotocin (60 mg/kg,i.p.). Platelet indices and in vitro adenosine diphosphate (ADP)-, protease-activated receptor 4 (PAR4) agonist-, and arachidonic acid (AA)-induced platelet aggregation were assessed at the age of 38 weeks. RESULTS: Compared to controls, diabetic rats presented lower platelet count and plateletcrit (both p≤0.001), and higher mean platelet volume (p<0.01). ADP- (p=0.04) and AA-induced (p<0.01) platelet aggregation were lower in diabetic compared with control rats, whereas PAR4 agonist-induced platelet aggregation was similar between the two groups (p=1.00). CONCLUSIONS: This study demonstrates a paradox of high intrinsic platelet reactivity and low in vitro ADP- and AA-induced platelet aggregation in diabetic rats compared with non-diabetic controls. The relevance of in vitro platelet aggregation to the contribution of platelets to in vivo thromboembolic events in diabetic rats remains questionable.

Long-term type 1 diabetes mellitus creates a pro-atherogenic environment conducive to early atherosclerosis in rats.

INTRODUCTION: Experimental models are essential for clarifying the pathogenesis of atherosclerosis in the context of diabetes mellitus (DM). We aimed to evaluate the presence and the magnitude of several factors known to promote atherogenesis, and to assess the potential of a pro-atherogenic environment to stimulate the development of atherosclerotic lesions in a rat model of long-term type 1 DM. MATERIALS AND METHODS: Six control and five DM Wistar rats were evaluated. DM was induced at 11 weeks of age using streptozotocin (STZ; 60 mg/kg, intraperitoneal). Animals were monitored up to 38 weeks of age, when plasma glucose, lipid profile, and markers specific for systemic inflammation, endothelial dysfunction, and oxidative stress were measured. The amount of fat within the aortic wall was assessed semiquantitatively using Oil Red O staining. RESULTS: Diabetic rats presented significantly higher plasma glucose (p < 0.001), total cholesterol and triglycerides (both p = 0.02), high-sensitivity C-reactive protein (p = 0.01), and vascular endothelial growth factor (p = 0.04) levels, and significantly lower interleukin-10 (p = 0.04), superoxide dismutase (p < 0.01), and glutathione peroxidase (p = 0.01) levels than the control rats. Mild (grade 1) atherosclerotic lesions were observed in the aortic wall of 80% of the diabetic rats and in none of the control rats. CONCLUSIONS: This study presents a STZ-induced type 1 DM rat model with one of the longest follow-ups in the literature. In this model, long-term DM created a highly pro-atherogenic environment characterised by hyperglycemia, dyslipidemia, systemic inflammation, endothelial dysfunction, and oxidative stress that resulted in the development of early aortic atherosclerotic lesions.

Lipid-lowering Therapy and Goal Achievement in High-risk Patients From French General Practice.

PURPOSE: The goal of this study was to summarize patterns of lipid-lowering therapy (LLT) usage and achievement of guideline-identified lipid goals in a 2015 general practice cohort of French patients with atherosclerotic cardiovascular disease (ASCVD) and/or diabetes mellitus (DM). METHODS: From the IMS Health Real-World Data database, patients aged ≥18years were classified hierarchically into mutually exclusive categories of ASCVD subgroups and DM. LLT use and lipid goal achievement were assessed on the date of lipid measurement. The data were compared with previously published results of LLT use and lipid goal achievement in a 2014 UK population. FINDINGS: Of 32,924 patients meeting the inclusion criteria, only 47.5% were prescribed a statin as of the index date. Hierarchically, the highest rates of use of any statin (73.3%) and high-intensity statins (43.3%) were among patients with recent acute coronary syndrome; rates in DM without ASCVD were 38.7% and 2.3%, respectively. Overall, achievement of LDL-C levels <1.8 mmol/L (<70 mg/dL) was only 13.9% for patients with ASCVD and 10.7% with DM. Relative to a 2014 UK population, the 2015 French cohort (data reanalyzed according to the UK statin categorization) were prescribed "high-dose statins" less frequently (31.4% vs 20.9%, and 18.7% vs 7.2%, for ASCVD and DM). Similarly, the proportion of patients with high-dose statins achieving LDL-C levels <1.8mmol/L was higher in the 2014 UK population than in the 2015 French population (37.3% vs 22.2%, and 36.8% vs 20.3%, for ASCVD and DM). IMPLICATIONS: In a large cohort of French patients with ASCVD and/or DM, LLT usage and LDL-C goal achievement were suboptimal, relative to current guidelines.

Statin utilization and lipid goal attainment in high or very-high cardiovascular risk patients: Insights from Italian general practice.

BACKGROUND AND AIMS: Statin utilization and lipid goal achievement were estimated in a large sample of Italian patients at high/very-high cardiovascular (CV) risk. METHODS: Patients aged ≥18 years with a valid low-density lipoprotein cholesterol (LDL-C) measurement in 2015 were selected from the IMS Health Real World Data database; non-high-density lipoprotein cholesterol (non-HDL-C) was assessed in those with available total cholesterol measurements. Index dates were defined as the last valid lipid measurement in 2015. Patients were hierarchically classified into mutually exclusive risk categories: heterozygous familial hypercholesterolemia (primary and secondary prevention), atherosclerotic CV disease (including recent acute coronary syndrome [ACS], chronic coronary heart disease, stroke, and peripheral arterial disease), and diabetes mellitus (DM) alone. Statin and non-statin lipid-modifying therapy (LMT) use, and European Society of Cardiology (ESC)/European Atherosclerosis Society (EAS) guideline-recommended goal attainment, were assessed. RESULTS: Among 66,158 patients meeting selection criteria, the overall rate of LMT prescriptions was 53.3%, including 7.7% on high-intensity statin therapy. Statin use was highest for recent ACS and lowest for DM alone. LDL-C goal attainment was 16.0% for <1.8 mmol/l and 45.0% for <2.5 mmol/l; 24.3% reached non-HDL-C <2.6 mmol/l and 52.2% were at <3.3 mmol/l. Goal achievement was greatest with high-intensity statin use. CONCLUSIONS: Statin use in this cohort was consistent with previous reports in Italian patients at high/very-high CV risk, and low relative to statin use in other European countries. The low rate of ESC/EAS lipid goal attainment observed was consistent with outcomes of other European studies.

The Implementation and Validation of a Virtual Environment for Training Powered Wheelchair Manoeuvres.

Navigating a powered wheelchair and avoiding collisions is often a daunting task for new wheelchair users. It takes time and practice to gain the coordination needed to become a competent driver and this can be even more of a challenge for someone with a disability. We present a cost-effective virtual reality (VR) application that takes advantage of consumer level VR hardware. The system can be easily deployed in an assessment centre or for home use, and does not depend on a specialized high-end virtual environment such as a Powerwall or CAVE. This paper reviews previous work that has used virtual environments technology for training tasks, particularly wheelchair simulation. We then describe the implementation of our own system and the first validation study carried out using thirty three able bodied volunteers. The study results indicate that at a significance level of 5 percent then there is an improvement in driving skills from the use of our VR system. We thus have the potential to develop the competency of a wheelchair user whilst avoiding the risks inherent to training in the real world. However, the occurrence of cybersickness is a particular problem in this application that will need to be addressed.

Utilization of lipid-modifying therapy and low-density lipoprotein cholesterol goal attainment in patients at high and very-high cardiovascular risk: Real-world evidence from Germany.

BACKGROUND AND AIMS: Elevated low-density lipoprotein cholesterol (LDL-C) is a causal risk factor for cardiovascular (CV) events. European guidelines recommend reducing LDL-C as the primary lipid target to reduce CV risk, using lifestyle modifications and lipid-lowering therapy (LLT). Many European patients do not achieve guideline-recommended LDL-C levels. The present database analysis aimed to assess LLT treatment patterns and LDL-C threshold attainment in Germany in a large, real-world cohort of patients. METHODS: Patients from the Cegedim Longitudinal Practice Database in Germany who met selection criteria were included: (a) LDL-C measurement in 2013; (b) ≥20 years of age; (c) high or very-high CV risk conditions: recent acute coronary syndrome (ACS), other coronary heart disease (CHD), ischemic stroke, peripheral arterial disease (PAD) (atherosclerotic cardiovascular disease [ASCVD]) or diabetes mellitus (DM) (non-ASCVD). LDL-C threshold attainment was assessed based on LDL-C targets from 2011 European guidelines. RESULTS: 42,767 patients met the inclusion criteria; 35% received current statin treatment, and 30% achieved guideline-recommended LDL-C targets. Attainment of LDL-C goals among ASCVD hierarchical categories was 46.7% for recent ACS, 35.8% for ischemic stroke, 34.9% for other CHD, and 26.9% for PAD. Among patients in the non-ASCVD group with DM, 23.6% achieved LDL-C goals. Similar results were observed when patients were grouped by prevalence (patients assigned to every risk group for which they qualified). CONCLUSIONS: In this high/very-high CV risk population in Germany, statin utilization was low; suggesting that LLTs are not prescribed as per European guidelines. These results highlight the need to increase LLT use among high-risk patients.

A Cost-Effective Virtual Environment for Simulating and Training Powered Wheelchairs Manoeuvres.

Control of a powered wheelchair is often not intuitive, making training of new users a challenging and sometimes hazardous task. Collisions, due to a lack of experience can result in injury for the user and other individuals. By conducting training activities in virtual reality (VR), we can potentially improve driving skills whilst avoiding the risks inherent to the real world. However, until recently VR technology has been expensive and limited the commercial feasibility of a general training solution. We describe Wheelchair-Rift, a cost effective prototype simulator that makes use of the Oculus Rift head mounted display and the Leap Motion hand tracking device. It has been assessed for face validity by a panel of experts from a local Posture and Mobility Service. Initial results augur well for our cost-effective training solution.

The economic burden of pulmonary arterial hypertension (PAH) in the US on payers and patients.

BACKGROUND: Pulmonary arterial hypertension (PAH) is a rare condition that can ultimately lead to right heart failure and death. In this study we estimated the health care costs and resource utilization associated with PAH in a large US managed care health plan. METHODS: Subjects with claims-based evidence of PAH from 1/1/2004 to 6/30/2010 (identification period) were selected. To be included in the final PAH study sample, subjects were required to have ≥2 claims with a primary PH diagnosis; ≥2 claims with a PAH related-diagnosis (connective tissue diseases, congenital heart diseases, portal hypertension); and ≥1 claim with evidence of a PAH-indicated medication. The earliest date of a claim with evidence of PAH-indicated medication during the identification period was set as the index date. Health care costs and resource utilization were compared between an annualized baseline period and a 12 month follow-up period. RESULTS: 504 PAH subjects were selected for the final study cohort. Estimated average total health care costs were approximately 16% lower in the follow-up period compared to the baseline period (follow-up costs = $98,243 [SD = 110,615] vs. baseline costs = $116,681 [SD = 368,094], p < 0.001), but substantively high in each period relative to costs reported for other chronic diseases. Pharmacy costs were significantly higher in the follow-up period vs. the baseline period, ($38,514 [SD = 34,817] vs. $6,440 [SD = 12,186], p < 0.001) but medical costs were significantly lower in the follow-up vs. baseline ($59,729 [SD = 106,683] vs. $110,241 [SD = 368,725], p < 0.001). These costs were mirrored in health-care resource utilization estimates. The average counts of ambulatory visits and inpatient stays were lower in the follow-up vs. the baseline (both p < 0.001). Results varied in exploratory analyses when less restrictive subject identification algorithms were used. CONCLUSIONS: Subjects with evidence of PAH had substantively high health care costs. Medical costs appeared to decrease following PAH medication use, but with a concomitant increase in pharmacy costs.

Cytomegalovirus retinitis in HIV/AIDS patients.

UNLABELLED: Human immunodeficiency virus (HIV) has the ability to affect any organ in the body. In 70% of HIV-infected patients ocular manifestations were observed, which in the vast majority reflect the systemic disease and may be the first sign of a disseminated infection. AIM: The purpose of this paper is to determine the prevalence and the clinical aspects of cytomegalovirus retinitis in HIV/AIDS (Acquired Immunodeficiency Syndrome) patients. METHOD: The study is retrospective, conducted in the Ophthalmology Office of "Matei Bals" Infectious Diseases Hospital in Bucharest during the period August 1, 2007 - August 1, 2013. Each patient was examined thoroughly at the slit lamp biomicroscope by using a lens of 90D and a 20D lens using the indirect microscope after administration of topical mydriatics. RESULTS: 131 patients were followed for HIV / AIDS with posterior segment ocular involvement. 36.64% of the 131 patients having affected the posterior segment have been diagnosed with CMV retinitis. CONCLUSIONS: Doctors should be aware of the existence of ocular damage in HIV/AIDS and to emphasize the importance of regular ophthalmologic examination of patients with HIV/AIDS.

Posterior segment ocular manifestations of HIV/AIDS patients.

UNLABELLED: Human immunodeficiency virus (HIV) has the ability to affect any organ in the body. In 70% of HIV -infected patients ocular manifestations were observed, these, in the vast majority reflect the systemic disease and may be the first signs of disseminated infections. AIM: The purpose of this paper is to determine the prevalence of posterior segment ocular manifestations in HIV / AIDS (Acquired Immunodeficiency Syndrome) patients. METHOD: The study is retrospective, conducted in the Cabinet of Ophthalmology of "Matei Bals" Infectious Diseases Hospital in Bucharest, during the period 1 August 2007 - 1 August 2013 . Each patient was examined thoroughly at the biomicroscope ocular slit by using 90D microscope lens and 20D indirect lens after the administration of topical mydriatics. RESULTS: 348 patients with HIV/AIDS and ocular disorders were followed. There was a high number of children and young people with HIV who had eye disorders (194 patients aged between 14 and 25 years). 44.25% of patients had posterior segment ocular damage, 17.55% of them had the anterior segment affected. 22.90% of the 131 patients with compromised posterior segment microangiopathy have been diagnosed with HIV / AIDS. CONCLUSIONS: Doctors should be aware of the existence of ocular damage in HIV / AIDS and to emphasize the importance of regular ophthalmologic examination of patients with HIV / AIDS.

Benefits of anterior chamber paracentesis in the management of glaucomatous emergencies.

UNLABELLED: Anterior chamber paracentesis (ACP) is an alternative technique to reduce intraocular pressure (IOP) in patients with acute closed-angle glaucoma (ACAG) and requires controlled drainage of aqueous humor from the anterior chamber using a needle or an incision paracentesis with a knife. PURPOSE: Evaluation of efficacy and safety of AC paracentesis in acute increases of intraocular pressure. METHOD: This was an observational study done on a group of 24 patients with acute, unilateral increases of IOP> 50mmHg. IOP was measured before, 10 minutes, 1 day, 7 days and 30 days after ACP using applanation tonometry. RESULTS: Intraocular pressure decreased from an average of 52.5 mmHg to 25.5 mmHg to 17.5 mmHg at 10 minutes and 7 days from the ACP. Anterior chamber paracentesis combined with glaucoma medication led to the cessation of symptoms in all patients included in the lot and the resolution of corneal edema in 20 cases. CONCLUSION: ACP is safe and effective in acute increases of IOP in the acute form of the primary angle closure glaucoma but remains an adjunct to conventional therapy drug.

OCT parameters in patients with diabetic maculopathy.

The treatment of the clinically significant macular edema in patients with diabetic maculopathy by the intravitreal administration of corticosteroids and antiangiogenic factors requires rapid and more accurate investigation methods aimed at following up the dynamic evolution of the structural parameters of the retina. The purpose of the study is to compare the outcome of OCT parameters for each group (Group A treated by intravitreal administered triamcinolone acetonide and Group B treated by intravitreal administered triamcinolone acetonide in combination with bevacizumab). Methods involved the selection of cases, dynamic measurements of the retina structures, so that, at the end, the data from the two groups of patients could be compared. The results showed a positive development in the short and medium term in both groups of patients.

Visual acuity outcome in patients with diabetic maculopathy.

The purpose of this study is to follow up visual acuity in patients diagnosed with clinically significant macular edema and treated by an intravitreal injection of triamcinolone acetonide or in combination with bevacizumab. The working method: based on the selectivity criteria we involved 295 patients (460 eyes), divided into 2 groups according to the treatment administered and one control group. The results showed a better preservation of the functional parameter for the group of patients treated with intravitreal injection of triamcinolone acetonide and bevacizumab.

Healthcare Resource Utilization and Costs Associated with Autosomal Dominant Polycystic Kidney Disease.

Background: Autosomal dominant polycystic kidney disease (ADPKD), a hereditary nephropathy, eventually leads to end-stage renal disease (ESRD), typically by mid-life. Objectives: The objective of this study was to assess real-world healthcare resource utilization and cost among commercially insured (COM) and Medicare Advantage (MAPD) ADPKD patients in addition to the cost profile by chronic kidney disease (CKD) stage. Methods: Patients diagnosed with ADPKD (two or more claims) with ≥30 days of continuous medical and pharmacy benefits and no evidence of autosomal recessive polycystic kidney disease were selected (Optum Research Database and Impact National Benchmarking Database: 1/1/06-8/31/12). Plan and patient paid healthcare costs and resource utilization per patient per month (PPPM) were described in total and by insurance type. CKD stage was established based on serum creatinine laboratory values or dialysis-related codes. Adjusted, CKD stage-specific costs were predicted for 4 years using regression models. Results: Of the 36,253,096 patients in the databases (1/1/06-8/31/12), 5,051 had evidence of ADPKD. Following exclusion criteria, 4,356 COM and 468 MAPD ADPKD patients remained. Total healthcare resource utilization and costs were high, and costs increased substantially from CKD stage 1-5. PPPM healthcare costs were 37% for ADPKD management and 52% for dialysis services. Predicted 4-year healthcare costs by CKD stage were $40,164 (stage 1), $33,397 (stage 2), $42,686 (stage 3), $148,402 (stage 4), and $207,548 (stage 5). Conclusions: Healthcare resource utilization and costs associated with ADPKD were substantial, irrespective of payer type, and primarily driven by CKD stage. Of the total healthcare costs, 88% were ADPKD- and dialysis-related. Most impactful was the spike in predicted cost when patients progressed from CKD stage 3 to stage 4 (by 348%) after multivariate adjustment. These stage 4-associated costs are primarily due to ultimate progression into stage 5 and ESRD within the 4-year time frame.