Gary Milligan

Impact of night-time symptoms in COPD: a real-world study in five European countries

Background Sleep quality is often poor in patients with chronic obstructive pulmonary disease (COPD). A cross-sectional European survey investigated the prevalence of night-time symptoms in COPD to evaluate the level of disconnect between physician and patient perceptions of the presence of night-time symptoms, and to compare the characteristics of patients with and without night-time symptoms. Methods A total of 251 primary care physicians and 251 respiratory specialists completed record forms on 2,807 patients with COPD. The forms captured information on patient demographics, lung function, COPD severity, and symptoms. Patients completed questionnaires on the time of day when their COPD symptoms bothered them, and the impact of COPD on their ability to get up in the morning and on sleep. Data were compared between groups (those with and without night-time symptoms) using t-tests or Wilcoxon signed rank tests. The kappa statistic was used to assess the level of disconnect between physician and patient perceptions of the impact of night-time symptoms. Results Most patients (78%) reported night-time disturbance. Patients with night-time symptoms experienced more daytime breathlessness (mean modified Medical Research Council dyspnea scale score 2.4 versus 1.1) and exacerbations in the previous 12 months (mean 1.7 versus 0.4), and received more maintenance therapy (mean of 2.8 versus 2.3 products) than those without. Concordance between the frequency of physician-reported (67.9% of patients) and patient-reported (68.5% of patients) night-time symptoms was good. Physicians significantly underestimated the impact of COPD on the patient’s ability to get up in the morning and on sleep (fair–moderate agreement). Physician-reported night-time symptoms were present for 41.2% of patients who could be categorized by Global initiative for chronic Obstructive Lung Disease (GOLD) group (n=937), increasing from 20.9% of those in the low-risk group to 77.4% of those in the high-riskgroup. Conclusion Patients with COPD experience night-time symptoms regardless of GOLD group, that impact on their ability to get up in the morning and on their sleep quality.

Fixed-Dose Combination Antidiabetic Therapy: Real-World Factors Associated with Prescribing Choices and Relationship with Patient Satisfaction and Compliance

IntroductionCompliance with antidiabetic therapy has the potential to impact on the risk for complications by an effect on glycemic control. Fixed-dose combinations (FDCs) offer a simplified dosing regimen that may improve patient compliance. We undertook a retrospective database analysis to understand the real-world association between FDCs, treatment practices, glycated hemoglobin (HbA1c) levels, and patient perspectives in type 2 diabetes.MethodsData were drawn from the Adelphi Diabetes Disease Specific Programme (DSP), a multicenter, patient recordbased market research study of primary care physicians and diabetologists/endocrinologists in Europe. The study is based on physician interviews, completion of detailed patient record forms by physicians, and a self-completion questionnaire by patients. Regression analyses were used to identify factors associated with (1) physician-reported dipeptidyl peptidase-4 inhibitor (DPP-4)/metformin FDC prescribing in dual or triple therapy regimens; (2) HbA1c of patients prescribed a DPP-4 FDC alone versus free-form DPP-4 plus metformin dual therapy regimens; and (3) differences between patients prescribed any oral antidiabetic therapy (OAD) FDC therapy (alone or in combination with one other OAD) versus those prescribed dual or triple OAD free-form combination therapy.ResultsPhysician-reported data were available for 5891 patients (mean age 61.5 years, 43% female, mean duration since diagnosis 5.7 years). Factors associated with DPP-4 FDC usage included physicians’ reason for choice being “improves patient compliance.” The relative mean % HbA1c level associated with being on a DPP-4 FDC rather than free-form independent of the physician perception of patient compliance was 0.25 lower (CI −0.40 to −0.09). When physician-perceived patient compliance was described as “fairly compliant” rather than “poorly compliant” or “not at all compliant,” the relative mean % HbA1c level was 0.42 lower (CI −0.67 to −0.18). Similarly, being perceived as “fully compliant” rather than “fairly compliant” was associated with a relative mean % HbA1c level that was 0.17 lower (CI −0.31 to −0.02). A significant predictor for the current regimen being any FDC (alone or in combination with one other OAD) regimen was patients’ satisfaction with treatment (odds ratio 1.32; 95% CI 1.10 to 1.58; P=0.003).ConclusionsThese results suggest that DPP-4 FDC prescribing is considered to be a positive prescribing choice to improve compliance and that choice is associated with improved glycemic control. From the patient’s perspective, the decision to prescribe an FDC is associated with improved satisfaction with treatment.

Clinical improvement and satisfaction with biologic therapy in patients with severe plaque psoriasis: results of a European cross-sectional observational study

Background: Efficacy of biologic therapies for psoriasis has been demonstrated in randomized trials, but effectiveness in real-world settings has yet to be fully determined. Objective: To compare clinical improvement and treatment satisfaction with biologic versus other therapies in patients with plaque psoriasis. Methods: European dermatologists recruited psoriasis patients into an observational study. Dermatologists reported disease severity before and after starting current therapy; dermatologists and patients reported treatment satisfaction. Results: These analyses included 2151 patients: topicals, n = 453; phototherapy, n = 666; conventional systemics, n = 683; biologics, n = 349. The percentage with severe disease declined from 70% before to 15% after biologics, a significantly greater decline than other therapies: topicals, 22–10%; phototherapy, 20–11%; conventional systemics, 49–15% (all p ≤ 0.03). Significantly more patients (59%) receiving biologics were satisfied with treatment versus topicals (45%), phototherapy (34%), or conventional systemics (50%) (all p < 0.001). Significantly more dermatologists were satisfied with biologics (60%) versus topicals (35%), phototherapy (26%), or conventional systemics (42%) (all p < 0.001). Conclusions: In this study, more patients receiving biologic therapies improved from severe to moderate or mild psoriasis than patients on other treatments. More patients with plaque psoriasis and their dermatologists were satisfied with biologics than any other treatment.

Trends in medication use in patients with type 2 diabetes mellitus: a long-term view of real-world treatment between 2000 and 2015

Background Despite the availability of a variety of treatments, many patients with type 2 diabetes mellitus (T2DM) are not achieving glucose control. We analyzed successive waves of the Adelphi Real World Diabetes Disease Specific Programmes (DSPs) to assess treatment patterns reported by primary care physicians (PCPs) and specialists and the effect of treatment on levels of glucose control. Methods Data were collected between 2000 and 2015 in the US and EU5 (France, Germany, Italy, Spain, and the UK). Physicians completed patient record forms for the next 10 patients consulting with T2DM. Key aspects captured were change over time in therapy usage, time to insulin introduction, and glycated hemoglobin (HbA1c) levels. Results Over 12 DSP waves, 3,555 specialists and 5,109 PCPs completed questionnaires for 70,657 patients. Treatment patterns changed considerably over time as new agents were introduced. The number of agents prescribed per patient increased over time, as did HbA1c levels at which physicians stated they would introduce insulin. The greatest improvements in HbA1c levels occurred during 2000–2008, with little improvement since 2008. Conclusion In this real-world setting, the proportion of patients with T2DM achieving good glucose control has not increased greatly since 2008. A better understanding of how to individualize treatment pathways may be required to improve control in these patients.

Real-World Use of Permixon® in Benign Prostatic Hyperplasia — Determining Appropriate Monotherapy and Combination Treatment

IntroductionBenign prostatic hyperplasia (BPH) is a major health concern for aging men. The resulting lower urinary tract symptoms may have a profound effect on a patient’s quality of life and it is recognized that patient acceptability of treatment is key to decreasing the human and economic burden of the condition. Alphaadrenergic antagonists (alpha-blockers), 5-alphareductase inhibitors (5-ARIs), and phytotherapy as monotherapy or in combination, form the mainstay of medical treatment.MethodsThe Adelphi Permixon Study, a cross-sectional study of representative consulting patients with BPH in two European countries, was undertaken to examine the reasons for choice of medication. Physicians completed patient record forms, and data were analyzed for clinical outcomes and their relationship with the choice of appropriate therapy.ResultsPatients receiving combination therapies for BPH are likely to be older and are more likely to be retired than those on monotherapy. Combination therapy is adopted in the real-world setting as first-line therapy on a not-infrequent basis. The analyses demonstrated an association between choice of Permixon® (Pierre Fabre Medicament, Castres, France) as appropriate monotherapy or in combination with alpha-blockers, and the following: BPH severity; treatment of general urinary symptoms, including storage and voiding symptoms; improvement of urinary flow rate; lack of a risk of sexual problems; and reduction of inflammation. Permixon combination with an alpha-blocker is associated with benefits in terms of speed of onset of action, reduction of inflammation, and a positive benefit regarding sexual problems when compared with use of alpha-blocker monotherapy.ConclusionIn the real clinical world, Permixon is considered an appropriate treatment for BPH as both monotherapy and in combination with alpha-blockers. Prescribing Permixon in combination with alpha-blockers can be demonstrated to provide benefits beyond use of either therapy alone.

Evidence for validity of a national physician and patient-reported, cross-sectional survey in China and UK: the Disease Specific Programme

Objective Diabetes represents a significant challenge for Chinese healthcare providers. Healthcare decision-making is generally based on many data sources, including randomised controlled and real-world studies; however, good-quality data from Chinese diabetes patients are scarce. We performed an initial validation to assess the representativeness of one source of real-world data—the Diabetes Adelphi Disease Specific Programme (DSP) in China. Setting China, UK. Participants The Chinese DSP included 2060 patients with previously diagnosed type 2 diabetes mellitus (T2DM) sampled by 200 physicians. The reference Chinese population comprised 238 639 patients with previously diagnosed T2DM. The UK DSP contained 1481 patients with T2DM sampled by 125 physicians; the reference UK population comprised 289 patients with diabetes. Primary and secondary outcomes The primary outcome was comparison of unweighted China DSP and reference data for sex, body mass index (BMI), blood pressure (BP), patients achieving glycosylated haemoglobin (HbA1c)<7%, total cholesterol, coronary heart disease and dyslipidaemia. The secondary outcome was comparison of weighted UK DSP and reference data for BMI, BP, mean HbA1c, total cholesterol, smoking and insulin status. Results Comparison of unweighted China DSP and reference data revealed statistical equivalence for BMI, systolic BP, proportion of patients achieving HbA1c <7%, total cholesterol, coronary heart disease and dyslipidaemia. Sex, age, diabetes duration, diastolic BP and mean HbA1c level were not equivalent, although differences were generally small. Weighting of data did not substantially affect the results. A similar pattern was observed for UK data. Conclusions This study provides evidence that the methodology used for the China and UK parts of the Diabetes DSP produces representative samples that are comparable with other independent sources of patient treatment outcomes data, which may ultimately inform public health decision-making. Although this method could be used in other countries, the current validation applies to UK and China. Further research is required for other countries.

The Effects of Isolated versus Multiple Lipid Disorders on Resource Utilization among Metabolic Syndrome Patients with Lipid Abnormalities despite Lipid-Modifying Treatment

Objective: The aim of this study was to compare resource utilization among metabolic syndrome (MetS) patients with multiple (≧2) lipid disorders (MLD) versus isolated (any 1) lipid disorder (ILD). Methods: Data for MetS patients on lipid-modifying therapy (LMT) were collected from the 2006 Adelphi Metabolic Syndrome Disease Specific Programme© cross-sectional study of patients from 5 European countries. The presence of MetS and lipid disorders, including elevated low-density lipoprotein cholesterol (LDL-C) and triglycerides (TG), and low high-density lipoprotein (HDL-C), were based on the National Cholesterol Education Program definitions. Analyses compared primary care physician (PCP) and specialist visits over the past 6 months among ILD versus MLD patients. Results: Among 4,836 MetS patients, 2,843 had ≧1 lipid disorders and were on LMT. Controlling for other risk factors, MLD patients had significantly higher physician visits than those with ILD (p = 0.009), but hospitalizations were not significantly different. Patients experiencing all 3 lipid disorders had significantly more endocrinologist visits (p = 0.002) as compared with ILD patients, while patients with elevated LDL-C and abnormal HDL-C and/or TG compared with isolated elevated LDL-C had significantly more PCP (p = 0.001) and cardiologist visits (p < 0.001). Conclusion: Among MetS patients on LMT, presence of MLD resulted in significantly higher PCP and specialist visits compared with ILD.

A Real-World Analysis of Migraine: A Cross-Sectional Study of Disease Burden and Treatment Patterns

The purpose of this cross‐sectional study was to assess the sociodemographics, disease burden, and treatment patterns of patients with episodic and chronic migraine in the United States.

Assessing The Level Of Resistance/Intolerance To Hydroxyurea Therapy Amongst Patients With Polycythemia Vera In Europe.

Presented at ISPOR 18th Annual European Congress, Milan, 7th – 11th November 2015, Milan ● Polycythemia vera (PV) is a rare myeloproliferative neoplasm that results in an abnormal increase in the number of blood cells. ● There is currently no curative treatment for PV and the principal goal is to reduce the hyperviscosity of the blood to prevent bleeding and clotting. ● This is managed through phlebotomy and, where required, through drug treatment in the form of aspirin or cytoreductive therapy: either hydroxyuria (HU), interferon or anagrelide. ● The most recent clinical guidelines for the management of PV are those issued in 2011 by the European LeukemiaNet.1 ● Response to cytoreductive therapy has been formally defined as haematocrit <45% without phlebotomy in addition to platelets ≤400x109/L, WBC ≤10x109/L, normal spleen size on imaging and no disease-related symptoms.1 ● The objective of the analysis was to assess the level of resistance/ intolerance to Hydroxyurea (HU) therapy in PV patients in the real world setting across Europe, based on the European LeukemiaNet (ELN) consensus paper.

Symptoms, Concomitant Conditions And Cardiac Risk In European Hydroxyurea Treated Polycythemia Vera Patients.

Presented at ISPOR 18th Annual European Congress, Milan, 7th – 11th November 2015, Milan • Polycythemia Vera (PV) is associated with an overproduction of blood cells which leads to increased risk of blood clots and associated cardiovascular (CV) complications and may result in increased morbidity and mortality. • PV is a rare condition, estimates relating to the prevalence of the condition vary. RARECARE estimate that the prevalence to be 5.5 per 100,000 in Europe1. Ma et al (2008) estimate the prevalence of PV to be 22 per 100,000 in the US2, whilst Ruben et al (2012) analysed two large US claims databases and estimated prevalence to be 48 per 100,000 and 57 per 100,0003. • The management of the condition is mainly through phlebotomy and, where required, through drug treatment in the form of aspirin or cytoreductive therapy: either hydroxyurea (HU), interferon or anagrelide. • This analysis seeks to evaluate the prevalence of the condition across a number of European markets and to examine the impact of Hydroxyurea (HU) treatment on symptoms, concomitant conditions and cardiac risk.