Profile of Patients with Diabetes Treated with Insulin Lispro 200 U/ml: A Real-World Study from Spain.

INTRODUCTION: Insulin lispro 200 U/ml (IL200) is a rapid-acting concentrated insulin used for the treatment of adults with diabetes requiring daily doses of > 20 units of rapid-acting insulin. The aim of this study was to describe the clinical/demographic and treatment characteristics of patients who initiated insulin IL200 therapy in Spain in a real-world setting (PROFILE-IL200). METHODS: This retrospective observational study based on the IQVIA database included adult (≥ 18 years) patients with type 1 (T1D) or type 2 (T2D) diabetes who initiated IL200 between June 2015 and December 2019. Demographic and clinical characteristics were analyzed descriptively. RESULTS: Main characteristics for the T1D/T2D groups (N = 65/167) were as follows: male, 63.1/55.7%; mean (standard deviation [SD]) age, 46.5 (15.5)/62.6 (12.8) years; time since first diabetes record, 6.6 (4.2)/7.9 (2.9) years; body mass index (BMI), 30.9 (5.8)/33.1 (5.5) kg/m2; glycated hemoglobin, 8.3 (2.1)/8.8 (1.8)%; and diabetes-associated comorbidity, 55.4/92.8%. Among patients with T1D/T2D and a prior diagnosis (N = 54/164), 96.3/90.2% had received previous insulin (rapid insulin in 81.5/62.2%), and 13.0/97.6% had received previous noninsulin antihyperglycemic therapy. The mean (SD) total insulin dose before IL200 initiation for T1D/T2D was 98.0 (73.9)/95.2 (59.8) U/day; IL200 was initiated at a dose of 56.3 (43.8)/51.5 (34.3) U/day, with basal insulin in 86.2/83.2% of the patients. IL200 was first prescribed by an endocrinologist or a primary care physician in 48.7% and 46.6% of patients, respectively. CONCLUSIONS: PROFILE-IL200 described the profile of patients treated with IL200 in clinical practice in Spain. Patients were middle-aged, with poor glycemic control, high BMI and associated comorbidities, and received high doses of insulin at IL200 initiation.

Insulin is one of the main treatments for people with diabetes. More concentrated versions of a fast-acting insulin such as insulin lispro 200 U/ml (IL200) can be better for people with diabetes who need large daily amounts of a fast-acting insulin to keep their blood glucose at appropriate levels, because the injection volume is smaller, and so one IL200 insulin pen lasts longer than other pens. However, there is limited information on the types of patients who start treatment with this type of insulin in the real world. By using a database of medical records, we studied the profile of patients who started treatment with IL200 between 2015 and 2019 in Spain. The study found that patients starting treatment with IL200 were middle-aged, overweight or obese, and with a poor control of blood glucose levels. The patients also had other conditions common in patients with diabetes, such as high blood pressure, high cholesterol and triglycerides, and heart disease, and were receiving high doses of insulin before starting treatment with IL200. Patients were generally prescribed IL200 by their diabetes specialist or general practitioner. The findings of this study could help identify the patients who may benefit the most from the characteristics of IL200, such as a smaller injection volume and longer duration of use for each insulin pen, which may result in patients using IL200 as directed for longer.

Real-world therapeutic management and evolution of patients with benign prostatic hyperplasia in primary care and urology in Spain.

OBJECTIVES: This study aimed to describe the real-world therapeutic management of patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) (LUTS/BPH) attending primary care and urology clinics in Spain. METHODS: This observational, retrospective, multicentre study included men ≥50 years of age diagnosed with LUTS/BPH (≤8 years prior to study visit) (N = 670). Therapeutic management according to healthcare service (primary care vs. urology clinics) or progression criteria, proportion of patients with treatment change, patient profile according to therapy and evolution of LUTS severity were assessed. RESULTS: Overall differences were noticed in the management of patients between healthcare service (P < .001) and with or without progression criteria (P < .05). Most patients received pharmacological treatment at diagnosis (70.7%; 474/670), which increased at study visit (81.6%; 547/670) with overall similar profiles between primary care and urology clinics for each therapy. α1-Blockers were the most used pharmacological treatment across healthcare settings at diagnosis (61.8%; 293/474) and study visit (51%; 279/547). Only 27.1% (57/210) of patients with progression criteria at diagnosis and 35.6% (99/278) at study visit received 5α-reductase inhibitor (5ARI) alone or in combination with a α1-blocker. Overall, most patients did not change treatment (60%; 402/670) with a trend of more patients worsening in symptoms when not receiving α1-blocker plus 5ARI combination therapy. CONCLUSION: Most patients with LUTS/BPH received pharmacological treatment; however, most men with progression criteria did not receive a 5ARI alone or in combination. These results support the need to reinforce both primary care and urologists existing clinical guideline recommendations for the appropriate medical management of patients with LUTS/BPH.

Real-world assessment and characteristics of men with benign prostatic hyperplasia (BPH) in primary care and urology clinics in Spain.

OBJECTIVES: To describe the real-world demographic and clinical characteristics of patients with lower urinary tract symptoms (LUTS) as a result of benign prostatic hyperplasia (BPH) in Spain. METHODOLOGY: This observational, retrospective, multicentre study conducted in primary care and urology clinics in Spain included men aged ≥50 years diagnosed (≤8 years prior to study visit) with LUTS caused by BPH. The primary endpoint was demographic and clinical characteristics; secondary endpoints included disease progression and diagnostic tests across both healthcare settings. RESULTS: A total of 670 patients were included (primary care: n = 435; urology: n = 235). Most patients had moderate/severe LUTS (74.6%) and prostate volume >30 cc (81.7%), with no differences between settings. More patients had prostate-specific antigen (PSA) ≥1.5 ng/mL in primary care (74.5%) versus urology (67.7%). Progression criteria were prevalent (48.9%). Clinical criteria were more commonly used than the International Prostate Symptom Score (IPSS) to evaluate LUTS at diagnosis (primary care: clinical criteria 73.0%; IPSS: 26.9%; urology: clinical criteria 76.5%; IPSS: 23.4%). Proportion of patients with moderate/severe LUTS at diagnosis was lower using clinical criteria than IPSS, and the proportion of patients with 'worsening' LUTS (diagnosis to study visit) was higher when using clinical criteria versus IPSS. In both healthcare settings, the most commonly used diagnostic tests were general and urological clinical history and PSA. CONCLUSION: Demographic and clinical characteristics of patients with BPH in Spain were similar in primary care and urology; however, assessment criteria to evaluate LUTS severity differ and are not completely aligned with clinical guideline recommendations. Increased use of recommended assessments may enhance optimal BPH management.

Assessing Pharmacists' Preferences towards Efficacy Attributes of Disease-Modifying Therapies in Relapsing-Remitting Multiple Sclerosis.

Introduction: Hospital pharmacists are increasingly playing a critical role in the care of patients with multiple sclerosis (MS). However, little is known about their preferences and perspectives towards different attributes of disease-modifying therapies (DMTs). The objective of this research was to assess pharmacists´ preferences for DMT efficacy attributes. Methods: A multicenter, non-interventional, cross-sectional, web-based study was conducted. Preventing relapses, delaying disease progression, controlling radiological activity, and preserving health-related quality of life (HRQoL) and cognition were the attributes selected based on a literature review and a focus group with six hospital pharmacists. Conjoint analysis was used to determine preferences in eight hypothetical treatment scenarios, combining different levels of each attribute and ranking them from most to least preferred. Results: Sixty-five hospital pharmacists completed the study (mean age: 43.5 ± 7.8 years, 63.1% female, mean years of professional experience: 16.1 ± 7.4 years). Participants placed the greatest preference on delaying disease progression (35.7%) and preserving HRQoL (21.6%) and cognition (21.6%). Importance was consistent in all groups of pharmacists stratified according to demographic characteristics, experience, research background, and volume of patients seen per year. Conclusions: Understanding which treatment characteristics are meaningful to hospital pharmacists may help to enhance their synergistic role in the multidisciplinary management of patients with MS.

Mapping AcroQoL scores to EQ-5D to obtain utility values for patients with acromegaly.

AIMS: To estimate a preference-based single index for the disease-specific instrument (AcroQoL) by mapping it onto the EQ-5D to assist in future economic evaluations. MATERIALS AND METHODS: A sample of 245 acromegaly patients with AcroQoL and EQ-5D scores was obtained from three previously published European studies. The sample was split into two: one sub-sample to construct the model (algorithm construction sample, n = 184), and the other one to confirm it (validation sample, n = 61). Various multiple regression models including two-part model, tobit model, and generalized additive models were tested and/or evaluated for predictive ability, consistency of estimated coefficients, normality of prediction errors, and simplicity. RESULTS: Across these studies, mean age was 50-60 years and the proportion of males was 36-59%. At overall level the percentage of patients with controlled disease was 37.4%. Mean (SD) scores for AcroQoL Global Score and EQ-5D utility were 62.3 (18.5) and 0.71 (0.28), respectively. The best model for predicting EQ-5D was a generalized regression model that included the Physical Dimension summary score and categories from questions 9 and 14 as independent variables (Adj. R2 = 0.56, with mean absolute error of 0.0128 in the confirmatory sample). Observed and predicted utilities were strongly correlated (Spearman r = 0.73, p < .001) and paired t-Student test revealed non-significant differences between means (p > .05). Estimated utility scores showed a minimum error of ≤10% in 45% of patients; however, error increased in patients with an observed utility score under 0.2. The model's predictive ability was confirmed in the validation cohort. LIMITATIONS AND CONCLUSIONS: A mapping algorithm was developed for mapping of AcroQoL to EQ-5D, using patient level data from three previously published studies, and including validation in the confirmatory sub-sample. Mean (SD) utilities index in this study population was estimated as 0.71 (0.28). Additional research may be needed to test this mapping algorithm in other acromegaly populations.

Conjoint analysis to understand preferences of patients with multiple sclerosis for disease-modifying therapy attributes in Spain: a cross-sectional observational study.

OBJECTIVE: To assess patients' preferences for a range of disease-modifying therapy (DMT) attributes in multiple sclerosis (MS). DESIGN: A cross-sectional observational study. SETTING: The data reported were from 17 MS units throughout Spain. PARTICIPANTS: Adult patients with relapsing-remitting MS. MAIN OUTCOME: A conjoint analysis was applied to assess preferences. A total of 221 patients completed a survey with 10 hypothetical DMT profiles developed using an orthogonal design and rating preferences from 1 (most acceptable) to 10 (least acceptable). Medication attributes included preventing relapse, preventing disease progression, side effect risk, route and frequency of administration. RESULTS: Patients placed the greatest relative importance on the side effect risk domain (32.9%), followed by route of administration (26.1%), frequency of administration (22.7%), prevention of disease progression (10.0%) and prevention of relapse (8.3%). These results were independent of the Expanded Disability Status Scale score. The importance assigned to side effect risk was highest for patients with a recent diagnosis. Patients who had previously received more than one DMT gave a higher importance to relapse rate reduction than patients receiving their first DMT. CONCLUSIONS: Patient DMT preferences were mainly driven by risk minimisation, route of administration and treatment schedule. The risk-benefit spectrum of available DMT for MS is becoming increasingly complicated. Understanding which treatment characteristics are meaningful to patients may help to tailor information for them and facilitate shared decision-making in clinical practice.

[The OASIS study: therapeutic management of acromegaly in standard clinical practice. Assessment of the efficacy of various treatment strategies]. / Estudio OASIS: manejo terapéutico de la acromegalia en un escenario de práctica clínica habitual. Evaluación de la eficacia de las diversas estrategias de tratamiento aplicadas.

BACKGROUND AND OBJECTIVES: The reported efficacy of treatments for acromegaly varies depending on reference centers and national registries. The aim of this study was to describe clinical management of this disease and to assess the efficacy of treatments used in standard clinical practice. MATERIAL AND METHODS: An epidemiological, observational, longitudinal, multicenter study was performed in adult patients with newly diagnosed acromegaly (n = 74) seen by 38 Spanish endocrinologists who collected during routine clinic visits data on disease treatment and control during 2 years of follow-up. RESULTS: Pituitary surgery and treatment with somatostatin analogs were the first choice therapies in 76% and 24% of patients respectively, with no differences related to tumor size. Surgery achieved disease control in 27% of operated patients. After surgery failure, the preferred therapeutic option were somatostatin analogs, which normalized insulin-like growth factor-1(IGF-I) in 52% of patients and achieved disease control criteria in more than 40% of patients. At the end of follow-up, normal IGF-I levels were found in 63% and 53% of patients with microadenomas and macroadenomas respectively. Only 19% of patients with macroadenoma met disease control criteria without requiring drug treatment, which was required by 85% of them at some time during follow-up. CONCLUSIONS: Surgery is the preferred initial treatment for patients with acromegaly, regardless of tumor size. Treatment efficacy in actual clinical practice is far from the success rates reported by reference centers.

Using HAQ-DI to estimate HUI-3 and EQ-5D utility values for patients with rheumatoid arthritis in Spain.

BACKGROUND/OBJECTIVE: Utility values are not usually assessed in clinical trials and do not allow cost-utility analysis to be performed with the data collected. The aim of this study was to derive relation functions so that Health Assessment Questionnaire - Disability Index (HAQ-DI) scores could be used to estimate Health Utilities Index - 3 (HUI-3) and EQ-5D utility values for patients with rheumatoid arthritis (RA). METHODS: An observational, cross-sectional, naturalistic, multicentre study was conducted. A total of 244 patients aged 18 years or older, with RA according to American College of Rheumatology diagnostic criteria, were recruited. Sociodemographic and clinical variables were recorded and patients completed three generic HRQoL questionnaires: the HAQ-DI, the HUI-3, and the EQ-5D. Two linear regression models were used to predict HUI-3 and EQ-5D utility values as functions of HAQ-DI scores, age, and gender. RESULTS: Patient mean age was 57.8 years old (standard deviation [SD], 13.3 years); 75.8% of the patients were women and 95.9% were white. Mean disease duration was 10.8 years (SD, 9 years). Patient distribution according to HAQ-DI severity was as follows: HAQ-DI < 0.5, 29%; 0.5 ≤ HAQ-DI < 1.1, 28%; 1.1 ≤ HAQ-DI < 1.6, 16%,1.6 ≤ HAQ-DI < 2.1, 15%; and HAQ-DI ≥ 2.1, 12%. HAQ-DI and EQ-5D mean scores were 1.02 (SD, 0.78) and 63.1 (SD, 20.3), respectively. Mean utility values for HUI-3 and time trade-off (TTO) were 0.75 (SD, 0.21) and 0.65 (SD, 0.3), respectively. The equations converting HAQ-DI scores to utilities were HUI-3 = 0.9527 - (0.2018 × HAQ-DI) +ε (R(2)=0.56), and TTO = 0.9567 - (0.309 × HAQ-DI) + ε (R(2)=0.54). Error distribution was non-normal. Age and gender were found to have no bearing on the utility functions. CONCLUSIONS: HAQ-DI scores can be used to estimate HUI-3 and EQ-5D utility values for patients with RA in data obtained from studies where utility values have not been collected.

Influencia del sexo en la mortalidad y el manejo del síndrome coronario agudo en España / Influence of sex on acute coronary syndrome mortality and treatment in Spain

La cardiopatía isquémica es un problema relevante de salud en la mujer. Supone en España la causa de muerte del 10% de las mujeres. El objetivo de este estudio es analizar las posibles diferencias por sexo en las características clínicas, el perfil de riesgo cardiovascular, las medidas diagnósticas, el tratamiento y el pronóstico de los pacientes ingresados con síndromes coronarios agudos (SCA) en España de 1994 a 2002. Para ello se han analizado los resultados de los registros de la Sección de Cardiopatía Isquémica y Unidades Coronarias de la Sociedad Española de Cardiología realizados en ese período (RISCI, PRIAMHO I y II, DESCARTES y TRIANA). Se efectuó una recodificación de las variables y la fusión en una única base de datos, de lo que resultó una muestra de 48.369 pacientes (el 75,7% varones y el 24,3% mujeres). En 13.405 pacientes se trataba de un SCASEST (el 26,6% de mujeres) y en 34.334 casos, de un SCACEST (el 23,2% de mujeres). Las mujeres tenían, respecto a los varones, una edad superior, un perfil de riesgo cardiovascular más desfavorable y antecedentes más frecuentes de insuficiencia cardiaca, recibieron con menor frecuencia bloqueadores beta y estatinas, se sometieron a intervencionismo coronario en menor proporción y presentaron mortalidad e incidencia de eventos adversos graves durante el ingreso un 50% superiores a las de los varones y mayor mortalidad en el seguimiento. Los resultados en el SCACEST presentaron las mismas diferencias en relación con el sexo; el porcentaje de mujeres sometidas a reperfusión fue inferior al de varones y el tiempo hasta la reperfusión, significativamente mayor en las mujeres. La mortalidad y las complicaciones hospitalarias y la mortalidad al mes en las mujeres duplicaron las de los varones. Sin embargo, el sexo femenino fue un predictor independiente de mortalidad hospitalaria a 1 mes y a 1 año en el SCACEST, pero no en el SCASEST. En conclusión, el estudio detecta diferencias en el perfil clínico y en el manejo relacionadas con el sexo de los pacientes ingresados por SCA en el período estudiado, aunque sólo el sexo se mostró como predictor independiente de mortalidad en el SCACEST (AU)

Coronary heart disease is a major health problem in women. In Spain, it is the cause of death in 10%. The aim of this study was to investigate possible sex differences in the clinical characteristics, cardiovascular risk profile, diagnostic assessment, treatment and prognosis of patients admitted with acute coronary syndrome (ACS) in Spain between 1994-2002. Data from trials conducted by the Working Group on Ischemic Heart Disease and Coronary Care Units of the Spanish Society of Cardiology Section during this period (i.e., RISCI, PRIAMHO I and II, DESCARTES and TRIANA) were analyzed. Data were reclassified and combined into a single database that included 48,369 patients (75.7% male and 24.3% female). Of these, 13,405 (26.6% female) had non-STelevation acute coronary syndrome (NSTEACS), while 34,334 (23.2% female) had ST-elevation acute coronary syndrome (STEACS). Compared with men, women were older, had a worse cardiovascular risk profile, more often had a history of heart failure, received beta-blockers and statins less often, were less likely to undergo percutaneous revascularization, presented on admission with a 50% higher mortality rate and incidence of serious adverse events, and had higher mortality during followup. The sex differences in those with STEACS were similar: fewer women underwent coronary reperfusion and the time to reperfusion was significantly longer. In addition, the initial mortality, in-hospital complication and 1-month mortality rates in women were double those in men. However, female gender was an independent predictor of in-hospital, 1-month and 1-year mortality only for STEACS, and not for NSTEACS. In conclusion, sex differences were found in the clinical profile and management of patients admitted for ACS. However, sex was an independent predictor of mortality only in those with STEACS (AU)