The purpose of this literature review was to compare the methodology used in the most recently published cost-effectiveness studies of antihypertensive treatments, and to identify methodological strengths and weaknesses that indicate the study's potential as a useful, decision-making tool. Based on the results of a search of several databases, spanning the years 1995 to 2000, 10 cost-effectiveness studies were identified. Although the majority of the studies reported their cost-effectiveness ratio in "costs per year of life gained," the studies also considered a varying range of components including additional end points. The methodology used to measure effectiveness, the cost variables included, and the characteristics of the patient population varied significantly across studies. Due to this lack of conformity, it would be difficult, if not impossible, to compare the results and draw conclusions about the relative cost-effectiveness of different types of antihypertensive drug therapies. This lack of uniform comparison across studies is likely to draw criticism from both the clinical and health-care decision-making communities. Future studies within this field should be thorough and useful for decision making. It is suggested that short-term outcomes should include systolic and diastolic blood pressure measurements and long-term outcomes should include end points such as myocardial infarction, stroke, congestive heart failure and renal events. Other positive outcomes such as a more favorable side-effect profile, should be used to enhance the primary outcomes. Additionally, when subpopulations are considered in submodels, studies should address the issue of generalizability. Cost calculations should be transparent and related to the perspective of the study. Modeling the cost-effectiveness of a drug may be an acceptable method provided that data sources and assumptions are valid and transparent.
This study set out to evaluate influenza- and respiratory-related illnesses recorded during primary care physician consultations in England following the H1N1 pandemic in 2009 and to enable the development of a dynamic disease model. Data were obtained from the Clinical Practice Research Datalink of primary care records over four influenza seasons (2010–2014). The primary outcome of the study was incidence of influenza- and respiratory-related diagnoses, calculated per practice and by season and age group. Upper respiratory tract infection diagnoses were most frequently recorded (mean seasonal practice level incidence; 3,762 consultations per 100,000 [SD = 1,989]), and influenza-related diagnoses were least frequently recorded across all seasons, except one. Incidence rates for the under 18 population were higher than those for the general population, in particular for upper respiratory tract infection (range of 8,024–9,950 versus 3,228–4,120, respectively) and otitis media diagnoses (2,668–3,652 versus 782–1,057, respectively). For influenza-related diagnoses, the 65+ age group, the 0 to <2 and 2 to <4 groups had a higher risk (risk ratio = 1.33, 1.12 and 1.16, respectively) than other age groups. This study provides valuable insight into the incidence of influenza- and respiratory-related diagnoses in the primary care setting in England, and suggests a higher burden of disease in young children and the elderly. The study also indicates that some influenza illness is likely to be reported under respiratory-related diagnoses, given the low incidence of influenza-related diagnoses in the study.
• Objectives: To determine persistence with therapy in patients newly starting oral hypoglycemic treatment for management of type 2 diabetes, and to determine differences in persistence according to sex, age, and initial agent. • Design: Retrospective medication claims analysis. • Setting and participants: 46,884 patients from a large U.S. pharmacy benefits manager (PBM) database who were older than 18 years of age and who newly started monotherapy with an oral agent for type 2 diabetes. • Methods: All patients were followed for 10 months for refill persistence patterns with their initial drug. Agents included in the analysis were glimepiride, immediaterelease glipizide, glipizide GITS (gastrointestinal therapeutic system), glyburide, metformin, pioglitazone, repaglinide, and rosiglitazone. • Results: The overall average length of therapy was 167 days out of 300 days of follow-up. Women were significantly less persistent than men (161 days versus 173 days, respectively). Persistence significantly increased with patient age, from a low of 126 days (18‐34 years) to 179 days (50‐64 years), but then fell to 161 days (≥ 65 years). Significant differences were also identified for the oral agents, with persistence ranging from 126 days with repaglinide to 177 days with glipizide GITS. • Conclusions: Overall persistence with the initial oral hypoglycemic drug treatment appears to be low in type 2 diabetes and differs within sex, age, and individual drug categories. Careful selection of the initial oral agent to minimize adverse events and reduce dosing frequency may improve persistence, enhance glycemic control, and reduce the economic burden of type 2 diabetes.
Early treatment intensification in patients with type 2 diabetes (T2D) is often required to achieve glycaemic control. Patients with T2D from the UK Clinical Practice Research Datalink, aged ≥18 years, initiating dapagliflozin between Nov 2012 and Aug 2016 and with prior oral T2D therapy (N=3,774) were included in this study. The relationship between early (2nd line) vs. later (≥3rd line) use of dapagliflozin and changes from baseline in HbA1c (≥1.0% absolute reduction), weight (kg) (≥5.0% relative loss) and systolic BP (≥2 mmHg absolute reduction) after 6-12 months were assessed with logistic regression models. Early use of dapagliflozin occurred in 25.2% patients (951/3774) vs. later use in 74.8% (2823/3774). Patients with later use were older [mean: 60.1 (SD 10.3) vs. 55.7 (SD 10.5) years], more likely to be male (61.6% vs. 55.3%), had T2D for longer [median 8.1 vs. 4.0 years] and higher CVD prevalence (13.9% vs. 11.2%). Patients with early and later use of dapagliflozin had similar baseline mean HbA1c levels [9.3% (SD 1.5) vs. 9.2% (SD 1.7)] and BP [134.2 (SD 14.2) vs. 135.0 (SD 14.6) mmHg]. Late users had lower BMI [mean 33.6 (SD 6.3) vs. 36.5 (SD 6.8) kg/m2] than early users. Early dapagliflozin users experienced mean (S.E) reductions of 1.6 (0.07)%, 3.8 (0.25)% and 3.0 (0.82) mmHg in HbA1c, weight and BP, respectively, vs. 1.0 (0.04)%, 4.6 (0.21)% and 3.1 (0.43) mmHg in later users. Compared to later dapagliflozin use, early initiation was associated with a greater likelihood of adjusted HbA1c reduction ≥1% (OR: 1.68, 95% CI: 1.15-2.45). Weight and BP reductions were observed with similar likelihood among early and late users (weight OR: 0.79, 95% CI: 0.54-1.14; BP OR: 0.87, 95% CI: 0.58-1.30). In conclusion, glycaemic benefits of dapagliflozin were greater in patients receiving it earlier in their treatment pathway. Weight and BP reductions were achieved with similar likelihood among early and later users. Disclosure J.P. Wilding: Other Relationship; Self; Astellas, AstraZeneca, Boehringer Ingelheim GmbH, Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi, Eli Lilly and Company, Orexigen Therapeutics, Inc., Merck & Co., Inc. U. Rigney: Employee; Self; AstraZeneca. B.T. Blak: Employee; Self; AstraZeneca. Stock/Shareholder; Self; AstraZeneca. S.T. Nolan: Employee; Self; AstraZeneca. P. Fenici: Employee; Self; AstraZeneca. J. Medina: Employee; Self; AstraZeneca.
To describe the use of 3 prostaglandin/timolol fixed combinations (FCs) in UK primary care, to summarize characteristics of recipients, and to assess 12-month persistence.This retrospective cohort study included first-time recipients of latanoprost/timolol FC, bimatoprost/timolol FC, or travoprost/timolol FC treated between April 1, 2007, and November 30, 2008, identified in The Health Improvement Network database, a large database of anonymized longitudinal electronic medical records of patients treated in UK primary care. Eligible patients were = 18 years old at the index date (date of first prescription). Persistence, defined as a gap =60 days between consecutive prescriptions, was assessed through 12 months post-index for each cohort (Cox proportional hazards models).A total of 2,015 patients were included: latanoprost/timolol FC, n = 898 (44.6%); bimatoprost/timolol FC, n = 733 (36.4%); travoprost/timolol FC, n = 384 (19.1%). The mean age was approximately 72 years across cohorts (p = 0.792). Glaucoma was the diagnosis for >90% of patients in each cohort. Twelve-month persistence was similar across treatments: latanoprost/timolol FC: 38.2%; bimatoprost/timolol FC: 38.6%; travoprost/timolol FC: 38.3% (p = 0.985). Mean time to therapy change for nonpersistent patients was also similar: 143.3 ± 89.8, 151.0 ± 87.9, and 151.8 ± 87.7 days, respectively (p = 0.095). Among persistent patients, additional therapy was prescribed for 36.2%, 41.7%, and 41.5% of patients, respectively. Among nonpersistent patients, 64.0%, 70.4%, and 69.2%, respectively, restarted the index therapy.The largest proportion of first-time recipients of prostaglandin/beta-blocker FC products treated in UK primary care was prescribed latanoprost/timolol FC. Twelve-month persistence was similar (<40%) across the 3 FCs evaluated.
Introduction: Clinical trials of acalabrutinib, a second-generation Bruton's tyrosine kinase inhibitor, show high response rates and an acceptable safety profile in patients with CLL. However, there is a lack of real-world data on the use of acalabrutinib in the first-line treatment of CLL. This interim analysis (IA) presents baseline demographics, clinical characteristics, and treatment patterns of patients with CLL up to 24 months post-initiation of first-line acalabrutinib via the UK Early Access Programme (EAP). Methods: EPIC is a retrospective multi-centre cohort study involving data collection from medical records (ClinicalTrials.gov: NCT05557695). Eligible patients were treatment-naïve CLL patients who initiated acalabrutinib between 1st April 2020 and 1st April 2021 as part of the EAP and were recruited from 5 sites in England for this IA. Data collected included baseline clinical and demographic characteristics, and acalabrutinib treatment patterns. This study has planned follow-up of up to 60 months from the date of acalabrutinib start (index date). Data cut for this IA was 23rd January 2023. Results: This IA includes 54 patients. Median age at index was 74.5 years (Interquartile range (IQR), 69.0–78.6); 59% (32/54) of patients were male, 84% (43/51) were White British. At index, 53% (20/38) of patients had creatinine clearance <60 mL/min. 7% (4/54) of patients had a confirmed ATM mutation, 6% (3/54) had a confirmed TP53 mutation, 2% (1/54) of patients had a confirmed IGHV mutation (≥2% difference from germline), and none had a chromosome 17p13.1 deletion. Median time between CLL diagnosis and index was 3.1 years (IQR, 1.4–7.3). The median duration of follow up was 27.4 months (IQR, 24.6–29.9); 87% (47/54) and 76% (41/54) of patients had durations of observation ≥1 year and ≥2 years, respectively. 43 patients remained on treatment at 12 months, 10 had discontinued (1 patient not recorded). The continuation rate at 12 months was 81.1% (95% CI, 71.3%–92.4%; n = 53). Of 54 patients with relevant medical records at the time of data cut, 28% (15/54) had discontinued acalabrutinib. Of the 14 recorded reasons given for treatment discontinuation, 64% (9/14) were due to adverse events, 7% (1/14) were patient decision and 29% (4/14) other; no discontinuations were recorded due to progressive disease. The median real-world overall time on treatment (n = 53; up to 12 months) was 12.0 months (IQR, 11.6–12.0). Of 27 patients with relevant medical records, 70% (19/27) had a recorded diagnosis of COVID-19; of these, 89% (17/19) had diagnoses confirmed via a test. The most common treatment received for COVID-19 (for 32% of patients; 6/19) was sotrovimab. Conclusions: This first IA shows an 81.1% (95% CI, 71.3%–92.4%; n = 53) acalabrutinib real-world continuation rate at 12 months in treatment-naïve patients with CLL. Future analyses are aiming at including retrospective data from around 40 clinical sites with approximately 350 eligible patients. Encore Abstract—previously submitted to EHA 2023 The research was funded by: AstraZeneca Keyword: Chronic Lymphocytic Leukemia (CLL) Conflicts of interests pertinent to the abstract T. A. Eyre Employment or leadership position: Consultant Haematologist—Oxford University Hospitals NHS Trust Consultant or advisory role AstraZeneca, Beigene, Roche, Abbvie, Gilead, Incyte, Loxo Lilly, Secura Bio Honoraria: AstraZeneca, Roche, Abbvie, Gilead, Research funding: AstraZeneca, Beigene Other remuneration: Loxo Oncology N. Martinez-Calle Employment or leadership position: Consultant Haematologist Consultant or advisory role Abbvie, Takeda Honoraria: Janssen, Abbvie, AstraZeneca, Takeda Educational grants: AstraZeneca, Abbvie R. Walewska Employment or leadership position: Consultant Haematologist Honoraria: AstraZeneca, Janssen, Abbvie, Secura Bio J. Hickey Employment or leadership position: Open Health B. T. Blak Employment or leadership position: AstraZeneca Stock ownership: AstraZeneca A. Pickin Employment or leadership position: AstraZeneca S. Hunjan Employment or leadership position: AstraZeneca O. Condon Employment or leadership position: AstraZeneca S. Hori Employment or leadership position: AstraZeneca
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