Estimating proportion of days covered (PDC) using real-world online medicine suppliers’ datasets

Abstract Background The proportion of days covered (PDC) is used to estimate medication adherence by looking at the proportion of days in which a person has access to the medication, over a given period of interest. This study aimed to adapt the PDC algorithm to allow for plausible assumptions about prescription refill behaviour when applied to data from online pharmacy suppliers. Methods Three PDC algorithms, the conventional approach (PDC1) and two alternative approaches (PDC2 and PDC3), were used to estimate adherence in a real-world dataset from an online pharmacy. Each algorithm has different denominators and increasing levels of complexity. PDC1, the conventional approach, is the total number of days between first dispensation and a defined end date. PDC2 counts the days until the end of supply date. PDC3 removes from the denominator specifically defined large gaps between refills, which could indicate legitimate reasons for treatment discontinuation. The distribution of the three PDCs across four different follow-up lengths was compared. Results The dataset included people taking ACE inhibitors (n = 65,905), statins (n = 100,362), and/or thyroid hormones (n = 30,637). The proportion of people taking ACE inhibitors with PDC ≥ 0.8 was 50–74% for PDC1, 81–91% for PDC2, and 86–100% for PDC3 with values depending on drug and length of follow-up. Similar ranges were identified in people taking statins and thyroid hormones. Conclusion These algorithms enable researchers and healthcare providers to assess pharmacy services and individual levels of adherence in real-world databases, particularly in settings where people may switch between different suppliers of medicines, meaning an individual supplier’s data may show temporary but legitimate gaps in access to medication. Accurately identifying problems with adherence provides the foundation for opportunities to improve experience, adherence and outcomes and to reduce medicines wastage. Research with people taking medications and prescribers is required to validate the algorithms’ assumptions.

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853. Real-World Persistency of Patients Receiving Tenofovir-Based Pre-Exposure Prophylaxis for the Prevention of HIV Infection in the US

Open Forum Infectious Diseases ◽

10.1093/ofid/ofab466.1048 ◽

2021 ◽

Vol 8 (Supplement_1) ◽

pp. S516-S517

Author(s):

Alan Oglesby ◽

Guillaume Germain ◽

Francois Laliberte ◽

Staci Bush ◽

Heidi Swygard ◽

...

Keyword(s):

Hiv Infection ◽

Real World ◽

Patient Characteristics ◽

Baseline Period ◽

Hiv Diagnosis ◽

Analysis Group ◽

Populations At Risk ◽

Proportion Of Days Covered ◽

Exposure Prophylaxis

Abstract Background Once-daily oral tenofovir-based combinations as pre-exposure prophylaxis (PrEP) have shown to be an effective biomedical HIV prevention strategy for populations at-risk of acquiring HIV-1. However, low adherence can lead to poor effectiveness. This study described the characteristics of commercially-insured US PrEP users. Methods This retrospective study used IQVIA™ PharMetrics Plus data (1/1/2015–3/31/2020) to identify adults newly initiated (index date) on emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or emtricitabine/tenofovir alafenamide (FTC/TAF) as daily PrEP. Users had ≥6 months of continuous enrollment pre-index (baseline); those diagnosed with HIV or with antiretroviral therapy (ART) use during baseline were excluded. User characteristics were described during the baseline period. For FTC/TDF users, proportion of days covered (PDC), persistence, treatment breaks, and switching were described during the follow-up period, which spanned from index to the earliest of disenrollment or end of data. Non-persistence was defined as a >90-day gap from last day of supply, with re-initiation after this gap indicating treatment break. For PDC and persistence, follow-up was censored at HIV infection, defined by both multi-class ART initiation and HIV diagnosis. Results In total 24,232 FTC/TDF and 1,187 FTC/TAF users were identified. Overall, mean age was 35.1 years and 94.5% were male (Table 1). Mean [median] length of follow-up was longer for FTC/TDF (504 [390] days) than FTC/TDF users (77 [70] days). On average, FTC/TDF users had 9.0 dispensings with 38.3 days of supply per dispensing over follow-up; 11.1% had ≥1 treatment break (mean length, 249 days). Among those initiated on FTC/TDF, 10.8% switched to FTC/TAF. The mean PDC for FTC/TDF users at 6 and 12 months was 0.74 and 0.67, respectively, corresponding to 63.7% and 57.9% of patients with PDC ≥0.70 (Figure 1). Persistence to FTC/TDF at 6 and 12 months was 70.2% and 57.4%, respectively (Figure 2). Table 1. Baseline Demographics and Clinical Characteristics of PrEP Users by Regimen Figure 1. Proportion of Days Covered of FTC/TDF Users Figure 2. Kaplan-Meier Persistence Rates of FTC/TDF Users Conclusion Patient characteristics of PrEP users are broadly similar between regimens, though switching from FTC/TDF to FTC/TAF is common. FTC/TDF users had lower real-world PDC and persistence than in recent clinical trials (DISCOVER and HPTN 083). Disclosures Alan Oglesby, MPH, GlaxoSmithKline (GSK) (Employee, Shareholder) Guillaume Germain, MSc, ViiV Healthcare (Other Financial or Material Support, I am an employee of Groupe d’analyse, Ltée, a consulting company that provided paid consulting services to ViiV Healthcare for the conduct of the present study.) Francois Laliberte, MA, Viiv (Research Grant or Support) Staci Bush, NP, GlaxoSmithKline (GSK) (Employee, Shareholder) Heidi Swygard, MD, ViiV Healthcare (Employee) Sean MacKnight, MScPH, Analysis Group (Employee) Annalise Hilts, BA, Analysis Group, Inc. (Employee) Mei Sheng Duh, MPH, ScD, ViiV Healthcare (Grant/Research Support)

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Early use of erenumab in US real-world practice

Cephalalgia Reports ◽

10.1177/25158163211020419 ◽

2021 ◽

Vol 4 ◽

pp. 251581632110204

Author(s):

Alina Bogdanov ◽

Victoria Chia ◽

Mark Bensink ◽

Robert Urman ◽

Lauren Fischer ◽

...

Keyword(s):

Real World ◽

The United States ◽

Baseline Period ◽

Calcitonin Gene ◽

Proportion Of Days Covered ◽

Early Use ◽

High Adherence ◽

The Mean ◽

Anxiety Depression

Background: Erenumab, a monoclonal antibody (mAb) developed to block the calcitonin gene-related peptide (CGRP) receptor, is approved for the prevention of migraine in adults. This retrospective observational study sought to describe early real-world use of erenumab. Methods: This study used the Practice Fusion ambulatory Electronic Health Record database, which represents approximately 6% of ambulatory care among primary care and specialist practices in the United States. Among migraine patients initiating erenumab, demographics, migraine type, comorbidities, and prior treatments were assessed during the 12-month baseline period. Treatment patterns including changes in acute and preventive medications, switches to other CGRP mAbs (fremanezumab and galcanezumab), and for erenumab, changes in dose and adherence were examined among patients with 6 months of follow-up. Results: Of 3,336 patients identified (85.9% female; mean age = 49.1 years), approximately 40% had documentation of chronic migraine. Common comorbidities included non-migraine headache, anxiety, depression, and hypertension. Most patients (76.3%) initiated on the 70 mg dose of erenumab. Among 1,638 patients included in the treatment pattern analysis, 53.1% used acute medications and 55.7% used other non-specific preventive migraine medications during follow-up, reductions of 9.8% and 10.2%, respectively, over the same period of time before index. Switching to fremanezumab and galcanezumab were observed in 12.2% and 13.8% of patients, respectively. The mean proportion of days covered by erenumab at 6 months was 79%. Dosage of erenumab increased (from 70 mg to 140 mg) in 13.0% and decreased (from 140 mg to 70 mg) in 24.9% of patients. Conclusion: This early real-world study showed high adherence among erenumab users. This combined with observed reductions in previously used acute and preventive medications are suggestive of erenumab’s benefit.

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928-P: Dulaglutide Has Higher Adherence and Persistence than Semaglutide and Exenatide QW: 6-Month Follow-Up from U.S. Real-World Data

Diabetes ◽

10.2337/db20-928-p ◽

2020 ◽

Vol 69 (Supplement 1) ◽

pp. 928-P

Author(s):

REEMA MODY ◽

MARIA YU ◽

BAL K. NEPAL ◽

MANIGE KONIG ◽

MICHAEL GRABNER

Keyword(s):

Real World ◽

Real World Data ◽

World Data ◽

Exenatide Qw

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Prior real-world experience influences non-linguistic statistical learning

10.31234/osf.io/yscn8 ◽

2020 ◽

Author(s):

Stephen Charles Van Hedger ◽

Ingrid Johnsrude ◽

Laura Batterink

Keyword(s):

Statistical Learning ◽

Real World ◽

Language Experience ◽

Pitch Range ◽

Test Items ◽

Instrument Measuring ◽

Statistical Regularities ◽

Context Free ◽

Specific Learning

Listeners are adept at extracting regularities from the environment, a process known as statistical learning (SL). SL has been generally assumed to be a form of “context-free” learning that occurs independently of prior knowledge, and SL experiments typically involve exposing participants to presumed novel regularities, such as repeating nonsense words. However, recent work has called this assumption into question, demonstrating that learners’ previous language experience can considerably influence SL performance. In the present experiment, we tested whether previous knowledge also shapes SL in a non-linguistic domain, using a paradigm that involves extracting regularities over tone sequences. Participants learned novel tone sequences, which consisted of pitch intervals not typically found in Western music. For one group of participants, the tone sequences used artificial, computerized instrument sounds. For the other group, the same tone sequences used familiar instrument sounds (piano or violin). Knowledge of the statistical regularities was assessed using both trained sounds (measuring specific learning) and sounds that differed in pitch range and/or instrument (measuring transfer learning). In a follow-up experiment, two additional testing sessions were administered to gauge retention of learning (one day and approximately one-week post-training). Compared to artificial instruments, training on sequences played by familiar instruments resulted in reduced correlations among test items, reflecting more idiosyncratic performance. Across all three testing sessions, learning of novel regularities presented with familiar instruments was worse compared to unfamiliar instruments, suggesting that prior exposure to music produced by familiar instruments interfered with new sequence learning. Overall, these results demonstrate that real-world experience influences SL in a non-linguistic domain, supporting the view that SL involves the continuous updating of existing representations, rather than the establishment of entirely novel ones.

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Effectiveness of Dulaglutide in the Real World and in Special Populations of Type 2 Diabetic Patients

The Journal of Clinical Endocrinology & Metabolism ◽

10.1210/clinem/dgaa204 ◽

2020 ◽

Vol 105 (7) ◽

pp. e2617-e2625 ◽

Cited By ~ 1

Author(s):

Mario Luca Morieri ◽

Vera Frison ◽

Mauro Rigato ◽

Michele D’Ambrosio ◽

Federica Tadiotto ◽

...

Keyword(s):

Body Weight ◽

Real World ◽

Disease Duration ◽

Diabetic Patients ◽

Type 2 Diabetic Patients ◽

Body Weight Reduction ◽

Background Population ◽

Glucagon Like Peptide 1

Abstract Context In randomized controlled trials (RCTs) on type 2 diabetes (T2D) patients, the glucagon-like peptide-1 (GLP-1) receptor agonist (GLP-RA) dulaglutide reduced HbA1c and body weight, but generalizability of such findings to real-world T2D patients is challenging. Objective We evaluated effectiveness of dulaglutide in routine clinical practice, especially in subgroups of patient that are underrepresented in RCTs. Design Retrospective multicenter study. Setting Diabetes outpatient clinics. Patients and intervention All consecutive patients who initiated dulaglutide between 2015 and 2018. Main outcome measures Changes in HbA1c and body weight were assessed up to 30 months after baseline. Effectiveness was analyzed in patient subgroups according to: prior use of GLP-1RA, persistence on treatment and dose, age, sex, disease duration, renal function, obesity, cardiovascular disease, or concomitant use of insulin or sulphonylurea. Results From a background population of 83,116 patients, 2084 initiated dulaglutide (15.3% switching from another GLP-1RA), 1307 of whom had at least 1 follow-up visit. Overall, dulaglutide reduced HbA1c by 1.0% and body weight by 2.9 kg at the end of observation. These effects were more pronounced in GLP-1RA-naïve patients and in those with shorter disease duration. Improvement in HbA1c was highly significant and consistent across all subgroups, including those aged ≥ 75 years, nonobese, or with chronic kidney disease. Body weight declined in all subgroups and significantly more with the 1.5-mg versus 0.75-mg dose. Conclusions In real-world T2D patients, effectiveness of dulaglutide on HbA1c and body weight reduction was highly consistent and significant even in subgroups of patients poorly represented in RCTs.

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Real-World Outcomes of Ivacaftor Treatment in People with Cystic Fibrosis: A Systematic Review

Journal of Clinical Medicine ◽

10.3390/jcm10071527 ◽

2021 ◽

Vol 10 (7) ◽

pp. 1527

Author(s):

Jamie Duckers ◽

Beth Lesher ◽

Teja Thorat ◽

Eleanor Lucas ◽

Lisa J. McGarry ◽

...

Keyword(s):

Systematic Review ◽

Cystic Fibrosis ◽

Real World ◽

Safety Profile ◽

Clinical Trial Data ◽

Patient Characteristics ◽

Healthcare Resource Utilization ◽

Patient Reported ◽

Clinical Benefits

Cystic fibrosis (CF) is a rare, progressive, multi-organ genetic disease. Ivacaftor, a small-molecule CF transmembrane conductance regulator modulator, was the first medication to treat the underlying cause of CF. Since its approval, real-world clinical experience on the use of ivacaftor has been documented in large registries and smaller studies. Here, we systematically review data from real-world observational studies of ivacaftor treatment in people with CF (pwCF). Searches of MEDLINE and Embase identified 368 publications reporting real-world studies that enrolled six or more pwCF treated with ivacaftor published between January 2012 and September 2019. Overall, 75 publications providing data from 57 unique studies met inclusion criteria and were reviewed. Studies reporting within-group change for pwCF treated with ivacaftor consistently showed improvements in lung function, nutritional parameters, and patient-reported respiratory and sino-nasal symptoms. Benefits were evident as early as 1 month following ivacaftor initiation and were sustained over long-term follow-up. Decreases in pulmonary exacerbations, Pseudomonas aeruginosa prevalence, and healthcare resource utilization also were reported for up to 66 months following ivacaftor initiation. In studies comparing ivacaftor treatment to modulator untreated comparator groups, clinical benefits similarly were reported as were decreases in mortality, organ-transplantation, and CF-related complications. The safety profile of ivacaftor observed in these real-world studies was consistent with the well-established safety profile based on clinical trial data. Our systematic review of real-world studies shows ivacaftor treatment in pwCF results in highly consistent and sustained clinical benefit in both pulmonary and non-pulmonary outcomes across various geographies, study designs, patient characteristics, and follow-up durations, confirming and expanding upon evidence from clinical trials.

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Identifying Patterns of Symptom Distress in Pregnant Women: A Pilot Study

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18126333 ◽

2021 ◽

Vol 18 (12) ◽

pp. 6333

Author(s):

Ching-Fang Lee ◽

Fur-Hsing Wen ◽

Yvonne Hsiung ◽

Jian-Pei Huang ◽

Chun-Wei Chang ◽

...

Keyword(s):

Pregnant Women ◽

Healthcare Providers ◽

First Trimester ◽

Symptom Distress ◽

Teaching Hospitals ◽

Lower Back ◽

Distress Symptoms ◽

Related Symptom ◽

Experienced Symptom

During pregnancy, a woman’s enlarged uterus and the developing fetus lead to symptom distress; in turn, physical and psychological aspects of symptom distress are often associated with adverse prenatal and birth outcomes. This study aimed to identify the trends in the trajectory of these symptoms. This longitudinal study recruited 95 pregnant women, with a mean age of 32 years, from the prenatal wards of two teaching hospitals in northern Taiwan. Symptom distress was measured by a 22-item scale related to pregnancy-induced symptoms. The follow-up measurements began during the first trimester and were taken every two to four weeks until childbirth. More than half of the pregnant women experienced symptom distress manifested in a pattern depicted to be “Decreased then Increased” (56.8%). Other noticeable patterns were “Continuously Increased” (28.4%), “Increased then Decreased” (10.5%) and “Continuously Decreased” (4.2%), respectively. It is worth noting that most pregnant women recorded a transit and increase in their symptom distress, revealed by their total scores, at the second trimester (mean 22.02 weeks) of pregnancy. The participants’ major pregnancy-related distress symptoms were physical and included fatigue, frequent urination, lower back pain, and difficulty sleeping. The mean scores for individual symptoms ranged from 2.32 to 3.61 and were below the “moderately distressful” level. This study provides evidence that could be used to predict women’s pregnancy-related symptom distress and help healthcare providers implement timely interventions to improve prenatal care.

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Real-World Experience with Bezlotoxumab for Prevention of Recurrence of Clostridioides difficile Infection

Journal of Clinical Medicine ◽

10.3390/jcm10010002 ◽

2020 ◽

Vol 10 (1) ◽

pp. 2

Author(s):

Rosa Escudero-Sánchez ◽

María Ruíz-Ruizgómez ◽

Jorge Fernández-Fradejas ◽

Sergio García Fernández ◽

María Olmedo Samperio ◽

...

Keyword(s):

Clinical Trials ◽

Real World ◽

Recurrence Rates ◽

Factors Associated ◽

Clostridioides Difficile ◽

Multicentre Cohort Study ◽

Clostridioides Difficile Infection ◽

Prevention Of Recurrence ◽

Multicentre Cohort

Bezlotoxumab is marketed for the prevention of recurrent Clostridioides difficile infection (rCDI). Its high cost could be determining its prescription to a different population than that represented in clinical trials. The objective of the study was to verify the effectiveness and safety of bezlotoxumab in preventing rCDI and to investigate factors related to bezlotoxumab failure in the real world. A retrospective, multicentre cohort study of patients treated with bezlotoxumab in Spain was conducted. We compared the characteristics of cohort patients with those of patients treated with bezlotoxumab in the pivotal MODIFY trials. We assessed recurrence rates 12 weeks after completion of treatment against C. difficile, and we analysed the factors associated with bezlotoxumab failure. Ninety-one patients were included in the study. The cohort presented with more risk factors for rCDI than the patients included in the MODIFY trials. Thirteen (14.2%) developed rCDI at 12 weeks of follow-up, and rCDI rates were numerically higher in patients with two or more previous episodes (25%) than in those who had fewer than two previous episodes of C. difficile infection (CDI) (10.4%); p = 0.09. There were no adverse effects attributable to bezlotoxumab. Despite being used in a more compromised population than that represented in clinical trials, we confirm the effectiveness of bezlotoxumab for the prevention of rCDI.

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Is the use of two versus one long-acting bronchodilator by patients with COPD associated with a higher risk of acute coronary syndrome in real-world clinical practice?

BMJ Open Respiratory Research ◽

10.1136/bmjresp-2020-000840 ◽

2021 ◽

Vol 8 (1) ◽

pp. e000840

Author(s):

Lianne Parkin ◽

Sheila Williams ◽

David Barson ◽

Katrina Sharples ◽

Simon Horsburgh ◽

...

Keyword(s):

Acute Coronary Syndrome ◽

Clinical Practice ◽

Real World ◽

Chronic Obstructive ◽

Treatment Intensification ◽

Cardiovascular Comorbidity ◽

Coronary Syndrome ◽

Long Acting ◽

The Impact

BackgroundCardiovascular comorbidity is common among patients with chronic obstructive pulmonary disease (COPD) and there is concern that long-acting bronchodilators (long-acting muscarinic antagonists (LAMAs) and long-acting beta2 agonists (LABAs)) may further increase the risk of acute coronary events. Information about the impact of treatment intensification on acute coronary syndrome (ACS) risk in real-world settings is limited. We undertook a nationwide nested case–control study to estimate the risk of ACS in users of both a LAMA and a LABA relative to users of a LAMA.MethodsWe used routinely collected national health and pharmaceutical dispensing data to establish a cohort of patients aged >45 years who initiated long-acting bronchodilator therapy for COPD between 1 February 2006 and 30 December 2013. Fatal and non-fatal ACS events during follow-up were identified using hospital discharge and mortality records. For each case we used risk set sampling to randomly select up to 10 controls, matched by date of birth, sex, date of cohort entry (first LAMA and/or LABA dispensing), and COPD severity.ResultsFrom the cohort (n=83 417), we identified 5399 ACS cases during 281 292 person-years of follow-up. Compared with current use of LAMA therapy, current use of LAMA and LABA dual therapy was associated with a higher risk of ACS (OR 1.28 (95% CI 1.13 to 1.44)). The OR in an analysis restricted to fatal cases was 1.46 (95% CI 1.12 to 1.91).ConclusionIn real-world clinical practice, use of two versus one long-acting bronchodilator by people with COPD is associated with a higher risk of ACS.

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Translating Virtual Reality Cue Exposure Therapy for Binge Eating into a Real-World Setting: An Uncontrolled Pilot Study

Journal of Clinical Medicine ◽

10.3390/jcm10071511 ◽

2021 ◽

Vol 10 (7) ◽

pp. 1511

Author(s):

Katherine Nameth ◽

Theresa Brown ◽

Kim Bullock ◽

Sarah Adler ◽

Giuseppe Riva ◽

...

Keyword(s):

Virtual Reality ◽

Eating Disorder ◽

Binge Eating ◽

Real World ◽

Exposure Therapy ◽

Post Treatment ◽

Cue Exposure ◽

Treatment Gains ◽

Intent To Treat

Binge-eating disorder (BED) and bulimia nervosa (BN) have adverse psychological and medical consequences. Innovative interventions, like the integration of virtual reality (VR) with cue-exposure therapy (VR-CET), enhance outcomes for refractory patients compared to cognitive behavior therapy (CBT). Little is known about the feasibility and acceptability of translating VR-CET into real-world settings. To investigate this question, adults previously treated for BED or BN with at least one objective or subjective binge episode/week were recruited from an outpatient university eating disorder clinic to receive up to eight weekly one-hour VR-CET sessions. Eleven of 16 (68.8%) eligible patients were enrolled; nine (82%) completed treatment; and 82% (9/11) provided follow-up data 7.1 (SD = 2.12) months post-treatment. Overall, participant and therapist acceptability of VR-CET was high. Intent-to-treat objective binge episodes (OBEs) decreased significantly from 3.3 to 0.9/week (p < 0.001). Post-treatment OBE 7-day abstinence rate for completers was 56%, with 22% abstinent for 28 days at follow-up. Among participants purging at baseline, episodes decreased from a mean of one to zero/week, with 100% abstinence maintained at follow-up. The adoption of VR-CET into real-world clinic settings appears feasible and acceptable, with a preliminary signal of effectiveness. Findings, including some loss of treatment gains during follow-up may inform future treatment development.

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