Modelling the effect of beliefs about asthma medication and treatment intrusiveness on adherence and preference for once-daily vs. twice-daily medication.
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SUBMITTER: Chapman S
PROVIDER: S-EPMC5686129 | biostudies-literature | 2017 Nov
REPOSITORIES: biostudies-literature
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Modelling the effect of beliefs about asthma medication and treatment intrusiveness on adherence and preference for once-daily vs. twice-daily medication.
Chapman Sarah S Dale Peter P Svedsater Henrik H Stynes Gillian G Vyas Nicola N Price David D Horne Rob R
NPJ primary care respiratory medicine 20171114 1
People with asthma who do not adhere to their maintenance medication may experience poorer asthma control and need more healthcare support than those who adhere. People (N = 1010) aged 18-55 years with self-reported asthma, taking one or more asthma maintenance medication(s), from five European countries, participated in a survey using validated scales (Medication Adherence Report Scale [MARS], Asthma Control Test™ [ACT], Beliefs about Medicine Questionnaire [BMQ] and the Asthma Treatment Intrus ...[more]
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Project description:AimTwice daily dosing is often perceived as inferior to once daily dosing due to a higher likelihood of missing a dose. However, more important is the extent to which drug action is maintained when doses are delayed or missed. We compared the estimated inhibition of platelet aggregation (eIPA) for ticagrelor twice daily and clopidogrel once daily, based on their pharmacokinetic/ pharmacodynamic relationships and patient dosing history data.MethodsDrug dosing histories of 5014 patients prescribed cardiovascular medications (primarily antihypertensive medicines) were extracted from an electronically compiled dosing history database. eIPA levels were simulated for 677 twice daily and 677 once daily dosing histories over a 30 day period, based on published onset/offset models for ticagrelor and clopidogrel IPA characteristics.ResultsWhile many patients treated twice daily missed at least one dose in 30 days, only 25.7% missed two consecutive doses. By comparison, 46.8% of patients treated once daily missed at least one dose. Simulations based on patient adherence over time showed that the average mean eIPA for ticagrelor twice daily remained significantly higher than for clopidogrel once daily (81.1% vs. 55.0%, P < 0.001). Ticagrelor twice daily patients had an eIPA below 10% for 0.20% of the 30 day period compared with 2.05% for clopidogrel once daily (P = 0.0001).ConclusionsThe projected level of platelet inhibition remained higher for ticagrelor twice daily than clopidogrel once daily, mainly due to the higher eIPA level achieved with ticagrelor and the relatively low likelihood of missing two consecutive twice daily doses. This modelling and simulation study suggests a therapeutic benefit of ticagrelor over clopidogrel when taking into account the most common dosing omissions.
| S-EPMC4004395 | biostudies-literature
Project description:BackgroundAntiretroviral therapy (ART) adherence is critical for successful HIV treatment outcomes. Once-daily dosing could improve adherence. Plasma concentrations of once-daily vs twice-daily abacavir + lamivudine are bioequivalent in children, but no randomized trial has compared virological outcomes.MethodsChildren taking abacavir + lamivudine-containing first-line regimens twice daily for more than 36 weeks in the ARROW trial (NCT02028676, ISRCTN24791884) were randomized to continue twice-daily vs move to once-daily abacavir + lamivudine (open-label). Co-primary outcomes were viral load suppression at week 48 (12% noninferiority margin, measured retrospectively) and lamivudine or abacavir-related grade 3/4 adverse events.ResultsSix hundred and sixty-nine children (median 5 years, range 1-16) were randomized to twice daily (n = 333) vs once daily (n = 336) after median 1.8 years on twice-daily abacavir + lamivudine-containing first-line ART. Children were followed for median 114 weeks. At week 48, 242/331 (73%) twice daily vs 236/330 (72%) once daily had viral load less than 80 copies/ml [difference -1.6% (95% confidence interval -8.4,+5.2%) P = 0.65]; 79% twice daily vs 78% once daily had viral load less than 400 copies/ml (P = 0.76) (week 96 results similar). One grade 3/4 adverse event was judged uncertainly related to abacavir + lamivudine (hepatitis; once daily). At week 48, 9% twice daily vs 10% once daily reported missing one or more ART pills in the last 4 weeks (P = 0.74) and 8 vs 8% at week 96 (P = 0.90). Carers strongly preferred once-daily dosing. There was no difference between randomized groups in postbaseline drug-resistance mutations or drug-susceptibility; WHO 3/4 events; ART-modifying, grade 3/4 or serious adverse events; CD4% or weight-for-age/height-for-age (all P > 0.15).ConclusionOnce-daily abacavir + lamivudine was noninferior to twice daily in viral load suppression, with similar resistance, adherence, clinical, immunological and safety outcomes. Abacavir + lamivudine provides the first once-daily nucleoside backbone across childhood that can be used to simplify ART.
| S-EPMC6217915 | biostudies-literature
Project description:Inhaled corticosteroids are the recommended first-line treatment for asthma but adherence to therapy is suboptimal. The objectives of this study were to compare the efficacy and safety of once-daily (OD) evening and twice-daily (BD) regimens of the novel inhaled corticosteroid fluticasone furoate (FF) in asthma patients.Patients with moderate asthma (age ? 12 years; pre-bronchodilator forced expiratory volume in 1 second (FEV1) 40-85% predicted; FEV1 reversibility of ? 12% and ? 200 ml) were randomized to FF or fluticasone propionate (FP) regimens in a double-blind, crossover study. Patients were not permitted to have used any ICS for ? 8 weeks prior to enrolment and subsequently received doses of FF or FP 200 ?g OD, FF or FP 100 ?g BD and matching placebo by inhalation for 28 days each. Primary endpoint was Day 28 evening pre-dose (trough) FEV1; non-inferiority of FF 200 ?g OD and FF 100 ?g BD was assessed, as was superiority of all active treatment relative to placebo. Adverse events (AEs) and 24-hour urinary cortisol excretion were assessed.The intent-to-treat population comprised 147 (FF) and 43 (FP) patients. On Day 28, pre-dose FEV1 showed FF 200 ?g OD to be non-inferior (pre-defined limit -110 ml) to FF 100 ?g BD (mean treatment difference 11 ml; 95% CI: -35 to +56 ml); all FF and FP regimens were significantly superior to placebo (p ? 0.02). AEs were similar to placebo; no serious AEs were reported. Urinary cortisol excretion at Day 28 for FF was lower than placebo (ratios: 200 ?g OD, 0.75; 100 ?g BD, 0.84; p ? 0.02).FF 200 ?g OD in the evening is an efficacious and well tolerated treatment for asthma patients and is not inferior to the same total BD dose.Clinicaltrials.gov; NCT00766090.
| S-EPMC3282675 | biostudies-literature
Project description:To evaluate whether once daily (q.d.) lopinavir/ritonavir is noninferior to twice daily (b.i.d.) dosing in children.International, multicentre, phase II/III, randomized, open-label, noninferiority trial (KONCERT/PENTA18/ANRS150).Clinical centres participating in the PENTA, HIV-NAT and PHPT networks.Children/adolescents with HIV-1 RNA viral load less than 50 copies/ml for at least 24 weeks on lopinavir/ritonavir-containing antiretroviral therapy.Children were randomized to continue lopinavir/ritonavir b.i.d. or change to q.d.Confirmed viral load ?50 copies/ml by 48 weeks (12% noninferiority margin).One hundred seventy-three children were randomized in the KONCERT trial (86 q.d., 87 b.i.d.); 46% men, median (IQR) age 11 (9-14) years, CD4% 33 (27-38)%. By week 48, 97 and 98% of time was spent on q.d. and b.i.d., respectively (one q.d. child lost at week 4). Twelve q.d. vs. seven b.i.d. children had confirmed viral load ?50 copies/ml within 48 weeks; estimated difference in percentage with viral load rebound 6% [90% CI (-2, 14)]. Numbers of children with grade 3/4 adverse events (11 vs. 7) or major resistance mutations (3 vs. 2) were similar, q.d. vs. b.i.d. (both P > 0.3). Among 26 children in an intrasubject lopinavir/ritonavir pharmacokinetic substudy, lower daily exposure (AUC0-24 161 h.mg/l vs. 224 h.mg/l) and lower Clast (1.03 mg/l vs. 5.69 mg/l) were observed with q.d. vs. b.i.d. dosing.Noninferiority for viral load suppression on q.d. vs. b.i.d. lopinavir/ritonavir was not demonstrated. Although results, therefore, do not support routine use of q.d. lopinavir/ritonavir, lack of safety concerns or resistance suggest that q.d. dosing remains an option in selected, adherent children, with close viral load monitoring.
| S-EPMC4645961 | biostudies-literature
Project description:BackgroundEmpirical research and health policies on asthma have focused on children and young adults, even though asthma morbidity and mortality are higher among older asthmatics.ObjectiveTo explore the relationship of asthma-related beliefs and self-reported controller medication adherence in older asthmatics.DesignAn observational study of asthma beliefs and self-management among older adults.ParticipantsAsthmatics ages ? 60 years (N?=?324, mean age 67.4 ± 6.8, 28 % white, 32 % black, 30 % Hispanic) were recruited from primary care practices in New York City and Chicago.Main measuresSelf-reported controller medication adherence was assessed using the Medication Adherence Report Scale. Based on the Common Sense Model of Self-Regulation, patients were asked if they believe they only have asthma with symptoms, their physician can cure their asthma, and if their asthma will persist. Beliefs on the benefit, necessity and concerns of treatment use were also assessed. Multivariate logistic regression was used to examine the association of beliefs with self-reported medication adherence.Key resultsThe majority (57.0 %) of patients reported poor adherence. Poor self-reported adherence was more common among those with erroneous beliefs about asthma illness and treatments, including the "no symptoms, no asthma" belief (58.7 % vs. 31.7 %, respectively, p?<?0.001), "will not always have asthma" belief (34.8 % vs. 12.5 %, p?<?0.001), and the "MD can cure asthma" belief (21.7 % vs. 9.6 %, p?=?0.01). Adjusting for illness beliefs, treatment beliefs and demographics, patients with a "no symptoms, no asthma" belief had lower odds of having good self-reported adherence (odds ratio [OR] 0.45, 95 % confidence interval [CI] 0.23-0.86), as did those with negative beliefs about the benefits (OR 0.73, 95 % CI 0.57-0.94) and necessity (OR 0.89, 95 % CI 0.83-0.96) of treatment.ConclusionsIllness and treatment beliefs have a strong influence on self-reported medication adherence in older asthmatics. Interventions to improve medication adherence in older asthmatics by modifying illness and treatment beliefs warrant study.
| S-EPMC3539042 | biostudies-literature
Project description:Background:Prevalence of immunosuppressant nonadherence in renal transplant recipients is high despite negative clinical outcomes associated with nonadherence. Simplification of dosing has been demonstrated to improve adherence in renal transplant recipients as measured through electronic monitoring and self-report. Objective:The purpose of this study was to replicate and extend previous findings by measuring adherence with multiple methods in a Canadian sample. Design:The study design was a randomized controlled medication dosing trial in adult renal transplant patients. The trial length was 4 months. Setting:This study was conducted within the Solid Organ Transplant (SOT) Clinic at Vancouver General Hospital (VGH; Vancouver, Canada). Patients:A total of 46 adult renal recipients (at least 1 year post-transplant) were recruited through the SOT clinic. With 8 withdrawals, 38 individuals completed all phases of the study. Measurements:Medication adherence was measured for a period of 4 months using multiple methods, including electronic monitoring (MEMS [Medication Event Monitoring System]), pharmacy refill data (medication possession ratio [MPR]), and by self-report using the Adherence subscale of the Transplant Effects Questionnaire (TEQ). Methods:Participants were randomized to twice-daily (n = 19) or once-daily tacrolimus dosing (n = 19) and followed over a 4-month period via monthly clinic study visits. Comparisons between the treatment groups were performed using the Mann-Whitney U and chi-square tests, for continuous and categorical variables, respectively. Results:As outlined in Table 3, the once-daily dosing group showed significantly better MEMS Dose Adherence (P = .001), whereas MEMS Timing Adherence showed a tendency toward better adherence for this group, but was not significant (P = .052). MEMS Days Adherent (P = .418), MPR% (P = .123), and self-reported adherence (P = .284) did not differ between the once- and twice-daily dosing groups when measured as continuous variables. The MPR% was significantly better for the once-daily dosing group when measured dichotomously but not continuously (P = .044). Notably, most of those exposed to once-daily dosing (63.2%) preferred this to the twice-daily regimen. Limitations:Limitations included small sample size and short follow-up period, precluding the examination of clinical outcome differences. Conclusions:Results for dose adherence replicate the finding that dose simplification increases adherence to immunosuppressants as measured through electronic monitoring. Such an advantage for the once-daily dosing group was not seen across the 2 other electronic monitoring measurement variables (days and timing adherence). This study extends previous research by examining adherence in once versus twice-daily dosing via prescription refill data in a Canadian sample. Given the gravity of potential health outcomes associated with nonadherence, although results indicate inconsistencies in significance testing across measurement methods, the medium to large effect sizes seen in the data favoring better adherence with once-daily dosing provide an indication of the potential clinical significance of these findings. Trial registration:This study was registered with ClinicalTrials.gov (NCT01334333) on April 11, 2011.
| S-EPMC6699008 | biostudies-literature
Project description:BackgroundMultiple daily dosing may be negatively associated with patient medication adherence; however, adherence-related data are lacking in a patient population with venous thromboembolism (VTE).ObjectiveTo assess the adherence rates between once-daily (OD) and twice-daily (BID) dosing regimens of chronic medications in patients with VTE.MethodsWe analyzed the PharMetrics Integrated Claims database (claims of commercial insurers in the US) from 1 January 2004, through 31 December 2009. Adult patients with continuous insurance coverage, newly initiated on diabetes mellitus or hypertension medication, and having at least one VTE diagnosis were included. Adherence to OD and BID therapies was calculated by using two measures: medication possession ratio (MPR) and proportion of days covered (PDC). Adherence was defined as an MPR or PDC ?0.8. Multivariate logistic regressions were conducted to compare the probability of adherence between the OD and BID groups adjusting for baseline confounders.ResultsA total of 4,867 OD and 1,069 BID patients were identified. Mean duration of exposure to therapy for OD and BID patients was 386 and 356 days (p = 0.011), respectively. Based on MPR, 69 % of OD and 62 % of BID patients were adherent (p < 0.001). For PDC at 12 months, the proportion of adherent patients for the OD and BID groups was 45 and 36 % (p < 0.001), respectively. Adjusted odds ratios (95 % CI) of adherence for the OD relative to BID group were 1.61 (1.37-1.89) based on MPR (p < 0.001) and 1.46 (1.16-1.83) based on PDC at 12 months (p = 0.001).ConclusionsThis study demonstrates that VTE patients treated with chronic medications on OD dosing regimens were associated with an approximately 39-61 % higher likelihood of adherence compared with subjects on BID dosing regimens.
| S-EPMC3751276 | biostudies-literature
Project description:IntroductionBromfenac is a well-known topical ophthalmic nonsteroidal anti-inflammatory drug (NSAID) that is commercialized in the USA and other regions of the world. A new formulation, 0.075% bromfenac in DuraSite®, was developed to treat postoperative inflammation and reduce pain in patients who have undergone cataract surgery. We hypothesized that efficacy and safety would be enhanced with twice-daily (BID) dosing compared to once-daily (QD) dosing.MethodsThis was a multicenter, double-masked, comparative study in which 40 and 45 subjects were randomized to groups receiving BID dosing and QD dosing, respectively. Subjects self-instilled the study drug for 14 days postoperative and were followed for an additional 2-week evaluation phase. The primary efficacy endpoint was the proportion of subjects with an anterior chamber cell (ACC) grade of 0 at day 15.ResultsA total of 45 subjects had cleared ACC (grade "0") at day 15, of whom 21 were in the BID group (52.5%) and 24 were in the QD group (53.5%). A secondary analysis found 7/40 (17.5%) subjects in the BID group and 10/45 (22.2%) subjects in the QD group achieved an ACC grade of 0 at day 8. There were more adverse events in the QD group (n = 16) than in the BID group (n = 12).ConclusionSimilar outcomes were observed for subjects using Bromfenac 0.075% in DuraSite® in the BID and QD dosing regimens for the treatment of post-cataract surgery inflammation.Trial registrationClinicalTrials.gov identifier, NCT01190878.FundingInSite Vision (now a division of Sun Pharma).
| S-EPMC5693819 | biostudies-literature
Project description:OBJECTIVE:To evaluate by survey the comfort upon instillation of timolol hemihydrate compared to timolol maleate with potassium sorbate. DESIGN:A prospective, multicenter, observational, non-interventional study. PARTICIPANTS:One hundred and three patients of open-angle glaucoma or ocular hypertension who were ?21 years old and were currently prescribed timolol hemihydrate (once or twice daily) or timolol maleate with potassium sorbate once daily as monotherapy or as a part of two-drug therapy. MATERIALS AND METHODS:Study was performed at seven clinical sites in the United States. Patients were surveyed on comfort upon instillation of timolol hemihydrate compared to timolol maleate with potassium sorbate. RESULTS:A difference between timolol hemihydrate and timolol maleate with potassium sorbate for questions 1 (burning/stinging on instillation, p < 0.001) and 4 (tearing on instillation, p = 0.024) was noted. There were no differences between treatment groups for any other question (p > 0.05). CONCLUSION:This survey suggests that timolol hemihydrate is associated with less stinging/burning and tearing than timolol maleate with potassium sorbate. How to cite this article: Stewart WC, Oehler JC, Choplin NT, Markoff JI, Moster MR, Ichhpujani P, Nelson LA. A Comfort Survey of Timolol Hemihydrate 0.5% Solution Once or Twice Daily vs Timolol Maleate in Sorbate. J Current Glau Prac 2013;7(1):11-16.
| S-EPMC4741129 | biostudies-literature
Project description:This study was conducted to confirm the 24-hour bronchodilator efficacy and pharmacokinetic profile of once-daily tiotropium Respimat® 5??g add-on to inhaled corticosteroids (ICS) in adults with symptomatic asthma. It used a trial protocol designed to minimize the risk of pharmacokinetic sample contamination resulting from improper sampling procedure, sample handling, or device handling during priming and subsequent inhalation procedure.A Phase II, randomized, double-blind, two-way crossover study (NCT01696071) comparing two daily dosing regimens of tiotropium for 4 weeks, once-daily 5??g (evening dosing) or twice-daily 2.5??g (morning and evening dosing), as add-on to maintenance therapy with ICS (400-800??g budesonide or equivalent) as controller medication. There was no washout between treatment periods.An increase in the area under the curve of the 24-hour forced expiratory volume in 1 second profile from study baseline was observed following once-daily tiotropium 5??g (217?mL) and twice-daily 2.5??g (219?mL), with no difference between the two regimens (-2?mL [95% confidence interval: -38, 34]). In a subset of the study population, total tiotropium exposure, expressed as area under the plasma concentration versus time curve over 24 hours, was comparable between dosing regimens. Unexpected tiotropium plasma levels were observed in two patients, possibly because of contamination.The observed bronchodilator efficacy over 24 hours was similar with once-daily tiotropium 5??g and twice-daily 2.5??g as add-on to ICS therapy, supporting the suitability of once-daily dosing to provide sustained improvements in lung function in adults with symptomatic asthma.
| S-EPMC5073218 | biostudies-literature