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Number of Patients Eligible for PCSK9 Inhibitors Based on Real-world Data From 2.5 Million Patients.
Zamora, A, Masana, L, Comas-Cufi, M, Plana, N, Vila, À, García-Gil, M, Alves-Cabratosa, L, Elosua, R, Marrugat, J, Ramos, R
Revista espanola de cardiologia (English ed.). 2018;(12):1010-1017
Abstract
INTRODUCTION AND OBJECTIVES PCSK9 inhibitors (PCSK9i) are safe and effective lipid-lowering drugs. Their main limitation is their high cost. The aim of this study was to estimate the number of patients eligible for treatment with PCSK9i according to distinct published criteria. METHODS Data were obtained from the Information System for the Development of Research in Primary Care. Included patients were equal to or older than 18 years and had at least 1 low-density lipoprotein cholesterol measurement recorded between 2006 and 2014 (n = 2 500 907). An indication for treatment with PCSK9i was assigned according to the following guidelines: National Health System, Spanish Society of Arteriosclerosis, Spanish Society of Cardiology, National Institute for Health and Care Excellence, and the European Society of Cardiology/European Atherosclerosis Society Task Force. Lipid-lowering treatment was defined as optimized if it reduced low-density lipoprotein levels by ≥ 50% and adherence was > 80%. RESULTS Among the Spanish population aged 18 years or older, the number of possible candidates to receive PCSK9i in an optimal lipid-lowering treatment scenario ranged from 0.1% to 1.7%, depending on the guideline considered. The subgroup of patients with the highest proportion of potential candidates consisted of patients with familial hypercholesterolemia, and the subgroup with the highest absolute number consisted of patients in secondary cardiovascular prevention. CONCLUSIONS The number of candidates to receive PCSK9i in conditions of real-world clinical practice is high and varies widely depending on the recommendations of distinct scientific societies.
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Individual differences in regulatory mode moderate the effectiveness of a pilot mHealth trial for diabetes management among older veterans.
Dugas, M, Crowley, K, Gao, GG, Xu, T, Agarwal, R, Kruglanski, AW, Steinle, N
PloS one. 2018;(3):e0192807
Abstract
mHealth tools to help people manage chronic illnesses have surged in popularity, but evidence of their effectiveness remains mixed. The aim of this study was to address a gap in the mHealth and health psychology literatures by investigating how individual differences in psychological traits are associated with mHealth effectiveness. Drawing from regulatory mode theory, we tested the role of locomotion and assessment in explaining why mHealth tools are effective for some but not everyone. A 13-week pilot study investigated the effectiveness of an mHealth app in improving health behaviors among older veterans (n = 27) with poorly controlled Type 2 diabetes. We developed a gamified mHealth tool (DiaSocial) aimed at encouraging tracking of glucose control, exercise, nutrition, and medication adherence. Important individual differences in longitudinal trends of adherence, operationalized as points earned for healthy behavior, over the course of the 13-week study period were found. Specifically, low locomotion was associated with unchanging levels of adherence during the course of the study. In contrast, high locomotion was associated with generally stronger adherence although it exhibited a quadratic longitudinal trend. In addition, high assessment was associated with a marginal, positive trend in adherence over time while low assessment was associated with a marginal, negative trend. Next, we examined the relationship between greater adherence and improved clinical outcomes, finding that greater adherence was associated with greater reductions in glycated hemoglobin (HbA1c) levels. Findings from the pilot study suggest that mHealth technologies can help older adults improve their diabetes management, but a "one size fits all" approach may yield suboptimal outcomes.
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A smartphone application supporting patients with psoriasis improves adherence to topical treatment: a randomized controlled trial.
Svendsen, MT, Andersen, F, Andersen, KH, Pottegård, A, Johannessen, H, Möller, S, August, B, Feldman, SR, Andersen, KE
The British journal of dermatology. 2018;(5):1062-1071
Abstract
BACKGROUND Adherence to topical psoriasis treatments is low, which leads to unsatisfactory treatment results. Smartphone applications (apps) for patient support exist but their potential to improve adherence has not been systematically evaluated. OBJECTIVES To evaluate whether a study-specific app improves adherence and reduces psoriasis symptoms compared with standard treatment. METHODS We conducted a randomized controlled trial (RCT, clinicaltrials.gov registration: NCT02858713). Patients received once-daily medication [calcipotriol/betamethasone dipropionate (Cal/BD) cutaneous foam] and were randomized to no app (n = 66) or app intervention (n = 68) groups. In total, 122 patients (91%) completed the 22-week follow-up. The primary outcome was adherence, which was defined as medication applied ≥ 80% of days during the treatment period and assessed by a chip integrated into the medication dispenser. Secondary outcomes were psoriasis severity measured by the Lattice System Physician's Global Assessment (LS-PGA) and quality of life, measured using the Dermatology Life Quality Index (DLQI) at all visits. RESULTS Intention-to-treat analyses using regression was performed. More patients in the intervention group were adherent to Cal/BD cutaneous foam than those in the nonintervention group at week 4 (65% vs. 38%, P = 0·004). The intervention group showed a greater LS-PGA reduction than the nonintervention group at week 4 (mean 1·86 vs. 1·46, P = 0·047). A similar effect was seen at weeks 8 and 26, although it did not reach statistical significance. CONCLUSIONS This RCT demonstrates that the app improved short-term adherence to Cal/BD cutaneous foam treatment and psoriasis severity.
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Impact of pharmaceutical care on clinical outcomes among hemodialysis patients: A multicenter randomized controlled study.
Mateti, UV, Nagappa, AN, Attur, RP, Nagaraju, SP, Rangaswamy, D
Saudi journal of kidney diseases and transplantation : an official publication of the Saudi Center for Organ Transplantation, Saudi Arabia. 2018;(4):801-808
Abstract
The aim of this study is to assess the impact of pharmaceutical care on medication adherence, hemoglobin (Hb) levels, blood pressure (BP), and interdialytic weight gain (IDW) among hemodialysis (HD) patients. An open-label randomized controlled study has been conducted at three different hospitals of HD centers. The patients have been randomized into two groups [usual care group (UCG) and pharmaceutical care group (PCG)] by block design. The assessment has been carried out at baseline, 6th, and 12th months. At the end of the study, a total number of 153 patients have been followed. Out of 153 patients, 83 (UCG: n = 41; PCG: n = 42), 18 (UCG: n = 09; PCG: n = 09), and 52 (UCG: n = 25; PCG: n = 27) patients have been followed from academic, government, and corporate hospitals, respectively. The PCG had significantly reduced its IDW and BP levels in comparison to UCG at different time intervals with a statistical significance of P <0.05. The Hb levels and medication adherence rate scores of HD patients had significantly increased in PCG compared to UCG at different time intervals. The "World Health Organization-International Pharmaceutical Federation pharmaceutical care" plan model delivered by the registered pharmacist regarding the knowledge about the disease, medications, life style changes, nutritional information, personal interview, and medication review had a positive impact on the on medication adherence, Hb levels, BP, and IDW.
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Barriers to medication adherence and links to cardiovascular disease risk factor control: the Framingham Heart Study.
Hennein, R, Hwang, SJ, Au, R, Levy, D, Muntner, P, Fox, CS, Ma, J
Internal medicine journal. 2018;(4):414-421
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BACKGROUND In the elderly, impaired cognition may weaken medication adherence and compromise treatment for cardiovascular disease (CVD). AIM: We examined risk factors for medication adherence and the relationship between adherence and levels of CVD risk factors among older participants with hypertension, dyslipidaemia and diabetes in the Framingham Heart Study. METHODS The four-item Morisky Medication Adherence Scale was administered to 1559 participants, median age 70 years, 53% women. We created an adherence score, ranging from 0 to 4, with low adherence defined as a score ≥2. CVD risk factors were assessed using standard protocols. Cognition was measured using the Mini-Mental State Examination (MMSE) and depressive symptoms were measured using the Center for Epidemiologic Studies of Depression (CES-D) scale. RESULTS Among participants who self-reported taking antihypertensive, lipid-lowering and/or hyperglycaemic medication(s), 12% (n = 191) had low medication adherence. The risk of low adherence increased by 45% (95% confidence interval (CI): 25-68%, P < 0.001) per five-unit increase in CES-D score. In participants taking antihypertensive medication (n = 1017), low adherence was associated with higher mean diastolic blood pressure (73 mmHg, 95% CI: 71-75 vs 71 mmHg, 95% CI: 70-71; P = 0.04) after adjusting for covariates. Among participants taking lipid-lowering medication (n = 937), low adherence was associated with higher mean low-density lipoprotein cholesterol (92 mg/dL, 95% CI: 87-96 vs 86 mg/dL, 95% CI: 84-88; P = 0.03). Low adherence was not associated with fasting plasma glucose (P = 0.10) or haemoglobin A1c (P = 0.68) in the subgroup of participants (n = 192) taking hypoglycaemic medication. CONCLUSIONS Depressive symptoms might act as a barrier for medication adherence, which exacerbates CVD risk factors in older-aged adults.
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Adherence to home fortification with micronutrient powders in Kenyan pre-school children: self-reporting and sachet counts compared to an electronic monitoring device.
Teshome, EM, Oriaro, VS, Andango, PEA, Prentice, AM, Verhoef, H
BMC public health. 2018;(1):205
Abstract
BACKGROUND The efficacy of home fortification with iron-containing micronutrient powders varies between trials, perhaps in part due to population differences in adherence. We aimed to assess to what extent adherence measured by sachet count or self-reporting forms is in agreement with adherence measured by electronic device. In addition, we explored how each method of adherence assessment (electronic device, sachet count, self-reporting forms) is associated with haemoglobin concentration measured at the end of intervention; and to what extent baseline factors were associated with adherence as measured by electronic device. METHODS Three hundred thirty-eight rural Kenyan children aged 12-36 months were randomly allocated to three treatment arms (home fortification with two different iron formulations or placebo). Home fortificants were administered daily by parents or guardians over a 30 day-intervention period. We assessed adherence using an electronic device that stores and provides information of the time and day of opening of the container that was used to store the fortificants sachets in each child's residence. In addition, we assessed adherence by self-reporting and sachet counts. We also measured haemoglobin concentration at the end of intervention. RESULTS Adherence, defined as having received at least 24 sachets (≥ 80%), during the 30-day intervention period was attained by only 60.6% of children as assessed by the electronic device. The corresponding values were higher when adherence was assessed by self-report (83.9%; difference: 23.3%, 95% CI: 18.8% to 27.8%) or sachet count (86.3%; difference: 25.7%, 95% CI: 21.0% to 30.4%). Among children who received iron, each 10 openings of the electronic cap of the sachet storage container were associated with an increase in haemoglobin concentration at the end of intervention by 1.2 g/L (95% CI: 0.0 to 1.9 g/L). Adherence was associated with the age of the parent but not with intervention group; with age, sex or anthropometric indices of the child; or with age or sex of the parent or guardian. CONCLUSIONS The use of self -reporting and sachet count may lead to overestimates of adherence to home fortification. TRIAL REGISTRATION The trial was registered with ClinicalTrials.gov ( NCT02073149 ) on 25 February 2014.
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TREATMENT OF NEOVASCULAR AGE-RELATED MACULAR DEGENERATION PATIENTS WITH VASCULAR ENDOTHELIAL GROWTH FACTOR INHIBITORS IN EVERYDAY PRACTICE: Identification of Health Care Constraints in Germany-The PONS Study.
Ehlken, C, Wilke, T, Bauer-Steinhusen, U, Agostini, HT, Hasanbasic, Z, Müller, S
Retina (Philadelphia, Pa.). 2018;(6):1134-1144
Abstract
PURPOSE The PONS study was conceived to analyze the extent of nonpersistence (NP) and nonadherence (NA) in the treatment of patients with neovascular age-related macular degeneration in everyday clinical practice in Germany. Further objectives were to identify factors that can affect NP and NA and to analyze clinical outcomes under everyday conditions. METHODS Nonpersistence (no contact with doctor for at least 3 months) and NA (no treatment or follow-up for at least 6 weeks) as well as clinical data were analyzed up to 24 months retrospectively and 12 months prospectively in 480 patients with neovascular age-related macular degeneration in 23 treatment centers. Patients were interviewed for factors possibly affecting NP and NA. RESULTS One third of patients fulfilled criteria of NA in the first 3 months and two thirds after 6 months. The NP was 18.8% after 12 months. Treatment exclusively at one center, a higher number of patients with neovascular age-related macular degeneration at the treating center, and fixed appointments were associated with a lower risk for NP. An initial gain in visual acuity after upload was not preserved after 12 months (mean change -0.5 Early Treatment Diabetic Retinopathy Study letters). Whereas visual acuity declined by 7.5 Early Treatment Diabetic Retinopathy Study letters in patients with good baseline visual acuity >20/40, visual acuity improved by 8.5 letters in patients with baseline visual acuity of ≤20/200. Only 7.5% of patients underwent an optical coherence tomography scan after 3 upload injections, and only 2.0 optical coherence tomographies were performed in the first 12 months. CONCLUSION The NP and NA were high in our study population and are likely to have contributed to a suboptimal clinical outcome compared with randomized clinical trials. Shortcomings in the management of patients with neovascular age-related macular degeneration, including restrictions in the timely and adequate follow-up (including optical coherence tomography) and retreatment, appear to be constraining factors in Germany.
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Community pharmacist-led interventions and their impact on patients' medication adherence and other health outcomes: a systematic review.
Milosavljevic, A, Aspden, T, Harrison, J
The International journal of pharmacy practice. 2018;(5):387-397
Abstract
INTRODUCTION Medication adherence can be defined as the extent to which one's medication-taking behaviour follows that mutually agreed upon by the prescribing physician. Optimal medication adherence is often deemed crucial for the success of a patient's treatment, as suboptimal adherence may lead to treatment failure and unnecessary medical expenditure. Increasing evidence has highlighted the positive contribution community pharmacist-led interventions can have on improving patients' adherence and health outcomes. OBJECTIVES To provide an overview of the published literature on community pharmacist-led interventions and their effectiveness in improving patients' adherence and health outcomes. METHODS A search strategy was developed, aiming to retrieve published reports of community pharmacy interventions worldwide. Medline, EMBASE, International Pharmaceutical Abstracts, Google Scholar and ProQuest Dissertations and Theses databases were searched. Articles meeting the inclusion criteria were collated, relevant data extracted, and a risk of bias assessment undertaken. KEY FINDINGS Twenty-two studies were included in the analysis, and their outcomes were reported in 26 peer-reviewed journal articles. Community pharmacist-led interventions have been shown to improve patients' adherence and contribute to better blood pressure control, cholesterol management, chronic obstructive pulmonary disease and asthma control. Studies in this review, however, did not report statistically significant effects of interventions on diabetes or depression control. CONCLUSION Community pharmacist-led interventions have been shown to contribute to improved adherence and better disease control. Future research should attempt to better understand which particular intervention components make the greatest contribution towards improving adherence and health outcomes, for patients with different medical conditions.
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Completion of isoniazid preventive therapy among human immunodeficiency virus positive adults in urban Malawi.
Thindwa, D, MacPherson, P, Choko, AT, Khundi, M, Sambakunsi, R, Ngwira, LG, Kalua, T, Webb, EL, Corbett, EL
The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease. 2018;(3):273-279
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SETTING Despite worldwide scale-up of human immunodeficiency virus (HIV) care services, relatively few countries have implemented isoniazid preventive therapy (IPT). Among other programmatic concerns, IPT completion tends to be low, especially when not fully integrated into HIV care clinics. OBJECTIVE To estimate non-completion of 6-month IPT and its predictors among HIV-positive adults aged 16 years. DESIGN A prospective cohort study nested within a cluster-randomised trial of TB prevention was conducted between February 2012 and June 2014. IPT for 6 months was provided with pyridoxine at study clinics. Non-completion was defined as loss to follow-up (LTFU), death, active/presumptive TB or stopping IPT for any other reason. Random-effects logistic regression was used to determine predictors of non-completion. RESULTS Of 1284 HIV-positive adults initiated on IPT, 885/1280 (69.1%) were female; the median CD4 count was 337 cells/μl (IQR 199-511); 320 (24.9%) did not complete IPT. After controlling for antiretroviral treatment status, IPT initiation year, age and sex, non-completion of IPT was associated with World Health Organization stage 3/4 (aOR 1.76, 95%CI 1.22-2.55), CD4 count 100-349 cells/μl (aOR 1.93, 95%CI 1.10-3.38) and any reported side effects (aOR 22.00, 95%CI 9.45-46.71). CONCLUSION Completion of IPT was suboptimal. Interventions to further improve retention should target immunosuppressed HIV-positive adults and address side effects.
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Multi-dose drug dispensing as a tool to improve medication adherence: A study in patients using vitamin K antagonists.
van Rein, N, de Geus, KS, Cannegieter, SC, Reitsma, PH, van der Meer, FJM, Lijfering, WM
Pharmacoepidemiology and drug safety. 2018;(1):46-51
Abstract
PURPOSE Multi-dose drug dispensing (MDD) is a dosing aid that provides patients with disposable bags containing all drugs intended for 1 dosing moment. MDD is believed to increase medication adherence, but studies are based on self-reported data, and results may depend on socially desirable answers. Therefore, our purpose was to determine the effect of MDD on medication adherence in non-adherent patients taking vitamin K antagonists (VKAs), and to compare with instructing patients on medication use. METHODS We conducted a before-after study in non-adherent patients where MDD was the exposure and change in adherence after MDD initiation was the outcome (within patient comparison). Time in therapeutic range (TTR) was selected as a measure for adherence, as this reflects stability of VKA treatment. To analyze whether MDD improved adherence as compared with standard care (ie, letters or calls from nurses of the anticoagulation clinic), non-adherent patients without MDD were also followed to estimate their TTR change over time (between patient comparison). RESULTS Eighty-three non-adherent VKA patients started using MDD. The median TTR was 63% before MDD and 73% 6 months after MDD. The within patient TTR increased on average by 13% (95%CI 6% to 21%) within 1 month after starting MDD and remained stable during the next 5 months. The TTR of MDD-patients increased 10% (95%CI 2% to 19%) higher as compared with non-MDD patients within 1 month but was similar after 4 months (TTR difference 3%, 95%CI -2% to 9%). CONCLUSIONS Adherence improved after initiation of MDD. Compared with instructing patients, MDD was associated with better adherence within 1 month but was associated with similar improvement after 4 months.