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Epidemiological and clinical profile of hypertensive octogenarian patients and factors associated with uncontrolled hypertension: observational study of 346 patients.
Bahloul, A, Hammami, R, Charfeddine, S, Triki, S, Bouattour, N, Abid, L, Kammoun, S
The Pan African medical journal. 2021;:202
Abstract
INTRODUCTION hypertension (HTN) is the main risk factor for most morbidities of elderly subjects. The objective of this study was to identify the epidemiological and clinical characteristics of hypertension in octogenarians and to identify the factors associated with uncontrolled hypertension in this population. METHODS we used data collected in the outpatient cardiology department of the University Hospital of Sfax between 15th April 2019 and 15th May 2019 as part of the National Tunisian Registry of Hypertension. We included in our study patients aged 80 years or more with hypertension. We described the epidemiological and clinical profile of this population, and we studied the associations between uncontrolled hypertension and socio-demographic, lifestyle, clinical and therapeutic factors using logistic regression models. RESULTS we included 346 subjects (45.1% (n=156) male and 54.9% (n=190) female), with a mean age of 84.36 (SD 4.01) years. More than half of them had uncontrolled hypertension. Dyslipidemia was the most common cardiovascular risk factor found in 43.6 % (n=151) of patients followed by diabetes (35.5%, n=122). One-third of patients had a history of coronary artery disease and/or stroke. Renal failure and kalemia disorders were observed, respectively, in 12.1% (n=42) and 25.2% (n=40) of patients. In multivariate analysis, factors associated with uncontrolled hypertension (HTN) were male sex (adjusted odds ratio (aOR): 1.663, 95% confidence interval (CI): 1.045-2.647; p=0.032), diabetes (aOR: 1.66, 95%CI: 1.031-2.688; p=0.037,) and poor adherence to blood pressure (BP) medications (aOR: 1.960, 95%CI: 1.195-3.214; p=0.008). CONCLUSION our results showed that more than half of octogenarian hypertensive patients did not reach the BP target and that poor adherence to BP medications was the main factor of uncontrolled HTN. In this population, the presence of other comorbidities and poor adherence to BP medications are very common. Systematic research for behaviors suggesting poor medication adherence should be a priority for physicians caring for these patients.
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Introducing longitudinal cumulative dose to describe chemotherapy patterns over time: Case study of a colon cancer trial.
Webster-Clark, M, Keil, AP, Sanoff, HK, Stürmer, T, Westreich, D, Lund, JL
International journal of cancer. 2021;(2):394-402
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Adjuvant chemotherapy regimens take months to complete. Despite this, studies evaluate chemotherapy adherence via measures assessed at the end of treatment (eg, number of patients missing any dose, relative dose intensity [RDI]). This approach ignores information like the timing of treatment delays. We propose longitudinal cumulative dose (LCD) to integrate impacts of dose reductions, missed doses and dose delays over time. We obtained data from the 2246 participants in the MOSAIC trial randomized to FOLFOX (all three agents) or 5-FU/LV (only 5-fluorouracil and leucovorin). We evaluated proportions of patients stopping treatment early and reducing, missing or delaying a dose in each arm for each chemotherapy agent at each cycle. We calculated LCD, the fraction of the final standard dose a participant reached by a given day, for each participant and each agent and compared it over time and at 24 weeks between treatment arms. Participants randomized to FOLFOX were more likely to stop treatment, reduce doses, miss doses or delay cycles; these differences increased over time. Median LCD for oxaliplatin in the FOLFOX arm at 24 weeks was 77%. The LCD for 5-fluorouracil differed between arms (FOLFOX arm median: 81%; 5-FU/LV arm median: 96%). Visualizing LCD highlighted the timing of deviations from standard administration in a way RDI could not, with major differences in 5-fluorouracil LCD across treatment arms beginning after the sixth dose. Further evaluation of LCD and its impacts on clinical outcomes may clarify mechanisms for heterogeneous patient outcomes.
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A Randomized Trial Comparing the Safety, Adherence, and Pharmacodynamics Profiles of Two Doses of Sodium Bicarbonate in CKD: the BASE Pilot Trial.
Raphael, KL, Isakova, T, Ix, JH, Raj, DS, Wolf, M, Fried, LF, Gassman, JJ, Kendrick, C, Larive, B, Flessner, MF, et al
Journal of the American Society of Nephrology : JASN. 2020;(1):161-174
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BACKGROUND Oral sodium bicarbonate (NaHCO3) may preserve kidney function in CKD, even if initiated when serum bicarbonate concentration is normal. Adequately powered trials testing this hypothesis have not been conducted, partly because the best dose for testing is unknown. METHODS This multicenter pilot trial assessed the safety, tolerability, adherence, and pharmacodynamics of two doses of NaHCO3 over 28 weeks in adults with eGFR 20-44 or 45-59 ml/min per 1.73 m2 with urinary albumin/creatinine (ACR) ≥50 mg/g and serum bicarbonate 20-28 meq/L. We randomly assigned 194 participants from ten clinical sites to receive higher-dose (HD-NaHCO3; 0.8 meq/kg of lean body wt per day; n=90) or lower-dose (LD-NaHCO3; 0.5 meq/kg of lean body wt per day; n=52) NaHCO3 or matching placebo (n=52). The dose was adjusted depending on side effects. The prescribed dose at week 28 was the primary outcome; a dose was considered acceptable for a full-scale trial if ≥67% of participants were on full-dose and ≥80% were on ≥25% of the per-protocol dose. RESULTS Mean±SD baseline eGFR was 36±9 ml/min per 1.73 m2, serum bicarbonate was 24±2 meq/L, and median (IQR) ACR was 181 (25-745) mg/g. Both doses were well tolerated without significant changes in BP, weight, or serum potassium. The proportions of adverse events and hospitalizations were similar across the groups. Consequently, 87% in HD-NaHCO3, 96% in LD-NaHCO3, and 87% in placebo were on full dose at week 28; and 91% in HD-NaHCO3, 98% in LD-NaHCO3, and 92% in placebo were on ≥25% of the per-protocol dose. Mean urinary ammonium excretion was 25% lower and serum bicarbonate concentration was 1.3 meq/L higher in HD-NaHCO3 compared with LD-NaHCO3 at week 28. However, mean ACR increased by 12% in the lower-dose group and 30% in the higher-dose group. CONCLUSIONS Both NaHCO3 doses were well tolerated over 28 weeks with no significant difference in adverse events or hospitalization compared with placebo. The higher dose lowered urinary ammonium excretion and increased serum bicarbonate more than the lower dose but was associated with a greater increase in ACR. The higher 0.8 meq/kg of lean body wt per day dose of NaHCO3 may be a reasonable choice for future trials.
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Community pharmacy-based study of adherence to non-vitamin K antagonist oral anticoagulants.
Capiau, A, Mehuys, E, Van Tongelen, I, Christiaens, T, De Sutter, A, Steurbaut, S, Moudallel, S, Rydant, S, Vrijens, B, de Backer, TLM, et al
Heart (British Cardiac Society). 2020;(22):1740-1746
Abstract
OBJECTIVE This study aimed to assess implementation adherence (how well the patient's actual intake matches the prescribed dosing regimen) to non-vitamin K antagonist oral anticoagulants (NOACs) and to explore experiences with and beliefs about NOACs in a real-world sample of long-term NOAC users. METHODS A cross-sectional observational study was conducted in home-dwelling adults who started taking a NOAC at least 1 year prior to inclusion. Pharmacy dispensing data were used to calculate the Medication Possession Ratio (MPR). Patients were recruited in 158 community pharmacies in Flanders, Belgium. They completed a questionnaire collecting basic characteristics and exploring self-reported adherence to NOACs (using the Medication Adherence Report Scale, MARS) and experiences with and beliefs about NOACs (using the Beliefs about Medicines Questionnaire, BMQ). RESULTS A total of 766 patients (mean age 76.2±8.8 years, median CHA2DS2-VASc score 4 (IQR=3-4)) were included. The majority (93.5%) used NOAC for stroke prevention in atrial fibrillation. The median MPR was 95.2% (IQR=87.8-99.7) which corresponds with half of the study population not taking their NOAC on at least 17 cumulative days per year. Almost 21% of participants reported non-adherence on the MARS (score <25), with unintentional non-adherence (forgetfulness) most frequently reported (15.4%). Although two-thirds of NOAC users indicated to experience adverse drug reactions, the BMQ demonstrated a positive attitude towards NOAC therapy, where necessity beliefs outweigh the concerns. CONCLUSIONS Our data indicate that long-term NOAC users have high implementation adherence and a positive attitude towards NOAC therapy. However, taking into account patients' thromboembolic risk and NOACs' short half-lives, further optimisation of NOAC use seems warranted in this population.
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Poor adherence to medication and salt restriction as a barrier to reaching blood pressure control in patients with hypertension: Cross-sectional study from 12 sub-Saharan countries.
Macquart de Terline, D, Kramoh, KE, Bara Diop, I, Nhavoto, C, Balde, DM, Ferreira, B, Houenassi, MD, Hounsou, D, Ikama, MS, Kane, A, et al
Archives of cardiovascular diseases. 2020;(6-7):433-442
Abstract
BACKGROUND Sub-Saharan Africa is experiencing a rising burden of hypertension. Antihypertensive medications and diet are the cornerstone of effective hypertension control. AIMS To assess adherence to medication and salt restriction in 12 sub-Saharan countries, and to study the relationship between adherence and blood pressure control in patients with hypertension. METHODS We conducted a cross-sectional survey in urban clinics in twelve sub-Saharan countries. Data were collected on demographics, treatment and adequacy of blood pressure control in patients with hypertension attending the clinics. Adherence was assessed by questionnaires completed by the patients. Hypertension grades were defined according to European Society of Cardiology guidelines. Association between adherence and blood pressure control was investigated using multilevel logistic regression analysis, adjusting for age, sex and country. RESULTS Among the 2198 patients, 77.4% had uncontrolled blood pressure, 34.0% were poorly adherent to salt restriction, 64.4% were poorly adherent to medication and 24.6% were poorly adherent to both. Poor adherence to salt restriction (odds ratio [OR] 1.33, 95% confidence interval [CI] 1.03-1.72), medication (OR 1.56, 95% CI 1.25-1.93) or both (OR 1.91 1.39-2.66) was related to uncontrolled blood pressure. Moreover, poor adherence to both medication and salt restriction was related to a 1.52-fold (95% CI 1.04-2.22), 1.8-fold (95% CI 1.22-2.65) and 3.08-fold (95% CI 2.02-4.69) increased likelihood of hypertension grade 1, 2 and 3, respectively. CONCLUSIONS High levels of poor adherence to salt restriction and medication were noted in this urban sub-Saharan study; both were significantly associated with uncontrolled blood pressure, representing major opportunities for intervention to improve hypertension control in sub-Saharan Africa.
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Adherence to treatment in children with growth hormone deficiency, small for gestational age and Turner syndrome in Mexico: results of the Easypod™ connect observational study (ECOS).
Blanco-López, A, Antillón-Ferreira, C, Saavedra-Castillo, E, Barrientos-Pérez, M, Rivero-Escalante, H, Flores-Caloca, O, Calzada-León, R, Rosas-Guerra, CC, Koledova, E, Chiquete, E, et al
Journal of endocrinological investigation. 2020;(10):1447-1452
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BACKGROUND Assessing adherence to growth hormone (GH) is challenging. The Easypod™ connect device delivers pre-set doses of recombinant human GH (r-hGH) and stores a digital record of adherence that can be shared with healthcare provider. We assessed adherence to r-hGH delivered with Easypod™ according to the approved pediatric indications for r-hGH: growth hormone deficiency (GHD), born small for gestational age (SGA) who failed to show catch-up growth and Turner syndrome (TS). METHODS ECOS (NCT01555528) was a multicenter (24 countries), 5-year, longitudinal, observational study, which aimed to evaluate country-specific adherence to r-hGH therapy prescribed via the Easypod™ electronic injection device. The primary endpoint was yearly adherence. Secondary endpoints were height velocity, height velocity standard deviation scores (SDS), height, height SDS and IGF-1 concentrations. Clinical and auxological data were obtained from medical records and adherence from Easypod™ logs. RESULTS This study included 147 Easypod™-naïve Mexican children assessed during 3 years (mean age: 9.96 ± 3.41 years, 56.8% boys, mean height SDS at baseline: - 2.17 ± 0.97): 118 with GHD, 24 SGA and 5 with TS. A total of 105 (71.4%) patients were GH naïve. Overall median adherence was > 90% over the first year of treatment and > 80% at 3 years. Adherence was not different by r-hGH indication or between GH-naïve or experienced patients. At 1-year follow-up, mean change in height SDS was 0.57 ± 0.34, whereas mean height velocity SDS was 2.85 ± 2.51. In all, 84.7% patients had normal IGF-1 concentrations at 1-year follow-up. Adherence was associated with change in height SDS (r = 0.239, p = 0.005) and height velocity SDS (r = 0.194, p = 0.027). CONCLUSION Adherence rates with the Easypod™ device are high and maintained over time in GHD, SGA and TS Easypod™-naïve Mexican patients. High adherence is associated with better outcomes. Easypod™ assists physicians in monitoring adherence to r-hGH.
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Ethnic Differences in 90-Day Poststroke Medication Adherence.
Lank, RJ, Lisabeth, LD, Levine, DA, Zahuranec, DB, Kerber, KA, Shafie-Khorassani, F, Case, E, Zuniga, BG, Cooper, GM, Brown, DL, et al
Stroke. 2019;(6):1519-1524
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Background and Purpose- We assessed ethnic differences in medication adherence 3 months poststroke in a population-based study as an initial step in investigating the increased stroke recurrence risk in Mexican Americans compared with non-Hispanic whites. Methods- Ischemic stroke cases from 2008 to 2015 from the Brain Attack Surveillance in Corpus Christi project in Texas were followed prospectively for 3 months poststroke to assess medication adherence. Medications in 5 drug classes were analyzed: statins, antiplatelets, anticoagulants, antihypertensives, and antidepressants. For each drug class, patients were considered adherent if they reported never missing a dose in a typical week. The χ2 tests or Kruskal-Wallis nonparametric tests were used for ethnic comparisons of demographics, risk factors, and medication adherence. A multivariable logistic regression model was constructed for the association of ethnicity and medication nonadherence. Results- Mexican Americans (n=692) were younger (median 65 years versus 68 years, P<0.001), had more diabetes mellitus ( P<0.001) and hypertension ( P<0.001) and less atrial fibrillation ( P=0.003), smoking ( P=0.003), and education ( P<0.001) than non-Hispanic whites (n=422). Sex, insurance status, high cholesterol, previous stroke/transient ischemic attack history, excessive alcohol use, tPA (tissue-type plasminogen activator) treatment, National Institutes of Health Stroke Scale score, and comorbidity index did not significantly differ by ethnicity. There was no significant difference in medication adherence for any of the 5 drug classes between Mexican Americans and non-Hispanic whites. Conclusions- This study did not find ethnic differences in medication adherence, thus challenging this patient-level factor as an explanation for stroke recurrence disparities. Other reasons for the excessive stroke recurrence burden in Mexican Americans, including provider and health system factors, should be explored.
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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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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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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.