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Articles published on Pill Burden

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  • Research Article
  • 10.1093/intqhc/mzaf132
The Impact of Pharmacist-Led Medication Reconciliation on Quality of Life and Hospital Stay in Chronic Kidney Disease: A Prospective Study in Jordan.
  • Dec 24, 2025
  • International journal for quality in health care : journal of the International Society for Quality in Health Care
  • Nahlah M Sallam + 2 more

Patients with chronic kidney disease (CKD) often experience a poor quality of life (QoL), prolonged hospital stays (length of stay, LOS), and an increased risk of drug-related problems (DRPs) due to high comorbidity rates, pill burden, and frequent care transitions. Providing effective management can significantly improve the overall health status of CKD patients. This study evaluated the impact of the pharmacist-led medication reconciliation service on health-related QoL and LOS in CKD inpatients and the prevalence of DRPs in this population. This 9-month prospective quasi-experimental study was conducted on hospitalized patients with CKD two phases: a control period and an intervention period. Control phase care followed usual hospital practice. In the intervention phase, the pharmacist carried out reconciliation and review of medications over the stay. Patients data were collected from hospital records and patient interviews. Detected drug-related problems (DRPs) were discussed with the physicians. Participants were followed for one month after discharge to measure QoL, using the EQ-5D-5L questionnaire. Predictors of high DRP burden were analyzed via logistic regression. Multivariable quantile regression was applied to explore factors influencing LOS and QoL at discharge and at the one-month follow-up. Of the study sample (212), 142 (67%) and 70 (33%) participants were enrolled during the intervention and control periods, respectively. A mean of 7.05 (SD 3.41) DRPs per CKD patient was recognized. Discrepancies and inappropriate medication and dosage selection were the most prevalent DRPs. Compared to the control, utility values (QoL) were higher in the intervention group at discharge (0.17 increase; 95% CI: 0.048, 0.298) and at follow-up (0.24 increase; 95%CI: 0.09, 0.39). The intervention group had a shorter LOS by 2.43 days than the control group (95% CI: -4.49, -0.37; P = 0.021). The pharmacist-led supplemented medication reconciliation demonstrated positive effects on QoL and LOS among CKD patients. These results support the integration of clinical pharmacy services into interdisciplinary healthcare for CKD management.

  • Research Article
  • 10.1080/09540121.2025.2602161
“Dream PrEP delivery package”: co-creating innovative PrEP delivery with pregnant or parenting young women in South Africa
  • Dec 16, 2025
  • AIDS Care
  • Jenny Chen-Charles + 5 more

ABSTRACT We conducted a participatory workshop with pregnant or parenting young women to co-create innovative PrEP delivery strategies informed by their lived experiences. Nine pregnant or parenting young women (n = 6 aged 18–24; n = 3 aged 25–28) were recruited from the FastPrEP study, an implementation project in South Africa. Participants ranked barriers to PrEP access and use, with early clinic closures listed as the biggest challenge, followed by community PrEP-related stigma, pill burden, side effects, partner resistance, and missed appointments. Their proposed solutions included after-hours clinic opening times and alternative delivery models such as mobile clinics, home courier delivery, locker pick-up, and pharmacy access; community education led by providers and peers; long-acting PrEP (particularly injectables); side-effect remedies and lower-toxicity options like vaginal rings; co-packaging of PrEP and condoms with educational materials; and appointments reminders. Participants also designed their “dream PrEP delivery package.” Participants wanted discreet packaging, convenient delivery platforms, and bundled access to sexual and reproductive health products, including PrEP, condoms, self-test kits, and menstrual hygiene items. Engaging pregnant or parenting young women as co-designers of PrEP delivery strategies is feasible and generates practical, user-driven solutions. Their insights underscore the importance of stigma-free, community-based, convenient, differentiated, and person-centred PrEP delivery.

  • Research Article
  • 10.1161/hyp.0000000000000258
Single-Pill Combination Therapy for the Management of Hypertension: A Scientific Statement From the American Heart Association.
  • Dec 15, 2025
  • Hypertension (Dallas, Tex. : 1979)
  • Jordan B King + 7 more

The growing global burden of hypertension and inadequate blood pressure control necessitate effective therapeutic strategies to improve blood pressure management and reduce the risks of cardiovascular diseases attributable to hypertension. Single-pill combination medications for hypertension combine ≥2 antihypertensive agents in a single tablet. Single-pill combination medications offer a promising opportunity to achieve faster and more sustained blood pressure control compared with stepped care (ie, prescribing antihypertensive monotherapy, titrating the dose, and later adding more antihypertensive agents). Single-pill combination medications combine complementary mechanisms of action of antihypertensive agents to more effectively lower blood pressure while reducing adverse effects. This approach simplifies treatment regimens by lowering pill burden, improves patient adherence, overcomes clinician inertia by simplifying prescribing, is cost-effective, and results in faster blood pressure control compared with using separate pills. Minor limitations of single-pill combination medications include constrained flexibility for dosing adjustments and lack of commercial availability of certain combinations of agents. By incorporating single-pill combination medications into routine practice for most patients with hypertension, health care professionals may improve long-term cardiovascular outcomes while reducing patient burden. This scientific statement provides an overview of the clinical evidence surrounding the use of single-pill combination medications for hypertension, strategies to implement single-pill combination medications into clinical practice, and knowledge gaps that merit further investigation.

  • Research Article
  • 10.3390/ph18121876
Safety, Pharmacokinetics, and Bioequivalence Characterization of Two Different Strengths of Mesalazine Gastro-Resistant Tablets
  • Dec 11, 2025
  • Pharmaceuticals
  • Dolores Ochoa Mazarro + 8 more

Background/Objectives: Ulcerative colitis (UC), a chronic inflammatory bowel disease, affects approximately 5 million individuals worldwide, exerting a considerable influence on global health and economic systems. Among the challenges in UC management, treatment non-adherence stands out as a critical issue, often compromising therapeutic efficacy. One strategy to address this challenge is by reducing pill burden, which may improve patient compliance and optimize treatment outcomes. Methods: This randomized, two-sequence, four-period, crossover replicate study evaluated the pharmacokinetic profiles, bioequivalence, and safety of a newly developed 1500 mg mesalazine gastro-resistant tablet compared to three of the reference 500 mg Claversal® gastro-resistant tablets (total dose 1500 mg) in 80 healthy participants under fasted conditions. Results: Bioequivalence between mesalazine formulations was observed in both the rate and extent of systemic bioavailability. The geometric mean ratios and their 90% CI were 102.51% (95.85–109.63) for AUC0–∞, 103.36% (96.40–110.83) for AUC0–t, 84.49% (78.24–91.24) for AUC8–48h, and 114.24% (100.15–130.32) for Cmax. All within the accepted bioequivalence ranges, confirming comparable pharmacokinetic performance. Secondary pharmacokinetic parameters such as tmax, t1/2, Ke, Cl, and MRT were also consistent across both formulations. The incidence of adverse events was comparable between the two mesalazine formulations, with only flatulence and mild self-limited rash considered possibly related to test treatment. Conclusions: Overall, the 1500 mg formulation demonstrated a pharmacokinetic profile and tolerability comparable to the reference formulation, offering a higher-strength option to reduce daily pill burden. This strategy is of clinical relevance, particularly for improving treatment adherence among UC patients who need to take multiple pills daily to achieve their required dosage. While adherence is influenced by various factors, reducing pill burden may facilitate compliance and optimize therapeutic efficacy.

  • Abstract
  • 10.1093/jacamr/dlaf230.100
P93 UK TB medication shortages—hard to swallow pills
  • Dec 4, 2025
  • JAC-Antimicrobial Resistance
  • Leena Begum + 1 more

BackgroundTB is a potentially fatal infection with a rising incidence in the UK. Curative treatment is available but requires prolonged courses of multiple medications (particularly during the initial phase treatment). Adherence to therapy is critical to success. Fixed-dose combination (FDC) products combine multiple medications into a single pill to maximize adherence and are used first-line. However, shortages of FDCs have plagued UK supply chains leading to a National Patient Safety Alert in July 2025. Supplying individual component medications in small amounts (1 month maximum) poses a risk to adherence and optimal outcomes. This is particularly concerning as many TB patients already have risk factors for poor adherence.Objectives(i) Quantify impact of FDC shortages on pill burden and quantities of medication supplied by Sandwell and West Birmingham NHS Trust from 1st July 2025. (ii) Contrast pill burden of dispensed therapy with an optimal FDC based regimen.MethodsDispensing records held within the hospital pharmacy computer system were accessed for all patients receiving rifampicin or a rifampicin containing medication between 1 July 2025 and 17 Sept 2025 (all available data). Patients not being treated for TB were excluded. The details of the medication dispensed (product, strength, dose, quantity) were recorded in Microsoft Excel and pill burden calculated. A pharmacist used hospital records to determine the appropriate first-line FDC regimen and calculate the pill burden of this hypothetical treatment.ResultsWe identified 94 relevant prescriptions for 62 patients. Of these, 32 patients were still in the initial phase of TB treatment during the shortage. All 32 patients received multi-product regimens instead of the first-line rifampicin with ethambutol, isoniazid and pyrazinamide FDC. However, one received partial treatment with the first-line FDC and 13 received a multi-product regimen which included a rifampicin with isoniazid FDC. The median pill burden across all prescriptions was 7 (IQR 4.75–11). The median pill burden of optimal regimen was 3 (IQR 2–5). The median supply duration was 28 days (IQR 28–56 days) but with significant outliers (min 7 days, max 168 days). Patients did not always receive the same regimen for the entire phase of treatment; 18 had a different combination of products for subsequent prescriptions.ConclusionsShortages of FDCs have more than doubled median pill burden for our patients. This is despite mitigation with unlicensed imports of rifampicin with isoniazid FDCs. Patients are required to reattend more frequently than usual to collect further supplies. Furthermore, there is no guarantee that a consistent combination of medication will be provided from one prescription to the next. These factors all contribute to an increased risk of poor adherence which is associated with treatment failure, onward transmission and increased drug resistance. Robust supply chains are critical to effective TB treatment.

  • Research Article
  • 10.1186/s12889-025-25683-9
Exploring barriers to hypertension medication adherence among people living with HIV enrolled in the iHEART-SA trial: a theoretical domains framework qualitative study
  • Dec 4, 2025
  • BMC Public Health
  • Wellington Maruma + 6 more

BackgroundHypertension significantly increases the risk of cardiovascular complications, posing a dual burden for people living with HIV (PLHIV) in Sub-Saharan Africa. This study explores the barriers and enablers of hypertension medication adherence among PLHIV attending three primary healthcare (PHC) facilities in Johannesburg, South Africa.MethodsA qualitative study design was employed, guided by the Theoretical Domains Framework (TDF). Data were collected through interviews and focus group discussions with a purposive sample of PLHIV and healthcare providers. Sessions were recorded, transcribed, de-identified, and analysed using inductive thematic analysis, with themes categorized using the TDF.ResultsNineteen participants (healthcare providers, n = 6; PLHIV, n = 13) identified four key themes influencing hypertension medication adherence: (1) delays in seeking hypertension care (2), gaps in hypertension-related knowledge among patients (3), the role of social support in encouraging adherence, and (4) limited integration of hypertension care services into HIV programs. Barriers included reliance on traditional medicine, high pill burden, socio-economic challenges, and long waiting times. Social support and targeted educational interventions were identified as facilitators to improve adherence.ConclusionAddressing barriers to hypertension medication adherence among PLHIV requires a multifaceted approach. Interventions focusing on improving health literacy, fostering social support, and integrating hypertension care into routine HIV services are essential for optimizing health outcomes.

  • Research Article
  • 10.1186/s12889-025-25357-6
Factors influencing antiretroviral therapy adherence among youth living with HIV: a systematic review and meta-analysis.
  • Dec 3, 2025
  • BMC public health
  • Pairin Saenjun + 2 more

Adherence to antiretroviral therapy (ART) is vital for controlling the viral load and disease progression in people living with HIV. Previous reviews on ART adherence among youths living with HIV (YLHIV) are outdated and lack coverage of youth populations. A systematic review and meta-analysis were conducted using the WHO framework to identify factors influencing ART adherence among youth living with HIV (YLHIV). Nine electronic databases were used for studies published between January 2015 and November 2024. Eligible quantitative studies were included. A meta-analysis using a random-effects model was used to calculate pooled odds ratios (ORs) with 95% confidence intervals (CIs). A systematic review of 45 studies revealed ART adherence rates ranging from 20% to 93.8% (mean: 69.34%), which were primarily assessed via self-reported measures with a 95% threshold for good adherence. The meta-analysis identified significant factors across WHO dimensions affecting adherence. Socioeconomically, older age is associated with poorer ART adherence (OR = 0.86, 95% CI: 0.79-0.95), and higher education improved adherence (OR = 3.68, 95% CI: 1.70-7.95), whereas parental death reduced it (OR = 0.32, 95% CI: 0.18-0.57). Patient-related factors positively associated with adherence included HIV knowledge (OR = 2.35, 95% CI: 1.82-3.03) and self-efficacy (OR = 2.81, 95% CI: 1.58-4.99), whereas HIV stigma (OR = 0.61, 95% CI: 0.47-0.79) and depression (OR = 2.01, 95% CI: 1.16-3.50 for nonadherence) had negative impacts. Clinical factors benefiting adherence included viral load suppression (OR = 4.28, 95% CI: 1.63-11.26), whereas comorbidities (OR = 0.43, 95% CI: 0.32-0.59) reduced it. Therapy-related barriers included increased pill burden (OR = 0.36, 95% CI: 0.29-0.45) and medication side effects (OR = 0.36, 95% CI: 0.20-0.65). Healthcare system facilitators included positive patient-provider relationships (OR = 1.76, 95% CI: 1.35-2.29) and adult accompaniment (OR = 1.75, 95% CI: 1.32-2.32), whereas barriers included longer travel times (OR = 0.58, 95% CI: 0.39-0.86) and missed appointments (OR = 0.44, 95% CI: 0.31-0.63). Optimal adherence to ART is crucial for achieving effective viral suppression and enhancing the quality of life of youths living with HIV. Understanding the facilitators of and obstacles to ART among YLHIVs could be beneficial in designing interventions to increase ART adherence. CRD42023441441.

  • Research Article
  • 10.1016/j.jadohealth.2025.07.025
Acceptability, Facilitators, and Barriers of Long-Acting Injectable Cabotegravir/Rilpivirine Among Youth With HIV in the United States.
  • Dec 1, 2025
  • The Journal of adolescent health : official publication of the Society for Adolescent Medicine
  • Justin Unternaher + 5 more

Acceptability, Facilitators, and Barriers of Long-Acting Injectable Cabotegravir/Rilpivirine Among Youth With HIV in the United States.

  • Research Article
  • 10.1007/s40266-025-01266-6
Appropriate Use of Proton Pump Inhibitors in Older Adults: Concerns and Solutions.
  • Nov 21, 2025
  • Drugs & aging
  • Jennifer Bolt + 2 more

Proton pump inhibitors (PPIs) are amongst the most commonly prescribed medications worldwide. Clinical practice guidelines identify clear indications for short-term and long-term use; however, many older adults are prescribed potentially unnecessary PPIs. Multiple concerns exist with unnecessary PPI therapy, including the potential long-term risk of adverse effects. An association between PPI use and fractures, dementia, and respiratory and gastrointestinal infections has been suggested in observational data; however, there is a paucity of high-quality data supporting a causative relationship. Despite this, PPIs remain a target for medication optimization in older adults because of the high rate of unnecessary use, cost, and contribution to pill burden and polypharmacy. A multidimensional approach is required to reduce unnecessary PPI's, including the alignment of initial prescribing with evidence-based indications, reassessment of existing prescriptions, enhancement of knowledge and resources for patients and prescribers, and support for deprescribing. To increase deprescribing success, barriers to PPI deprescribing must be addressed, including the fear of symptom recurrence, insufficient time and education, and lack of concern regarding long-term use. Deprescribing strategies, such as tapering, can aid in success, as can the utilization of nonpharmacological and lower risk options for managing symptoms of gastric-acid-related disorders.

  • Research Article
  • 10.1007/s11060-025-05324-2
Effects of temozolomide dosing on outcome in glioblastoma
  • Nov 19, 2025
  • Journal of Neuro-Oncology
  • Anuradha Raghu + 2 more

PurposeTemozolomide (TMZ) with concomitant radiation is the standard therapy for treating glioblastomas (GBM) and is dosed based on body surface area (BSA) using a goal dose of 75 mg/m2. Neurooncologists have different methods of dosing patients, with some dosing within 5 mg of the calculated dose and others rounding to reduce patient burden. We aimed to determine the effect of rounded doses of TMZ on survival.MethodsWe conducted a single-center retrospective review of 380 patients with GBM from 2013 to 2024. Relevant data was extracted from electronic medical records. Kaplan-Meier curves and Cox regression models were used to determine survival outcomes.ResultsNo significant impact on survival outcomes was observed when distance from the calculated temozolomide dose was analyzed as a continuous variable (p = 0.156), adjusting for MGMT, the extent of resection, radiation fractions, and Karnofsky performance scores (KPS). Even limited to just MGMT-methylated tumors, TMZ dose did not affect survival. BMI had no impact on survival outcomes. Our subgroup analysis revealed that patients with MGMT-methylated tumors, total resection, higher KPS, and ≥ 30 radiation fractions had improved survival (p < 0.01). Dose interruptions were not more likely with doses above 75 mg/m2 (14%) than with doses at or below 75 mg/m2 (9%) (p = 0.22).ConclusionRounding temozolomide doses does not significantly impact survival outcomes or risk of treatment interruptions for patients with GBM. These findings may allow neuro-oncologists to prioritize reducing pill burden and treatment costs without compromising patient outcomes.

  • Research Article
  • 10.47941/ijhs.3334
Prevalence of awareness and factors associated with acceptability of HIV Pre-Exposure Prophylaxis among female University Students aged 18 to 24 years in Rwanda
  • Nov 18, 2025
  • International Journal of Health Sciences
  • Clarisse Murebwayire + 2 more

Purpose: HIV Pre-Exposure Prophylaxis (PrEP) is a key prevention tool for people at substantial risk of HIV like young women (YW). This study determined the prevalence and factors associated with PrEP acceptability among YW in Rwanda. Methodology: This study was a cross-sectional study that gathered quantitative information from 455 YW students in selected universities in Rwanda. A structured questionnaire was used to collect participants’ information about their socio-demography, along with PrEP awareness and acceptability. The data were analyzed using STATA 17 descriptively and a logistic regression model was built to determine factors associated with the PrEP acceptability. Findings: Of the participants, 87.5% had heard of PrEP, and 87.9% expressed willingness to use it when advised by a healthcare provider. Students unaware of PrEP were significantly more likely to accept it [aOR: 13.8], while those informed about both pill and injectable forms had higher acceptability [aOR: 15.8–20.4]. Students reporting no barriers and those likely to recommend PrEP were also more accepting [aOR: 4.5 and 153, respectively]. Unique contribution to theory, practice and policy: The study highlights high awareness and acceptability, though concerns about oral PrEP's pill burden persist. Enhancing education to counter myths and expanding access to injectable PrEP could improve uptake among YW in Rwanda.

  • Research Article
  • 10.1093/inthealth/ihaf130
A qualitative study on pre-exposure prophylaxis uptake and retention among men who have sex with men and transgender women in Myanmar.
  • Nov 13, 2025
  • International health
  • Ni Ni Tun + 10 more

Oral pre-exposure prophylaxis (PrEP) is efficacious in reducing human immunodeficiency virus transmission among people at substantial risk. In Myanmar's PrEP demonstration project among men who have sex with men (MSM) and transgender women (TGW), 39% (n=216) of eligible MSM/TGW initiated daily oral PrEP and 43% (n=93) of them remained on PrEP at 1y. Here we aimed to understand the barriers and facilitators of PrEP uptake and retention among Myanmar's MSM/TGW and healthcare providers. We conducted three focus group discussions among 29 MSM/TGW (PrEP users and non-users) and in-depth interviews among 18 MSM/TGW and 8 healthcare providers (non-PrEP and PrEP prescribers) from Yangon. Interviews were audio recorded and transcribed in Burmese. Transcripts were analysed using thematic analysis. Among 47 participating MSM/TGW, the median age was 27y, half identified as TGW (51% [n=24]) and 49% (n=23) were MSM and 53% (n=25) were taking PrEP during the study. Among healthcare providers, the median age was 31y, seven were male, one was female and half were PrEP providers. In our study, perceived stigma linked with homosexuality, the daily pill burden and community misconceptions of PrEP as antiretroviral therapy were barriers. Providing telemedicine services and incentives and having a supportive network and peers facilitated PrEP uptake and retention.

  • Research Article
  • 10.5588/ijtldopen.25.0369
Optimising child-friendly TB preventive treatment regimens
  • Nov 12, 2025
  • IJTLD OPEN
  • C Mulder + 7 more

SUMMARYBACKGROUNDThe World Health Organization recommends rifamycin-based TB preventive treatment (TPT) for children, but factors influencing regimen acceptability are not well understood. We explored perceptions of two short-course regimens – 3HP (weekly dosing) and 3RH (daily dosing) – among interest-holders in Ethiopia.METHODSForty-seven in-depth interviews were conducted with caregivers of TB-exposed children, community health workers, health care providers, and policymakers following the CHIP-TB trial, which evaluated home-based TPT delivery. Thematic content analysis was used to assess acceptability across factors such as palatability, dosing frequency, pill burden, adherence, and side effects.RESULTSBoth regimens were generally well tolerated. Caregivers reported good palatability, though some children vomited or spit out the medication. Weekly dosing with 3HP was seen as less burdensome but easier to forget, requiring additional support for adherence. Daily 3RH was considered more difficult due to the routine burden on caregivers. Interest-holders preferred 3HP overall but noted concerns about the high number of pills per dose. Mild side effects were reported with both regimens but did not result in discontinuation.CONCLUSIONInterest-holders favoured 3HP for its lower dosing burden, despite concerns about pill burden. Child-friendly, fixed-dose formulations and consideration of caregiver and child preferences are essential to improving adherence and treatment outcomes.

  • Research Article
  • 10.1093/neuonc/noaf201.0896
INNV-07. Effects of Temozolomide Dose Rounding on Outcome in Glioblastoma
  • Nov 11, 2025
  • Neuro-Oncology
  • Anuradha Raghu + 2 more

Abstract BACKGROUND Temozolomide (TMZ) with concomitant radiation is the standard therapy for treating glioblastomas (GBM) and is dosed based on body surface area (BSA) using a goal dose of 75 mg/m2. Neurooncologists have different methods of dosing patients, with some dosing within 5mg of the calculated dose and others rounding to reduce patient burden. We aimed to determine the effect of rounded doses of TMZ on survival. METHODS We conducted a single-center retrospective review of 380 patients with GBM from 2013 to 2024. Relevant patient data was extracted from electronic medical records. Kaplan-Meier curves and Cox regression models were used to determine survival outcomes. RESULTS No significant impact on survival outcomes was observed when distance from the calculated temozolomide dose was analyzed as a continuous variable (p = 0.309) adjusting for MGMT, the extent of resection, the number of radiation fractions, and performance status. Even limited to just MGMT methylated tumors, TMZ dose did not affect survival. When compared to people with dose within 5mg of 75mg/m2, survival was not changed with doses of 5-20 mg below the calculated dose (HR 0.842, p= 0.226). BMI had no impact on survival outcomes. Multivariable analysis revealed that patients with MGMT methylated tumors, total resection, higher Karnofsky performance scores, and ≥ 30 radiation fractions had improved survival (p &amp;lt; 0.01). Dose interruptions were not significantly more likely with doses above 75 mg/m2 (14%) than with doses at or below 75 mg/m2 (9%) (p = 0.22). CONCLUSION Rounding temozolomide doses does not significantly impact survival outcomes or risk of treatment interruptions for patients with GBM. These findings may allow neuro-oncologists to prioritize reducing pill burden and treatment costs without compromising patient outcomes. Clinical trials should consider dropping requirements for temozolomide dose within 5mg of 75mg/m2.

  • Research Article
  • Cite Count Icon 1
  • 10.1161/circoutcomes.125.012834
Patient Perspectives on a Polypill Strategy for Heart Failure with Reduced Ejection Fraction: A Convergent-Parallel Mixed Methods Study Embedded in a Randomized Clinical Trial.
  • Nov 10, 2025
  • Circulation. Cardiovascular quality and outcomes
  • Neil Keshvani + 9 more

Background: Heart failure with reduced ejection fraction (HFrEF) guideline-directed medical therapy (GDMT) remains underutilized, particularly in socioeconomically disadvantaged populations. It has been proposed that the use of combination pills (polypills) may facilitate prescribing of GDMT and increase adherence. Understanding patient perspectives on implementation barriers and facilitators to the use of polypills is needed for developing effective strategies. Methods: A convergent, parallel, mixed-methods study was conducted with participants who participated in a Phase II randomized controlled trial of an HFrEF polypill (POLY-HF; NCT04633005) in Dallas, Texas. Six focus groups were conducted with participants from both polypill and usual care arms, followed by brief surveys. Qualitative data were analyzed using directed content analysis organized by a socioecological framework to identify barriers and facilitators across individual, interpersonal, and systems levels. Descriptive statistics characterized medication burden and polypill preferences. Results: Study participants (n=41) included trial participants (n=36, mean 53 years, 53% Black race, 39% Hispanic) and caregivers (n=5). Quantitative data revealed substantial medication burden, with 58% taking ≥6 medications and 50.0% reporting missed doses, primarily due to forgetting (44%). 88.6% expressed interest in a polypill approach, and 83% believed it would improve adherence. Qualitative analysis identified multi-level implementation barriers and facilitators. Individual-level barriers included pill size concerns and uncertainty about polypill contents, while facilitators encompassed reduced pill burden, psychological benefits of taking fewer medications, and perceived health improvements. Interpersonal facilitators included caregiver enthusiasm for simplified medication management and strong provider trust. Systems level barriers centered on cost concerns, while institutional trust facilitated acceptance. Mixed-methods integration revealed convergent findings. Quantitative medication burden aligned with qualitative themes of regimen complexity, while high quantitative interest in polypills was contextualized by practical implementation considerations regarding formulation and delivery. Conclusions: In socioeconomically disadvantaged patients with HFrEF, a polypill strategy demonstrated strong patient acceptability, supporting further implementation research.

  • Research Article
  • 10.37275/bsm.v10i1.1492
Beyond Phosphate Binding: A Systematic Review and Meta-Analysis on the Efficacy and Safety of the Novel Paracellular Phosphate Inhibitor, Tenapanor, for Hyperphosphatemia in Dialysis Patients
  • Nov 4, 2025
  • Bioscientia Medicina : Journal of Biomedicine and Translational Research
  • Eva Julita + 4 more

Background: Hyperphosphatemia is a critical driver of cardiovascular morbidity and mortality in patients with chronic kidney disease (CKD) undergoing dialysis. Current management, reliant on phosphate binders, is hampered by high pill burden and poor adherence. Tenapanor, a first-in-class, minimally-absorbed sodium/hydrogen exchanger 3 (NHE3) inhibitor, reduces paracellular phosphate absorption. We performed a systematic review and meta-analysis of all available Phase 3 trials to quantify its efficacy and safety. Methods: We searched PubMed, Embase, and Cochrane CENTRAL through October 2025 for Phase 3 clinical trials evaluating tenapanor for hyperphosphatemia in dialysis patients. Data were extracted from 6 eligible studies (N=1573). We conducted separate random-effects meta-analyses for different study designs: 1) parallel-group monotherapy vs. placebo, 2) withdrawal-design monotherapy vs. placebo, 3) parallel-group add-on therapy vs. placebo, and 4) safety (diarrhea incidence) vs. placebo. Efficacy was measured by Mean Difference (MD) in serum phosphate change; safety by Risk Ratio (RR). Results: Tenapanor demonstrated significant efficacy across all study designs. In parallel-group monotherapy (1 study, N=167), tenapanor was superior to placebo (MD: -1.89 mg/dL; 95% CI: -2.36 to -1.42). In withdrawal-design studies (2 RCTs, N=373), tenapanor maintained serum phosphate levels significantly better than placebo (Pooled MD: -0.75 mg/dL; 95% CI: -1.05 to -0.45; I2=0%). As an add-on therapy (1 RCT, N=235), tenapanor provided additional phosphate reduction versus binders alone (MD: -0.65 mg/dL; 95% CI: -0.96 to -0.35). Tenapanor significantly increased the risk of diarrhea versus placebo (3 RCTs, N=521; Pooled RR: 4.10; 95% CI: 2.50 to 6.72; I2=30%), which was the primary adverse event leading to discontinuation. Conclusion: Tenapanor represents a new mechanistic paradigm for hyperphosphatemia management. It is a highly effective phosphate-lowering agent, both as monotherapy and add-on therapy, but is associated with a significant, mechanism-based risk of gastrointestinal side effects.

  • Research Article
  • 10.1007/s13346-025-02006-4
Optimization of print parameters for batch and continuous manufacturing of three-dimensional (3D) printed dosage forms using artificial intelligence and machine learning.
  • Nov 4, 2025
  • Drug delivery and translational research
  • Kshitij Chitnis + 5 more

Three-dimensional printing (3DP) holds significant potential for developing personalized pharmaceutical oral dosage forms (printlets). 3D printing has the advantage of fabricating complex geometric structures for versatile drug release profiles, enhancing patient preference, palatability and swallowability, reducing the pill burden, and increasing dose accuracy. Optimizing printing parameters is crucial in determining the quality of the printlets during dosage development. The integration of machine learning (ML) can reduce production costs and time through parameter optimization based on trained datasets. This research is focused on optimizing parameters for fused deposition modeling (FDM) based batch and continuous printing methods. The algorithm was trained using a three-level full factorial design, which generated data in the form of printlets with different parameters. Both defect and defect-free printlets were analyzed using image segmentation. Machine learning tools including Gaussian Process Regressor (GPR) and Efficient Global Optimization (EGO) were used to predict and select processing parameters for a targeted percentage surface defect. The final trained algorithm predicted new parameter sets for both batch (R2-0.8783) and continuous (R2-0.9364) printing methods to achieve zero defects, and the same was confirmed through printing and characterization of printlets which showed no defects. The algorithm was later adapted successfully to a variety of materials within the temperature range of 190-220 ℃ and predicted zero-defect printlets. Scanning electron microscopy (SEM) revealed the absence of defects on the surfaces of the materials. Results showed that flow rate (110 and 120 mm3/s) had a significant impact on printlet quality withwithout defects for both batch and continuous printing, compared to print speed, print temperature, and infill density. This research provides new insights into the development of optimized FDM printlets using batch and continuous printing with adaptive machine learning for pharmaceutical dosage manufacturing.

  • Research Article
  • 10.1016/j.eprac.2025.07.011
Chronic Hypoparathyroidism-Current and Emerging Therapies.
  • Nov 1, 2025
  • Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists
  • Sarah Khan + 1 more

Chronic Hypoparathyroidism-Current and Emerging Therapies.

  • Research Article
  • 10.54112/bcsrj.v6i10.2043
Factors of Non-Adherence to Antihypertensive Medicine in the Elderly Population
  • Oct 31, 2025
  • Biological and Clinical Sciences Research Journal
  • Neelam Nafees + 3 more

Hypertension is a leading cause of cardiovascular morbidity and mortality, particularly among the elderly. Despite the availability of effective antihypertensive therapies, medication non-adherence remains a major barrier to optimal blood pressure control. Understanding the multifactorial determinants of non-adherence among elderly hypertensive patients in low- and middle-income countries like Pakistan is essential for designing targeted interventions. Objective: To identify the factors contributing to non-adherence to antihypertensive medication among elderly hypertensive patients attending tertiary care hospitals in Lahore, Pakistan. Methods: A cross-sectional descriptive study was conducted at four public sector hospitals in Lahore from September 2019 to March 2020. A total of 200 hypertensive patients aged ≥60 years were recruited through purposive sampling. Data were collected using two standardized tools—the Drug Attitude Inventory-10 (DAI-10) and the Modified Drug Adherence Work-Up Tool (M-DRAW)—translated into Urdu and validated for internal consistency (Cronbach's α = 0.70 and 0.758, respectively). Descriptive statistics were used to summarize demographic data. In contrast, chi-square, independent t-tests, and ANOVA with post hoc Tukey's test were used to determine associations between demographic and adherence-related variables in SPSS version 20. A p-value &lt;0.05 was considered statistically significant. Results: The mean age of participants was 66.74 ± 5.39 years; 52% were male, and 54.5% had no formal education. Most patients (73.5%) had been under treatment for &gt;6 months, and 53.5% were taking three antihypertensive medications. The majority (68.5%) exhibited unintentional non-adherence, while 31.5% demonstrated intentional non-adherence. Financial burden (50%), pill burden (60.5%), and difficulty in maintaining medication schedules were the most frequent barriers. Condition-related factors (mean 3.0 ± 0.7) were the most significant contributors, followed by patient-related and socioeconomic factors (p&lt; 0.001). Significant associations were found between perceived benefit of therapy and education level (p = 0.017), dose adjustment and number of tablets (p = 0.010), and gender with treatment doubts (p = 0.018). Beliefs and health perceptions more strongly influenced intentional non-adherence, whereas unintentional non-adherence was associated with financial and regimen-related constraints. Conclusion: Non-adherence to antihypertensive medication among elderly patients is a multifaceted issue influenced by socioeconomic, educational, psychological, and treatment-related factors. Condition-related beliefs and patient-related perceptions play a dominant role, particularly in intentional non-adherence. Interventions should focus on patient education, simplifying medication regimens, enhancing family and social support, and providing financial assistance to improve long-term adherence and reduce hypertension-related complications in elderly populations.

  • Research Article
  • Cite Count Icon 1
  • 10.1093/ejendo/lvaf222
Revised European Society of Endocrinology Clinical Practice Guideline: Treatment of Chronic Hypoparathyroidism in Adults.
  • Oct 30, 2025
  • European journal of endocrinology
  • Jens Bollerslev + 12 more

In the present European Society of Endocrinology (ESE) clinical guideline, we present recommendations for the diagnosis, management, and monitoring of chronic hypoparathyroidism (HypoPT) in adults. Management of HypoPT has changed since the first ESE clinical guideline was published in 2015, as has the knowledge on patient burden of the disease, and the understanding of associated morbidities. In line with the ESE policy, the 2015 guidelines were updated based on up-to-date scientific evidence. As HypoPT is an orphan disease, strong evidence for most outcomes is scarce and recommendations were based on careful synthesis of the literature and expert opinion. Postsurgical HypoPT should be defined as persisting more than 12 months following surgery; recovery could be expected even thereafter (clinical question I [Q I]). For Q II (optimal treatment of chronic HypoPT), relevant data regarding conventional treatment are lacking for clinically relevant endpoints and long-term effects. PTH replacement therapy reduces the pill burden of conventional therapy, improves various biochemical parameters, and potentially improves QoL. We cannot recommend a substantial role for parathyroid allotransplantation in the treatment of chronic HypoPT (Q III). In conclusion, we present recommendations for the diagnosis, management, and monitoring of chronic HypoPT in adults, to give health care providers practical clinical guidance on the management of this condition. The guideline can serve as a source for preparation of educational materials to empower patients and clinicians.

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