Patients and healthcare workers' preferences for using smart lockers in accessing and dispensing chronic disease medication in Nigeria: Findings from a descriptive cross-sectional study.

The use of smart locker technology has been beneficial for patients with chronic diseases who require regular medication and face challenges accessing healthcare facilities due to distance, time, or mobility issues. This study aimed to assess preferences for utilizing Smart Lockers in accessing and dispensing chronic disease medication among healthcare workers (HCWs) and patients in Nigeria. A descriptive cross-sectional survey was conducted between November 8th and December 4th, 2021, across secondary healthcare facilities in five states of Adamawa, Akwa Ibom, Cross River, Benue, and Niger. Among 1,133 participants included in the analysis, 405 were HCWs and 728 were patients with chronic illnesses. Descriptive statistics, including frequencies and percentages, were used to summarize the data, while chi-square tests were employed to assess significant differences between healthcare workers (HCWs) and patients. Results indicated a strong preference among both HCWs and patients for one-on-one counseling as the preferred method for orientating patients on using Smart Lockers, with 53.8% of HCWs and 58.1% of patients expressing this preference (p = 0.25). Additionally, there was a shared preference for hospitals or clinics as secure locations for Smart Lockers, with 68.9% of HCWs and 71.6% of patients preferring this option (p < 0.05). The majority of participants favored receiving notification of drug delivery via phone call, with 49.1% of HCWs and 48.8% of patients expressing this preference (p = 0.63). There was a significant difference in preferences for access hours, the majority (HCWs: 65.4% and patients: 52.6%) favored 24-hour access (p < 0.05). Participants identified patients with HIV within the age range of 18-40 as the most suitable population to benefit from using Smart Lockers for medication dispensing. These findings offer insights into healthcare policies aimed at enhancing medication access and adherence among patients with chronic diseases in Nigeria. The development of models for using smart lockers to dispense chronic disease medications to chronically ill persons in Nigeria and other populations is recommended.

Innovative Approaches to Enhance and Measure Medication Adherence in Chronic Disease Management: A Review.

Medication non-adherence is a problem that affects up to 50% of patients with chronic diseases. The result is a failure to achieve therapeutic goals and an increased burden on the healthcare system. It is, therefore, highly appropriate to develop models to assess patient adherence to prescribed therapy. To date, there are many methods for doing this. However, several tools have been developed that subjectively or objectively, directly or indirectly, assess the level of patient adherence. Electronic medication packaging devices are among the most rapidly evolving methods of measuring adherence. Other emerging technologies include the use of artificial intelligence algorithms and ingestible biosensors. The former is being used to create applications for mobile phones and laptops. The latter appears to be the least susceptible to the risk of overestimating adherence but remains very expensive. Here, we present recent developments in measuring patient adherence, and provide details of achievements in objective methods for assessing adherence, such as electronic monitoring devices, video-observed therapy, and ingestible biosensors. A dedicated section on using artificial intelligence and machine learning in adherence measurement and reviewing questionnaires and scales used in specific diseases is also included. Methods are discussed along with their advantages and potential limitations. This article aimed to review current measures and future initiatives to improve patient medication adherence.

Intervention strategies to improve adherence to treatment for selected chronic conditions in sub-Saharan Africa: a systematic review.

INTRODUCTION: Evidence-based intervention strategies to improve adherence among individuals living with chronic conditions are critical in ensuring better outcomes. In this systematic review, we assessed the impact of interventions that aimed to promote adherence to treatment for chronic conditions. METHODS: We systematically searched PubMed, Web of Science, Scopus, Google Scholar and CINAHL databases to identify relevant studies published between the years 2000 and 2023 and used the QUIPS assessment tool to assess the quality and risk of bias of each study. We extracted data from eligible studies for study characteristics and description of interventions for the study populations of interest. RESULTS: Of the 32,698 total studies/records screened, 2814 were eligible for abstract screening and of those, 497 were eligible for full-text screening. A total of 82 studies were subsequently included, describing a total of 58,043 patients. Of the total included studies, 58 (70.7%) were related to antiretroviral therapy for HIV, 6 (7.3%) were anti-hypertensive medication-related, 12 (14.6%) were anti-diabetic medication-related and 6 (7.3%) focused on medication for more than one condition. A total of 54/82 (65.9%) reported improved adherence based on the described study outcomes, 13/82 (15.9%) did not have clear results or defined outcomes, while 15/82 (18.3%) reported no significant difference between studied groups. The 82 publications described 98 unique interventions (some studies described more than one intervention). Among these intervention strategies, 13 (13.3%) were multifaceted (4/13 [30.8%] multi-component health services- and community-based programmes, 6/13 [46.2%] included individual plus group counselling and 3/13 [23.1%] included SMS or alarm reminders plus individual counselling). DISCUSSION: The interventions described in this review ranged from adherence counselling to more complex interventions such as mobile health (mhealth) interventions. Combined interventions comprised of different components may be more effective than using a single component in isolation. However, the complexity involved in designing and implementing combined interventions often complicates the practicalities of such interventions. CONCLUSIONS: There is substantial evidence that community- and home-based interventions, digital health interventions and adherence counselling interventions can improve adherence to medication for chronic conditions. Future research should answer if existing interventions can be used to develop less complicated multifaceted adherence intervention strategies.

Quantification of Oversupply of Chronic Disease Medications among Patients Aged ≥55 Years in Japan.

Medication waste may be caused by medication oversupply; however, the degree of medication oversupply in Japan is unclear. This study aimed to quantify the degree of oversupply of chronic disease medications per patient, the proportion of oversupplied patients, and the excess days and costs of the oversupplied medications in Japan. This retrospective nationwide cohort study using a large insurance claims database from Japan was conducted in patients aged ≥55 years who received one or a combination of the following five classes of medications dispensed in FY 2019: third-generation calcium antagonists, angiotensin 2 receptor blockers, statins, dipeptidyl peptidase-4 inhibitors, and biguanides. Medications with the same ingredient having the same specification were treated as the same medication. Medication oversupply was defined as a medication possession ratio (MPR) during persistence >1.0. The proportions of oversupplied patients and excessively oversupplied patients with ≥30 excess days/year were approximately 16 and 1-2% for all drug classes, respectively. Three-quarters of the oversupplied patients had fewer excess day (≤14/year), and the median oversupplied medication cost was less than 1000 yen/year for all classes. However, there was a patient with oversupplied medication estimated as 983 excess days per year and a patient with oversupplied medication costs of nearly 90000 yen per year. Using the MPR and excess days as indicators, it is necessary to accelerate estimation of the oversupply per patient, as well as the development of patient intervention strategies and a national system to reduce medication oversupply.

[Translated article] Validated questionnaires on medication adherence and associated factors in chronic patients: A systematic review.

OBJECTIVE: To identify validated questionnaires to assess medication adherence, and its associated factors, in adult patients with chronic pathologies. METHOD: A systematic review of scientific publications that describe validated medication adherence questionnaires in PubMed and Scopus was carried out during May 2022. The search strategy combined the MeSH heading "Medication adherence" with the keywords: "Questionnaire" and "Validation"; adding "Spanish" to rescue questionnaires in our language. Systematic reviews, meta-analyses, or scientific articles with full text available in Spanish or English were selected; published from January 2000 to April 2022; that present the application and validation of a medication adherence questionnaire in adults with chronic pathologies; and publications of the initial validation of a questionnaire, recovered through bibliographic citations of the previously identified publications, even if they are prior to the year 2000. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were followed to represent the search process, inclusion and exclusion of the retrieved publications. RESULTS: (97) records in PubMed and 3 adding "Spanish" were retrieved; in Scopus, 334 records were retrieved and 13 with "Spanish". 118 records were retrieved through bibliographic citations identification. From the analysis of the previous publications, 14 validated questionnaires were identified that assess medication adherence and are applied in English and/or Spanish in adult patients with chronic pathologies. For each questionnaire, the following characteristics were described: name, authors, year of publication, dimensions (barriers and facilitators factors), number and wording of the items, response scale, form of administration, language, and pathologies of the initial validation. Of the subsequent validations, only those carried out in English and/or Spanish were presented. So far, 6 questionnaires were validated in Spanish and only for certain chronic pathologies. CONCLUSIONS: (14) validated questionnaires were identified, 6 of them were validated in Spanish. They are designed to evaluate medication adherence in a comprehensive manner, being useful to be applied in hospital and community pharmaceutical services. This review provides health professionals with tools to develop and validate their own questionnaire, adapting the wording to the local language and context of the health system.

[Potentially inappropriate medication in older adults with palliative care at home]. / Medicación potencialmente inapropiada en adultos mayores con necesidades paliativas en domicilio.

INTRODUCTION: Older adults with advanced chronic diseases and palliative care needs are more exposed to polypharmacy and use of potentially inappropriate medication, which generates a high risk of adverse events and impaired quality of life. The objective of this study was to describe the frequency of potentially inappropriate medication use among older adults with palliative care needs receiving home care services after hospital discharge. METHODS: Observational cross-sectional study of pharmacy dispensing and electronic health records, of older adults in a home care system and with palliative care needs according to the screening with the NECPAL tool or the PROFUND and/or PALIAR indexes. Dispensed medications during 180 days after admission to home care were analyzed. Medications were classified as potentially inappropriate according to the LESS-CHRON criteria. RESULTS: We included 176 patients, mean age 87.4 years, 67% were women; 73% were pluripathologic patients and 22% had one chronic progressive disease. Mortality at 6 months was 73%. Median frequency of dispensed medications per patient was 9.1 (IQR = 4-9.7). The frequency of potentially inappropriate medication dispensation among patients was 87%, mainly antihypertensives, benzodiazepines and antipsychotics. CONCLUSION: This study observed that dispensation of potentially inappropriate medication among older adults with palliative care needs and home care services is very high. This emphasizes the need for effective patient-centered interventions to prevent inadequate prescription and stimulate de-prescription.

Introducción: Los adultos mayores con enfermedades crónicas avanzadas y necesidad de cuidados paliativos están más expuestos a la polifarmacia y a consumir medicación potencialmente inapropiada, la cual genera un alto riesgo de eventos adversos y alteración de la calidad de vida. El objetivo de este estudio fue describir la frecuencia de consumo de medicación potencialmente inapropiada de adultos mayores con necesidad de cuidados paliativos que ingresaron a cuidados domiciliarios luego de una hospitalización. Métodos: Estudio de corte transversal observacional de registros de dispensación e historias clínicas electrónicas, de adultos mayores en un sistema de cuidados domiciliarios y con necesidades de cuidados paliativos según el rastreo con la herramienta NECPAL, los índices PROFUND y/o PALIAR. Se analizó el consumo de fármacos durante los 180 días posteriores al ingreso a cuidados domiciliarios. Se clasificaron los fármacos como potencialmente inapropiados según criterios de LESS-CHRON. Resultados: Se incluyeron 176 pacientes, edad promedio 87.4 años, 67% mujeres; 78% eran pluripatológicos y 22% presentaban una enfermedad única crónica progresiva. La mortalidad a los 6 meses fue 73%. La mediana de consumo de fármacos por paciente fue 9.1 (RIC = 4-9.7). El 87% consumía medicación potencialmente inapropiada, principalmente antihipertensivos, benzodiacepinas y antipsicóticos. Conclusión: Este estudio observó que los adultos mayores, con necesidad de cuidados paliativos en cuidados domiciliarios, tienen un alto consumo de medicación potencialmente inapropiada. Esto refuerza la necesidad de implementar intervenciones efectivas centradas en el paciente, para prevenir la prescripción inadecuada y estimular la de-prescripción.

Pharmacotherapy of Chronic Neuropsychiatric Conditions During Pregnancy.

Many pregnant persons will experience neuropsychiatric conditions during pregnancy, including migraine, attention deficit disorder, depression, and anxiety. Treatment of each of these conditions requires shared decision-making among the individual, family, and health care team. Although medications may include risk, the benefits often outweigh the potential fetal risks. In this article, we review pharmacologic treatment options for each of these conditions and appropriate use in pregnancy to maintain the stability of conditions and to optimize maternal and fetal outcomes.

Cost Effectiveness of Fremanezumab in Episodic and Chronic Migraine Patients from a Japanese Healthcare Perspective.

BACKGROUND AND OBJECTIVES: Fremanezumab is an effective treatment for episodic (EM) and chronic migraine (CM) patients in Japan, but its cost effectiveness remains unknown. The objective of this study was to determine the cost effectiveness of fremanezumab compared with standard of care (SOC) in previously treated EM and CM patients from a Japanese healthcare perspective. METHODS: Estimated regression models were implemented in a probabilistic Markov model to inform effectiveness and health-related quality-of-life data for fremanezumab and SOC. The model was further populated with data from the literature. The adjusted Japanese healthcare perspective included productivity losses. The main model outcomes were quality-adjusted life-years (QALYs), costs (2022 Japanese Yen [¥]), and incremental outcomes including the incremental cost-effectiveness ratio (ICER). Analyses were performed separately for the EM and CM patients and combined. Costs and effects were discounted at an annual rate of 2.0%. RESULTS: The mean QALYs over a 25-year time horizon for the EM and CM populations combined were 13.03 for SOC and 13.15 for fremanezumab. The associated costs were ¥27,550,292 for SOC and ¥28,371,048 for fremanezumab. QALYs were higher and costs lower for EM patients compared with CM patients for both fremanezumab and SOC. The deterministic ICERs of fremanezumab versus SOC were ¥6,334,861 for EM, ¥7,393,824 for CM, and ¥6,530,398 for EM and CM combined. Indirect costs and choice of mean migraine days model distribution had a substantial impact on the ICER. CONCLUSION: Using fremanezumab in a heterogeneous mixture of Japanese EM and CM patients resulted in a reduction of monthly migraine days and thus more QALYs compared with SOC. The cost effectiveness of fremanezumab versus SOC in EM and CM patients resulted in an ICER of ¥6,530,398, from an adjusted Japanese public healthcare perspective.

Fremanezumab is an effective treatment for episodic and chronic migraine patients in Japan, but it is unknown how the costs relate to the health benefits. The current research determined the relation between costs and effects of fremanezumab compared with the current standard of care in Japanese clinical practice, to see if the costs are justified by the health benefits. A model was used to inform the treatment effect of fremanezumab and standard of care. Data on costs, the frequency in which health care was used, and impairment of work due to migraine were also included in the model and obtained from the literature. The main outcomes were the number of years that patients were alive while taking their quality of life into account, costs, and the difference in these outcomes between patients who were treated with fremanezumab and those receiving standard of care. Subsequently, it was estimated how costs and effects related to one another and whether the costs were justified by the health benefits. The outcomes showed that patients treated with fremanezumab had a better quality of life compared with those receiving standard of care, while the costs associated with fremanezumab were higher. Compared with standard of care, the health benefits of treating patients with fremanezumab were justified by the costs within an acceptable range. Taking the absence from work due to illness into account had a substantial impact on the model outcomes.

[Research progress on curcumin improving chronic low-grade inflammation and related diseases].

Chronic low-grade inflammation(CLGI), a relatively new concept without a clear definition, refers to a nonspecific, chronic, continuous, and low-grade inflammation state, and it is closely associated with various chronic diseases, including obesity, inflammatory bowel disease, neurodegenerative diseases, and tumors. Improvement of CLGI can slow down disease progression. Anti-inflammatory treatment is an important strategy for prevention and treatment of CLGI. However, there is currently no definitive drug treatment method. Curcumin is a polyphenolic compound extracted from the rhizome of zingiberaceae, with significant anti-inflammatory activity. Research has shown that curcumin can play an anti-inflammatory role by regulating NF-κB, JAK/STAT, PI3K/Akt, MAPK, NLRP3 inflammasome, Nrf2/ARE, and other inflammation-related pathways. This paper summarized the anti-inflammatory mechanisms, pharmacological effect, and clinical application of curcumin in improving CLGI and other diseases, so as to provide a reference for in-depth research and clinical application of curcumin in improving CLGI.

Evaluation of adherence to pharmacological treatments by undocumented migrants with chronic diseases: a 10-year retrospective cohort study.

OBJECTIVES: To investigate the time course of medication adherence and some of the factors involved in this process in undocumented migrants with chronic diseases. DESIGN: Retrospective cohort study. SETTING: A big non-governmental organisation in Milano, Italy, giving medical assistance to undocumented migrants. PARTICIPANTS: 1918 patients, 998 females and 920 males, with at least one chronic condition (diabetes, cardiovascular diseases (CVDs), mental health disorders) seen over a period of 10 years (2011-2020). Their mean age was 49.2±13 years. RESULTS: Adherence to medications decreased over 1 year in all patients. This was more evident during the first 2 months of treatment. Patients on only one medication were less adherent than those on more than one medication; at 6 months the percentage of patients with high adherence was 33% vs 57% (p<0.0001) for diabetes, 15% vs 46% (p<0.0001) for mental disorders and 35% vs 59% (p<0.0001) for CVDs. Patients with mental disorders had the lowest adherence: 25% at 6 months and 3% at 1 year. Mental disorders, when present as comorbidities, greatly reduced the probability of being highly adherent: risk ratio (RR) 0.72 (95% CI 0.57 to 0.91; p=0.006) at 3 months, RR 0.77, (95% CI 0.59 to 1.01; p=0.06) at 6 months, RR 0.35 (95% CI 0.13 to 0.94; p=0.04) at 1 year. This was especially evident for patients with CVDs, whose percentage of high adherents decreased to 30% (p=0.0008) at 6 months and to 3% (p=0.01) at 1 year. We also noted that highly adherent patients usually were those most frequently seen by a doctor. CONCLUSIONS: Interventions to increase medication adherence of undocumented migrants with chronic diseases are necessary, particularly in the first 2 months after beginning treatment. These should be aimed at people-centred care and include more outpatient consultations. Educational interventions should especially be taken into consideration for patients on monotherapy.

Cost-utility analysis of add-on vericiguat for the treatment of chronic heart failure with reduced ejection fraction in China.

OBJECTIVE: This study aimed to evaluate the cost-utility of the addition of vericiguat for treating chronic heart failure (CHF) in China from the healthcare payer's perspective. METHODS: A Markov model was built to estimate the cost and utility of treating CHF using vericiguat plus standard treatment (vericiguat group) vs. standard treatment alone (standard treatment group). The clinical parameters (mortality of cardiovascular and hospitalization rate of HF) were calculated according to the VICTORIA clinical trial. The HF cost and utility data were obtained from the literature published in China. One-way sensitivity analysis and probability sensitivity analysis were performed. RESULTS: According to the 13-year model, vericiguat was more expensive (155599.07 CNY vs. 259396.83 CNY) and more effective (4.41 QALYs vs. 4.54 QALYs). The incremental cost-utility ratio (ICUR) was 802389.27 CNY per QALY. One-way sensitivity analysis revealed that cardiovascular mortality in the two groups was the parameter that had the greatest impact on the results. The GDP per capita in 2022 in China was 85,700 CNY. The probability sensitivity analysis (PSA) showed that the probability of vericiguat being cost-effective was only 41.7% at the willingness-to-pay (WTP) threshold of 3 times GDP per capita (257,100 CNY). CONCLUSIONS: In China, the treatment of CHF with vericiguat is not cost-effective. The drug price could decrease to 145.8 CNY, which could be considered cost-effective.

Exploring the pathways of drug repurposing and Panax ginseng treatment mechanisms in chronic heart failure: a disease module analysis perspective.

Chronic Heart Failure (CHF) is a significant global public health issue, with high mortality and morbidity rates and associated costs. Disease modules, which are collections of disease-related genes, offer an effective approach to understanding diseases from a biological network perspective. We employed the multi-Steiner tree algorithm within the NeDRex platform to extract CHF disease modules, and subsequently utilized the Trustrank algorithm to rank potential drugs for repurposing. The constructed disease module was then used to investigate the mechanism by which Panax ginseng ameliorates CHF. The active constituents of Panax ginseng were identified through a comprehensive review of the TCMSP database and relevant literature. The Swiss target prediction database was utilized to determine the action targets of these components. These targets were then cross-referenced with the CHF disease module in the STRING database to establish protein-protein interaction (PPI) relationships. Potential action pathways were uncovered through Gene Ontology (GO) and KEGG pathway enrichment analyses on the DAVID platform. Molecular docking, the determination of the interaction of biological macromolecules with their ligands, and visualization were conducted using Autodock Vina, PLIP, and PyMOL, respectively. The findings suggest that drugs such as dasatinib and mitoxantrone, which have low docking scores with key disease proteins and are reported in the literature as effective against CHF, could be promising. Key components of Panax ginseng, including ginsenoside rh4 and ginsenoside rg5, may exert their effects by targeting key proteins such as AKT1, TNF, NFKB1, among others, thereby influencing the PI3K-Akt and calcium signaling pathways. In conclusion, drugs like dasatinib and midostaurin may be suitable for CHF treatment, and Panax ginseng could potentially mitigate the progression of CHF through a multi-component-multi-target-multi-pathway approach. Disease module analysis emerges as an effective strategy for exploring drug repurposing and the mechanisms of traditional Chinese medicine in disease treatment.

Characteristics and efficacy of traditional Chinese medicine in the therapeutic strategy of chronic coronary syndrome: A systematic review and meta-analysis.

BACKGROUND AND AIMS: Chronic coronary syndrome (CCS) has always been controversial in its therapeutic strategy. Although invasive treatment and optimal medication therapy (OMT) are the most commonly used treatments, doctors continue to debate the best strategy. However, traditional Chinese medicine (TCM) for CCS is effective clinically. METHODS: To identify potentially eligible observational and experimental studies, we searched Pubmed, the Web of Science, and the China National Knowledge Internet. To be eligible, studies had to report with end-of treatment outcomes, such as major adverse cardiac events (MACE), deaths from myocardial infarctions (MI), all-cause mortality, angina, cardiac mortality, the effectiveness rate of electrocardiographs, and the reduction rate of the Nitroglycerin tablets. Risk differences (RDs) and 95 % confidence intervals (95 % CIs) were calculated based on random-effects models or fixed-effects models. Citation screening, data abstraction, risk assessment, and strength-of-evidence grading were completed by 2 independent reviewers. RESULTS: In Section 1 (13 studies, involving 17,287 patients), showed no significant difference between invasive treatment and medication treatment in MACE (RD = -0.04, 95% CI = -0.08 to 0.00, I2 = 76.4 %), all-cause mortality (RD = -0.01, 95%CI = -0.022 to 0.01, I2 = 73.44 %), MI (RD = 0.00, 95%CI = -0.00 to 0.01, I2 = 0.00 %) and cardiac mortality (RD = 0.00, 95 %CI = -0.01 to 0.01, I2 = 34.9 %). In Section 2 (21 studies, including 1820 patients), compared with WM treatment, TCM + WM treatment increased ECG effectiveness by 18 %, angina effectiveness by 20 %, and stopping or reducing Nitroglycerin tablets by 20 %. In Section 3 (25 studies, including 2859 patients) showed that TCM revealed a better electrocardiogram effective rate (RD = 0.10, 95 %CI = 0.05 to 0.14, I2 = 44.7 %) and angina effective rate (RD = 0.12, 95 %CI = 0.09 to 0.15, I2 = 44.9 %). We identified that TCM treatment properties of "Circulating blood and transforming stasis" and application of warm/heat-properties medicines were frequently used in CCS treatment. CONCLUSIONS: TCM treatment has shown superior beneficial cardioprotective in CCS therapy strategy, among which "Circulating blood and transforming stasis" and the application of warm/heat-properties medicine are its characteristics.

Integration of persistence in the 5P-medicine approach for age-related chronic diseases.

5P medicine is defined as Personalized, Predictive, Preventive, Participatory, and Population-based. 5P medicine may be improved by including a factor that could provide information about the therapeutic value of a particular drug treatment and measure its effectiveness in clinical practice. We propose that this factor may be treatment persistence, and that its addition to 5P medicine would allow to define a new improved 6P medicine. Persistence is the length of time between initiation and the last dose, which immediately precedes discontinuation, that is, a definitive suspension of the treatment. By including this sixth P, the persistence, we would be able to present the value of a treatment for each individual patient with its own characteristics, state of the disease, with more than one age-related diseases and patient journey. Persistence is a concept of the value of a treatment that includes the three main stakeholders of the pharmacotherapeutic process: Patient, Physician, and Pharmacist. Persistence is becoming a useful measure to evaluate the long-term effectiveness of therapies in real-world setting in chronic diseases. Drug treatments with longer persistence are more likely to provide better disease control and to be amenable to dose adjustment in order to optimize treatment cost in age-related chronic diseases. Long-term persistence could be a measure of a drug´s real-world performance and has been shown to aid in clinical decision-making.

Could GLP-1 Receptor Agonists Like Semaglutide Treat Addiction, Alzheimer Disease, and Other Conditions?

This Medical News story examines other potential uses of GLP-1 receptor agonists, the popular type 2 diabetes and weight-loss drugs.

Dietary Influence on Drug Efficacy: A Comprehensive Review of Ketogenic Diet-Pharmacotherapy Interactions.

It is widely acknowledged that the ketogenic diet (KD) has positive physiological effects as well as therapeutic benefits, particularly in the treatment of chronic diseases. Maintaining nutritional ketosis is of utmost importance in the KD, as it provides numerous health advantages such as an enhanced lipid profile, heightened insulin sensitivity, decreased blood glucose levels, and the modulation of diverse neurotransmitters. Nevertheless, the integration of the KD with pharmacotherapeutic regimens necessitates careful consideration. Due to changes in their absorption, distribution, metabolism, or elimination, the KD can impact the pharmacokinetics of various medications, including anti-diabetic, anti-epileptic, and cardiovascular drugs. Furthermore, the KD, which is characterised by the intake of meals rich in fats, has the potential to impact the pharmacokinetics of specific medications with high lipophilicity, hence enhancing their absorption and bioavailability. However, the pharmacodynamic aspects of the KD, in conjunction with various pharmaceutical interventions, can provide either advantageous or detrimental synergistic outcomes. Therefore, it is important to consider the pharmacokinetic and pharmacodynamic interactions that may arise between the KD and various drugs. This assessment is essential not only for ensuring patients' compliance with treatment but also for optimising the overall therapeutic outcome, particularly by mitigating adverse reactions. This highlights the significance and necessity of tailoring pharmacological and dietetic therapies in order to enhance the effectiveness and safety of this comprehensive approach to managing chronic diseases.

Associations Between Surrogate Markers and Clinical Outcomes for Nononcologic Chronic Disease Treatments.

Importance: Surrogate markers are increasingly used as primary end points in clinical trials supporting drug approvals. Objective: To systematically summarize the evidence from meta-analyses, systematic reviews and meta-analyses, and pooled analyses (hereafter, meta-analyses) of clinical trials examining the strength of association between treatment effects measured using surrogate markers and clinical outcomes in nononcologic chronic diseases. Data sources: The Food and Drug Administration (FDA) Adult Surrogate Endpoint Table and MEDLINE from inception to March 19, 2023. Study Selection: Three reviewers selected meta-analyses of clinical trials; meta-analyses of observational studies were excluded. Data Extraction and Synthesis: Two reviewers extracted correlation coefficients, coefficients of determination, slopes, effect estimates, or results from meta-regression analyses between surrogate markers and clinical outcomes. Main Outcomes and Measures: Correlation coefficient or coefficient of determination, when reported, was classified as high strength (r ≥ 0.85 or R2 ≥ 0.72); primary findings were otherwise summarized. Results: Thirty-seven surrogate markers listed in FDA's table and used as primary end points in clinical trials across 32 unique nononcologic chronic diseases were included. For 22 (59%) surrogate markers (21 chronic diseases), no eligible meta-analysis was identified. For 15 (41%) surrogate markers (14 chronic diseases), at least 1 meta-analysis was identified, 54 in total (median per surrogate marker, 2.5; IQR, 1.3-6.0); among these, median number of trials and patients meta-analyzed was 18.5 (IQR, 12.0-43.0) and 90 056 (IQR, 20 109-170 014), respectively. The 54 meta-analyses reported 109 unique surrogate marker-clinical outcome pairs: 59 (54%) reported at least 1 r or R2, 10 (17%) of which reported at least 1 classified as high strength, whereas 50 (46%) reported slopes, effect estimates, or results of meta-regression analyses only, 26 (52%) of which reported at least 1 statistically significant result. Conclusions and Relevance: Most surrogate markers used as primary end points in clinical trials to support FDA approval of drugs treating nononcologic chronic diseases lacked high-strength evidence of associations with clinical outcomes from published meta-analyses.