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1.
BMC Musculoskelet Disord ; 25(1): 440, 2024 Jun 05.
Article En | MEDLINE | ID: mdl-38840084

BACKGROUND: Low back pain (LBP) is a common health condition and the leading cause of years lived with disability worldwide. Most LBP episodes have a favourable prognosis, but recurrences within a year are common. Despite the individual and societal impact related to LBP recurrences, there is limited evidence on effective strategies for secondary prevention of LBP and successful implementation of intervention programmes in a real-world context. The aim of this study is to analyse the effectiveness of a tailored exercise and behavioural change programme (MyBack programme) in the secondary prevention of LBP; and evaluate acceptability, feasibility and determinants of implementation by the different stakeholders, as well as the implementation strategy of the MyBack programme in real context. METHODS: This protocol describes a hybrid type I, randomized controlled trial to evaluate the effectiveness and implementation of MyBack programme in the context of primary health care. The Behaviour Change Wheel framework and FITT-VP principles will inform the development of the behaviour change and exercise component of MyBack programme, respectively. Patients who have recently recovered from an episode of non-specific LBP will be randomly assigned to MyBack and usual care group or usual care group. The primary outcome will be the risk of LBP recurrence. The secondary outcomes will include disability, pain intensity, musculoskeletal health, and health-related quality of life. Participants will be followed monthly for 1 year. Costs data related to health care use and the MyBack programme will be also collected. Implementation outcomes will be assessed in parallel with the effectiveness study using qualitative methods (focus groups with participants and health providers) and quantitative data (study enrolment and participation data; participants adherence). DISCUSSION: To our knowledge, this is the first study assessing the effectiveness and implementation of a tailored exercise and behaviour change programme for prevention of LBP recurrences. Despite challenges related to hybrid design, it is expected that data on the effectiveness, cost-effectiveness, and implementation of the MyBack programme may contribute to improve health care in patients at risk of LBP recurrences, contributing to direct and indirect costs reduction for patients and the health system. TRIAL REGISTRATION NUMBER: NCT05841732.


Exercise Therapy , Low Back Pain , Secondary Prevention , Humans , Low Back Pain/prevention & control , Low Back Pain/therapy , Exercise Therapy/methods , Secondary Prevention/methods , Recurrence , Treatment Outcome , Adult , Cost-Benefit Analysis , Male , Female , Quality of Life , Health Behavior , Pain Measurement
2.
Ann Cardiol Angeiol (Paris) ; 73(3): 101761, 2024 Jun.
Article Fr | MEDLINE | ID: mdl-38754180

After a first episode of unprovoked vein thrombosis, the risk of recurrence persists for many years. Long term of anticoagulant therapy prevents the recurrence of vein thrombosis but is associated with a major risk of bleeding. As platelets play a role in the initiation and propagation of venous thromboembolism as well, antiplatelet agents, may play a role in the treatment and prevention of this disease. This review summarizes available evidence on effect of aspirin in the prevention of recurrent deep vein thrombosis.


Aspirin , Platelet Aggregation Inhibitors , Secondary Prevention , Venous Thromboembolism , Humans , Aspirin/therapeutic use , Venous Thromboembolism/prevention & control , Platelet Aggregation Inhibitors/therapeutic use , Recurrence
3.
BMJ Open ; 14(5): e078053, 2024 May 30.
Article En | MEDLINE | ID: mdl-38816049

OBJECTIVES: This systematic review with meta-analyses of randomised trials evaluated the preventive effects of vitamin A supplements versus placebo or no intervention on clinically important outcomes, in people of any age. METHODS: We searched different electronic databases and other resources for randomised clinical trials that had compared vitamin A supplements versus placebo or no intervention (last search 16 April 2024). We used Cochrane methodology. We used the random-effects model to calculate risk ratios (RRs), with 95% CIs. We analysed individually and cluster randomised trials separately. Our primary outcomes were mortality, adverse events and quality of life. We assessed risks of bias in the trials and used Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) to assess the certainty of the evidence. RESULTS: We included 120 randomised trials (1 671 672 participants); 105 trials allocated individuals and 15 allocated clusters. 92 trials included children (78 individually; 14 cluster randomised) and 28 adults (27 individually; 1 cluster randomised). 14/105 individually randomised trials (13%) and none of the cluster randomised trials were at overall low risk of bias. Vitamin A did not reduce mortality in individually randomised trials (RR 0.99, 95% CI 0.93 to 1.05; I²=32%; p=0.19; 105 trials; moderate certainty), and this effect was not affected by the risk of bias. In individually randomised trials, vitamin A had no effect on mortality in children (RR 0.96, 95% CI 0.88 to 1.04; I²=24%; p=0.28; 78 trials, 178 094 participants) nor in adults (RR 1.04, 95% CI 0.97 to 1.13; I²=24%; p=0.27; 27 trials, 61 880 participants). Vitamin A reduced mortality in the cluster randomised trials (0.84, 95% CI 0.76 to 0.93; I²=66%; p=0.0008; 15 trials, 14 in children and 1 in adults; 364 343 participants; very low certainty). No trial reported serious adverse events or quality of life. Vitamin A slightly increased bulging fontanelle of neonates and infants. We are uncertain whether vitamin A influences blindness under the conditions examined. CONCLUSIONS: Based on moderate certainty of evidence, vitamin A had no effect on mortality in the individually randomised trials. Very low certainty evidence obtained from cluster randomised trials suggested a beneficial effect of vitamin A on mortality. If preventive vitamin A programmes are to be continued, supporting evidence should come from randomised trials allocating individuals and assessing patient-meaningful outcomes. PROSPERO REGISTRATION NUMBER: CRD42018104347.


Dietary Supplements , Randomized Controlled Trials as Topic , Vitamin A , Humans , Vitamin A/administration & dosage , Vitamin A/therapeutic use , Primary Prevention/methods , Secondary Prevention/methods , Quality of Life , Vitamins/therapeutic use , Vitamins/administration & dosage
4.
Sr Care Pharm ; 39(6): 218-227, 2024 Jun 01.
Article En | MEDLINE | ID: mdl-38803024

Background National guidelines no longer recommend adults 60 years of age and older to begin treatment with low-dose daily aspirin for primary prevention of atherosclerotic cardiovascular disease (CVD) due to a lack of proven net benefit and a higher risk of bleeding. Objective The objective of this cross-sectional retrospective analysis was to evaluate the appropriateness of low-dose aspirin prescribing and subsequent gastrointestinal bleeding in older persons receiving primary care in a large academic health system. Setting Large, academic health system within Colorado. Patients Patients with an active order for daily low-dose aspirin as of July 1, 2021, were assessed for appropriateness based on indication (primary vs secondary prevention) and use of a concomitant proton-pump inhibitor (PPI). Incident gastrointestinal bleeds (GIBs) in the subsequent 12 months and GIB risk factors were also evaluated. Results A total of 19,525 patients were included in the analysis. Eighty-nine percent of patients identified as White and 54% identified as male. Of the total cohort, 44% had CVD and 19% were co-prescribed a PPI. GIB occurred in 247 patients (1.27%) within the subsequent year. Risk factors significantly associated with a GIB within 1 year included: history of GIB, history of peptic ulcer disease, other esophageal issue (esophagitis, Barrett's esophagus, Mallory Weiss tears, etc.), 75 years of age or older, and history of gastroesophageal reflux disease. Conclusion This evaluation found that many older persons at this institution may be inappropriately prescribed aspirin, providing opportunities for pharmacists to improve medication safety by deprescribing aspirin among primary prevention patients or potentially co-prescribing a PPI in secondary prevention patients.


Aspirin , Gastrointestinal Hemorrhage , Humans , Aspirin/adverse effects , Aspirin/therapeutic use , Aspirin/administration & dosage , Male , Gastrointestinal Hemorrhage/prevention & control , Gastrointestinal Hemorrhage/chemically induced , Gastrointestinal Hemorrhage/epidemiology , Female , Aged , Retrospective Studies , Middle Aged , Cross-Sectional Studies , Proton Pump Inhibitors/therapeutic use , Proton Pump Inhibitors/administration & dosage , Proton Pump Inhibitors/adverse effects , Aged, 80 and over , Colorado/epidemiology , Primary Health Care , Risk Factors , Platelet Aggregation Inhibitors/adverse effects , Platelet Aggregation Inhibitors/therapeutic use , Platelet Aggregation Inhibitors/administration & dosage , Primary Prevention , Academic Medical Centers , Secondary Prevention/methods , Cardiovascular Diseases/prevention & control , Cardiovascular Diseases/drug therapy
5.
Aging Clin Exp Res ; 36(1): 103, 2024 May 05.
Article En | MEDLINE | ID: mdl-38704788

BACKGROUND: Hip fractures are the most serious fragility fractures due to their associated disability, higher hospitalization costs and high mortality rates. Fracture Liaison Service (FLS) programs have enhanced the management of osteoporosis-related fractures and have shown their clinical effectiveness. AIMS: To analyze the effect of the implementation of a FLS model of care over the survival and mortality rates following a hip fracture. METHODS: We conducted a prospective cohort study on patients over 60 years of age who suffered a hip fracture before and after the implementation of the FLS in our center (between January 2016 and December 2019). Patients were followed for three years after the index date. Mortality, complications and refracture rates were compared between the two groups using a Multivariate Cox proportional hazard model. RESULTS: A total of 1366 patients were included in this study (353 before FLS implementation and 1013 after FLS implementation). Anti-osteoporotic drugs were more frequently prescribed after FLS implementation (79.3% vs 12.5%; p < 0.01) and there was an increase in adherence to treatment (51.7% vs 30.2%; p < 0.01). A total of 413 (40.8%) patients after FLS implementation and 141 (39.9%) individuals before (p = 0.47) died during the three-years follow-up period. A second fracture occurred in 101 (10.0%) patients after FLS implementation and 37 (10.5%) individuals before (p = 0.78). Patients after the implementation of the FLS protocol had a lower all cause one-year mortality [adjusted Hazard Ratio (HR) 0.74 (0.57-0.94)] and a decreased risk of suffering a second osteoporotic fracture [adjusted HR 0.54 (0.39-0.75) in males and adjusted HR 0.46 (0.30-0.71) in females]. CONCLUSIONS: The implementation of a FLS protocol was associated with a lower all-cause one-year mortality rate and a higher survivorship in elderly hip fracture patients. However, no three-year mortality rate differences were observed between the two groups. We also found a reduction in the complication and second-fracture rates.


Hip Fractures , Osteoporosis , Osteoporotic Fractures , Secondary Prevention , Humans , Hip Fractures/mortality , Female , Male , Aged , Aged, 80 and over , Osteoporotic Fractures/prevention & control , Osteoporotic Fractures/mortality , Secondary Prevention/methods , Prospective Studies , Middle Aged , Proportional Hazards Models , Bone Density Conservation Agents/therapeutic use
6.
Arch Osteoporos ; 19(1): 35, 2024 May 09.
Article En | MEDLINE | ID: mdl-38722400

This study demonstrated a large treatment gap in elderly subjects experiencing fragility fracture in Spanish primary care, a low treatment persistence among subjects who do receive treatment, and more than one-quarter having no follow-up visits post-fracture. These data highlight the need to improve secondary fracture prevention in primary care. PURPOSE: To describe osteoporosis (OP) treatment patterns and follow-up in subjects with fragility fracture seen in Spanish primary care (PC). METHODS: This observational, retrospective chart review included subjects aged ≥ 70 years listed in the centers' records (November 2018 to March 2020), with ≥ 1 fragility fracture and prior consultation for any reason; subjects who had participated in another study were excluded. Outcomes included OP treatments and follow-up visits post-fragility fracture. RESULTS: Of 665 subjects included, most (87%) were women; overall mean (SD) age, 82 years. Fewer than two thirds (61%) had received any prior OP treatment (women, 65%; men, 38%); of these, 38% had received > 1 treatment (women, 25%; men, 13%). Among treated subjects, the most frequent first-line treatments were alendronate (43%) and RANKL inhibitor denosumab (22%), with a higher discontinuation rate and shorter treatment duration observed for alendronate (discontinuation, 42% vs 16%; median treatment duration, 2.5 vs 2.1 years). Over one-quarter (26%) of subjects had no follow-up visits post-fragility fracture, with this gap higher in women than men (35% versus 25%). The most common schedule of follow-up visits was yearly (43% of subjects with a fragility fracture), followed by half-yearly (17%) and biennial (10%), with a similar trend in men and women. Most OP treatments were prescribed by PC physicians, other than teriparatide and zoledronate. CONCLUSIONS: Across Spanish PC, we observed a large gap in the treatment and follow-up of elderly subjects experiencing a fragility fracture. Our data highlights the urgent need to improve secondary fracture prevention in PC.


Bone Density Conservation Agents , Osteoporotic Fractures , Primary Health Care , Secondary Prevention , Humans , Female , Male , Aged , Spain/epidemiology , Aged, 80 and over , Retrospective Studies , Primary Health Care/statistics & numerical data , Bone Density Conservation Agents/therapeutic use , Osteoporotic Fractures/prevention & control , Osteoporotic Fractures/epidemiology , Osteoporosis/drug therapy , Osteoporosis/epidemiology , Osteoporosis/complications , Alendronate/therapeutic use , Alendronate/administration & dosage , Denosumab/therapeutic use
7.
Hepatol Commun ; 8(6)2024 Jun 01.
Article En | MEDLINE | ID: mdl-38727685

BACKGROUND: The aim was to examine rifaximin plus lactulose efficacy in patients with cirrhosis at a risk of developing overt HE who were stratified by important baseline characteristics such as comorbid ascites or diabetes. METHODS: Pooled post hoc subgroup analysis of adults receiving rifaximin 550 mg twice daily plus lactulose or lactulose alone for 6 months in a phase 3 randomized, double-blind trial and a phase 4 open-label trial was conducted. RESULTS AND CONCLUSION: Rifaximin plus lactulose was more efficacious than lactulose alone for reducing the risk of overt HE recurrence and HE-related hospitalization in adults grouped by select baseline disease characteristics.


Drug Therapy, Combination , Gastrointestinal Agents , Hepatic Encephalopathy , Lactulose , Recurrence , Rifaximin , Humans , Rifaximin/therapeutic use , Rifaximin/administration & dosage , Lactulose/therapeutic use , Lactulose/administration & dosage , Male , Middle Aged , Double-Blind Method , Female , Gastrointestinal Agents/therapeutic use , Gastrointestinal Agents/administration & dosage , Hepatic Encephalopathy/drug therapy , Hepatic Encephalopathy/prevention & control , Liver Cirrhosis/complications , Liver Cirrhosis/drug therapy , Adult , Secondary Prevention/methods , Aged , Treatment Outcome
8.
BMJ ; 385: e079006, 2024 05 15.
Article En | MEDLINE | ID: mdl-38749550

OBJECTIVES: To evaluate the clinical effectiveness of long acting progestogens compared with the combined oral contraceptive pill in preventing recurrence of endometriosis related pain. DESIGN: The PRE-EMPT (preventing recurrence of endometriosis) pragmatic, parallel group, open label, randomised controlled trial. SETTING: 34 UK hospitals. PARTICIPANTS: 405 women of reproductive age undergoing conservative surgery for endometriosis. INTERVENTIONS: Participants were randomised in a 1:1 ratio using a secure internet facility to a long acting progestogen (depot medroxyprogesterone acetate or levonorgestrel releasing intrauterine system) or the combined oral contraceptive pill. MAIN OUTCOME MEASURES: The primary outcome was pain measured three years after randomisation using the pain domain of the Endometriosis Health Profile 30 (EHP-30) questionnaire. Secondary outcomes (evaluated at six months, one, two, and three years) included the four core and six modular domains of the EHP-30, and treatment failure (further therapeutic surgery or second line medical treatment). RESULTS: 405 women were randomised to receive a long acting progestogen (n=205) or combined oral contraceptive pill (n=200). At three years, there was no difference in pain scores between the groups (adjusted mean difference -0.8, 95% confidence interval -5.7 to 4.2, P=0.76), which had improved by around 40% in both groups compared with preoperative values (an average of 24 and 23 points for long acting progestogen and combined oral contraceptive pill groups, respectively). Most of the other domains of the EHP-30 also showed improvement at all time points compared with preoperative scores, without evidence of any differences between groups. Women randomised to a long acting progestogen underwent fewer surgical procedures or second line treatments compared with those randomised to the combined oral contraceptive pill group (73 v 97; hazard ratio 0.67, 95% confidence interval 0.44 to 1.00). CONCLUSIONS: Postoperative prescription of a long acting progestogen or the combined oral contraceptive pill results in similar levels of improvement in endometriosis related pain at three years, with both groups showing around a 40% improvement compared with preoperative levels. While women can be reassured that both options are effective, the reduced risk of repeat surgery for endometriosis and hysterectomy might make long acting reversible progestogens preferable for some. TRIAL REGISTRATION: ISRCTN registry ISRCTN97865475.


Contraceptives, Oral, Combined , Endometriosis , Levonorgestrel , Medroxyprogesterone Acetate , Humans , Female , Endometriosis/surgery , Endometriosis/drug therapy , Endometriosis/complications , Contraceptives, Oral, Combined/therapeutic use , Contraceptives, Oral, Combined/administration & dosage , Adult , Levonorgestrel/administration & dosage , Levonorgestrel/therapeutic use , Medroxyprogesterone Acetate/administration & dosage , Medroxyprogesterone Acetate/therapeutic use , Pelvic Pain/drug therapy , Pelvic Pain/prevention & control , Pelvic Pain/etiology , Progestins/administration & dosage , Progestins/therapeutic use , Pain Measurement , Secondary Prevention/methods , Treatment Outcome , Young Adult , Intrauterine Devices, Medicated
9.
J Am Heart Assoc ; 13(10): e033611, 2024 May 21.
Article En | MEDLINE | ID: mdl-38761083

BACKGROUND: Recent clinical trials established the benefit of dual antiplatelet therapy with aspirin and clopidogrel (DAPT-AC) in early-presenting patients with minor ischemic stroke. However, the impact of these trials over time on the use and outcomes of DAPT-AC among the patients with nonminor or late-presenting stroke who do not meet the eligibility criteria of these trials has not been delineated. METHODS AND RESULTS: In a multicenter stroke registry, this study examined yearly changes from April 2008 to August 2022 in DAPT-AC use for stroke patients ineligible for CHANCE/POINT (Clopidogrel in High-Risk Patients with Acute Nondisabling Cerebrovascular Events/Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke) clinical trials due to National Institutes of Health Stroke Scale >4 or late arrival beyond 24 hours of onset. A total of 32 118 patients (age, 68.1±13.1 years; male, 58.5%) with National Institutes of Health Stroke Scale of 4 (interquartile range, 1-7) were analyzed. In 2008, DAPT-AC was used in 33.0%, other antiplatelets in 62.7%, and no antiplatelet in 4.3%. The frequency of DAPT-AC was relatively unchanged through 2013, when the CHANCE trial was published, and then increased steadily, reaching 78% in 2022, while other antiplatelets decreased to 17.8% in 2022 (Ptrend<0.001). From 2011 to 2022, clinical outcomes nonsignificantly improved, with an average relative risk reduction of 2%/y for the composite of stroke, myocardial infarction, and all-cause mortality, both among patients treated with DAPT-AC and patients treated with other antiplatelets. CONCLUSIONS: Use of DAPT-AC in stroke patients with stroke ineligible for recent DAPT clinical trials increased markedly and steadily after CHANCE publication in 2013, reaching deployment in nearly 4 of every 5 patients by 2022. The secondary prevention in patients with ischemic stroke seems to be gradually improving, possibly due to the enhancement of risk factor control.


Aspirin , Clopidogrel , Dual Anti-Platelet Therapy , Ischemic Stroke , Platelet Aggregation Inhibitors , Registries , Humans , Clopidogrel/therapeutic use , Aspirin/therapeutic use , Male , Aged , Female , Ischemic Stroke/drug therapy , Ischemic Stroke/mortality , Ischemic Stroke/diagnosis , Ischemic Stroke/prevention & control , Dual Anti-Platelet Therapy/adverse effects , Platelet Aggregation Inhibitors/therapeutic use , Platelet Aggregation Inhibitors/adverse effects , Middle Aged , Treatment Outcome , Aged, 80 and over , Time Factors , Japan/epidemiology , Secondary Prevention/methods , Secondary Prevention/trends , Drug Therapy, Combination , Risk Factors
10.
Vestn Oftalmol ; 140(2. Vyp. 2): 102-108, 2024.
Article Ru | MEDLINE | ID: mdl-38739138

A group of patients was found to have a special form of recurrent corneal erosion caused by types I and II herpes virus. This form represents an independent form of ophthalmic herpes - herpetic recurrent erosion (HRE) of the cornea. The herpetic etiology of recurrent corneal erosion was confirmed by the immunofluorescence study of scraping from the conjunctiva, which revealed a high concentration of the herpes simplex virus antigen. Treatment of patients (171 patients, 182 eyes) with HRE included 2 consecutive stages: stage I - relief of acute symptoms of the disease with the help of conservative treatment (instillations of interferon inducers, autologous serum, corneal protectors, tear substitutes, use of therapeutic soft contact lenses); in some cases, phototherapeutic keratectomy was used in the absence of the effect of conservative therapy, as well as in the localization of the focus in the optical zone. Stage II involved anti-relapse therapy based on the use of a Russian-produced herpes vaccine in the intercurrent period. After vaccination, observation for 2 years or more showed that 81.3% of patients achieved clinical recovery (complete cessation of HRE recurrences), 15.8% had a decrease in the frequency and severity of relapses, while 2.9% of patients did not respond to the treatment.


Keratitis, Herpetic , Humans , Male , Female , Keratitis, Herpetic/diagnosis , Keratitis, Herpetic/etiology , Keratitis, Herpetic/therapy , Keratitis, Herpetic/prevention & control , Middle Aged , Adult , Recurrence , Cornea , Treatment Outcome , Antiviral Agents/therapeutic use , Secondary Prevention/methods , Eye Infections, Viral/diagnosis , Eye Infections, Viral/etiology , Eye Infections, Viral/prevention & control , Eye Infections, Viral/therapy
11.
Sex Transm Dis ; 51(6): 437-440, 2024 Jun 01.
Article En | MEDLINE | ID: mdl-38733973

OBJECTIVES: Live biotherapeutic products (LBPs) containing vaginal Lactobacillus crispatus are promising adjuvant treatments to prevent recurrent bacterial vaginosis (BV) but may depend on the success of initial antibiotic treatment. METHODS: A post hoc analysis of data collected during the phase 2b LACTIN-V randomized control trial (L. crispatus CTV-05) explored the impact of clinical BV cure defined as Amsel criteria 0 of 3 (excluding pH, per 2019 Food and Drug Administration guidance) 2 days after completion of treatment with vaginal metronidazole gel on the effectiveness of an 11-week LACTIN-V dosing regimen to prevent BV recurrence by 12 and 24 weeks. RESULTS: At enrollment, 88% of participants had achieved postantibiotic clinical BV cure. The effect of LACTIN-V on BV recurrence compared with placebo differed by initial clinical BV cure status. The LACTIN-V to placebo risk ratio of BV recurrence by 12 weeks was 0.56 (95% confidence interval, 0.35-0.77) among participants with initial clinical BV cure after metronidazole treatment and 1.34 (95% confidence interval, 0.47-2.23) among participants without postantibiotic clinical BV cure. Among women receiving LACTIN-V, those who had achieved postantibiotic clinical BV cure at enrollment reached higher levels of detectable L. crispatus CTV-05 compared with women failing to achieve postantibiotic clinical BV cure. CONCLUSIONS: LACTIN-V seems to only decrease BV recurrence in women with clinical cure of BV after initial antibiotic treatment. Future trials of LBPs should consider limiting enrollment to these women.


Anti-Bacterial Agents , Lactobacillus crispatus , Metronidazole , Probiotics , Vaginosis, Bacterial , Humans , Female , Vaginosis, Bacterial/drug therapy , Vaginosis, Bacterial/prevention & control , Vaginosis, Bacterial/microbiology , Metronidazole/administration & dosage , Anti-Bacterial Agents/administration & dosage , Anti-Bacterial Agents/therapeutic use , Adult , Lactobacillus crispatus/physiology , Probiotics/administration & dosage , Treatment Outcome , Recurrence , Secondary Prevention , Administration, Intravaginal , Young Adult , Vagina/microbiology , Double-Blind Method
12.
Expert Opin Drug Metab Toxicol ; 20(5): 359-376, 2024 May.
Article En | MEDLINE | ID: mdl-38712571

INTRODUCTION: Direct oral anticoagulants (DOAC) are the guideline-recommended therapy for prevention of stroke in atrial fibrillation (AF) and venous thromboembolism. Since approximately 10% of patients using antiepileptic drugs (AED) also receive DOAC, aim of this review is to summarize data about drug-drug interactions (DDI) of DOAC with AED by using data from PubMed until December 2023. AREAS COVERED: Of 49 AED, only 16 have been investigated regarding DDI with DOAC by case reports or observational studies. No increased risk for stroke was reported only for topiramate, zonisamide, pregabalin, and gabapentin, whereas for the remaining 12 AED conflicting results regarding the risk for stroke and bleeding were found. Further 16 AED have the potential for pharmacodynamic or pharmacokinetic DDI, but no data regarding DOAC are available. For the remaining 17 AED it is unknown if they have DDI with DOAC. EXPERT OPINION: Knowledge about pharmacokinetic and pharmacodynamic DDI of AED and DOAC is limited and frequently restricted to in vitro and in vivo findings. Since no data about DDI with DOAC are available for 67% of AED and an increasing number of patients have a combined medication of DOAC and AED, there is an urgent need for research on this topic.


Anticoagulants , Anticonvulsants , Atrial Fibrillation , Drug Interactions , Secondary Prevention , Stroke , Humans , Stroke/prevention & control , Stroke/etiology , Anticonvulsants/administration & dosage , Anticonvulsants/pharmacokinetics , Anticonvulsants/adverse effects , Anticonvulsants/pharmacology , Anticoagulants/administration & dosage , Anticoagulants/pharmacokinetics , Anticoagulants/adverse effects , Anticoagulants/pharmacology , Atrial Fibrillation/drug therapy , Atrial Fibrillation/complications , Administration, Oral , Secondary Prevention/methods , Hemorrhage/chemically induced , Venous Thromboembolism/prevention & control , Primary Prevention/methods , Animals
13.
Implement Sci ; 19(1): 35, 2024 May 24.
Article En | MEDLINE | ID: mdl-38790045

BACKGROUND: Providing secondary prevention through structured and comprehensive cardiac rehabilitation programmes to patients after a myocardial infarction (MI) reduces mortality and morbidity and improves health-related quality of life. Cardiac rehabilitation has the highest recommendation in current guidelines. While treatment target attainment rates at Swedish cardiac rehabilitation centres is among the highest in Europe, there are considerable differences in service delivery and variations in patient-level outcomes between centres. In this trial, we aim to study whether centre-level guideline adherence and patient-level outcomes across Swedish cardiac rehabilitation centres can be improved through a) regular audit and feedback of cardiac rehabilitation structure and processes through a national quality registry and b) supporting cardiac rehabilitation centres in implementing guidelines on secondary prevention. Furthermore, we aim to evaluate the implementation process and costs. METHODS: The study is an open-label cluster-randomized effectiveness-implementation hybrid trial including all 78 cardiac rehabilitation centres (attending to approximately 10 000 MI patients/year) that report to the SWEDEHEART registry. The centres will be randomized 1:1:1 to three clusters: 1) reporting cardiac rehabilitation structure and process variables to SWEDEHEART every six months (audit intervention) and being offered implementation support to implement guidelines on secondary prevention (implementation support intervention); 2) audit intervention only; or 3) no intervention offered. Baseline cardiac rehabilitation structure and process variables will be collected. The primary outcome is an adherence score measuring centre-level adherence to secondary prevention guidelines. Secondary outcomes include patient-level secondary prevention risk factor goal attainment at one-year after MI and major adverse coronary outcomes for up to five-years post-MI. Implementation outcomes include barriers and facilitators to guideline adherence evaluated using semi-structured focus-group interviews and relevant questionnaires, as well as costs and cost-effectiveness assessed by a comparative health economic evaluation. DISCUSSION: Optimizing cardiac rehabilitation centres' delivery of services to meet standards set in guidelines may lead to improvement in cardiovascular risk factors, including lifestyle factors, and ultimately a decrease in morbidity and mortality after MI. TRIAL REGISTRATION: ClinicalTrials.gov. Identifier: NCT05889416 . Registered 2023-03-23.


Cardiac Rehabilitation , Guideline Adherence , Myocardial Infarction , Humans , Cardiac Rehabilitation/methods , Myocardial Infarction/rehabilitation , Secondary Prevention/standards , Secondary Prevention/methods , Sweden , Implementation Science , Quality of Life , Registries , Practice Guidelines as Topic
14.
Front Endocrinol (Lausanne) ; 15: 1349579, 2024.
Article En | MEDLINE | ID: mdl-38706701

Osteoporosis is a widespread disease and affects over 500,000 people in Austria. Fragility fractures are associated with it and represent not only an individual problem for the patients, but also an enormous burden for the healthcare system. While trauma surgery care is well provided in Vienna, there is an enormous treatment gap in secondary prevention after osteoporotic fracture. Systematic approaches such as the Fracture Liaison Service (FLS) aim to identify patients with osteoporosis after fracture, to clarify diagnostically, to initiate specific therapy, and to check therapy adherence. The aim of this article is to describe the practical implementation and operational flow of an already established FLS in Vienna. This includes the identification of potential FLS inpatients, the diagnostic workup, and recommendations for an IT solution for baseline assessment and follow-up of FLS patients. We summarize the concept, benefits, and limitations of FLS and provide prospective as well as clinical and economic considerations for a city-wide FLS, managed from a central location. Future concepts of FLS should include artificial intelligence for vertebral fracture detection and simple IT tools for the implementation of FLS in the outpatient sector.


Osteoporotic Fractures , Secondary Prevention , Humans , Austria , Osteoporotic Fractures/economics , Osteoporotic Fractures/therapy , Secondary Prevention/economics , Osteoporosis/therapy , Osteoporosis/economics , Osteoporosis/diagnosis
15.
Arq Bras Cardiol ; 121(3): e20230487, 2024.
Article Pt, En | MEDLINE | ID: mdl-38597553

BACKGROUND: Adhering to a diet adequate in macronutrients is crucial for the secondary prevention of cardiovascular diseases. OBJECTIVE: To assess the prevalence of adherence to recommendations for the consumption of dietary fatty acids for the prevention and treatment of cardiovascular diseases and to estimate whether the presence of certain cardiovascular risk factors would be associated with adherence. METHODS: Cross-sectional study using baseline data from 2,358 participants included in the "Brazilian Cardioprotective Nutritional Program Trial". Dietary intake and cardiovascular risk factors were assessed. Adequate intake of polyunsaturated fatty acids (PUFA) was considered as ≥10% of total daily energy intake; for monounsaturated fatty acids (MUFA), 20%; and for saturated fatty acids (SFA), <7% according to the Brazilian Society of Cardiology. A significance level of 5% was considered in the statistical analysis. RESULTS: No participant adhered to all recommendations simultaneously, and more than half (1,482 [62.9%]) did not adhere to any recommendation. Adherence exclusively to the SFA recommendation was the most prevalent, fulfilled by 659 (28%) participants, followed by adherence exclusively to the PUFA (178 [7.6%]) and MUFA (5 [0.2%]) recommendations. There was no association between the number of comorbidities and adherence to nutritional recommendations (p = 0.269). Participants from the Brazilian Northeast region showed a higher proportion of adherence to SFA consumption recommendations (38.42%) and lower adherence to PUFA intake (3.52%) (p <0.001) compared to other regions. CONCLUSIONS: Among the evaluated sample, there was low adherence to nutritional recommendations for dietary fatty acid consumption.


FUNDAMENTO: A adesão à uma alimentação adequada em macronutrientes é fundamental para a prevenção secundária de doenças cardiovasculares. OBJETIVO: Avaliar a prevalência de adesão às recomendações de consumo de ácidos graxos para prevenção e tratamento de doenças cardiovasculares, e estimar se a presença de determinados fatores de risco cardiovascular estaria associada à adesão. MÉTODOS: Estudo transversal com os dados de linha de base de 2358 participantes do estudo "Brazilian Cardioprotective Nutritional Program Trial". Dados de consumo alimentar, e fatores de risco cardiovascular foram avaliados. Foi considerada, de acordo com a Sociedade Brasileira de Cardiologia, uma ingestão adequada de ácidos graxos poli-insaturados (AGPI) ≥10% do consumo total de energia diária, para ácidos graxos monoinsaturados (AGM), 20% e para ácidos graxos saturados (AGS), <7%. Na análise estatística foi considerando nível de significância de 5%. RESULTADOS: Nenhum participante aderiu a todas as recomendações de forma simultânea e mais da metade (1482 [62,9%]) não aderiu a nenhuma recomendação. A adesão exclusivamente à recomendação de AGS foi a mais prevalente, sendo cumprida por 659 (28%) dos participantes, seguida da adesão exclusivamente à recomendação de AGP (178 [7,6%]) e de AGM (5 [0,2%]). Não houve associação entre o número de comorbidades e a adesão às recomendações nutricionais (p =0,269). Os participantes da região Nordeste do país apresentaram maior proporção de adesão às recomendações para consumo de AGS (38,42%), e menor para ingestão de AGPI (3,52%) (p <0,001) em comparação às demais. CONCLUSÕES: Na amostra avaliada, evidenciou-se baixa adesão às recomendações nutricionais para consumo de ácidos graxos.


Cardiovascular Diseases , Fatty Acids , Humans , Dietary Fats , Cardiovascular Diseases/etiology , Secondary Prevention , Cross-Sectional Studies , Fatty Acids, Unsaturated , Fatty Acids, Monounsaturated
17.
JMIR Mhealth Uhealth ; 12: e44463, 2024 Apr 24.
Article En | MEDLINE | ID: mdl-38659156

Background: Some common modified vascular risk factors remain poorly controlled among stroke survivors, and educational programs may help improve these conditions. Objective: This study aimed to evaluate the effect of a planned web-based educational intervention based on the health belief model (HBM) in promoting secondary prevention among patients with ischemic stroke. Methods: An evaluation-blinded quasi-experimental trial with a historical control group was conducted. Patients admitted from March to June 2020 were assigned to the historical control group, and patients admitted from July to October 2020 were assigned to the intervention group. The control group received routine health management. The intervention group received 6 additional sessions based on the HBM via Tencent Meeting, an audio and video conferencing application, within 3 months after discharge. Sessions were held every 2 weeks, with each session lasting approximately 40 minutes. These sessions were conducted in small groups, with about 8 to 10 people in each group. The primary outcomes were changes in blood pressure (BP), low-density lipoprotein cholesterol (LDL-C), hemoglobin A1c (HbA1c), and the proportion of patients achieving the treatment target. The secondary outcomes were medication adherence, assessed with the Morisky Medicine Adherence Scale (MMAS), and disability, assessed with the modified Rankin scale. Results: In total, 315 patients experiencing their first-ever stroke were analyzed. More patients in the intervention group had controlled BP (41.9% vs 28.4%; adjusted odds ratio [aOR] 1.93; P=.01), LDL-C (83.1% vs 67.7%; aOR 2.66; P=.001), and HbA1c (91.9% vs 83.9%; aOR: 3.37; P=.04) levels as well as a significant postintervention decrease in the systolic BP (adjusted ß -3.94; P=.02), LDL-C (adjusted ß -0.21; P=.008), and HbA1c (adjusted ß -0.27; P<.001), compared with control groups. Significant between-group differences were observed in medication adherence (79.4% vs 63.2%; aOR 2.31; P=.002) but not in favorable functional outcomes. Conclusions: A web-based education program based on the HBM may be more effective than current methods used to educate patients having strokes on optimal vascular risk factors and medication adherence.


COVID-19 , Health Belief Model , Ischemic Stroke , Secondary Prevention , Humans , Male , Female , China/epidemiology , Middle Aged , Secondary Prevention/methods , Secondary Prevention/statistics & numerical data , Secondary Prevention/standards , Aged , Ischemic Stroke/prevention & control , COVID-19/prevention & control , COVID-19/psychology , Internet-Based Intervention , Patient Education as Topic/methods
18.
G Ital Cardiol (Rome) ; 25(5): 295-299, 2024 May.
Article It | MEDLINE | ID: mdl-38639118

Patent foramen ovale (PFO) is a remnant of normal fetal anatomy which may persist into adulthood, mostly asymptomatic. In some adults, PFO may result in a potential for shunting venous thromboembolism to the arterial circulation; less frequently it can cause interatrial, right-to-left shunting of deoxygenated blood. The pathogenesis of several medical conditions is related to the presence of PFO. Some randomized clinical trials have shown evidence of benefit for device closure as compared with medical therapy in patients with cryptogenic stroke. The literature reported several cases of carbon dioxide embolism during general laparoscopic surgery and sometimes stroke after laparoscopic or neurosurgery but there are neither prospective studies addressing these issues, nor randomized clinical trials assessing the effectiveness of pharmacotherapy or interventional procedures at decreasing risk. The European position paper suggests routine monitoring in non-cardiac surgery of patients with a PFO and no actual indications for closure. This article aims to further stratify the risk of periprocedural stroke and paradoxical embolism in this category of patients.


Embolism, Paradoxical , Foramen Ovale, Patent , Stroke , Adult , Humans , Foramen Ovale, Patent/complications , Foramen Ovale, Patent/surgery , Prospective Studies , Stroke/prevention & control , Stroke/complications , Secondary Prevention/methods , Embolism, Paradoxical/etiology , Embolism, Paradoxical/prevention & control , Treatment Outcome
19.
G Ital Cardiol (Rome) ; 25(5): 367-381, 2024 May.
Article It | MEDLINE | ID: mdl-38639128

The issue of suboptimal drug regimen adherence in secondary cardiovascular prevention presents a significant barrier to improving patient outcomes. To address this, the utilization of drug combinations, specifically single pill combinations (SPCs) and polypills, was proposed as a strategy to simplify treatment regimens. This approach aims to enhance treatment accessibility, affordability, and adherence, thereby reducing healthcare costs and improving patient health. The document is an ANMCO scientific statement on simplifying drug regimens for secondary cardiovascular prevention. It discusses the underuse of treatments despite available, effective, and accessible options, highlighting a significant gap in secondary prevention across different socioeconomic statuses and countries. The statement explores barriers to implementing evidence-based treatments, including patient, healthcare provider, and system-related challenges. The paper also reviews international guidelines, the role of SPCs and polypills in clinical practice, and their economic impact, advocating for their use in secondary prevention to improve patient outcomes and adherence.


Cardiovascular Diseases , Humans , Cardiovascular Diseases/prevention & control , Cardiovascular Diseases/drug therapy , Secondary Prevention , Drug Combinations , Combined Modality Therapy , Antihypertensive Agents/therapeutic use
20.
PLoS One ; 19(4): e0302364, 2024.
Article En | MEDLINE | ID: mdl-38669261

BACKGROUND: Lifestyle changes, in addition to preventive medications, optimise stroke secondary prevention. Evidence from systematic reviews support behaviour-change interventions post-stroke to address lifestyle-related risk. However, understanding of the theory-driven mediators that affect behaviour-change post-stroke is lacking. METHODS: Electronic databases MEDLINE, Embase, Epistemonikos and Cochrane Library of Systematic Reviews were searched to March 2023 for systematic reviews addressing behaviour-change after stroke. Primary studies from identified systematic reviews were interrogated for evidence supporting theoretically-grounded interventions. Data were synthesized in new meta-analyses examining behaviour-change domains of the Theoretical Domains Framework (TDF) and secondary prevention outcomes. RESULTS: From 71 identified SRs, 246 primary studies were screened. Only 19 trials (N = 2530 participants) were identified that employed theoretically-grounded interventions and measured associated mediators for behaviour-change. Identified mediators mapped to 5 of 14 possible TDF domains. Trial follow-up ranged between 1-12 months and no studies addressed primary outcomes of recurrent stroke or cardiovascular mortality and/or morbidity. Lifestyle interventions targeting mediators mapped to the TDF Knowledge domain may improve the likelihood of medication adherence (OR 6.08 [2.79, 13.26], I2 = 0%); physical activity participation (OR 2.97 [1.73, 5.12], I2 = 0%) and smoking cessation (OR 10.37 [3.22, 33.39], I2 = 20%) post-stroke, supported by low certainty evidence; Lifestyle interventions targeting mediators mapping to both TDF domains of Knowledge and Beliefs about Consequences may improve medication adherence post-stroke (SMD 0.36 [0.07, 0.64], I2 = 13%, very low certainty evidence); Lifestyle interventions targeting mediators mapped to Beliefs about Capabilities and Emotions domains may modulate low mood post-stroke (SMD -0.70 [-1.28, -0.12], I2 = 81%, low certainty evidence). CONCLUSION: Limited theory-based research and use of behaviour-change mediators exists within stroke secondary prevention trials. Knowledge, Beliefs about Consequences, and Emotions are the domains which positively influence risk-reducing behaviours post-stroke. Behaviour-change interventions should include these evidence-based constructs known to be effective. Future trials should address cardiovascular outcomes and ensure adequate follow-up time.


Risk Reduction Behavior , Stroke , Humans , Stroke/prevention & control , Stroke/psychology , Secondary Prevention/methods , Life Style , Exercise
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