24 research outputs found

    Comparative cardiovascular benefits of individual SGLT2 inhibitors in type 2 diabetes and heart failure: a systematic review and network meta-analysis of randomized controlled trials

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    BackgroundIn patients with type 2 diabetes (T2D) and a history of heart failure (HF), sodium–glucose cotransporter-2 inhibitors (SGLT2is) have demonstrated cardiovascular (CV) benefits. However, the comparative efficacy of individual SGLT2is remains uncertain. This network meta-analysis (NMA) compared the efficacy and safety of five SGLT2is (canagliflozin, dapagliflozin, empagliflozin, ertugliflozin, and sotagliflozin) on CV outcomes in these patients.Materials and methodsPubMed, Embase, and the Cochrane Central Register of Controlled Trials were searched up to September 23, 2022, to identify all randomized controlled trials (RCTs) comparing SGLT2is to placebo in T2D patients with HF. The main outcomes included composite CV death/heart failure hospitalization (HFH), HFH, CV death, all-cause mortality, and adverse events. Pairwise and NMA approaches were applied.ResultsOur analysis included 11 RCTs with a total of 20,438 patients with T2D and HF. All SGLT2is significantly reduced HFH compared to standard of care (SoC) alone. “Add-on” SGLT2is, except ertugliflozin, significantly reduced composite CV death/HFH relative to SoC alone. Moreover, canagliflozin had lower composite CV death/HFH compared to dapagliflozin. Based on the surface under the cumulative ranking curve (SUCRA), the top-ranked SGLT2is for reducing HFH were canagliflozin (95.5%), sotagliflozin (66.0%), and empagliflozin (57.2%). Head-to-head comparisons found no significant differences between individual SGLT2is in reducing CV death. “Add-on” SGLT2is reduced all-cause mortality compared with SoC alone, although only dapagliflozin was statistically significant. No SGLT2is were significantly associated with serious adverse events. A sensitivity analysis focusing on HF-specific trials found that dapagliflozin, empagliflozin, and sotagliflozin significantly reduced composite CV death/HFH, consistent with the main analysis. However, no significant differences were identified from their head-to-head comparisons in the NMA. The SUCRA indicated that sotagliflozin had the highest probability of reducing composite CV death/HFH (97.6%), followed by empagliflozin (58.4%) and dapagliflozin (44.0%).ConclusionSGLT2is significantly reduce the composite CV death/HFH outcome. Among them, canagliflozin may be considered the preferred treatment for patients with diabetes and a history of heart failure, but it may also be associated with an increased risk of any adverse events compared to other SGLT2is. However, a sensitivity analysis focusing on HF-specific trials identified sotagliflozin as the most likely agent to reduce CV death/HFH, followed by empagliflozin and dapagliflozin.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/, identifier CRD42022353754

    Comparative cardiovascular benefits of individual SGLT2 inhibitors in type 2 diabetes and heart failure: a systematic review and network meta-analysis of randomized controlled trials

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    Background: In patients with type 2 diabetes (T2D) and a history of heart failure (HF), sodium–glucose cotransporter-2 inhibitors (SGLT2is) have demonstrated cardiovascular (CV) benefits. However, the comparative efficacy of individual SGLT2is remains uncertain. This network meta-analysis (NMA) compared the efficacy and safety of five SGLT2is (canagliflozin, dapagliflozin, empagliflozin, ertugliflozin, and sotagliflozin) on CV outcomes in these patients. Materials and methods: PubMed, Embase, and the Cochrane Central Register of Controlled Trials were searched up to September 23, 2022, to identify all randomized controlled trials (RCTs) comparing SGLT2is to placebo in T2D patients with HF. The main outcomes included composite CV death/heart failure hospitalization (HFH), HFH, CV death, all-cause mortality, and adverse events. Pairwise and NMA approaches were applied. Results: Our analysis included 11 RCTs with a total of 20,438 patients with T2D and HF. All SGLT2is significantly reduced HFH compared to standard of care (SoC) alone. “Add-on” SGLT2is, except ertugliflozin, significantly reduced composite CV death/HFH relative to SoC alone. Moreover, canagliflozin had lower composite CV death/HFH compared to dapagliflozin. Based on the surface under the cumulative ranking curve (SUCRA), the top-ranked SGLT2is for reducing HFH were canagliflozin (95.5%), sotagliflozin (66.0%), and empagliflozin (57.2%). Head-to-head comparisons found no significant differences between individual SGLT2is in reducing CV death. “Add-on” SGLT2is reduced all-cause mortality compared with SoC alone, although only dapagliflozin was statistically significant. No SGLT2is were significantly associated with serious adverse events. A sensitivity analysis focusing on HF-specific trials found that dapagliflozin, empagliflozin, and sotagliflozin significantly reduced composite CV death/HFH, consistent with the main analysis. However, no significant differences were identified from their head-to-head comparisons in the NMA. The SUCRA indicated that sotagliflozin had the highest probability of reducing composite CV death/HFH (97.6%), followed by empagliflozin (58.4%) and dapagliflozin (44.0%). Conclusion: SGLT2is significantly reduce the composite CV death/HFH outcome. Among them, canagliflozin may be considered the preferred treatment for patients with diabetes and a history of heart failure, but it may also be associated with an increased risk of any adverse events compared to other SGLT2is. However, a sensitivity analysis focusing on HF-specific trials identified sotagliflozin as the most likely agent to reduce CV death/HFH, followed by empagliflozin and dapagliflozin. Systematic review registration: https://www.crd.york.ac.uk/prospero/, identifier CRD42022353754.</p

    Cost–utility and budget impact analysis of tocilizumab for the treatment of refractory systemic juvenile idiopathic arthritis in Thailand

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    Objectives This study aimed to analyse the cost–utility and budget impact of adding tocilizumab to the standard treatment for patients with refractory systemic juvenile idiopathic arthritis (sJIA) in Thailand.Design Economic evaluation using a decision-analytical model.Setting Thailand.Participants Patients with refractory sJIA who were ≥2 years old.Methods The use of tocilizumab as an add-on therapy to standard treatment was compared with standard treatment alone. A simulated health state transition model was used to estimate the lifetime costs and health outcomes from a societal perspective. Direct medical costs were collected from tertiary hospital databases while direct non-medical costs were derived from interviews. Health-related quality of life (QoL) was measured using the proxy version of three-level EuroQol five-dimensional questionnaire (EQ-5D-3L). Future costs and outcomes were discounted at an annual rate of 3%. The base case population was patients aged 9.41 years old at refractory disease onset. The results were reported as incremental cost-effectiveness ratios (ICER) in US dollar (USD). One-way and probabilistic sensitivity analysis were conducted to investigate parameter uncertainty. The 5-year budget impact was estimated from a governmental perspective.Results The ICER of standard treatment plus tocilizumab was US35799perqualityadjustedlifeyear(QALY)gainedcomparedwithstandardtreatmentalone,whichwasnotcosteffectiveatthethresholdofUS35 799 per quality-adjusted life-year (QALY) gained compared with standard treatment alone, which was not cost-effective at the threshold of US5128 per QALY gained. The estimated 5 years budget impact was approximately US$4.8 million.Conclusions The use of standard treatment plus tocilizumab was not cost-effective in the Thai context, which has limited data. However, there is currently no second-line treatment for refractory sJIA in the Thai National List of Essential Medicines; thus, patients must receive higher doses of standard treatment which can cause many side effects. In contrast, tocilizumab showed obvious efficacy in clinical trials in improving treatment response and QoL. Therefore, the price of tocilizumab should be negotiated to reduce the financial impact on the healthcare system

    A real-world study of effectiveness of intravitreal bevacizumab and ranibizumab injection for treating retinal diseases in Thailand

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    Abstract Background To evaluate the effectiveness of intravitreal bevacizumab (IVB) and intravitreal ranibizumab (IVR) in actual practice for treating patients with retinal diseases in Thailand. Methods A prospective, multi-centre, observational study was conducted among eight hospitals in their ophthalmology outpatient departments. Participants consisted of patients who had previously not received any IVB or IVR treatment between 2013 and 2014. The primary outcome measurement was the change in best-corrected visual acuity (BCVA) at the end of the follow-up period compared to baseline. Results There were 1629 treatment-naïve patients for the pro re nata (PRN) treatment pattern and 226 treatment-naive patients for the three-injections (3Inj) treatment pattern. BCVA improvements were found in 35% of the PRN group and 47% of the 3Inj group; however, it was not clinically meaningful between the IVB and IVR groups (P-value = 0.568 for PRN, P-value = 0.103 for 3Inj). A multivariable logistic regression (using the propensity score) showed that positive factors associated with vision improvement for the PRN pattern were the number of drug injections, having retinal vein occlusion, and under 60 years of age, while good BCVA at baseline was a negative predictive factor. For the 3Inj pattern, under 60 years of age and baseline BCVA were statistically significant predictors. Nonetheless, diabetes mellitus (DM) without other comorbidities was a statistically significant predictor of low response to vision improvement compared to DM with other comorbidities. Conclusions This study was the first observational, prospective study to evaluate the real-life effectiveness of IVB and IVR in Thailand. The majority of participants who used IVB or IVR showed improvements in BCVA after treatment. Further evaluation such as long-term follow-ups and subsequent comparison of effectiveness between IVB and IVR should be investigated due to the limited sample of IVR patients. Trial registration Thai Clinical Trial Registry TCTR20141002001. Registered 02 October 2014 (retrospectively registered)

    Development of an alcohol intervention model for predicting healthcare costs, life years, quality-adjusted life years and using for economic evaluation

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    Objectives To develop an alcohol intervention model that predicts life years (LYs), quality adjusted life years (QALYs), and healthcare costs classified by the Alcohol Use Disorder Identification Test (AUDIT) screening tool and other various risk factors related to alcohol consumption. Furthermore, the developed model was transferred to the Thai setting. Methods Eight Scottish Health Surveys from 1995-2012 were linked to Scottish morbidity records and death records for the period 1981 to the end of 2013. Parametric survival analysis was used to estimate the hazard risks of first alcohol-related and non-alcohol related hospitalisations and deaths. For men and women, multivariate data analyses were applied separately for each gender in modelling the utility score, risks of subsequent hospitalisation and annual healthcare costs within the follow-up period. Risk profiles were used for the covariates of the models as follows: age, socio-economic status, health condition, alcohol drinking (i.e. AUDIT and binge drinking), smoking, body mass index, and physical activity. According to the under-reporting bias of alcohol consumption among the survey population, this study adjusted the reported alcohol consumption using alcohol sales data. Multiple imputation approach was applied to deal with missing data. A health-state transition model with annual cycle length was developed to predict LYs, QALYs, lifetime costs, and cost-effectiveness. Probabilistic sensitivity analysis was also performed to deal with parameter uncertainty. Moreover, a methodological transferability protocol of the Thai study was detailed. Results The sample size of the cohort was 46,230. The developed model showed the association between drinking and alcohol-related and non-alcohol related hospitalisations and deaths which were calculated as LYs and QALYs. Other risk factors were also taken into account that would likely affect the outcomes of interest. The modelling showed that an increasing AUDIT score and the number of cigarettes per day were associated with an increased risk of first alcohol-attributable hospitalisation. Predicted outcomes for a male aged 30 year with high-risk drinking levels (AUDIT >7) were worse than males with low risk drinking (AUDIT ≤7), with approximately 5 LY gained and 7 QALY gained. The same results for females were obtained for high-risk drinking (AUDIT >4) compared to low-risk drinking (AUDIT ≤4), with approximately 10 LY gained and 12 QALY gained. Furthermore, an economic evaluation was performed to compare the no-intervention situation with a hypothetical health promotion intervention - which aimed to stop drinking (measured by the AUDIT) and smoking (measured by the number of cigarettes per day) behaviours. To compare the costs and benefits of the hypothetical intervention and no intervention over the lifetime period, a within-trial analysis combined with the developed model was able to capture both short- and longer-term consequences (i.e. LYs, QALYs, and healthcare costs) of the intervention. Finally, the model was able to compare cost-effectiveness ratio between risk behaviours without the new intervention and the modified risk behaviours when the new intervention is implemented. Conclusions The study highlights the potential and importance of developing health economic models utilising data from routine national health surveys linked to national hospitalisation and death records. The developed framework can be used for further economic evaluation of alcohol interventions and other health behaviour change interventions. The framework can further be transferred to other country settings

    Real-world safety of intravitreal bevacizumab and ranibizumab treatments for retinal diseases in Thailand: a prospective observational study

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    Background: There is very limited evidence examining serious systemic adverse events (SSAEs) and post-injection endophthalmitis of intravitreal bevacizumab (IVB) and intravitreal ranibizumab (IVR) treatments in Thailand and low- and middle-income countries. Moreover, findings from the existing trials might have limited generalizability to certain populations and rare SSAEs. Objectives: This prospective observational study aimed to assess and compare the safety profiles of IVB and IVR in patients with retinal diseases in Thailand. Methods: Between 2013 and 2015, 6354 patients eligible for IVB or IVR were recruited from eight hospitals. Main outcomes measures were prevalence and risk of SSAEs, mortality, and endophthalmitis during the 6-month follow-up period. Results: In the IVB and IVR groups, 94 and 6% of patients participated, respectively. The rates of outcomes in the IVB group were slightly greater than in the IVR group. All-cause mortality rates in the IVB and IVR groups were 1.10 and 0.53%, respectively. Prevalence rates of endophthalmitis and non-fatal strokes in the IVB group were 0.04% of 16,421 injections and 0.27% of 5975 patients, respectively, whereas none of these events were identified in the IVR group. There were no differences between the two groups in the risks of mortality, arteriothrombotic events (ATE), and non-fatal heart failure (HF). Adjustment for potential confounding factors and selection bias using multivariable models for time-to-event outcomes and propensity scores did not alter the results. Conclusions: The rates of SAEs in both groups were low. The IVB and IVR treatments were not associated with significant risks of mortality, ATE, and non-fatal HF. Trial Registration: Thai Clinical Trial Registry identifier TCTR20141002001

    HIV/AIDS health care challenges for cross-country migrants in low- and middle-income countries: a scoping review.

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    INTRODUCTION: HIV/AIDS has been one of the world's most important health challenges in recent history. The global solidarity in responding to HIV/AIDS through the provision of antiretroviral therapy (ART) and encouraging early screening has been proved successful in saving lives of infected populations in past decades. However, there remain several challenges, one of which is how HIV/AIDS policies keep pace with the growing speed and diversity of migration flows. This study therefore aimed to examine the nature and the extent of HIV/AIDS health services, barriers to care, and epidemic burdens among cross-country migrants in low-and middle-income countries. METHODS: A scoping review was undertaken by gathering evidence from electronic databases and gray literature from the websites of relevant international initiatives. The articles were reviewed according to the defined themes: epidemic burdens of HIV/AIDS, barriers to health services and HIV/AIDS risks, and the operational management of the current health systems for HIV/AIDS. RESULTS: Of the 437 articles selected for an initial screening, 35 were read in full and mapped with the defined research questions. A high HIV/AIDS infection rate was a major concern among cross-country migrants in many regions, in particular sub-Saharan Africa. Despite a large number of studies reported in Africa, fewer studies were found in Asia and Latin America. Barriers of access to HIV/AIDS services comprised inadequate management of guidelines and referral systems, discriminatory attitudes, language differences, unstable legal status, and financial hardship. Though health systems management varied across countries, international partners consistently played a critical role in providing support for HIV/AIDS services to uninsured migrants and refugees. CONCLUSION: It was evident that HIV/AIDS health care problems for migrants were a major concern in many developing nations. However, there was little evidence suggesting if the current health systems effectively addressed those problems or if such management would sustainably function if support from global partners was withdrawn. More in-depth studies were recommended to further explore those knowledge gaps

    Variation of health-related quality of life assessed by caregivers and patients affected by severe childhood infections.

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    BACKGROUND: The agreement between self-reported and proxy measures of health status in ill children is not well established. This study aimed to quantify the variation in health-related quality of life (HRQOL) derived from young patients and their carers using different instruments. METHODS: A hospital-based cross-sectional survey was conducted between August 2010 and March 2011. Children with meningitis, bacteremia, pneumonia, acute otitis media, hearing loss, chronic lung disease, epilepsy, mild mental retardation, severe mental retardation, and mental retardation combined with epilepsy, aged between five to 14 years in seven tertiary hospitals were selected for participation in this study. The Health Utilities Index Mark 2 (HUI2), and Mark 3 (HUI3), and the EuroQoL Descriptive System (EQ-5D) and Visual Analogue Scale (EQ-VAS) were applied to both paediatric patients (self-assessment) and caregivers (proxy-assessment). RESULTS: The EQ-5D scores were lowest for acute conditions such as meningitis, bacteremia, and pneumonia, whereas the HUI3 scores were lowest for most chronic conditions such as hearing loss and severe mental retardation. Comparing patient and proxy scores (n = 74), the EQ-5D exhibited high correlation (r = 0.77) while in the HUI2 and HUI3 patient and caregiver scores were moderately correlated (r = 0.58 and 0.67 respectively). The mean difference between self and proxy-assessment using the HUI2, HUI3, EQ-5D and EQ-VAS scores were 0.03, 0.05, -0.03 and -0.02, respectively. In hearing-impaired and chronic lung patients the self-rated HRQOL differed significantly from their caregivers. CONCLUSIONS: The use of caregivers as proxies for measuring HRQOL in young patients affected by pneumococcal infection and its sequelae should be employed with caution. Given the high correlation between instruments, each of the HRQOL instruments appears acceptable apart from the EQ-VAS which exhibited low correlation with the others

    Is a HIV vaccine a viable option and at what price? An economic evaluation of adding HIV vaccination into existing prevention programs in Thailand

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    <p>Abstract</p> <p>Background</p> <p>This study aims to determine the maximum price at which HIV vaccination is cost-effective in the Thai healthcare setting. It also aims to identify the relative importance of vaccine characteristics and risk behavior changes among vaccine recipients to determine how they affect this cost-effectiveness.</p> <p>Methods</p> <p>A semi-Markov model was developed to estimate the costs and health outcomes of HIV prevention programs combined with HIV vaccination in comparison to the existing HIV prevention programs without vaccination. The estimation was based on a lifetime horizon period (99 years) and used the government perspective. The analysis focused on both the general population and specific high-risk population groups. The maximum price of cost-effective vaccination was defined by using threshold analysis; one-way and probabilistic sensitivity analyses were performed. The study employed an expected value of perfect information (EVPI) analysis to determine the relative importance of parameters and to prioritize future studies.</p> <p>Results</p> <p>The most expensive HIV vaccination which is cost-effective when given to the general population was 12,000 Thai baht (US$1 = 34 Thai baht in 2009). This vaccination came with 70% vaccine efficacy and lifetime protection as long as risk behavior was unchanged post-vaccination. The vaccine would be considered cost-ineffective at any price if it demonstrated low efficacy (30%) and if post-vaccination risk behavior increased by 10% or more, especially among the high-risk population groups. The incremental cost-effectiveness ratios were the most sensitive to change in post-vaccination risk behavior, followed by vaccine efficacy and duration of protection. The EVPI indicated the need to quantify vaccine efficacy, changed post-vaccination risk behavior, and the costs of vaccination programs.</p> <p>Conclusions</p> <p>The approach used in this study differentiated it from other economic evaluations and can be applied for the economic evaluation of other health interventions not available in healthcare systems. This study is important not only for researchers conducting future HIV vaccine research but also for policy decision makers who, in the future, will consider vaccine adoption.</p

    A cost-utility and budget impact analysis of allogeneic hematopoietic stem cell transplantation for severe thalassemic patients in Thailand

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    <p>Abstract</p> <p>Background</p> <p>Hematopoietic stem cell transplantation (HSCT) is the only curative treatment available to severe thalassemic patients. The treatment, however, is very costly, particularly in the context of low and middle income countries, and no studies have been carried out to explore its economic justifiability. This study aimed to estimate the cost-utility of HSCT compared with blood transfusions combined with iron chelating therapy (BT-ICT) for severe thalassemia in Thailand, and to investigate the affordability of HSCT using a budget impact analysis.</p> <p>Methods</p> <p>A Markov model was used to estimate the relevant costs and health outcomes over the patients' lifetimes taking a societal perspective as recommended by Thailand's health technology assessment guidelines. All future costs and outcomes were discounted at a rate of 3% per annum. Primary outcomes of interest were lifetime costs, quality adjusted life years (QALYs) gained, and the incremental cost-effectiveness ratio (ICER) in Thai baht (THB) per QALY gained.</p> <p>Results</p> <p>Compared to BT-ICT, the incremental cost-effectiveness ratio increased with patient age from 80,700 to 183,000 THB per QALY gained for related HSCT and 209,000 to 953,000 THB per QALY gained for unrelated HSCT among patients aged 1 to 15 years (US$1= 34 THB). The governmental budget impact analysis showed that providing 200 related HSCT to patients aged 1 to 10 years, in accordance with the current infrastructure limitations, would initially require approximately 90 million additional THB per year.</p> <p>Conclusions</p> <p>At a societal willingness to pay of 100,000 THB per QALY gained, related HSCT was likely to be a cost-effective and affordable treatment for young children with severe thalassemia in Thailand.</p
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