scholarly journals Discontinuing statins or not in the elderly? Study protocol for a randomized controlled trial

2019 ◽  
Author(s):  
Fabrice Bonnet ◽  
Antoine Bénard ◽  
Pierre Poulizac ◽  
Mélanie Afonso ◽  
Aline Maillard ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Primary Prevention ◽  
Controlled Trial ◽  
The Elderly ◽  
Randomised Clinical Trial ◽  
Open Label ◽  
Medication Therapy ◽  
Life Years ◽  
The Cost ◽  
Overall Mortality

Abstract Background The risk/benefit ratio of using statins for cardiovascular (CV) primary prevention in elderly people has not been established. The main objectives of the present study are to assess the cost-effectiveness of statin cessation and to examine the non-inferiority of statin cessation in terms of mortality in patients aged 75 and over treated with statins for primary prevention. Methods The Statins In The Elderly (SITE) Study is an ongoing 3-year follow-up, open-label comparative multi-centre randomised clinical trial that is being conducted in two parallel groups in outpatient primary care offices. Participants meeting the following criteria are being included: people aged 75 years and older being treated with statins as primary prevention for CV events who provide informed consent. After randomisation, patients in the statin-cessation strategy are instructed to withdraw their treatment. In the comparison strategy, patients continue their statin treatment at the usual dosage. The cost-effectiveness of the statin-cessation strategy compared to continuing statins will be estimated through the incremental cost per quality-adjusted life years (QALY) gained at 36 months based on the perspective of the French healthcare system. Overall mortality will be the primary clinical endpoint. We assumed that the mortality rate at 3 years will be 15%. The sample size was computed to achieve 90% power in showing the non-inferiority of statin cessation, assuming a non-inferiority margin of 5% of the between-group difference in overall mortality. In total, the SITE study will include 2,430 individuals. Discussion There is some debate regarding the value of statins in people over 75 years old, especially for primary prevention, due to a lack of evidence of their efficacy in this population, potential compliance-related events, drug-drug interactions and side effects that could impair quality of life. Data from clinical trials guide the initiation of medication therapy for primary or secondary prevention of CV disease but do not define the timing, safety, or risks of discontinuing the agents. The SITE study is one of the first to examine whether treatment cessation is a cost-effective strategy that has no adverse effects on the prognosis of people over 75 years old formerly treated with statins. Trial registration This research has been registered at clinicaltrials.gov under number NCT02547883, 11 September 2015, https://clinicaltrials.gov/ct2/show/NCT02547883

scholarly journals Discontinuing statins or not in the elderly? Study protocol for a randomized controlled trial

2019 ◽  
Author(s):  
Fabrice Bonnet ◽  
Antoine Bénard ◽  
Pierre Poulizac ◽  
Mélanie Afonso ◽  
Aline Maillard ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Primary Prevention ◽  
Controlled Trial ◽  
The Elderly ◽  
Randomised Clinical Trial ◽  
Open Label ◽  
Medication Therapy ◽  
Life Years ◽  
The Cost ◽  
Overall Mortality

Abstract Background The risk/benefit ratio of using statins for cardiovascular (CV) primary prevention in elderly people has not been established. The main objectives of the present study are to assess the cost-effectiveness of statin cessation and to examine the non-inferiority of statin cessation in terms of mortality in patients aged 75 and over treated with statins for primary prevention.Methods The Statins In The Elderly (SITE) Study is an ongoing 3-year follow-up, open-label comparative multi-centre randomised clinical trial that is being conducted in two parallel groups in outpatient primary care offices. Participants meeting the following criteria are being included: people aged 75 years and older being treated with statins as primary prevention for CV events who provide informed consent. After randomisation, patients in the statin-cessation strategy are instructed to withdraw their treatment. In the comparison strategy, patients continue their statin treatment at the usual dosage. The cost-effectiveness of the statin-cessation strategy compared to continuing statins will be estimated through the incremental cost per quality-adjusted life years (QALY) gained at 36 months based on the perspective of the French healthcare system. Overall mortality will be the primary clinical endpoint. We assumed that the mortality rate at 3 years will be 15%. The sample size was computed to achieve 90% power in showing the non-inferiority of statin cessation, assuming a non-inferiority margin of 5% of the between-group difference in overall mortality. In total, the SITE study will include 2,430 individuals. Discussion There is some debate regarding the value of statins in people over 75 years old, especially for primary prevention, due to a lack of evidence of their efficacy in this population, potential compliance-related events, drug-drug interactions and side effects that could impair quality of life. Data from clinical trials guide the initiation of medication therapy for primary or secondary prevention of CV disease but do not define the timing, safety, or risks of discontinuing the agents. The SITE study is one of the first to examine whether treatment cessation is a cost-effective strategy that has no adverse effects on the prognosis of people over 75 years old formerly treated with statins. Trial registration This research has been registered at clinicaltrials.gov under number NCT02547883, 11 September 2015, https://clinicaltrials.gov/ct2/show/NCT02547883

scholarly journals Discontinuing statins or not in the elderly? Study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
Fabrice Bonnet ◽  
Antoine Bénard ◽  
Pierre Poulizac ◽  
Mélanie Afonso ◽  
Aline Maillard ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Primary Prevention ◽  
Controlled Trial ◽  
The Elderly ◽  
Randomised Clinical Trial ◽  
Open Label ◽  
Medication Therapy ◽  
Life Years ◽  
The Cost ◽  
Overall Mortality

Abstract Background The risk/benefit ratio of using statins for cardiovascular (CV) primary prevention in elderly people has not been established. The main objectives of the present study are to assess the cost-effectiveness of statin cessation and to examine the non-inferiority of statin cessation in terms of mortality in patients aged 75 and over treated with statins for primary prevention. Methods The Statins In The Elderly (SITE) Study is an ongoing 3-year follow-up, open-label comparative multi-centre randomised clinical trial that is being conducted in two parallel groups in outpatient primary care offices. Participants meeting the following criteria are being included: people aged 75 years and older being treated with statins as primary prevention for CV events who provide informed consent. After randomisation, patients in the statin-cessation strategy are instructed to withdraw their treatment. In the comparison strategy, patients continue their statin treatment at the usual dosage. The cost-effectiveness of the statin-cessation strategy compared to continuing statins will be estimated through the incremental cost per quality-adjusted life years (QALY) gained at 36 months based on the perspective of the French healthcare system. Overall mortality will be the primary clinical endpoint. We assumed that the mortality rate at 3 years will be 15%. The sample size was computed to achieve 90% power in showing the non-inferiority of statin cessation, assuming a non-inferiority margin of 5% of the between-group difference in overall mortality. In total, the SITE study will include 2,430 individuals. Discussion There is some debate regarding the value of statins in people over 75 years old, especially for primary prevention, due to a lack of evidence of their efficacy in this population, potential compliance-related events, drug-drug interactions and side effects that could impair quality of life. Data from clinical trials guide the initiation of medication therapy for primary or secondary prevention of CV disease but do not define the timing, safety, or risks of discontinuing the agents. The SITE study is one of the first to examine whether treatment cessation is a cost-effective strategy that has no adverse effects on the prognosis of people over 75 years old formerly treated with statins. Trial registration This research has been registered at clinicaltrials.gov under number NCT02547883, 11 September 2015, https://clinicaltrials.gov/ct2/show/NCT02547883

scholarly journals Electroacupuncture with Usual Care for Patients with Non-Acute Pain after Back Surgery: Cost-Effectiveness Analysis Alongside a Randomized Controlled Trial

2020 ◽  
Vol 12 (12) ◽  
pp. 5033
Author(s):  
NamKwen Kim ◽  
Kyung-Min Shin ◽  
Eun-Sung Seo ◽  
Minjung Park ◽  
Hye-Yoon Lee
Keyword(s):  
Cost Effectiveness ◽  
Usual Care ◽  
Societal Perspective ◽  
National Health ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Acute Low Back Pain ◽  
Life Years ◽  
Back Surgery ◽  
The Cost

Electroacupuncture (EA) is used to treat pain after back surgery. Although this treatment is covered by national health insurance in Korea, evidence supporting its cost-effectiveness and contribution to the sustainability of the national health care system has yet to be published. Therefore, an economic evaluation, alongside a clinical trial, was conducted to estimate the cost-effectiveness of EA and usual care (UC) versus UC alone to treat non-acute low back pain (LBP). In total, 108 patients were recruited and randomly assigned to treatment groups; 106 were included in the final cost utility analysis. The incremental cost-effectiveness ratio of EA plus UC was estimated as 7,048,602 Korean Rate Won (KRW) per quality-adjusted life years (QALYs) from the societal perspective (SP). If the national threshold was KRW 30 million per QALY, the cost-effectiveness probability of EA plus UC was an estimated 85.9%; and, if the national threshold was over KRW 42,496,372 per QALY, the cost-effectiveness probability would be over 95% percent statistical significance. Based on these results, EA plus UC combination therapy for patients with non-acute LBP may be cost-effective from a societal perspective in Korea.

scholarly journals Cost-effectiveness of injectable opioid treatment v. oral methadone for chronic heroin addiction

2013 ◽  
Vol 203 (5) ◽  
pp. 341-349 ◽  
Author(s):  
Sarah Byford ◽  
Barbara Barrett ◽  
Nicola Metrebian ◽  
Teodora Groshkova ◽  
Maria Cary ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Social Services ◽  
Controlled Trial ◽  
Cost Effective ◽  
Heroin Addiction ◽  
Future Research ◽  
Open Label ◽  
Opioid Treatment ◽  
Oral Methadone ◽  
Life Years

BackgroundDespite evidence of the effectiveness of injectable opioid treatment compared with oral methadone for chronic heroin addiction, the additional cost of injectable treatment is considerable, and cost-effectiveness uncertain.AimsTo compare the cost-effectiveness of supervised injectable heroin and injectable methadone with optimised oral methadone for chronic refractory heroin addiction.MethodMultisite, open-label, randomised controlled trial. Outcomes were assessed in terms of quality-adjusted life-years (QALYs). Economic perspective included health, social services and criminal justice resources.ResultsIntervention costs over 26 weeks were significantly higher for injectable heroin (mean £8995 v. £4674 injectable methadone and £2596 oral methadone; P<0.0001). Costs overall were highest for oral methadone (mean £15805 v. £13410 injectable heroin and £10945 injectable methadone; P =n.s.) due to higher costs of criminal activity. In cost-effectiveness analysis, oral methadone was dominated by injectable heroin and injectable methadone (more expensive and less effective). At willingness to pay of £30 000 per QALY, there is a higher probability of injectable methadone being more cost-effective (80%) than injectable heroin.ConclusionsInjectable opioid treatments are more cost-effective than optimised oral methadone for chronic refractory heroin addiction. The choice between supervised injectable heroin and injectable methadone is less clear. There is currently evidence to suggest superior effectiveness of injectable heroin but at a cost that policy makers may find unacceptable. Future research should consider the use of decision analytic techniques to model expected costs and benefits of the treatments over the longer term.

scholarly journals Cost-effectiveness of intrapleural use of tissue plasminogen activator and DNase in pleural infection: evidence from the MIST2 randomised controlled trial

2019 ◽  
Vol 54 (2) ◽  
pp. 1801550 ◽  
Author(s):  
Ramon Luengo-Fernandez ◽  
Erika Penz ◽  
Melissa Dobson ◽  
Ioannis Psallidas ◽  
Andrew J. Nunn ◽  
...  
Keyword(s):  
Economic Evaluation ◽  
Cost Effectiveness ◽  
Plasminogen Activator ◽  
Tissue Plasminogen Activator ◽  
Controlled Trial ◽  
Combined Therapy ◽  
Cost Effective ◽  
Life Years ◽  
Tissue Plasminogen ◽  
The Cost

The MIST2 (Second Multicentre Intrapleural Sepsis Trial) trial showed that combined intrapleural use of tissue plasminogen activator (t-PA) and recombinant human DNase was effective when compared with single agents or placebo. However, the treatment costs are significant and overall cost-effectiveness of combined therapy remains unclear.An economic evaluation of the MIST2 trial was performed to assess the cost-effectiveness of combined therapy. Costs included were those related to study medications, initial hospital stay and subsequent hospitalisations. Outcomes were measured in terms of life-years gained. All costs were reported in euro and in 2016 prices.Mean annual costs were lowest in the t-PA–DNase group (EUR 10 605 for t-PA, EUR 17 856 for DNase, EUR 13 483 for placebo and EUR 7248 for t-PA–DNase; p=0.209). Mean 1-year life expectancy was 0.988 for t-PA, 0.923 for DNase, and 0.969 for both placebo and t-PA–DNase (p=0.296). Both DNase and placebo were less effective, in terms of life-years gained, and more costly than t-PA. When placebo was compared with t-PA–DNase, the incremental cost per life-year gained of placebo was EUR 1.6 billion, with a probability of 0.85 of t-PA–DNase being cost-effective.This study demonstrates that combined t-PA–DNase is likely to be highly cost-effective. In light of this evidence, a definitive trial designed to facilitate a thorough economic evaluation is warranted to provide further evidence on the cost-effectiveness of this promising combined intervention.

scholarly journals On the cost-effectiveness of insecticide-treated wall liner and indoor residual spraying as additions to insecticide treated bed nets to prevent malaria: findings from cluster randomized trials in Tanzania

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Kihomo Robert Mpangala ◽  
Yara A. Halasa-Rappel ◽  
Mohamed Seif Mohamed ◽  
Ruth C. Mnzava ◽  
Kaseem J. Mkuza ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomized Trial ◽  
Economies Of Scale ◽  
Controlled Trial ◽  
National Income ◽  
Indoor Residual Spraying ◽  
Bed Nets ◽  
Life Years ◽  
Management Procedures ◽  
The Cost

Abstract Background Despite widespread use of long-lasting insecticidal nets (LLINs) and other tools, malaria caused 409,000 deaths worldwide in 2019. While indoor residual spraying (IRS) is an effective supplement, IRS is moderately expensive and logistically challenging. In endemic areas, IRS requires yearly application just before the main rainy season and potential interim reapplications. A new technology, insecticide-treated wall liner (ITWL), might overcome these challenges. Methods We conducted a 44-cluster two-arm randomized controlled trial in Muheza, Tanzania from 2015 to 2016 to evaluate the cost and efficacy of a non-pyrethroid ITWL to supplement LLINs, analyzing operational changes over three installation phases. The estimated efficacy (with 95% confidence intervals) of IRS as a supplement to LLINs came mainly from a published randomized trial in Muleba, Tanzania. We obtained financial costs of IRS from published reports and conducted a household survey of a similar IRS program near Muleba to determine household costs. The costs of ITWL were amortized over its 4-year expected lifetime and converted to 2019 US dollars using Tanzania’s GDP deflator and market exchange rates. Results Operational improvements from phases 1 to 3 raised ITWL coverage from 35.1 to 67.1% of initially targeted households while reducing economic cost from $34.18 to $30.56 per person covered. However, 90 days after installing ITWL in 5666 households, the randomized trial was terminated prematurely because cone bioassay tests showed that ITWL no longer killed mosquitoes and therefore could not prevent malaria. The ITWL cost $10.11 per person per year compared to $5.69 for IRS. With an efficacy of 57% (3–81%), IRS averted 1162 (61–1651) disability-adjusted life years (DALYs) per 100,000 population yearly. Its incremental cost-effectiveness ratio (ICER) per DALY averted was $490 (45% of Tanzania’s per capita gross national income). Conclusions These findings provide design specifications for future ITWL development and implementation. It would need to be efficacious and more effective and/or less costly than IRS, so more persons could be protected with a given budget. The durability of a previous ITWL, progress in non-pyrethroid tools, economies of scale and competition (as occurred with LLINs), strengthened community engagement, and more efficient installation and management procedures all offer promise of achieving these goals. Therefore, ITWLs merit ongoing study. First posted 2015 (NCT02533336).

scholarly journals Cost-effectiveness analyses for mirtazapine and sertraline in dementia: randomised controlled trial

2013 ◽  
Vol 202 (2) ◽  
pp. 121-128 ◽  
Author(s):  
Renee Romeo ◽  
Martin Knapp ◽  
Jennifer Hellier ◽  
Michael Dewey ◽  
Clive Ballard ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Cost Effective ◽  
Cost Effectiveness Analysis ◽  
Effectiveness Analysis ◽  
People With Dementia ◽  
Life Years ◽  
The Cost ◽  
The Impact

BackgroundDepression is a common and costly comorbidity in dementia. There are very few data on the cost-effectiveness of antidepressants for depression in dementia and their effects on carer outcomes.AimsTo evaluate the cost-effectiveness of sertraline and mirtazapine compared with placebo for depression in dementia.MethodA pragmatic, multicentre, randomised placebo-controlled trial with a parallel cost-effectiveness analysis (trial registration: ISRCTN88882979 and EudraCT 2006-000105-38). The primary cost-effectiveness analysis compared differences in treatment costs for patients receiving sertraline, mirtazapine or placebo with differences in effectiveness measured by the primary outcome, total Cornell Scale for Depression in Dementia (CSDD) score, over two time periods: 0–13 weeks and 0–39 weeks. The secondary evaluation was a cost-utility analysis using quality-adjusted life years (QALYs) computed from the Euro-Qual (EQ-5D) and societal weights over those same periods.ResultsThere were 339 participants randomised and 326 with costs data (111 placebo, 107 sertraline, 108 mirtazapine). For the primary outcome, decrease in depression, mirtazapine and sertraline were not cost-effective compared with placebo. However, examining secondary outcomes, the time spent by unpaid carers caring for participants in the mirtazapine group was almost half that for patients receiving placebo (6.74 v. 12.27 hours per week) or sertraline (6.74 v. 12.32 hours per week). Informal care costs over 39 weeks were £1510 and £1522 less for the mirtazapine group compared with placebo and sertraline respectively.ConclusionsIn terms of reducing depression, mirtazapine and sertraline were not cost-effective for treating depression in dementia. However, mirtazapine does appear likely to have been cost-effective if costing includes the impact on unpaid carers and with quality of life included in the outcome. Unpaid (family) carer costs were lower with mirtazapine than sertraline or placebo. This may have been mediated via the putative ability of mirtazapine to ameliorate sleep disturbances and anxiety. Given the priority and the potential value of supporting family carers of people with dementia, further research is warranted to investigate the potential of mirtazapine to help with behavioural and psychological symptoms in dementia and in supporting carers.

scholarly journals Cost-effectiveness of surgical treatments compared with early structured physiotherapy in secondary care for adults with primary frozen shoulder

2021 ◽  
Vol 2 (8) ◽  
pp. 685-695
Author(s):  
Belen Corbacho ◽  
Stephen Brealey ◽  
Ada Keding ◽  
Gerry Richardson ◽  
David Torgerson ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Secondary Care ◽  
Controlled Trial ◽  
Frozen Shoulder ◽  
Cost Effective ◽  
Cost Utility ◽  
Sensitivity Analyses ◽  
Arthroscopic Capsular Release ◽  
Life Years ◽  
The Cost

Aims A pragmatic multicentre randomized controlled trial, UK FROzen Shoulder Trial (UK FROST), was conducted in the UK NHS comparing the cost-effectiveness of commonly used treatments for adults with primary frozen shoulder in secondary care. Methods A cost utility analysis from the NHS perspective was performed. Differences between manipulation under anaesthesia (MUA), arthroscopic capsular release (ACR), and early structured physiotherapy plus steroid injection (ESP) in costs (2018 GBP price base) and quality adjusted life years (QALYs) at one year were used to estimate the cost-effectiveness of the treatments using regression methods. Results ACR was £1,734 more costly than ESP ((95% confidence intervals (CIs) £1,529 to £1,938)) and £1,457 more costly than MUA (95% CI £1,283 to £1,632). MUA was £276 (95% CI £66 to £487) more expensive than ESP. Overall, ACR had worse QALYs compared with MUA (-0.0293; 95% CI -0.0616 to 0.0030) and MUA had better QALYs compared with ESP (0.0396; 95% CI -0.0008 to 0.0800). At a £20,000 per QALY willingness-to-pay threshold, MUA had the highest probability of being cost-effective (0.8632) then ESP (0.1366) and ACR (0.0002). The results were robust to sensitivity analyses. Conclusion While ESP was less costly, MUA was the most cost-effective option. ACR was not cost-effective. Cite this article: Bone Jt Open 2021;2(8):685–695.

scholarly journals Cost-Effectiveness Analysis of BCG Vaccination against Tuberculosis in Indonesia: A Model-Based Study

Vaccines ◽  
2020 ◽  
Vol 8 (4) ◽  
pp. 707
Author(s):  
Afifah Machlaurin ◽  
Franklin Christiaan Karel Dolk ◽  
Didik Setiawan ◽  
Tjipke Sytse van der Werf ◽  
Maarten J. Postma
Keyword(s):  
Cost Effectiveness ◽  
Univariate Analysis ◽  
Cost Effective ◽  
Epidemiological Data ◽  
Control Programme ◽  
Detection Rates ◽  
Middle Income ◽  
Bcg Vaccination ◽  
Life Years ◽  
The Cost

Bacillus Calmette–Guerin (BCG), the only available vaccine for tuberculosis (TB), has been applied for decades. The Indonesian government recently introduced a national TB disease control programme that includes several action plans, notably enhanced vaccination coverage, which can be strengthened through underpinning its favourable cost-effectiveness. We designed a Markov model to assess the cost-effectiveness of Indonesia’s current BCG vaccination programme. Incremental cost-effectiveness ratios (ICERs) were evaluated from the perspectives of both society and healthcare. The robustness of the analysis was confirmed through univariate and probabilistic sensitivity analysis (PSA). Using epidemiological data compiled for Indonesia, BCG vaccination at a price US$14 was estimated to be a cost-effective strategy in controlling TB disease. From societal and healthcare perspectives, ICERs were US$104 and US$112 per quality-adjusted life years (QALYs), respectively. The results were robust for variations of most variables in the univariate analysis. Notably, the vaccine’s effectiveness regarding disease protection, vaccination costs, and case detection rates were key drivers for cost-effectiveness. The PSA results indicated that vaccination was cost-effective even at US$175 threshold in 95% of cases, approximating the monthly GDP per capita. Our findings suggest that this strategy was highly cost-effective and merits prioritization and extension within the national TB programme. Our results may be relevant for other high endemic low- and middle-income countries.

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