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Revisión sistemática

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Comparative effectiveness of oral therapies targeting the prostacyclin pathway in pulmonary arterial hypertension: A systematic review and network meta-analysis.

Revista Vascular pharmacology
Año 2024
Enlaces Pubmed DOI

Este artículo incluye 8 Estudios primarios 8 Estudios primarios (8 referencias)

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BACKGROUND: Oral prostanoids are recommended in patients with pulmonary arterial hypertension (PAH) and an unsatisfactory response to first-line therapy. OBJECTIVE: To compare the effectiveness of oral therapies targeting the prostacyclin pathway in PAH patients. METHODS: An online search of Medline, Cochrane Registry, Scopus and EMBASE libraries (from inception to May, 12,020) was conducted. Eight randomized controlled studies were included in the meta-analysis involving 3023 patients, with 828 receiving oral treprostinil, 607 patients receiving selexipag, 125 patients receiving beraprost, and 1463 patients receiving placebo. RESULTS: Compared to placebo, oral treprostinil (WMD 9.05, 95% CI 3.0280-15.0839, p = 0.0032) and beraprost (WMD 21.98, 95% CI 5.0536-38.9063, p = 0.0109) were associated with a significant increase in 6-min walking distance (6MWD) at follow-up from baseline, whereas selexipag use was associated with a non-significant increase in 6MWD (WMD 15.41, 95% CI -0.6074; 31.4232, p = 0.0593). Compared to placebo, the risk of clinical worsening was significantly lowered by selexipag (RR 0.47, 95% CI 0.35-0.65, p < 0.001) and oral treprostinil (RR 0.65, 95% CI 0.46-0.90, p 0.012), whereas a non-significant reduction of the outcome was related to beraprost use (RR 0.70, 95% CI 0.36-1.38, p 0.31). No significant difference in 6MWD change and clinical worsening reduction were found among oral treprostinil and selexipag. Beraprost use less frequently caused adverse events as compared to selexipag and oral treprostinil. CONCLUSIONS: No differences in 6MWD change, clinical worsening reduction and adverse events rates were found among oral treprostinil and selexipag, resulting in similar efficacy and safety profiles.

Revisión sistemática

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Treatment of pulmonary arterial hypertension in patients with connective tissue diseases: a systematic review and meta-analysis.

Revista Internal and emergency medicine
Año 2024
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Este artículo incluye 12 Estudios primarios 15 Estudios primarios (12 referencias)

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The evidence for the treatment of connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH) mostly depends on subgroup or post hoc analysis of randomized controlled trials (RCTs). Thus, we performed a meta-analysis of RCTs that reported outcomes for CTD-PAH. PubMed and EMBASE were searched for CTD-PAH treatment. The selected outcomes were functional class (FC) change, survival rates, 6-min walk distance (6-MWD), clinical worsening (CW), N-terminal prohormone BNP (NT-proBNP), pulmonary vascular resistance (PVR), mean pulmonary arterial pressure (mPAP), right atrial pressure (RAP), and cardiac index (CI). The meta-analysis was conducted according to the PRISMA guidelines and registered in PROSPERO (CRD42020153560). Twelve RCTs conducted with 1837 patients were included. The diagnoses were systemic sclerosis in 59%, SLE in 20%, and other CTDs in 21%. The pharmacological interventions were epoprostenol, treprostinil, sildenafil, tadalafil, bosentan, macitentan, ambrisentan, riociguat, and selexipag. There was a significant difference between interventions and placebo in FC, 6MWD, CW, PVR, RAP, and CI that favored intervention. Our analysis showed a 39% reduction in the CW risk with PAH treatment. The short-term survival rates and mean serum NT-proBNP changes were similar between the study and control groups. Treatment for CTD-PAH had favorable effects on clinical and hemodynamic outcomes but not on survival and NT-proBNP levels. Different from the previous meta-analyses that focused on 6-MWD, time to clinical worsening, and CW as outcomes, this meta-analysis additionally reports the pooled analysis of change in FC, hemodynamic measurements (RAP, PVR, CI), and NT-proBNP, some of which have prognostic value for PAH.

Revisión sistemática

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Heterogeneity of treatment effects by risk in pulmonary arterial hypertension.

Revista The European respiratory journal
Año 2023
Enlaces Pubmed DOI PubMed Central

Este artículo incluye 17 Estudios primarios 19 Estudios primarios (17 referencias)

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BACKGROUND: It is currently unknown if disease severity modifies response to therapy in pulmonary arterial hypertension (PAH). We aimed to explore if disease severity, as defined by established risk-prediction algorithms, modified response to therapy in randomised clinical trials in PAH. METHODS: We performed a meta-analysis using individual participant data from 18 randomised clinical trials of therapy for PAH submitted to the United States Food and Drug Administration to determine if predicted risk of 1-year mortality at randomisation modified the treatment effect on three outcomes: change in 6-min walk distance (6MWD), clinical worsening at 12 weeks and time to clinical worsening. RESULTS: Of 6561 patients with a baseline US Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL 2.0) score, we found that individuals with higher baseline risk had higher probabilities of clinical worsening but no difference in change in 6MWD. We detected a significant interaction of REVEAL 2.0 risk and treatment assignment on change in 6MWD. For every 3-point increase in REVEAL 2.0 score, there was a 12.49 m (95% CI 5.86-19.12 m; p=0.001) greater treatment effect in change in 6MWD. We did not detect a significant risk by treatment interaction on clinical worsening with most of the risk-prediction algorithms. CONCLUSIONS: We found that predicted risk of 1-year mortality in PAH modified treatment effect as measured by 6MWD, but not clinical worsening. Our findings highlight the importance of identifying sources of treatment heterogeneity by predicted risk to tailor studies to patients most likely to have the greatest treatment response.

Revisión sistemática

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Selexipag in patients with pulmonary hypertension: a systematic review and meta-analysis of randomized controlled trials.

Autores Qin J , Wang G , Han D
Revista Current problems in cardiology
Año 2023
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Este artículo incluye 5 Estudios primarios 5 Estudios primarios (5 referencias)

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BACKGROUND: Despite the availability of treatments for all subgroups of pulmonary hypertension (PH), the prognosis for PH remains poor. This systematic review and meta-analysis aimed to determine the efficacy and safety of selexipag in patients with PH. METHODS: A systematic search was made of PubMed, Embase, Cochrane Library, and clinicaltrials.gov, without language restrictions. Randomized controlled trials (RCTs) on treatment of PH with selexipag, compared with placebo or blank, were reviewed. Studies were pooled to weighted mean differences (WMDs) and risk ratios (RRs), with 95% confidence intervals (CIs). RESULTS: Five RCTs (enrolling 1558 participants) met the inclusion criteria. Selexipag showed significant effects on hospitalization for worsening of PH (RR 0.69, 95% CI 0.54 to 0.87), improvement in World Health Organization functional class (WHO FC) (RR 1.24, 95% CI 1.01 to 1.51), mean pulmonary artery pressure (mPAP) (WMD -0.70 mmHg, 95% CI -1.11 to -0.29 mmHg), N-terminal pro-brain natriuretic peptide (NT-proBNP) (WMD -150.19 ng/L, 95% CI -185.88 to -114.51 ng/L), and cardiac index (WMD 0.37 L/min/m2, 95% CI 0.10 to 0.64 L/min/m2). CONCLUSION: Selexipag was safe and significantly improved hospitalization for worsening of PH, WHO FC, mPAP, NT-proBNP, and cardiac index in patients with PH. Selexipag should be considered in patients with pulmonary arterial hypertension or chronic thromboembolic PH.

Revisión sistemática

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Effect of Phosphodiesterase-5 (PDE-5) Inhibitors on Clinical Outcomes in Patients With Pulmonary Hypertension: A Meta-Analysis of Randomized Control Trials.

Revista Cureus
Año 2023
Enlaces Pubmed DOI PubMed Central

Este artículo incluye 17 Estudios primarios 17 Estudios primarios (17 referencias)

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We intended to summarize the most recent research pertaining to the use of phosphodiesterase-5 (PDE5) inhibitors in pulmonary hypertension in light of recent developments in the knowledge of the pathophysiological mechanisms and treatments for pulmonary hypertension, with major contributions in the area in the last decade. The aim of this meta-analysis is to determine the efficacy of PDE5 inhibitors for pulmonary hypertension in adults. We followed the preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines to carry out this meta-analysis. Online database searching to identify eligible trials was performed in MEDLINE, EMBASE, and the Cochrane Library by two authors independently. Outcomes assessed in the current meta-analysis included change in the cardiac index from baseline in liters per minute per square meter (L/min/m2), mean peripheral arterial pressure (PAP) in mm Hg, mortality, hospitalization, and six-minute walking distance (6MWD) in meters (m). Overall, 17 articles met the inclusion criteria and were included in the current meta-analysis. PDE5 inhibitors significantly improve cardiac index (mean difference: 0.18, 95% CI: 0.04, 0.32, p-value: 0.01), mean PAP (mean difference: -5.61, 95% CI: -7.60, -3.62, p-value: 0.01), and 6MWD (mean difference: 26.26, 95% CI: 16.95, 35.57, p-value: 0.001) as compared to the patients in the control group. No significant difference was found in terms of risk of mortality (risk ratio (RR): 0.51, 95% CI: 0.17, 1.54) and risk of hospitalization (RR: 0.59, 95% CI: 0.23, 1.55) between the two groups. The current meta-analysis concluded that PDE5 inhibitors improve 6MWD, mean PAP, and cardiac index in patients with pulmonary hypertension. However, no significant difference was reported in terms of mortality and hospitalization between the two groups.

Revisión sistemática

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Efficacy and safety of non-prostanoid prostacyclin receptor agonist for pulmonary hypertension: A meta-analysis.

Autores Wang P , Feng H , Guo Y , Wu N , Yin H , Zhang Y , Pei S , Gao J , Lu Y , Hu Y , Zhang Y , Deng Z
Revista Pulmonary pharmacology & therapeutics
Año 2023
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Este artículo incluye 7 Estudios primarios 7 Estudios primarios (7 referencias)

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BACKGROUND: Oral non-prostanoid prostacyclin receptor agonists therapies have been recommended for pulmonary arterial hypertension in many countries. OBJECTIVE: We aimed to evaluate the specific impact of non-prostanoid prostacyclin receptor agonists on pulmonary hypertension and to explore the influence of study characteristics on results. METHODS: PubMed, Embase, and ClinicalTrials.gov were systematically searched from inception to July 12, 2022. Randomized controlled trials comparing non-prostanoid prostacyclin receptor agonists administration with placebo for treating pulmonary hypertension were included. Two researchers independently selected eligible studies, assessed the bias risk and extracted related data. RevMan5.1 was used for performing the statistical analysis and the assessment of bias risk of the enrolled studies. PROSPERO registered number CRD42022304172. RESULTS: Seven trials involving 1727 patients were included. Pooled analyses indicated non-prostanoid prostacyclin receptor agonists significantly reduced clinical worsening events (risk ratio [RR], 0.63; 95% confidence interval [CI], 0.54 to 0.74), increased 6-min walk distance (mean difference [MD], 10 m; 95% CI, 3-17 m), decreased pulmonary vascular resistance (MD, -121 dyn s/cm5; 95% CI, -172 to -69 dyn s/cm5) and increased cardiac index (MD, 0.38 L/min/m2; 95% CI, 0.26-0.50 L/min/m2) compared with the control. No significant differences in all-cause mortality (RR, 0.86; 95% CI, 0.26 to 2.78), NYHA/WHO functional class (RR, 1.16; 95% CI, 0.61 to 2.18), mean pulmonary artery pressure (MD, -0.88 mmHg; 95% CI, -2.20 to 0.44 mmHg), right atrial pressure (MD, 0.66 mmHg; 95% CI, -0.59 to 1.90 mmHg) and total adverse events (RR, 1.05; 95% CI, 0.99 to 1.10) were found between non-prostanoid prostacyclin receptor agonists group and control group. CONCLUSION: Non-prostanoid prostacyclin receptor agonists treatment exerted benefits on clinical worsening, pulmonary vascular resistance, and cardiac index in pulmonary hypertension patients, without increasing the incidence of total adverse events.

Revisión sistemática

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Efficacy and safety of selexipag, an oral prostacyclin receptor agonist for the treatment of pulmonary hypertension: A meta-analysis.

Autores Chen M , Lai Y , Chen R , Lu J , Zhang Y , Liu H , Wang D , Zhong Y , Zheng Z , Hong C
Revista Pulmonary pharmacology & therapeutics
Año 2022
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Este artículo incluye 10 Estudios primarios 8 Estudios primarios (10 referencias)

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BACKGROUND AND OBJECTIVE: This meta-analysis was performed to evaluate the effect and safety of selexipag in the treatment of pulmonary hypertension and to explore the effect of selexipag on cardiac function indexes in PAH patients. METHODS: Electronic databases, including the Cochrane Library, EMBASE, and PubMed databases, were searched. Endnote software X9 was used for study selection, and the Cochrane Risk of Bias Tool was used for literature screening and quality assessment. Data analysis was performed using RevMan 5.3 software, and GRADE was used to assess the evidence level. RESULTS: Ten studies were finally selected in accordance with the standard. A total of 10 papers were included. A total of 1322 patients were included, including 723 in the trial group and 599 in the control group. Patients with PAH treated with selexipag were included in the trial group, and patients with PAH treated with placebo were included in the control group. The results of the study showed that selexipag was effective in reducing mortality in patients (WMD=0.70, 95% CI: 0.53-0.94, P = 0.02). Selexipag effectively increased the 6-min walk distance (WMD=33.79, 95% CI: 2.69-64.90, P=0.03). Selexipag also effectively increased the 6-min distance between baseline and follow-up (WMD = 15.28, 95% CI: 7.76-22.80, P < 0.0001). Selexipag effectively reduced PVR (WMD = -230.96, 95% CI: 445.94 to -15.97, P = 0.04). Selexipag significantly reduced PVR between baseline and follow-up (WMD = -139.62, 95% CI: 215.32 to -63.91, P = 0.0003). The adverse reactions of selexipag were mild with headache, diarrhea and nausea reported as the main symptoms. CONCLUSION: Selexipag is a new drug with mild adverse reactions and is safe for the treatment of PAH. This drug significantly prolongs the level of 6MWD in PAH patients, reduces the fatality rate, improves WHO FC and reduces PVR. The effects of this drug on CI, mPAP, MRAP, SvO2 and other indicators still need to be further confirmed. PROSPERO REGISTRATION: CRD42021245557.

Revisión sistemática

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Endothelin receptor antagonists for pulmonary arterial hypertension.

Autores Liu C , Chen J , Gao Y , Deng B , Liu K
Revista The Cochrane database of systematic reviews
Año 2021
Enlaces Pubmed DOI PubMed Central

Este artículo está incluido en 1 Síntesis amplia 11 Síntesis amplias (1 referencia)

Este artículo incluye 11 Estudios primarios 11 Estudios primarios (11 referencias)

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BACKGROUND: Pulmonary arterial hypertension is a devastating disease that leads to right heart failure and premature death. Endothelin receptor antagonists have shown efficacy in the treatment of pulmonary arterial hypertension. OBJECTIVES: To evaluate the efficacy of endothelin receptor antagonists (ERAs) in pulmonary arterial hypertension. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and the reference sections of retrieved articles. The searches are current as of 4 November 2020. SELECTION CRITERIA: We included randomised trials and quasi-randomised trials involving participants with pulmonary arterial hypertension. DATA COLLECTION AND ANALYSIS: Two of five review authors selected studies, extracted data and assessed study quality according to established criteria. We used standard methods expected by Cochrane. The primary outcomes were exercise capacity (six-minute walk distance, 6MWD), World Health Organization (WHO) or New York Heart Association (NYHA) functional class, Borg dyspnoea scores and dyspnoea-fatigue ratings, and mortality. MAIN RESULTS: We included 17 randomised controlled trials involving a total of 3322 participants. Most trials were of relatively short duration (12 weeks to six months). Sixteen trials were placebo-controlled, and of these nine investigated a non-selective ERA and seven a selective ERA.   We evaluated two comparisons in the review: ERA versus placebo and ERA versus phosphodiesterase type 5 (PDE5) inhibitor. The abstract focuses on the placebo-controlled trials only and presents the pooled results of selective and non-selective ERAs. After treatment, participants receiving ERAs could probably walk on average 25.06 m (95% confidence interval (CI) 17.13 to 32.99 m; 2739 participants; 14 studies; I2 = 34%, moderate-certainty evidence) further than those receiving placebo in a 6MWD. Endothelin receptor antagonists probably improved more participants' WHO functional class (odds ratio (OR) 1.41, 95% CI 1.16 to 1.70; participants = 3060; studies = 15; I2 = 5%, moderate-certainty evidence) and probably lowered the odds of functional class deterioration (OR 0.43, 95% CI 0.26 to 0.72; participants = 2347; studies = 13; I2 = 40%, moderate-certainty evidence) compared with placebo. There may be a reduction in mortality with ERAs (OR 0.78, 95% CI 0.58, 1.07; 2889 participants; 12 studies; I2 = 0%, low-certainty evidence), and pooled data suggest that ERAs probably improve cardiopulmonary haemodynamics and may reduce Borg dyspnoea score in symptomatic patients. Hepatic toxicity was not common, but may be increased by ERA treatment from 37 to 67 (95% CI 34 to 130) per 1000 over 25 weeks of treatment (OR 1.88, 95% CI 0.91 to 3.90; moderate-certainty evidence). Although ERAs were well tolerated in this population, several cases of irreversible liver failure caused by sitaxsentan have been reported, which led the licence holder for sitaxsentan to withdraw the product from all markets worldwide.  As planned, we performed subgroup analyses comparing selective and non-selective ERAs, and with the exception of mean pulmonary artery pressure, did not detect any clear subgroup differences for any outcome. AUTHORS' CONCLUSIONS: For people with pulmonary arterial hypertension with WHO functional class II and III, endothelin receptor antagonists probably increase exercise capacity, improve WHO functional class, prevent WHO functional class deterioration, result in favourable changes in cardiopulmonary haemodynamic variables compared with placebo. However, they are less effective in reducing dyspnoea and mortality. The efficacy data were strongest in those with idiopathic pulmonary hypertension. The irreversible liver failure caused by sitaxsentan and its withdrawal from global markets emphasise the importance of hepatic monitoring in people treated with ERAs. The question of the effects of ERAs on pulmonary arterial hypertension has now likely been answered.. The combined use of ERAs and phosphodiesterase inhibitors may provide more benefit in pulmonary arterial hypertension; however, this needs to be confirmed in future studies.

Revisión sistemática

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Comparative effectiveness of pulmonary arterial hypertension drugs in treatment-naive patients: A network meta-analysis

Autores Petrovič M , Locatelli I
Revista Journal of comparative effectiveness research
Año 2020
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Este artículo incluye 20 Estudios primarios 22 Estudios primarios (20 referencias)

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Aim: No network meta-analysis has been conducted to study efficacy of drug therapies specific for treatment of pulmonary arterial hypertension in treatment-naive patients only. Methods: Randomized controlled trials on pulmonary arterial hypertension-specific drug therapies were searched and a Bayesian network meta-analysis was performed. The 6-min walking distance (6MWD) and all-cause mortality were efficacy outcomes, whereas discontinuation due to adverse events was a safety-related outcome. Results: Analysis included 3.713 patients from 21 trials. Combination of ambrisentan and tadalafil showed the greatest impact on 6MWD, followed by epoprostenol and intravenous treprostinil (high dose). The latter two demonstrated marked effect size on mortality, although not statistically significant. Conclusion: According to 6MWD, ambrisentan/tadalafil combination was considered as most effective among all comparisons. Prospero ID: CRD42019110832. © 2020 Future Medicine Ltd.. All rights reserved.

Revisión sistemática

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Vasomodulators and liver transplantation for portopulmonary hypertension: evidence from a systematic review and meta-analysis.

Revista Hepatology (Baltimore, Md.)
Año 2020
Enlaces Pubmed DOI

Este artículo incluye 26 Estudios primarios 26 Estudios primarios (26 referencias)

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Untreated portopulmonary hypertension (PoPH) carries poor prognosis. Previous reports have described vasomodulator therapy (VM) and liver transplantation (LT) as treatment options. However, no study has systematically summarized the reported effects on pulmonary hemodynamics and survival. We aimed to provide summary estimates on these endpoints in patients with PoPH, treated with different modalities. We performed a systematic review with meta-analysis of mainly observational and case-control studies describing no treatment, VM, LT or VM+LT in patients with PoPH. Twenty-six studies (1019 patients) were included. Both VM and VM+LT improve pulmonary hemodynamics. A substantial proportion of patients treated with VM becomes eligible for LT (44%, 95%CI:31-58). Pooled estimates for 1-, and 3-year post-diagnosis survival in patients treated with VM were 86% (95%CI:81-90) and 69% (95%CI:50-84), versus 82% (95%CI:52-95) and 67% (95%CI:53-78) in patients treated with VM+LT. Of note, studies reporting on the effect of VM mainly included Child-Pugh A/B patients, while studies reporting on VM+LT mainly included Child-Pugh B/C. Seven studies (238 patients) included both patients who received VM only and patients who received VM+LT. The risk of death in VM-only-treated patients was significantly higher than in patients who could be transplanted too (odds ratio 3.5; 95%CI:1.4-8.8), however, importantly, patients who proceeded to transplant had been selected very strictly. In 50% of patients, VM can be discontinued post-LT (95%CI:38-62). Conclusion: VM and VM+LT both improve pulmonary hemodynamics and prognosis in PoPH. In a strictly selected subpopulation of cases where LT is indicated based on severe liver disease and where LT is considered safe and feasible, treatment with VM+LT confers better prognosis. Considering successful VM, 44% can proceed to LT, with half of them being able to postoperatively stop medication.