were excluded. Follow-up began after index date and continued until end of first drug exposure, end of continuous enrollment, all-cause death, or end of data, whichever was first. Multivariable Cox proportional hazard and Poisson regression was used to compare the effects of oral treprostinil to selexipag on PH-related hospitalization risk and rates, respectively. RESULTS: The study population included 99 patients treated with oral treprostinil and 123 patients treated with selexipag. The study population, on average, was 61 years old and predominately female (71%). After adjusting for confounders, selexipag reduced the risk for first PH-related hospitalization by 47% compared to oral treprostinil (hazard ratio: 0.53; 95% CI (confidence interval): 0.31, 0.93; p-value: 0.03). Compared to oral treprostinil, PH-related hospitalization rate with selexipag was reduced by 46% after adjusting for confounders (rate ratio: 0.54; 95% CI: 0.35, 0.82; p-value: 0.004). CONCLUSIONS: Selexipag is associated with lower PHrelated hospitalization risk and rates compared to oral treprostinil.
OBJECTIVES:A popular approach to estimate treatment effects is the meta-analysis of individual participant data (IPD). This study aimed to assess through IPD the impact of exercise-based cardiac rehabilitation (ExCR) on exercise capacity and health-related quality of life (HRQoL) and identify subgroups of patients with heart failure (HF) that may respond differently to ExCR. METHODS: The Exercise Training Meta-Analysis of Trials for Chronic Heart Failure (ExTraMATCH II) collected IPD from RCTs that compared exercise rehabilitation with a non-exercise control and a minimum follow-up of 6 months. Outcomes of interest were the 6 Minutes Walk Test (6MWT), peak volume of oxygen consumption (pVO2), the Minnesota Living with Heart Failure (MLHF) or other HRQoL questionnaires. The primary analyses included one-stage and two-stage IPD meta-analyses carried out at 6 and 12 months. All primary analyses used IPD hierarchical random effects regression models, adjusted for the baseline value of the outcome measure. RESULTS: Thirteen studies provided anonymised IPD for 3,000 patients (1,496 ExCR, 1,504 control) with a median followup of 33 weeks. Compared to control, average treatment effects from the one-stage meta-analysis over 12 months showed a significant improvement in MLHF: 5.94 (95% CI 1.0 to 10.9), standardised HRQoL score: 0.20 (95% CI 0.03 to 0.37), 6MWT: 21.0 (95% CI 1.57 to 40.4) and standardised exercise capacity score: 0.27 (95% CI 0.11 to 0.43) for patients assigned to ExCR. No significant difference in peak VO2 was observed: 1.01 (95% CI -0.42 to 2.44). Interaction analyses revealed no consistent interaction between the effect of ExCR and the predefined subgroups. CONCLUSIONS: Access to individual data from several RCTs allows to address important questions on the benefits of ExCR in HF failure. Results from this IPD must be discussed in light of findings from previous aggregate data meta-analyses on the same topic.
end of data collection, death or transfer out of practice, whichever came first. Age-, sex-and comorbidity-adjusted hospitalisation rate ratios (RRs) and hazard ratios (HRs) were calculated. Results: Data from 28,335 patients with HF and 85,005 controls were examined (mean age 75.4 years; 45.4% women). At baseline, patients with HF had higher cardiovascular disease (CVD)-related and metabolic medication use (83.7% vs 50.2%) and a higher Charlson Comorbidity Index score (2.03 vs 1.30) than controls. CVD-related comorbidities were more common among patients with HF than controls, whereas malignancies, liver and rheumatological diseases were similarly prevalent in both groups. All-cause hospitalisation rate (RR, 1.90; 95% CI, 1.88-1.91; p< 0.001) and risk of hospitalisation (HR, 1.81; 95% CI, 1.78-1.85; p< 0.001) were significantly higher in individuals with HF than controls. A greater proportion of individuals with HF than controls had died or were lost to follow-up after 5 years (34.6% vs 20.4%). ConClusions: Increased hospitalisation rates and morbidity in patients with HF versus an age-and sex-matched population without HF demonstrate the burden of HF on the healthcare system in England.
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