Canadian Cardiovascular Society/Canadian Thoracic Society Position Statement on Pulmonary Hypertension

Hirani, Naushad; Brunner, Nathan W.; Kapasi, A.; Chandy, George; Rudski, Lawrence; Paterson, Ian; Langleben, David; Mehta, Sanjay; Mielniczuk, Lisa

doi:10.1016/j.cjca.2019.11.041

Cited by 34 publications

(44 citation statements)

References 120 publications

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“…[13][14][15]17,18,[26][27][28][29][30][31][32][33][34] Women were appointed as co-chair with a man in 12 guidelines committees. [13][14][15]17,18,[26][27][28][29][30]34 Finally, women served as solo chairs or with another woman as co-chair in only 3 guideline committees. [31][32][33] Discussion:…”

Section: Resultsmentioning

confidence: 99%

National Trends of Gender Disparity in Canadian Cardiovascular Society Guideline Authors, 2001-2020

et al. 2021

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This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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Section: Resultsmentioning

confidence: 99%

National Trends of Gender Disparity in Canadian Cardiovascular Society Guideline Authors, 2001-2020

et al. 2021

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“…The results of these studies contributed to updated European Society of Cardiology and European Respiratory Society guidelines, 5 which recommend that combination therapy be given as sequential or up‐front combination therapy if treatment targets are not met. The Canadian Cardiovascular Society/Canadian Thoracic Society Position Statement on Pulmonary Hypertension (2020) 6 notes that combination PAH‐targeted medical therapy is standard of care for most PAH patients and recommends initial dual oral combination therapy in intermediate‐risk treatment‐naive PAH patients.…”

Section: Introductionmentioning

confidence: 99%

Bioequivalence and food effect of a fixed‐dose combination of macitentan and tadalafil: Adaptive design in the COVID‐19 pandemic

Csonka

Fishman

Natarajan

et al. 2021

Pharmacology Res & Perspec

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The COVID‐19 pandemic has forced clinical studies to accommodate imposed limitations. In this study, the bioequivalence part could not be conducted as planned. Thus, the aim was to demonstrate bioequivalence, using an adaptive study design, of tadalafil in fixed‐dose combination (FDC) tablets of macitentan/tadalafil with single macitentan and tadalafil (Canadian‐sourced) tablets and assess the effect of food on FDC tablets in healthy subjects. This Phase 1, single‐center, open‐label, single‐dose, two‐part, two‐period, randomized, crossover study enrolled 62 subjects. Tadalafil bioequivalence as part of FDC of macitentan/tadalafil (10/40 mg) with single‐component tablets of macitentan (10 mg) and tadalafil (40 mg) was determined by pharmacokinetic (PK) assessment under fasted conditions. The effect of food on FDC was evaluated under fed and fasted conditions. Fasted 90% confidence intervals (CIs) for geometric mean ratios (GMRs) were within bioequivalence limits for tadalafil and macitentan. Fed and fasted 90% CIs for area under the curve (AUC) GMR were within bioequivalence limits. However, 90% CIs for maximum plasma concentration (Cmax) GMR for macitentan and tadalafil were outside bioequivalence limits. One FDC‐treated subject experienced a serious adverse event of transient ischemic attack (bioequivalence part). To address pandemic‐imposed limitations, an adaptive study design was implemented to demonstrate that the FDC tablet was bioequivalent to the free combination of macitentan and tadalafil (Canadian‐sourced). No clinically significant differences in PK were determined between fed and fasted conditions; the FDC formulation could be taken irrespective of meals. The FDC formulation under fasted and fed conditions was well tolerated with no clinically relevant differences in safety profiles between the treatment groups. NCT Number: NCT04235270.

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“…More non-survivors suffered from respiratory failure (91.7% vs. 42.9%) and shock (50.0% vs. 0%) than survivors. The median of APACHE II score at ICU admission was higher in non-survivors' group [16 ( 14 – 26 )] than that in survivors' group [10 ( 9 – 14 )], whereas the median of BVAS scores were comparable between the two groups.…”

Section: Resultsmentioning

confidence: 89%

“…Interstitial lung disease (ILD) was defined according to British Thoracic Society guidelines, excluding the causes of infection, medication and pulmonary edema (25). Pulmonary arterial hypertension was diagnosed if the tricuspid regurgitation jet velocity was more than 2.8 m/s or systolic pulmonary artery pressure was more than 35 mmHg determined by echocardiography or confirmed by right heart catheterization (26,27). Renal insufficiency was diagnosed by the presence of glomerular filtration rate (GFR) <60 ml/min per 1.73 m 2 , rapidly rising plasma creatinine or oliguria (urine volume <30 mL/h or 400 mL/day) (28).…”

Section: Definition Of Termsmentioning

confidence: 99%

Predictors of Mortality in Critically Ill Patients With Antineutrophil Cytoplasmic Antibody-Associated Vasculitis

et al. 2021

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Background: Patients with antineutrophil cytoplasmic antibody-associated vasculitis (AAV) may require intensive care unit (ICU) admission due to different reasons, and the in-ICU mortality is high among AAV patients. The aim of this study was to explore the clinical features and risk factors of mortality of patients with AAV in the ICU.Methods: A retrospective study was conducted based on 83 AAV patients admitted to the ICU in a tertiary medical institution in China. Data on clinical characteristics, laboratory tests, treatment in ICU and outcomes were collected. The data were analyzed using univariate and multivariate logistic regression analysis to explore the variables that were independently related to mortality. Kaplan–Meier method was used to assess the long-term survival.Results: Among the 83 patients, 41 (49.4%) were female. The mean age of patients was 66 ± 13 years. Forty-four patients deceased, with the in-ICU mortality of 53%. The most common cause for ICU admission was active vasculitis (40/83, 48.2%). The main cause of death was infection (27/44, 61.4%) followed by active vasculitis (15/44, 34.1%). A multivariate analysis revealed that the Acute Physiology and Chronic Health Evaluation II (APACHE II) at ICU admission (OR = 1.333, 95% CI: 1.031–1.722) and respiratory failure (OR = 620.452, 95% CI: 11.495–33490.306) were independent risk factors of in-ICU death. However, hemoglobin (OR = 0.919, 95% CI: 0.849–0.995) was an independent protective factor. The nomogram established in this study was practical in predicting the risk of in-ICU mortality for AAV patients. Moreover, for 39 patients survived to the ICU stay, the cumulative survival rates at 0.5, 1, and 5 years were 58.3%, 54.2%, and 33.9%, respectively, and the median survival time was 14 months.Conclusion: In our study, active vasculitis was the most frequent reason for ICU admission, and the main cause of death was infection. APACHE II and respiratory failure were independent risk factors while hemoglobin was an independent protective factor of in-ICU mortality for AAV patients admitted to the ICU. The risk prediction model developed in this study may be a useful tool for clinicians in early recognition of high-risk patients and applying appropriate management.

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Canadian Cardiovascular Society/Canadian Thoracic Society Position Statement on Pulmonary Hypertension

Cited by 34 publications

References 120 publications

National Trends of Gender Disparity in Canadian Cardiovascular Society Guideline Authors, 2001-2020

National Trends of Gender Disparity in Canadian Cardiovascular Society Guideline Authors, 2001-2020

Bioequivalence and food effect of a fixed‐dose combination of macitentan and tadalafil: Adaptive design in the COVID‐19 pandemic

Predictors of Mortality in Critically Ill Patients With Antineutrophil Cytoplasmic Antibody-Associated Vasculitis

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