Pulmonary Arterial Hypertension Market Thriving Technology, Latest Industry Expansion ,Potential Gro - PharmiWeb.com
Pulmonary Arterial Hypertension Market Thriving Technology, Latest Industry Expansion ,Potential Gro - PharmiWeb.com |
- Pulmonary Arterial Hypertension Market Thriving Technology, Latest Industry Expansion ,Potential Gro - PharmiWeb.com
- Bayer Announces Publication of Phase IV Adempas® (riociguat) Data in The Lancet Respiratory Medicine - Business Wire
- Pulmonary Arterial Capacitance Is a Strong Predictor of Mortality in PAH, PH-LHD - AJMC.com Managed Markets Network
| Posted: 01 Mar 2021 12:00 AM PST  Pulmonary hypertension or PAH is type of blood pressure that affects the arteries in lungs and right side of the heart. In this condition, blood pressure rises in the pulmonary artery, vein, or capillaries (collectively known as lung vasculature), which might lead to shortness of breath, fainting, leg swelling, and dizziness. Pulmonary hypertension may be a relentless disease with a noticeable reduction in exercise tolerance. PAH also indicates that the patient has high blood pressure in arteries that carry blood from the heart to the lungs. This high blood pressure either makes arteries in lungs thin or get blocked. In simple words, it means that the heart works harder to pump blood. It may lead to weakening of the heart muscles after a certain period of time. Ultimately, pulmonary arterial hypertension may cause heart failure. Request Sample Copy of the Business Report: https://www.coherentmarketinsights.com/insight/request-sample/203 Based on the reports gathered from a variety of sources, including the Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO), the global prevalence of pulmonary arterial hypertension is projected to be 100,000 – 200,000, that is about 15 – 50 patients per million of the population. Even though, the treatment available for pulmonary arterial hypertension is rather limited, various treatment options are available to decrease symptoms, slow down disease progression, and improve the quality of life. Endothelin receptor antagonists or ERAs, phosphodiesterase-5 (PDE-5) inhibitors and Prostacyclin and prostacyclin analogs are some of the widely prescribed drug classes used for treatment of the disease. Lately, a new drug class known as the soluble guanylate cyclase or sGC stimulators has been recognized to be effective in treating people with PAH. On the contrary, the expiry of patents of major pulmonary arterial hypertension drugs such as Letairis, Tracleer, Tyvaso, and Adcirca is expected to hinder growth of the market in the near future, as the generic versions of these drugs will be sold at 70% to 80% lower prices than that of the present branded drugs. Various breakthrough therapies for treatment of pulmonary arterial hypertension is projected to be a growth factor for the PAH treatment drug manufacturers, since the available drugs for the same are not sufficient to meet the patient's needs. These factors will fuel growth of the global pulmonary arterial hypertension (PAH) market during the forecast period. Tailored Information as per niche requirement: Get Discount For Buyers UPTO 30% OFF On Any Research Report Global Pulmonary Arterial Hypertension (PAH) Market Taxonomy On the basis of drug class, the global pulmonary arterial hypertension (PAH) market is classified into:
On the basis of application, the global pulmonary arterial hypertension (PAH) market is classified into:
On the basis of drug lass, ERA segment held the dominant positions in the global pulmonary arterial hypertension (PAH) market. Moreover, the prostacyclin and prostacyclin analogs segment is projected to expand at the highest CAGR over the forecast period, owing to the authorization of Orenitram (treprostinil extended-release tablet) in 2013 and the expected endorsement of Uptravi (selexipag) in 2016. Market Dynamics Growing prevalence of cardiac diseases to drive growth of the global pulmonary arterial hypertension (PAH) market Sedentary lifestyles, growing consumption of fast food, and lack of exercise, the global numbers for the patients with cardiac diseases is expected to increase significantly over the forecast period thereby, increasing the susceptibility of pulmonary arterial hypertension among the global population. Thus, these factors are expected to drive growth of the global pulmonary arterial hypertension (PAH) market during the forecast period. Regional Insights Among regions, North America accounted for the largest market share of the global pulmonary arterial hypertension (PAH) treatment market, followed by Europe. These regional market are projected to witness considerable growth in the forecast period, owing to the freshly approved PAH medicines in the market and high prevalence of heart diseases. Competitive Landscape Key players operating in the pulmonary arterial hypertension global pulmonary arterial hypertension (PAH) market are Actelion Pharmaceuticals, Ltd., Gilead Sciences, Inc., United Therapeutics Corporation, Bayer HealthCare, Pfizer, Inc., Novartis International AG, and GlaxoSmithKline plc. View Press Release For More Information @ https://www.coherentmarketinsights.com/press-release/pulmonary-arterial-hypertension-pah-market-2691 Key Developments Key institutes and organizations are involved in various strategies such as research and development, in order to produce novel products for pulmonary hypertension. For instance, in August 2019, researchers from the Boston University and UT Southwestern Medical Center, William P. Clements Jr. University Hospital conducted Phase 2 study to assess the efficacy, safety, and tolerability of immediate-release orally administered ralinepag, a selective, non-prostanoid prostacyclin receptor (IP) agonist for the treatment of pulmonary arterial hypertension (PAH). The research published in the European Respiratory Journal found that ralinepag reduces pulmonary vascular resistance in pulmonary arterial hypertension. Similarly, in August 2019, Altavant Sciences, a clinical-stage biopharmaceutical company, announced that it has dosed the first patient in a Phase 2a study to assess the efficacy of rodatristat ethyl, a tryptophan hydroxylase inhibitor designed to reduce the body's peripheral production of serotonin, in patients with pulmonary arterial hypertension (PAH). Special Requirements? Share your precise requirements @ https://www.coherentmarketinsights.com/insight/request-customization/203 In August 2019, researchers from University of South China and other Chinese institutes determined the functions of Eukaryotic initiation factor 2α (eIF2α) and autophagy in the vascular remodeling of the monocrotaline-induced PAH rats and to clarified the correlation between eIF2α and autophagy. In the research published in Dovepress, the team found that eIF2α promotes the proliferation of pulmonary artery smooth muscle cells and vascular remodeling in monocrotaline-induced PAH rats through accelerating autophagy pathway. About Us:Coherent Market Insights is a global market intelligence and consulting organization focused on assisting our plethora of clients achieve transformational growth by helping them make critical business decisions. We are headquartered in India, having office at global financial capital in the U.S. and sales consultants in United Kingdom and Japan. Our client base includes players from across various business verticals in over 150 countries worldwide. We pride ourselves in catering to clients across the length and width of the horizon, from Fortune 500 enlisted companies, to not-for-profit organization, and startups looking to establish a foothold in the market. We excel in offering unmatched actionable market intelligence across various industry verticals, including chemicals and materials, healthcare, and food & beverages, consumer goods, packaging, semiconductors, software and services, Telecom, and Automotive. We offer syndicated market intelligence reports, customized research solutions, and consulting services. To know more about us, please visit our website – www.coherentmarketinsights.com Contact: Coherent Market Insights  | |
| Posted: 29 Mar 2021 05:00 AM PDT WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer today announced that The Lancet Respiratory Medicine has published results from the Phase IV REPLACE (Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy) study in which intermediate-risk adult patients with pulmonary arterial hypertension (PAH) (WHO Group 1) transitioned to Adempas® (riociguat) after an insufficient response to phosphodiesterase-5 inhibitor (PDE5i) therapy. Specifically, 41 percent (45/111) of patients receiving Adempas therapy achieved the composite primary endpoint of clinical improvement in the absence of clinical worsening, compared with 20 percent (23/113) in the PDE5i group (odds ratio [OR]=2.78, 95 percent confidence interval (CI) [1.53-5.06]; p=0.0007).1 The most common adverse events (AEs) were generally consistent with those seen in the pivotal PATENT study. These data, which are part of a collaboration between Bayer and Merck (known as MSD outside the United States and Canada), were previously presented at the 2020 virtual annual meeting of the European Respiratory Society (ERS). The pivotal PATENT-1 trial, a 12-week, multicenter, double-blind, randomized, placebo-controlled study, investigated the efficacy and safety of riociguat for the treatment of adult patients (n=443) with PAH (WHO Group 1) who were treatment-naïve or were pretreated with endothelin receptor antagonists (ERA) or prostanoids (oral, inhaled or subcutaneous [SC]). Improvements were demonstrated in clinically relevant endpoints, including 6-minute walk distance (6MWD) 36 meters (m) (95 percent CI: 20m – 52m; p<0.0001), WHO functional class (FC) (p=0.0033; majority of patients had a WHO FC II or III at baseline), time to clinical worsening (TTCW) (p=0.0046) and pulmonary vascular resistance (–226 dyn·s·cm–5 [95 percent CI: -281 to -170], p<0.001), N-terminal pro b-type natriuretic peptide [NT-proBNP]; –432 ng/mL [95 percent CI: –782 to –82], p<0.001). In the PATENT study, the most common AEs occurring more frequently (in more than or equal to 3 percent of patients) on Adempas than placebo were headache (27 percent versus 18 percent), dyspepsia/gastritis (21 percent versus 8 percent), dizziness (20 percent versus 13 percent), nausea (14 percent versus 11 percent), diarrhea (12 percent versus 8 percent), hypotension (10 percent versus 4 percent), vomiting (10 percent versus 7 percent), anemia (7 percent versus 2 percent), gastroesophageal reflux disease (5 percent versus 2 percent) and constipation (5 percent versus 1 percent). Other events that were seen more frequently in Adempas compared to placebo and potentially related to treatment were palpitations, nasal congestion, epistaxis, dysphagia, abdominal distension and peripheral edema. "The scientific rationale for the REPLACE study comes from ESC/ERS guidelines suggesting the need to set a treatment goal of low-risk status in patients with pulmonary arterial hypertension, and from clinical practice where many intermediate-risk patients do not reach or maintain specific treatment goals when treated with a PDE5i-based regimen1," said Sameer Bansilal, M.D., M.S., Executive Director, U.S. Medical Affairs at Bayer. "We remain dedicated to providing ongoing research to reinforce the value of Adempas that may further help adult patients with PAH (WHO Group 1), a chronic and often debilitating condition of the heart and lungs." Adempas has a warning for embryo-fetal toxicity. Adempas cannot be used in pregnant women because it may cause fetal harm. In females of reproductive potential, pregnancy must be excluded before the start of treatment, monthly during treatment and one month after stopping treatment. To prevent pregnancy, females of reproductive potential must use effective forms of contraception during treatment and for one month after stopping treatment. For all female patients, Adempas is available only through a restricted program called the Adempas Risk Evaluation and Mitigation Strategy (REMS) Program. About the REPLACE Study REPLACE (Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy) was a prospective global, multicenter, double-arm, randomized, controlled, open-label Phase IV study.1,2 Conducted in 81 sites in 22 countries, the 24-week study assessed the clinical effects of transitioning to Adempas from PDE5i therapy in 226 patients with PAH who demonstrated an insufficient clinical response to stable treatment with PDE5i (sildenafil or tadalafil) either as monotherapy or in combination with an ERA. The 24-week study involved patients with PAH at intermediate risk despite treatment with PDE-5 inhibitors (sildenafil or tadalafil) with or without ERA combination.1 Intermediate risk was defined as WHO functional class (WHO FC) III, with a 6MWD of 165-440m, despite receiving stable doses of PDE5i, an ERA based on the European Society of Cardiology/European Respiratory Society (ESC/ERS) treatment guidelines.1 The blinded, centrally adjudicated composite primary efficacy endpoint was clinical improvement at week 24 (defined as two of the following: ≥10 percent/≥30 meter increase in 6MWD from baseline, WHO FC I/II, or ≥30 percent reduction in NT-proBNP from baseline) in the absence of clinical worsening (death from any cause, hospitalization for worsening PAH or disease progression).1 6-minute walking distance and WHO FC were assessed blind and clinical worsening events were independently adjudicated. Response rates were consistent with the overall results across the different types of PAH and pre-treatment therapies. The safety results are consistent with the known safety profile of riociguat. About Pulmonary Arterial Hypertension Pulmonary arterial hypertension is defined by elevated pressure in the arteries going from the right side of the heart to the lungs.3 Typical symptoms of PAH include shortness of breath on exertion, fatigue, weakness, chest pain and syncope.4 Pulmonary arterial hypertension is caused by abnormalities in the walls of the pulmonary arteries.5 About Adempas® (riociguat) Riociguat, licensed in the U.S. as Adempas, is a stimulator of soluble guanylate cyclase (sGC) and is the only treatment approved in the U.S. for use in two types of pulmonary hypertension (WHO Groups 1 and 4). In October 2013, the U.S. Food and Drug Administration (FDA) approved riociguat under the name Adempas® for use in patients with PAH, as well as inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) or persistent/recurrent CTEPH after surgery. In March 2014, the European Medicines Agency approved riociguat under the name Adempas® for use in patients with PAH and inoperable CTEPH or persistent/recurrent CTEPH after surgical treatment. Riociguat has been granted orphan drug designation (ODD) in both the European Union and the U.S. In Japan, riociguat has been granted ODD for use in patients with inoperable CTEPH or persistent/recurrent CTEPH after surgical treatment; it was approved in Japan for this indication in January 2014, and for use in patients with PAH in February 2015. Bayer and Merck (known as MSD outside the United States and Canada) are in a worldwide collaboration in the field of sGC modulators. The collaboration brings together two leading companies that have stated their intent to fully evaluate this therapeutic class in areas of unmet medical need. Adempas®, the first sGC stimulator of this collaboration, is developed by Bayer and MSD. It has received marketing authorization in the U.S., Canada, EU, Japan and several other countries around the world. Bayer retains marketing rights for Adempas in the U.S. INDICATIONS Adempas (riociguat) tablets is indicated for the treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) (WHO Group 4) after surgical treatment, or inoperable CTEPH, to improve exercise capacity and WHO functional class. Adempas is indicated for the treatment of adults with pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity, improve WHO functional class, and to delay clinical worsening.* Efficacy was shown in patients on Adempas monotherapy or in combination with endothelin receptor antagonists or prostanoids. Studies establishing effectiveness included predominantly patients with WHO functional class II–III and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (25%). *Time to clinical worsening was a combined endpoint defined as death (all-cause mortality), heart/lung transplantation, atrial septostomy, hospitalization due to persistent worsening of pulmonary hypertension, start of new PAH-specific treatment, persistent decrease in 6MWD, and persistent worsening of WHO functional class. IMPORTANT SAFETY INFORMATION
Contraindications Adempas is contraindicated in:
Warnings and Precautions Embryo-Fetal Toxicity. Based on data from animal reproduction studies, Adempas may cause embryo-fetal toxicity when administered to a pregnant female and is contraindicated in females who are pregnant. Advise females of reproductive potential of the potential risk to a fetus. Obtain a pregnancy test before the start of treatment, monthly during treatment, and for one month after stopping treatment. Advise females of reproductive potential to use effective contraception during treatment with Adempas and for at least one month after the last dose. For females, Adempas is only available through a restricted program under the Adempas REMS Program. Adempas REMS Program. Females can only receive Adempas through the Adempas REMS Program, a restricted distribution program. Important requirements of the Adempas REMS Program include the following:
Further information, including a list of certified pharmacies, is available at www.AdempasREMS.com or 1-855-4ADEMPAS. Hypotension. Adempas reduces blood pressure. Consider the potential for symptomatic hypotension or ischemia in patients with hypovolemia, severe left ventricular outflow obstruction, resting hypotension, autonomic dysfunction, or concomitant treatment with antihypertensives or strong CYP and P-gp/BCRP inhibitors. Consider a dose reduction if patient develops signs or symptoms of hypotension. Bleeding. In the placebo-controlled clinical trials, serious bleeding occurred in 2.4% of patients taking Adempas compared to 0% of placebo patients. Serious hemoptysis occurred in 5 (1%) patients taking Adempas compared to 0 placebo patients, including one event with fatal outcome. Serious hemorrhagic events also included 2 patients with vaginal hemorrhage, 2 with catheter-site hemorrhage, and 1 each with subdural hematoma, hematemesis, and intra-abdominal hemorrhage. Pulmonary Veno-Occlusive Disease. Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD). Therefore, administration of Adempas to such patients is not recommended. Should signs of pulmonary edema occur, the possibility of associated PVOD should be considered and if confirmed, discontinue treatment with Adempas. Most Common Adverse Reactions The most common adverse reactions occurring more frequently (≥3%) on Adempas than placebo were headache (27% vs 18%), dyspepsia/gastritis (21% vs 8%), dizziness (20% vs 13%), nausea (14% vs 11%), diarrhea (12% vs 8%), hypotension (10% vs 4%), vomiting (10% vs 7%), anemia (7% vs 2%), gastroesophageal reflux disease (5% vs 2%), and constipation (5% vs 1%). Other events that were seen more frequently in Adempas compared to placebo and potentially related to treatment were palpitations, nasal congestion, epistaxis, dysphagia, abdominal distension, and peripheral edema. For important risk and use information, please see the full Prescribing Information, including Boxed Warning. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2020, the Group employed around 100,000 people and had sales of 41.4 billion euros. R&D expenses before special items amounted to 4.9 billion euros. For more information, go to www.bayer.com. Find more information at www.pharma.bayer.com BAYER, the Bayer Cross, and Adempas(R) are registered trademarks of Bayer. Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. References:
COR-PF-PUL-US-0017-1  | |
| Posted: 05 Mar 2021 12:00 AM PST  Targeting pulmonary arterial capacitance or compliance can improve overall survival and quality of life in patients with pulmonary arterial hypertension (PAH) and pulmonary hypertension secondary to left heart disease (PH-LHD). Treatments that target pulmonary arterial capacitance or compliance (PAC) have the potential to improve overall survival and quality of life in patients with pulmonary arterial hypertension (PAH) and pulmonary hypertension secondary to left heart disease (PH-LHD), according to a paper published in International Journal of Cardiology. Different hemodynamic parameters have been used to predict mortality in patients with PAH or PH-LHD, but "studies have consistently shown that PAC is a better independent predictor of mortality in patients with PH compared to [pulmonary vascular resistance]," the authors wrote. The researchers conducted a systematic review and meta-analysis to evaluate the pooled risk of mortality in patients with PAH and PH-LHD. Fifteen studies were included that reported the HRs for mortality per 1 mL/mm Hg change in PAC: 8 among patients with PAH and 7 among patients with PH-LHD. Multiple studies were able to consistently demonstrate that PAC had prognostic significance in PAH and that baseline values and the change over time could be used to predict mortality. For instance, one study divided 104 patients with idiopathic PAH into 4 cohorts based on their capacitance. Although the group with the highest capacitance had no deaths, patients in the lowest capacitance group had a mortality of 62%. However, 1 French study of 981 patients did not find an association between mortality and PAC. Among patients with PH-LHD, PAC was able to predict mortality attributed to heart failure with preserved ejection fraction and heart failure with reduced ejection fraction (HFrEF). One study of 724 patients with HFrEF found that a lower PAC was associated with more adverse clinical events of all-cause mortality. The researchers divided the patients into 2 groups: one with median PAC ≤ 2.5 mL/mm Hg and one with PAC > 2.5 mL/mm Hg. The patients in the ≤ 2.5 mL/mm Hg group had lower mean ejection fraction and higher brain natriuretic peptide, which indicates more severe disease. According to the researchers, a reduction in PAC by 1 mL/mm Hg from baseline in patients with PAH was associated with all-cause mortality, with a pooled HR of 4.25% (95% CI, 1.42-12.71; P = .021). Among patients with PH-LHD, when PAC decreased, there was a nearly 30% higher risk of mortality (HR, 1.29; 95% CI; 1.07-1.56; P =.019), and when PAC increased, there was a 30% reduced mortality risk (HR, 0.70; 95% CI; 0.52-0.94; P = .03). The authors concluded that not only is PAC a "strong and independent predictor of all-cause mortality, clinical worsening, and a valuable marker of prognosis in patients with PAH and PH-LHD," but that it can be used as a therapeutic target. "We suggest that PAC, which is a simple hemodynamic measurement obtained during the right heart catheterization, can be of great assistance to the treating cardiologists and pulmonologists in stratifying disease severity and clinical decision making," they wrote. Reference Rajdev K, Lahan S, Wichman T. Role of pulmonary arterial capacitance in predicting mortality in patients with pulmonary hypertension: a systematic review and meta-analysis. Int J Cardiol. Published online February 20, 2021. doi:10.1016/j.ijcard.2021.02.043  |
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