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Paediatric
2 Min Read
28 Feb

Novel biobased polyester cast provides matching stability to conventional fiberglass cast and improves patient satisfaction

According to a recent study, novel biobased polyester cast provides clinical outcomes similar to the conventional fiberglass casts and improves overall patient satisfaction in an eco-friendlier and safer way. This study was published in the journal, BMC Musculoskeletal Disorders.

This was a single-center, prospective, randomized trial that included 100 children with cast-immobilized stable upper limb fractures. They were randomly divided into either biobased polyester or synthetic fiberglass groups. All the patients were followed up till the cast removal which was done at approximately 3-4 weeks after immobilizing. Subjective patient questionnaire and objective clinical findings for the study were collected and analyzed.

Both the groups did not show any loss of reduction, based on the radiographs taken on the day of cast removal. Occurrence of skin problems was 3.4 times higher in the synthetic fiberglass group than in the biobased polyester group. The biobased polyester cast was preferred in every sub-item in the subjective questionnaire.

Based on the above results, it can be concluded that the novel biobased polyester cast may provide an improved patient satisfaction and matching stability to conventional fiberglass casts in an eco-friendlier and safer way.

Novel biobased polyester cast provides matching stability to conventional fiberglass cast and improves patient satisfaction

According to a recent study, novel biobased polyester cast provides clinical outcomes similar to the conventional fiberglass casts and improves overall patient satisfaction in an eco-friendlier and safer way. This study was published in the journal, BMC Musculoskeletal Disorders.

This was a single-center, prospective, randomized trial that included 100 children with cast-immobilized stable upper limb fractures. They were randomly divided into either biobased polyester or synthetic fiberglass groups. All the patients were followed up till the cast removal which was done at approximately 3-4 weeks after immobilizing. Subjective patient questionnaire and objective clinical findings for the study were collected and analyzed.

Both the groups did not show any loss of reduction, based on the radiographs taken on the day of cast removal. Occurrence of skin problems was 3.4 times higher in the synthetic fiberglass group than in the biobased polyester group. The biobased polyester cast was preferred in every sub-item in the subjective questionnaire.

Based on the above results, it can be concluded that the novel biobased polyester cast may provide an improved patient satisfaction and matching stability to conventional fiberglass casts in an eco-friendlier and safer way.

Paediatric
2 Min Read
28 Feb

Novel biobased polyester cast provides matching stability to conventional fiberglass cast and improves patient satisfaction

According to a recent study, novel biobased polyester cast provides clinical outcomes similar to the conventional fiberglass casts and improves overall patient satisfaction in an eco-friendlier and safer way. This study was published in the journal, BMC Musculoskeletal Disorders.

This was a single-center, prospective, randomized trial that included 100 children with cast-immobilized stable upper limb fractures. They were randomly divided into either biobased polyester or synthetic fiberglass groups. All the patients were followed up till the cast removal which was done at approximately 3-4 weeks after immobilizing. Subjective patient questionnaire and objective clinical findings for the study were collected and analyzed.

Both the groups did not show any loss of reduction, based on the radiographs taken on the day of cast removal. Occurrence of skin problems was 3.4 times higher in the synthetic fiberglass group than in the biobased polyester group. The biobased polyester cast was preferred in every sub-item in the subjective questionnaire.

Based on the above results, it can be concluded that the novel biobased polyester cast may provide an improved patient satisfaction and matching stability to conventional fiberglass casts in an eco-friendlier and safer way.

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Cardiac
2 Min Read
27 Feb

Acoramidis is safe and effective in transthyretin myloid cardiomyopathy

According to a new study, acoramidis, a high-affinity misfolded monomeric transthyretin (TTR) stabilizer, is safe and effective in transthyretin amyloid cardiomyopathy. This study’s findings were published in the New England Journal of Medicine.

This phase 3, double-blind trial included 632 patients with transthyretin amyloid cardiomyopathy, who were randomly assigned in a 2:1 ratio to receive acoramidis hydrochloride at a dose of 800 mg twice daily or a matching placebo for a period of 30 months. Efficacy was evaluated for patients with an estimated glomerular filtration rate of at least 30 ml per minute per 1.73 m2 of body surface area.  The primary hierarchical analysis comprised four key steps, encompassing death from any cause, hospitalization related to cardiovascular events, alterations from baseline in the N-terminal pro-B-type natriuretic peptide (NT-proBNP) level, and the alterations from baseline in the 6-minute walk distance. The secondary outcomes of the study were death from any cause, the 6-minute walk distance, the score on the Kansas City Cardiomyopathy Questionnaire-Overall Summary, and the serum TTR level.

At the end of the study, the primary analysis demonstrated a significant preference for acoramidis compared to placebo, the corresponding win ratio was 1.8, indicating that in 63.7% of pairwise comparisons, acoramidis was favoured, while placebo was favoured in 35.9%. The combination of deaths from any cause and cardiovascular-related hospitalization were responsible for over half of the wins and losses in the win ratio (58% of all pairwise comparisons). Additionally, NT-proBNP pairwise comparisons demonstrated the highest ratio of wins to losses (23.3% vs. 7.0%).

It was observed that, among patients with transthyretin amyloid cardiomyopathy, the administration of acoramidis resulted in a significantly better four-step primary hierarchical outcome, encompassing elements of mortality, morbidity, and function, compared to the placebo.

Acoramidis is safe and effective in transthyretin myloid cardiomyopathy

According to a new study, acoramidis, a high-affinity misfolded monomeric transthyretin (TTR) stabilizer, is safe and effective in transthyretin amyloid cardiomyopathy. This study’s findings were published in the New England Journal of Medicine.

This phase 3, double-blind trial included 632 patients with transthyretin amyloid cardiomyopathy, who were randomly assigned in a 2:1 ratio to receive acoramidis hydrochloride at a dose of 800 mg twice daily or a matching placebo for a period of 30 months. Efficacy was evaluated for patients with an estimated glomerular filtration rate of at least 30 ml per minute per 1.73 m2 of body surface area.  The primary hierarchical analysis comprised four key steps, encompassing death from any cause, hospitalization related to cardiovascular events, alterations from baseline in the N-terminal pro-B-type natriuretic peptide (NT-proBNP) level, and the alterations from baseline in the 6-minute walk distance. The secondary outcomes of the study were death from any cause, the 6-minute walk distance, the score on the Kansas City Cardiomyopathy Questionnaire-Overall Summary, and the serum TTR level.

At the end of the study, the primary analysis demonstrated a significant preference for acoramidis compared to placebo, the corresponding win ratio was 1.8, indicating that in 63.7% of pairwise comparisons, acoramidis was favoured, while placebo was favoured in 35.9%. The combination of deaths from any cause and cardiovascular-related hospitalization were responsible for over half of the wins and losses in the win ratio (58% of all pairwise comparisons). Additionally, NT-proBNP pairwise comparisons demonstrated the highest ratio of wins to losses (23.3% vs. 7.0%).

It was observed that, among patients with transthyretin amyloid cardiomyopathy, the administration of acoramidis resulted in a significantly better four-step primary hierarchical outcome, encompassing elements of mortality, morbidity, and function, compared to the placebo.

Cardiac
2 Min Read
27 Feb

Acoramidis is safe and effective in transthyretin myloid cardiomyopathy

According to a new study, acoramidis, a high-affinity misfolded monomeric transthyretin (TTR) stabilizer, is safe and effective in transthyretin amyloid cardiomyopathy. This study’s findings were published in the New England Journal of Medicine.

This phase 3, double-blind trial included 632 patients with transthyretin amyloid cardiomyopathy, who were randomly assigned in a 2:1 ratio to receive acoramidis hydrochloride at a dose of 800 mg twice daily or a matching placebo for a period of 30 months. Efficacy was evaluated for patients with an estimated glomerular filtration rate of at least 30 ml per minute per 1.73 m2 of body surface area.  The primary hierarchical analysis comprised four key steps, encompassing death from any cause, hospitalization related to cardiovascular events, alterations from baseline in the N-terminal pro-B-type natriuretic peptide (NT-proBNP) level, and the alterations from baseline in the 6-minute walk distance. The secondary outcomes of the study were death from any cause, the 6-minute walk distance, the score on the Kansas City Cardiomyopathy Questionnaire-Overall Summary, and the serum TTR level.

At the end of the study, the primary analysis demonstrated a significant preference for acoramidis compared to placebo, the corresponding win ratio was 1.8, indicating that in 63.7% of pairwise comparisons, acoramidis was favoured, while placebo was favoured in 35.9%. The combination of deaths from any cause and cardiovascular-related hospitalization were responsible for over half of the wins and losses in the win ratio (58% of all pairwise comparisons). Additionally, NT-proBNP pairwise comparisons demonstrated the highest ratio of wins to losses (23.3% vs. 7.0%).

It was observed that, among patients with transthyretin amyloid cardiomyopathy, the administration of acoramidis resulted in a significantly better four-step primary hierarchical outcome, encompassing elements of mortality, morbidity, and function, compared to the placebo.

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Oncology
2 Min Read
26 Feb

Trifluridine/tipiracil shows survival benefits in patients with metastatic gastric/gastroesophageal junction cancer

A recent study found that trifluridine/tipiracil shows survival and functioning benefits in patients with metastatic gastric/gastroesophageal junction cancer in later lines of therapy. This study was published in the Journal of cancer research and clinical oncology.

The TAGS trial was a phase 3, randomized study that included 507 patients with metastatic gastric/gastroesophageal junction cancer and ≥ 2 prior chemotherapies. The participants were categorized into the following overlapping subgroups: ramucirumab ± other agents (n = 169), no ramucirumab (n = 338), paclitaxel but no ramucirumab (n = 136), ramucirumab + paclitaxel in combination or sequentially (n = 154). Other subgroups included neither paclitaxel nor ramucirumab (n = 202), irinotecan (n = 281), and no irinotecan (n = 226). Overall and progression-free survival (PFS), safety, and time to Eastern Cooperative Oncology Group performance status (ECOG PS) ≥ 2 were assessed.

Median overall survival across subgroups was found to be 4.6-6.1 versus 3.0-3.8 months while the median PFS was 1.9-2.3 versus 1.7-1.8 months. Similarly, the median time to ECOG PS ≥ 2 was 4.0-4.7 versus 1.9-2.5 months. Median overall and progression-free survival was longer in trifluridine/tipiracil-randomized patients who did not receive ramucirumab, paclitaxel and ramucirumab, or irinotecan. The safety profile for the interventional drug remained consistent across subgroups.

Thus, it can be concluded that trifluridine/tipiracil may show overall and progression-free survival as well as functioning benefits in patients with metastatic gastric/gastroesophageal junction cancer in later lines.

 

Trifluridine/tipiracil shows survival benefits in patients with metastatic gastric/gastroesophageal junction cancer

A recent study found that trifluridine/tipiracil shows survival and functioning benefits in patients with metastatic gastric/gastroesophageal junction cancer in later lines of therapy. This study was published in the Journal of cancer research and clinical oncology.

The TAGS trial was a phase 3, randomized study that included 507 patients with metastatic gastric/gastroesophageal junction cancer and ≥ 2 prior chemotherapies. The participants were categorized into the following overlapping subgroups: ramucirumab ± other agents (n = 169), no ramucirumab (n = 338), paclitaxel but no ramucirumab (n = 136), ramucirumab + paclitaxel in combination or sequentially (n = 154). Other subgroups included neither paclitaxel nor ramucirumab (n = 202), irinotecan (n = 281), and no irinotecan (n = 226). Overall and progression-free survival (PFS), safety, and time to Eastern Cooperative Oncology Group performance status (ECOG PS) ≥ 2 were assessed.

Median overall survival across subgroups was found to be 4.6-6.1 versus 3.0-3.8 months while the median PFS was 1.9-2.3 versus 1.7-1.8 months. Similarly, the median time to ECOG PS ≥ 2 was 4.0-4.7 versus 1.9-2.5 months. Median overall and progression-free survival was longer in trifluridine/tipiracil-randomized patients who did not receive ramucirumab, paclitaxel and ramucirumab, or irinotecan. The safety profile for the interventional drug remained consistent across subgroups.

Thus, it can be concluded that trifluridine/tipiracil may show overall and progression-free survival as well as functioning benefits in patients with metastatic gastric/gastroesophageal junction cancer in later lines.

 

Oncology
2 Min Read
26 Feb

Trifluridine/tipiracil shows survival benefits in patients with metastatic gastric/gastroesophageal junction cancer

A recent study found that trifluridine/tipiracil shows survival and functioning benefits in patients with metastatic gastric/gastroesophageal junction cancer in later lines of therapy. This study was published in the Journal of cancer research and clinical oncology.

The TAGS trial was a phase 3, randomized study that included 507 patients with metastatic gastric/gastroesophageal junction cancer and ≥ 2 prior chemotherapies. The participants were categorized into the following overlapping subgroups: ramucirumab ± other agents (n = 169), no ramucirumab (n = 338), paclitaxel but no ramucirumab (n = 136), ramucirumab + paclitaxel in combination or sequentially (n = 154). Other subgroups included neither paclitaxel nor ramucirumab (n = 202), irinotecan (n = 281), and no irinotecan (n = 226). Overall and progression-free survival (PFS), safety, and time to Eastern Cooperative Oncology Group performance status (ECOG PS) ≥ 2 were assessed.

Median overall survival across subgroups was found to be 4.6-6.1 versus 3.0-3.8 months while the median PFS was 1.9-2.3 versus 1.7-1.8 months. Similarly, the median time to ECOG PS ≥ 2 was 4.0-4.7 versus 1.9-2.5 months. Median overall and progression-free survival was longer in trifluridine/tipiracil-randomized patients who did not receive ramucirumab, paclitaxel and ramucirumab, or irinotecan. The safety profile for the interventional drug remained consistent across subgroups.

Thus, it can be concluded that trifluridine/tipiracil may show overall and progression-free survival as well as functioning benefits in patients with metastatic gastric/gastroesophageal junction cancer in later lines.

 

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Neuro
2 Min Read
26 Feb

Safety and tolerability of dimdazenil in adults with insomnia disorder

A recent study found that 2.5 mg of dimdazenil had a significant benefit on sleep maintenance and sleep onset in individuals suffering from insomnia disorder. This study was published in the journal, Sleep.

This phase III, 2-week, multicenter, randomized, double-blind, placebo-controlled trial included 546 participants with insomnia, aged ≥18 years. They were randomized in a 2:1 ratio to receive either an oral dose of dimdazenil (2.5 mg) or placebo. Primary efficacy outcome of the study was total sleep time (TST) analyzed by polysomnography (PSG) on day 13/14. Similarly, latency to persistent sleep (LPS), sleep efficiency (SE), and wake after sleep onset (WASO) were analyzed using PSG. Secondary outcomes of the study were average subjective sleep latency (sSL), subjective SE (sSE), subjective TST (sTST), subjective WASO (sWASO), and subjective number of awakenings (sNAW), which were analyzed from sleep diary data. Also, the insomnia severity index (ISI) was assessed. Throughout the study, treatment-emergent adverse events (TEAEs) were monitored.

At the end of the study, it was observed that in comparison to baseline and placebo, dimdazenil exhibited significant improvements in PSG measures, increased TST (71.09, 31.68 minutes, respectively), reduced WASO (49.67, 20.16 minutes, respectively), increased SE (13.26%, 5.55%, respectively, and reduced LPS (21.65 minutes, 6.46 minutes, respectively). Dimdazenil also improved key self-reported measures of sSL (4.23 minutes), sSE (2.97%), sTST (18.33 minutes), sWASO (14.60 minutes), and sNAW (0.29). Those participants who were treated with dimdazenil, reported a significant improvement in ISI.

From the above results, it can be concluded that 2.5 mg of dimdazenil may provide significant benefit on sleep maintenance and sleep onset in individuals with insomnia disorder, as it is safe and well-tolerated.

Safety and tolerability of dimdazenil in adults with insomnia disorder

A recent study found that 2.5 mg of dimdazenil had a significant benefit on sleep maintenance and sleep onset in individuals suffering from insomnia disorder. This study was published in the journal, Sleep.

This phase III, 2-week, multicenter, randomized, double-blind, placebo-controlled trial included 546 participants with insomnia, aged ≥18 years. They were randomized in a 2:1 ratio to receive either an oral dose of dimdazenil (2.5 mg) or placebo. Primary efficacy outcome of the study was total sleep time (TST) analyzed by polysomnography (PSG) on day 13/14. Similarly, latency to persistent sleep (LPS), sleep efficiency (SE), and wake after sleep onset (WASO) were analyzed using PSG. Secondary outcomes of the study were average subjective sleep latency (sSL), subjective SE (sSE), subjective TST (sTST), subjective WASO (sWASO), and subjective number of awakenings (sNAW), which were analyzed from sleep diary data. Also, the insomnia severity index (ISI) was assessed. Throughout the study, treatment-emergent adverse events (TEAEs) were monitored.

At the end of the study, it was observed that in comparison to baseline and placebo, dimdazenil exhibited significant improvements in PSG measures, increased TST (71.09, 31.68 minutes, respectively), reduced WASO (49.67, 20.16 minutes, respectively), increased SE (13.26%, 5.55%, respectively, and reduced LPS (21.65 minutes, 6.46 minutes, respectively). Dimdazenil also improved key self-reported measures of sSL (4.23 minutes), sSE (2.97%), sTST (18.33 minutes), sWASO (14.60 minutes), and sNAW (0.29). Those participants who were treated with dimdazenil, reported a significant improvement in ISI.

From the above results, it can be concluded that 2.5 mg of dimdazenil may provide significant benefit on sleep maintenance and sleep onset in individuals with insomnia disorder, as it is safe and well-tolerated.

Neuro
2 Min Read
26 Feb

Safety and tolerability of dimdazenil in adults with insomnia disorder

A recent study found that 2.5 mg of dimdazenil had a significant benefit on sleep maintenance and sleep onset in individuals suffering from insomnia disorder. This study was published in the journal, Sleep.

This phase III, 2-week, multicenter, randomized, double-blind, placebo-controlled trial included 546 participants with insomnia, aged ≥18 years. They were randomized in a 2:1 ratio to receive either an oral dose of dimdazenil (2.5 mg) or placebo. Primary efficacy outcome of the study was total sleep time (TST) analyzed by polysomnography (PSG) on day 13/14. Similarly, latency to persistent sleep (LPS), sleep efficiency (SE), and wake after sleep onset (WASO) were analyzed using PSG. Secondary outcomes of the study were average subjective sleep latency (sSL), subjective SE (sSE), subjective TST (sTST), subjective WASO (sWASO), and subjective number of awakenings (sNAW), which were analyzed from sleep diary data. Also, the insomnia severity index (ISI) was assessed. Throughout the study, treatment-emergent adverse events (TEAEs) were monitored.

At the end of the study, it was observed that in comparison to baseline and placebo, dimdazenil exhibited significant improvements in PSG measures, increased TST (71.09, 31.68 minutes, respectively), reduced WASO (49.67, 20.16 minutes, respectively), increased SE (13.26%, 5.55%, respectively, and reduced LPS (21.65 minutes, 6.46 minutes, respectively). Dimdazenil also improved key self-reported measures of sSL (4.23 minutes), sSE (2.97%), sTST (18.33 minutes), sWASO (14.60 minutes), and sNAW (0.29). Those participants who were treated with dimdazenil, reported a significant improvement in ISI.

From the above results, it can be concluded that 2.5 mg of dimdazenil may provide significant benefit on sleep maintenance and sleep onset in individuals with insomnia disorder, as it is safe and well-tolerated.

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Paediatric
2 Min Read
23 Feb

Efficacy of CoolSense in reducing the pain of intravenous cannulation

A recent study found that CoolSense demonstrated greater efficacy in minimizing the pain associated with intravenous cannulation compared to the EMLA cream. This study’s findings were published in the Indian journal of pediatrics.

In this randomized, controlled trial, a total of 140 children aged 6-12 years, classified by the American Society of Anesthesiologist I/II, who needed intravenous cannulation before anesthesia induction, were divided into two groups of 70 each. Group I received CoolSense pretreatment, while Group II was given EMLA cream pretreatment prior to intravenous cannulation. The primary outcome was to assess the effectiveness of CoolSense and EMLA cream in reducing pain during intravenous cannulation. The secondary outcomes included measuring the anxiety levels of children, the success rate of the first cannulation attempt, any technical challenges encountered, adverse reactions, and the satisfaction score of parents.

During intravenous cannulation, the CoolSense group demonstrated a significant decrease in pain scores compared to the EMLA cream group (mean pain score was 7.14 ± 4.322 vs. 29.32 ± 8.95). The CoolSense group experienced a decrease in anxiety levels before and after the procedure when compared to the EMLA group. Additionally, the application duration of CoolSense was significantly shorter than that of EMLA cream.

To summarize, CoolSense demonstrated superior effectiveness in reducing the pain associated with intravenous cannulation compared to the EMLA cream. Within the pediatric population, CoolSense presents itself as a simple and rapid method for delivering sufficient pain relief during venous cannulation.

Efficacy of CoolSense in reducing the pain of intravenous cannulation

A recent study found that CoolSense demonstrated greater efficacy in minimizing the pain associated with intravenous cannulation compared to the EMLA cream. This study’s findings were published in the Indian journal of pediatrics.

In this randomized, controlled trial, a total of 140 children aged 6-12 years, classified by the American Society of Anesthesiologist I/II, who needed intravenous cannulation before anesthesia induction, were divided into two groups of 70 each. Group I received CoolSense pretreatment, while Group II was given EMLA cream pretreatment prior to intravenous cannulation. The primary outcome was to assess the effectiveness of CoolSense and EMLA cream in reducing pain during intravenous cannulation. The secondary outcomes included measuring the anxiety levels of children, the success rate of the first cannulation attempt, any technical challenges encountered, adverse reactions, and the satisfaction score of parents.

During intravenous cannulation, the CoolSense group demonstrated a significant decrease in pain scores compared to the EMLA cream group (mean pain score was 7.14 ± 4.322 vs. 29.32 ± 8.95). The CoolSense group experienced a decrease in anxiety levels before and after the procedure when compared to the EMLA group. Additionally, the application duration of CoolSense was significantly shorter than that of EMLA cream.

To summarize, CoolSense demonstrated superior effectiveness in reducing the pain associated with intravenous cannulation compared to the EMLA cream. Within the pediatric population, CoolSense presents itself as a simple and rapid method for delivering sufficient pain relief during venous cannulation.

Paediatric
2 Min Read
23 Feb

Efficacy of CoolSense in reducing the pain of intravenous cannulation

A recent study found that CoolSense demonstrated greater efficacy in minimizing the pain associated with intravenous cannulation compared to the EMLA cream. This study’s findings were published in the Indian journal of pediatrics.

In this randomized, controlled trial, a total of 140 children aged 6-12 years, classified by the American Society of Anesthesiologist I/II, who needed intravenous cannulation before anesthesia induction, were divided into two groups of 70 each. Group I received CoolSense pretreatment, while Group II was given EMLA cream pretreatment prior to intravenous cannulation. The primary outcome was to assess the effectiveness of CoolSense and EMLA cream in reducing pain during intravenous cannulation. The secondary outcomes included measuring the anxiety levels of children, the success rate of the first cannulation attempt, any technical challenges encountered, adverse reactions, and the satisfaction score of parents.

During intravenous cannulation, the CoolSense group demonstrated a significant decrease in pain scores compared to the EMLA cream group (mean pain score was 7.14 ± 4.322 vs. 29.32 ± 8.95). The CoolSense group experienced a decrease in anxiety levels before and after the procedure when compared to the EMLA group. Additionally, the application duration of CoolSense was significantly shorter than that of EMLA cream.

To summarize, CoolSense demonstrated superior effectiveness in reducing the pain associated with intravenous cannulation compared to the EMLA cream. Within the pediatric population, CoolSense presents itself as a simple and rapid method for delivering sufficient pain relief during venous cannulation.

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Cardiac
2 Min Read
23 Feb

Early up-titration of hydralazine with evidence-based medications improves outcomes in severe systolic dysfunction and mitral regurgitation

According to a recent study, hydralazine combined with conventional therapy improves outcome in patients with severe systolic dysfunction and significant mitral regurgitation (MR). This study was published in the journal, ESC Heart Failure.

This study trial was an open-labelled, one-to-one ratio randomized designed. The 408 participants who were enrolled for this study had decompensated heart failure (HF) symptoms, left ventricular ejection fraction (LVEF) < 35%, and mitral regurgitation (MR) more than moderate severity. Out of these, 203 patients were in the conventional treatment and 205 in hydralazine + conventional treatment, comprising of evidence-based medications (EBMs). Up-titration of hydralazine in conjunction with EBMs was administered to the hydralazine + conventional treatment group during the follow-up period and on Days 1–5 of the index admission. The end points of the study included cardiovascular (CV) death and HF rehospitalization.

After 3.5 years of mean follow-up period, it was found that 51% (104 out of 203 cases) reached endpoints in conventional group and 34.6% (71 out of 205 cases) in hydralazine + conventional treatment group, leading to a significant reduction in CV events. It was also noted that in-hospital death during the index admission was significantly higher in conventional group (5.4% vs. 0.5%, respectively).

Thus, it can be concluded that combining early up-titration of hydralazine with EBMs may improve outcome in patients with severe systolic dysfunction and significant MR, making it safe and well-tolerated for use.

Early up-titration of hydralazine with evidence-based medications improves outcomes in severe systolic dysfunction and mitral regurgitation

According to a recent study, hydralazine combined with conventional therapy improves outcome in patients with severe systolic dysfunction and significant mitral regurgitation (MR). This study was published in the journal, ESC Heart Failure.

This study trial was an open-labelled, one-to-one ratio randomized designed. The 408 participants who were enrolled for this study had decompensated heart failure (HF) symptoms, left ventricular ejection fraction (LVEF) < 35%, and mitral regurgitation (MR) more than moderate severity. Out of these, 203 patients were in the conventional treatment and 205 in hydralazine + conventional treatment, comprising of evidence-based medications (EBMs). Up-titration of hydralazine in conjunction with EBMs was administered to the hydralazine + conventional treatment group during the follow-up period and on Days 1–5 of the index admission. The end points of the study included cardiovascular (CV) death and HF rehospitalization.

After 3.5 years of mean follow-up period, it was found that 51% (104 out of 203 cases) reached endpoints in conventional group and 34.6% (71 out of 205 cases) in hydralazine + conventional treatment group, leading to a significant reduction in CV events. It was also noted that in-hospital death during the index admission was significantly higher in conventional group (5.4% vs. 0.5%, respectively).

Thus, it can be concluded that combining early up-titration of hydralazine with EBMs may improve outcome in patients with severe systolic dysfunction and significant MR, making it safe and well-tolerated for use.

Cardiac
2 Min Read
23 Feb

Early up-titration of hydralazine with evidence-based medications improves outcomes in severe systolic dysfunction and mitral regurgitation

According to a recent study, hydralazine combined with conventional therapy improves outcome in patients with severe systolic dysfunction and significant mitral regurgitation (MR). This study was published in the journal, ESC Heart Failure.

This study trial was an open-labelled, one-to-one ratio randomized designed. The 408 participants who were enrolled for this study had decompensated heart failure (HF) symptoms, left ventricular ejection fraction (LVEF) < 35%, and mitral regurgitation (MR) more than moderate severity. Out of these, 203 patients were in the conventional treatment and 205 in hydralazine + conventional treatment, comprising of evidence-based medications (EBMs). Up-titration of hydralazine in conjunction with EBMs was administered to the hydralazine + conventional treatment group during the follow-up period and on Days 1–5 of the index admission. The end points of the study included cardiovascular (CV) death and HF rehospitalization.

After 3.5 years of mean follow-up period, it was found that 51% (104 out of 203 cases) reached endpoints in conventional group and 34.6% (71 out of 205 cases) in hydralazine + conventional treatment group, leading to a significant reduction in CV events. It was also noted that in-hospital death during the index admission was significantly higher in conventional group (5.4% vs. 0.5%, respectively).

Thus, it can be concluded that combining early up-titration of hydralazine with EBMs may improve outcome in patients with severe systolic dysfunction and significant MR, making it safe and well-tolerated for use.

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Diabetes
2 Min Read
22 Feb

Efficacy and safety of bempedoic acid in patients with and without diabetes

A recent study demonstrated that bempedoic acid reduces LDL cholesterol and high-sensitivity C-reactive protein and the risk of cardiovascular events in both Diabetic and non-diabetic patients .The findings of this study were published in the journal, Lancet. Diabetes & Endocrinology.

CLEAR Outcomes was a randomised, double-blind, placebo-controlled trial that included 13,970 patients, who were randomly assigned to those with diabetes (n=6373), prediabetes (n= 5796), and normoglycaemia (n=1801). Patients with or without cardiovascular disease who were unwilling or unable to adhere to the recommended doses of statins and an LDL cholesterol of 2·59 mmol/L or more were randomly assigned (1:1) to receive either bempedoic acid 180 mg once per day or placebo. Using the intention-to-treat population stratified by baseline glycaemia status, the efficacy endpoint of the prespecified analysis was a time-to-event analysis of four-component major adverse cardiovascular event (MACE-4), which is the composite of nonfatal myocardial infarction, cardiovascular death, nonfatal stroke, or coronary revascularisation. At baseline, the risk of new-onset diabetes and HbA1c increase was analysed in patients without diabetes.

After a median follow-up of 3.4 years, patients with diabetes had significant relative and absolute cardiovascular risk reductions in MACE-4 endpoints with bempedoic acid (absolute risk reduction of 2·4%) compared to the placebo. The incidence of new-onset diabetes was comparable in both the bempedoic acid and placebo groups. The HbA1c concentrations were similar between randomised groups in patients who had prediabetes and normoglycaemia, at 12 months and end of the study. Placebo-corrected LDL cholesterol concentrations and high-sensitivity C-reactive protein at 6 months showed reductions in each glycaemic stratum (diabetes, prediabetes, and normoglycemia) for patients who were randomly assigned to bempedoic acid.

It was observed that bempedoic acid reduces LDL cholesterol and high-sensitivity C-reactive protein and the risk of cardiovascular events among patients with diabetes. With bempedoic acid, participants without diabetes had no increase in new-onset diabetes or worsening HbA1c. Based on the findings of this study, it can be concluded that the efficacy and cardiometabolic safety profile of bempedoic acid makes it a valuable clinical option for those with and without diabetes.

Efficacy and safety of bempedoic acid in patients with and without diabetes

A recent study demonstrated that bempedoic acid reduces LDL cholesterol and high-sensitivity C-reactive protein and the risk of cardiovascular events in both Diabetic and non-diabetic patients .The findings of this study were published in the journal, Lancet. Diabetes & Endocrinology.

CLEAR Outcomes was a randomised, double-blind, placebo-controlled trial that included 13,970 patients, who were randomly assigned to those with diabetes (n=6373), prediabetes (n= 5796), and normoglycaemia (n=1801). Patients with or without cardiovascular disease who were unwilling or unable to adhere to the recommended doses of statins and an LDL cholesterol of 2·59 mmol/L or more were randomly assigned (1:1) to receive either bempedoic acid 180 mg once per day or placebo. Using the intention-to-treat population stratified by baseline glycaemia status, the efficacy endpoint of the prespecified analysis was a time-to-event analysis of four-component major adverse cardiovascular event (MACE-4), which is the composite of nonfatal myocardial infarction, cardiovascular death, nonfatal stroke, or coronary revascularisation. At baseline, the risk of new-onset diabetes and HbA1c increase was analysed in patients without diabetes.

After a median follow-up of 3.4 years, patients with diabetes had significant relative and absolute cardiovascular risk reductions in MACE-4 endpoints with bempedoic acid (absolute risk reduction of 2·4%) compared to the placebo. The incidence of new-onset diabetes was comparable in both the bempedoic acid and placebo groups. The HbA1c concentrations were similar between randomised groups in patients who had prediabetes and normoglycaemia, at 12 months and end of the study. Placebo-corrected LDL cholesterol concentrations and high-sensitivity C-reactive protein at 6 months showed reductions in each glycaemic stratum (diabetes, prediabetes, and normoglycemia) for patients who were randomly assigned to bempedoic acid.

It was observed that bempedoic acid reduces LDL cholesterol and high-sensitivity C-reactive protein and the risk of cardiovascular events among patients with diabetes. With bempedoic acid, participants without diabetes had no increase in new-onset diabetes or worsening HbA1c. Based on the findings of this study, it can be concluded that the efficacy and cardiometabolic safety profile of bempedoic acid makes it a valuable clinical option for those with and without diabetes.

Diabetes
2 Min Read
22 Feb

Efficacy and safety of bempedoic acid in patients with and without diabetes

A recent study demonstrated that bempedoic acid reduces LDL cholesterol and high-sensitivity C-reactive protein and the risk of cardiovascular events in both Diabetic and non-diabetic patients .The findings of this study were published in the journal, Lancet. Diabetes & Endocrinology.

CLEAR Outcomes was a randomised, double-blind, placebo-controlled trial that included 13,970 patients, who were randomly assigned to those with diabetes (n=6373), prediabetes (n= 5796), and normoglycaemia (n=1801). Patients with or without cardiovascular disease who were unwilling or unable to adhere to the recommended doses of statins and an LDL cholesterol of 2·59 mmol/L or more were randomly assigned (1:1) to receive either bempedoic acid 180 mg once per day or placebo. Using the intention-to-treat population stratified by baseline glycaemia status, the efficacy endpoint of the prespecified analysis was a time-to-event analysis of four-component major adverse cardiovascular event (MACE-4), which is the composite of nonfatal myocardial infarction, cardiovascular death, nonfatal stroke, or coronary revascularisation. At baseline, the risk of new-onset diabetes and HbA1c increase was analysed in patients without diabetes.

After a median follow-up of 3.4 years, patients with diabetes had significant relative and absolute cardiovascular risk reductions in MACE-4 endpoints with bempedoic acid (absolute risk reduction of 2·4%) compared to the placebo. The incidence of new-onset diabetes was comparable in both the bempedoic acid and placebo groups. The HbA1c concentrations were similar between randomised groups in patients who had prediabetes and normoglycaemia, at 12 months and end of the study. Placebo-corrected LDL cholesterol concentrations and high-sensitivity C-reactive protein at 6 months showed reductions in each glycaemic stratum (diabetes, prediabetes, and normoglycemia) for patients who were randomly assigned to bempedoic acid.

It was observed that bempedoic acid reduces LDL cholesterol and high-sensitivity C-reactive protein and the risk of cardiovascular events among patients with diabetes. With bempedoic acid, participants without diabetes had no increase in new-onset diabetes or worsening HbA1c. Based on the findings of this study, it can be concluded that the efficacy and cardiometabolic safety profile of bempedoic acid makes it a valuable clinical option for those with and without diabetes.

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Oncology
2 Min Read
21 Feb

Lenvatinib plus pembrolizumab shows improved efficacy and overall survival in patients with advanced renal cell carcinoma

A recent study suggests that lenvatinib plus pembrolizumab shows improved efficacy and overall survival (OS) in specific subgroups of patients with advanced renal cell carcinoma(RCC). This study was published in the journal, European Urology Oncology.

The CLEAR trial was a phase 3, open-label, multicenter, randomized study that included 1069 patients who were randomized in a 1:1:1 ratio. The participants received either 20mg orally once a day of lenvatinib plus 200mg pembrolizumab intravenously once every 3 weeks, lenvatinib plus everolimus, or 50 mg sunitinib taken orally once daily for a period of 4 weeks and subsequently no treatment for 2 weeks. The International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk subgroup analyzed progression-free survival, duration of response and objective response rate (ORR).

It was found that the patients administered with lenvatinib plus pembrolizumab with a confirmed complete response or >75% target-lesion reduction by 6 months showed an OS of ≥91.7% at 24 months. Compared to sunitinib, lenvatinib plus pembrolizumab showed longer median progression-free survival and a higher ORR. Based on the above results, it can be concluded that lenvatinib plus pembrolizumab may provide improved efficacy and better survival than sunitinib in patients with advanced RCC.

Lenvatinib plus pembrolizumab shows improved efficacy and overall survival in patients with advanced renal cell carcinoma

A recent study suggests that lenvatinib plus pembrolizumab shows improved efficacy and overall survival (OS) in specific subgroups of patients with advanced renal cell carcinoma(RCC). This study was published in the journal, European Urology Oncology.

The CLEAR trial was a phase 3, open-label, multicenter, randomized study that included 1069 patients who were randomized in a 1:1:1 ratio. The participants received either 20mg orally once a day of lenvatinib plus 200mg pembrolizumab intravenously once every 3 weeks, lenvatinib plus everolimus, or 50 mg sunitinib taken orally once daily for a period of 4 weeks and subsequently no treatment for 2 weeks. The International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk subgroup analyzed progression-free survival, duration of response and objective response rate (ORR).

It was found that the patients administered with lenvatinib plus pembrolizumab with a confirmed complete response or >75% target-lesion reduction by 6 months showed an OS of ≥91.7% at 24 months. Compared to sunitinib, lenvatinib plus pembrolizumab showed longer median progression-free survival and a higher ORR. Based on the above results, it can be concluded that lenvatinib plus pembrolizumab may provide improved efficacy and better survival than sunitinib in patients with advanced RCC.

Oncology
2 Min Read
21 Feb

Lenvatinib plus pembrolizumab shows improved efficacy and overall survival in patients with advanced renal cell carcinoma

A recent study suggests that lenvatinib plus pembrolizumab shows improved efficacy and overall survival (OS) in specific subgroups of patients with advanced renal cell carcinoma(RCC). This study was published in the journal, European Urology Oncology.

The CLEAR trial was a phase 3, open-label, multicenter, randomized study that included 1069 patients who were randomized in a 1:1:1 ratio. The participants received either 20mg orally once a day of lenvatinib plus 200mg pembrolizumab intravenously once every 3 weeks, lenvatinib plus everolimus, or 50 mg sunitinib taken orally once daily for a period of 4 weeks and subsequently no treatment for 2 weeks. The International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk subgroup analyzed progression-free survival, duration of response and objective response rate (ORR).

It was found that the patients administered with lenvatinib plus pembrolizumab with a confirmed complete response or >75% target-lesion reduction by 6 months showed an OS of ≥91.7% at 24 months. Compared to sunitinib, lenvatinib plus pembrolizumab showed longer median progression-free survival and a higher ORR. Based on the above results, it can be concluded that lenvatinib plus pembrolizumab may provide improved efficacy and better survival than sunitinib in patients with advanced RCC.

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