Publications by authors named "Balarama Gundapaneni"
Article Synopsis
- The ATTR-ACT study aimed to assess the effectiveness of tafamidis in treating transthyretin amyloid cardiomyopathy (ATTR-CM) over a period of up to 2.5 years, with participants either receiving tafamidis or a placebo.
- In the long-term extension study, participants who initially received tafamidis maintained their quality of life and heart failure symptoms, while those who switched from placebo to tafamidis experienced slower worsening of their conditions.
- The researchers concluded that tafamidis is beneficial in slowing down the decline in quality of life and heart failure symptoms for people with ATTR-CM, suggesting that early treatment is important.
Background: Atrial fibrillation/atrial flutter (AF/AFL) are common manifestations of transthyretin amyloid cardiomyopathy (ATTR-CM) but have not been found to be predictive of mortality.
Objectives: This analysis aimed to examine whether baseline or historical AF/AFL at enrollment was prognostic for all-cause mortality.
Methods: In the ATTR-ACT (Tafamidis in Transthyretin Cardiomyopathy Clinical Trial), a 30-month study of tafamidis vs placebo for ATTR-CM, AF/AFL was evaluated as an independent prognostic factor for all-cause mortality using Cox proportional hazards modelling.
Article Synopsis
- Chronic kidney disease is prevalent in patients with amyloid cardiomyopathy, prompting a study on tafamidis, which was previously approved for treating transthyretin amyloid cardiomyopathy (ATTR-CM) based on the ATTR-ACT trial.
- A post hoc analysis of the ATTR-ACT trial assessed renal function changes over 30 months among patients taking tafamidis versus a placebo, measuring estimated glomerular filtration rate (eGFR) and a composite endpoint of renal decline events.
- Results indicated that those treated with tafamidis experienced less decline in eGFR, improved CKD staging, and a lower rate of reaching critical renal failure events compared to the placebo
Aims: To evaluate the effect of long-term tafamidis treatment on health-related quality of life (HRQoL) in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) enrolled in the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT) and long-term extension (LTE) study.
Methods And Results: We examined change from baseline in Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS) and clinical summary (KCCQ-CS) scores in patients who received tafamidis meglumine 80 mg for 30 months in ATTR-ACT and tafamidis (meglumine 80 mg or bioequivalent free acid 61 mg) for 30 months in the LTE study, and in patients who received placebo for 30 months in ATTR-ACT and tafamidis for 30 months in the LTE study. In ATTR-ACT, 176 and 177 patients were randomized to tafamidis 80 mg and placebo, respectively.
Article Synopsis
- Tafamidis has been shown to improve survival rates in patients with transthyretin amyloid cardiomyopathy (ATTR-CM), but its specific impact on cardiac function was unclear, prompting further investigation.
- The study analyzed data from the ATTR-ACT clinical trial, involving 436 patients with ATTR-CM, to compare cardiac function measures over 30 months between those receiving tafamidis and a placebo.
- Results indicated that patients treated with tafamidis experienced less deterioration in key cardiac function metrics, suggesting a potential benefit of the drug in managing cardiac issues related to ATTR-CM.
Background: Tafamidis was approved to treat patients with transthyretin amyloid cardiomyopathy (ATTR-CM) on the basis of findings from the phase 3 Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT).
Objectives: This study was a post hoc analysis exploring tafamidis efficacy in octogenarian patients.
Methods: Analysis of patients aged <80 and ≥80 years in ATTR-ACT and its ongoing open-label long-term extension (LTE) study, where all patients receive tafamidis.
Aim: The value of disease-modifying therapies (such as tafamidis) in patients with transthyretin amyloid cardiomyopathy (ATTR-CM) and severe heart failure symptoms has been debated. This study assessed long-term all-cause survival in patients with New York Heart Association (NYHA) class III symptoms in the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT) long-term extension (LTE) study.
Methods And Results: At the baseline of ATTR-ACT, 55/176 (31.
Article Synopsis
- - The summary discusses a long-term study that builds on earlier research (ATTR-ACT) focusing on transthyretin amyloid cardiomyopathy (ATTR-CM), a heart disease that can lead to heart failure and death.
- - Participants either received the drug tafamidis or a placebo in the initial study, and the extension study allowed continued use of tafamidis or switching from placebo to tafamidis for another 2½ years.
- - Early and continuous treatment with tafamidis is associated with a lower risk of death compared to those who switched from placebo, emphasizing the need for early detection and treatment of ATTR-CM for better long-term survival.
Background: Transthyretin amyloid cardiomyopathy (ATTR-CM) is a fatal disease. Tafamidis was approved to treat patients with ATTR-CM based on findings from the ATTR-ACT (Tafamidis in Transthyretin Cardiomyopathy Clinical Trial).
Objectives: This post hoc analysis examined the proportion of patients who experienced improved efficacy measures through 30 months of treatment with tafamidis or placebo in ATTR-ACT.
What Is This Plain Language Summary About?: This plain language summary describes some results of a study called ATTR-ACT. This was the first large study to include people with wild-type and hereditary transthyretin amyloid cardiomyopathy (ATTR-CM for short). ATTR-CM is a type of heart disease that happens when abnormal clumps of protein build up in the heart.
View Article and Find Full Text PDFArticle Synopsis
- Tafamidis is a drug approved for treating transthyretin amyloid cardiomyopathy, and this study analyzes its long-term effectiveness through ongoing trials following a major clinical trial called ATTR-ACT.
- In the study, patients previously on tafamidis or those switching from placebo to tafamidis were monitored for all-cause mortality over a median follow-up of about 58 months.
- Results showed that patients continuously treated with tafamidis had a significantly lower death rate compared to those who switched from placebo, emphasizing the critical role of early treatment in improving survival outcomes in this condition.
This plain language summary describes the results of a study called ATTR-ACT, which was published in the . In ATTR-ACT, researchers looked at the effects of tafamidis treatment in people with transthyretin amyloid cardiomyopathy (called ATTR-CM for short). Tafamidis is currently available in the USA and other countries as an oral treatment for adults with ATTR-CM.
View Article and Find Full Text PDFAims: Transthyretin amyloid cardiomyopathy (ATTR-CM) is a progressive, fatal disorder that remains underdiagnosed. The Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT) was the first large clinical trial to include both wild-type (ATTRwt) and hereditary (ATTRv) patients. A description of the natural history of ATTR-CM, utilizing data from placebo-treated patients in ATTR-ACT, will provide a greater understanding of presentation and progression of ATTR-CM and may aid in disease awareness, earlier diagnosis and treatment monitoring.
View Article and Find Full Text PDFIn the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT), tafamidis significantly reduced mortality and cardiovascular (CV)-related hospitalizations compared with placebo in patients with transthyretin amyloid cardiomyopathy (ATTR-CM). This analysis aimed to assess the causes of CV-related death and hospitalization in ATTR-ACT to provide further insight into the progression of ATTR-CM and efficacy of tafamidis. ATTR-ACT was an international, double-blind, placebo-controlled, and randomized study.
View Article and Find Full Text PDFArticle Synopsis
- Tafamidis is an effective treatment for transthyretin amyloid cardiomyopathy (ATTR-CM), with this study specifically analyzing its effects on variant (ATTRv) versus wild-type (ATTRwt) forms of the disease.
- Results showed that patients with ATTRwt had less severe disease and slower progression compared to those with ATTRv.
- Tafamidis treatment led to similar reductions in all-cause mortality and improvements in physical and quality of life measures for both ATTRwt and ATTRv patients.
In the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial, tafamidis significantly reduced all-cause mortality and cardiovascular-related hospitalizations in patients with transthyretin amyloid cardiomyopathy (ATTR-CM). ATTR-CM is associated with a significant burden of disease; further analysis of patient-reported quality of life will provide additional data on the efficacy of tafamidis. In the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial, 441 adult patients with ATTR-CM were randomized (2:1:2) to tafamidis 80 mg, tafamidis 20 mg, or placebo for 30 months, with pooled tafamidis (80 mg and 20 mg) compared with placebo.
View Article and Find Full Text PDFAims: Tafamidis is an effective treatment for transthyretin amyloid cardiomyopathy (ATTR-CM) in the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT). While ATTR-ACT was not designed for a dose-specific assessment, further analysis from ATTR-ACT and its long-term extension study (LTE) can guide determination of the optimal dose.
Methods And Results: In ATTR-ACT, patients were randomized (2:1:2) to tafamidis 80 mg, 20 mg, or placebo for 30 months.
Tafamidis is approved in over 40 countries to delay neurologic progression in patients with transthyretin amyloid polyneuropathy (ATTR-PN). A comprehensive, integrated analysis of safety data from interventional, observational and surveillance studies of tafamidis in ATTR-PN patients was conducted. Safety data from all sponsored, completed, or ongoing, Phase 2/3 studies of tafamidis in ATTR-PN patients as of 3 January 2017 were pooled.
View Article and Find Full Text PDFBackground: Emerging evidence suggests that several factors can impact disease progression in transthyretin amyloid polyneuropathy (ATTR-PN). The present analysis used longitudinal data from Val30Met patients participating in the tafamidis (selective TTR stabilizer) clinical development program to evaluate the impact of baseline neurologic severity on disease progression in ATTR-PN.
Methods: A linear mixed-effects model for repeated measures (MMRM) was constructed using tafamidis and placebo data from the intent-to-treat Val30Met population of the original registration study as well as tafamidis data from the two consecutive open-label extension studies.
Article Synopsis
- Transthyretin amyloid cardiomyopathy is a heart condition caused by abnormal proteins, and tafamidis helps stabilize these proteins to prevent disease progression.
- In a phase 3 clinical trial with 441 patients, those taking tafamidis showed significantly lower death rates and fewer hospitalizations due to cardiovascular issues compared to placebo.
- Tafamidis also improved physical health and quality of life measurements, indicating it is an effective treatment for this condition.
Treatment With Tafamidis Slows Disease Progression in Early-Stage Transthyretin Cardiomyopathy.
Clin Med Insights Cardiol
September 2017
Background: Transthyretin cardiomyopathy (TTR-CM) is a progressive, fatal disease caused by the accumulation of misfolded transthyretin (TTR) amyloid fibrils in the heart. Tafamidis is a kinetic stabilizer of TTR that inhibits misfolding and amyloid formation.
Methods: In this post hoc analysis, data from an observational study (Transthyretin Amyloidosis Cardiac Study; n = 29) were compared with an open-label study of tafamidis in patients with TTR-CM (Fx1B-201; n = 35).
Unlabelled: Transthyretin amyloidosis is a rare, life-threatening disease resulting from aggregation and deposition of transthyretin amyloid fibrils in various tissues. There are 2 predominate phenotypic presentations of the disease: transthyretin familial amyloid polyneuropathy, which primarily affects the peripheral nerves, and transthyretin cardiomyopathy (TTR-CM), which primarily affects the heart. However, there is a wide overlap with symptoms at presentation and disease course being highly variable and influenced by the underlying transthyretin mutation, age of the affected individual, sex, and geographic location.
View Article and Find Full Text PDFBackground: Tafamidis, a non-NSAID highly specific transthyretin stabilizer, delayed neurologic disease progression as measured by Neuropathy Impairment Score-Lower Limbs (NIS-LL) in an 18-month, double-blind, placebo-controlled randomized trial in 128 patients with early-stage transthyretin V30M familial amyloid polyneuropathy (ATTRV30M-FAP). The current post hoc analyses aimed to further evaluate the effects of tafamidis in delaying ATTRV30M-FAP progression in this trial.
Methods: Pre-specified, repeated-measures analysis of change from baseline in NIS-LL in this trial (ClinicalTrials.