Publications by authors named "Prem Pais"
Background: Cardiovascular disease (CVD) continues to impart a large burden on the global population, especially in lower income countries where affordability limits the use of cardiovascular medicines. A fixed dose combination strategy of at least 2 blood pressure lowering medications and a statin with aspirin in a single pill has been shown to reduce the risk of incident CVD by 38% in primary prevention in a recent meta-analysis. We report the in-trial (median follow-up: 5 years) cost-effectiveness of a fixed dose combination (FDC) pill in different income groups based on data from that meta-analysis.
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- Current smoking significantly elevates stroke risk globally, particularly for ischemic stroke, with odds ratios indicating a stronger link in high-income countries.
- Environmental tobacco smoke (ETS) exposure also raises stroke risk, with a notable increase for those exposed for over 10 hours weekly, impacting all stroke types.
- The study highlights varying risk associations based on tobacco type and regional income levels, with large vessel strokes showing the strongest correlation with current smoking.
Background: Fixed-dose combination treatments reduce cardiovascular disease in primary prevention. We aim to explore whether those benefits differ in the presence of CKD.
Methods: We conducted an individual participant data meta-analysis in 18,162 participants on the efficacy and safety of treatment for the primary prevention of cardiovascular disease.
Objective: To evaluate the effects of fixed dose combination (FDC) medications on cardiovascular outcomes in different age groups in an individual participant meta-analysis of three primary prevention randomised trials.
Methods: Participants at intermediate risk (17.7% mean 10-year Framingham Cardiovascular Risk Score), randomised to FDC of two or more antihypertensives and a statin with or without aspirin, or to their respective control, were followed up for 5 years.
Background: India has a high burden of stroke, but there are limited data available on the characteristics of patients presenting with stroke in India.
Aims: We aimed to document the clinical characteristics, practice patterns, and outcomes of patients presenting with acute stroke to Indian hospitals.
Methods: A prospective registry study of patients admitted with acute clinical stroke was conducted in 62 centers across different regions in India between 2009 and 2013.
Background: In clinical practice, anthropometric measures other than BMI are rarely assessed yet may be more predictive of cardiovascular (CV) risk. We analyzed the placebo group of the REWIND CV Outcomes Trial to compare several anthropometric measures as baseline risk factors for cardiovascular disease (CVD)-related outcomes in participants with type 2 diabetes (T2D).
Methods: Data from the REWIND trial placebo group (N = 4952) were analyzed.
Article Synopsis
- The study investigates whether a polypill, containing antihypertensives and a statin, can help reduce cognitive and functional decline in older adults with vascular risk factors but no cardiovascular disease.
- Conducted as a randomized clinical trial across 8 countries with 5,713 participants, it particularly focused on 2,098 individuals aged 65 and older who underwent cognitive assessments at the beginning of the study and again after two years.
- Results showed a high completion rate of assessments among participants, with many showing hypertension and elevated LDL cholesterol levels, indicating a substantial at-risk population for cognitive decline.
Patients with chronic kidney disease (CKD) carry a high cardiovascular (CV) risk. Since whether this risk is reduced by aspirin is unclear, we examined if the effect of aspirin on cardiovascular outcomes varied by baseline kidney function in a primary cardiovascular disease prevention trial. The International Polycap Study-3 (TIPS-3) trial had randomized people without previous cardiovascular disease to aspirin (75 mg daily) or placebo.
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- The THEMIS trial explores the efficacy of ticagrelor compared to a placebo in patients with diabetes and stable coronary artery disease (CAD), intending to evaluate participant eligibility based on existing criteria.
- Out of the 10,156 patients from the REACH registry with diabetes and stable CAD, 28.1% met the eligibility requirements for the study, while the majority were excluded mainly due to a history of myocardial infarction or the use of anticoagulants.
- The study highlights that while a significant number of patients are deemed eligible for THEMIS, many still have conditions that prevent their inclusion, indicating a need for careful selection in clinical trials.
Background: The large number of patients worldwide infected with the SARS-CoV-2 virus has overwhelmed health-care systems globally. The Anti-Coronavirus Therapies (ACT) outpatient trial aimed to evaluate anti-inflammatory therapy with colchicine and antithrombotic therapy with aspirin for prevention of disease progression in community patients with COVID-19.
Methods: The ACT outpatient, open-label, 2 × 2 factorial, randomised, controlled trial, was done at 48 clinical sites in 11 countries.
Aims: People with diabetes are at high risk for cardiovascular events including heart failure (HF). We examined the effect of the glucagon-like peptide 1 agonist dulaglutide on incident HF events and other cardiovascular outcomes in those with or without prior HF in the randomized placebo-controlled Researching Cardiovascular Events with a Weekly Incretin in Diabetes (REWIND) trial.
Methods And Results: The REWIND major adverse cardiovascular event (MACE) outcome was the first occurrence of a composite endpoint of non-fatal myocardial infarction, non-fatal stroke, or death from cardiovascular causes (including unknown causes).
Article Synopsis
- The study investigates the relationship between different lipoproteins and apolipoproteins in various stroke types, highlighting inconsistent associations with stroke risk.
- Results show that higher levels of apoB and LDL-C are linked to an increased risk of ischemic stroke, while apoA1 and HDL-C have opposed effects depending on the stroke type.
- The findings suggest that specific lipoprotein ratios, particularly apoB/A1, may offer more insight into ischemic stroke risk than traditional measurements.
Background: Effective treatments for COVID-19 are urgently needed, but conducting randomized trials during the pandemic has been challenging.
Methods: The Anti-Coronavirus Therapy (ACT) trials are parallel factorial international trials that aimed to enroll 3500 outpatients and 2500 inpatients with symptomatic COVID-19. The outpatient trial is evaluating colchicine vs usual care, and aspirin vs usual care.
The cost implications of a polypill for primary prevention in the TIPS-3 trial.
Eur Heart J Qual Care Clin Outcomes
November 2022
Article Synopsis
- The TIPS-3 trial showed that a polypill combining several medications significantly reduces cardiovascular events by 20% compared to a placebo in individuals without existing cardiovascular disease.
- The trial revealed that costs for the polypill varied significantly across economic regions, with lower-middle-income countries experiencing a cost increase of $291 per participant and upper-middle-income countries facing an increase of $1068 over 4.6 years.
- Despite these increases, the polypill is deemed affordable across all economic groups and is particularly cost-effective in high-income countries.
Background: In randomised controlled trials, fixed-dose combination treatments (or polypills) have been shown to reduce a composite of cardiovascular disease outcomes in primary prevention. However, whether or not aspirin should be included, effects on specific outcomes, and effects in key subgroups are unknown.
Methods: We did an individual participant data meta-analysis of large randomised controlled trials (each with ≥1000 participants and ≥2 years of follow-up) of a fixed-dose combination treatment strategy versus control in a primary cardiovascular disease prevention population.
Background And Purpose: The HOPE-3 trial (Heart Outcomes Prevention Evaluation–3) found that antihypertensive therapy combined with a statin reduced first stroke among people at intermediate cardiovascular risk. We report secondary analyses of stroke outcomes by stroke subtype, predictors, treatment effects in key subgroups.
Methods: Using a 2-by-2 factorial design, 12 705 participants from 21 countries with vascular risk factors but without overt cardiovascular disease were randomized to candesartan 16 mg plus hydrochlorothiazide 12.
Aims: Rosuvastatin (10 mg per day) compared with placebo reduced major adverse cardiovascular (CV) events by 24% in 12 705 participants at intermediate CV risk after 5.6 years. There was no benefit of blood pressure (BP) lowering treatment in the overall group, but a reduction in events in the third of participants with elevated systolic BP.
View Article and Find Full Text PDFObjective: Approximately 10% of patients with myocardial infarction (MI) have no obstructive coronary artery disease. The prognosis and role of intensified antiplatelet therapy in those patients were evaluated.
Methods: We analysed data from the Clopidogrel and Aspirin Optimal Dose Usage to Reduce Recurrent Events-Seventh Organisation to Assess Strategies in Ischaemic Symptoms trial randomising patients with ACS referred for early intervention to receive either double-dose (600 mg, day 1; 150 mg, days 2-7; then 75 mg/day) or standard-dose (300 mg, day 1; then 75 mg/day) clopidogrel.
Article Synopsis
- South Asian patients with chronic cardiovascular disease, particularly those with heart failure, often struggle with adherence to evidence-based medications, which is recognized as part of their self-care process that needs further exploration.
- Researchers conducted detailed interviews with 22 heart failure patients and 17 caregivers in Southern India to better understand the factors influencing self-care in this demographic.
- The study identified three categories of determinants affecting self-care: negative factors (like lack of knowledge and financial issues), intermediate factors (such as patient expectations and hospital hopping), and positive factors (intrinsic and extrinsic facilitators), highlighting the significant role of gender and cultural background in shaping these determinants.
Objective: Hypertension is the most important modifiable risk factor for stroke globally. We hypothesised that country-income level variations in knowledge, detection and treatment of hypertension may contribute to variations in the association of blood pressure with stroke.
Methods: We undertook a standardised case-control study in 32 countries (INTERSTROKE).
Background: The Researching cardiovascular Events with a Weekly INcretin in Diabetes (REWIND) double blind randomized trial demonstrated that weekly subcutaneous dulaglutide 1.5 mg, a glucagon like peptide-1 receptor agonist, versus matched placebo reduced the first outcome of major adverse cardiovascular event (MACE), cardiovascular death, nonfatal myocardial infarction or nonfatal stroke (594 versus 663 events) in 9901 persons with type 2 diabetes and either chronic cardiovascular disease or risk factors, and followed during 5.4 years.
View Article and Find Full Text PDFObjective: Recent European Guidelines for Diabetes, Prediabetes and Cardiovascular Diseases introduced a shift in managing patients with type 2 diabetes at high risk for or established cardiovascular (CV) disease by recommending GLP-1 receptor agonists and SGLT-2 inhibitors as initial glucose-lowering therapy. This is questioned since outcome trials of these drug classes had metformin as background therapy. In this post hoc analysis, the effect of dulaglutide on CV events was investigated according to the baseline metformin therapy by means of a subgroup analysis of the Researching Cardiovascular Events with a Weekly Incretin in Diabetes (REWIND) trial.
View Article and Find Full Text PDFBackground: A polypill comprising statins, multiple blood-pressure-lowering drugs, and aspirin has been proposed to reduce the risk of cardiovascular disease.
Methods: Using a 2-by-2-by-2 factorial design, we randomly assigned participants without cardiovascular disease who had an elevated INTERHEART Risk Score to receive a polypill (containing 40 mg of simvastatin, 100 mg of atenolol, 25 mg of hydrochlorothiazide, and 10 mg of ramipril) or placebo daily, aspirin (75 mg) or placebo daily, and vitamin D or placebo monthly. We report here the outcomes for the polypill alone as compared with matching placebo, for aspirin alone as compared with matching placebo, and for the polypill plus aspirin as compared with double placebo.
The 143 low- and middle-income countries (LMICs) of the world constitute 80% of the world's population or roughly 5.86 billion people with much variation in geography, culture, literacy, financial resources, access to health care, insurance penetration, and healthcare regulation. Unfortunately, their burden of cardiovascular disease in general and acute ST-segment-elevation myocardial infarction (STEMI) in particular is increasing at an unprecedented rate.
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