MedicalResearch.com Interview with:
Jordi Salas-Salvadó Professor of Nutrition
Human Nutrition Unit Department of Biochemistry & Biotechnology
IISPV School of Medicine.
Rovira i Virgili University CIBERobn, Instituto Carlos III
Medical Research: What is the background for this study? What are the main findings?
Response: Excess sodium intake is associated with high blood pressure, a major risk factor for cardiovascular disease (CVD). The 2010 Dietary Guidelines for Americans recommended a sodium intake below 2300 mg per day (equivalent to less than 1 teaspoon of salt per day) in the general population. However it is unknown whether decreasing sodium intake below 2300 mg/d has an effect on CVD or all-cause mortality. The recent Institute of Medicine (IOM) explicitly concluded that studies on health outcomes are inconsistent in quality and insufficient in quantity to determine that sodium intake below 2300 mg/d may increase or decrease the risk of heart disease, stroke or all cause of mortality.
MedicalResearch.com Interview with:
Jiun-Ling Wang MD
Associated professor at Medical school in I-Shou University
infectious disease doctor at E-DA Hospital, Kaohsiung , Taiwan
Medical Research: What is the background for this study? What are the main findings?
Dr. Wang: Some study showed increase cardiovascular death in azithromycin user. But there lacks of data in other antibiotics in the treatment for respiratory tract infections.
So we used the Taiwan National Health Insurance Database to perform a nationwide, population-based study comparing the risks of ventricular arrhythmia and cardiovascular death among patients using these antibiotics. And we find azithromycin, and moxifloxacin were associated with higher risk of ventricular arrhythmia cardiovascular death than amoxicillin/clavunate.
MedicalResearch.com Interview with:
Beth Taylor, PhD
Director of Exercise Physiology Research
Department of Preventive Cardiology
Hartford Hospital
Hartford, CT 06102
Medical Research: What is the background for this study?
Dr. Taylor: Statins reduce incidence of cardiac events, and thus are extremely effective drugs. However, they may cause muscle side effects such as pain, weakness and soreness (i.e., statin myalgia) in up to 10% of patients. One potential mechanism underlying statin myalgia may be the depletion of Coenzyme Q10, a mitochondrial transport element used in energy production, as statin therapy produces a 30-50% reduction in intramuscular Coenzyme Q10. Seven previous studies to date have produced conflicting results, yet CoQ10 supplementation is used by many patients and recommended by many clinicians despite the absence of definitive results. The purpose of the present study was to assess the effect of CoQ10 on muscle pain, muscle strength and aerobic performance in confirmed myalgics (i.e., patients who tested positive for myalgia during a randomized, double-blinded cross-over trial of statin therapy vs. placebo to confirm myalgia prior to CoQ10 treatment).
Medical Research: What are the main findings?
Dr. Taylor: The first main finding was that after our randomized double-blind cross-over run-in phase, only 35.8% of patients experienced myalgia on simvastatin and did not experience it on placebo, what we term true or confirmed statin myalgia, and 17.5% of patients had no symptoms on simvastatin or placebo which could have been because the dose we selected was too low. However, 29.2% experienced pain on placebo but not on simvastatin and 17.5% experienced pain on both simvastatin and placebo during the confirmation phase.
Secondly, we found that Coenzyme Q10 supplementation had no effect on the incidence and severity of myalgia, time to onset of pain, muscle strength, or aerobic performance. Serum levels of CoQ10 went up, suggesting dosing worked, and LDL-C went down similarly in both groups, suggesting the statin was not compromised. Therefore we did not find an observable effect of CoQ10 on any muscle outcome.
Finally, there were no reductions from baseline in muscle strength or aerobic performance when statins were combined with placebo in our verified statin myalgics. This is notable because while there have been observational reports of decreased muscle strength and aerobic performance in statin myalgics, there have been few rigorous assessments of muscle strength and aerobic performance with statins and myalgia. In our previous study, the The Effect of STatins On Skeletal Muscle Performance (STOMP) trial , we randomized healthy, statin-naïve patients to atorvastatin 80 mg daily or placebo for 6 months, confirming myalgia via a challenge-dechallenge protocol. In that study, we also found no significant differences in the two groups in muscle and exercise performance, and thus the present results confirm those findings.
MedicalResearch.com Interview with:
Dr. Glenn I. Fishman MD
Professor; William Goldring Professor of Medicine
Vice Chair Research Dept of Medicine
Director of the Leon H. Charney Division of Cardiology
NYU Langone
Medical Research: What is the background for this study? What are the main findings?
Dr. Fishman: Sudden cardiac arrest (SCA) due to life-threatening ventricular arrhythmias is one of the leading causes of death in the US. Conditions that predispose to SCA can be acquired, as in atherosclerotic coronary artery disease, or inherited in the form of mutated cardiac ion channels, i.e. ion channelopathies. Mutations in the SCN5A cardiac sodium channel gene have been linked to progressive cardiac conduction disorders as well as atrial and ventricular arrhythmias. Understanding the mechanistic basis for lethal arrhythmias in cardiac sodium channelopathy patients has been limited in part due to the lack of adequate model systems that replicate human physiology. To address this limitation, we have developed the first genetically modified porcine model of an inherited channelopathy. A mutation in the SCN5A gene first identified in a child with the arrhythmic condition Brugada syndrome was introduced into the pig genome. Mutant pig hearts displayed conduction abnormalities and ventricular fibrillation bearing striking resemblance to the human condition.
MedicalResearch.com Interview with: Giovanni Filardo, PhD, MPH Director of Epidemiology, Baylor Scott & White Health, Dallas, TX The Bradley Family Endowed Chair in Cardiovascular Epidemiology, Baylor University Medical Center Director of Cardiovascular Epidemiology, The Heart Hospital Baylor, Plano, TX Research Associate Professor of Statistics, Southern Methodist University, Dallas, TX Medical Research: What should clinicians and patients take away...
MedicalResearch.com Interview with:
Madhav Swaminathan, MBBS, MD, FASE, FAHA
Associate Professor with Tenure
Clinical Director, Division of Cardiothoracic Anesthesiology & Critical Care Medicine Department of Anesthesiology
Duke University Health System Durham, NC 27710
Medical Research: What is the background for this study? What are the main findings?
Dr. Swaminathan: The background is the need for salvage therapies for acute kidney injury (AKI,) which is a common complication in hospitalized patients. It is particularly a problem in the postoperative period after cardiac surgery. Preventive strategies have not worked well for decades. Hence the focus on strategies that target kidney recovery. Mesenchymal stem cells have been shown to be useful in enhancing kidney recovery in pre-clinical trials. We therefore hypothesized that administration of human Mesenchymal stem cells (AC607, Allocure Inc, Burlington, MA) to patients with established post-cardiac surgery AKI would result in a shorter time to kidney recovery. We conducted a phase 2, double blinded, placebo controlled, randomized clinical trial to test our hypothesis. Unfortunately we could not confirm the hypothesis and there were no significant differences in time to kidney recovery among patients that received AC607 versus placebo in 156 randomized cardiac surgery subjects.
MedicalResearch.com Interview with:
Winnie Nelson PharmD, MS, MBA
Director, Health Economics & Outcomes Research
Janssen Pharmaceuticals
Medical Research: What is the background for this study? What are the main findings?
Dr. Nelson: Although warfarin has long served as the standard of care for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF), research has shown nearly one-third of international normalized ratio (INR) levels among stabilized patients on warfarin are out-of-range. Data recently published in the International Journal of Clinical Pharmacy underscores the potential complications of out-of-range INRs, with the aim of informing patient care.
The analysis of a U.S. Veterans Health Administration dataset showed out-of-range INRs were associated with a significantly increased risk of adverse clinical outcomes, including stroke and major bleeding. Of particular interest, the study also showed the magnitude of risk of thromboembolic events – such as ischemic stroke – was several folds higher in sub-therapeutic INR levels (i.e., INR <2) than risk of bleeding events when INR measures were >3. In another words, the research found more risks to patients when INRs were too low than when INRs were too high.
MedicalResearch.com Interview with:
Atsushi Sorita, MD, MPH
Mayo Clinic, Division of Preventive Medicine
Rochester, MN 55905.
Medical Research: What is the background for this study? What are the main findings?
Dr. Sorita: Prior studies have suggested that patients with heart attack who are admitted during off-hours (weekends, nights and holidays) have higher risk of death when compared with patients admitted during regular hours. In our study, we found that patients undergoing percutaneous coronary interventions for heart attack who were admitted during off-hours did not have higher mortality or readmission rates as compared with ones admitted during regular hours at a highly-integrated academic center in the United States.
MedicalResearch.com Interview with:
James J. DiNicolantonio, PharmD
Associate Editor BMJ Open Heart
Cardiovascular Research Scientist
Saint Luke's Mid America Heart Institute
Medical Research: What is the background for this study? What are the main findings?
Dr. DiNicolantonio: Cardiovascular disease is the leading cause of premature mortality in the developed world, and hypertension is its most important risk factor. Controlling hypertension is a major focus of public health initiatives, and dietary approaches have historically focused on sodium.
A reduction in the intake of added sugars, particularly fructose, and specifically in the quantities and context of industrially-manufactured consumables, would help not only curb hypertension rates, but would also help address broader problems related to cardiometabolic disease.
MedicalResearch.com Interview with:
Anders Nissen Bonde MBs
Department of Cardiology
Copenhagen University Hospital Gentofte,
Gentofte, Denmark
Medical Research: What is the background for this study? What are the main findings?
Response: Patients with severe chronic kidney disease have been excluded from
randomized trials of antithrombotic therapy in atrial fibrillation.They
represent a very fragile group as they are both at increased risk of
stroke/thromboembolism and major bleedings, and previous observational
studies have had conflicting conclusions regarding the safety and benefits
of the treatment. A previous study from our department reported both
increased risk of bleeding and reduced risk of stroke with warfarin.
We wanted to assess the net clinical benefit of aspirin and warfarin in
these patients, balancing stroke and major bleeding associated with the
treatment.
MedicalResearch.com Interview with:
Dr. Amit Navin Vora MD, MPH
Third Year Cardiovascular Fellow
John Hopkins University
Medical Research: What is the background for this study? What are the main findings?
Response: Current guidelines recommend timely reperfusion in patients presenting with ST-elevation myocardial infarction, with primary PCI being the preferred method if delivered in an expedient fashion. Otherwise, guidelines recommend that eligible patients should be treated with fibrinolysis prior to transfer to a PCI capable hospital. In our study, we used Google Maps to estimate drive times between the initial presenting hospital and the PCI-capable hospital looked at the association between estimated drive time and reperfusion strategy (primary PCI or fibrinolysis) selection.
We found that less than half of eligible patients with an estimated drive time of more than 30 minutes received primary PCI in time, and only half of patients with more than an hour’s drive received lytics before transfer. This suggests that neither primary PCI nor pre-transfer fibrinolytic therapy is being used optimally. Among eligible patients with a drive time of 30-120 minutes, we found no significant mortality difference but higher bleeding risk among patients receiving lytics prior to transfer; this increased bleeding risk was focused in patients that required rescue PCI.
MedicalResearch.com Interview with:
Simin Liu, MD, ScD, Professor of Epidemiology
School of Public Health, Professor of Medicine
The Warren Alpert School of Medicine
Director, Molecular Epidemiology and Nutrition
Brown University
MedicalResearch: What is the background for this study? What are the main findings?
Dr. Liu: Cardiovascular Disease (CVD) and type 2 diabetes (T2D) are highly heritable and share many risk factors and show ethnic-specific prevalence. Nevertheless, a comprehensive molecular-level understanding of these observations is lacking. We conducted a comprehensive assessment of whole genome assessment using network-based analysis in >15,000 women and identified eight molecular pathways share in both diseases as well as several “key driver” genes that appear to form the gene networks in which these pathways connect and interact.
MedicalResearch.comInterview with: Amro Qaddoura BHSc Research Student of Adrian Baranchuk, MD Department of Medicine, Queen's University, Kingston, Ontario, Canada MedicalResearch: What is the background for this study? What are the main findings? Response: This publication was a letter to the editor in response to comments on our recent systematic review and meta-analysis that showed...
MedicalResearch.com Interview with:
Dr. John Seeger, PharmD, DrPH
Department of Medicine, Brigham and Women’s Hospital
Dr. Seeger: What is the background for this study? What are the main findings?
Response: This study is part of an ongoing research program initiated in 2013 to assess prescribing patterns and real-world safety and effectiveness of oral anticoagulants, including dabigatran, for the reduction of stroke risk. The study program is expected to run through the end of 2016. Boehringer Ingelheim and Brigham and Women’s Hospital are aiming to gather data from more than 100,000 U.S. NVAF patients.
Using a sequential matched cohort design, the safety and effectiveness of dabigatran compared to warfarin among patients with non-valvular atrial fibrillation (NVAF) receiving these medications in routine care settings can be assessed periodically. The interim findings at this stage come from 38,378 non-valvular atrial fibrillation patients in two health insurance databases, MarketScan (31,058 patients) and UnitedHealth (7,320 patients). The primary analysis follows patients from start of therapy until a switch or discontinuation of the anticoagulant, an outcome event, or disenrollment. The average follow-up was five months for patients in the dabigatran group and four months for those taking warfarin. The primary outcomes measured in the analysis are stroke and major hemorrhage.
Interim findings from the combined databases showed a 25 percent reduction in the rate of major hemorrhage (hazard ratio [HR] 0.75, 95 percent confidence interval [CI] 0.65-0.87, 354 vs. 395 events) and a 23 percent reduction in strokes (HR 0.77, CI 0.54-1.09, 62 vs 69 events) for dabigatran compared to warfarin among these patients with NVAF. The database-specific results indicate a reduction in the rate of major hemorrhage with dabigatran (MarketScan: HR 0.78, CI 0.67- 0.91; UnitedHealth: HR 0.56, CI 0.36-0.86). In the larger MarketScan database, dabigatran reduced the stroke rate by 36 percent (HR 0.64, CI 0.44-0.95), while in the smaller UnitedHealth database, stroke rates were not different between the two anticoagulants, as there were only 26 strokes in total which led to wide confidence intervals (HR=1.62, CI 0.72-3.66).
MedicalResearch.com Interview with:
Concetta Crivera MPH, Pharm.D
Associate Director, Outcomes Research
Ortho-McNeil Janssen Scientific Affairs, LLC
Medical Research: What is the background for this study? What are the main findings?
Response: Findings from the study presented at the American Heart Association (AHA) 2014 Scientific Sessions showed once-daily XARELTO® (rivaroxaban) is associated with significantly fewer hospitalization days and outpatient visits compared to warfarin in patients with non-valvular atrial fibrillation (NVAF). Corresponding hospitalization and outpatient healthcare costs were also significantly lower for XARELTO® compared to warfarin in NVAF patients, according to longitudinal, real-world findings from this observational study.
MedicalResearch.com Interview with:
Dr. Roberta Williams MD
Professor of Pediatrics
Keck School of Medicine at the University of Southern California
MedicalResearch.com: What is the background for this study?
Dr. Williams: Although a large number of children with chronic disease are surviving into adulthood, the extent and type of health resource needs remains a mystery. Patients with congenital heart disease (CHD) require lifelong care, so it is important to understand present resource utilization both as a foundation for planning services and as a reference point to assess the changes that occur with presumed improved access to care due to health care reform.
MedicalResearch.com Interview with
Dr. Mary T. Hawn MD
Center for Surgical, Medical Acute Care Research, and Transitions,
Birmingham Veterans Affairs Medical Center
University of Alabama at Birmingham, Birmingham
Medical Research: What are the main findings?
Dr. Hawn: The main findings of the study are that the recommendations made in the guidelines published by the American College of Cardiology / American Heart Association in 2007 were effective at reducing postoperative major adverse cardiac events following noncardiac surgery in patients with a cardiac stent.1 These guidelines recommended the delay of noncardiac surgeries in patients with a drug-eluting stent for 365 days if the surgery was not emergent or the delay of surgery for 4 to 6 weeks among patients with a bare metal stent. In addition to a 26% reduction in postoperative major adverse cardiac events, we also found an increase in the time between drug-eluting stent placement and non-cardiac surgery consistent with the guideline recommendations.
MedicalResearch.com Interview with:
Carl "Chip" Lavie MD, FACC
Medical Director, Cardiac Rehabilitation and Prevention
Director, Exercise Laboratories
John Ochsner Heart and Vascular Institute
Professor of Medicine
Ochsner Clinical School-UQ School of Medicine
Editor-in-Chief, Progress in Cardiovascular Diseases
Medical Research: What are the key points of your editorial?
Dr. Lavie:
1) The importance of higher fitness to predict a lower rate of developing Heart Failure;
2) improvements in fitness over time predict a lower rate of developing Heart Failure, and
3) Once Heart Failure develops, higher fitness predicts a more favorable prognosis.