Author Interviews, Cleveland Clinic, Lancet, Multiple Sclerosis / 16.02.2016

MedicalResearch.com Interview with: [caption id="attachment_21655" align="alignleft" width="155"]Dr Jeffrey A Cohen MD Neurological Institute Cleveland Clinic, Cleveland OH 44195, USA Dr. Jeffrey Cohen[/caption] Dr Jeffrey A Cohen MD Mellen Center, Neurological Institute Cleveland Clinic, Cleveland OH 44195, USA Medical Research: What is the background for this study? What are the main findings? Dr. Cohen: Fingolimod, a non-selective sphingosine 1-phosphate receptor (S1PR) modulator, was the first oral medication approved to treat relapsing multiple sclerosis.  Though generally well tolerated, fingolimod’s first dose cardiac effects and other potential adverse effects complicate its use.  Ozanimod is a selective S1PR modulator with several other potentially advantageous pharmacologic properties. The results of phase 2 RADIANCE trial were recently published.  In this trial, participants were randomized to placebo (n=88), ozanimod 0.5 mg (n=87), or ozanimod 1 mg (n=83) PO once daily for 24 weeks.  The mean cumulative number of gadolinium-enhancing lesions on monthly MRI scans at weeks 12-24, the primary endpoint, was reduced from 11.1 +/- 29.9 with placebo to 1.5 +/- 3.7 with ozanimod 0.5 mg and 1.5 +/- 3.4 with ozanimod 1 mg (both p<0.0001).  Other MRI endpoints supported the primary endpoint.  Ozanimod was well tolerated with good safety.  Importantly, the dose up-titration protocol effectively mitigated first dose cardiac effects.
Author Interviews, Epilepsy, Lancet, Pharmacology / 15.02.2016

MedicalResearch.com Interview with: [caption id="attachment_21621" align="alignleft" width="160"]Dr. Michael Privitera MD Professor of the Department of Neurology and director of the Epilepsy Center University of Cincinnati Neuroscience Institute Dr. Michael Privitera[/caption] Dr. Michael Privitera MD Professor of the Department of Neurology and director of the Epilepsy Center University of Cincinnati Neuroscience Institute  Medical Research: What is the background for this study? What are the main findings? Dr. Privitera: Generic substitution of medications has saved the American health care system billions of dollars per year. However, based on a series of uncontrolled studies, patients and clinicians share concerns that generic substitution of antiepileptic drugs may lead to loss of efficacy or emergence of adverse effects. To answer this question we undertook a prospective, randomized study that tested bioequivalence of two generic products of the antiepileptic drug lamotrigine. Lamotrigine was identified in several publications as a possible source of problems after generic switches. FDA studies test a single generic versus the brand name product in a single dose study in normal volunteers. We designed a study that would be most likely to show a difference between generics if one existed. We compared the two generic lamotrigine products showing the most difference in prior testing in patients with epilepsy taking the drug daily using rigorous pharmacokinetic methods. Each patient took each of the two generics for 2 four week periods. Our study showed the two generics were essentially indistinguishable and easily met bioequivalence standards. No patient had loss of seizure control or unexpected adverse effects.
Author Interviews, Compliance, HIV, Lancet / 03.02.2016

MedicalResearch.com Interview with: [caption id="attachment_21259" align="alignleft" width="134"]Dr Marcel Yotebieng, PhD Department of Epidemiology Ohio State University, 304 Cunz Hall Columbus, OH Dr. Marcel Yotenbieng[/caption] Dr Marcel Yotebieng, PhD Department of Epidemiology Ohio State University, 304 Cunz Hall Columbus, OH Medical Research: What is the background for this study? What are the main findings? Response: With the current World Health Organization recommended treatment for the prevention of mother-to-child HIV transmission (PMTCT), the risk of transmission of HIV from an infected mother to her baby can be cut from 35-45% to less than 5% in breastfeeding population and <1% in non-breastfeeding population. But in sub-Saharan Africa where over 90% of HIV-infected pregnant women worldwide live, transportation costs and opportunity costs to attend regular clinic visits (to collect drugs) have been identified as important barriers to PMTCT. The provision of economic incentives has the potential to help women overcome these economic barriers. In addition, by creating immediate rewards that “nudge” individuals towards positive health behaviors, financial incentives can also address psychological barriers to health-seeking behavior of HIV-infected pregnant and breastfeeding women. This is the first study to use small cash incentives to encourage women to attend clinic visit and received available PMTCT care. We found that, among newly diagnosed HIV-infected women, small, incremental cash incentives resulted in increased retention along the  prevention of mother-to-child HIV transmission cascade and uptake of available services.
Author Interviews, Brigham & Women's - Harvard, Cancer Research, Lancet, Pediatrics, Radiation Therapy / 02.02.2016

MedicalResearch.com Interview with: [caption id="attachment_21220" align="alignleft" width="120"]Dr. Torunn Yock, MD Director, Pediatric Radiation Oncology Associate Professor, Harvard Medical School Radiation Oncology Quality Assurance Massachusetts General Hospital, Proton Center Boston, MA Dr. Torunn Yock[/caption] Dr. Torunn Yock, MD Director, Pediatric Radiation Oncology Associate Professor, Harvard Medical School Radiation Oncology Quality Assurance Massachusetts General Hospital, Proton Center Boston, MA Medical Research: What is the background for this study? Dr. Yock: Proton radiotherapy is a highly targeted form of radiation therapy that can spare normal tissues better than standard x-ray/photon based radiotherapy. Because, all side effects from radiotherapy come from radiation dose to normal healthy tissues, it is widely believed that proton radiotherapy has great potential to mitigate the side effects of treatment, both acute and long term side effects. There have been many planning studies that show that proton radiation can achieve a more highly conformal dose distribution and appear to spare 50% or more normal tissue from unnecessary irradiation.  However, there have been only a handful of retrospective studies that report disease control and side effects of treatment. While the technology looked promising, the definitive clinical data has been lacking to date. Because of this lack of clinical outcome data, the role and benefit of proton radiotherapy has been a subject of great debate in the oncology community.  Critics assert that proton radiotherapy is expensive and unproven and therefore a leading culprit in escalating costs of oncologic health care. Proponents assert that when used in the appropriate patient setting, the margin of benefit in terms of improved health outcomes, outweighs the increased cost of treatment. We embarked on this study to answer help answer the call for prospectively collected clinical outcome data to better define the most appropriate role for proton radiotherapy. Importantly, this study addresses both disease control and side effects of treatment in a pediatric medulloblastoma cohort of children. Medical Research: What are the main findings? Dr. Yock: This study shows that disease control in the pediatric medulloblastoma population is very much the same as that which is achieved by photon based radiotherapy treatments. However, more importantly, late side effects commonly attributed to radiotherapy such as neurocognitive decline over time and hearing loss appear to be improved compared with published photon treated cohorts of pediatric medulloblastoma patients.  Additionally, adverse late side effects on the cardiopulmonary, GI, and reproductive systems were essentially eliminated.
Author Interviews, Diabetes, Lancet / 31.01.2016

MedicalResearch.com Interview with: [caption id="attachment_21036" align="alignleft" width="200"]Dr Abbas Dehghan PhD Assistant Professor, Department of Epidemiology Erasmus University Medical Centre Rotterdam, Netherlands Dr. Abbas Dehghan[/caption] Dr Abbas Dehghan PhD Assistant Professor, Department of Epidemiology Erasmus University Medical Centre Rotterdam, Netherlands MedicalResearch.com: What is the background for this study? Dr. Dehghan: Diabetes is an important health treat given its serious complications including cardiovascular disease, blindness, kidney failure, and lower-extremity amputations. Descriptive studies have so far either reported the prevalence of diabetes which is a snapshot of the percentage of people who have diabetes or the risk that people will develop diabetes in next 5 or 10 years. These estimates are not optimal since they overlook the risk of developing diabetes later in life. We calculated the lifetime risk of type 2 diabetes which is the risk that every person carries to develop type 2 diabetes up to end of his life. Moreover, we provided estimates for prediabetes, a high risk status that people experience before developing diabetes, and need for insulin therapy that might indicates severity of the disease. MedicalResearch.com: What are the main findings?  Dr. Dehghan: Our data suggest that the lifetime risk of developing prediabetes for a normoglycemic individual aged 45 years is one in two, and one in three nondiabetic individuals aged 45 years will develop diabetes. Three-quarters of individuals with prediabetes at age 45 years will eventually progress to diabetes, and half of the patients with diabetes at the same age will start insulin treatment. Stratification by BMI showed that normoglycemic people with healthy weight at age 45 years had a significantly lower prediabetes lifetime risk compared with overweight and obese individuals. Stratification by waist circumference showed similar effects on lifetime risks for diabetes in individuals with prediabetes. Similarly, in individuals with diabetes, the lifetime risk for insulin use among patients with diabetes was higher with increasing BMI and waist circumference.
Asthma, Author Interviews, Lancet, Pharmacology / 20.01.2016

[caption id="attachment_19464" align="alignleft" width="133"]Professor of Pediatrics Hans Bisgaard, MD, DMSc Copenhagen Prospective Studies on Asthma in Childhood Herlev and Gentofte Hospital, University of Copenhagen, Denmark. Prof. Bisgaard[/caption] More on Asthma on MedicalResearch.com MedicalResearch.com Interview with: Hans Bisgaard, MD, DMSc Professor of Pediatrics The Faculty of Health Sciences University of Copenhagen Head of the Copenhagen Prospective Studies on Asthma in Childhood University  of Copenhagen and Naestved Hospital Medical Research: What is the background for this study? Dr. Bisgaard: Childhood asthma is often preceded by recurrent asthma-like symptoms in relation to airway infections in the first years of life. Bacteria and viruses are equally associated with the risk of episodes of asthma-like symptoms in these children, suggesting antibiotics as a potential treatment for such episodes. Medical Research: What are the main findings? Dr. Bisgaard: Our study demonstrates a clinically significant shortening of symptom duration by 63% after intervention. The effect size increased with early initiation of treatment, showing a reduction in episode duration of 83% if treatment was initiated before day 6 of the episode. Azithromycin was effective in shortening the episodes even though no pathogenic bacteria was detected. This study is, to our knowledge, the first randomized trial of azithromycin treatment of acute episodes of asthma-like symptoms in young children with a history of recurrent episodes.
Author Interviews, Geriatrics, Heart Disease, Lancet / 15.01.2016

Click Here for More on Heart Disease on MedicalResearch.com MedicalResearch.com Interview with: Bjørn Bendz MD PhD and Nicolai K. Tegn, MD Department of Cardiology, Oslo University Hospital, Rikshospitalet Oslo, Norway  Medical Research: What is the background for this study? What are the main findings? Response: According to life expectancy statistics, a person who reaches age 80 can expect to live an average of 8 years (in men) and 9 years (in women). People over 80 yrs are underrepresented in clinical trials, they are less likely to receive treatment according to guidelines. Our study, which directly targets the over-80 population, is the first to demonstrate that a more invasive strategy results in better outcomes in these patients. We believe our study provides a sufficient basis to recommend an invasive approach.”
Alcohol, Author Interviews, Lancet, Pediatrics / 08.01.2016

[caption id="attachment_20503" align="alignleft" width="200"]Svetlana Popova, M.D., Ph.Ds., M.P.H. Senior Scientist Social and Epidemiological Research, Centre for Addiction and Mental Health Associate Professor, Epidemiology Division, Dalla Lana School of Public Health, University of Toronto Associate Professor, Factor-Inwentash Faculty of Social Work, University of Toronto Graduate Faculty Associate Member, Institute of Medical Science, University of Toron Dr. Svetlana Popova[/caption] MedicalResearch.com Interview with: Svetlana Popova, M.D., Ph.Ds., M.P.H. Senior Scientist Social and Epidemiological Research, Centre for Addiction and Mental Health Associate Professor, Epidemiology Division, Dalla Lana School of Public Health, University of Toronto Associate Professor, Factor-Inwentash Faculty of Social Work, University of Toronto Graduate Faculty Associate Member, Institute of Medical Science, University of Toronto MedicalResearch: What is the background for this study? Dr. Popova: It has been known for many years that prenatal alcohol exposure is associated with a number of adverse health consequences for both the mother and developing fetus. Women who consume alcohol during pregnancy place their child(ren) at risk of developing Fetal Alcohol Spectrum Disorders (FASD), and can experience a number of other adverse pregnancy outcomes including stillbirth, spontaneous abortion, premature birth, intrauterine growth retardation, and low birth weight. It was also previously known that people with FASD have many comorbidities (the simultaneous presence of two or more chronic diseases or conditions in a patient) due to the permanent damage of prenatal alcohol exposure on the fetus. However, until now it was unknown how many and what type of diseases, and at what frequencies they occur. Therefore, we reviewed the medical and epidemiological literature to identify the disease conditions that have been found to occur in people with FASD. Then based on the identified studies we estimated the pooled (combined) prevalence of the comorbid conditions found to occur among individuals with Fetal Alcohol Syndrome (FAS; the most severe and visibly identifiable form of FASD). We restricted our analysis to FAS because it is the only expression of FASD in the World Health Organization’s International Classification of Diseases, version 10 (ICD-10).
Author Interviews, Lancet, Nutrition, Sugar, Weight Research / 08.01.2016

[caption id="attachment_20446" align="alignleft" width="144"]Kawther Hashem MSc RNutr (Public Health) Nutritionist and Researcher Action on Sugar Wolfson Institute of Preventive Medicine, Queen Mary, University of London London UK Kawther Hashem[/caption] MedicalResearch.com Interview with: Kawther Hashem MSc RNutr (Public Health) Nutritionist and Researcher Action on Sugar Wolfson Institute of Preventive Medicine, Queen Mary, University of London London UK Medical Research: What is the background for this study? What are the main findings? Response: The calculations showed that a 40% reduction in free sugars added to Sugar Sweetened Beverages (SSBs) over five years would lead to an average reduction in energy intake of 38 kcal per day by the end of the fifth year. This would lead to an average reduction in body weight of 1.20kg in adults,  resulting in a reduction in overweight and obese adults by approximately half a million and 1 million respectively. This would in turn prevent between 274,000-309,000 obesity-related type 2 diabetes over the next two decades. Policies such as this will reduce cases of overweight and obesity and type 2 diabetes, this will have a major clinical impact and reduce healthcare costs.
Author Interviews, Blood Pressure - Hypertension, Heart Disease, Lancet / 24.12.2015

[caption id="attachment_11475" align="alignleft" width="150"]Kazem Rahimi | FRCP DM MSc FESC Associate Professor of Cardiovascular Medicine, University of Oxford Deputy Director, The George Institute for Global Health James Martin Fellow in Healthcare Innovation, Oxford Martin School Honorary Consultant Cardiologist, Oxford University Hospitals NHS Trust Prof. Kazem Rahimi[/caption] MedicalResearch.com Interview with: Kazem Rahimi | FRCP DM MSc FESC Associate Professor of Cardiovascular Medicine, University of Oxford Deputy Director, The George Institute for Global Health James Martin Fellow in Healthcare Innovation, Oxford Martin School Honorary Consultant Cardiologist, Oxford University Hospitals NHS Trust Medical Research: What is the background for this study? What are the main findings? Prof. Rahimi: Although the benefits of blood pressure lowering treatment for prevention of cardiovascular disease are well established, the extent to which these effects differ by baseline blood pressure, presence of co-morbidities (such as stroke or diabetes), or drug class is less clear. Medical Research: What should clinicians and patients take away from your report? Prof. Rahimi: Our study has several implications for clinical practice. Our findings suggest that blood pressure lowering to levels below those recommended in current guidelines (ie, systolic blood pressure of less than 140 mm Hg) will reduce the risk of cardiovascular disease. By showing no evidence for a threshold below which blood pressure lowering ceases to work, the findings call for blood pressure lowering based on an individual’s potential net benefit from treatment rather than treatment of the risk factor to a specific target. Furthermore, the differences we identified between classes of drugs support more targeted drug use for individuals at high risk of specific outcomes (eg, calcium channel blocker therapy for individuals at high risk of stroke or and diuretics are more eff ective for prevention of heart failure). Overall, our findings clearly show that treating blood pressure to a lower level than currently recommended could greatly reduce the incidence of cardiovascular disease and potentially save millions of lives if the treatment was widely implemented. The results provide strong support for reducing systolic blood pressure to less than 130 mmHg, and blood pressure-lowering drugs should be offered to all patients at high risk of having a heart attack or stroke, whatever their reason for being at risk. 
Author Interviews, Lancet, Leukemia / 12.12.2015

[caption id="attachment_20035" align="alignleft" width="145"]Dr. Christoph Röllig Medizinische Klinik und Poliklinik I Universitätsklinikum der Technischen Universitä Dresden, Germany Dr. Röllig[/caption] MedicalResearch.com Interview with: Dr. Christoph Röllig Medizinische Klinik und Poliklinik I Universitätsklinikum der Technischen Universitä Dresden, Germany Medical Research: What is the background for this study? What are the main findings? Dr. Röllig: When this trial began in 2009, standard treatment for Acute Myelogenous Leukemia (AML) consisted of a combination of cytarabine plus anthracyclin/anthracendion and the need for improvement was obvious in the light of only around 50% long-term survivors even amongst younger patients. Although a promising approach, the use of kinase inhibitors in AML had not been shown to be beneficial and was not widely used. Sorafenib had been shown to be tolerable as single agent and in combination with commonly used chemotherapeutic agents. The results of the trial show that the addition of sorafenib to standard chemotherapy for newly diagnosed AML patients up to the age of 60 years is associated with significant prolongation of event-free survival and relapse-free survival compared to placebo plus standard chemotherapy. That means that patient who took sorafenib had less AML relapses. To our knowledge, this is the first randomized-controlled showing that integrating a kinase inhibitor into standard intensive chemotherapy of younger patients with AML is associated with significant improvement of relapse-free survival, with no increase in treatment-related mortality. After a decade of evaluating the potential of kinase inhibitors in AML, their use in combination with standard treatment is becoming an important option for newly diagnosed younger patients.
Author Interviews, Lancet, Psychological Science / 10.12.2015

[caption id="attachment_19910" align="alignleft" width="138"]Dr Bette Liu MD PhD University of New South Wales Sydney, NSW Dr. Bette Liu[/caption] MedicalResearch.com Interview with: Dr Bette Liu MD PhD University of New South Wales Sydney, NSW Medical Research: What is the background for this study? What are the main findings? Dr. Liu: There is a generally held belief that being happier makes you live longer. We wanted to look at this question. We examined over 700,000 women enrolled in the UK Million Women Study. We found that being in poor health was associated with being unhappy but after accounting for an individuals poor health, unhappiness in itself was not associated with an increased risk of death. This finding was true for overall deaths, for deaths from heart disease and from cancer and it was true for stress as well as for unhappiness. 
Aging, Author Interviews, Disability Research, Lancet / 09.12.2015

[caption id="attachment_19952" align="alignleft" width="200"]MedicalResearch.com Interview with: Prof. Carol Jagger AXA Professor of Epidemiology of Ageing and Deputy Director of the Newcastle University Institute for Ageing (NUIA) Institute of Health & Society Campus for Ageing and Vitality Newcastle upon Tyne Medical Research: What is the background for this study? Prof. Jagger: Although we know that life expectancy at older ages is increasing, there is still uncertainty about whether the extra years are healthy ones. Our results are based on data from the Cognitive Function and Ageing Studies (CFASI and II), two cohorts of people aged 65 years and over in three centres in England (Cambridgeshire, Newcastle and Nottingham) who were interviewed in 1991 and 2011. The participants, over 7000 people in each study, were recruited from general practices in the area and included those living in care homes to ensure our results reflect the total older population. Medical Research: What are the main findings? Prof. Jagger: We used three health measures to calculate the health expectancies at age 65: cognitive impairment, self-perceived health and disability (mild and moderate/severe). Over the 20 year period women’s life expectancy at age 65 increased by 3.6 years whilst they gained 4.4 years free of cognitive impairment, 3.1 years in good self-perceived health but only 0.5 years free of disability. Men on the other hand lived an extra 4.5 years in total with gains of 4.2 years free of disability, 3.8 years in good self-perceived health and 2.6 years free of disability. So all the extra years of life were free of cognitive impairment for women but most were spent with disability, although the gains were in mild rather than more severe disability. Medical Research: What should clinicians and patients take away from your report? Prof. Jagger: Health services still seem to be much better at saving lives than reducing the disabling consequences of diseases. Clinicians should optimally manage pain and recommend therapies to ensure that older people with mild disability can remain active. Medical Research: What recommendations do you have for future research as a result of this study? Prof. Jagger: Our future research will explore which diseases and conditions are responsible for the increase in mild disability and whether inequalities between social groups in disability-free life expectancy have widened over the 20 years. Citation: A comparison of health expectancies over two decades in England: results of the Cognitive Function and Ageing Study I and II Jagger, Carol et al. The Lancet DOI: http://dx.doi.org/10.1016/S0140-6736(15)00947-2 Prof. Jagger[/caption] MedicalResearch.com Interview with: Prof. Carol Jagger AXA Professor of Epidemiology of Ageing and Deputy Director of the Newcastle University Institute for Ageing (NUIA) Institute of Health & Society Campus for Ageing and Vitality Newcastle upon Tyne  Medical Research: What is the background for this study? Prof. Jagger: Although we know that life expectancy at older ages is increasing, there is still uncertainty about whether the extra years are healthy ones. Our results are based on data from the Cognitive Function and Ageing Studies (CFASI and II), two cohorts of people aged 65 years and over in three centres in England (Cambridgeshire, Newcastle and Nottingham) who were interviewed in 1991 and 2011. The participants, over 7000 people in each study, were recruited from general practices in the area and included those living in care homes to ensure our results reflect the total older population. Medical Research: What are the main findings? Prof. Jagger: We used three health measures to calculate the health expectancies at age 65: cognitive impairment, self-perceived health and disability (mild and moderate/severe). Over the 20 year period women’s life expectancy at age 65 increased by 3.6 years whilst they gained 4.4 years free of cognitive impairment, 3.1 years in good self-perceived health but only 0.5 years free of disability. Men on the other hand lived an extra 4.5 years in total with gains of 4.2 years free of disability, 3.8 years in good self-perceived health and 2.6 years free of disability. So all the extra years of life were free of cognitive impairment for women but most were spent with disability, although the gains were in mild rather than more severe disability.
Author Interviews, Lancet, Multiple Sclerosis, Pharmacology, UCLA / 07.12.2015

[caption id="attachment_19869" align="alignleft" width="150"]Professor Rhonda Voskuhl, M.D. Jack H. Skirball Chair in MS Research Director of the UCLA MS Program David Geffen School of Medicine University of California, Los Angeles Prof. Voskuhl[/caption] MedicalResearch.com Interview with: Professor Rhonda Voskuhl, M.D. Jack H. Skirball Chair in MS Research Director of the UCLA MS Program David Geffen School of Medicine University of California, Los Angeles Medical Research: What is the background for this study? What are the main findings? Dr. Voskuhl: It had been known for decades that relapses were reduced during pregnancy in women with Multiple Sclerosis (MS), psoriasis and rheumatoid arthritis. We viewed this as a major clue to help find new disease modifying treatments. Focusing on MS, we investigated treatment with estriol, an estrogen that is made by the fetus/placenta during pregnancy. Preclinical studies and a pilot clinical trial at UCLA showed good results leading to the current Phase 2 clinical trial at 16 sites across the U.S. It showed that treatment with estriol pills compared to placebo pills, each in combination with standard of care (glatirmar acetate) injections, reduced relapses by one third to one half over and above standard of care treatment.
Author Interviews, Breast Cancer, Lancet, Mammograms, Radiology / 05.12.2015

[caption id="attachment_19820" align="alignleft" width="180"]Prof Stephen Duffy BSc MSc CStat Professor Of Cancer Screening Wolfson Institute Of Preventive Medicine Queen Mary University of London Prof. Stephen W. Duffy[/caption] MedicalResearch.com Interview with: Prof Stephen Duffy BSc MSc CStat Professor Of Cancer Screening Wolfson Institute Of Preventive Medicine Queen Mary University of London Medical Research: What is the background for this study? What are the main findings? Prof. Duffy: There is debate on the value of diagnosing and treating ductal carcinoma in situ (DCIS) of the breast, depending mainly on different theories about the risk of progression to invasive breast cancer if DCIS were untreated. No-one asserts that no DCIS is progressive and no-one asserts that all DCIS is progressive. There is, however, a range of opinions on the proportion of progressive disease. We found that those mammography screening units in the UK with higher detection rates of DCIS had lower subsequent rates of invasive cancers in the three years after screening.
Author Interviews, Karolinski Institute, Lancet, OBGYNE, Weight Research / 03.12.2015

[caption id="attachment_19785" align="alignleft" width="180"]Professor Sven Cnattingius Professor in reproductive epidemiology Clinical Epidemiology Unit, Department of Medicine Karolinska University Hospital Karolinska Institutet, Stockholm, Sweden Prof. Cnattingius[/caption] MedicalResearch.com Interview with: Professor Sven Cnattingius Professor in reproductive epidemiology Clinical Epidemiology Unit, Department of Medicine Karolinska University Hospital Karolinska Institutet, Stockholm, Sweden  Medical Research: What is the background for this study? Prof. Cnattingius: Maternal overweight and obesity are associated with increased risks of stillbirth and infant mortality. Weight gain between pregnancies increases risks of other obesity-related complications, including preeclampsia, gestational diabetes, and preterm birth. Weight gain appear to increase these risks especially in women who start off with normal weight. As these complications increases risks of stillbirth and infant mortality, we wanted to study the associations between weight change between successive pregnancies and risks of stillbirth and infant mortality (deaths during the first year of life). Medical Research: What are the main findings? Prof. Cnattingius: The main findings include:
  • Weight gain increases risk of stillbirth in a dose-response manner.
  • In women starting off with normal weight (BMI <25), weight gain  increases risk of infant mortality in a dose-response manner.
  • In women starting off with overweight or obesity (BMI >25), weight loss reduces the risk of neonatal mortality (deaths during the first four weeks of life).
Author Interviews, Lancet, OBGYNE / 29.11.2015

[caption id="attachment_19661" align="alignleft" width="200"]Gordon C S Smith, MD PhD DSc FMedSci Professor & Head of Department, Obstetrics and Gynaecology, Cambridge University Cambridge UK Prof. Gordon Smith[/caption] MedicalResearch.com Interview with: Gordon C S Smith, MD PhD DSc FMedSci Professor & Head of Department, Obstetrics and Gynaecology, Cambridge University Cambridge UK Medical Research: What were the key findings of the study? Dr. Smith: We demonstrated that using ultrasound to scan all women in the last 3 months of pregnancy increased the detection of small babies. Our routine approach to antenatal care identified 1 in 5 small babies. Our research approach on the same patients, where all women were scanned in the last third of pregnancy, resulted in 3 in 5 small babies being detected. We also found that, when we identified small babies, there was a scan measurement which helped us to distinguish which of those small babies were at increased risk of complications. Medical Research: What's the problem with small babies? Dr. Smith: We have known for many years that small babies are at increased risk of subsequent complications, both in the short term and long term. For example, they are more likely than normal sized babies to have difficulties during labour due to shortage of oxygen. We assume that this is because their growth has been restricted. This leads to them being less well prepared to face the stress of labour. We think that the poor growth usually occurs because of a problem in the way the placenta functions. The placenta, also known as the afterbirth, is the organ which allows the transfer of nutrients and oxygen to the baby. If the placenta isn’t functioning properly it is likely to impair the growth of the baby in the womb. If we suspect during a pregnancy that the baby is small, it influences a number of aspects of the care of the mother. For example, we might deliver the baby earlier, we might recommend delivery in a high risk unit. It might also influence decisions about whether a mother has a caesarean delivery, or how the baby is monitored during labour.
Author Interviews, Bipolar Disorder, Kidney Disease, Lancet, Mental Health Research, Pharmacology / 24.10.2015

MedicalResearch.com Interview with: Dr. Stefan Clos MSc Applied Health Statistics Psychiatrist Murray Royal Hospital Scotland UK Medical Research: What is the background for this study? Dr. Clos: For more than 40 years there has been a debate about the long-term effect of lithium maintenance therapy on renal function. There is a lack of good quality data from randomized clinical trials and two previous meta-analyses from 2010 and 2012 suggest that little evidence exists for a clinically significant reduction in renal function in most patients who are on lithium therapy. However, the two publications point out the poor quality of available study data, emphasising the need for large scale epidemiological studies that control for confounders. Several population-based studies have since attempted to address this problem, but had insufficient ability to adjust for confounders or had limitations because of inappropriate cross-sectional study design or did not include an appropriate comparator group. 
Author Interviews, Infections, Lancet, Outcomes & Safety, Respiratory / 22.10.2015

[caption id="attachment_18646" align="alignleft" width="125"]Yuichiro Shindo, M.D., Ph.D. Visiting Researcher Department of Anesthesiology Washington University School of Medicine St. Louis, MO Assistant Professor Institute for Advanced Research, Nagoya University, Department of Respiratory Medicine, Nagoya University Graduate School of Medicine Showa-ku, Nagoya Japan Dr. Yuichiro Shindo[/caption] MedicalResearch.com Interview with: Yuichiro Shindo, M.D., Ph.D. Assistant Professor Institute for Advanced Research, Nagoya University, Department of Respiratory Medicine, Nagoya University Graduate School of Medicine Showa-ku, Nagoya Japan Medical Research: What is the background for this study? What are the main findings? Dr. Shindo: Appropriate initial antibiotic treatment is essential for the treatment of pneumonia.  However, many patients may develop adverse outcomes, even if they receive appropriate initial antibiotics.  To our knowledge, there have been no studies that clearly demonstrated the risk factors in patients who receive appropriate antibiotic treatment.  If these factors are clarified, we can identify those patients with pneumonia for whom adjunctive therapy other than antibiotic treatment can prove beneficial in terms of improved outcomes.  This study aimed to clarify the risk factors for 30-day mortality in patients who received appropriate initial antibiotic treatment and elucidate potential candidates for adjunctive therapy. In this study, the 30-day mortality in 579 pneumonia patients who received appropriate initial antibiotics was 10.5%.  The independent risk factors included albumin < 3.0 mg/dL, nonambulatory status, pH < 7.35, respiration rate ≥ 30/min, and blood urea nitrogen ≥ 20 mg/dL.  The 30-day mortality for the number of risk factors was 0.8% (0), 1.2% (1), 16.8% (2), 22.5% (3), and 43.8% (4–5).
Author Interviews, Breast Cancer, Lancet, Surgical Research / 14.10.2015

MedicalResearch.com Interview with: Dr. R. A. Badwe, MS Director, Tata Memorial Centre E. Borges Marg, Parel Mumbai -India  Medical Research: What is the background for this study? What are the main findings? Response:   The available retrospective clinical data suggested an overall survival benefit for metastatic breast cancer patients treated with surgery, with or without radiation, for the primary breast tumor. These studies were fraught with biases and at the same time, studies showed  removal of the primary tumor improved survival in patients with metastatic renal cell carcinoma. Additionally data from animal experiments suggested that surgical removal of the primary tumor could potentially increase metastatic spread. Our study was thus planned to address the uncertainty on role of surgery of the primary in women presenting with metastatic breast cancer. The main findings of this study suggest that there is no evidence to suggest that loco-regional treatment of the primary tumor confers an overall survival advantage in patients with de-novo metastatic breast cancer and this procedure should not be routinely done. Additionally, we noted though there was significant local control in the loco regional treatment arm, there was a detriment in distant progression-free survival and no difference in overall survival.
Author Interviews, Genetic Research, Lancet, Macular Degeneration, Ophthalmology / 12.10.2015

Professor P. Elizabeth Rakoczy Centre for Ophthalmology and Visual Sciences The University of Western Australia Head of Department - Molecular Ophthalmology Lions Eye Institute AustraliaMedicalResearch.com Interview with: Professor  P. Elizabeth Rakoczy Centre for Ophthalmology and Visual Sciences The University of Western Australia Head of Department - Molecular Ophthalmology Lions Eye Institute Australia Medical Research: What is the background for this study? Prof. Rakoczy: Wet age related macular (wet-AMD) is the major cause of blindness in the developed world. It is treated with frequent anti-VEGF injections into the eye. Our preclinical studies demonstrated that following the subretinal injection of a recombinant adeno-associated vector (rAAV) carrying a natural inhibitor of neovascularization (sFlt-1), leaky new, abnormal vessels can be controlled and retinal anatomy improved. The rAAV.sFlt-1 based Ocular Biofactory™ platform has potentially significant advantages over existing technologies as it is designed to provide sustained production of a naturally occurring antiangiogenic agent, sFlt-1, in situ in the eye. In this trial we investigated the safety of rAAV.sFlt-1 in patients diagnosed with wet-AMD.
Author Interviews, Lancet, Mental Health Research / 24.09.2015

Professor Jane Pirkis PhD Centre for Mental Health Melbourne School of Population and Global Health University of Melbourne, AustraliaMedicalResearch.com Interview with: Professor Jane Pirkis PhD Centre for Mental Health Melbourne School of Population and Global Health University of Melbourne, Australia Medical Research: What is the background for this study? What are the main findings? Professor Pirkis:  Public sites that gain a reputation as places where people might go to seek to end their lives are a particular problem in suicide prevention.  Any suicide is tragic, but suicides at these sites have an extra level of complexity because they can lead to copycat acts and can have a major impact on people who work at or live near these sites, or visit them for other reasons.  Our meta-analysis, which pooled data from 18 individual studies from around the world,  found that three interventions work really well in reducing suicides at these sites.
  • Restricting access to means (e.g., installing barriers) can reduce suicides at these sites by 90% or more, and
  • encouraging help-seeking (e.g., installing phones that link directly to crisis services) and
  • increasing the likelihood of someone intervening (e.g., installing CCTV cameras, training staff who work at these sites) can each reduce them by around 50%, or more in some cases.  The interventions seem to work well together and complement each other too.  
Author Interviews, Cost of Health Care, Flu - Influenza, Geriatrics, Lancet, Vaccine Studies / 20.09.2015

Dr Ayman Chit PhD Sanofi Pasteur Swiftwater, PA 18370MedicalResearch.com Interview with: Dr Ayman Chit PhD Sanofi Pasteur Swiftwater, PA 18370 Medical Research: What is the background for this study? What are the main findings? Dr. Chit: Our analysis used data from a large-scale, multi-center efficacy trial, in which a higher-dose split-virus inactivated influenza vaccine (IIV-HD, Fluzone® High-Dose vaccine, Sanofi Pasteur) was compared to a standard-dose split-virus inactivated influenza vaccine (IIV-SD, Fluzone vaccine, Sanofi Pasteur) in persons 65 years of age and older.  These data were supplemented with US healthcare cost data. In the efficacy trial, a total of 31,989 adults 65 years of age and older were randomly assigned in a 1:1 ratio to receive either IIV-HD or IIV-SD and followed for six to eight months post-vaccination for the occurrence of influenza, serious adverse events, and medical encounters. Healthcare utilization (HCU) data were captured for all participants through a surveillance program that covered each influenza season, including the following events occurring within 30 days after any respiratory illness: use of prescription and non-prescription medications (limited to antipyretics/analgesics/non-steroidal anti-inflammatory drugs, antivirals and antibiotics), emergency room visits, non-routine or urgent care visits, and hospitalizations. In addition, all hospitalizations were captured for participants for the entire duration of the study. The primary results from the efficacy trial were published in The New England Journal of Medicine, which reported that IIV-HD was 24.2% (95% confidence interval [CI], 9.7% to 36.5%) more effective in preventing laboratory-confirmed influenza-like illness compared to IIV-SD.1 In the current supplemental analysis of the trial, we used US healthcare cost data to evaluate economic impacts of using IIV-HD compared to IIV-SD within the efficacy trial participants. In this analysis, total healthcare payer costs (the combined costs of study vaccine, prescription drugs, emergency room visits, non-routine and urgent-care visits, and hospital admissions) were about $116 less per person.
  1. DiazGranados et al, NEJM, 2014;14;371(7):635-45 
Author Interviews, Diabetes, Lancet, Surgical Research / 17.09.2015

Martin Neovius PhD Department of Medicine, SolnaMedicalResearch.com Interview with: Martin Neovius PhD Department of Medicine, Solna Medical Research: What is the background for this study? What are the main findings? Dr. Neovius: Long-term real world data on economic effects of bariatric surgery versus nonsurgical treatment are scarce. We have previously looked at long-term drug costs, inpatient and outpatient care in the overall bariatric surgery population (Neovius, Narbro et al, JAMA 2012). However, overall findings may mask important subgroup variations. Based on data from the Swedish Obese Subjects (SOS) study, we documented large drug cost savings over 15 years after bariatric surgery versus non-surgically treated controls in patients who had diabetes and prediabetes before intervention. No savings were seen in patients who were euglycemic at baseline. In terms of overall healthcare costs, we saw cost-neutrality versus non-surgically treated patients for the diabetes group, while costs were higher for both patients with normal blood glucose and those with prediabetes (due to the initial high cost of surgery and inpatient care). For the subgroup of patients with diabetes, we also found that patients with recent diabetes onset had more favorable economic outcomes than patients with established diabetes. 
Author Interviews, HIV, Lancet, Sexual Health / 10.09.2015

Prof-Sheena-McCormack.jpgMedicalResearch.com Interview with: Professor Sheena McCormack Clinical Epidemiology Medical Research Council Clinical Trials Unit University College London Medical Research: What is the background for this study? What are the main findings? Prof. McCormack: PROUD is the first study of pre-exposure prophylaxis (PrEP) to prevent HIV carried out in the UK. The results show that PrEP could play a major role in reducing the number of new infections among men who have sex with men who are at risk of catching HIV. Pre-exposure prophylaxis (PrEP) is a HIV prevention strategy that involves HIV-negative people taking some of the drugs we use for treatment of HIV to reduce the risk of becoming infected. The PROUD study (www.proud.mrc.ac.uk) looked at whether offering daily PrEP to men who have sex with men was an effective way to prevent HIV infection. The results show that pre-exposure prophylaxis is highly protective, reducing the risk of infection for this group by 86%. The drug used in the trial – the antiretroviral Truvada – was already known to reduce the incidence of HIV infection compared to placebo (a dummy pill).  The PROUD study was designed to see how good Truvada would be found as pre-exposure prophylaxis in a real world situation when participants knew they were taking an active drug.  It aimed to address outstanding questions such as whether taking PrEP would change sexual risk behaviour – for example increasing the number of partners they did not use condoms with and increasing the rate of other sexually transmitted infections (STIs) – and whether or not it would be cost-effective to make it available on the NHS.
Author Interviews, Kidney Disease, Lancet, Weight Research / 21.08.2015

Dr. Csaba P. Kovesdy MedicalResearch.com Interview with: Dr. Csaba P. Kovesdy, MD Professor of Medicine University of Tennessee Health Science Center Chief of Nephrology Memphis Veterans Affairs Medical Center Medical Research: What is the background for this study? What are the main findings? Dr. Kovesdy: Obesity has reached epidemic proportions in modern societies, and has been linked to adverse outcomes such as diabetes mellitus, hypertension, cardiovascular disease and mortality. In addition, obesity is also associated with chronic kidney disease through a variety of mechanisms. Our population is ageing, and previous studies have suggested that the effect of obesity on certain outcomes like mortality may be different in older vs. younger individuals, but this has not been previously examined for chronic kidney disease. We have this examined the association of granular BMI categories with progressive loss of kidney function in a very large cohort of patients with normal estimated GFR in patients of different ages. We found that the association of a BMI of >30 kg/m2 with progressive loss of kidney function was not present in younger individuals (< 40 years of age), and increased as people aged, with >80 years old displaying the strongest associations between obesity and loss of kidney function. In addition to this we also examined the association of BMI with mortality in different age groups, and found uniform U-shaped associations that did not vary by age.
Author Interviews, Lancet, Stroke / 20.08.2015

Professor Mika Kivimäki Chair of Social Epidemiology Epidemiology & Public Health Institute of Epidemiology & Health Faculty of Population Health Sciences University College London London MedicalResearch.com Interview with: Professor Mika Kivimäki Chair of Social Epidemiology Epidemiology & Public Health Institute of Epidemiology & Health Faculty of Population Health Sciences University College London Medical Research: What is the background for this study? What are the main findings? Prof Kivimäki:  Long working hours have been implicated in the cause of cardiovascular disease, but the evidence is limited. We conducted a systematic review of published studies on this topic and located additional individual-level data by searching open-access data archives and by including unpublished data from IPD-Work, a consortium of prospective cohort studies. This resulted in a pooled sample of over 600,000 men and women who were followed for cardiovascular disease 7-8 years after the assessment of working hours. During the follow-up, more than 4700 participants had a coronary event and 1700 had a stroke. Our findings show that individuals who worked 55 hours or more per week had a 1.3-times higher risk of stroke compared to those working standard 35-40 hours. This finding remained unchanged in analyses adjusted for other stroke risk factors, such as age, sex, socioeconomic position and health behaviours.
Author Interviews, Chemotherapy, Lancet / 17.08.2015

Bernardo L. Rapoport M. D. The Medical Oncology Centre of Rosebank Johannesburg, South AfricaMedicalResearch.com Interview with: Bernardo L. Rapoport M. D. The Medical Oncology Centre of Rosebank Johannesburg, South Africa Medical Research: What is the background for this study? What are the main findings? Dr. Rapoport: Chemotherapy-induced nausea and vomiting (CINV) is one of the most feared side effects of chemotherapy, and can lead to dose reductions or discontinuations of life-extending anti-cancer therapy. In the past, the serotonin (5-HT3) receptor antagonists, such as granisetron, palonosetron , and ondansetron, have shown effectiveness in preventing acute CINV (0-24 hours after chemotherapy administration), but many chemotherapies, such as cisplatin, carboplatin, and anthracycline/cyclophosphamide combinations, can cause delayed chemotherapy-induced nausea and vomiting that occurs from >24 hours to 5 days or more after chemotherapy. Neurokinin-1 receptor antagonists (NK-1 RAs) work though the substance P signaling pathway and are effective at preventing the delayed phase of chemotherapy-induced nausea and vomiting. Aprepitant was the first NK-1 RA to come to market in 2003, followed by a fixed dose of netupitant plus palonosetron late last year.
Author Interviews, Lancet, Pain Research, Surgical Research / 14.08.2015

Dr Martin Hirsch Clinical Research Fellow Women’s Health Research Unit Queen Mary University of LondoMedicalResearch.com Interview with: Dr Martin Hirsch Clinical Research Fellow Women’s Health Research Unit Queen Mary University of London and Dr Jenny Hole Foundation Year 1 Doctor Kettering University Hospital Dr Jenny Hole Foundation Year 1 Doctor Kettering University Hospital   MedicalResearch: What is the background for this study? What are the main findings? Response: As doctors we see medicines being prescribed on a daily basis and the benefit but also harm that they can cause. We wanted to assess the role of non pharmaceutical interventions which can benefit patients with a low or minimal potential for harm. We all have an interest in music of different genres and we agreed that we didn’t know anybody who did not like music of one sort or another. On the basis that we all have gained pleasure from music, we wanted to see if this pleasurable experience at the time of a difficult and painful stimulus could reduce the problems encountered as people recover from surgery. We searched all published medical literature and found 73 of the highest quality studies (randomised controlled trials) to compare and combine their findings in a meta-analysis. This technique aims to strengthen the validity by producing a combined result. We found that using music before during or after surgery reduced pain, reduced the requirement for pain killers, reduced anxiety, and improved satisfaction.
Author Interviews, Diabetes, Kidney Disease, Lancet / 12.08.2015

[caption id="attachment_16540" align="alignleft" width="238"]Prof. Der-Cherng Tarng, MD, PhD Division of Nephrology Taipei Veterans General Hospital, and National Yang-Ming University, Taiwan Prof. Der-Cherng Tarng[/caption] MedicalResearch.com Interview with: Prof. Der-Cherng Tarng, MD, PhD Division of Nephrology Taipei Veterans General Hospital, and National Yang-Ming University, Taiwan MedicalResearch: What is the background for this study? What are the main findings? Prof. Tarng: Metformin is generally recommended as a first-line therapy for type 2 diabetes mellitus, but the use of metformin has been limited in patients with impaired kidney function because of the perceived risk of lactic acidosis. More recently, available evidence supports the cautious expansion of metformin use in patients with mild to moderate chronic kidney disease (CKD). However, no studies have yet examined whether metformin can be prescribed more widely to patients with advanced CKD. We conducted a propensity score-matched cohort study using Taiwan’s National Health Insurance Research Database to assess the safety of metformin in patients with type 2 diabetes and serum creatinine levels >6 mg/dL, enrolled between January 1, 2000 and June 30, 2009 and followed-up until December 31, 2009, before Taiwan’s prescribing guidelines for metformin contraindicated its use in patients with CKD. From a consecutive sample of 12350 patients, 1005 (8.1%) were metformin users. Of these, 813 were successfully matched 1:3 to 2439 metformin nonusers. After multivariate adjustment, metformin use remained was an independent risk factor for mortality (hazard ratio 1.35, 95% confidence interval 1.20–1.45; p<0.0001). The increased risk was dose-dependent and was consistent across all subgroup analyses. However, metformin users compared with non-users were associated with a higher but insignificant risk of metabolic acidosis (hazard ratio 1.30, 95% confidence interval 0.88–1.93; p=0.188).