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EMA Gives Thumbs Up For Ebola Vaccine

  European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the V920 Ebola Zaire vaccine (Ervebo, Merck ), the first vaccine to protect against the Ebola virus disease caused by Zaire Ebola virus in at-risk adults aged 18 years or older.

 “This is an important step towards relieving the burden of this deadly disease. The CHMP’s recommendation is the result of many years of collaborative global efforts to find and develop new medicines and vaccines against Ebola,” Guido Rasi, EMA’s executive director, said in a news release.

 The CHMP’s decision is a “triumph for public health, and a testimony to the unprecedented collaboration between scores of experts worldwide,” Tedros Adhanom Ghebreyesus, PhD, director-general of the World Health Organization (WHO), said in a news release.

 He offered his “deepest gratitude is to the studies’ volunteers, researchers, health workers in Guinea, other countries and the Democratic Republic of the Congo who have put themselves at risk to ensure people are protected with this vaccine.”

 The mortality rate in Ebola patients has varied from 25% to 90% in past outbreaks. The largest Ebola outbreak to date occurred in West Africa in 2014-2016, with more than 11,000 deaths.

 The current outbreak in the Democratic Republic of Congo (DRC), which is caused by Ebola Zaire, has a case fatality rate of roughly 67%. More than 3000 people have been infected with Ebola during the ongoing outbreak, which the WHO declared a public health emergency of international concern in July.

 Ghebreyesus said that in the current Ebola outbreak in the DRC more than 236,000 people have been vaccinated with Ervebo donated by Merck to the WHO, including more than 60,000 health and frontline workers in the DRC and in Uganda, South Sudan, Rwanda, and Burundi. “This vaccine has already saved many lives in the current Ebola outbreak, and the decision by European regulator will help it to eventually save many more,” Ghebreyesus said.

 Ervebo is a genetically engineered, replication-competent, attenuated live vaccine. Data from clinical trials and compassionate use programs have shown that a single dose of Ervebo protects against Ebola virus disease.

 The CHMP’s recommendation, completed under accelerated assessment, will now be considered by the European Commission, which will issue a final decision. 

 Ervebo is currently under review by the US Food and Drug Administration (FDA), which granted it breakthrough therapy designation.

 Last week, as reported by Medscape Medical News, the FDA approved OraQuick Ebola Rapid Antigen Test (OraSure Technologies), the first rapid diagnostic test to identify Ebola virus antigens, or proteins, in certain body fluids from living and deceased individuals.

Courtesy : Medscape

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Antibiotic Resistance In Race

   Resistance to commonly-used antibiotic clarithromycin is rising among Indian patients and that too at quite a fast pace, health experts have warned.

  Clarithromycin is used to treat a wide variety of bacterial infections. This medication can also be used in combination with anti-ulcer medications to treat certain types of stomach ulcers.

   According to the World Health Organization (WHO), antibiotic resistance is one of the biggest threats to global health, food security and development today.

   Sunil Sofat, Additional Director, Department of Interventional Cardiology (Adult) at Jaypee Hospital in Noida, said that every antibiotic medicine has its own mechanism to treat diseases.

   “Yes, this is true that the resistance to clarithromycin is rising among the Indian patients and that too at quite a fast pace. There are multiple factors for the same but one of the major reasons behind it is self-medication,” Sofat told IANS.

   “In India, a huge population prefers to consume over-the-counter (OTC) drugs without even consulting a doctor. In the long run, this may make them resistant to most of the antibiotics including clarithromycin,” Sofat added.

   In a recent study presented at United European Gastroenterology (UEG) Week Barcelona 2019, researchers have found that resistance to clarithromycin, one of the most established antimicrobials used to eradicate Helicobacter pylori (H. pylori), had increased from 9.9 percent in 1998 to 21.6 percent last year, with increases in resistance also seen for levofloxacin and metronidazole.

   The study, which analysed 1,232 patients from 18 countries across Europe, investigated resistance to antibiotics regularly taken for Helicobacter pylori infection, a harmful bacterium associated with gastric ulcers, lymphoma and gastric cancer.

   According to Gaurav Jain, Senior Consultant, Internal Medicine at Dharamshila Narayana Superspeciality Hospital, New Delhi, antibiotic resistance is a major concern.

   “In India the consumption of antibiotics without consulting a qualified physician is quite common which is leading to its resistance,” Jain told IANS.

   “There is increase in resistance to antibiotics including clarithromycin which is undoubtedly a worrisome situation in the country,” Jain said.

   However, Deepak Verma of Internal Medicine at Columbia Asia Hospital, Ghaziabad said: “Most of the cases that we see in India are connected to gram-negative bacteria such as e.coli that causes urinary tract infection (UTI).”

   He added that the main causes for antibiotic resistance in India are its rampant misuse where people indulge in self-doctoring as well as taking medicines prescribed by unregistered medical practitioners, including quacks who suggest antibiotics quite indiscriminately.

   “They primarily use antibiotics symptomatically which is not a correct method for all ailments — without blood and urine culture. Antibiotics can force the pathogen to develop resistance,” Verma explained.

   “Since the clinical culture in India is different from that of the western countries, the lack of awareness of the right process to prescribe antibiotics increases the chances of people using antibiotics without questioning,” he stressed.

Courtesy : India Today

 

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Which is the best time for excercise to loose weight ?

   The research was performed on 30 men and extended over a period of one and a half months. The men were classified as obese or overweight and compared results from two intervention groups (who ate breakfast before/after exercise) and a control group (who made no lifestyle changes), found that people who performed exercise before breakfast burned double the amount of fat than the group who exercised after breakfast.

   The study established that increased fat use is mainly due to lower insulin levels during exercise when people have fasted overnight, which means that they can use more of the fat from their fat tissue and the fat within their muscles as a fuel.

   While this did not show any significant weight loss, it has a very positive impact on their health because their bodies were better able to respond to insulin, keeping blood sugar levels under control and potentially lowering the risk of diabetes and heart disease. The researches also wanted to focus on the impact on the fat stores in muscles for individuals who either worked out before or after eating and the effect this had on insulin response to feeding.

   In the trial that extended over a period of a month and a half, the research team found that the muscles from the group who exercised before breakfast were more responsive to insulin compared to the group who exercised after breakfast, in spite of identical training sessions and matched food intake.

   The muscles from those who exercised before breakfast also showed greater increases in key proteins, specifically those involved in transporting glucose from the bloodstream to the muscles. For the insulin response to feeding after the six-week study, remarkably, the group who exercised after breakfast were in fact no better than the control group, the study said.

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Knee, Hip Steroid Injections May Speed Joint Damage in Some

   Steroid injections are frequently used to relieve pain associated with osteoarthritis of the knee and hip, but new evidence suggests the treatment may do more harm than good for some people. Experts now stress the need for better informed consent about potential risks and benefits of injections.

   Data from more than 450 patients who received intra-articular corticosteroid injections for osteoarthritis at Boston University show that the treatment may speed the pace of osteoarthritis and contribute to joint destruction.

   The article was published online October 15 in the journal Radiology.

   “We are now seeing [that] these injections can be very harmful to the joints, with serious complications such as osteonecrosis, subchondral insufficiency fracture, and rapid progressive osteoarthritis,” senior author Ali Guermazi, MD, PhD, said in a press release. Guermazi is chief of radiology at the Veterans Affairs Boston Healthcare System and professor of radiology at Boston University School of Medicine.  

   Some patients may be more prone than others to poor outcomes from the treatment, but it’s not yet known how to identify these people. The researchers stress the importance of informed consent, and urge radiologists to take x-rays before administering steroid injections, in order to identify underlying problems that may contribute to adverse events.  

   “Intra-articular corticosteroid injection should be seriously discussed for pros and cons. Critical considerations about the complications should be part of the patient consent, which is currently not the case right now,” Guermazi added.

Long-term Data Has Been Lacking

   The first-line treatment for osteoarthritis, which most commonly affects the hip and knee, is conservative pain control, but many patients eventually need joint replacement. Yet people with osteoarthritis are often older and have multiple medical problems that make them ineligible for surgery or long-term treatment with acetaminophen or nonsteroidal anti-inflammatory (NSAIDs) medication.

   Steroid joint injections have been widely used for decades to treat patients like these, and others with inadequate pain control. While short-term complications are rare, most studies on the long-term effects are of low quality. Some evidence from animal and human laboratory studies suggests steroid joint injections may contribute to progression of osteoarthritis. Professional societies differ on whether or not to recommend steroid joint injections for osteoarthritis.

   Therefore, Andrew Kompel, MD, also from Boston University School of Medicine, and colleagues reviewed the records of 459 individuals who received at least one corticosteroid injection in the hip or knee joint in 2018 at an inner city hospital in Boston.

   Overall, 8% (n = 36) of patients experienced an adverse joint event after receiving a steroid joint injection. These individuals ranged in age from 37 to 79 years (mean age, 57 years) and most (72%) showed moderate osteoarthritis at baseline. They received an average of 1.4 injections and developed joint complications anywhere between 2 to 15 months after injection, with an average of 7 months.

   The authors identified four main adverse joint events after steroid joint injections. The most common was accelerated progression of osteoarthritis, found in 6% of individuals (n = 26).  

   The second most common adverse joint event was subchondral insufficiency fracture, found in 0.9% (n = 4) of individuals. Subchondral insufficiency fracture has traditionally been thought to occur in older individuals with weak bones, but recent evidence suggests it may be more common and affect younger patients.

   The condition is potentially underdiagnosed due to lack of awareness. Delayed diagnosis can lead to joint damage and eventual joint replacement.  Diagnosis is important before giving steroid joint injections, which can impair healing in these kinds of fractures, according to the authors.  

   In addition, osteonecrosis and rapid joint destruction each affected 0.7% (n = 3) of patients, respectively.

   Osteonecrosis refers to decreased blood flow to the bone that can cause breakdown of the bone, eventual fracture, and need for joint replacement. Patients with osteonecrosis but without fracture sometimes receive steroid joint injections. The authors emphasize the need to inform such patients that steroid joint injections could potentially worsen their condition.

   They also note that rapid joint destruction and accelerated bone loss may occur after the first steroid injection and in patients without evidence of underlying disease on x-ray. In these patients, they suggest closely reviewing the need for injection and repeating x-rays before giving further injections.

   The authors conclude: “The radiology community should actively engage in high-quality research to further understand these adverse joint findings and how they possibly relate to [intra-articular corticosteroid] injections to prevent or minimize complications.”

   In an accompanying editorial, Richard Kijowski, MD, of the University of Wisconsin School of Medicine and Public Health, notes several limitations of the study, including the small number of patients and lack of standardized methods.

   “The report is neither a prospective clinical trial nor a retrospective observational study…The objective is to educate radiologists that the intra-articular corticosteroid injection they routinely perform with little, if any, thought about long-term safety may cause more harm than benefit,” he writes.

   He agreed with the authors about the importance of informed consent.

   “Patients might be more than willing to take the small risk of an adverse joint event requiring eventual joint replacement for the possibility of at least some degree of pain relief after intra-articular corticosteroid injection,” he concludes. “However, patients have the right to make this decision for themselves, and this requires radiologists to discuss all potential risks and benefits with the patient when obtaining written informed consent.”

   The study authors acknowledge that they could not determine whether these adverse joint events were already present when patients had their steroid joint injections, or if the injections caused these problems.

Courtesy : Medscape

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Statins & Osteoporosis

   The protective effect of statin therapy on bone health that has been demonstrated in some studies may be dose-related, and although low doses are associated with a reduced risk for osteoporosis, high doses were linked to an increased risk of the bone disease in new research.

   “To the best of our knowledge, this is the first study which shows that it is important to consider the different kinds of substances and dosages when investigating the relationship of osteoporosis and statin therapy,” say Michael Leutner, MD, of the Clinical Division of Endocrinology and Metabolism, Unit of Gender Medicine, Medical University of Vienna, Austria, and colleagues in an article published online in the Annals of the Rheumatic Diseases.

   “The results were surprising for us,” senior author Alexandra Kautzky-Willer, Dr Med, also of the Medical University of Vienna, told Medscape Medical News.

   “We propose that monitoring high-risk patients, that is, postmenopausal female patients under high-dosage statin therapy, might be useful in order to offer an individual therapy to prevent or treat osteoporosis,” she said.

   Asked to comment, Ching-Lung Cheung, PhD, assistant professor in the Department of Pharmacology and Pharmacy and investigator with the Center for Genomic Sciences at the University of Hong Kong, said key caveats to consider in the study include the role of high cholesterol, which prompts the need for higher doses of statins.

   “Elevated serum low-density lipoprotein (LDL) cholesterol is associated with reduced bone mineral density (BMD); thus, it is possible that those patients receiving high-dose statins had a lower baseline BMD compared to those receiving low-dose statins, which confound the observed association,” Cheung, who is also involved in research on the relationship between statins and bone health, told Medscape Medical News.

Large Study in Austrian Population

   For the large population study, Leutner and colleagues reviewed data on all Austrians younger than 90 years, nearly 8 million, from January 2006 to December 2007.

   They identified 353,502 patients who had been taking one of the seven statins available at the time for at least 1 year, including simvastatin, lovastatin, pravastatin, fluvastatin, atorvastatin, cerivastatin and rosuvastatin. The patients were approximately evenly divided among males and females.

   Among them, 11,701 patients, including 1765 males and 9936 females, were diagnosed with osteoporosis, according to International Classification of Diseases, 10th Revision (ICD10) codes.

   They were compared with a control group of about 7.5 million patients who were not treated with statins. About 3.5 million were male and 4 million were female. Among them, 68,699 were diagnosed with osteoporosis, including 10,410 males and 58,289 females.

   Overall, treatment with statins was associated with more than threefold greater odds of having osteoporosis compared to nonstatin use among control persons (odds ratio [OR], 3.62; P < .01).

   However, low-dose statin therapy (0 – 10 mg/day) was associated with a lower risk for osteoporosis.

   The effects were similar for the different drugs, including lovastatin (OR, 0.39; P < .05), pravastatin (OR, 0.68; P < .01), simvastatin (OR, 0.70; P < .01), and rosuvastatin (OR, 0.69; P < .01).

   However, risk for osteoporosis increased among those taking higher doses of statins, defined as doses exceeding 40 mg for simvastatin (OR, 1.64; P < .01) and exceeding 20 mg for atorvastatin (OR, 1.78; P < .01) and rosuvastatin (OR, 2.04; P < .01), compared to control persons.

   The study controlled for other prescribed drugs and for comorbidities that included diabetes and diseases typically treated with corticosteroids that are known risk factors for the development of osteoporosis.

Could Higher Doses of Statins Affect Sex Hormones?

   Kautzky-Willer explained, “In mouse models and in vitro, statins have been shown to enhance bone formation ― for example, by increasing the expression of bone morphogenic protein (BMP-2), which is an osteoprotective protein. However, statin dosages were insufficiently considered in existing studies.

   “In lower dosages of statins, this osteoprotective effect of BMP-2 could be a major reason for the lower rates of diagnosed osteoporosis,” she said.

   However, estrogen, which plays a crucial role in the maintenance of BMD, is derived from cholesterol.

   Therefore, the strong cholesterol-lowering effects of stains at high doses could also lower estrogen and have an effect on the bones similar to that of menopause, which is a leading cause of osteoporosis.

   “Our hypothesis is that in higher dosages of statins, the possible inhibiting effect of statins on sex hormones could overrule the osteoprotective effect,” Kautzky-Willer said.

   Likewise, statin use has been associated with reduced levels of testosterone in some research. One study showed that higher levels of non–sex hormone–binding globulin-bound testosterone were associated with a decrease in BMD in Korean men.

   “Taken together, these findings suggest a connection between sex hormone levels and statins in the pathogenesis of osteoporosis,” the Austrian authors conclude.

Whether Statins Affect Levels of Sex Hormones Requires Further Study

   Cheung and some of his colleagues focused on the roles of LDL cholesterol and statins in bone health in research reported as a poster at last month’s annual meeting of the American Society for Bone and Mineral Research.

   Using a US cohort from NHANES III (n = 3638) and another from the Hong Kong Osteoporosis Study (n = 1128), they found that reductions in LDL cholesterol were significantly associated with increases in femoral neck and lumbar spine BMD.

   Furthermore, statins’ LDL cholesterol–lowering proxies were associated with increased total body BMD.

   These findings “suggest that statin use was associated with increased BMD,” Cheung said.

   In further commenting on the Austrian study, Cheung agreed that the potential effect of high-dose statins on sex hormones is noteworthy.

   “This is an interesting hypothesis,” he said. “Although the authors mention a few studies showing a significant association between statins and sex hormones, there [are also] a few studies showing null association of statins with sex hormones.

   “Thus, whether statins use affects sex hormone requires further study,” he commented.

   Cheung also underscored the fact that the use of ICD codes to define osteoporosis is a “major limitation” of the Austrian study.

   “The authors should validate the accuracy of the coding, as this is extremely important in a pharmacoepidemiology study, especially [because] BMD is not routinely measured. [Therefore,] accuracy of the coding of osteoporosis is doubtful,” he said.

Courtesy : Medscape

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Blood : A Significant Unmet Need

   The World Health Organization (WHO) recently added blood and its components to the Model List of Essential Medicines, underscoring the importance of an adequate blood supply to optimize patient care.

   However, a new analysis finds that many countries are critically short of blood and that current targets for blood collection are often inadequate to meet local needs. These findings, based on data from 195 countries, were published online today in the journal The Lancet Haematology.

   For the study, Christina Fitzmaurice, MD, MPH, from the University of Washington, Seattle, and colleagues estimated blood availability from the WHO Global Status Report on Blood Safety and Availability between 2011 and 2013. The authors then calculated disease-specific transfusion needs for 20 medical conditions using United States data collected between 2000 and 2014 for the Healthcare Cost and Utilization Project.

   They then used data from the 2017 Global Burden of Disease study to determine disease prevalence in each of the 195 countries and estimate how much blood would be needed to treat every patient requiring a blood transfusion.

   The researchers estimate that in 2017 the global blood supply was approximately 272 million units; however, the global demand was approximately 304 million units, resulting in a deficit of over 30 million units.

   However, the supply gap was unevenly distributed among countries. Specifically, when the authors considered just the 119 countries where need outstripped supply, they uncovered a shortage of over 100 million units, equal to 1849 units per 100,000 population. Countries in sub-Saharan Africa, Oceania, as well as South Asia and Southeast Asia, had the greatest unmet need despite having relatively small blood needs across all causes.

   The WHO suggests that 10 to 20 donations for every 1000 people is sufficient to provide adequate blood component supplies. The authors propose, however, that this target may underestimate actual blood needs, noting that all countries included in this study were above this goal. Assuming a ratio of five units of components for every unit of whole blood donated, 40 countries required more than 30 donations per 1000 people and four countries required more than 40 donations per 1000 people.

   The authors acknowledge that the ideal blood usage rates by cause are unknown and transfusion recommendations outside of the US will differ based on disease severity. Further, estimates of blood need also assumed a standard of care similar to what is available in the United States and acknowledge that this may not be the case in middle- and low-income countries.  

   The causes for blood transfusion also varied greatly among countries. Injuries and cardiovascular disease were the primary causes for blood transfusion in high-income countries, whereas respiratory diseases (eg, tuberculosis) and nutritional deficiencies were the more common causes in low-income countries.

   “Many countries face critical undersupply of transfusions, which will become more pronounced as access to care improves,” Fitzmaurice and colleagues write.

   “A more detailed understanding of a country’s blood needs will allow stakeholders such as ministries of health, non-governmental entities that focus on global health, and national transfusion services and blood banks to better predict the needed supply and plan for adequate transfusion services,” the authors write.

   “This study is a reminder that a safe and sufficient blood supply is needed to manufacture unique cell based or protein therapeutic products,” writes Thierry Burnouf, PhD, from the Taipei Medical University, Taiwan, in an accompanying editorial.

   “Comprehensive strategies, through national and regional commitment, international cooperation, and transfer of technologies to blood establishments, can help fill the gap and strengthen local blood systems so that patient access to life-saving blood therapies gradually improves,” he concludes.

Courtesy : Medscape