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Healthcare online Keeping you up-to-date
VOL.  16     ISSUE:  6  June  2018 Medical Services Department

SQUARE Pharmaceuticals Ltd.

Features

EDITORIAL TEAM

OMAR AKRAMUR RAB

MBBS, FCGP, FIAGP,

P G Dip. Business Management

MAHFUZUR RAHMAN

MBBS, MBA

MD. SAIFUL ALAM

MBBS, MPH

EDITORIAL

Dear Doctor:

Welcome to this edition of 'e-SQUARE' !

Hope you are enjoying this version of online healthcare bulletin  !

This issue features the articles including "Leadless Pacemaker !", "Glioblastoma !", "Chlamydia !", "Flu & New Drug !", "'Vitamin B12 and Folate !", "Virtual Reality !".

In our regular feature, we have some new products information of SQUARE Pharmaceuticals Ltd. as well.

We welcome your feedback regarding "e-SQUARE" ! 

Click on to reply mode.

Yours sincerely,

 

Editorial Team

Reply Mode      : e-square@squaregroup.com

The views expressed in this publication do not necessarily reflect those of its editor or SQUARE PHARMACEUTICALS LTD.

 Leadless Pacemaker !

                                                      Leadless pacemaker patients experience fewer complications

Approximately one million pacemakers are implanted annually, providing electrical stimulation to regulate a patient's heartbeat. Conventional pacemakers are surgically placed under the skin of a patient's chest, with wires, or leads, stretching from the shoulder vein and attaching to the heart. These wires and the surgical implantation are the most common source of complications, occurring in up to 12 percent of device recipients, according to previous research. Leadless pacemakers, by contrast, do not need wires. The small self-contained devices about 10 percent of the size of a traditional pacemaker are placed directly into the heart using a catheter passed through the femoral vein in the leg. Leadless pacemakers were introduced in 2014, and the first leadless pacemaker was approved by the FDA in 2016. The new multi-center study compared short- and mid-term complications between 718 patients receiving the Nanostim leadless pacemaker and 1,436 patients with conventional (transvenous) pacemakers. Leadless pacemaker patient data was taken from the LEADLESS II trial, a prospective, nonrandomized, multicenter clinical trial. Transvenous patient data were obtained from Truven Health MarketScan claims databases for patients implanted with single-chamber pacemakers between April 2010 and March 2014 and more than 1 year of pre-implant enrollment data. Statistical methods were used to match patients between the two groups to compare the outcomes of a leadless vs. traditional pacemaker with other key clinical variables being equal. At one month, the study found that patients receiving one type of leadless pacemaker (Nanostim) overall had fewer complications (5.8 percent vs. 9.4 percent). Leadless pacemakers completely eliminated lead and pocket complications, including infection. By comparison, complications among traditional pacemaker recipients included lead complications (3.62 percent), pocket complications (0.42 percent) and infection (1.74 percent). There were no significant differences between the groups in regard to rates of vascular complications, electrode dislodgement and generator complications. However, the study did find that those receiving leadless pacemakers had an increased risk of developing pericardial effusion bleeding between the heart and the sac that surrounds the heart (1.53 percent vs. 0.35 percent). These complications were uncommon but serious, and sometimes required surgery. Beyond one month and up to 18 months of follow-up, leadless patients continued to experience overall fewer complications than transvenous patients (0.56 percent vs. 4.94 percent). In the conventional pacemaker group, there were a number of complications wholly absent from the leadless group, including lead-related complications, electrode dislodgement, infection and pocket complications.

SOURCE: HealthDay News, June 2018

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 Glioblastoma !

                                     Success of poliovirus therapy for recurrent glioblastoma

A genetically modified poliovirus therapy developed shows significantly improved long-term survival for patients with recurrent glioblastoma, with a three-year survival rate of 21 percent in a phase 1 clinical trial. Comparatively, just 4 percent of patients with the same type of recurring brain tumors were alive at three years when undergoing the previously available standard treatment. Glioblastoma remains a lethal and devastating disease, despite advances in surgical and radiation therapies, as well as new chemotherapy and targeted agents. There is a tremendous need for fundamentally different approaches with the survival rates in this early phase of the poliovirus therapy. The therapy includes a genetically modified form of the poliovirus vaccine, which is infused directly into the brain tumor via a surgically implanted catheter. The modified virus preferentially zeroes in on tumor cells, igniting a targeted immune response. Initially in the phase 1 clinical trial, the lead researcher planned to increase the dosage of the therapy infusion; a safe dose amount is a primary goal of phase 1 studies. But at higher dosages, some patients experienced too much inflammation, resulting in seizures, cognitive disturbances and other adverse events, so the amount infused was reduced. All but 15 of the 61 patients enrolled in the study had one of the lower dosages. Study participants were selected according to strict guidelines based on the size of their recurring tumor, its location in the brain and other factors designed for patient protection. A comparison group of patients was drawn from historical cases, involving patients who would have matched the poliovirus enrollment criteria. The rate of overall survival of poliovirus patients at 24 months was 21 percent, compared to 14 percent for the historical controls. At three years, the gap widened further, with a survival rate of 21 percent for poliovirus patients, compared to 4 percent in the control group. Combining the poliovirus with other approved therapies is one approach already being tested to improve survival. A phase 2 study now underway combines the poliovirus therapy with the chemotherapy drug lomustine for patients with recurrent glioblastomas.

SOURCE: HealthDay News, June 2018

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 Chlamydia !

Chlamydia: Blockade at the receptor

Chlamydia trachomatis is the main cause of sexually transmitted diseases. More than 131 million people are infected with this bacterium worldwide. If detected at an early stage and treated with antibiotics the infection with Chlamydia can be treated very well. However, infections with Chlamydia develop often without symptoms therefore in many cases remain unnoticed. This promotes the spread of the pathogen and increases the chance for further infections, e.g. with the HI virus or with Neisseria gonorrhoeae, the causative agent of gonorrhea. How does Chlamydia trachomatis accomplish to avoid the attack of the human immune system and thereby also to prevent the typical symptoms of an infection, an answer given by lead researcher. The bacterium actively deactivates special cells of the immune system, so-called polymorphic nuclear leukocytes (PMNs) and for this reason secures its own survival. The struggle between pathogen and immune system follows a defined process in humans: Special leukocytes which are part of the innate immune response become active following an infection. On the one hand they can take up pathogenic organisms and digest them. On the other hand they secrete special substances which damage bacteria in the surrounding. Thirdly, they form structures called neutrophil extracellular traps which bind microorganisms and kill them. However, many pathogens have developed mechanisms in the course of evolution to destroy these traps for their part as Chlamydia trachomatis can do. From previous studies it was already known that Chlamydia is disturbing single steps of the innate immune signal pathways. But the exact mechanism was unknown up to now. Now the lead researcher succeeded to decipher vital details of these disturbances The researchers have identified two receptors and a special protein as main players in this battle between bacteria and immune system the formyl peptide receptor type 1 (FPR1) and type 2 (FPR2) as well as the chlamydial protease like activating factor (CPAF). Both receptors constitute the "antennae" of the immune cells. In case they recognize a potential invader they transmit a signal to the interior of the cell and in this way initiate the immune response. Whereas FPR1 recognizes only particular peptides, FPR2 can bind broader spectrum of proteins, peptides and lipids. The lead researcher now revealed how Chlamydia accomplishes to prevent the activation of this process. Chlamydia which could not produce CPAF could be identified and efficiently killed by immune cells without problem. The fact that CPAF plays a crucial role in the process of infection outside of the cell holds the chance for new drugs against the pathogen in the view of the scientists. A substance that blocks CPAF could be an appropriate therapeutic agent against Chlamydia infections. For this, however, a deeper understanding of the strategies Chlamydia accomplish to paralyze the innate immune system of the host is necessary.

SOURCE: HealthDay News, June 2018

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Flu & New Drug !

                                                                          Flu's response to new drug explored

The new influenza drug baloxavir marboxil, was approved for clinical use in Japan in February 2018. The lead researcher now investigated the drug's mode of action in detail, and uncovered possible mechanisms by which viral resistance to it could emerge. Every year, 290,000 to 650,000 deaths and 3 to 5 million cases of severe illness worldwide are associated with flu, an infectious disease caused by influenza viruses A and B. Vaccines and anti-viral drugs are available for flu, but viral strains with resistance to these drugs are emerging. The need for an effective drug with a novel mechanism of action is high. Baloxavir Marboxil is the first entirely new anti-influenza drug approved for clinical use since the 1990s. The body metabolizes Baloxavir Marboxil into baloxavir acid, which inhibits a key viral enzyme known as influenza polymerase. With this enzyme inactivated, the virus is unable to replicate and an infection cannot proceed. Clinical trials on healthy patients have shown that one oral dose of Baloxavir Marboxil is effective in reducing viral production and relieving symptoms. The lead researcher delved into the mode of action of the drug and possible mechanisms by which viral resistance to it could emerge. During two clinical trials, lead researcher took nose/throat swabs of patients before and after treatment with Baloxavir Marboxil , and sequenced the viral RNA. They showed that in a minority of treated patients, a specific mutation occurs in the virus's polymerase enzyme. This mutation makes the virus around 30 to 50 times less susceptible to the drug. However, this mutation also caused impairment of viral replication, and did not seem to have a negative effect on the treatment outcome so far. The lead researcher determined crystal structures of the drug bound to the typical polymerase of the virus as well as the mutant polymerase. The mutation only leads to a very small structural change: one amino acid is mutated into another, smaller by just a single methyl group. However the virus pays a price for escaping the drug, since we found that the same mutation also lowers the activity of the polymerase, meaning that the mutant virus is less effective at replicating itself. It is therefore uncertain whether this Baloxavir Marboxil -resistant virus would ever spread. The knowledge from this paper can be already be used to try to tweak and improve the drug further. But before making definite claims about the possibility of resistance developing, Baloxavir Marboxil will need to be used by many people around the world. Only that way can we find out if resistance spreads and becomes a problem.

SOURCE: HealthDay News, June 2018

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 Vitamin B12 and Folate !

Many older adults are deficient in vitamin B12 and folate  

A new has shown for the first time that a substantial number of adults over 50 are at risk of deficiency in vitamin B12 and folate. The lead researcher found that one in eight adults in Ireland are deficient in vitamin B12; one in seven are deficient in folate; and there are variations in deficiency across different provinces in Ireland, in addition to variations dependent on health, lifestyle and the time of year measured. The findings form part of the largest representative study of its kind conducted among older persons in Ireland. Both vitamin B12 and folate are essential for nerve function, brain health and the production of red blood cells and DNA. Numerous studies have shown that low nutritional status of folate and B12 are linked to poor long-term health, especially among older people. In Ireland, fortification of food products is voluntary and some foods are enriched with micronutrients such as folic acid, though this is inconsistent between products fortified and over time, resulting in haphazard exposure. There have been repeated calls for an official policy of mandatory fortification of staple foods such as bread, with folic acid, to reduce the occurrence of neural tube defects in babies. Such a policy would also reduce the prevalence of folate deficiency in older adults who are most at risk. Before this can occur, however, comprehensive information is needed on the prevalence and determinates of deficiency. Our study suggests that the current custom of voluntary food fortification is ineffective in preventing deficiency or low status of these vitamins among older people. The results are of relevance not just for Ireland but for all countries that do not have mandatory fortification. One in eight adults over 50 were low to deficient in vitamin B12 while one in seven were low to deficient in folate. The prevalence of low or deficient folate increased with age, from 14% among those aged 50-60 years to 23% among people over 80 years old. Low folate status was also more common in smokers, the obese, and those who lived alone. Low or deficient vitamin B12 was more common in smokers (14%), people who lived alone (14.3%) and those from lower socio-economic backgrounds (13%). Use of both vitamin B12 and folic acid supplementation was low, with higher rates among women than men but less than 4% overall taking supplements of either vitamin. This is the largest representative and most comprehensive study of vitamin B12 and folate status in older adults ever conducted in Ireland. There are striking differences in the prevalence of deficiency across different lifestyle factors such as obesity and smoking both of which are modifiable risk factors. Our findings will provide useful data to help inform public health policy -particularly regarding the proposition of mandatory folic acid and/or vitamin B12 fortification. To place our findings in context, in a country such as the United States where mandatory folic acid fortification occurs, rates of low folate status are around 1.2% in older adults compared with 15% in Ireland.

SOURCE: HealthDay News, June 2018

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 Virtual Reality !

                                          Virtual reality (VR) technology transforming cardiovascular medicine

Virtual reality (VR) technology transforming cardiovascular medicine
Rapid advancements in the field of virtual reality are leading to new developments in cardiovascular treatment and improved outcomes for patients. Extended reality applications in cardiac care include education and training, pre-procedural planning, visualization during a procedure and rehabilitation in post-stroke patients. For years, virtual reality technology promised the ability for physicians to move beyond 2D screens in order to understand organ anatomy noninvasively. However, bulky equipment and low-quality virtual images hindered these developments. Led by the mobile device industry, recent hardware and software developments such as head mounted displays and advances in display systems have enabled new classes of 3D platforms that are transforming clinical cardiology. Virtual reality provides complete control over the wearer's visual and auditory experience as they interact within a completely synthetic environment, while augmented reality allows the wearer to see their native environment while placing 2D or 3D images within it. Merged reality and mixed reality allow for interaction with digital objects while preserving a sense of presence within the true physical environment. These technologies make up the full spectrum of extended reality, which is transforming the practice of cardiovascular medicine. Advances in this technology allow patients and family members to better understand their cardiac conditions, helping them to make more informed decisions surrounding their medical care. Medical students and trainees can better visualize cardiac abnormalities with virtual reality, which allows trainees to simulate operating environments and multiple physicians to interact while viewing the same educational material in a natural environment. Additionally, 3D workstations may assist physicians in assessing the heart in surgical situations where it may be difficult to see. Still, according to the research, early data show that improved visualization due to this technology will allow physicians to learn more quickly, interpret images more accurately and accomplish interventions in less time. These improvements will most likely translate into lower cost procedures and better outcomes for patients.

SOURCE: HealthDay News, June 2018

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New Products of SQUARE Pharmaceuticals Ltd.

  Product SpecbacTM
Generic Name Meropenem
  Strength 250 mg
  Dosage form IV Injection
  Therapeutic Category Penem Antibiotic
  Product AvasprayTM
Generic Name

Fluticasone Furoate

Strength

27.5 mcg/Spray

Dosage form Spray
Therapeutic Category Topical Nasal Preparation
  Product Maxbon KitTM
  Generic Name Ibandronic Acid and Calcium Orotate
  Strength 150 mg and 400 mg
  Dosage form Tablet
  Therapeutic Category Antiosteoporosis

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