clinical trial

Benefits of taking statins has been underestimated

Posted by

0

The benefits of the cholesterol-reducing drug statins are underestimated and the harms exaggerated, a major review suggests.

Published in the Lancet and backed by a number of major health organisations, it says statins lower heart attack and stroke risk.

The review also suggests side effects such as muscle pain do occur, although in relatively few people.

But critics say healthy people are unnecessarily taking medication.

Statins reduce the build-up of fatty plaques that lead to blockages in blood vessels. According to the report authors:

  • About six million people are currently taking statins in the UK
  • Of those, two million are on them because they have already had a heart attack, stroke or other cardiovascular event
  • The remaining four million take statins because of risk factors such as age, blood pressure or diabetes
  • Up to two million more should possibly take statins

The Lancet review, led by Prof Rory Collins from the Clinical Trial Service Unit at the University of Oxford, looked at the available evidence for the effects of taking an average 40mg daily dose of statins in 10,000 patients over five years.

It suggested cholesterol levels would be lowered enough to prevent 1,000 “major cardiovascular events” such as heart attacks, strokes and coronary artery bypasses in people who had existing vascular disease – and 500 in people who were at risk due to age or other illnesses such as high blood pressure or diabetes.

 

Read at BBC News

Cambridge Biomedical announces that Tim Smith has been appointed Chief Financial Officer, effective Feb 1st, 2016.

Posted by

0

BOSTON,MA (PRWEB) JANUARY 25, 2016

Cambridge Biomedical announces that Tim Smith has been appointed Chief Financial Officer reporting to Brad Yount, President and Chief Operating Officer, effective Feb 1st, 2016.

“Tim has extensive experience in bringing operational improvements and financial acumen to developing companies. I have worked with Tim in previous organizations and have tremendous confidence that he will help to further strengthen Cambridge Biomedical’s capabilities” said Brad Yount, President and Chief Operating Officer Officer.

Smith will assume responsibility for financial operations in Cambridge Biomedical and is focused on improving operational efficiencies within the company as it positions itself for continuing double-digit growth.

“Cambridge Biomedical’s strength in bioanalytical assays and diagnostic testing is well known in the industry” Smith commented “and I am excited by this opportunity to help develop the infrastructure within the company with its team of highly experienced staff through its next phase of growth”

Prior to this appointment, Smith was responsible for the the financial operations of several different companies in Maine, Massachusetts, New Jersey and Europe. Mr. Smith received a BS in Management from Susquehanna University and an MBA from Lehigh University and is also a certified CPA.

About Cambridge Biomedical

Cambridge Biomedical, based in Boston, Massachusetts, supports sponsors by developing customized assays for small and large molecules, biomarkers, and other critical analytes, along with validation and sample testing in our CLIA certified and CAP accredited, GLP/GCLP compliant facilities,

The Company has extensive expertise in technology transfer, assay development, optimization and validation. It also offers specific services in analytical support for PK/PD studies, biomarker development, clinical assay development, assay validation, specimen analysis, and testing services in support of clinical trial and drug or device development.

Our personalized project methodology, along with a focus on delivering quality results and regulatory submission ready documentation and rapid turnaround times, ensures we meet our client’s product development timelines.

Freeze-dried pills being tested for obesity treatment Trial will offer some of the first human data on microbe transplants and weight.

Posted by

0

‘The freeze-dried poop method’ might not sound like a weight-loss strategy that would catch on, but—as some researchers are now testing—it may be an effective way to slim down.

In a randomized, controlled clinical trial starting this year, researchers will test out such a fecal formula for the treatment of obesity. They’ll also try to glean critical details about the human microbiome and its role in our health and metabolism. The trial, led by Elaine Yu, an assistant professor and clinical researchers at Massachusetts General Hospital, will involve taking fecal samples from lean, healthy donors then freeze-drying the stool, putting a gram or two into capsules, and giving them to 20 obese patients.

Such poop-packed pills, which are designed to replace a person’s intestinal microbes with those from a donor via their feces, have proven effective at treating tenacious gut infections. This has led researchers to ponder whether the transplants could remedy other health problems, including obesity and metabolic disorders. A few animal studies and some anecdotal data in humans suggests the answer is yes—and Yu hopes to get a final answer with the upcoming trial.

 

Link to full article

Single course of antibiotics can mess up the gut microbiome for a year

Posted by

0

In a battle against an infection, antibiotics can bring victory over enemy germs. Yet that war-winning aid can come with significant collateral damage; microbial allies and innocents are killed off, too. Such casualties may be unavoidable in some cases, but a lot of people take antibiotics when they’re not necessary or appropriate. And the toll of antibiotics on a healthy microbiome can, in some places, be serious, a new study suggests.

In two randomized, placebo-controlled trials of healthy people, a single course of oral antibiotics altered the composition and diversity of the gut microbiome for months, and in some cases up to a year. Such shifts could clear the way for pathogens, including the deadly Clostridium difficile. Those community changes can also alter microbiome activities, including interacting with the immune system and helping with digestion. Overall, the data, published Tuesday in the journal mBio, suggests that antibiotics may have more side effects than previously thought—at least in the gut.

 

Link to full article at Ars Technica

Landmark Huntington’s trial starts

Posted by

0

The first drug that can potentially correct the underlying defect that causes Huntington’s disease has been taken by patients in a clinical trial.

Doctors at University College London, which is leading the study, said it was an important moment in tackling the incurable condition.

Current medication treats the symptoms, but cannot slow or prevent the progressive damage to the brain.

The Huntington’s Disease Association said the trial was “very exciting”.

The disease is caused by the brain producing a mutant protein called huntingtin which damages and ultimately kills off brain cells.

As Huntington’s progresses it leads to uncontrolled movements, behaviour changes and poor cognition. Life expectancy after diagnosis can be as short as 10 years.

 

Link to BBC

Long sleep and high blood copper levels go hand in hand

Posted by

0

People who sleep fewer than 6 hours or more than 10 hours per night suffer from low-grade inflammation more often than people who sleep 7-8 hours per night. This was observed in a University of Eastern Finland study focusing on the health and lifestyle habits among middle-aged men.

“Earlier studies have found a relation between reduced sleep and low-grade inflammation,” says Maria Luojus, MHSc, one of the study researchers.

Link to full article on Science Daily

Lower Blood Pressure Guidelines Could Be ‘Lifesaving,’ Federal Study Says

Posted by

0

Declaring they had “potentially lifesaving information,” federal health officials said on Friday that they were ending a major study more than a year early because it has already conclusively answered a question cardiologists have puzzled over for decades: How low should blood pressure go?

The answer: way lower than the current guidelines.

For years doctors have been uncertain what the optimal goal should be for patients with high blood pressure. The aim of course is to bring it down, but how far and how aggressively remained a mystery. There are trade-offs — risks and side effects from drugs — and there were lingering questions about whether older patients needed somewhat higherblood pressure to push blood to the brain.

The study found that patients who were assigned to reach a systolic blood pressure goal below 120 — far lower than current guidelines of 140, or 150 for people over 60 — had their risk of heart attacks, heart failure and strokes reduced by a third and their risk of death reduced by nearly a quarter.

Link to full story on NYT