Bempedoic Acid

Bempedoic Acid: Statin’s Younger Sibling for Hypercholesteremia

High cholesterol levels in blood vessels has been a hot topic in the media for several years now, ever since its link to heart attacks and strokes have been preached by physicians over the course of fifty-odd years. For nearly 30 years, statins have been the drug of choice to combat high cholesterol and low-density lipoproteins (LDL)—aka “bad cholesterol”—which increase the risk of atherosclerosis and coronary heart disease. The most severe side effect of statins is myotoxicity that can range from myopathy and myalgia (muscle pain and weakness) to myositis and rhabdomyolysis, which can lead to kidney failure, clotting/bleeding disorders (disseminated intravascular coagulation), and ultimately death. Though the latter rarely occurs, muscle pain and weakness that statins can invoke have drudged up reluctance to comply with the daily intake of the medication. Bempedoic acid is a potentially new cholesterol-lowering drug that’s almost as effective as statins but without the muscle achiness.

Cholesterol is synthesized by the liver, and despite its bad reputation, is vital to most cellular processes that keep humans alive. In excess, mostly contributed by high-fat and high-carb diets, along with genetic predisposition in some cases, LDL sticks to the walls of blood vessels, causing plaque buildup, and in turn obstruct blood flow. The fallout: heart disease, hardened blood vessels, heart attacks, and strokes.

Statins work by inhibiting an enzyme called HMG-CoA reductase, which is responsible for creating mevalonate which is then converted into cholesterol. Bempedoic acid, on the other hand, targets a different enzyme—adenosine triphosphate citrate lyase (ACL)—to decrease cholesterol production in the liver. This alternate pathway does not utilize any enzymes that are present in skeletal muscle, eliminating any potential muscle ache and soreness as a possible side effect.

A clinical trial led by Imperial College London tested the drug 2,200 participants over the course of a year as a once-daily oral medication. The trial results indicated bempedoic acid as a safe, well-tolerated medication without the muscle weakness. However, cholesterol and LDL-lowering efficacy fell behind statins at 18 percent versus 50 percent with statins.

If compliance to cholesterol-lowering medication is dictated by a single factor—muscle ache—then bempedoic acid may, in the long run, prove to be a better option to prevent fatal cardiac conditions.

C. difficile Treatment

Utilizing Fecal Microbiota Treatment Modalities for C. difficile Treatment

An infection with Clostridium difficile, or C. difficile, is an unpleasant matter resulting in severe diarrhea and ultimately dehydration with its sequelae of electrolyte imbalances that has profound impacts on the heart and the nervous system. Most cases occur in hospitals, though it has been known to occur in the community within people who are typically immunocompromised.

A powerful new C. difficile treatment method has been pioneered by the University of Alberta, Canada, in which capsules containing bacteria from the fecal material of a healthy donor have been developed, intended for ingestion by a C. difficile patient, so as to help restore balance to the gut. The fecal microbiota transplant (FMT) procedure consists of feces from a healthy donor which have been filtered and processed until it contains only bacteria, and this filtered material is then encapsulated within a gel that breaks down easily in the recipient’s gut.

The human digestive and immune systems are host to literally hundreds of different kinds of gut bacteria, whose combined purpose is to assist with digestion and the body’s immune system. When someone becomes infected with any kind of harmful agent that requires the use of antibiotics, the normal healthy balance in the gut can be severely disrupted. This creates a window of opportunity for microorganisms such as Clostridium difficile to enter the picture and create havoc in the gut.

Patients who participated in the study declared that there was no unpleasant odor or taste associated with the capsules, because the transferred stool bacteria are encased in a gel included within the capsule. Not only are the capsules close to 100 percent effective, but they are far less invasive compared to a colonoscopy.

In addition to the less invasive nature of the treatment, the capsules are inexpensive, and does not involve any form of sedation for the person being treated. The capsules can also be administered in a doctor’s office, with no preparation necessary.

As a large percentage of people who have contracted C. difficile have been bothered by the recurrent nature of the disease, the recurrence factor seems to have been eliminated in participants who ingested FMT capsules as a form of C. difficile treatment. Once the gut of an FMT recipient has been restored to its normal healthy balance by the bacteria included in the capsules, recurrence is no longer an issue, and repeat treatments have not been necessary.

Many of the participants in the study experienced significant relief within just a few days of undergoing treatment. Since only a single treatment is needed to achieve success, with no ongoing treatments being necessary, there could hardly be a faster, more effective solution to the problem. To this point, no adverse reactions have been reported by patients and have been well tolerated thus far.

However, to achieve effective C. difficile treatment results, a fairly large number of capsules have to be ingested all within the space of an hour. In order for the desired effects to be achieved, it is necessary to deliver a high volume of healthy donor fecal material, and this must be accomplished by ingesting as many as 40 of the prepared capsules in a relatively short period of time—a small price to pay for relief.

Apart from transforming the way C. difficile treatments will be administered, it is expected that the capsule delivery method will entirely revolutionize the way FMT will be administered in the future, because of its ease of use, low cost, low impact on recipients, and extremely high rate of success.

Dipstick Technology

Dipstick Technology Allows for Fast Disease Detection Without Sophisticated Equipment

Scientists at the University of Queensland in Australia (UQ) have developed a simple and effective method for diagnosing diseases in living organisms, which has implications for use on isolated regions where advanced technology has not yet populated. Dubbed ‘dipstick technology,’ the process can purify and analyze ribonucleic acid (RNA) and deoxyribonucleic acid (DNA) from microorganic samples in less than a minute—without the need for special equipment or personnel requiring a particular skill set.

Pathogens can consist of viruses, bacteria, fungi, and other microorganisms that may trigger diseases in plants, animals, and humans. Being capable of analyzing biologic samples quickly will make devising of treatment plans easier and faster, which can prove enormously beneficial when time is critical.

 The dipstick has already been used on isolated plantations in Papua New Guinea with great success, allowing for the exposure of pathogens in trees, humans, livestock, and water sources for drinking. Even in low-tech settings, disease can quickly be isolated and evaluated, allowing for time to develop a useful solution.

The findings on the field encourages researchers to believe that it might be especially effective in underdeveloped nations where health equipment and facilities are in short supply. In such locations, dipstick technology has the potential to tackle agricultural problems, health issues, and environmental disasters that plague nations and communities.

The UQ team of scientists maintain that nucleic acid purification is a powerful tool in molecular biology but too cumbersome to use for most field operations, as the process is time-consuming and requires the expertise of trained and specialized workers. Extracting genetic material from biological samples has always been done in a laboratory setting and usually involves complex machinery and time to process the information.

The researchers had a breakthrough when they discovered a proprietary medium that could capture and isolate nucleic acids while preventing the degradation of the genetic sample during the process of washing away contaminants. Dipstick technology was born, which passed preliminary testing on a narrow range of biological samples only to discover later that a much broader range of samples could also be captured and analyzed effectively.

UniQuest, the commercial arm of UQ, has filed a patent for their dipstick technology, but they are also seeking commercial partners who are willing to finance large-scale production for the purpose of distributing the tech to less developed countries. Regardless of the logistics of who uses the dipstick, its application and role in modern medicine is tantamount to advancing the science of medicine.

Rapid HIV Test

Viral Load Can Be Detected with New Rapid HIV Test

Scientists at Imperial College London, together with DNA Electronics, have developed a rapid HIV test using a USB drive that can detect HIV viral load in 20 minutes. Only a drop of blood is needed for the USB stick—similar to diabetics checking glucose levels with a fingerstick—which is then inserted into a desktop or portable notebook, where it communicates with an app, feeding data to the software, and the user can read the results in less than 30 minutes. The viral load, if any, is detected through the presence of the virus genetic material, RNA; if present, amount is also indicated in the results. Using blood samples of 991 participants, results were 95 percent accurate compared with the traditional method, which takes at least a couple of days to process results.

According to the World Health Organization (WHO), approximately 37 million people worldwide are living with HIV/AIDS, of which 2 million are children. Majority of the population infected with the virus reside in sub-Saharan Africa. Moreover, 18.2 million are on antiretroviral therapy (ART) to keep viral count down. With the rapid HIV test, HIV levels can be easily tracked at home for ART recipients to determine medication efficacy. If drug resistance occurs, regular home monitoring can detect it sooner than later and a new treatment regimen can be implemented. Also, in developing regions where access to technology is limited, the USB stick technique can easily test for HIV using a portable device, and implement treatment to help staunch transmission, as in the case of mother to child via birth or breastfeeding.

The rapid HIV test using a USB drive with a litmus medium that detects change in pH as evidence of RNA material of the virus is still in its beginning phase and will be a long time before we see it used in homes. However, scientists have high hopes for its use and are concomitantly developing the device to detect hepatitis virus as well.

Portable Vaccine Kit

Portable Vaccine Kits Can Be Transported to High-Risk Areas Without Power to Create On-the-Spot Vaccines by Just Adding Water

For vaccines to be effective, a continual chain of refrigeration is important to keep them viable. In areas where power sources are limited or nonexistent, such as developing nations, or in areas where elaborate medical equipment isn’t found for miles around, a portable vaccine kit could be the turning key to keeping an epidemic in check, thus saving many lives.

A team of researchers at Harvard’s Wyss Institute sought out to create a practical and mobile method to create medical treatments anywhere. A portable system was developed that enables the technician to produce an essential biomolecule as needed without requiring the aid of a refrigerator or a laboratory—instead, simply add water.

At the core of the scientists’ “portable biomolecular manufacturing kit” are two freeze-dried pellets that can be mixed and matched to create different compounds that cater to specific treatment modalities. Water is the only component needed to rehydrate and mix the ingredients. The pellets have a shelf life of at least a year, potentially longer.

The pellets come in two forms: reaction pellets and instruction pellets. The former contains no cells and genetic material and acts as the base that can be used to generate different drugs, whereas the instruction pellets contain DNA instructions to direct the reaction pellet and thus specifies the type of medication to produce. By combining the two pellets with water, a vast array of vaccines, antibacterial peptides, and antibody conjugates can be manufactured on the spot. Therapy from the rehydrated pellets can be administered orally, topically, or as injections to treat food poisoning, prevent wounds from getting infected, and dispense vaccines during a viral outbreak, such as influenza.

The portable vaccine kit is also an inexpensive biomolecular manufacturing kit at approximately three cents per microliter. Apart from its clinical use, researchers and students can use the kits for study purposes when state-of-the-art facilities and appliances are inaccessible.

Ultrasound Hypertension Therapy

Ultrasound Hypertension Therapy Delivers Promising Results to High Blood Pressure Patients Unresponsive to Medication

According to a new study, people with type 2 diabetes and comorbid treatment-resistant high blood pressure may have better treatment response with ultrasound hypertension therapy. A research team in Tohoku University’s Department of Diabetes Technology in Japan treated 212 patients with type 2 diabetes, who also had persistent hypertension, with ultrasound technology and found overall decreased blood pressure levels in the study groups.

The subjects were divided into four groups. Two groups each received 20 minutes of low-intensity ultrasound irradiation to the forearm at different frequencies—one at 500 kHz and the second at 800 kHz—where the other two groups served as control groups and received placebos. After treatment, blood pressure and heart rates were significantly decreased compared to pretreatment values. Values were also lower than the ones in the placebo groups, particularly subjects from the 500 kHz group.

Mechanism of action as to how ultrasound waves decrease blood pressure is unclear. One theory is that it subdues sympathetic nerve pathways from the forearm to the rest of the cardiovascular system. The sympathetic nervous system is responsible for the “flight-and-fight” response in humans and a major homeostatic regulatory component in the body that is largely responsible for vasoconstriction, which increases blood pressure.

The 212 participants of the study experienced no adverse effects post-treatment. Ultrasound technology has been safely used for several years as a medical imaging and diagnostic tool, particularly for fetal imaging. It uses sound waves, similar to sonar, instead of ionizing radiation, like x-rays and gamma rays that can harm organs and tissues especially with repeated use.

More research is needed to establish complete safety and efficacy. However, ultrasound hypertension therapy appears to be an inexpensive and noninvasive treatment protocol for intractable hypertension.

Diagnosing Hepatitis C

Urine Test for Diagnosing Hepatitis C

Diagnosing hepatitis C can be made simpler with an easy urine test instead of the conventional and costlier two-step approach with a blood test that is currently utilized. Scientists at University of California Irvine School of Medicine have developed a test that uses enzyme-linked immunosorbent assay (ELISA)—a common diagnostic tool when using wet lab samples—to detect hepatitis C antigens indicative of a current infection.

With the traditional blood test, the first step involves detecting anti-hepatitis C antibodies. A positive result, however, does not indicate an active infection as these antibodies will be present if a person was exposed to the hepatitis C virus (HCV) in the past and the immune system fought off the pathogen. A positive test is followed by a HCV RNA test to detect viral RNA in the blood to determine an active infection. Genotyping may also be ordered to discern the most effective treatment and predict the expected length of therapy.

Urine from 110 people and blood from 138 people was collected. The results were compared using the two approaches, in which the urine test matched the blood test results completely. The new method not only increases sensitivity and specificity, it is also less expensive as the HCV RNA test can cost up to $200. In less developed nations where skilled phlebotomists and blood-processing equipment are not readily available, a simple urine test for diagnosing hepatitis C may be a lifesaver.

Hepatitis C is a blood-borne pathogen and is acquired through blood and bodily fluids, i.e. passed from infected mother to child, sharing of needles, engaged in unprotected sex, received organ transplants before 1992 and blood transfusions before 1987. According to the World Health Organization (WHO), 130-150 million people suffer from chronic hepatitis C, of which 2.7 million are Americans. During the early stages, a person infected with HCV is asymptomatic and usually goes undetected until complications develop later, which includes cirrhosis and liver failure. Diagnosing hepatitis C effectively and efficiently can staunch transmission rates and prevent future generations from unknowingly acquiring the disease.

Urine Odor for Prostate Cancer Diagnosis

Using Urine Odor for Prostate Cancer Diagnosis Noninvasively

A device known as Odoreader can accurately detect signs of prostate cancer by essentially “sniffing out” urine. Scientists at University of Liverpool in conjunction with University of the West of England in Bristol originally developed Odoreader in 2013 to analyze urine samples for bladder cancer by examining odors in the specimen. Researchers claim 100 percent were accurately diagnosed with bladder cancer in 98 urine samples using this method. Now, this technique is being adapted to noninvasively diagnose prostate cancer.

Current prostate cancer screenings include measuring prostate-specific antigen (PSA) levels in men through a blood test, which are not specific to prostate cancer. Elevated PSA levels can also indicate prostatitis (inflamed prostate) or benign prostatic hyperplasia (BPH), also known as an enlarged prostate. PSA levels above 4.0 ng/mL are considered high and a prostate biopsy is usually performed to confirm cancer diagnosis. Over time, scientists have found PSA measurements revealed too many false-positives, as well as false-negatives, to be used as a reliable screening method, not to mention unnecessary prostate biopsies were performed as a result.

Odoreader is a machine that uses gas chromatography to analyze odors emitted in urine. A mix of heated tin and zin oxide is used as a detector in the column (in the gas chromatography oven) and heats the liquid urine sample into a gas. As the gas moves along the 98-feet column, adsorption rate varies by molecules found in the sample, which is used to identify cancer cells by comparing the readings to an algorithm. Results are displayed on a computer screen within 30 minutes.

Urine samples from 155 men were analyzed using Odoreader and diagnosed 58 men with prostate cancer, 24 men with bladder cancer, and 73 men as having a weak stream with hematuria (blood in urine) without cancer. Accuracy rate of diagnosing prostate cancer was 90 percent and over 95 percent for bladder cancer, compared to PSA screenings which amount to 65-75 percent accuracy.

If Odoreader passes clinical trials, using urine odor for cancer diagnosis will be hot on the heels of urologists and save several men from undergoing needless painful prostate biopsies.

Transdermal Ibuprofen Patch

Transdermal Ibuprofen Patch for Local Pain Relief

Ibuprofen is an over-the-counter nonsteroidal anti-inflammatory drug (NSAID) used widely for its analgesic, antipyretic, and, in higher doses, for its anti-inflammatory effects. NSAIDs are commonly used to treat everyday maladies, such as headaches, menstrual cramps, joint pain, and low-grade fever. NSAIDs in pill form are designed to work systemically, although pain and discomfort experienced by a person who uses this medication are typically isolated to one area. As a method of solving this conundrum, scientists at University of Warwick in England have developed the first transdermal ibuprofen patch that, when applied to the skin, can achieve local pain relief.

NSAIDs work by inhibiting cyclooxygenases (COX-1 and COX-2)—enzymes responsible for producing prostaglandins, which, in turn, promote inflammation, pain, and fever. COX-1, however, also produces prostaglandins that activate platelets and protect the stomach and intestinal lining from the stomach’s acidic environment. Due to the drug’s systemic effects, large doses and long-term use of NSAIDs can lead to gastrointestinal (GI) bleeding and ulcers.

With the help of the Bostik company, who custom-designed a flexible adhesive polymer, the transdermal ibuprofen patch can hold up to 30 percent ibuprofen by weight—compared to other drug-carrying patches and gels that contains 5-10 times less. There are ibuprofen-containing gels currently on the market, but they don’t hold as much of the drug as the patch and application is messy. Once on the skin, the patch delivers continuous and consistent levels of ibuprofen directly to the affected area for 12 hours, without passing through the bloodstream first. Once applied, the patch remains on the skin for 12 hours and easily peels off with no sticky residue, while causing no discomfort to wearer.

The scientists are currently testing the polymer for other types of medication for transdermal drug delivery that weren’t possible with traditional polymers. In the meantime, the transdermal ibuprofen patch is expected to be to be released by Medherant, an offshoot company of University of Warwick, in two years’ time.

Testosterone Nasal Gel

New Testosterone Nasal Gel Raises Testosterone Levels Effectively

Natesto, the new testosterone nasal gel, was approved by the U.S. Food and Drug Administration (FDA) last May, and it is currently the only FDA-approved testosterone delivery system of its kind. Manufactured by Trimel Pharmaceuticals, results of Natesto’s phase 3 clinical trials were recently evaluated and found, when the nasal gel was applied three times a day, blood testosterone levels in men were in the normal range after 90 days.

Popular modes of testosterone delivery to treat low testosterone levels in adult males (or hypogonadism) are topicals that are applied to the skin, which can increase the risk of unintentional secondary testosterone exposure to women and children through contact. The nasal gel comes in a multi-dose pump dispenser that allots a predetermined amount of medication (5.5 mg) directly into the nostrils, limiting the potential for secondary exposure.

During phase 3 clinical trials, 306 men with low testosterone levels in 39 U.S. outpatient centers were given the testosterone nasal gel to self-administer in their homes. During 90 days, 228 men applied the gel in both nostrils twice a day while 78 men were randomly assigned to use it three times a day. After 90 days, blood testosterone levels were in the normal range for 90 percent of the men who used it three times a day compared to 71 percent of men who used it twice a day. As a result, the manufacturer recommends 33 mg per day distributed three times a day in each nostril. Of those treated, elevated moods and improved erectile function were also expressed.

Side effects and tolerance to the testosterone nasal gel were also studied as the participants were asked to stay on the gel for 90 or 180 days, in which no serious adverse reactions were noted in either groups. However, 3.7 percent of men who were using the medication three times a day stopped due to side effects, which may include headache, runny nose, sinusitis, nasal scab, upper respiratory tract infection, nosebleeds, nasal irritation, and bronchitis.

Low testosterone levels in men (usually due to aging) are associated with insomnia, increased body fat, reduced muscle bulk, decreased sex drive (libido), moodiness, and worsening of existing chronic medical conditions. With its simple-to-use application and minimal side effects, the new testosterone nasal gel is a safe and effective solution to treat low testosterone levels in adult men.