High vitamin D levels may help prevent cancer

In continuation of my update on Vitamin D, 

The study reinforces the existing theory that vitamin D helps defend against certain cancers. Exposure to sunlight stimulates the production of vitamin D by our skin. Vitamin D contributes to calcium level maintenance in our bodies, which in turn helps teeth, muscles and bones remain healthy. Aside from established benefits of vitamin D on bone diseases, evidence continues to emerge that vitamin D could be effective for other cancers and chronic diseases.   

Yet more comprehensive research needs to be conducted, as to date, the majority of studies have been conducted throughout American and European populations, and more studies focusing on Asian populations are necessary.
It is vital to determine whether the effects are the same in non-Caucasian populations, since Vitamin D metabolism and concentrations differ dependant on ethnicity.
The study published by the BMJ was carried out to determine if vitamin D was linked to site specific and total cancer.

Data spanning nine public health centres across Japan was analysed, from 33,736 female and male participants between the ages of 40 and 69 years old.
Participants were required to disclose a comprehensive overview of their lifestyle, diet and medical history and have blood samples taken to assess their vitamin D levels. Factors such as seasons affected vitamin D levels; summer and autumn typically produced higher levels compared to spring or winter. Samples were then assigned to one of four groups, based on levels.

Researchers then monitored the study participants for a mean period of 16 years, during which 3,301 new cancer cases were registered.
Once multiple known cancer risk factors had been accounted for, including weight (BMI), physical activity, age, dietary factors, smoking and alcohol intake, researchers discovered that high levels of vitamin D  reduced the overall risk of cancer by 20% in both women and men.

Higher levels were linked to a 30-50% lower relative risk of liver cancer, and more so in men than women. No cancers exhibited a higher risk connected to high vitamin D levels, and there was no evidence of a link to prostate or lung cancer.
Adjustments were made for dietary and other factors to confirm the strength of the findings, but this did little to affect the results. One limitation of the study was an insufficient number of organ specific cancers. In addition, even with the risk factor adjustments, there is no absolute certainty that the results were skewed by unidentified factors.  For this reason, no concrete conclusions about cause and effect can be asserted.

The large sample size for overall cancer, large number of blood samples tested and the extensive follow up period were vital strengths of the study. The result reinforce the theory that vitamin D has a role in defending against the risk of cancer, but the authors emphasize that vitamin D may carry additional health benefits too, that were not measured in this study.  

Further studies are needed to clarify the optimal concentrations (of vitamin D) for cancer prevention."

Further studies are needed to clarify the optimal concentrations (of vitamin D) for cancer prevention."

Ref : https://www.eurekalert.org/pub_releases/2018-03/b-hvd030618.php

High vitamin D levels may help prevent cancer

Taking vitamin D with quetiapine can help avoid new-onset diabetes risk

In continuation of my update on quetiapine

Atypical antipsychotics, though effective for treating disorders like schizophrenia, bipolar disorder, and depression, gives patients a heightened risk of developing new-onset diabetes. A new data mining study, however, has found a way to relieve this side effect. The study, published in Scientific Reports, shows that taking vitamin D ameliorates the risk of developing new-onset diabetes from atypical antipsychotics like quetiapine.

 quetiapine.

The consequences of developing diabetes from taking antipsychotics are dire, as they occasionally cause life-threatening conditions and sometimes even death.

Members of Shuji Kaneko's lab at Kyoto University looked for potential antidotes on the US FDA's Adverse Event Reporting (FAERS) system, which is the largest database of self-reported adverse side effects. "We found that patients who had coincidentally been prescribed vitamin D with quetiapine were less likely to have hyperglycaemia," says Kaneko. "It's unusual for vitamin D to be prescribed with quetiapine because it is typically prescribed to treat osteoporosis; in fact, there were only 1232 cases in the world where vitamin D was prescribed with quetiapine. Data mining proved helpful in locating these cases."

The team confirmed this finding with further tests on mice; the group of mice that was fed vitamin D along with quetiapine had significantly lower levels of blood sugar than those that took only quetiapine.

"Interestingly, vitamin D on its own doesn't lower diabetes risk, but it certainly defends against the insulin-lowering effects of quetiapine," elaborates lead author Takuya Nagashima. "We clarified the molecular mechanisms of how quetiapine causes hyperglycaemia using datasets in a genomics data repository. Through this we found that quetiapine reduces the amount of a key enzyme called PI3K that gets produced. Vitamin D stops quetiapine from lowering PI3K production."

"Databases like FAERS aren't just for making drug regulations; they have so much potential for side-effect relief using pre-existing drugs," says Kaneko. "There's a lot we can hope for from reverse translational research like this. "

Ref : http://www.kyoto-u.ac.jp/en/research/research_results/2016/160523_2.html

FDA Approves Rayaldee (calcifediol) to Treat Secondary Hyperparathyroidism in Patients with Chronic Kidney Disease

OPKO Health, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Rayaldee (calcifediol) extended release capsules for the treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. Rayaldee is a patented extended release product containing 30 mcg of a prohormone called calcifediol (25-hydroxyvitamin D3).

 calcifediol

"FDA's approval of Rayaldee represents an important milestone for OPKO," noted Dr. Phillip Frost, CEO and Chairman of OPKO. "Rayaldee is the first product to receive FDA approval for this important indication and is one of OPKO's many pharmaceutical products being developed for significant medical problems which will benefit from new treatment options."

Results from two 26 week placebo controlled, double blind phase 3 trials demonstrated that a larger proportion of stage 3 or 4 CKD patients with SHPT and vitamin D insufficiency achieved ≥30% reductions in plasma intact parathyroid hormone (iPTH) when treated with Rayaldee than with placebo. Vitamin D insufficiency was corrected in more than 80% of the patients receiving Rayaldee compared with less than 7% of subjects receiving placebo. Mean serum calcium and phosphorus levels increased by 0.1 mg/dL during Rayaldee treatment compared to placebo treatment, but these changes were deemed clinically irrelevant. No differences in Rayaldee's efficacy or safety were observed between patients with stage 3 CKD or stage 4 CKD.

"Rayaldee fills a large void in the current treatment options for SHPT in predialysis patients," commented Dr. Charles W. Bishop, CEO of OPKO's Renal Division. "The current standard of care is high dose vitamin D supplementation, an approach for treating SHPT that is neither FDA approved nor demonstrated to be safe and effective in this population. SHPT is a progressive disease that becomes increasingly debilitating and difficult to treat, necessitating timely and effective treatment."

"Rayaldee is an important new option for treating SHPT in patients with stage 3 or 4 CKD and vitamin D insufficiency," stated Kevin J. Martin, Director of Research, Division of Nephrology at Saint Louis University School of Medicine. "The great majority of SHPT cases in this patient population are associated with vitamin D insufficiency, a problem that Rayaldee can correct."

About Rayaldee

Rayaldee (calcifediol) extended release capsules are approved by the U.S. Food and Drug Administration (FDA) for the treatment of SHPT in adult patients with stage 3 or 4 CKD and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. Rayaldee has a patented formulation designed to raise serum total 25-hydroxyvitamin D (prohormone) concentrations to targeted levels (at least 30 ng/mL) and to reduce elevated iPTH. OPKO expects to launch Rayaldee in the U.S. through its dedicated renal sales force in the second half of 2016. Rayaldee is not indicated in patients with stage 5 chronic kidney disease or end-stage renal disease on dialysis. The full prescribing information for Rayaldee will be available at www.opkorenal.com.

Potential side effects of Rayaldee include hypercalcemia (elevated serum calcium), which can also lead to digitalis toxicity, and adynamic bone disease with subsequent increased risk of fractures if intact PTH levels are suppressed by Rayaldee to abnormally low levels. Severe hypercalcemia may require emergency attention; symptoms of hypercalcemia may include feeling tired, difficulty thinking clearly, loss of appetite, nausea, vomiting, constipation, increased thirst, increased urination, and weight loss. Digitalis toxicity can be potentiated by hypercalcemia of any cause. Excessive administration of Rayaldee can cause hypercalciuria, hypercalcemia, hyperphosphatemia, or oversuppression of intact PTH. Common symptoms of vitamin D overdosage may include constipation, decreased appetite, dehydration, fatigue, irritability, muscle weakness, or vomiting. Patients concomitantly taking cytochrome P450 inhibitors, thiazides, cholestyramine, phenobarbital or other anticonvulsants may require dose adjustments and more frequent monitoring.

The most common adverse reactions in clinical trials (≥3% and more frequent than placebo) were anemia, nasopharyngitis, increased blood creatinine, dyspnea, cough, congestive heart failure and constipation.

Blueberries, Red Grapes May Boost Body's Immune Function

Researchers found that both fruits contain compounds called stilbenoids, which work with vitamin D to increase expression of the human cathelicidin antimicrobial peptide (CAMP) gene, which is involved in immune function.

The stilbenoid compounds included resveratrol in red grapes and pterostilbene in blueberries.

"Out of a study of hundreds of compounds, just these two popped right out," Adrian Gombart, a principal investigator at the Linus Pauling Institute at Oregon State University, said in a university news release.

"Their synergy with vitamin D to increase CAMP gene expression was significant and intriguing," said Gombart, an associate professor in the university's college of science. "It's a pretty interesting interaction."

Gombart and colleagues noted, however, that these findings were made in laboratory cell cultures and do not prove that eating blueberries and red grapes would boost a person's immune function.

The study was published Sept. 17 in the journal Molecular Nutrition and Food Research.

The CAMP gene has been shown to play a key role in the innate immune system -- the body's first line of defense that gives it the ability to fight bacterial infection. The response is especially crucial as many antibiotics become less effective.

Previous research has found a strong association between adequate vitamin D levels and the function of the CAMP gene. This new study suggests that certain other compounds may play a role as well.

Blueberries, Red Grapes May Boost Body's Immune Function - Drugs.com MedNews

Benefits of calcium and vitamin D in preventing fractures confirmed

Benefits of calcium and vitamin D in preventing fractures confirmed

Cancer Fighting Foods.............

Cancer Fighting Foods:

How can food fight cancer, you ask? In many, many ways! Certain healthy foods can lower your risk for cancer by repairing damaged cells and protect sensitive skin. Incorporating more plant-based foods into your diet is a relatively small lifestyle change that can really reduce your cancer risk.

Orange Juice:

Oranges are high in folate, and recent research suggests that people with low levels of folate are more likely have mutations occur in their DNA, which can lead to mutated cancer cells.  Leafy greens, like spinach and Brussels sprouts, are also high in folate. In recent research, men who consumed their daily suggested intake of folate were able to decrease their risk for pancreatic cancer by 50-percent.

Milk:

We’ve all heard that calcium is important for healthy bones, but milk is also high in vitamin D, another nutrient that is linked to combating cancer—researchers suggest that vitamin D helps stop the growth of cancerous cells. In fact, it has been shown to significantly decrease the risk of breast cancer.

Beans:

The more you eat, the more you—well, the more you decrease your risk for cancer.  Beans, in addition to being high in protein and fiber (great for vegetarian diet), are also high in antioxidants that are key in the fight against cancer.  Antioxidants protect your cells against free radicals—free radicals, which can come from activities like smoking, cause damage to cells, leading to cancer and other complications.

Other foods that are high in antioxidants: Berries, cruciferous vegetables (think broccoli and cabbage), potatoes and nuts. A good general rule of thumb is to eat fruits and veggies that have a lot of color to them, as they usually contain the highest amount antioxidants.

Salad :

Your mom was right—you really should eat up all of your leafy greens .  Leafy greens (like spinach and kale) contain a substance called chlorophyllin, which can help fight cancer—it works by blocking toxins. People who consume more leafy greens show lower rates of stomach cancer.

And A Glass of Wine!

Grapes and wine contain resveratrol, which is another substance that slows the growth of cancerous cells. It does so by limiting growth and acts as a catalyst for apoptosis (a cancer cell death).  In addition to it’s anti-carcinogenic properties, it also helps prevent Alzheimer’s and diabetes. More importantly (ha-ha), it’s also been linked to anti-aging properties: it helps stimulate the production of SIRT1, a serum that helps slow the aging process.

So, there you have it; your first steps to prevent cancer (along with SPF and quitting smoking) are right here.  A healthier diet with more fruits and veggies will do more than lower your risk of cancer; it will change your quality of life. And, if eating healthy is not your thing, start with small changes, and build from there!

Virginia Cunningham is a freelance writer from Los Angeles whose writing covers a range of health topics, including holistic alternatives, healthy cooking and personal fitness. She not only includes these cancer-fighting foods into her diet, but she enjoys them as well!

FDA Approves Sorilux for Adolescent Plaque Psoriasis

In continuation of my update on Sorilux(calcipotriene) 

 

Mayne Pharma Group Limited, announced that the US Food and Drug Administration (FDA) has approved Sorilux(calcipotriene) Foam, 0.005% in adolescents.

Sorilux is now approved for treating plaque psoriasis of the scalp and body in patients aged 12 years and older.

The FDA approved Sorilux in 2010 based on evidence from two 8-week placebo controlled clinical trials in patients with mild to moderate plaque psoriasis of the body and one 8-week placebo controlled clinical trial in patients with moderate plaque psoriasis of the scalp. Further data was obtained in a follow-on open label study in patients aged 12 to 17 years of age with psoriasis.

Sorilux Foam contains calcipotriene, a synthetic vitamin D analog that has a similar receptor binding affinity as natural vitamin D. The exact mechanism of action contributing to the clinical efficacy is unknown.

Psoriasis is a chronic disease of the immune system affecting approximately 7.5 million Americans each year[1]. The most common form, plaque psoriasis affects roughly 80 percent of people who have the condition.

Mayne Pharma's CEO, Mr Scott Richards, said "Sorilux is an elegant foam formulation that is marketed by Mayne Pharma's Specialty Brands sales team alongside recently launched LEXETTE™ (halobetasol propionate) Foam, a potent topical corticosteroid also used to treat plaque psoriasis in adult patients. Topical products are the mainstay of treatment for plaque psoriasis patients and the foam delivery platform has a well-established reputation with dermatologists due to ease of application and lack of greasiness and stickiness, especially in hair-bearing areas and under clothing."

Mayne Pharma directly markets more than 60 products in the US including four branded dermatology products FABIOR® (tazarotene) Foam, Sorilux Foam, DORYX® MPC (doxycycline hyclate) delayed-release tablets and LEXETTE Foam. The Company also markets TOLSURA® (SUBA®-itraconazole) capsules used to treat certain fungal infections which was recently approved and launched this year.

https://en.wikipedia.org/wiki/Calcipotriol

The Secret of Lowering Cholesterol Through Diet...

I am really happy to share an interesting and important article  'the secret of lowering cholesterol through diet' by  Deborah Land, who has written this article exclusively for the readers of  my blog.......

The Secret of Lowering Cholesterol Through Diet

a. The Myth of Cholesterol - the Bad and the Good:

Most people think that cholesterol is always bad, but there are actually two types of cholesterol. LDL is  considered the "bad" cholesterol, and HDL is considered the "good" cholesterol. If there is too much LDL in our bloodstream, it will form plaque on our arteries. Over time, this narrows our arteries and can eventually block blood flow completely. Dietary cholesterol actually isn't the primary reason for high cholesterol in the blood; it is high amounts of saturated fat and trans fat. To keep cholesterol low, you should eat unsaturated fats, eat fibrous foods, and exercise more.

b. Number Relevance in Cholesterol :
Every adult should have their cholesterol checked at least every 5 years. When you get a cholesterol test, you'll usually get back four different results. Here are the 4 categories and the healthy range you want to be in.

Total Cholesterol - less than 200 mg/dL (5.2 mmol/L);
LDL Cholesterol - less than 100 mg/dL (2.6 mmol/L);
HDL Cholesterol - greater than 40 mg/dL (1.0 mmol/L) &
Triglycerides - less than 150 mg/dL (1.7 mmol/L).

If you are over or under the desired level on any category, it is usually indicative that a diet or exercise change is needed.

c. Heart Protection and Vitamin E:
Vitamin E, an important vitamin, is sourced in vegetable oils, nuts and leafy vegetables. Vitamin E can decrease your heart disease risk, but it will not prevent a heart attack.

d. Lowering Cholesterol with these Five Foods :
1. Oatmeal and Oat Bran: These contain a high amount of soluble fiber, which can lower LDL.
2. Fish: Fish is a great source of omega 3 fatty acids, which lowers LDL and raises HDL.
3. Nuts: Not only are nuts high in fiber, but they contain the healthy fats you need to keep LDL in check.
4. Plant Sterols: This is found in foods like margarine, salad dressing, orange juice, and functional cookies. 2  grams per day will lower your LDL by 10-15%.
5. Soy: This popular meat replacement can lower LDL by up to 3%.

e. Plant Sterols and Benefits to Health :
Foods such as VitaTops Muffin Tops, Benecol Spread, granola bars and fat free milk are rich sources of plant sterols. You can easily help your heart when you start eating foods packed with plant sterols and avoid eating foods that contain saturated fats. A saturated fat-filled diet is not canceled out by this. Exercising often as well as eating healthy food will keep your cholesterol in check.

About the Author - Deborah Land writes for Cholesterol Lowering Diet Blog  ,  her personal hobby blog focused on tips to eat healthy to prevent high cholesterol. I find the blog very informative, do visit for more details...

First EffRx NDA accepted for filing by the FDA...

EffRx Pharmaceuticals SA, an Epalinges/Lausanne, Switzerland based drug delivery company announces that the New Drug Application (NDA) for the company's lead development program EX101 has been accepted for filing by the US Food and Drug Administration. EX101 is a proprietary buffered effervescent dosage form of alendronate sodium administered once weekly for treatment of osteoporosis in postmenopausal women and to increase bone mass in men with osteoporosis. The EX101 formulation is the first and only effervescent bisphosphonate alternative to tablets. EX101 has a pleasant taste of strawberry and is quickly and completely dissolved. 

About Alendronate : Alendronic acid or alendronate sodium ( sold as Fosamax by Merck) is a bisphosphonate drug used for osteoporosis and several other bone diseases. It is marketed alone as well as in combination with vitamin D (2,800 U and 5600 U, under the name Fosamax+D). Merck's U.S. patent on alendronate expired in 2008 and Merck lost a series of appeals to block a generic version of the drug from being certified by the FDA. On February 6, 2008, the US FDA approved the first generic versions of alendronate, which were marketed by Barr Pharmaceuticals and Teva Pharmaceuticals USA. Teva Pharmaceuticals manufactures generic alendronate in 5-milligram, 10-milligram, and 40-milligram daily doses, and in 35-milligram and 70-milligram weekly doses, while Barr made generic alendronate in 70-milligram tablets, which were taken once weekly. Barr pharmaceuticals were subsequently acquired by Teva in July 2008...

Ref : http://www.effrx.com/firsteffrxnda.htm

Mouse study finds black raspberries can prevent colorectal cancer

We know that, The blackberries, as well as various other Rubus species with mounding or rambling growth habits, are often called brambles. However, this name is not used for those like the raspberry that grow as upright canes, or for trailing or prostrate species such as most dewberries, or various low-growing boreal, arctic, or alpine species. Black raspberries have been also reported to possess antioxidant, anti-cancer, anti-neurodegenerative and anti-inflammatory properties, now the researchers from UIC College of Medicine have looked at the fruit's ability to prevent colon cancer.

The researchers used two strains of mice, Apc1638 and Muc2, which each have a specific gene knocked out, causing the mice to develop either intestinal tumors (in the case of Apc1638) or colitis in the case of Muc2. Colitis is an inflammation of the large intestine that can contribute to the development of colorectal cancer.

Both mouse strains were randomized to be fed either a Western-style, high-risk diet (high in fat and low in calcium and vitamin D) or the same diet supplemented with 10 percent freeze-dried black raspberry powder for 12 weeks.

The researchers found that in both mouse strains the black raspberry-supplemented diet produced a broad range of protective effects in the intestine, colon and rectum and inhibited tumor formation.

In the Apc1638 mice, tumor incidence was reduced by 45 percent and the number of tumors by 60 percent. The researchers found that black raspberries inhibited tumor development by suppressing a protein, known as beta-catenin, which binds to the APC gene.

In the Muc2 mice, tumor incidence and the number of tumors were both reduced by 50 percent, and black raspberries inhibited tumor development by reducing chronic inflammation associated with colitis.

The researchers now hope to obtain funding to begin clinical trials in humans. Because black raspberries not only prevent cancer but also inflammation, they may also protect against other diseases, such as heart disease.

I read an article in the same lines, wherein the researchers attribute the colorectal anticancer activity due to the anthocyanins present

More...