HEALTH

Study suggests calcium, vitamin D helps postmenopausal women lower cholesterol

BY Antoinette Alexander

CLEVELAND, Ohio — A new study suggests that calcium and vitamin D supplements after menopause can improve women’s cholesterol profiles, and much of that effect is tied to raising vitamin D levels.

The study is from the Women’s Health Initiative and was recently published online in Menopause, the journal of the North American Menopause Society.

The study, "Calcium/vitamin D supplementation, serum 25-hydroxyvitamin D concentrations and cholesterol profiles in the Women’s Health Initiative calcium/vitamin D randomized trial," will be published in the August 2014 print edition of Menopause.

Whether calcium or vitamin D can indeed improve cholesterol levels has been debated. Studies of women taking the combination could not separate the effects of calcium from those of vitamin D on cholesterol. However, this study, led by NAMS board of trustees member Peter Schnatz is helping to settle those questions because it looked both at how a calcium and vitamin D supplement changed cholesterol levels and how it affected blood levels of vitamin D in postmenopausal women.

Daily, the women in the WHI CaD trial took either a supplement containing 1,000 mg of calcium and 400 IU of vitamin D3 or a placebo. This analysis looked at the relationship between taking supplements and levels of vitamin D and cholesterol in some 600 of the women who had both their cholesterol levels and their vitamin D levels measured.

The women who took the supplement were more than twice as likely to have vitamin D levels of at least 30 ng/mL (i.e., normal according to the Institute of Medicine), as were the women who took the placebo.

Supplement users also had low-density lipoprotein (LDL — the "bad" cholesterol) levels that were between four and five points lower. The investigators discovered, in addition, that among supplement users, those with higher blood levels of vitamin D had higher levels of high-density lipoprotein (HDL — the "good" cholesterol) and lower levels of triglycerides (although for triglycerides to be lower, blood levels of vitamin D had to reach a threshold of about 15 ng/mL).

Taking the calcium and vitamin D supplements was especially helpful in raising vitamin D levels in women who were older, women who had a low intake and women who had levels first measured in the winter. But lifestyle also made a difference. The supplements also did more to raise vitamin D levels in women who did not smoke and who drank less alcohol.

Whether these positive effects of supplemental calcium and vitamin D on cholesterol will translate into such benefits as lower rates of cardiovascular disease for women after menopause remains to be seen, but these results, said the authors, are a good reminder that women at higher risk for vitamin D deficiency should consider taking calcium and vitamin D.

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Maker of Clif energy bars expands portfolio with Zbar protein bar for kids

BY Antoinette Alexander

EMERYVILLE, Calif. — Clif Kid, a maker of organic snacks for kids, has announced the nationwide availability of the newest addition to the Clif Kid Zbar line — Zbar Protein.

A snack made with organic whole grains, Zbar Protein is designed to be a good source of complete protein.

“It can be challenging to find protein snacks that are convenient and nutritious,” stated Michelle Ferguson, EVP of marketing for Clif Kid. “Easy-to-grab Zbar Protein not only contributes to kids’ daily intake of protein, which is needed for growth, but tastes great thanks to kid-approved ingredients like organic chocolate chips and organic peanut butter.”

Made with pea and whey protein, plus a blend of rice crisps and organic oats atop a thin layer of chocolate, Zbar Protein is a source of calcium, fiber, iron, zinc and vitamin D. Zbar Protein comes in three flavors: Chocolate Chip, Chocolate Mint and Peanut Butter Chocolate.

In addition to Zbar Protein, Clif Kid has also introduced its newest flavor to the Zbar family — Zbar Iced Lemon Cookie, which features lemon blended into organic whole grain oats and topped with a drizzle of organic vanilla-flavored icing.

Zbar Iced Lemon Cookie is USDA-certified organic and portion-sized for kids offering 9 g of whole grains, 3 g of fiber and provides 12 vitamins and minerals.

As with all Clif Kid snacks, the Clif Kitchen sources ingredients that are not genetically engineered, and leaves out such ingredients as partially-hydrogenated oils, high fructose corn syrup, synthetic preservatives and artificial flavors. Zbar Protein and Iced Lemon Cookie also contain 0 grams trans fat.

 

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FDA makes unprecedented Rx-to-OTC switches

BY Michael Johnsen

Two Rx-to-OTC switches in the past year may serve as a harbinger of what the Food and Drug Administration will consider “switch” worthy. They both address chronic care needs, and they both represent first of their kind medicines to the nonprescription aisle.

The first of the two is Merck Consumer Care’s Oxytrol for Women, a thin, flexible patch for the relief of overactive bladder in women. It is the first and only over-the-counter option that treats OAB symptoms, including urinary incontinence, urgency and frequency. With 20 million OAB sufferers, sales of Oxytrol are projected to reach as high as $50 million.

The second is Chattem’s Nasacort Allergy 24HR — the first and only nasal corticosteroid on OTC shelves. Kline Healthcare’s industry analyst Laura Mahecha projected Nasacort Al-lergy’s annual sales potential to reach as high as $200 million.

“You are seeing a new openness, I think, on the part of the FDA to the switching of products that maybe heretofore wouldn’t have been considered for switch,” Jim Mackey, Merck Consumer Care SVP, U.S. region head, told DSN. “[Oxytrol] is the type of product — treating a chronic condition — that is really a first for the FDA,” said Mackey, who also is chairman of the Consumer Healthcare Products Association. “We’re very favorably disposed to the direction that the FDA is following, and we [as an industry] are very interested in working with them to enable more novel switches in the future.”

“[All told], Rx-to-OTC switches are expected to continue, with more than $10 billion in branded prescription sales likely to switch in the next five years,” said Joseph Papa, Perrigo chairman, CEO and president.

Much of that includes other medicines in the respective classes of Oxytrol (e.g., Pfizer’s Detrol LA) and Nasacort (e.g., Merck’s Nasonex). Pfizer is expected to bring the proton-pump inhibitor Nexium and its $2.1 billion volume in prescription dollars over-the-counter this spring, if not later this year.

Statins, such as Pfizer’s Lipitor, also remain speculative switch potentials despite the FDA having denied statin switches in the past. To date, no switch application has taken advantage of the FDA’s Nonprescription Drug Safe Use Regulatory Expansion that opens the door to utilizing healthcare professionals and technology in expanding the FDA’s conditions of safe use.

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