News May 2013 Issue

In The News: May 2013

High Intake of Calcium Supplements Linked to Increased Male Cardiovascular Disease Risk

Men who take a high amount of calcium supplements appear to have a greater risk of cardiovascular disease (CVD) death, according to a new study published in JAMA Internal Medicine (February 2013). The study indicates that women do not seem to be affected by the supplement in the same way. Calcium supplements are relied upon for the prevention and treatment of osteoporosis, yet it’s not clear what non-skeletal health effects they might have. In order to determine whether the consumption of dietary and supplemental calcium might be linked to total cardiovascular, heart and cerebrovascular diseases, the researchers followed 388,229 men and women aged 50 to 71 years for an average of 12 years. The participants were part of the National Institutes of Health (NIH)—AARP Diet and Health Study, which took place across six states and two major cities from 1995 to the end of 1996. During that time, 3,974 CVD deaths in women and 7,904 in men were identified. In the NIH-AARP Health Study, calcium supplements were taken by 51 percent of the men and 71 percent of the women. Men who took over 1,000 mg/day calcium supplementation had a 20 percent greater risk of CVD death including 19 percent higher heart disease and 14 percent higher cerebrovascular disease risk of death, the study’s authors noted.

Women Not as Successful with Hip Implants

Failure rates for hip implants were 29 percent higher for women than men, according to a study published in JAMA Internal Medicine (February 2013). In a large review of 35,140 patients undergoing primary total hip arthroplasty followed for a median of three years, the crude all-cause rate of failure (defined as subsequent revision surgery) was 2.3 percent for women compared with 1.9 percent for men, reported the researchers. Data for the study came from Kaiser Permanente system’s registry of total joint replacements from 2001 to 2010; the registry is the largest of its type in the U.S. Procedures were performed at 46 hospitals in California, Hawaii, Oregon, Washington and Colorado by 319 different surgeons. One component of failure in the women was larger femoral hip implant head sizes; femoral head sizes of 36 mm or more led to a failure rate of 95 percent in women. Metal-on-metal implants also showed an increased risk of failure in women, according to the study.

Metal-on-Metal Hip Implant Manufacturers Should Face Higher Scrutiny, FDA Recommends

The Food and Drug Administration (FDA) is proposing the makers of metal-on-metal hip implants take greater responsibility by proving their products are safe prior to marketing them. Already an established subject of concern due to adverse reactions, metal-on-metal hip implants gained greater scrutiny when a recent FDA review found the artificial hips may pose problems for women and those who received larger-size implants. The FDA order proposed “to require the filing of premarket approval application (PMA) or a notice of completion of a product development protocol (PDP)” for metal-on-metal hip implants (January 17, 2013). Prior to this statement, manufacturers could market the implants without a PMA, which would require the submission of safety and effectiveness data. An additional Safety Communication posted on the FDA website indicated that “metal-on-metal hip implants have unique risks in addition to the general risks of all hip implants” because “metal release will cause some tiny metal particles to wear off of the device around the implant, which may cause damage to bone and/or soft tissue surrounding the implant or joint.” The communication also stated that soft tissue damage may lead to pain, implant loosening, device failure and the need for revision surgery. “Some of the metal ions released will enter the bloodstream and travel to other parts of the body, where they may cause illness.”