Cardio Metabolic Health Congress – Official Blog

The Shared Cardiovascular Health of Couples

As married couples and domestic partners have been reported to share similar environments, adopt similar behavior and lifestyle habits, and have similar transferable characteristics, they are also likely to share similar levels of cardiovascular risk factors. Environmental exposures, low physical activity levels, smoking status, and unhealthy dietary habits, are all risk factors for cardiovascular disease (CV) which couples may share. However, the degree to which couples have similar levels of behavioral and health risk factors remains unknown.

An emerging study published in JAMA Network Open reveals that most couples are concordant in cardiovascular risk factors with the majority ranking poorly across categories.

CV Risk Factors in Couples 

Led by Dov Shiffman, PhD, from Quest Diagnostics Nichols Institute in San Juan Capistrano, California, the study’s authors examined within couple concordance for the American Heart Association Life’s Simple 7 risk factors: smoking status, physical activity, healthy diet, total cholesterol, blood pressure, fasting blood glucose, and body mass index.

The study population was comprised of men ranging from 41 to 57 years of age and women from 39 to 55 years of age; this is important to note as CV factors tend to worsen with age while the risk for cardiovascular diseases increases with age as well.

The team of researchers assessed those cardiovascular risk factors and lifestyle behaviors in nearly 5,400 U.S. couples enrolled in an employee wellness program representing a diverse economic and racial population. They assessed health status through questionnaires, exams, and lab tests. The researchers also performed five risk assessments that continued for several years. Participants’ results were categorized individually and as a couple as either poor, intermediate, or ideal for each risk factor category and overall.

Shared Habits, Behaviors, and Environments

Data from the study revealed that approximately 1 in 5 couples were both classified as ideal while the remaining 4 out of 5 couples were in the non-ideal category. Over half of the participants were in the ideal category for smoking status, total cholesterol, and fasting blood glucose. At the same time, more than a quarter of the cohort rated poor for BMI and adequate exercise risk factors.

The researchers reported that most couples shared categories; both members were either in the ideal category or in the non-ideal category. However, concordance varied between 53% and 95% for cholesterol and dietary choices, respectively. Nonetheless, the study’s findings point to a significant correlation between partners’ health in married couples and domestic partners.

As evidenced by the latest findings, individuals tend to have marital and domestic partners who are similar to them in lifestyle, interests, socioeconomic status, and behavioral habits. This increases the likelihood of similarities in cardiovascular health risk factors and outcomes. The high concordance noted for non-ideal CV risk factors and behaviors within couples implies that behavioral interventions may benefit both members of the couple, regardless of which member is targeted by the intervention.

“These observations may help inform public health initiatives that focus on couples-targeted lifestyle modification and may help improve the probability of successful implementation of programs that would benefit both members of a couple,” the authors concluded.

Diabetes Drug Metformin Recall Continues

This post was updated on 11/10/20’ to include the FDA identified specific lot number of contaminated products manufactured by Nostrum Laboratories.

Frequently prescribed for type 2 diabetes treatment, metformin hydrochloride is designed to lower blood glucose levels and has also been used off-label for polycystic ovary syndrome and investigated from a growing number of indications. Following a recall of metformin 500 mg tablets this past summer, the United States Food and Drug Administration (FDA) announced an extended recall notice for additional manufacturers, forms, and dosages on October 8, 2020. The list of recalled drug combinations continues to grow as investigators discover additional contaminated compounds, now totaling 175 different formulations. On November 2, 2020, the FDA identified specific lot numbers of contaminated products manufactured by Nostrum Laboratories.

Recalled Lot Numbers

Two lots of widely prescribed type 2 diabetes medication, metformin, are being recalled due to possible contamination with potentially cancer-causing compound nitrosamine, or NDMA – an organic chemical used to make liquid rocket fuel. 

The latest news reveals that products under the recall are packaged in HDPE bottles of 100 tablets, under NDC 29033-056-01. The impacted products are Metformin HCl Extended Release Tablets, USP 750 mg lots under NDC 29033-056-01, lot numbers MET200101 as well as MET200301 with the expiration date 05/2022. These products can be identified as off-white oblong tablets debossed with “NM7”.

To date, no adverse health events have been reported related to the recalled products.

NDMA-contaminated Medication

The commonly used drug has been recalled due to high levels of a carcinogen contaminant called N-Nitrosodimethylamine (NDMA), which led to the recall of Zantac tablets earlier this year. NDMA is a common contaminant found in water and grilled or cured meats, however, it can also enter drugs during manufacturing processes. 

Risks associated with nitrosamines remains unclear although the FDA believes that short-term exposure to NDMA at high levels is likely not dangerous. Long-term exposure, on the other hand, is believed to lead to jaundice, nausea, fever, and liver damage as well as an increased risk of cancer.

Widespread Metformin Recall

Both Marksans Pharma Limited, a pharmaceutical company based in India, and Sun Pharmaceutical Industries have recently recalled metformin hydrochloride extended-release tablets as a result of high NDMA levels as part of the 175 different drug combinations affected. However, it appears that immediate release tablets have not been contaminated. 

The recall applies to tablets between 500 mg and 750 mg sold under the brand name Time-Cap Labs, Inc.; a complete list of products identified by their National Drug Code numbers can be found here.

“We recalled one lot of metformin hydrochloride extended-release tablets, after the U.S. FDA tested it and showed results for N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI),” Jordan Berman, Apotex Vice President, Global Corporate Affairs, Transformation & Strategy, told SingleCare in an interview. “Out of an abundance of caution, we extended the recall to all lots of metformin hydrochloride extended-release tablets in the US. Apotex stopped selling this product in the U.S. in February 2019, and there remains only limited product on the market. To date, we have not received any reports of adverse events related to use of the product.”

Current Prescriptions 

For patients currently taking metformin extended release tablets, transitioning to a replacement medication is recommended; they should not abruptly stop taking the medication as this can lead to adverse effects. Alternatives include immediate-release formulas, which are also the most commonly prescribed forms of metformin and are equally effective and often more affordable. 

Per data from the Centers for Disease Control and Prevention, over 34 million people in the United States have diabetes; approximately 90% to 90% of those have been diagnosed with type 2 diabetes. A widespread diabetes medication recall places a significant proportion of the population at risk.

Coupled with the prior recall of the same product this summer, the current recall adds to a growing list of metformin products contaminated with NDMA discovered in the past year. The Food and Drug Administration is continuing to investigate the source of the carcinogen contaminants found in the medication tablets and potential other formulations that may have been affected.