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April 2016, Vol 4, No 4 - The Vitals

 

In This Article


 

FDA Issues Draft Guidance for Greater Access to Generic Abuse-Deterrent Opioids

According to a recent announcement by the US Food and Drug Administration (FDA), the agency has taken an important step toward increasing development of—and access to—approved, generic opioids with abuse-deterrent formulations. The draft guidance will ensure that generic opioids are no less abuse-deterrent than their brand-name counterparts. This draft guidance is the latest move by the FDA in accordance with its plan to reassess its approach to opioid medications.

“For the millions of Americans who suffer from significant pain, and the health systems that serve them, generic opioids can be an appropriate and affordable option for patient care,” explained Robert Califf, MD, Commissioner of Food and Drugs, FDA, Silver Spring, MD, in the announcement. “We recognize that abuse-deterrent technology is still evolving and is only one piece of a much broader strategy to combat the problem of opioid abuse. But strongly encouraging innovation to increase access to generic forms of abuse-deterrent opioid medications is an important element in that strategy.”

The guidance encourages development of pain medicines that are tougher to abuse than they already are via abuse-deterrent formulations, which make certain methods for abuse (eg, crushing a tablet so it can be snorted) less rewarding or harder to achieve.

  1. US Food and Drug Administration. FDA takes important step to increase the development of, and access to, abuse-deterrent opioids. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm492237.htm. Updated March 25, 2016. Accessed March 30, 2016.

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Morbidity, Mortality Greatest in Patients Diagnosed with Type 2 Diabetes at a Young Age

The negative impact of diabetes on morbidity and mortality is greatest in patients diagnosed at a young age compared with patients with an onset at an older age, according to the results of a recent study published online first in Diabetes Care.

Abdulghani H. Al-Saeed, Diabetes Centre, Royal Prince Alfred Hospital, Sydney, NSW, Australia, and colleagues conducted a study comparing the occurrence of complications in 354 patients diagnosed with type 2 diabetes between the ages of 15 and 30 years against those in a duration-matched cohort of 1062 patients who were diagnosed with the same condition between the ages of 40 and 50 years.

Although younger, patients who were diagnosed between the ages of 15 and 30 years had more severe albuminuria and neuropathy scores than the patients in the other cohort. Patients diagnosed at a younger age were treated less frequently for hypertension and dyslipidemia, compared with patients who were diagnosed between the ages of 40 and 50 years, but were as commonly affected by metabolic syndrome factors as their counterparts who were diagnosed at older ages.

Dr Al-Saeed and colleagues observed an inverse relationship between standardized mortality ratio and age of diabetes onset, highest in patients diagnosed between the ages of 15 and 30 years.

“The negative effect of diabetes on morbidity and mortality is greatest for those diagnosed at a young age compared with [type 2 diabetes diagnoses] of usual onset,” the authors concluded. “These results highlight the growing imperative to direct attention toward young-onset [type 2 diabetes diagnoses,] and for effective interventions to be applied before middle age.”

  1. Al-Saeed AH, Constantino MI, Molyneaux L, et al. An inverse relationship between age of type 2 diabetes onset and complication risk and mortality: the impact of youth-onset type 2 diabetes. Diabetes Care. 2016 Mar 22. Epub ahead of print.

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Preconception Lifestyle Choices Linked to Early Pregnancy Loss

A couples’ lifestyle choices may be associated with pregnancy loss, including a negative pregnancy test result, onset of menses, or clinical confirmation, according to a recent study published online first in Fertility and Sterility. Lifestyle choices included cigarette smoking, and consumption of multivitamins, alcoholic and caffeinated beverages.

Researchers seeking to continue refinement of preconception guidance examined the incidence of and risk factors for pregnancy loss in a cohort of modern couples whose lifestyles were measured during sensitive reproduction windows (ie, preconception, early pregnancy, and periconception) to identify factors associated with pregnancy loss in the Longitudinal Investigation of Fertility and the Environment Study.

The study, which included 344 couples from 16 counties across Michigan and Texas, did not include any interventions, and involved recording of the couples’ daily use of cigarettes, caffeinated and alcoholic beverages, and multivitamins.

Pregnancy loss was observed in 98 (28%) of 344 women in the study, and associated with women aged ≥35 years, women’s vitamin adherence, and women and men’s consumption of >2 caffeinated drinks daily in the preconception window. Lifestyle findings were similar for participants during the early pregnancy and periconception windows.

Results of the study indicate the likelihood of prepregnancy consumption of caffeinated drinks directly contributing to pregnancy loss.

“Our findings provide useful information for couples who are planning a pregnancy and who would like to minimize their risk for early pregnancy loss,” stated lead author Germaine Buck Louis, PhD, Director, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health (NIH), Bethesda, MD, in a news release from the NIH. “Our findings also indicate that the male partner matters, too…Male preconception consumption of caffeinated beverages was just as strongly associated with pregnancy loss as females’.”

  1. Buck Louis GM, Sapra KJ, Schisterman EF, et al. Lifestyle and pregnancy loss in a contemporary cohort of women recruited before conception: The LIFE Study. Fertil Steril. 2016 Mar 22. Epub ahead of print.
  2. Couples’ pre-pregnancy caffeine consumption linked to miscarriage risk [news release]. Bethesda, MD; Eunice Kennedy Shriver National Institute of Child Health and Human Development; March 24, 2016. www.nih.gov/news-events/news-releases/couples-pre-pregnancy-caffeine-consumption-linked-miscarriage-risk. Accessed March 30, 2016.

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The International Risk for Ebola Spreading Now Low, WHO Says

The risk for transmission of the Ebola virus in West Africa is no longer an extraordinary event, and, internationally, is now low, the World Health Organization (WHO) stated in a recent announcement.

The Emergency Committee, which was convened by the WHO Director-General under the International Health Regulations (IHR), recently held its 9th meeting to discuss the Ebola virus outbreak in West Africa. The WHO Director-General had requested that the Committee provide information on whether or not the outbreak event still constitutes a Public Health Emergency of International Concern (PHEIC), and whether the Temporary Recommendations currently in place should be extended, withdrawn, or revised.

Following presentations from representatives of Guinea, Sierra Leone, and Liberia on the methods by which their respective countries are working to respond to and prevent Ebola reemergence, the Committee noted that the 3 countries had met standards for confirming interruption of their original Ebola virus transmission chains since the Committee’s last meeting.

In particular, the 3 nations impressed the Committee with their rapid detection of, and response to, Ebola case clusters to date—the most recent of which was reported in Guinea on March 17, 2016, and is currently ongoing.

According to the Emergency Committee, Ebola transmission in West Africa is no longer considered an extraordinary event, the risk of the virus spreading internationally is now low, and countries are currently able to respond rapidly to new emergences of the virus. Thus, the Committee promotes the fact that the Ebola event in West Africa is no longer a PHEIC, and termination of the Temporary Recommendations, which were adopted in response to the situation.

In response to the Emergency Committee’s advice, the WHO Director-General assessed the situation and subsequently ended the West African Ebola virus outbreak PHEIC, in accordance with IHR. The Director-General also terminated the Temporary Recommendations, and emphasized how important it is for States Parties to lift any travel or trade restrictions in place with these countries immediately.

  1. World Health Organization. Statement on the 9th meeting of the IHR Emergency Committee regarding the Ebola outbreak in West Africa. www.who.int/mediacentre/news/statements/2016/end-of-ebola-pheic. Published March 29, 2016. Accessed March 30, 2016.

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Active Commuting Independently Associated with Healthier Bodyweight

Recent data indicate that active commuters, including people who bike or walk to work, have significantly healthier bodyweights than people who only use cars. Use of public transport was also associated with significantly lower body fat and body mass index.

Ellen Flint, PhD, and Steven Cummins, PhD, Department of Social and Environmental Health Research, London School of Hygiene & Tropical Medicine, London, UK, sought to examine the association between active commuting (ie, walking, biking, public transportation) and obesity in midlife, using cross-sectional, observational data from UK Biobank collected from men and women aged 40 to 69 years. Data comprised assessments collected from 22 centers across the United Kingdom between 2006 and 2010.

Using self-reported commuting methods, the investigators assessed participants’ body mass indexes and percentage body fat, as well as their self-reported commuting methods, which were split into 7 categories based on level of physical exertion.

“Active commuting was significantly and independently associated with reduced [body mass index] and percentage body fat for both sexes, with a graded pattern apparent across the 7 commuting categories,” the authors reported in their findings.

The first study to use UK Biobank data to address the topic of active commuting and obesity, results demonstrate robust, independent associations between active commuting and healthier body weight and composition.

“These findings support the case for interventions to promote active travel as a population-­level policy response for prevention of obesity in mid-­life,” Dr Flint and Dr Cummins concluded.

  1. Flint E, Cummins S. Active commuting and obesity in mid-life: cross-sectional, observational evidence from UK Biobank. Lancet Diabetes Endocrinol. 2016 Mar 16. Epub ahead of print.

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Last modified: April 28, 2016
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