Public Release: 

ACP strongly recommends generic bisphosphonates for osteoporosis

American College of Physicians

1. ACP strongly recommends treatment with bisphosphonates or denosumab to prevent fractures in women with osteoporosis

ACP's clinical guideline emphasizes the use of generics over brand-name drugs

Guideline: http://annals.org/aim/article/doi/10.7326/M15-1361

Editorial: http://annals.org/aim/article/doi/10.7326/M17-0957

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VIDEO available: HD video soundbites of ACP's president discussing treatment of low bone density or osteoporosis are available to download at http://www.dssimon.com/MM/ACP-osteoporosis-guideline.

The American College of Physicians (ACP) strongly recommends bisphosphonates (alendronate, risedronate, zoledronic acid) or denosumab for reducing fracture risk in women with osteoporosis. ACP advises physicians to prescribe generics over brand name drugs whenever possible and to discuss medication adherence with their patients, especially for bisphosphonates. The American Academy of Family Physicians has endorsed ACP's evidence-based clinical practice guideline, which is published in Annals of Internal Medicine.

ACP recommends against using menopausal estrogen therapy or menopausal estrogen plus progestin therapy or raloxifene for the treatment of osteoporosis in women. Estrogen treatment is associated with serious harms such as increased risk for cerebrovascular accidents and venous thromboembolic events that outweigh the potential benefits.

ACP's guideline focuses on the comparative benefits and risks of short- and long-term drug treatments for low bone density or osteoporosis, including prescriptions, calcium, vitamin D, and estrogen. Evidence suggests that physicians should treat women with osteoporosis with drug therapy for 5 years. ACP recommends against bone density monitoring during the 5-year treatment period because the evidence does not show any benefit for monitoring during treatment. The evidence also does not support frequent monitoring of women with normal bone density for osteoporosis, as most women with normal bone density measurements did not progress to osteoporosis within 15 years.

Physicians should offer bisphosphonates to reduce the risk for vertebral fractures in men with known osteoporosis. The decision to treat osteopenic women 65 years of age or older who are at a high risk for fracture should be based on a discussion of patient preferences; fracture risk profile; and the benefits, harms, and costs of medications.

Osteoporosis is an enormous public health problem affecting about half of all Americans over the age of 50. The author of an editorial from Oregon Health and Science University in Portland writes that ACP's recommendation to offer bisphosphonates or denosumab to women with osteoporosis is particularly important because, despite the wealth of evidence, osteoporosis remains underdetected and undertreated. ACP's guideline provides a solid basis for informed clinical decision-making.

Media contact: For an embargoed PDF, please contact or an interview with someone from ACP, please contact Steve Majewski at SMajewski@acponline.org or 215-351-2514.

2. Hepatitis C on the rise among reproductive-aged women

Findings suggest a need for routine HCV screening for pregnant women

Abstract: http://annals.org/aim/article/doi/10.7326/M16-2350

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The number of hepatitis C virus (HCV) cases reported in reproductive-aged women in the United States has increased substantially in recent years. Thus, more children are being born to HCV-infected mothers than at any time since HCV became detectable. The findings, published in Annals of Internal Medicine, suggest a need for routine HCV screening during pregnancy.

The incidence of HCV infection has increased among young persons who inject drugs, about half of whom are women of reproductive age. As such, concerns have arisen about the risk of HCV transmission from pregnant women to their infants.

To assess the extent of HCV infection in reproductive-aged and pregnant women, as well as in infants born to them, researchers from the Centers for Disease Control and Prevention (CDC) analyzed two of the largest population data sets available in the United States - the National Notifiable Diseases Surveillance System (NNDSS) of the CDC and the Quest Diagnostics Health Trends national database. The data showed that HCV cases essentially doubled among reproductive-aged women between 2006 and 2014, from 15,550 to 31,039.

Applying the Quest HCV infection rate among pregnant women to annual live births, about 29,000 HCV-infected women give birth each year, meaning that about 1,700 infants would acquire HCV this way annually. However, only 200 childhood cases are reported to the NNDSS each year, suggesting that cases are underreported. According to the researchers, these findings should inform discussions about HCV screening programs for pregnant women.

Media contacts: For an embargoed PDF, please contact Cara Graeff. To speak with the lead author, Kathleen N. Ly, MPH at the CDC, please contact Brian Katzowitz, MS, at bkatzowitz@cdc.gov or 404-639-1470.

3. EpiPens still potent long after expiration date

Findings suggest that the process for establishing expiration dates for EpiPens should be revised

Abstract: http://annals.org/aim/article/doi/10.7326/L16-0612

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EpiPen products can retain substantial amounts of epinephrine well beyond their expiration dates. Although concentrations of epinephrine decline over time, the dose available 50 months after expiration would likely still provide beneficial pharmacologic response. The findings are published in Annals of Internal Medicine.

Researchers at California Poison Control System in San Diego collected 31 unused, expired EpiPens from patients and practitioners at a community clinic over a 2-week period. The pens were examined for color changes and expiration date and two separate samples from each pen were quantitatively analyzed for epinephrine concentration. The researchers found that none of the pens were discolored and all were 1 to 50 months past expiration. Sixty-five percent of the EpiPens and 56 percent of the EpiPen Jrs contained at least 90 percent of their stated amount of epinephrine.

The researchers conclude that expiration dates for EpiPen products should be reexamined. Since 2007, the price of EpinPen products has risen more than 400 percent.

Media contacts: For an embargoed PDF, please contact Cara Graeff. Lead author, Lee Cantrell, PharmD, can be reached directly at lcantrell@calpoison.org or 858-715-6303.

4. Antibiotics often overprescribed in elderly patients

Later-career physicians and those in high-volume practices were more likely to prescribe antibiotics for nonbacterial acute upper respiratory infections

Abstract: http://annals.org/aim/article/doi/10.7326/M16-1131

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Nearly 1 in 2 elderly patients who visited a primary care physician for a nonbacterial acute upper respiratory infection received an antibiotic, despite opposing advice from clinical guidelines. The study found that later-career physicians and those in busier practices were more likely to overprescribe antibiotics. The findings are published in Annals of Internal Medicine.

Unnecessary antibiotic use is a major public health issue associated with adverse drug events, increased health care costs, and the emergence of antibiotic-resistant infections. It is important to understand the factors associated with antibiotic overprescribing so that interventions can be developed to reduce the practice.

Researchers at the Institute for Clinical Evaluative Sciences (ICES) Western site and Lawson Health Research Institute in London, Ontario, Canada, reviewed health records for 185,014 elderly patients (>65 years) who saw their primary care physician for a nonbacterial acute upper respiratory infection, including the common cold, acute bronchitis, acute sinusitis, or acute laryngitis. Their goal was to determine the prevalence of antibiotic prescribing for these patients and whether prescribing rates varied by physician characteristics.

The data showed that 46 percent of patients received an antibiotic prescription for their nonbacterial acute upper respiratory infection. Patients who received antibiotic prescriptions were more commonly managed by physicians with high daily patient volumes, mid- or late-career physicians, and physicians who received their medical training outside of the U.S. or Canada.

These finding suggest that interventions aimed at reducing physician pressures for high patient volumes could help to curb inappropriate antibiotic prescribing.

Media contacts: For an embargoed PDF, please contact Cara Graeff. To speak with the lead author, Michael S. Silverman MD, FACP, FRCPC, please contact Robert DeLaet, Communications & External Relations, Lawson Health Research Institute (http://www.lawsonresearch.ca), at 519-685-8500 ext. 75664 or robert.delaet@lawsonresearch.com.

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