Osteoporosis and heart failure are common, chronic, and costly conditions that share common etiologic factors such as older age, postmenopausal status, and diabetes. Previous studies have suggested that heart failure may predispose a patient to fractures not only because it increases the incidence of falling, but because both heart failure itself and its medical treatments can lead to loss of bone mass.

The researchers conducted a population cohort study consisting of 45,509 adults undergoing bone mineral density testing for the first time and followed them for up to 10 years. Of 45,509 adults included in the study, 1841 had recent-onset heart failure. After adjusting for traditional osteoporosis risk factors, the researchers found that heart failure was associated with a 30% increase in major fractures.

The authors believe that screening for osteoporosis should include a review of chest x-rays for patients with heart failure. These patients tend to undergo many x-rays that often, incidentally, show many fractures of the spine that could provide an indication of severe osteoporosis and need for treatment.

1. Majumdar S, Ezekowitz JA, Lix LM, Leslie L. Heart failure is a clinically and densitometrically independent risk factor for osteoporotic fractures: population-based cohort study of 45,509 subjects. J Clin Endocrinal Metab. 2012. Epub ahead of print. January 18, 2012. Abstract available at: http://jcem.endojournals.org/content/early/2012/01/12/jc.2011-3055.abstract?sid=2c1ac1c3-1fc5-4f25-abd9-cedb116f1c04. Accessed February 3, 2012.

Vismodegib is the first drug approved for metastatic basal cell carcinoma and was reviewed under the agency’s priority review program, which provides for an expedited 6-month review of drugs that may offer major advances in treatment. The drug is being approved ahead of the March 8, 2012, prescription user fee goal date.

Vismodegib is an oral medication taken once daily and works by inhibiting the Hedgehog pathway, a pathway that is active in most basal cell cancers and only a few normal tissues, such as hair follicles. The safety and effectiveness were evaluated in a single, multicenter clinical study in 96 patients with locally advanced or metastatic basal cell carcinoma. The clinical study’s primary endpoint was objective response rate (ORR) or the percentage of patients who experienced complete and partial shrinkage or disappearance of the cancerous lesions after treatment. Of the patients with metastatic disease who received vismodegib, 30% experienced a partial response and 43% of patients with locally advanced disease experienced a complete or partial response.

The most common side effects were muscle spasms, hair loss, weight loss, nausea, diarrhea, fatigue, distorted sense of taste, decreased appetite, constipation, vomiting, and loss of taste function in the tongue.

Vismodegib was approved with a “black box” warning alerting patients and healthcare professionals of the potential risk of death or severe birth defects. Pregnancy status must be verified prior to the start of treatment and both male and female patients should be warned about these risks and the need for birth control.

To read more about vismodegib from Hayes Technology Prognosis Click here.

1. Food and Drug Administration (FDA). News & Events. FDA News Release. January 30, 2012. FDA approves new treatment for most common type of skin cancer. Available at:
   http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm289545.htm. Accessed February 2, 2012.

In 2010, a total of 28,664 organ transplants were performed in the U.S., including 16,899 kidney, 6291 liver, 2333 heart, and 1770 lung transplants. Previous studies have been unable to accurately estimate the risk of both common and rarer cancers among this population.

The research team linked data from the U.S. registry of transplant recipients from 1987 through 2008 with 13 U.S. cancer registries. They observed a twofold overall increased risk of cancer among all U.S. transplant recipients. They also noted elevated risk for 32 different types of cancer, some known to be related to infectious agents (e.g., anal cancer, Kaposi sarcoma) and others unrelated to infections (e.g., melanoma, thyroid cancer).

The most common cancers among transplant recipients were non-Hodgkin’s lymphoma (14.1%), lung cancer (12.6%), liver cancer (8.7%), and kidney cancer (7.1%). The authors carried out additional analyses of these four cancers and, based on known risk and their new study, report the following:

• Non-Hodgkin’s lymphoma is elevated more than sevenfold in transplant recipients, with non-Hodgkin’s lymphoma incidence highest among those who received transplants as children or older adults. Non-Hodgkin’s lymphoma incidence was highest in lung recipients, intermediate in liver and heart recipients, and lowest in kidney recipients.
• Lung cancer risk was highest in lung recipients, with smoking-related disease often the reason for the transplant. The studies of cancer show that among lung recipients, most of whom received a single lung transplant, lung cancer typically arises in the recipient’s remaining diseased lung rather than the transplanted one. The increased risk for lung cancer may also be related to inflammation or chronic lung infections.
• The risk of liver cancer was elevated only among liver recipients, which can be attributed in part to recurrent hepatitis B or C infection in the transplanted liver.
• The risk of kidney cancer is increased for all kidney recipients, due in part to the presence of multiple kidney cysts, which can become cancerous. However, an elevated risk was also observed among recipients of other organs. Therefore, the researchers suggest that the risk for kidney cancer could be partly due to exposure to immune-suppressive medications, which may have direct carcinogenic effects.

1. Engels EA, Pfeiffer RM, Fraumeni JF, et al. Spectrum of cancer risk among US solid organ transplant recipients. JAMA. 2011;306(17):1891-901. Abstract available at: http://www.ncbi.nlm.nih.gov/pubmed/22045767. Accessed February 1, 2012.

In 2010, breast cancer screening rates were 72.4%, below the Healthy People 2020 target of 81%; cervical cancer screening was 83%, below the target of 93%; and colorectal cancer screening was 58.6%, below the target of 70.5%.

The screening rates for all three cancers were significantly lower among Asians compared with other groups, the study found. Hispanics were less likely to be screened for cervical and colorectal cancer when compared with non-Hispanics.

To assess the use of currently recommended cancer screening tests by age, race, ethnicity, education, length of residence in the United States, and the source and financing of healthcare, researchers analyzed data from the 2010 National Health Interview Survey, which tracks progress toward the achievement of Healthy People 2020 objectives.

Significant findings include:

• Screening rates for breast cancer remained relatively stable and varied no more than 3% over the period 2000 to 2010.
• From 2000 to 2010, colorectal cancer screening rates increased markedly for men and women, with the rate for women increasing slightly faster so that rates among both sexes were nearly identical (58.5% for men and 58.8% for women) in 2010.
• From 2000 to 2010, a small but statistically significant downward trend of 3.3% was observed in the rate of women who reported getting a Pap test within the last 3 years.
• Considerably lower breast, cervical, and colorectal cancer screening use was reported by those without any usual source of healthcare or health insurance.

The authors note that this study reinforces the need to identify and track cancer screening disparities. Additionally, the report provides guidance for the development programs to increase the use of screening tests in order to meet Healthy People 2020 targets and simultaneously reduce cancer morbidity and mortality.

According to the authors, the Affordable Care Act is expected to reduce financial barriers to care by expanding insurance coverage. Other efforts are needed such as developing systems that identify individuals eligible for cancer screening tests, actively encouraging the use of screening tests, and monitoring participation to improve screening rates.

1. Klabunde CN, Brown M, Ballard-Barbash R, et al.; Centers for Disease Control and Prevention. Cancer Screening United States, 2010. MMWR Morb Mortal Wkly Rep. 2012;61(03)41-45. Available at:
   http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6103a1.htm?s_cid=mm6103a1_w. Accessed January 30, 2012.

The updated evidence review from AHRQ’s Effective Health Care Program, Comparative Effectiveness of Second Generation Antidepressants in the Pharmacologic Treatment of Adult Depression—An Update to a 2007 Report, reviews the evidence on 13 second-generation antidepressants—bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, fluvoxamine, mirtazapine, nefazodone, paroxetine, sertraline, trazodone, and venlafaxine.

The report updates current evidence on the comparative efficacy, benefits, and harms of second-generation therapies in treating patients with major depressive disorder, dysthymia, and subsyndromal depression. It also highlights areas for future research, including the need for research on the efficacy of second-generation antidepressants in populations with accompanying symptoms such as anxiety, insomnia, pain, or fatigue and in patients who have not responded to initial treatments. Likewise, future research should clarify the differences of second-generation antidepressants in subgroups based on age, sex, race, or ethnicity, and common comorbidities.

Finally, no evidence in this report addresses how second-generation antidepressants compare when a patient responds to one agent and then is required to switch to a different agent (e.g., because of changes in insurance benefit). Because these circumstances may be relevant for many patients, future studies should consider this question.

1. Gartlehner G, Hansen RA, Morgan LC, et al. Comparative Effectiveness of Second Generation Antidepressants in the Pharmacologic Treatment of Adult Depression: An Update of the 2007 Comparative Effectiveness Review. Comparative Effectiveness Review No. 46 (Prepared by the RTI InternationalUniversity of North Carolina Evidence-based Practice Center under Contract No. 290-2007-10056-I). Rockville, MD: Agency for Healthcare Research and Quality. December 2011. AHRQ Publication No. 12-EHC012-EF. Available at: http://www.effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=862. Accessed January 26, 2012.

The researchers analyzed data from the National Hospital Discharge Survey on non–traumatic lower–limb amputations and from the National Health Interview Survey on the prevalence of diagnosed diabetes from 1988 to 2008. The researchers found that the decrease in lower–limb amputation rates was greater among people with diagnosed diabetes compared with those without diabetes. However, the rate in 2008 was still approximately 8 times higher among people with diagnosed diabetes compared with those without it.

The age–adjusted rate of nontraumatic lower–limb amputations was 3.9 per 1000 people with diagnosed diabetes in 2008 compared with 11.2 per 1000 in 1996. Non–traumatic lower–limb amputations refer to those caused by circulatory problems that are a common complication among people with diabetes rather than amputations caused by injuries.

The study also found that, among people with diagnosed diabetes in 2008, men had higher age–adjusted rates of leg and foot amputations than women (6 per 1000 versus 1.9), and blacks had higher rates than whites (4.9 per 1000 versus 2.9). Adults aged 75 years and older had the highest rate—6.2 per 1000—compared with other age groups.

The study authors note that improvements in blood sugar control, foot care, and diabetes management, along with declines in cardiovascular disease, are likely to have contributed to the decline in leg and foot amputations among people with diagnosed diabetes.

In addition to being the leading cause of nontraumatic lower–limb amputations, diabetes is the leading cause of kidney failure and new cases of blindness among adults, and the seventh leading cause of death in the United States. People with diabetes are at increased risk of other complications such as heart attacks, strokes, and high blood pressure.

1. Li Yanfeng, Burrows NR, Gregg EW, Albright A, Geiss LS. Declining rates of hospitalization for nontraumatic lower-extremity amputation in the diabetic population aged 40 years or older: U.S., 1988-2008. Diabetes Care. 2012;35(2):273-277. Abstract available at: http://care.diabetesjournals.org/content/35/2/273.abstract. Accessed January 25, 2012.

The first study, published in the Archives of Internal Medicine, concludes that yoga classes and stretching classes were both more effective in reducing symptoms of chronic back pain than a self-care book for patients. However, yoga was no more effective than stretching classes at any point during the 26-week study, calling into question whether the benefit of yoga was limited to the stretching and not to the mental or behavioral component.

A total of 228 adults with chronic LBP were randomized to 12 weekly yoga classes (n=92), conventional stretching exercise classes (n=91), or a self-care book that provided advice on exercising, lifestyle modifications, and managing flare-ups (n=45). The patients had only moderate back pain and used relatively few prescription medications and opiates for pain relief. The primary outcomes measured were back-related functional status and how much the back pain was bothering the patients. Telephone interviews were conducted at baseline, and at 6, 12, and 26 weeks after randomization.

Back-related dysfunction declined over time in all three groups. Compared with the self-care group, the yoga group reported superior function at 12 and 26 weeks (average difference, –2.5 and –1.8, respectively) and the stretching group reported superior function at 6, 12, and 26 weeks (–1.7, –2.2, –1.5, respectively). There were no statistically or clinically significant differences between the yoga and stretching groups at any time point.

The second study, published in the Annals of Internal Medicine, randomized adults with chronic or recurrent LBP to a 12-session, 3-month yoga program (n=156) or usual care (n=157). The yoga group had better back function but similar back pain and general health scores at 3, 6, and 12 months compared with the usual care group. Eight participants reported adverse events, such as increased pain, that were perhaps related to yoga.

These trials evaluated several safe, inexpensive, and accessible treatment strategies in a real-world population, and determined that two of the interventions provided some improvement in LBP. An accompanying editorial to the first study urges: (1) healthcare providers to refer their patients with LBP to exercise and/or yoga classes; (2) practitioners to standardize their exercise and yoga programs for patients with chronic LBP; and (3) that payers implement a value-based reimbursement policy by minimizing co-payments for these classes.

1. Sherman KJ, Cherkin DC, Wellman RD, et al. A randomized trial comparing yoga, stretching, and a self-care book for chronic low back pain. Arch Intern Med. 2011;171(22):2019-2026. Abstract available at: http://archinte.ama-assn.org/cgi/content/short/archinternmed.2011.524. Accessed January 24, 2012.
2. Tilbrook HE, Cox H, Hewitt CE, et al. Yoga for chronic low back pain: a randomized trial. Ann Intern Med. 2011;155(9):569-578. Abstract available at: http://www.ncbi.nlm.nih.gov/pubmed/22041945. Accessed January 24, 2012.

ICM are frequently used in scans and imaging procedures such as cardiac catheterization and computed tomography (CT) scans. Although certain complications of ICM—such as contrast-induced nephropathy—have been extensively studied, there has been little examination of the effect of ICM on thyroid function.

A team of Boston-based researchers examined data from patients treated between January 1990 and June 2010 who did not have preexisting hyperthyroidism or hypothyroidism. The patients were matched with controls who had normal thyroid function, and claims data were used to assess exposure to ICM.

A total of 178 patients with incident hyperthyroidism and 213 patients with incident hypothyroidism were matched to 655 and 779 euthyroid persons, respectively. The authors found a significant association between exposure to ICM and incident hyperthyroidism (odds ratio [OR], 1.98; 95% confidence interval [CI], 1.08 to 3.60), but not with incident hypothyroidism (OR, 1.58; 95% CI, 0.95 to 2.62).

Secondary analysis indicated an association between ICM and incident overt (clinical [diagnosed based on characteristic clinical features]) hypothyrodism and incident overt (clinical) hyperthyroidism.

Given the pervasive use of ICM in contemporary practice, the authors urge physicians and patients to be aware of the potential thyroidal complications associated with ICM and decide whether to undergo monitoring of thyroid function. This would include patients who might be unable to tolerate thyroid dysfunction, such as those with underlying unstable cardiovascular disease.

1. Rhee CM, Bhan I, Alexander EK, Brunelli SM. Association between iodinated contrast media exposure and incidence hyperthyroidism and hypothyroidism. Arch Intern Med. 2012;172(2):153-159. Abstract available at: http://archinte.ama-assn.org/cgi/content/short/172/2/153. Accessed January 24, 2012.

• The median (50th percentile) length of service in 2010 was 19.7 days, a decrease from 21.1 days in 2009.
• The average length of service dropped to 67.4 days in 2010 from 69 days in 2009.

In other words, half of hospice patients received care for less than 20 days. With drops in both the median and average length of service, there is concern that hospice providers are not reaching the patients and family caregivers who need hospice support in a timely manner.

In previous decades, hospices overwhelmingly cared for people with cancer. In 2010, cancer diagnoses dropped to 35.6% (from 40.1% in 2009). At 14.3%, heart disease—the leading cause of death in the U.S.—is the leading non-cancer diagnosis among hospice patients.