Inhaled Insulin Approved for Treatment of Diabetes

The US Food and Drug Administration (FDA) approved a rapid-acting insulin inhaler (Afrezza, MannKind) to improve gylcemic control in adults with diabetes, according to a press release.1

The product delivers insulin powder via an inhaler, which is intended to be used at the start of a meal. The insulin powder dissolves rapidly upon inhalation to the deep lung. This method of delivery allows insulin to quickly enter the bloodstream, resulting in peak insulin levels within 12 to 15 minutes of administration and a return to pre-use insulin levels at approximately 180 minutes.

“Today's FDA action validates the years of clinical research and commitment that powered the development of this unique therapy,” Alfred Mann, MannKind's CEO said in the press release. “[The drug's] distinct profile and noninjectable administration will address many … unmet needs for mealtime insulin therapy, and has the potential to change the way that diabetes is treated.”

The inhaler is approved for adults with diabetes. For patients with type 1 diabetes, the inhaler must be used in combination with long-acting insulin therapy.

  1. MannKind corporation announces FDA approval of Afrezza; A novel, rapid-acting inhaled insulin for the treatment of diabetes [press release]. Valencia, CA: MannKind Corporation; June 27, 2014.

HIV Diagnosis Rates Dropped by Nearly a Third During Past Decade

The HIV diagnosis rate in the United States has dropped by more than 30% in the past decade, according to a research letter published in JAMA1 Researchers relied on accurate HIV diagnosis data that recently became available for all states.

From 2002 to 2011, 493 372 patients were diagnosed with HIV in the United States. In 2002, 24.1 per 100 000 patients were diagnosed with the disease; by 2011, the number fell to 16.1 per 100 000. The annual diagnosis rate decreased by 33.2% (estimated annual percentage change = -4.0%; 95% CI, -4.1 to -3.9) during that time.

Infections due to injection drug use or heterosexual contact decreased, as did diagnoses in women, people aged 35 to 44, and multiracial people. No change was observed in Asians or Native Hawaiians/Pacific Islanders.

Diagnoses due to male homosexual contact remained stable overall. Diagnoses attributed to male homosexual contact increased among males aged 13 to 24, 45 to 54, and 55 or older, and decreased among males aged 35 to 44. The largest increase was observed in males 13 to 24 (132.5%; estimated annual percentage change = 10.5).

  1. Johnson AS, Hall HI, Hu X, et al. Trends in diagnoses of HIV infection in the United States, 2002-2011. JAMA. 2014;312(4):432-434.

Structured, Moderate-Intensity Physical Activity Reduced Major Mobility Disability in Older Adults

A structured, moderate-intensity physical activity regimen reduced major mobility disability in older adults who were at risk for disability, according to a study published in JAMA.1 The study found that participants enrolled in a physical activity program had fewer incidents of major mobility disability or persistent mobility disability than participants enrolled in a health education program.

The multicenter, randomized trial enrolled 1635 sedentary men and women aged 70 to 89 years who participated for an average of 2.6 years. The participants were recruited from urban, suburban, and rural communities at 8 centers through the US. All participants had physical limitations as defined by their score on the Short Physical Performance Battery; patients who scored a 9 or below but were able to walk 400 m were eligible to participate.

Participants were randomized to a structured, moderate-intensity physical activity program (n = 818) or a health education program (n = 817). The physical activity program included aerobic, resistance, and flexibility training activities done at a center 2 times per week and at home 3 to 4 times per week. The education program consisted of workshops and stretching exercises.

The primary outcome was the rate of major mobility disability, which was defined as the inability to complete a 400-m walk test within 15 minutes without sitting or without the use of a walker or another person. (Use of a cane was accepted.)

Of the 818 participants enrolled in a physical activity program, 246 (30.1%) had an incident of major mobility disability; of the 817 participants in a health education program, 290 (35.5%) had an incident of major mobility disability (hazard ratio [HR], 0.82 [95% CI, 0.69–0.98]; P = .03).

Persistent mobility disability occurred in 120 participants (14.7%) in the physical activity group and 162 participants (19.8%) in the health education group (HR, 0.72 [95% CI, 0.57–0.91]; P = .006). In the physical activity group, 404 participants (49.4%) reported serious adverse events; in the health education group, 373 participants (45.7%) reported severe adverse events (risk ratio 1.08 [95% CI, 0.98–1.20]).

  1. Pahor M, Guralnik JM, Ambrosius WT, et al. Effect of structured physical activity on prevention of major mobility disability in older adults. JAMA. 2014;311(23):2387-2396.

Use of Sildenafil Citrate Linked to Increased Risk of Melanoma, Study Reported

Use of sildenafil citrate was associated with increased risk of melanoma in US men between 2000 and 2010, according to a study published in JAMA. Internal Medicine.1

The prospective cohort study analyzed the incidence rates of skin cancers and use of sildenafil in 25 848 men who participated in the Health Professionals' Follow-up Study in 2000. The study tracked the skin cancers melanoma, squamous cell carcinoma (SCC), and basal cell carcinoma (BCC). Incidence of skin cancer was self-reported, and the diagnosis of melanoma and SCC was pathologically confirmed. Participants who reported cancer at baseline were excluded from the study.

During follow-up from 2000 to 2010, researchers identified 142 cases of melanoma, 580 cases of SCC, and 3030 cases of BCC.

“Recent sildenafil use at baseline was significantly associated with an increased risk of subsequent melanoma with a multivariate-adjusted HR of 1.84 (95% CI, 1.04–3.22),” the researchers wrote. “Ever use of sildenafil was also associated with a higher risk of melanoma (HR, 1.92; 95% CI, 1.14–3.22)…[T]he HR of melanoma was 2.24 (95% CI, 1.05–4.78) for sildenafil use at baseline and 2.77 (1.32–5.85) for ever use.”

Erectile dysfunction was not associated with heightened risk of melanoma. Use of sildenafil was not associated with increased risk of SCC (HR, 0.84; 95% CI, 0.59–1.20) or BCC (HR, 1.08; 0.93–1.25).

  1. Li Q, Qureshi AA, Robinson KC, Han J. Sildenafil use and increased risk of incident melanoma in US men. JAMA Intern Med. 2014;174(6):964-970.

Lifetime Intellectual Enrichment May Delay Onset of Dementia, Alzheimer Disease

Individuals at risk for Alzheimer disease (AD) who engaged in high lifetime intellectual enrichment delayed the onset of cognitive impairment by approximately 8.7 years compared with at-risk individuals who engaged in little lifetime intellectual enrichment, according to a study published in JAMA. Neurology.1

The prospective analysis of individuals enrolled in the Mayo Clinic Study of Aging, which is a longitudinal, population-based study of cognitive aging in Olmsted County, Minnesota, studied 1995 individuals without dementia (1718 with no cognitive impairment and 277 with mild cognitive impairment). All participants completed intellectual lifestyle enrichment measures at baseline and had at least 1 follow-up session.

Researchers documented 2 nonoverlapping principal components for each participant to measure their level of lifetime intellectual enrichment: level of education and occupation, and mid/late-life cognitive activity. Scores for each component were based on self-reported surveys.

Among patients with the APOE4 genotype (ie, at risk for AD), those in the 75th percentile of the education/occupation score and the mid/late-life cognitive activity score delayed the onset of cognitive impairment by approximately 8.7 years compared with patients with the APOE4 genotype who were in the 25th percentile of education/occupation and mid/late-life cognitive activity.

Researchers found that the interaction between the principal components was significant (P < .03): Benefits derived from mid/late-life cognitive activity were reduced with increasing scores in education/occupation.

“Lifetime intellectual enrichment might delay the onset of cognitive impairment and be used as a successful preventive intervention to reduce the impending dementia epidemic,” the study authors wrote.

  1. Vemuri P, Lesnick TG, Przybelski SA, et al. Association of lifetime intellectual enrichment with cognitive decline in the older population [published online ahead of print]. JAMA Neurol. doi:10.1001/jamaneurol.2014.963

Management Structure at Health and Human Services Changed

Sylvia Burwell, the newly approved Secretary of the US Department of Health and Human Services (HHS), announced that several positions have been created at the Centers for Medicare and Medicaid Services (CMS), according to a press release.1 The new management structure is a response to the problems encountered during the rollout of HealthCare.gov and recommendations submitted to Secretary Burwell.

There are 3 new operations-focused positions at CMS: principal deputy administrator, marketplace chief executive officer (CEO), and marketplace chief technology officer (CTO).

HHS announced that it has hired Andy Slavitt for the position of principal deputy administrator. The responsibilities of that position include coordination of Medicare, Medicaid, the Children's Health Insurance Program, and the Marketplace; investigating health care fraud; and reforming health care delivery. Mr. Slavitt, who held the position as group executive vice president for Optum prior to accepting the position at CMS, spent more than 20 years in the private sector.

The marketplace CTO will report to the marketplace CEO and will work with the CMS Office of Information Services “to ensure proper alignment of project milestones and deliverables,” according to the press release.

Neither the marketplace CEO nor marketplace CTO positions have been filled, but CMS is actively recruiting for the position.

  1. Secretary Burwell announces steps to bolster management and accountability ahead of the 2015 open enrollment period [press release]. Washington, DC: US Department of Health and Human Services; June 20, 2014.

One in 25 People Fall Asleep at the Wheel, According to CDC

Among respondents (n = 92 102) to a survey conducted by the US Centers for Disease Control and Prevention (CDC), 4% of drivers over the age of 18 reported falling asleep while driving during the preceding 30 days, according the CDC's Morbidity and Mortality Weekly Report1.

Respondents who slept less than 5 hours per day reported higher rates of drowsy driving (9.1%) compared with those who slept 6 hours (5.2%; P < .001) or at least 7 hours (2.7%; P < .001). Those who reported snoring were more likely than those who did not report snoring to report drowsy driving (5.6% vs 2.9%, respectively; P < .001).

Respondents who reported binge drinking were more likely to report falling asleep while driving than non-binge-drinkers or alcohol abstainers (5.2% vs 4.7% [P = .028] and 3.6% [P < .005], respectively). Falling asleep while driving was reported at a higher rate by those who do not follow seat belt laws than by those who follow seat belt laws (6.6% vs 3.9%, P = .005).

Self-reported smoking status (ie, current smoker, former smoker, never smoker) and education level had no impact on rates of sleeping while driving.

Rates of sleeping while driving decreased with age (linear trend, P < .001). Of drivers aged 18 to 24, 5.9% reported falling asleep while driving; of drivers 65 or older, 1.8% reported falling asleep at the wheel. Men (5.0%) reported higher rates than women (3.0%; P < .001).

  1. Centers for Disease Control and Prevention. Drowsy driving and risk behaviors—10 states and Puerto Rico, 2011-2012. Morbidity and Mortality Weekly Report. 2014:63(26);57-562.

David S. Boyer, MD, is a clinical professor of ophthalmology at the University of Southern California Keck School of Medicine, Department of Ophthalmology, in Los Angeles. He is a member of the Retina Today Editorial Board. Dr. Boyer may be reached at +1-310-854-6201; or via email at vitdoc@aol.com.