Category: Internal Medicine

Hot Topics: FDA Approves First Drug For Severe Multiple Sclerosis

FDA approves new drug to treat multiple sclerosis

Food and Drug Administration, U.S. Department of Health and Human Services. (2017). FDA approves new drug to treat multiple sclerosis. Retrieved from https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm549325.htm.

On March 28, the U.S. Food and Drug Administration approved Ocrevus (ocrelizumab) to treat adult patients with relapsing forms of multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS). This is the first drug approved by the FDA for PPMS. Ocrevus is an intravenous infusion given by a health care professional.

“Multiple sclerosis can have a profound impact on a person’s life,” said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “This therapy not only provides another treatment option for those with relapsing MS, but for the first time provides an approved therapy for those with primary progressive MS.”

Posted in Central Nervous System Disorders, Front Page, Hot Topics in Research

Hot Topics: Cardiologists Weigh In On Nutrition Facts and Fads

Trending Cardiovascular Nutrition Controversies

Freeman AM, Morris PB, Barnard N, et al. Trending cardiovascular nutrition controversies. J Am Coll Cardiol. 2017;69(9):1172-1187. http://dx.doi.org/10.1016/j.jacc.2016.10.086.

The potential cardiovascular benefits of several trending foods and dietary patterns are still incompletely understood, and nutritional science continues to evolve. However, in the meantime, a number of controversial dietary patterns, foods, and nutrients have received significant media exposure and are mired by hype. This review addresses some of the more popular foods and dietary patterns that are promoted for cardiovascular health to provide clinicians with accurate information for patient discussions in the clinical setting.

Posted in Cardiology, Hot Topics in Research, Nutrition

Hot Topics: More Species of Mosquitos Than Previously Thought May Transmit Zika

Data-driven identification of potential Zika virus vectors

Evans MV, Dallas TA, Han BA, Murdock CC, Drake JM. Data-driven identification of potential zika virus vectors. eLife. 2017;6:e22053. https://dx.doi.org/10.7554/eLife.22053.

Zika is an emerging virus whose rapid spread is of great public health concern. Knowledge about transmission remains incomplete, especially concerning potential transmission in geographic areas in which it has not yet been introduced. To identify unknown vectors of Zika, we developed a data-driven model linking vector species and the Zika virus via vector-virus trait combinations that confer a propensity toward associations in an ecological network connecting flaviviruses and their mosquito vectors. Our model predicts that thirty-five species may be able to transmit the virus, seven of which are found in the continental United States, including Culex quinquefasciatus and Cx. pipiens. We suggest that empirical studies prioritize these species to confirm predictions of vector competence, enabling the correct identification of populations at risk for transmission within the United States.

Posted in Hot Topics in Research, Infectious Disease

Hot Topics: Gum Disease a Warning Sign for Diabetes

Teeuw WJ, Kosho MXF, Poland DCW, Gerdes VEA, Loos BG. Periodontitis as a possible early sign of diabetes mellitus. BMJ Open Diab Res Care. 2017;5(1). http://dx.doi.org/10.1136/bmjdrc-2016-000326.

Objective The early diagnosis of (pre)diabetes mellitus is essential for the prevention of diabetes complications. It has been suggested that gum disease (periodontitis) might be an early complication of diabetes and may be a useful risk indicator for diabetes screening. Therefore, a dental office could be a good location for screening for (pre)diabetes in patients with periodontitis using a validated glycated hemoglobin (HbA1c) dry spot analysis.

Research design and methods A total of 313 individuals from a university dental clinic participated. From 126 patients with mild/moderate periodontitis, 78 patients with severe periodontitis and 109 subjects without periodontitis, HbA1c values were obtained by the analysis of dry blood spots. Differences in mean HbA1c values and the prevalence of (pre)diabetes between the groups were analyzed.

Results The mild/moderate and severe periodontitis groups showed significantly higher HbA1c values (6.1%±1.4% (43 mmol/mol±15 mmol/mol) and 6.3%±1.3% (45 mmol/mol±15 mmol/mol), respectively) compared with the control group (5.7%±0.7% (39 mmol/mol±8 mmol/mol), p=0.003). In addition, according to the American Diabetes Association (ADA) guidelines for diagnosis, there was a significant over-representation of subjects with suspected diabetes (23% and 14%) and pre-diabetes (47% and 46%) in the severe periodontitis group and mild/moderate periodontitis groups, respectively, compared with the control group (10% and 37%, p=0.010). Notably, 18.1% of patients with suspected new diabetes were found among subjects with severe periodontitis compared with 9.9% and 8.5% among subjects with mild/moderate periodontitis and controls, respectively (p=0.024).

Conclusions The dental office, with particular focus on patients with severe periodontitis, proved to be a suitable location for screening for (pre)diabetes; a considerable number of suspected new diabetes cases were identified. The early diagnosis and treatment of (pre)diabetes help to prevent more severe complications and benefit the treatment of periodontitis.

Posted in Diabetes, Hot Topics in Research

Hot Topics: Stem Cell Transplants May Slow Progression of Multiple Sclerosis

Long-term Outcomes After Autologous Hematopoietic Stem Cell Transplantation for Multiple Sclerosis

Muraro PA, Pasquini M, Atkins HL,et al. Long-term outcomes after autologous hematopoietic stem cell transplantation for multiple sclerosis. JAMA Neurology. 2017. http://dx.doi.org/10.1001/jamaneurol.2016.5867.

Importance  Autologous hematopoietic stem cell transplantation (AHSCT) may be effective in aggressive forms of multiple sclerosis (MS) that fail to respond to standard therapies.

Objective  To evaluate the long-term outcomes in patients who underwent AHSCT for the treatment of MS in a large multicenter cohort.

Design, Setting, and Participants  Data were obtained in a multicenter, observational, retrospective cohort study. Eligibility criteria were receipt of AHSCT for the treatment of MS between January 1995 and December 2006 and the availability of a prespecified minimum data set comprising the disease subtype at baseline; the Expanded Disability Status Scale (EDSS) score at baseline; information on the administered conditioning regimen and graft manipulation; and at least 1 follow-up visit or report after transplant. The last patient visit was on July 1, 2012. To avoid bias, all eligible patients were included in the analysis regardless of their duration of follow-up. Data analysis was conducted from September 1, 2014 to April 27, 2015.

Exposures  Demographic, disease-related, and treatment-related exposures were considered variables of interest, including age, disease subtype, baseline EDSS score, number of previous disease-modifying treatments, and intensity of the conditioning regimen.

Main Outcomes and Measures  The primary outcomes were MS progression-free survival and overall survival. The probabilities of progression-free survival and overall survival were calculated using Kaplan-Meier survival curves and multivariable Cox proportional hazards regression analysis models.

Results  Valid data were obtained from 25 centers in 13 countries for 281 evaluable patients, with median follow-up of 6.6 years (range, 0.2-16 years). Seventy-eight percent (218 of 281) of patients had progressive forms of MS. The median EDSS score before mobilization of peripheral blood stem cells was 6.5 (range, 1.5-9). Eight deaths (2.8%; 95% CI, 1.0%-4.9%) were reported within 100 days of transplant and were considered transplant-related mortality. The 5-year probability of progression-free survival as assessed by the EDSS score was 46% (95% CI, 42%-54%), and overall survival was 93% (95% CI, 89%-96%) at 5 years. Factors associated with neurological progression after transplant were older age (hazard ratio [HR], 1.03; 95% CI, 1.00-1.05), progressive vs relapsing form of MS (HR, 2.33; 95% CI, 1.27-4.28), and more than 2 previous disease-modifying therapies (HR, 1.65; 95% CI, 1.10-2.47). Higher baseline EDSS score was associated with worse overall survival (HR, 2.03; 95% CI, 1.40-2.95).

Conclusions and Relevance  In this observational study of patients with MS treated with AHSCT, almost half of them remained free from neurological progression for 5 years after transplant. Younger age, relapsing form of MS, fewer prior immunotherapies, and lower baseline EDSS score were factors associated with better outcomes. The results support the rationale for further randomized clinical trials of AHSCT for the treatment of MS.

Posted in Hot Topics in Research, Neurology

Hot Topics: Financial Concerns Hinder Younger Cancer Survivors’ Treatment Compliance

Do cancer survivors change their prescription drug use for financial reasons? Findings from a nationally representative sample in the United States

Zheng Z, Han X, Guy GP, et al. Do cancer survivors change their prescription drug use for financial reasons? Findings from a nationally representative sample in the United States. Cancer. 2017:n/a-n/a. http://dx.doi.org/10.1002/cncr.30560.

BACKGROUND
There is limited evidence from nationally representative samples about changes in prescription drug use for financial reasons among cancer survivors in the United States.
METHODS
The 2011 to 2014 National Health Interview Survey was used to identify adults who reported ever having been told they had cancer (cancer survivors; n = 8931) and individuals without a cancer history (n = 126,287). Measures of changes in prescription drug use for financial reasons included: 1) skipping medication doses, 2) taking less medicine, 3) delaying filling a prescription, 4) asking a doctor for lower cost medication, 5) buying prescription drugs from another country, and 6) using alternative therapies. Multivariable logistic regression analyses were controlled for demographic characteristics, number of comorbid conditions, interactions between cancer history and number of comorbid conditions, and health insurance coverage. Main analyses were stratified by age (nonelderly, ages 18-64 years; elderly, ages ≥65 years) and time since diagnosis (recently diagnosed, <2 years; previously diagnosed, ≥2 years).
RESULTS
Among nonelderly individuals, both recently diagnosed (31.6%) and previously diagnosed (27.9%) cancer survivors were more likely to report any change in prescription drug use for financial reasons than those without a cancer history (21.4%), with the excess percentage changes for individual measures ranging from 3.5% to 9.9% among previously diagnosed survivors and from 2.6% to 2.7% among recently diagnosed survivors (P < .01). Elderly cancer survivors and those without a cancer history had comparable rates of changes in prescription drug use for financial reasons.
CONCLUSIONS
Nonelderly cancer survivors are particularly vulnerable to changes in prescription drug use for financial reasons, suggesting that targeted efforts are needed. Cancer 2017. © 2017 American Cancer Society.
Posted in Hot Topics in Research, Oncology

Hot Topics: Larger Racial Disparity in Cervical Cancer Gap Than Previously Estimated

Hysterectomy-corrected cervical cancer mortality rates reveal a larger racial disparity in the United States

Beavis AL, Gravitt PE, Rositch AF. Hysterectomy-corrected cervical cancer mortality rates reveal a larger racial disparity in the United States. Cancer. 2017. http://dx.doi.org/10.1002/cncr.30507.

BACKGROUND
The objectives of this study were to determine the age-standardized and age-specific annual US cervical cancer mortality rates after correction for the prevalence of hysterectomy and to evaluate disparities by age and race.

METHODS
Estimates for deaths due to cervical cancer stratified by age, state, year, and race were derived from the National Center for Health Statistics county mortality data (2000-2012). Equivalently stratified data on the prevalence of hysterectomy for women 20 years old or older from the Behavioral Risk Factor Surveillance System survey were used to remove women who were not at risk from the denominator. Age-specific and age-standardized mortality rates were computed, and trends in mortality rates were analyzed with Joinpoint regression.

RESULTS
Age-standardized rates were higher for both races after correction. For black women, the corrected mortality rate was 10.1 per 100,000 (95% confidence interval [CI], 9.6-10.6), whereas the uncorrected rate was 5.7 per 100,000 (95% CI, 5.5-6.0). The corrected rate for white women was 4.7 per 100,000 (95% CI, 4.6-4.8), whereas the uncorrected rate was 3.2 per 100,000 (95% CI, 3.1-3.2). Without the correction, the disparity in mortality between races was underestimated by 44%. Black women who were 85 years old or older had the highest corrected rate: 37.2 deaths per 100,000. A trend analysis of corrected rates demonstrated that white women’s rates decreased at 0.8% per year, whereas the annual decrease for black women was 3.6% (P < .05).

CONCLUSIONS
A correction for hysterectomy has revealed that cervical cancer mortality rates are underestimated, particularly in black women. The highest rates are seen in the oldest black women, and public health efforts should focus on appropriate screening and adequate treatment in this population. Cancer 2017. © 2017 American Cancer Society.

Posted in Front Page, Hot Topics in Research, Oncology

Hot Topics: New Free Database Crowdsources Cancer Mutation Research

CIViC is a Community Knowledgebase for Expert Crowdsourcing the Clinical Interpretation of Variants in Cancer

Griffith M, Spies NC, Krysiak K, et al. CIViC is a community knowledgebase for expert crowdsourcing the clinical interpretation of variants in cancer. Nat Genet. 2017;49(2):170-174. http://dx.doi.org/10.1038/ng.3774.

CIViC is an expert-crowdsourced knowledgebase for Clinical Interpretation of Variants in Cancer describing the therapeutic, prognostic, diagnostic and predisposing relevance of inherited and somatic variants of all types. CIViC is committed to open-source code, open-access content, public application programming interfaces (APIs) and provenance of supporting evidence to allow for the transparent creation of current and accurate variant interpretations for use in cancer precision medicine.

Posted in Front Page, Hot Topics in Research, Oncology

Hot Topics: Women in Poverty More at Risk for Heart Attacks Than Men

Sex differences in the relationship between socioeconomic status and cardiovascular disease: A systematic review and meta-analysis

Backholer K, Peters SAE, Bots SH, Peeters A, Huxley RR, Woodward M. Sex differences in the relationship between socioeconomic status and cardiovascular disease: A systematic review and meta-analysis. Journal of Epidemiology and Community Health. 2016. http://dx.doi.org/10.1136/jech-2016-207890.

Background Low socioeconomic status (SES) is a known risk factor for cardiovascular disease (CVD) but whether its effects are comparable in women and men is unknown.

Methods PubMed MEDLINE was systematically searched. Studies that reported sex-specific estimates, and associated variability, of the relative risk (RR) for coronary heart disease (CHD), stroke or CVD according to a marker of SES (education, occupation, income or area of residence), for women and men were included. RRs were combined with those derived from cohort studies using individual participant data. Data were pooled using random effects meta-analyses with inverse variance weighting. Estimates of the ratio of the RRs (RRR), comparing women with men, were computed.

Results Data from 116 cohorts, over 22 million individuals, and over 1 million CVD events, suggest that lower SES is associated with increased risk of CHD, stroke and CVD in women and men. For CHD, there was a significantly greater excess risk associated with lower educational attainment in women compared with men; comparing lowest with highest levels, the age-adjusted RRR was 1.24 (95% CI 1.09 to 1.41) and the multiple-adjusted RRR was 1.34 (1.09 to 1.63). For stroke, the age-adjusted RRR was 0.93 (0.72 to 1.18), and the multiple-adjusted was RRR 0.79 (0.53 to 1.19). Corresponding results for CVD were 1.18 (1.03 to 1.36), 1.23 (1.03 to 1.48), respectively. Similar results were observed for other markers of SES for all three outcomes.

Conclusions Reduction of socioeconomic inequalities in CHD and CVD outcomes might require different approaches for men and women.

Posted in Cardiology, Front Page, Hot Topics in Research

Hot Topics: Bed Cycling Safe for ICU Patients

TryCYCLE: A Prospective Study of the Safety and Feasibility of Early In-Bed Cycling in Mechanically Ventilated Patients

Kho ME, Molloy AJ, Clarke FJ, et al. TryCYCLE: A prospective study of the safety and feasibility of early in-bed cycling in mechanically ventilated patients. PLOS ONE. 2016;11(12):e0167561.

Introduction

The objective of this study was to assess the safety and feasibility of in-bed cycling started within the first 4 days of mechanical ventilation (MV) to inform a future randomized clinical trial.

Methods

We conducted a 33-patient prospective cohort study in a 21-bed adult academic medical-surgical intensive care unit (ICU) in Hamilton, ON, Canada. We included adult patients (≥ 18 years) receiving MV who walked independently pre-ICU. Our intervention was 30 minutes of in-bed supine cycling 6 days/week in the ICU. Our primary outcome was Safety (termination), measured as events prompting cycling termination; secondary Safety (disconnection or dislodgement) outcomes included catheter/tube dislodgements. Feasibility was measured as consent rate and fidelity to intervention. For our primary outcome, we calculated the binary proportion and 95% confidence interval (CI).

Results

From 10/2013-8/2014, we obtained consent from 34 of 37 patients approached (91.9%), 33 of whom received in-bed cycling. Of those who cycled, 16(48.4%) were female, the mean (SD) age was 65.8(12.2) years, and APACHE II score was 24.3(6.7); 29(87.9%) had medical admitting diagnoses. Cycling termination was infrequent (2.0%, 95% CI: 0.8%-4.9%) and no device dislodgements occurred. Cycling began a median [IQR] of 3 [2, 4] days after ICU admission; patients received 5 [3, 8] cycling sessions with a median duration of 30.7 [21.6, 30.8] minutes per session. During 205 total cycling sessions, patients were receiving invasive MV (150 [73.1%]), vasopressors (6 [2.9%]), sedative or analgesic infusions (77 [37.6%]) and dialysis (4 [2.0%]).

Conclusions

Early cycling within the first 4 days of MV among hemodynamically stable patients is safe and feasible. Research to evaluate the effect of early cycling on patient function is warranted.

Posted in Critical Care, Hot Topics in Research, January, Physical Therapy