The U.S. Food and Drug Administration today approved Exondys 51 (eteplirsen) injection, the first drug approved to treat patients with Duchenne muscular dystrophy (DMD). Exondys 51 is specifically indicated for patients who have a confirmed mutation of the dystrophin gene amenable to exon 51 skipping, which affects about 13 percent of the population with DMD.
from Food and Drug Administration--Press Releases http://ift.tt/2cTaI9X
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Monday, September 19, 2016
Changes in Medication Use After Dementia Diagnosis in an Observational Cohort of Individuals with Diabetes Mellitus - American Geriatric Society
Objectives
To assess changes in medication use after a diagnosis of dementia in individuals with type 2 diabetes mellitus.
Design
Difference-in-differences analysis of changes in the number of dispensed chronic medications between individuals with and without newly diagnosed dementia.
Setting
Integrated healthcare delivery system, Kaiser Permanente Northern California.
Participants
Individuals aged 50 and older without prevalent dementia with type 2 diabetes mellitus enrolled in a baseline survey. During 5 years of follow-up, 193 individuals with a new diagnosis of dementia were identified, and risk-set sampling was used to randomly select five reference subjects per case matched on 5-year age categories and sex (965 matched participants), resulting in an analytical sample of 1,158.
Measurements
The exposure was new diagnosis of dementia. The primary outcome was change in number of current chronic medications (total, cardiovascular (blood pressure and lipid control), diabetes mellitus) at three times: 1 year before index date (preindex date), date of diagnosis of dementia or matched reference date (index date), and up to 1 year after index date or end of follow-up if censored before 1 year (postindex date).
Results
After adjustment, the number of chronic medications and the subset of cardiovascular medications declined after a dementia diagnosis in the overall cohort and in age-, sex-, and time-matched reference individuals, but the decline was significantly greater in the group with dementia (0.71 medications fewer than the reference group, P = .02). The number of diabetes mellitus medications declined in both groups, but the declines were not statistically different (0.18 medications fewer than the reference group, P = .008).
Conclusions
Use of cardiometabolic medications fell after a diagnosis of dementia, as recommended in national guidelines.
from Journal of the American Geriatrics Society http://ift.tt/2cM1Z5R
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Weight Loss Interventions in Older Adults with Obesity: A Systematic Review of Randomized Controlled Trials Since 2005 - American Geriatric Society
Objectives
To identify geriatric obesity interventions that can guide clinical recommendations.
Design
Systematic review using Medline (PubMed), Cochrane Central Register of Controlled Trials, Web of Science, CINAHL, EMBASE (Ovid), and PsycINFO (Proquest) from January 1, 2005, to October 12, 2015, to identify English-language randomized controlled trials.
Participants
Individuals aged 60 and older (mean age ≥65) and classified as having obesity (body mass index ≥30 kg/m2).
Interventions
Behavioral weight loss interventions not involving pharmacological or procedural therapies lasting 6 months or longer.
Measurements
Two investigators performed the systematic review using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses criteria and achieved a high concordance rate (97.3%) in summarizing the primary outcomes. The three primary outcomes were weight loss, physical performance, and quality of life.
Results
Of 5,741 citations, 19 were included. (Six studies were unique, and the remaining 13 were based on the same study population.) Duration ranged from 6 to 18 months (n = 405 participants, age range 66.7–71.1). Weight loss in the intervention groups ranged from 0.5 to 10.7 kg (0.1–9.3%). Five studies had a resistance exercise program accompanying a dietary component. Greater weight loss was observed in groups with a dietary component than those with exercise alone. Exercise alone led to better physical function but no significant weight loss. Combined dietary and exercise components led to the greatest improvement in physical performance measures and quality of life and mitigated reductions in muscle and bone mass observed in diet-only study arms. Heterogeneous outcomes were observed, which limited the ability to synthesize the data quantitatively.
Conclusions
The evidence supporting geriatric obesity interventions to improve physical function and quality of life is of low to moderate quality. Well-designed trials are needed in this population.
from Journal of the American Geriatrics Society http://ift.tt/2conAUK
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Hypertension Treatment and Concern About Falling: Baseline Data from the Systolic Blood Pressure Intervention Trial - American Geriatric Society
Objectives
To determine the extent of concern about falling in older adults with hypertension, whether lower blood pressure (BP) and greater use of antihypertensive medications are associated with greater concern about falling, and whether lower BP has a greater effect on concern about falling in older and more functionally impaired individuals.
Design
Secondary analysis involving cross-sectional study of baseline characteristics of participants enrolled in the Systolic Blood Pressure Intervention Trial (SPRINT).
Setting
Approximately 100 outpatient sites.
Participants
SPRINT enrollees aged 50 and older (mean age 69) diagnosed with hypertension (N = 2,299).
Measurements
Concern about falling was determined using the shortened version of the Falls Efficacy Scale International as measured at the baseline examination.
Results
Mild concern about falling was present in 29.3% of participants and moderate to severe concern in 17.9%. Neither low BP (systolic BP<120 mmHg, diastolic BP <70 mmHg) nor orthostatic hypotension was associated with concern about falling (P > .10). Participants with moderate to severe concern about falling were taking significantly more antihypertensive medications than those with mild or no concern. After adjusting for baseline characteristics, no associations were evident between BP, medications, and concern about falling. Results were similar in older and younger participants; interactions between BP and age and functional status were not significantly associated with concern about falling.
Conclusion
Although concern about falling is common in older adults with hypertension, it was not found to be associated with low BP or use of more antihypertensive medications in baseline data from SPRINT.
from Journal of the American Geriatrics Society http://ift.tt/2cjqFqu
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Physical Restraints: Consensus of a Research Definition Using a Modified Delphi Technique - American Geriatric Society
Objectives
To develop an internationally accepted research definition of physical restraint.
Design
Comprehensive literature search followed by a web-based, three-round, modified Delphi technique comprising reviews and feedback.
Setting
Clinical care settings.
Participants
An international group of 48 experts consisting of researchers and clinicians from 14 countries who have made sustained contribution to research and clinical application in the field of physical restraint in clinical care.
Measurements
Data were collected using an online survey program and one in-person meeting. Results of the online survey and the in-person meeting were used for distribution in subsequent rounds until consensus on a definition was reached. Consensus was defined as 90% of the participating experts agreeing with the proposed definition of physical restraint.
Results
Thirty-four different definitions were identified during the literature search and served as a starting point for the modified Delphi technique. After three rounds, 45 (95.7%) of 47 remaining experts agreed with the newly proposed definition: “Physical restraint is defined as any action or procedure that prevents a person's free body movement to a position of choice and/or normal access to his/her body by the use of any method, attached or adjacent to a person's body that he/she cannot control or remove easily.”
Conclusion
A multidisciplinary, internationally representative panel of experts reached consensus on a research definition for physical restraints in older persons. This is a necessary step toward improved comparisons of the prevalence of physical restraint use across studies and countries. This definition can further guide research interventions aimed at reducing use of physical restraints.
from Journal of the American Geriatrics Society http://ift.tt/2cjpPdC
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