News & Analysis
Clinical Trials Update
Tranexamic Acid Improves Outcomes
in TBI
Tranexamic acid reduces the risk of death
from mild to moderate traumatic brain in-
jury (TBI) when treatment is delivered within
3 hours, according to a trial in the Lancet.
The study randomized 12 737 patients
with TBI to receive tranexamic acid (loading
dose 1 g over 10 minutes then infusion of 1 g
over 8 hours) or placebo. About 72% of pa-
tients were treated within 3 hours of injury.
The risk of injury-related death within 28
days was 18.5% in the tranexamic acid group
compared with 19.8% in the placebo group
among patients treated within 3 hours. How-
ever, tranexamic acid reduced death in pa-
tients with mild to moderate TBI but not in pa-
tients with severe head injury who already
had extensive intracranial hemorrhage be-
fore treatment. When patients with severe
TBI were excluded from the analysis, the risk
of death was 12.5% in the tranexamic acid
group vs 14.0% in the placebo group.
Free Medications Boost Treatment
Adherence
Distributing free medications to primary care
patients who could not afford them im-
proved adherence to treatment, reported a
trial in JAMA Internal Medicine.
The 786 patients at 9 primary care prac-
tices in Canada were randomly assigned to
receive free essential medicines from a list
of 128 for acute conditions (such as antibi-
otics and analgesics) and chronic condi-
tions (antipsychotics, antiretrovirals, and
blood pressure and diabetes medications),
or to usual medicine access. All participants
received usual care.
After 1 year, 38.2% of participants receiv-
ing free medications were adherent to all their
medicationscomparedwith26.6%ofthecon-
trol group. Blood pressure improved among
thosewhoreceivedfreemedication,butthere
were no significant differences in hemoglo-
bin A1c level or low-density lipoprotein cho-
lesterol levels between groups.
Statins in Childhood May Reduce CVD
From Familial Hypercholesterolemia
Patients with familial hypercholesterol-
emia who took a statin in childhood had
jama.com
© 2019 American Medical Association. All rights reserved.
Downloaded From: https://jamanetwork.com/ by a McMaster University User on 12/21/2019
a lower risk of cardiovascular disease (CVD),
reported a 20-year follow-up study in the
New England Journal of Medicine.
The follow-up study examined cardiovas-
cular outcomes from 184 of 214 patients with
familial hypercholesterolemia who partici-
pated in the original placebo-controlled trial
evaluating 2-year pravastatin efficacy and
safety. Participants began taking the statin
when they were between 8 and 18 years old;
the mean age at follow-up was 31.7 years. The
investigatorscomparedcardiovascularevents
between the now adult participants and their
affected parents, for whom statins weren’t
available until later in life.
The cumulative incidence of cardiovas-
cular events at age 39 years was 1% among
those who received statins in childhood
compared with 26% among affected par-
ents. None of the trial participants died of
cardiovascular disease before age 40 years
compared with 7% of their parents.
Circadian Timing of Medications
Affects CVD Outcomes
Patients with hypertension who took all their
blood pressure medications at bedtime in-
stead of on awakening had better ambula-
tory blood pressure (ABP) control and lower
risk of cardiovascular disease (CVD), con-
cluded a trial in the European Heart Journal.
The 19 084 patients were assigned to
take their daily dose of at least 1 hyperten-
sion medication at bedtime or on awaken-
ing. At every scheduled clinic visit, ABP moni-
toring was performed for 48 hours.
During the median follow-up of 6.3 years,
patients in the bedtime-treatment group had
an adjusted 45% lower risk of the primary
CVD outcome (myocardial infarction, coro-
nary revascularization, heart failure, stroke,
and CVD death) than did patients who took
their medications after they had awak-
ened. The bedtime group also had greater
ABP control, improved renal function, and a
more favorable lipid profile than the morn-
ing group. The reduced CVD outcome risk in
the bedtime group “is partly linked to bet-
ter achievement of those novel therapeutic
goals through improved targeting of under-
lying circadian rhythm–organized biologi-
cal mechanisms,” the authors wrote.
(Reprinted) JAMA December 24/31, 2019 Volume 322, Number 24
Tranexamic acid can reduce death from TBI,
according to a recent Lancet trial.
Wireless Technology Quickly Confirms
TB Medication Adherence
A sensor swallowed with tuberculosis (TB)
medication accurately recorded patients’
adherence to treatment 7 days a week,
reported a trial in PLOS Medicine. Patients
also preferred the FDA-approved wire-
lessly observed therapy (WOT) over di-
rectly observed therapy (DOT).
Wirelessly observed therapy consists of
an ingestion sensor and a detector patch
worn on the torso. The system transmits
near real-time data to the patient’s mobile
device and to a secured data repository.
The positive detection accuracy of WOT
was 99.3%. After establishing detection
accuracy, investigators then randomly
assigned 61 participants with active
Mycobacterium tuberculosis complex dis-
ease to WOT or DOT 5 days a week. In the
WOT group, if ingestions were not remotely
confirmed, the participant was contacted
within 24 hours by text or cell phone to
provide support.
On the group level, 92.9% of pre-
scribed doses were confirmed in the WOT
group compared with only 63.1% in the
DOT group. The difference between the 2
groups was attributed to confirming doses
7 days a week for WOT vs only 5 days
a week for DOT. − Anita Slomski, MA
Note: Source references are available through
embedded hyperlinks in the article text online.
2375