MD Conference Express - ENDO 2015 - (Page 12)
ClINICAl TrIAl HIGHlIGHTS
DREAM: Dual-Release
Hydrocortisone Improves
NK Cell Levels in AI
Written by Emma Hitt Nichols, PhD
A once-daily, dual-release oral formulation of hydrocortisone (HC) led to significant improvement in natural killer
(NK) cell levels, body weight, and systolic blood pressure
in patients with adrenal insufficiency (AI) compared with
patients who received conventional therapy with either
cortisone acetate or oral HC. Andrea M. Isidori, MD, PhD,
Sapienza University of Rome, Rome, Italy, presented data
from the DREAM trial [NCT02277587].
Treatment of AI with conventional glucocorticoid
therapies is associated with early mortality compared
with the general population, as a result of cardiovascular
disease, infection, and malignancies. A potential mechanism for this is that conventional glucocorticoid therapies do not adequately mimic circadian cortisol release,
resulting in inappropriate exposure time. The purpose
of the DREAM trial was to determine if a once-daily,
dual-release HC tablet (DR-HC) would more closely
mimic natural circadian cortisol release compared with
conventional therapies.
In the single-blind, parallel, phase 4 DREAM study,
80 patients were randomly assigned to continue their
conventional therapy or receive DR-HC for 6 months;
interim analysis was conducted on 58 patients. Primary
AI was present in 21 patients, 22 patients had secondary AI, and 15 patients served as healthy controls. All
patients with AI were treated with cortisone acetate or
HC upon enrollment.
At baseline, patients with AI had significantly lower
levels of NK cells compared with the healthy controls
(5.5% ± 5.7% vs 10.9% ± 4.2%; P < .01) and a trend of greater
classical monocyte levels (28.9% ± 17.0% vs 21.5% ± 3.5%;
P = .08); T-cell and granulocyte levels were similar among
both groups. All patients underwent biochemical, hematologic, and metabolic assessments at 0, 3, and 6 months.
At the 3-month analysis, patients with AI who
received DR-HC experienced a significant increase in
NK cells (+5.2 ± 7.4; P < .01) compared with patients who
received conventional therapy (cortisone acetate or HC;
+0.8 ± 5.9) or healthy controls (+1.0 ± 3.4). The improvement occurred regardless of primary vs secondary AI
or type of glucocorticoid treatment at enrollment. In
addition, patients who received DR-HC experienced
significant improvement in body weight (P < .01) and
systolic blood pressure (P < .05), as well as a trend toward
decreased HbA1c levels (P = .07), compared with patients
who received conventional therapy.
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May 2015
Prof Isidori stated that the difference in monocyte levels between the DR-HC and conventional therapy arms
may be immune suppression as a result of a difference
in bioavailability of the agents; however, the significant
increase in NK cell levels in patients treated with DR-HC
refuted this mechanism, suggesting that a chronobiological effect was the most likely explanation. In addition,
Prof Isidori suggested that improvement in NK cell levels
in patients with AI is an important finding because NK
cells play a critical role in fighting infections and malignant cells.
VIDOS: Vitamin D Supplementation
Does Not Improve the
Incidence of Falls
Written by Emma Hitt Nichols, PhD
Elderly women who received 1600 to 3200 IU QD of vitamin D supplementation experienced a lower incidence
of falls compared with women who received lower
or higher doses of vitamin D or placebo, but overall
differences were not significant. Shervin Yousefian,
MD, Creighton University, Omaha, Nebraska, USA,
presented data from the VIDOS study [NCT00472823].
Results regarding the effect of vitamin D supplementation on falls and physical performance in elderly
patients have been inconsistent. The purpose of
VIDOS was to evaluate the effect of vitamin D supplementation on falls and physical performance in vitamin D-deficient postmenopausal women living in the
community.
In this interventional study, 163 postmenopausal
white women were randomly assigned to receive vitamin D supplementation with 400, 800, 1600, 2400, 3200,
4000, or 4800 IU QD or placebo for one year. Women
were required to be vitamin D deficient, with a serum
25-hydroxyvitamin D (25[OH]D) level of ≤ 20 ng/mL.
The mean age of the 147 women who completed the
study was 66.2 years and the mean body mass index was
30.3 kg/m2. Patients were excluded if they had active
nephrolithiasis, chronic kidney or liver disease, persistent hypercalcemia, or a medical condition prohibiting
physical activity or if they had a disease or were receiving
medication that affected calcium or bone metabolism.
Accounting for data from 7-day food diaries, calcium
supplementation was administered to achieve a daily
calcium intake of 1200 mg.
In the placebo arm, patients who did not experience
falls had greater serum levels of 1,25 dihydroxyvitamin D (1,25[OH]2D) than patients who did experience
falls. Patients who received vitamin D supplementation
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Contents
MD Conference Express - ENDO 2015
MD Conference Express - ENDO 2015 - (Page Cover1)
MD Conference Express - ENDO 2015 - (Page Cover2)
MD Conference Express - ENDO 2015 - (Page i)
MD Conference Express - ENDO 2015 - (Page ii)
MD Conference Express - ENDO 2015 - Contents (Page 1)
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