Kaitlyn D’Onofrio

DocwireNews

Patients undergoing maintenance dialysis for chronic kidney disease who do not have hyperparathyroidism will not reduce their risk of certain cardiovascular events with oral&nbsp;alfacalcidol, according to a new study.&nbsp;The study&nbsp;randomized&nbsp;976 patients from&nbsp;108&nbsp;dialysis centers in Japan&nbsp;receiving maintenance hemodialysis with serum intact parathyroid hormone levels less than or equal to 180&nbsp;pg/mL&nbsp;between Aug. 18, 2008, and Jan. 26, 2011. Final follow-up was on April 4, 2015. Patients were treated either&nbsp;with 0.5&nbsp;&mu;g&nbsp;of oral&nbsp;alfacalcidol&nbsp;per day (intervention group; n = 495)&nbsp;or&nbsp;without vitamin D receptor activators (control group; n = 481).&nbsp;Primary outcomes were fatal and nonfatal cardiovascular (CV) events,&nbsp;myocardial infarctions, hospitalizations for congestive heart failure, stroke, aortic dissection/rupture, amputation of lower limb due to ischemia, and cardiac sudden death; coronary revascularization; and leg artery revascularization. Secondary outcome was all-cause mortality.&nbsp;<blockquote class="twitter-tweet" data-width="500" data-dnt="true">
Oral alfacalcidol, a vitamin D receptor activator (VDRA), is not associated with reduced cardiovascular risk among patients without secondary hyperparathyroidism receiving maintenance hemodialysis. <a href="https://twitter.com/JAMA_current?ref_src=twsrc%5Etfw">@JAMA_current</a>
&mdash; PhysiciansFirstWatch (@Physns1stWatch) <a href="https://twitter.com/Physns1stWatch/status/1073042079226490881?ref_src=twsrc%5Etfw">December 13, 2018</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>Of the total cohort, 944 patients completed the trial (intervention group, 488; control group, 476). CV events occurred in 21.1% (n = 103/488) of the intervention group and 17.9% (n = 85/476) of the control group&nbsp;(absolute difference, 3.25% [95% CI, &minus;1.75% to 8.24%]; hazard ratio, 1.25 [95% CI, 0.94-1.67]; P = .13).&nbsp;All-cause mortality rates were 18.2% in the intervention group and 16.8% in the control group (hazard ratio, 1.12 [95% CI, 0.83-1.52]; P = .46).&nbsp;Serious CV-related adverse events occurred in 40.8% (n = 199) of the intervention group; 13.1% (n = 64) sustained an infection, and 4.5% (n = 22)&nbsp;experienced malignancy-related serious adverse events. In the control group. 40.1% (n = 191) had a serious CV-related adverse event, while 13.2% (n = 63) and 4.4% (n = 21) experienced serious infection and&nbsp;malignancy-related adverse events, respectively.&nbsp;<blockquote class="twitter-tweet" data-width="500" data-dnt="true">
Alfacalcidol Does Not Lower CV Risk in Dialysis, Trial Suggests <a href="https://t.co/lp9cn4lrlu">https://t.co/lp9cn4lrlu</a> via <a href="https://twitter.com/Medscape?ref_src=twsrc%5Etfw">@medscape</a>
&mdash; Irish Medicines Formulary (IMF) and IMF-Online (@FormularyIE) <a href="https://twitter.com/FormularyIE/status/1074691946440986624?ref_src=twsrc%5Etfw">December 17, 2018</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script><blockquote class="twitter-tweet" data-width="500" data-dnt="true">
Effect of Oral Alfacalcidol on Clinical Outcomes in Patients Without SecHPT Receiving Maintrnance Hemodialysis: The J-DAVID Randomized Clinical Trial. J-DAVID Investigators, Shoji T et al. JAMA. 2018 Dec 11 <a href="https://t.co/A0Q4ypgE2B">https://t.co/A0Q4ypgE2B</a> &hellip;no significant effect <a href="https://t.co/6ZkaIfzwBU">pic.twitter.com/6ZkaIfzwBU</a>
&mdash; Osteoporosis NL (@Osteoporosis_NL) <a href="https://twitter.com/Osteoporosis_NL/status/1073139298923413504?ref_src=twsrc%5Etfw">December 13, 2018</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>The study&rsquo;s findings appear in&nbsp;JAMA.&nbsp;The researchers wrote, in sum, &ldquo;Among patients without secondary hyperparathyroidism undergoing maintenance hemodialysis, oral&nbsp;alfacalcidol&nbsp;compared with usual care did not reduce the risk of a composite measure of select cardiovascular events. These findings do not support the use of vitamin D receptor activators for patients such as these.&rdquo;&nbsp;<blockquote class="twitter-tweet" data-width="500" data-dnt="true">
Open-label RCT of alfacalcidol vs. control shows no effect on CVD in ESKD. Some reservations re. trial design and inclusion criteria aside, I can&rsquo;t say I&rsquo;m surprised. Worry that much (if not) all we do to treat MBD in clinical practise is useless for CVD&hellip; <a href="https://t.co/wb8KAQ8zuo">https://t.co/wb8KAQ8zuo</a>
&mdash; Iain Bressendorff, MD PhD (@IBressendorff) <a href="https://twitter.com/IBressendorff/status/1072790001128226817?ref_src=twsrc%5Etfw">December 12, 2018</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script><a href="https://proddocwire.wpengine.com/conference-coverage/american-heart-association-2018-scientific-sessions/vital-omega-3-and-vitamin-d-supplements-did-not-reduce-major-cvd-events-invasive-cancers/">VITAL: Omega-3 and Vitamin D Supplements Did Not Reduce Major CVD Events, Invasive Cancers</a>&nbsp;<a href="https://proddocwire.wpengine.com/docwire-pick/study-vitamin-d-supplements/">Study: Vitamin D Supplements Do Not Affect Bone Health</a>&nbsp;<a href="https://proddocwire.wpengine.com/abstracts/vitamin-d3-administration-inflammatory/">The effect of vitamin D administration on inflammatory markers in patients with inflammatory bowel disease</a>&nbsp;<a href="https://proddocwire.wpengine.com/abstracts/prevalence-vitamin-d-deficiency/">Prevalence of vitamin D deficiency in postmenopausal high- and low-energy fracture patient</a>&nbsp;Source:&nbsp;<a href="https://jamanetwork.com/journals/jama/article-abstract/2718066">JAMA</a>

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