Vitamin D therapy failed to improve cardiac structure, function in CKD patients

In patients with chronic kidney disease, 48 weeks of treatment with the active vitamin D compound paricalcitol did not alter left ventricular mass or improve certain measures of diastolic dysfunction.

In the Paricalcitol Capsule Benefits in Renal Failure-Induced Cardiac Morbidity (PRIMO) trial, researchers randomly assigned 115 patients with chronic kidney disease (CKD), mild to moderate LV hypertrophy and preserved LV ejection fraction to 2 mcg/day of paricalcitol (Zemplar, Abbott) and 112 patients to placebo from July 2008 to September 2010. LV mass, renal function and laboratory measures were evaluated during a 6-week screening period. Vital signs and serum intact parathyroid hormone were measured and concomitant medications were recorded up to 48 weeks.

Primary endpoint was change in LV mass index during 48 weeks by CV MRI and secondary endpoints included echocardiographic changes in LV diastolic function.

Within 4 weeks, treatment with paricalcitol reduced parathyroid hormone levels, according to results, and maintained levels within the normal range throughout the study. Researchers found that change in LV mass index did not differ between the paricalcitol (0.34 g/m^2.7; 95% CI, –0.14 to 0.83 g/m^2.7) and placebo (–0.07 g/m^2.7; 95% CI, –0.55 to 0.42 g/m^2.7) groups at 48 weeks. Similarly, the paricalcitol and placebo groups did not differ in Doppler measures of diastolic function, including peak early diastolic lateral mitral annula tissue (–0.01 cm/s vs. –0.30 cm/s). The paricalcitol group experienced more frequent episodes of hypercalcemia vs. the placebo group. However, researchers found fewer hospitalizations for CVD in the paricalcitol group.

In an accompanying editorial, Stefan D. Anker, MD, PhD, and Stephan von Haehling, MD, PhD, of Charité Campus Virchow-Klinikum in Berlin, said the study “adds to the overall evidence of the lack of effectiveness of active vitamin D compounds.”

Overall, they said improvement in important clinical outcomes should be the deciding factor for prescribing paricalcitol to patients with CKD.

“At this time, paracalcitol cannot be recommendd for patients with CKD. The PRIMO trial needs to be followed by a larger trial adequately powered to assess clinical endpoints such as cardiac-related hospitalizations, dialysis events and mortality,” Anker and Haehling concluded. “Considering the competition for public funding or clinical trials in CKD, the pro-vitamin D research groups may face an uphill battle to keep this treatment option viable for patients with chronic kidney disease.”

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Disclosure: Several of the study researchers report a financial interest with Abbott. Drs. Anker and Haehling report no relevant financial disclosures.

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