The OPTIMA study: assessing a new cinacalcet (Sensipar/Mimpara) treatment algorithm for secondary hyperparathyroidism

Area of Science:

• Nephrology
• Endocrinology
• Pharmacology

Background:

• Secondary hyperparathyroidism (SHPT) is a common complication in dialysis patients.
• Current treatments, including vitamin D and phosphate binders, often fail to meet stringent KDOQI targets.
• Cinacalcet offers a novel approach by targeting the calcium-sensing receptor.

Purpose of the Study:

• To compare the efficacy of a cinacalcet-based regimen versus conventional care for SHPT in dialysis patients.
• To assess the achievement of KDOQI targets for parathyroid hormone (PTH), calcium, and phosphorus.
• To evaluate the impact on vitamin D dosage.

Main Methods:

• Multicenter, open-label study with randomized patients.
• Hemodialysis patients with poorly controlled SHPT were assigned to conventional care (n=184) or cinacalcet-based regimen (n=368).
• Dose optimization phase using algorithms for cinacalcet, vitamin D, and phosphate binders; primary endpoint: mean intact PTH < or =300 pg/ml.

Main Results:

• Significantly higher achievement of PTH targets (71% vs. 22%, P < 0.001) with cinacalcet.
• Improved control of Ca x P (77% vs. 58%, P < 0.001), calcium (76% vs. 33%, P < 0.001), and phosphorus (63% vs. 50%, P = 0.002).
• Reduced vitamin D dosage by 22% in patients receiving vitamin D at baseline.

Conclusions:

• A cinacalcet-based treatment algorithm significantly increases the achievement of KDOQI targets in dialysis patients with SHPT.
• This approach is more effective than conventional therapy when it is insufficient to control SHPT.
• Efficacy was notable even in patients with less severe SHPT, requiring lower cinacalcet doses.