The OPTIMA Approach

In the OPTIMA study, adding Sensipar® at iPTH 300 to 500 pg/mL with low mean doses of vitamin D and phosphate binders, if prescribed, enabled more patients to achieve secondary hyperparathyroidism (HPT) treatment goals1

The OPTIMA study treatment approach1,2

The OPTIMA study protocol (for patients receiving vitamin D)1,2

  1. In patients with iPTH > 300 pg/mL and serum calcium
    ≥ 8.4 mg/dL, Sensipar® was initiated
  2. Parathyroid hormone (PTH) was measured monthly and Sensipar® was titrated* until PTH goal (≤ 300 pg/mL) was achieved
  3. Based on PTH, calcium, and phosphorus levels, vitamin D and phosphate binders, if prescribed, were adjusted as necessary. Vitamin D doses were:
    • Reduced for patients with:
      • iPTH 150 to 300 pg/mL, serum calcium
        ≥ 9.5 mg/dL, or serum phosphorus ≥ 5.5 mg/dL
      • iPTH < 150 pg/mL
    • Maintained for patients with iPTH 150 to 300 pg/mL, serum calcium < 9.5 mg/dL, and serum phosphorus
      < 5.5 mg/dL
    • Increased for patients on maximum Sensipar® dose with iPTH > 300 pg/mL, serum calcium < 9.5 mg/dL, and serum phosphorus < 5.5 mg/dL

OPTIMA Study Design

The OPTIMA study included 2 Sensipar®-based algorithms determined by baseline vitamin D use.1

In this multicenter, open-label study, dialysis patients with uncontrolled secondary HPT were randomized 2:1 to receive a Sensipar®-based regimen (n = 368) or conventional care (n = 184). Key inclusion criteria were mean baseline iPTH ≥ 300 pg/mL and < 800 pg/mL, and mean baseline corrected serum calcium
≥ 8.4 mg/dL. The conventional care group (vitamin D and phosphate binders) was permitted complete treatment flexibility, with no medication or dosage restrictions. In the Sensipar® group, patients were to be treated according to the predefined treatment algorithm. In the Sensipar® group, in patients with iPTH < 150 pg/mL, serum calcium ≥ 9.5 mg/dL, or serum phosphorus ≥ 5.5 mg/dL, the dose of vitamin D was reduced to enable simultaneous control of PTH and Ca x P.1

The treatment algorithm described was for patients receiving vitamin D. A separate algorithm was used for patients not receiving vitamin D at baseline. The dose of Sensipar® was increased if iPTH was > 300 pg/mL unless serum calcium was
≤ 8.0 mg/dL, the patient was receiving the maximum dose of Sensipar®, or the patient experienced an adverse event that precluded the dose increase. Serum calcium must have been
≥ 8.4 mg/dL.1 There were 552 patients randomized with 368 receiving Sensipar® and 184 receiving conventional care. Approximately two-thirds of the patients in each group received vitamin D and almost all were receiving phosphate binders at enrollment.1

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*The Sensipar® prescribing information recommends, if serum calcium falls below 7.5 mg/dL or if symptoms of hypocalcemia persist and the dose of vitamin D cannot be increased, withholding administration of Sensipar® until serum calcium levels reach 8.0 mg/dL and/or symptoms of hypocalcemia have resolved.