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Benefits of Initiating Sensipar® Earlier

Control of Secondary Hyperparathyroidism Parameters

>> The OPTIMA Approach

>> Control of Phosphorus

>> Simultaneous Control of Parathyroid Hormone and Phosphorus

>> Simultaneous Control of Parathyroid Hormone and Calcium

>> Simultaneous Reduction of Key Secondary Hyperparathyroidism Parameters

>> Current KDOQI™ Guidelines

Patient Monitoring and Dose Titration

The Role of the Calcium-Sensing Receptor

Sensipar® for Parathyroid Carcinoma

Resources and Coverage

Simultaneous Control of Secondary Hyperparathyroidism Parameters

In the Phase 3, OPTIMA, and TARGET studies, Sensipar®, added to low mean doses of vitamin D, demonstrated improved simultaneous achievement of secondary hyperparathyroidism (HPT) treatment goals^1-4

The OPTIMA and TARGET studies supported the findings of three 6-month phase 3, multicenter, randomized, double-blind, placebo-controlled clinical trials of chronic kidney disease (CKD) patients with secondary HPT on dialysis (N = 1,136).¹ Click here for Phase 3 summary description. In all 3 analyses, patients treated with Sensipar® and traditional therapy demonstrated simultaneous improvements of both parathyroid hormone (PTH) and calcium-phosphorus product (Ca x P) greater than those with traditional therapy alone.^1-4 Traditional therapy included vitamin D and phosphate binders, if prescribed.^1,3,4 Goals were defined as iPTH ≤ 300 pg/mL and Ca x P < 55 mg²/dL².

In the OPTIMA trial, significantly more patients treated with Sensipar® and traditional therapy reached the targets for PTH, Ca x P, calcium, and phosphorus compared to patients who received only traditional therapy. Of patients on Sensipar® and traditional therapy simultaneously, 59% achieved the combined goals for PTH and Ca x P versus only 16% on traditional therapy. Moreover, 71% of patients in the Sensipar® group achieved PTH target alone in comparison to 22% on traditional therapy. Goal achievement for serum calcium and phosphorus were also superior in the Sensipar® plus traditional therapy group versus traditional therapy alone: 76% vs 33% (Ca) and 63% vs 50% (P), respectively. OPTIMA was a multicenter, open-label study, conducted in patients on dialysis with uncontrolled secondary HPT (N = 552). Subjects were randomized 2:1 to receive a Sensipar®-based regimen or conventional care. 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.³

In the TARGET study, 54% of patients on Sensipar® and traditional therapy simultaneously achieved PTH goals versus only 3% of patients on traditional therapy. TARGET was a multicenter, single-arm, open-label study in patients on dialysis with moderate to severe secondary HPT (N = 444). Patients
(> 18 years and receiving dialysis for ≥ 3 months) had to have an iPTH^‡ level between 300 pg/mL and 800 pg/mL, and calcium
≥ 8.4 mg/dL. Sensipar® was initiated at a dose of 30 mg/day and was titrated sequentially every 2 weeks for 8 weeks to a maximum dose of 180 mg/day (or until an adverse event precluded a dose increase). The Sensipar® dose was decreased if the PTH level for 2 consecutive study visits was < 150 pg/mL and vitamin D therapy had been discontinued. In patients receiving vitamin D, doses ≥ 2.0 µg paricalcitol or their equivalents^§ per dialysis treatment were reduced to 2.0 µg (or equivalent) per treatment at the second week of the titration phase. Vitamin D doses could be increased if serum calcium was < 8.4 mg/dL (or symptoms of hypocalcemia were present), or if iPTH was > 500 pg/mL and Ca x P was < 70 mg²/dL² after the maximum dose of Sensipar® was reached. Vitamin D doses were decreased if 2 consecutive iPTH values were <150 pg/mL.⁴ The most commonly reported adverse events included nausea (28%), vomiting (23%), diarrhea (19%), headache (11%), and dizziness (11%). Adverse events were generally mild to moderate in severity.