Hyperglycemia and diabetes occurs with initiation of SIGNIFOR therapy; intensive glucose monitoring is recommended and may require initiation or adjustment of anti-diabetic treatment per standard...
THE LARGEST PHASE III TRIAL ADDRESSES AN UNMET MEDICAL NEED IN THE TREATMENT OF CUSHING'S DISEASE
aAfter 3 months of treatment, patients with a mean 24-hour urinary free cortisol (UFC) ≤2.0 x the upper limit of normal (ULN) and below or equal to their baseline values continued blinded treatment at the randomized dose until Month 6. Patients who did not meet these criteria were unblinded and the dose was increased by 0.3 mg bid.2
The proportion of patients who achieved normalization of mean 24-hour urinary free cortisol (UFC) levels (UFC ≤ULN) after 6 months of treatment without a dose increase1
SIGNIFOR: UFC NORMALIZATION IN PATIENTS WITH CUSHING'S DISEASE1
The percentages of patients with mean urinary free cortisol (mUFC) ≤ the upper limit of normal or ≥50% reduction from baseline, a less stringent end point than the primary end point, were 34% in the 0.6 mg bid and 41% in the 0.9 mg bid groups.1
OTHER CLINICAL END POINTS
DECREASES OBSERVED IN BLOOD PRESSURE1,2
Because the study allowed initiation of antihypertensive medication and dose increases in patients already receiving such medications, the individual contribution of SIGNIFOR or of antihypertensive medication adjustments cannot be clearly established.1
DECREASES OBSERVED IN WEIGHT, BODY MASS INDEX (BMI), AND WAIST CIRCUMFERENCE1
Individual patients showed varying degrees of improvement in Cushing's disease manifestations, but because of the variability in response and the absence of a control group in this trial, it is uncertain whether these changes could be ascribed to the effects of SIGNIFOR.1
SIGNIFOR: DECREASES OBSERVED IN MEAN URINARY FREE CORTISOL (UFC)1
aOnly patients who completed 6 months of treatment are included in this analysis (n=110).1
SIGNIFOR: UFC REDUCED IN THE MAJORITY OF PATIENTS IN BOTH DOSE GROUPS1
aChange in urinary free cortisol (UFC) at Month 6 of 103 patients with baseline and Month 6 UFC measurements, sorted by baseline UFC level. 103 out of 162 patients were in the study at Month 6. Reference line is the upper limit of normal (ULN) for UFC, which is 145 nmol/24 h.1
The percentages of patients with mUFC ≤ULN or ≥50% reduction from baseline, a less stringent end point than the primary end point, were 34% in the 0.6 mg bid group and 41% in the 0.9 mg bid groups.2
SIGNIFOR® (pasireotide) Injection, for subcutaneous use
SIGNIFOR is indicated for the treatment of adult patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions:
The most common adverse reactions (frequency ≥20% in either group) occurring in patients receiving SIGNIFOR in clinical trials were:
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