e of 50,000 to 60,000 international unitsof vitamin D within one week of randomization (if serum 25-hydroxyvitamin D concentrations were40 ng/mL or less).
In Study 1, during the 12-month double-blind treatment period, the incidence of all-cause mortality was0.7% (24/3576) in the placebo group and 0.8% (29/3581) in the EVENITY group. The incidence ofnonfatal serious adverse events was 8.3% in the placebo group and 9.1% in the EVENITY group. Thepercentage of patients who withdrew from the study due to adverse events was 1.1% in the placebo groupand 1.1% in the EVENITY group. The most common adverse reactions reported with EVENITY (greater
han or equal to 5% and at a higher incidence than placebo) were arthralgia and headache. The mostcommon adverse reaction leading to discontinuation of EVENITY was arthralgia (6 subjects [0.2%] in theplacebo group and 5 subjects [0.1%] in the EVENITY group).
In Study 2, during the 12-month double-blind treatment period, the incidence of all-cause mortality was1.1% (22/2014) in the alendronate group and 1.5% (30/2040) in the EVENITY group. The incidence ofnonfatal serious adverse events was 13.3% in the alendronate group and 11.9% in the EVENITY group.
The percentage of patients who withdrew from the study due to adverse events was 1.2% in thealendronate group and 1.2% in the EVENITY group. The most common adverse reactions reported withEVENITY (greater than or equal to 5%) were arthralgia and headache.
Table 1 outlines the most common adverse reactions occurring in greater than or equal to 2% of
EVENITY treated women in at least one study.
Table 1 Adverse Reactions Occurring in ≥ 2% of EVENITY-Treated Women in at Least One Study
(Studies 1 and 2)
The adverse reactions described below are from the 12-month treatment periods of Study 1 (placebocontrolled)
and Study 2 (alendronate-controlled).
Major Adverse Cardiac Events (MACE)
During the 12-month double-blind treatment period of the placebo-controlled trial (Study 1), myocardialinfarction occurred in 9 women (0.3%) in the EVENITY group and 8 (0.2%) women in the placebogroup; stroke occurred in 8 women (0.2%) in the EVENITY group and 10 (0.3%) women in the placebogroup. These events occurred in patients with and without a history of myocardial infarction or stroke.
Cardiovascular death occurred in 17 women (0.5%) in the EVENITY group and 15 (0.4%) women in theplacebo group. The number of women with positively adjudicated MACE was 30 (0.8%) in theEVENITY group and 29 (0.8%) in the placebo group, yielding a hazard ratio of 1.03 (95% confidenceinterval [0.62, 1.72]) for EVENITY compared to placebo.
During the 12-month double-blind treatment period of the active-controlled trial (Study 2), myocardialinfarction occurred in 16 women (0.8%) in the EVENITY group and 5 (0.2%) women in the alendronategroup; stroke occurred in 13 women (0.6%) in the EVENITY group and 7 (0.3%) women in thealendronate group. These events occurred in patients with and without a history of myocardial infarctionor stroke. Cardiovascular death occurred in 17 women (0.8%) in the EVENITY group and 12 (0.6%)
women in the alendronate group. The number of women with positively adjudicated MACE was 41(2.0%) in the EVENITY group and 22 (1.1%) in the alendronate group, yielding a hazard ratio of 1.87(95% confidence interval [1.11, 3.14]) for EVENITY compared to alendronate [see Boxed Warning andWarnings and Precautions (5.1)].
Hypersensitivity Reactions
Across both trials, hyperse |
