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Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Bleeding

In 6010 patients undergoing PCI treated in the REPLACE-2 trial, Angiomax (bivalirudin) patients exhibited statistically significantly lower rates of bleeding, transfusions, and thrombocytopenia as noted in Table 2.

Table 2: Major Hematologic Outcomes REPLACE-2 Study (Safety Population)

In 4312 patients undergoing PTCA for treatment of unstable angina in 2 randomized, double-blind studies comparing Angiomax (bivalirudin) to heparin, Angiomax (bivalirudin) patients exhibited lower rates of major bleeding and lower requirements for blood transfusions. The incidence of major bleeding is presented in Table 3. The incidence of major bleeding was lower in the Angiomax (bivalirudin) group than in the heparin group.

Table 3: Major Bleeding and Transfusions in BAT Trial (all patients)¹

In the AT-BAT study, of the 51 patients with HIT/HITTS, 1 patient who did not undergo PCI had major bleeding during CABG on the day following angiography. Nine patients had minor bleeding (mostly due to access site bleeding), and 2 patients developed thrombocytopenia.

Other Adverse Reactions

Adverse reactions, other than bleeding, observed in clinical trials were similar between the Angiomax (bivalirudin) treated patients and the control groups.

Adverse reactions (related adverse events) seen in clinical studies in patients undergoing PCI and PTCA are shown in Tables 4 and 5.

Table 4 : Most frequent ( ≥ 0.2%) treatment-related adverse events (reactions) (through 30 days) in the REPLACE-2 Safety population

 Table 5: Adverse Events Other Than Bleeding Occurring In ≥ 5% Of Patients In Either Treatment Group In BAT Trial

Serious, non-bleeding adverse events were experienced in 2% of 2161 Angiomax (bivalirudin) -treated patients and 2% of 2151 heparin-treated patients. The following individual serious non-bleeding adverse events were rare ( > 0.1% to < 1%) and similar in incidence between Angiomax (bivalirudin) - and heparin-treated patients. These events are listed by body system: Body as a Whole: fever, infection, sepsis; Cardiovascular: hypotension, syncope, vascular anomaly, ventricular fibrillation; Nervous: cerebral ischemia, confusion, facial paralysis; Respiratory: lung edema; Urogenital: kidney failure, oliguria. In the BAT trial, there was no causality assessment for adverse events.

Immunogenicity/Re-Exposure

In in vitro studies, Angiomax (bivalirudin) exhibited no platelet aggregation response against sera from patients with a history of HIT/HITTS.

Among 494 subjects who received Angiomax (bivalirudin) in clinical trials and were tested for antibodies, 2 subjects had treatment-emergent positive bivalirudin antibody tests. Neither subject demonstrated clinical evidence of allergic or anaphylactic reactions and repeat testing was not performed. Nine additional patients who had initial positive tests were negative on repeat testing.

Postmarketing Experience

Because postmarketing adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following adverse reactions have been identified during postapproval use of Angiomax (bivalirudin) : fatal bleeding; hypersensitivity and allergic reactions including reports of anaphylaxis; lack of anticoagulant effect; thrombus formation during PCI with and without intracoronary brachytherapy, including reports of fatal outcomes.

In clinical trials in patients undergoing PCI/PTCA, co-administration of Angiomax (bivalirudin) with heparin, warfarin, thrombolytics, or GPIs was associated with increased risks of major bleeding events compared to patients not receiving these concomitant medications.

There is no experience with co-administration of Angiomax (bivalirudin) and plasma expanders such as dextran.

Last reviewed on RxList: 7/20/2010
This monograph has been modified to include the generic and brand name in many instances.