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Clinical Studies 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.
Pre-marketing safety data on Ventavis were obtained from 215 patients with pulmonary arterial hypertension receiving iloprost in two 12-week clinical trials and two long-term extensions. Patients received inhaled Ventavis for periods of from 1 day to more than 3 years. The median number of weeks of exposure was 15. Forty patients completed 12 months of open-label treatment with iloprost.
The following table shows adverse events reported by at least 4 Ventavis patients and reported at least 3% more frequently for Ventavis patients than placebo patients in the 12week placebo-controlled study.
Table 1: Adverse Events in Phase 3 Clinical Trial
n = 101
n = 102
|Placebo subtracted %|
|Alk phos increased||6||1||5|
Pre-marketing serious adverse events reported with the use of inhaled Ventavis and not shown in Table 1 include congestive heart failure, chest pain, supraventricular tachycardia, dyspnea, peripheral edema, and kidney failure.
In a small clinical trial (the STEP trial) [see Clinical Studies], safety trends in patients receiving concomitant bosentan and Ventavis were consistent with those observed in the larger experience of the Phase 3 study in patients receiving only Ventavis or bosentan.
Adverse events with higher doses
In a study in healthy subjects (n=160), inhaled doses of iloprost solution were given every 2 hours, beginning with 5 mcg and increasing up to 20 mcg for a total of 6 dose inhalations (total cumulative dose of 70 mcg) or up to the highest dose tolerated in a subgroup of 40 subjects. There were 13 subjects (32%) who failed to reach the highest scheduled dose (20 mcg). Five were unable to increase the dose because of (mild to moderate) transient chest pain/discomfort/tightness, usually accompanied by headache, nausea, and dizziness. The remaining 8 subjects discontinued for other reasons.
The following adverse reactions have been identified during the postapproval use of Ventavis. Because these 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.
Cases of bronchospasm and wheezing have been reported, particularly in patients with a history of hyperreactive airways [see WARNINGS AND PRECAUTIONS]. Bleeding events most commonly reported as epistaxis and hemoptysis were observed on Ventavis treatment [see DRUG INTERACTIONS]. Cases of thrombocytopenia, dizziness, diarrhea, mouth and tongue irritation, nasal congestion, dysgeusia, hypersensitivity, and rash have also been reported with the use of Ventavis.
Read the Ventavis (iloprost) Side Effects Center for a complete guide to possible side effects
During clinical trials, iloprost was used concurrently with anticoagulants, diuretics, cardiac glycosides, calcium channel blockers, analgesics, antipyretics, nonsteroidal anti-inflammatory drugs, corticosteroids, and other medications. Intravenous infusion of iloprost had no effect on the pharmacokinetics of digoxin. Acetylsalicylic acid did not alter the clearance (pharmacokinetics) of iloprost.
Although clinical studies have not been conducted with Ventavis (inhaled iloprost), in vitro studies of iloprost indicate that no relevant inhibition of cytochrome P450 drug metabolism would be expected.
Antihypertensives and Vasodilators
In studies in normal subjects, there was no pharmacodynamic interaction between intravenous iloprost and either nifedipine, diltiazem, or captopril. However, Ventavis has the potential to increase the hypotensive effect of vasodilators and antihypertensive agents.
Anticoagulants and Platelet Inhibitors
Since Ventavis inhibits platelet function, there is a potential for increased risk of bleeding, particularly in patients maintained on anticoagulants or platelet inhibitors.
Read the Ventavis Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 12/12/2013
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