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Indications for use
Pulmonary arterial hypertension, including primary pulmonary arterial hypertension, secondary pulmonary arterial hypertension in the background of scleroderma
The list of side effects includes headache, hot flashes, feeling of fever, liver dysfunction, edema of the lower extremities and anemia. All these phenomena were dose-dependent. The table below shows the side effects, which were observed in 3% or more patients diagnosed with pulmonary arterial hypertension, who were taking Tracleer (125 mg and 250 mg 2 times/day) during placebo-controlled clinical trials.
Side effects, which were observed in some cases: anemia, gastroesophageal reflux, bleeding from the rectum. In total, there was 2.4% in the group of Tracleer, compared with 0% in the placebo group. Discontinuation of therapy due to the development of side effects in patients with pulmonary arterial hypertension during the reception of the drug in doses of 125 mg and 250 mg 2 times a day was less common in the group that used Tracleer than in patients in the placebo group.
The effect of Tracleer is associated with dose-dependent increases of liver enzymes (ACT, ALT). Increased activity of liver enzymes was, as a rule, observed in the first 16 weeks of therapy, developed gradually, was asymptomatic and returned without consequences to baseline levels in all cases during the period from several days to 9 weeks, spontaneously or after reducing/eliminating the dose. The mechanism of these side effects remains unclear.
During the clinical studies, 3-fold excess of hepatic enzyme activity was observed in 11.2% of patients in Tracleer group compared with 1.8% in the placebo group. A 3-fold excess of bilirubin level was associated with increased levels of transaminases in 2 patients (0, 3%) of those, who was treated with Tracleer. 9 of 74 patients with more than 3-fold elevation of transaminases in the group of Tracleer noticed pain in the abdomen, nausea, vomiting and fever.