Aromasin

Patients were randomly assigned in a 1:1 ratio to treatment with exemestane (Aromasin; Pfizer, New York, NY), 25 mg orally daily, or letrozole (Femara; Novartis, Basel, Switzerland), 2.5 mg orally daily. Randomization was stratified by prior chemotherapy, prior tamoxifen, and bisphosphonate use. At baseline and after 1, 3, 6, 12, and 24 months, patients were clinically evaluated and completed PRO questionnaires (see next section). Blood samples were collected at baseline and after 3 months of therapy for evaluation of estrogen metabolites and pharmacokinetics (PK).

Enrolled patients continued treated with the standard-dose of a third-generation AI; 1 mg Anastrozole (Arimidex; AstraZeneca Pharmaceuticals), 25 mg Exemestane (Aromasin; Pfizer), or 2.5 mg Letrozole (Femara; Novartis) orally daily. Patients who had been taking a stable dose of medication for treatment of pain (eg, nonsteroidal anti-inflammatory medications, cyclooxygenase-2 inhibitors and acetaminophen), and/or bisphosphonates every 6 month at the time of enrollment were permitted to continue the medication. Lasilactone® 50 mg; (produced by: Sanofi Aventis Egypt s.a.e. Under Licence of: Sanofi Aventis/ Germany) an oral combination of Frusemide 20 mg/Spironolactone 50 mg in a film-coated tablet, was coadministrated every other day with breakfast for 4 weeks. Patients were also instructed to avoid taking concomitant medications with the potential to interact with Lasilactone® as described in the package insert.