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| |  Dostinex Launched for Pituitary Gland Disorders KALAMAZOO, Mich., March 18, 1997 -- Dostinex Tablets (cabergoline tablets) for treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas (tumors), is now available by prescription in the United States. Dostinex, a long-acting dopamine agonist, offers greater dosing convenience than bromocriptine, the only other drug on the market indicated for hyperprolactinemia. Dostinex allows a simple, twice-weekly dosing compared with up to twice-a-day dosing with bromocriptine. "Dostinex offers advantages to patients due to the convenient twice-a-week dosing and improvements in efficacy and tolerance," said Anne Klibanski, M.D., chief of the neuroendocrine unit, Massachusetts General Hospital in Boston. She added that, "Given the efficacy and safety profile demonstrated in clinical trials, I believe Dostinex will become a valuable treatment choice for hyperprolactinemia." Hyperprolactinemia is usually caused by a benign tumor on the pituitary gland that results in excess production of prolactin, the hormone that controls lactation. Doctors treat from 70,000 to 100,000 patients with the condition each year, the vast majority of whom are women. It most commonly affects women ages 20-50 and can cause cessation of menstruation, excessive breast milk discharge and infertility due to anovulation. In men the condition can cause decreased libido and impotence. In a clinical trial involving approximately 450 patients, Dostinex was compared with bromocriptine in treating hyperprolactinemia. In the eight-week, double- blind portion of the trial, prolactin levels returned to normal in 77% of patients treated with Dostinex (0.5 mg twice-weekly) compared with 59% of those treated with bromocriptine (2.5 mg twice-daily). Restoration of menses occurred in 77% of women treated with Dostinex, compared with 70% of those treated with bromocriptine. Among patients with galactorrhea (excessive breast milk discharge), the symptom disappeared in 73% of those treated with Dostinex, compared with 56% of those treated with bromocriptine. Clinical studies also showed the safety profile of Dostinex compares favorably to bromocriptine. Two percent of 221 patients taking Dostinex discontinued treatment due to side effects, versus six percent of 231 patients taking bromocriptine. Nausea was the most common reported side effect in both treatment groups. During the eight-week, double-blinded portion of the trial, 14% fewer patients experienced nausea with Dostinex than with bromocriptine. Dostinex is contraindicated in patients with uncontrolled hypertension or known hypersensitivity to ergot derivatives. The product is manufactured by Pharmacia & Upjohn, Inc., a research-based pharmaceutically-focused company.
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