Dopamine agonists, in clinical studies and clinical experience, appear to impair the systemic regulation of blood pressure, with resulting postural hypotension, especially during dose escalation. In addition, patients with Parkinson’s disease appear to have an impaired capacity to respond to a postural challenge. For these reasons, patients being treated with dopaminergic agonists ordinarily (1) require careful monitoring for signs and symptoms of postural hypotension, especially during dose escalation, and (2) should be informed of this risk [see Patient Counseling Information (17.2)]. 

In a placebo-controlled trial involving patients with advanced Parkinson’s disease, hypotension was reported as an adverse event in 5 of 202 patients (2%) receiving Ropinirole Extended-release Tablets and in none of the 191 patients receiving placebo. Orthostatic hypotension was reported as an adverse event in 5% of patients receiving Ropinirole Extended-release Tablets, and in 1% of placebo recipients. 

An analysis of the randomized, double-blinded, placebo-controlled study in advanced Parkinson's disease was conducted using a variety of adverse event terms possibly suggestive of hypotension, including hypotension, orthostatic hypotension, dizziness, vertigo, and blood pressure decreased. This analysis showed a higher incidence of these events with Ropinirole Extended-release Tablets (7%, 15 of 202) vs. placebo (3%, 6 of 191). This increased incidence was observed in a setting in which patients were very carefully titrated, and patients with clinically relevant cardiovascular disease or symptomatic orthostatic hypotension at baseline had been excluded from this study. 

Orthostatic vital signs (semi-supine to standing) were monitored throughout the study in the advanced Parkinson’s disease study and changes related to Ropinirole Extended-release Tablets (compared with placebo) from baseline were assessed. 

The frequency of any orthostatic hypotension at any time during the study was 38% for Ropinirole Extended-release Tablets vs. 31% for placebo for mild to moderate systolic blood pressure decrements (≥20 mm Hg), 63% for Ropinirole Extended-release Tablets vs. 58% for placebo for mild to moderate diastolic blood pressure decrements (≥10 mm Hg), 10% for Ropinirole Extended-release Tablets vs. 7% for placebo for severe diastolic blood pressure decrements (≥20 mm Hg), and 23% for Ropinirole Extended-release Tablets vs. 19% for placebo for mild to moderate combined systolic and diastolic blood pressure decrements. 

Significant decrements in blood pressure unrelated to standing were also reported in some patients taking Ropinirole Extended-release Tablets. In the semi-supine position, the frequency was 10% for Ropinirole Extended-release Tablets vs. 8% for placebo for severe systolic blood pressure decrease (≥40 mm Hg), and was 25% for Ropinirole Extended-release Tablets vs. 21% for placebo for severe diastolic blood pressure decrease (≥20 mm Hg). 

The increased incidence for hypotension and/or orthostatic hypotension was observed in both the titration and maintenance phases and in some cases persisted into the maintenance period after developing in the titration phase.