title: Double-blind comparator trials with pinacidil, a potassium channel opener.
abstract: The antihypertensive effects of pinacidil, a potassium channel opener, were studied in 4, dose titration, double-blind trials. Patients had mild to severe hypertension, with supine diastolic arterial pressures between 91 and 150mm Hg during the qualification assessment. Efficacy was assessed using an 'intention-to-treat' analysis. In one study, pinacidil-treated patients had a response rate significantly greater than placebo-treated patients. In another study, the pinacidil group had a response rate significantly greater than the prazosin group (83% vs 75%, respectively). In a third study, the response rate in the pinacidil group was marginally greater than in the hydralazine group (77% vs 73%, respectively). In a 'step 2' trial, pinacidil was as effective as methyldopa and more effective than placebo. Adverse experiences with pinacidil were associated with vasodilatation. Electrocardiographic T wave changes occurred intermittently and may be related to its mechanism of action. These studies suggest that antihypertensive monotherapy with pinacidil was effective and generally well tolerated.
authors.affiliation: Lilly Research Laboratory, Eli Lilly and Company, Indianapolis, Indiana.
authors.forename: J T
authors.initials: JT
authors.lastname: Callaghan
authors.forename: M R
authors.initials: MR
authors.lastname: Goldberg
authors.forename: R
authors.initials: R
authors.lastname: Brunelle
mesh_terms: D000959:Antihypertensive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D006146:Guanidines / Q000009:adverse effects / Q000627:therapeutic use*; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D006830:Hydralazine / Q000009:adverse effects / Q000627:therapeutic use; D006973:Hypertension / Q000188:drug therapy* / Q000503:physiopathology; D008750:Methyldopa / Q000009:adverse effects / Q000627:therapeutic use; D008875:Middle Aged; D020110:Pinacidil; D015221:Potassium Channels / Q000187:drug effects*; D011224:Prazosin / Q000009:adverse effects / Q000627:therapeutic use; D011897:Random Allocation
chemical_list: D000959:Antihypertensive Agents; D006146:Guanidines; D015221:Potassium Channels; D006830:Hydralazine; D008750:Methyldopa; D020110:Pinacidil; D011224:Prazosin