:A Double-blind Cross-over Study with lnactive Placebo Control and Concomitant Thiazide Diuretic Treatment

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The antihypertensive effectiveness and usefulness of penbutolol were evaluated by means of a double-blind cross-over study, employing an inactive placebo as control, in patients with essential hypertension unable to be controlled by a thiazide diuretic. The study consisted of a 4-week control period, followed by Treatment Periods I and each 6 weeks in duration. The following results were obtained: 1) Among a total of 113 patients enrolled, 101 were analyzable. Eleven of these patients were evaluated for adverse reactions and safety only. 2) The demographic characteristics of the penbutolol-placebo group and the placebo-penbutolol group were comparable. 3) Blood pressure during Treatment Period I decreased significantly in both the penbutolol and placebo groups compared to the control period. During Treatment Period II, blood pressure in the placebo group did not change significantly compared to the end of Treatment Period I but that in the penbutolol group decreased significantly. Pulse rate during Treatment Periods I and II decreased significantly compared to the control period in the penbutolol group but did not show any change in the placebo group. 4) Since the order and time of treatment was found to influence blood pressure, only data derived from Treatment Period I were subjected to intergroup comparison. Penbutolol was found to be significantly superior to placebo in terms of the global judgment of antihypertensive effect (p<0.05). 5) Although order- and time-related effects were noted, an assessment of efficacy data derived from both Treatment Periods I and II revealed penbutolol to be signifi-cantly superior to placebo with regard to the global judgment of antihypertensive effect, overall improvement, and usefulness (p<0.01). Intragroup comparison of Treatment Periods I and II demonstrated penbutolol to be significantly superior to placebo for global evaluation of antihypertensive effect, overall improvement and usefulness (p<0.01). 6) Adverse reactions occurred in 4 patients (4.2%, 1 with gastrointestinal disturb-ances and 3 with bradycardia) during penbutolol treatment and 3 patients, (3.1%, 1 with chest compression, shortness of breath and effort palpitation, 1 with malaise, and 1 with dizziness) during placebo treatment. All symptoms appearing during penbutolol treatment disappeared after discontinuing the drug or switching to placebo. Laboratory examinations did not reveal any severe changes. These results demonstrated that penbutolol, 40 mg per day in two divided doses, was superior to placebo for antihypertensive effect, overall improvement, and usefulness during concomitant thiazide treatment.
一般社団法人日本臨床薬理学会の論文

:A Double-blind Cross-over Study with lnactive Placebo Control and Concomitant Thiazide Diuretic Treatment

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