Long-Term Experience with Tertatolol in Hypertension

Abstract

The long-term antihypertensive activity and acceptability of a new β-blocking agent tertatolol (T) (5 mg once daily) was assessed in a 12-month (M0-M12) open study, in 110 out-patients (64 men, 46 women, mean age 53.5 ± 1.0 years), presenting with stable placebo-resistant hypertension (HT) (95 ≤ diastolic blood pressure < 130 mm Hg on 3 occasions during a 1-month placebo run-in period). To obtain normalization of blood pressure (BP), treatment was adapted as from M3, adding a combined thiazide- and potassium sparing-diuretic (D) and, if necessary, the vasodilator dihydralazine (V). At Ml2, 93.6% of patients were controlled (supine diastolic BP < 95 mm Hg) among whom 72.7% under T monotherapy, 16.4% under double therapy (T + D) and 4.5% under triple therapy (T + D + V). Overall variations of BP were 26.4 mm Hg for SBP (from 171.7 ± 1.6 to 145.3 ± 1.3 mm Hg; p < 0.01) and 19.9 mm Hg for DBP (from 105.6 ± 0.7 to 85.7 ± 0.6 mm Hg; p < 0.01). Under T monotherapy, reduction in diastolic BP occurred early (15.0 mm Hg at Ml) and was sustained thereafter (19.5 mm Hg at M12); HT control was comparable in the 40- to 60- and > 60-year-old age groups (respectively 67.6% and 74.1%) and higher in the < 40-year-old group (100%). It also rose from 61.2% when initial diastolic BP was > 105 mm Hg to 82.0% when it was ≤ 105 mm Hg. Overall side effects were rare with only 5.8% of withdrawals. No significant antinuclear antibody titers were observed. Under monotherapy, blood creatinine levels decreased by 9.9% (from 97.5 ± 1.6 to 87.8 ± 1.6 μmol/l; p < 0.01), and HDL cholesterol increased by 22.1% (from 1.59 ± 0.07 to 1.94 ± 0.06 mmol/l; p. < 0.01), resulting in an improvement in the LDL/HDL cholesterol ratio. Thus, chronic administration of tertatolol 5 mg once daily effectively controls HT while having favorable effects on plasma lipid profiles and renal function.

European Experience with Artex: The Tertatolol International Multicentre Study (TIMS)

“…The efficacy of tertatolol was pre viously reported in two 1-year studies involv ing 110 patients [2] and 2,338 patients [8]. In these studies, blood pressure was also con trolled in 88.5% of the population: 69.2% with tertatolol alone and 19.3% in combina tion with diuretics.…”

“…The efficacy and tolerabili ty of tertatolol, a beta-blocker with vasodilat ing properties, has been demonstrated in pa tients with mild and moderate hypertension in a long-term study [2], In addition, the vaso dilator effects of tertatolol on the renal circu lation [3,4] have been shown to be particu larly beneficial in preserving renal function during long-term therapy [2], In most of the patients whose diastolic BP remained ele vated with tertatolol alone, further reduction in BP was achieved by the addition of a diuretic [2], as has been previously reported with propranolol [5], This study was initiated to confirm the efficacy and tolerability of tertatolol in mildto-moderate hypertension, over a 12-month period.…”

Overview of Novel Renal Properties of Tertatolol

“…In addition, in clinical studies performed over a one year period, creatinine plasma level did not change in hypertensive patients with normal renal function and decreased significantly in pa tients with high creatinine plasma levels [7,8], The renal vasodilatating properties of ter tatolol demonstrated in animals have been confirmed in man.…”

Preserving the Autoregulation of Renal Hemodynamics

“…From Komajda et ai. [10], 0.015) in those patients whose pretreatment value exceeded 100 pmol/1. As in the preced ing study, this decrease appeared only in pa tients with single therapy with tertatolol.…”

“…The first one, reported by Komajda et al [10], was an open study conducted with a population of 110 outpatients. After a 3-month run-in placebo period, patients re ceived tertatolol, 5 mg a day, for 1 year.…”