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The clinical experience of 763 medical practitioners who treated 3,708 hypertensive patients (51% men) with indoramin, administered alone or in combination with diuretics and/or beta-adrenergic antagonists, is reported. All patients had baseline diastolic blood pressure (DBP) of 95 mm Hg or greater, even though most of the patients (62%) already were receiving optimum doses of diuretics (20%), beta-adrenergic antagonists (15%), or diuretics and beta-adrenergic antagonists (27%). After 6 to 10 weeks of indoramin therapy, the DBP of 70% of the patients was 90 mm Hg or lower; another 17% had treated DBP between 91 and 95 mm Hg. Response rates were similar among patients treated with indoramin alone and those who received concomitant antihypertensive treatment. Indoramin doses of 50 mg/day or less (dose range, 12.5 to 125 mg/day) were required in approximately 70% of the patients. Weight gain and reflex tachycardia were not observed. The most frequently reported side effects were drowsiness/tiredness, dizziness, and dry mouth. Only 6% of the patients discontinued indoramin treatment because of side effects. The results of this study indicate that indoramin, administered alone or in combination with diuretics and/or beta-adrenergic antagonists, is a safe and effective antihypertensive agent when used in relatively low doses in clinical practice.
J Cardiovasc Pharmacol 1986
PMID:Antihypertensive therapy in the Federal Republic of Germany: clinical practice experience with indoramin (Wydora). 242 96

The safety and efficacy of indoramin and prazosin added to hydrochlorothiazide (HCTZ) were compared in a double-blind trial involving 209 patients with mild to moderately severe essential hypertension. Patients whose supine diastolic blood pressure (SDBP) did not decrease to less than or equal to 90 mm Hg after 6 weeks of HCTZ therapy had indoramin or prazosin added to their regimen. Mean SDBP during 6 months of combination therapy with either regimen decreased by approximately 10 mm Hg from that at the final evaluation during HCTZ therapy (p less than 0.001); differences between the groups were not statistically significant. Mean heart rate was unchanged, whereas mean weight increased (p less than 0.001) above final HCTZ values by approximately 2 kg in both groups. Mean weight increased significantly (p less than 0.01) from baseline values, however, only in the prazosin/HCTZ group. Approximately 95% of the patients in each group had clinically significant decreases in SDBP. Fatigue or tiredness and dizziness were the most commonly reported adverse effects, and their frequencies were not significantly different in the two groups. Cardiac arrhythmias occurred only in patients in the prazosin/HCTZ group and were significantly (p less than 0.05) more frequent than among patients in the indoramin/HCTZ group; less severe adverse experiences, i.e., dry mouth, ejaculatory problems, drowsiness, and sedation, were significantly (p less than 0.05) more frequent in the indoramin/HCTZ group. When added to HCTZ, indoramin and prazosin are equally safe and effective in the treatment of hypertension.
J Cardiovasc Pharmacol 1986
PMID:Antihypertensive effects of indoramin and prazosin in combination with hydrochlorothiazide. 242 99

The antihypertensive efficacy and safety of indoramin, an alpha 1-adrenergic antagonist, were evaluated in 215 elderly patients. Data were collected from patients aged 60 years and older who were treated under similar protocols with indoramin administered alone (n = 58) or in combination with a thiazide diuretic (n = 157). After at least 6 months of treatment, the mean daily dosage of indoramin was higher among patients who received indoramin alone (122 mg/day) than among those who received indoramin plus a diuretic (92 mg/day). Mean supine blood pressure decreased (p less than 0.001) from 174/105 to 152/191 mm Hg in indoramin-treated patients and from 179/101 to 150/91 mm Hg in patients who were treated with indoramin plus a diuretic. Clinically satisfactory blood pressure decreases occurred in the majority of the patients who received indoramin, either alone (69%) or with a diuretic (75%). Both treatments were well tolerated by elderly patients; only 15 patients (7%) discontinued therapy because of adverse effects. Drowsiness, fatigue, and dizziness were the most frequently reported side effects. The results of this analysis indicate that indoramin, administered alone or in combination with a thiazide diuretic, is a safe and effective therapeutic regimen for elderly hypertensive patients.
J Cardiovasc Pharmacol 1986
PMID:Antihypertensive therapy with indoramin in the elderly. 242 7

This study evaluated the 24-h antihypertensive effect of single daily doses of celiprolol, a beta-1 adrenoceptor antagonist. Patients with supine diastolic BP between 95 and 114 mm Hg started on placebo or celiprolol 200 mg daily for 2 weeks; non-responders received 400 mg daily for 2 weeks and then 600 mg daily for another 2 weeks. Response was defined as a reduction of diastolic BP to 90 mm Hg or below. One hundred ninety patients were evaluated for efficacy, 114 in the celiprolol group and 76 in the placebo group, 84 men and 106 women, mean age 52 years. Blood pressure after 6 weeks fell from 165/103 to 149/92 on celiprolol and from 162/103 to 157/97 on placebo. The fall in systolic and diastolic BP after celiprolol is statistically different (p less than 0.001) from that after placebo. The pulse rate was reduced to a similar extent by the two treatments. The percent of patients with supine diastolic BP either reduced by at least 10 mm Hg or to 90 mm Hg or below, was 66% after celiprolol and 38% after placebo (p less than 0.001). The incidence of adverse reactions was comparable in the two groups: 31% during celiprolol, 25% during placebo. The most frequent reactions observed in both groups were gastrointestinal symptoms, dizziness, fatigue, headache. In conclusion, celiprolol proved to be a safe and effective beta-blocker in the treatment of mild and moderate hypertension.
J Cardiovasc Pharmacol 1986
PMID:A placebo-controlled double-blind multicenter study of celiprolol in the treatment of mild and moderate hypertension. 242 40

The protective effect of calcium antagonists on ischemic heart has been attributed to decreased energy expenditure. We administered one of the newer calcium antagonists, DL-bepridil (0.1-10 microM), to Langendorff rat hearts 10 or 15 min before ischemia (flow reduction approximately 80%). Vasodilation during normoxia was already observed with 0.3 microM DL-bepridil (flow increase 34%, p less than 0.005). This concentration decreased normoxic contractility and ischemic purine release, a marker for ATP breakdown. In the absence of bepridil, purine release of hearts that were made ischemic was 8.5-fold higher than that of normoxic control hearts. With 1 microM bepridil, the ischemic purine efflux was suppressed by 55% (p less than 0.05), with negative inotropy (p greater than 0.05) during normoxia. At 3 and 10 microM, bepridil decreased normoxic contractility by 40 and 75%, respectively (p less than 0.001), concomitant with a decrease in ischemic purine release by 80 and 76%, respectively (p less than 0.01). At the end of ischemia, myocardial ATP and creatine phosphate had decreased by 22 and 55%, respectively (p less than 0.05), and ADP, AMP, and creatine had increased 1.5-3.5-fold (p less than 0.05). Bepridil (3 microM) normalized the adenine nucleotide values; creatine and creatine phosphate approached control levels. The dose-dependent protection of the ischemic heart by bepridil appears to arise from its negative inotropic action during normoxia.
J Cardiovasc Pharmacol 1987 Jul
PMID:Protection by bepridil against myocardial ATP-catabolism is probably due to negative inotropy. 244 Nov 54

A double-blind controlled, randomized, parallel, multicenter 12-week study was conducted to compare the antihypertensive efficacy of lisinopril with that of metoprolol in treatment of moderate to severe hypertension. Initially, 118 patients were recruited on lisinopril and 61 on metoprolol; and for the purpose of efficacy analysis at week 8, 115 patients on lisinopril and 60 on metoprolol were included. The doses of lisinopril or metoprolol were 40-80 mg/day and 100-200 mg/day, respectively. At week 4, the pretreatment diastolic blood pressure of 111 mm Hg was decreased to 97 mm Hg (p less than 0.01) with lisinopril: metoprolol decreased the diastolic blood pressure from 110 to 99 mm Hg (p less than 0.01). Similar decreases were noted at week 8; however, the drop in blood pressure with lisinopril was not significantly different from that with metoprolol. Systolic blood pressure also demonstrated a decrease of about 18 mm Hg with lisinopril and 12 mm Hg with metoprolol (p less than 0.01). This larger decrease in systolic blood pressure with lisinopril was statistically significant at week 4 (p less than 0.05). These decreases in systolic blood pressures were maintained at week 8, again with statistical significance (p less than 0.01). Of the 118 lisinopril-treated patients, four were discontinued from lisinopril therapy because of headache, dizziness, rash, flushing, or lymphadenopathy. Four patients out of 61 (9.8%) were discontinued from metoprolol therapy because of fatigue, somnolence, asthenia, weight gain, flatulence, tremor, or bronchospasm. In conclusion, lisinopril 40-80 mg once daily is as effective as metoprolol 100-200 mg once daily in reducing diastolic blood pressure in patients with moderate to severe hypertension.(ABSTRACT TRUNCATED AT 250 WORDS)
J Cardiovasc Pharmacol 1987
PMID:Evaluation of antihypertensive efficacy of lisinopril compared to metoprolol in moderate to severe hypertension. 244 53

The safety and tolerability of lisinopril were assessed in 1,476 patients [1,165 hypertensives and 311 patients with congestive heart failure (CHF)] and 211 normal volunteers. The duration of lisinopril therapy ranged from 1 day to 16 months, with a mean duration of 105 days. In the hypertensive population, the most frequent clinical adverse experiences on lisinopril alone were headache, dizziness, cough, and diarrhea. Not all of these adverse experiences were thought to be drug related. Five percent of patients were discontinued because of adverse clinical experiences; cough and dizziness were the most common reasons for discontinuation. Two of 1,165 (0.17%) hypertensive patients treated with lisinopril died, compared to 0.41% of hypertensive patients on other therapies. Neither case was considered to be drug related. In patients with CHF, the most frequent clinical adverse experiences were dizziness, diarrhea, hypotension, fatigue, headache, and rash. Not all of these adverse experiences were thought to be drug related. The percent of CHF patients discontinuing because of an adverse clinical experience was 7.4%; the most frequent causes for discontinuation were hypotension, dizziness, or renal impairment. Twelve deaths occurred in 311 CHF patients treated with lisinopril (3.9%) compared to 4/104 (3.8%) of CHF patients treated with placebo and 2/65 (3.1%) treated with captopril. Hypotension, orthostatic effects, or dizziness following the initial lisinopril dose occurred infrequently in patients treated with lisinopril. In hypertensive patients with normal renal function, including those treated previously or concomitantly with diuretic therapy, a first-dose hypotensive episode was reported in six of 955, or 0.6%. The incidence was higher (6.7%) in hypertensive patients with impaired renal function.(ABSTRACT TRUNCATED AT 250 WORDS)
J Cardiovasc Pharmacol 1987
PMID:The safety and tolerability of lisinopril in clinical trials. 244 61

In the Swiss Ketanserin Study the antihypertensive efficacy and tolerability of ketanserin (given in 20 or 40 mg doses twice daily) was investigated, after a placebo run-in phase, as monotherapy (n = 68) as well as in combination with either atenolol (100 mg/day) (n = 30) or the potassium-sparing diuretic hydrochlorothiazide (50 mg/day) and amiloride (5 mg/day) (n = 26) in 124 patients with essential hypertension, aged 41 to 82 years. With the addition of ketanserin, diastolic blood pressure fell by 8 +/- 8, 8 +/- 8, and 7 +/- 9 (+/- SD) mm Hg, respectively (p less than 0.05 for all) in the three treatment groups; heart rate remained unchanged or fell slightly. Ketanserin had no effect on body weight, or biochemical variables, including total serum cholesterol and triglycerides, with the exception of a minor increase in apolipoprotein B. Using a patient self-assessment questionnaire (30 items), the addition of ketanserin was associated with a reduction of most of the symptoms encountered in the placebo phase, including sleep disturbances, general feeling of weakness, headaches, nervousness, and fatigue, but there was a tendency toward increases in stuffy nose and dry mouth. In patients older than 60 years, the antihypertensive efficacy of ketanserin was greater, with 59% achieving a diastolic pressure less than or equal to 95 mm Hg versus 45% in the younger patients. This age trend also emerged when ketanserin was combined with either atenolol or the diuretic.
J Cardiovasc Pharmacol 1987
PMID:Antihypertensive efficacy of ketanserin alone or in combination with a beta-blocker or a diuretic: the Swiss Ketanserin Study. 244 58

Lisinopril, a long-acting angiotensin converting enzyme inhibitor, and the calcium channel blocker nifedipine in its retard formulation, were compared as monotherapy in a group of 45 patients with essential hypertension. Lisinopril in single daily doses (range 20-80 mg, median dose 40 mg) and nifedipine retard in twice daily doses (total daily dose range 40-80 mg, median dose 60 mg) were equally effective in controlling hypertension. The lisinopril group (n = 30), at baseline supine blood pressure 178/109 +/- 23/9 mm Hg (mean +/- 1 SD), after 12 weeks' therapy measured 148/88 +/- 27/14 mm Hg; the nifedipine group (n = 15), at baseline 185/110 +/- 23/11 mm Hg, after 12 weeks' therapy measured 151/89 +/- 14/10 mm Hg. The number of patients who experienced clinical adverse effects was significantly greater in the nifedipine group: 8 of 15 (53%) compared to 4 of 30 (13%) in the lisinopril group. The commonest adverse effects of patients on nifedipine were swollen ankles, flushing, and headache. Two patients on nifedipine were withdrawn from the study because of their adverse experiences. Of the patients on lisinopril there were single reports of flushing, ankle swelling, tiredness, and chest pain. No patient withdrew from lisinopril because of an adverse experience. No adverse laboratory experiences were recorded in either group. In conclusion, lisinopril and nifedipine retard were equally effective in controlling essential hypertension. Lisinopril was, however, better tolerated during this study.
J Cardiovasc Pharmacol 1987
PMID:Comparative efficacy of lisinopril and nifedipine retard in essential hypertension: a double-blind, placebo-controlled trial. 245 54

The antihypertensive effect and safety of doxazosin once-daily was compared with that of atenolol once-daily in 40 patients with mild to moderate hypertension. During the first 4 weeks all patients received placebo therapy. During the subsequent 10 weeks patients were randomized to doxazosin or atenolol treatment. Treatment was initiated with 1 mg doxazosin or 50 mg atenolol once-daily. The dose could be doubled biweekly until a final dose of 16 mg doxazosin or 100 mg atenolol was reached. The average final dose of doxazosin was 6.4 +/- 0.8 mg (SEM) and that of atenolol 66.7 +/- 5.7 mg. During the 10 weeks of active treatment, the systolic and diastolic blood pressure tended to be lower (p less than 0.05) in patients on atenolol, this difference was however not significant for the standing blood pressure. Recumbent and standing heart rate were lower (p less than 0.01) during atenolol. Multiple regression analysis showed that in the doxazosin group the recumbent systolic blood pressure after 10 weeks of treatment was significantly (p less than 0.05) and independently related to age, recumbent systolic blood pressure at randomization, and the changes in recumbent heart rate. In neither group severe adverse reactions were observed. However, two patients on doxazosin dropped out of the study: one because of blurred vision and persistent high blood pressure, and one because of fatigue and palpitations. No patient dropped out of the atenolol group during the study.
J Cardiovasc Pharmacol 1988 Oct
PMID:Short-term double-blind comparison of doxazosin and atenolol in patients with mild to moderate hypertension. 246 47


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