Biomedical subjects
J F Burris
Publications and source records attributed to J F Burris.
Therapeutic adherence in the elderly: transdermal clonidine compared to oral verapamil for hypertension.
This double-blind, double-dummy, randomized clinical trial, conducted in elderly patients with mild hypertension, compared adherence to treatment, efficacy, side effects, and quality of life during treatment with transdermal clonidine versus oral sustained-release verapamil (verapamil-SR). Blood pressure declined significantly--from 148/95 mm Hg at baseline to 139/84 after titration and 135/86 after maintenance--with transdermal clonidine (n = 29), and from 156/96 to 144/85 and 148/88, respectively, with verapamil-SR (n = 29). Adverse event rates and quality-of-life questionnaire responses were similar in the two treatment groups. Transdermal clonidine was worn as directed during more than 96% of patient-weeks of treatment. Compliance with the oral verapamil regimen was less consistent: Verapamil-SR was taken as directed during approximately 50% of patient-weeks of therapy, and individual compliance, assessed by tablet counts, varied from 50-120%. In all, 86% of subjects were satisfied or highly satisfied with the convenience of transdermal therapy; 87% reported that side effects were slightly or not bothersome; 65% indicated that transdermal patches were more convenient than oral therapy; and almost 60% preferred transdermal to oral therapy. In this study transdermal clonidine and oral verapamil were equally safe and effective. A substantial majority of patients preferred transdermal to oral therapy, and adherence to treatment was greater with transdermal therapy.
Practical considerations in treating the elderly hypertensive patient.
More than half of all older Americans die of cardiovascular diseases. Hypertension is a major risk factor for cardiovascular diseases, and its prevalence increases with age. Older patients are both at higher risk for end-organ complications and less likely than younger ones to survive such complications as myocardial infarction and stroke. Clinical studies have shown that reduction of elevated blood pressure is beneficial in many older persons. Optimal selection of antihypertensive therapy requires consideration of the special characteristics of the elderly, who differ from their younger counterparts in physiology, response to therapy and frequency of concomitant illnesses and medications. Calcium antagonists are particularly effective in these patients; other agents are useful in selected situations. Drugs that are likely to cause central nervous system side effects or orthostatic hypotension generally should be avoided in this patient population. Therapy should begin with a low dose and be titrated upward slowly, thus avoiding excessive reduction of blood pressure and the development of orthostatic hypotension. Treatment should be altered as necessary to minimize side effects that may impair quality of life or lead to poor compliance.
Evaluation of labetalol in elderly patients with essential hypertension.
Labetalol was evaluated in a multicenter, placebo-controlled study of elderly patients (greater than or equal to 60 years) with mild to moderate essential hypertension. After a placebo-washout period, doses were titrated from 100 mg BID to a maximum of 400 mg BID over a 6-week period. Once blood pressure control (standing diastolic blood pressure [SDBP] less than 90 mm Hg and greater than or equal to 10 mm Hg reduction from baseline) was achieved or the maximum allowable dosage had been given, the dosage remained the same until the end of the study. The titration phase was followed by a 4-week maintenance period. Blood pressure control was achieved in 37/54 (69%) of the patients who were treated with labetalol compared with 21/58 (36%) of the patients who received placebo (P less than .001). Twenty-nine (78%) of those controlled on labetalol responded to doses of 200 mg or less BID, and there was no significant difference between groups with respect to orthostatic blood pressure changes. Adverse experiences were generally mild and occurred with similar frequency in the labetalol and placebo groups; six patients who received labetalol and five who received placebo withdrew from the study due to adverse experiences, but in only one case (labetalol) was the adverse experience considered drug-related. In summary, labetalol effectively and safely lowered diastolic blood pressure in the elderly without producing significant orthostatic changes.
Dose comparability of atenolol and betaxolol.
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Pentoxifylline in the treatment of vascular impotence--case reports.
Vascular impotence is a common medical problem for which available therapies are limited. Three impotent patients observed in the authors' practice who were receiving pentoxifylline for treatment of claudication of the lower extremities spontaneously reported improved sexual function. A controlled trial of pentoxifylline for vascular impotence may be warranted.
Dose-finding study of cilazapril (Inhibace) in patients with uncomplicated essential hypertension.
Cilazapril, an angiotensin converting enzyme (ACE) inhibitor with a long half-life, effectively reduced sitting diastolic blood pressure in patients with uncomplicated essential hypertension at dosages of 2.5, 5.0, and 10.0 mg/day, evaluated in a double-blind, placebo-controlled study. After a four-week placebo run-in period, 235 patients received either cilazapril or placebo for four weeks. At the end of the treatment period, significant decreases from baseline in sitting diastolic blood pressure were seen in all four groups (mean decreases of 3.3 mm Hg with placebo and 6.4, 9.2 and 8.3 mm Hg with 2.5, 5.0 and 10.0 mg cilazapril, respectively). The cilazapril groups had significantly greater blood pressure reductions than did the placebo group (p less than or equal to 0.02). The 5.0 mg cilazapril dose was significantly more effective than the 2.5 mg dose (p less than 0.03). The response rate was notably greater in the cilazapril treatment groups than in the placebo group (placebo, 27.5%; 2.5 mg cilazapril, 42.9%; 5.0 mg cilazapril 62.5%; 10.0 mg cilazapril, 50.0%). Cilazapril was well tolerated at all three dosages.
The effect of ramipril on ambulatory blood pressure: a multicenter trial.
The antihypertensive efficacy of ramipril was evaluated using 24-h noninvasive ambulatory sphygmomanometry in this double-blind, placebo-controlled study. One hundred subjects with mild-to-moderate essential hypertension were randomized to ramipril, 10 mg or placebo once daily for a 4-week treatment period. Ramipril decreased systolic and diastolic blood pressures throughout the 24-h period after dosing. Blood pressures measured manually 24 h postdose also showed that ramipril significantly reduced supine and standing blood pressures when compared with placebo. Incidences of adverse events were similar in the two study groups. Ramipril proved to be a well-tolerated agent with a sustained 24-h antihypertensive effect in this study.
A double-blind evaluation of the effect of amlodipine on ambulatory blood pressure.
The effects of amlodipine on ambulatory blood pressure were investigated in patients with mild-to-moderate hypertension. Ambulatory recordings showed that amlodipine maintained diastolic and systolic blood pressure below baseline levels for a full 24-h period without altering the normal circadian rhythm. No reflex tachycardia occurred and side effects were rare.
Caring for older patients with high blood pressure.
Hypertension, a major risk factor for cardiovascular disease, is common in older patients. Optimal selection of antihypertensive therapy in the elderly requires consideration of the unique risks, physiology and concomitant illnesses in this age group. Since the U.S. population is aging rapidly, appropriate management of hypertension in older patients is likely to remain an important concern.
Mild hypertension and cardiovascular risks.
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An assessment of diltiazem and hydrochlorothiazide in hypertension. Application of factorial trial design to a multicenter clinical trial of combination therapy.
This multicenter, factorial-design trial assessed the safety and additive antihypertensive efficacy of a slow-release (SR) formulation of diltiazem hydrochloride given alone or in combination with hydrochlorothiazide for treatment of mild to moderate hypertension. After a 4- to 6-week placebo run-in period, 297 qualifying patients were randomized to receive placebo, 1 of 4 doses of diltiazem SR monotherapy, 1 of 3 doses of hydrochlorothiazide monotherapy, or 1 of 12 possible combinations of diltiazem SR and hydrochlorothiazide for 6 weeks. A dose-related reduction in blood pressure was demonstrated for each drug as monotherapy and for the two drugs in combination. Absolute blood pressures of patients who received combination therapy were lower by an overall mean of 3.0 mm Hg diastolic and 8.0 mm Hg systolic vs diltiazem SR used alone and 3.5 mm Hg diastolic and 4.0 mm Hg systolic vs hydrochlorothiazide used alone. At the largest doses used, 50% of patients achieved goal blood pressure while taking hydrochlorothiazide, 57% while taking diltiazem SR, and 75% while taking combination therapy. Combination therapy was well tolerated. This trial clearly demonstrates that diltiazem SR and hydrochlorothiazide have additive antihypertensive effects.
Pill hoarding and hypercompliance.
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The perils of pet therapy.
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Treatment of isolated systolic hypertension with labetalol in the elderly.
Antihypertensive therapy with labetalol was evaluated in a prospective, randomized, multicenter, double-blind study of 133 elderly patients with isolated systolic hypertension (standing systolic blood pressure [BP] greater than or equal to 160 mm Hg; diastolic BP less than 95 mm Hg). Following a placebo-washout period, patients received either labetalol (n = 70) or placebo (n = 63), which was titrated as necessary from 100 to 400 mg twice a day over a 6-week period. Once the BP was controlled (standing systolic BP less than 160 mm Hg, and greater than or equal to 10-mm Hg decrease from baseline) or the maximum dosage had been given, patients continued receiving the same regimen until the end of the titration period and throughout a 4-week maintenance period. Blood pressure was controlled in 57 (81%) of 70 of the labetalol-treated patients (86% receiving less than or equal to 200 mg twice a day) compared with 34 (54%) of 63 of the placebo-treated patients. Throughout the active treatment periods, BP was significantly lower in patients treated with labetalol compared with those taking placebo; mean standing systolic BP decreased 26 mm Hg in the labetalol group vs 9 mm Hg in the placebo group. Side effects were generally mild, and the dropout rates due to adverse experiences were similar between treatment groups (14% in the labetalol group vs 10% in the placebo group). In summary, labetalol can effectively lower systolic BP in the elderly without causing adverse orthostatic changes.
Publish? Perish the thought!
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Humoral Na+-K+ pump inhibitory activity in essential hypertension and in normotensive subjects after acute volume expansion.
Plasma from black male patients with essential hypertension was bioassayed for vascular Na+-K+ pump inhibitory activity. Halves of the same rat tail artery were incubated for two hours in boiled plasma supernates from a hypertensive patient and a paired age-, sex-, and race-matched normotensive subject and then ouabain-sensitive 86Rb uptake was measured. Ouabain-sensitive 86Rb uptake by their leukocytes was also measured. Eighteen pairs of subjects were studied. The uptakes were not significantly different in the hypertensive patients and control subjects. However, when we selected from the eighteen hypertensive patients, nine with low plasma renin activity on the day of the study, uptakes were reduced in the hypertensive patients relative to the paired control subjects. We also assayed plasma supernates from normotensive black and white male subjects before and after acute volume expansion (2.5 L saline IV + 1.5 L distilled water orally over a three-hour period) and from paired normotensive subjects before and after sham volume expansion and obtained a positive bioassay in the expanded subjects both on intraindividual and interindividual comparisons. These studies demonstrate increased vascular Na+-K+ pump inhibitory activity in the plasma of black male patients with low renin essential hypertension and in the plasma of normotensive subjects after acute volume expansion. The findings suggest that the inhibitory activity in the hypertensive subjects' plasma is related to volume expansion, relative or absolute.