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Disposition of tablet and capsule formulations of digoxin in the elderly.

STUDY OBJECTIVE: To compare digoxin tablets and liquid-filled capsules with respect to excretion of the drug and its metabolites in urine and feces at steady state. DESIGN: A randomized, crossover trial, each period lasting 3 weeks, with no washout period. SETTING: A university hospital. PATIENTS: Six patients, five of whom were elderly, with histories of gastrointestinal disorders, such as hypochlorhydria, intestinal bacterial overgrowth, and inflammatory bowel disease. INTERVENTIONS: The patients received digoxin once/day in either tablet or capsule form for 3 weeks, and then were switched to the other formulation. Total urinary and fecal excretion from the last 3 days of each regimen were analyzed for the drug and metabolites. MEASUREMENTS AND MAIN RESULTS: No statistically significant differences were found between tablets and capsules in recovery of digoxin or its metabolites in urine or feces (p = 0.05). One subject had a 4-fold increase in urinary drug excretion and 50% decrease in fecal excretion after taking the capsules compared with tablets. Intersubject variability in extent and type of metabolite excretion was greater than intrasubject variability. CONCLUSIONS: Fecal analyses may be an accurate way to classify patients as formers of digoxin reduction products.

Aged↗

Sodium paradoxically reduces the gastropressor response in patients with orthostatic hypotension.

Orthostatic hypotension (OH) can cause syncope that is difficult to treat. We have found that 473 mL (16 oz) of water can increase systolic blood pressure (SBP) by > 30 mm Hg in many OH patients (the gastropressor response). OH patients are routinely advised to increase their sodium intake to augment their blood volume. We tested the hypothesis that the ingestion of salt with water would increase the magnitude of the acute pressor response compared with water alone in patients with OH. Patients with OH (n = 9; female = 5; 65+/-3 years) underwent a randomized crossover trial of drinking water (H2O) and salt water (NaCl-H2O). Noninvasive heart rate and BP were measured with the patient seated for > or = 60 minutes after ingestion. The area under the curve for SBP was greater with H2O than NaCl-H2O for the 30 minutes (714+/-388 mm Hg x min versus 364+/-369 mm Hg x min; P = 0.002) and 60 minutes (1454+/-827 mm Hg x min versus 812+/-734 mm Hg x min; P = 0.048) after ingestion. The increase in SBP with H2O was greater than with NaCl-H2O at 30 minutes (37+/-6 versus 18+/-5 mm Hg; P = 0.006) but not at 60 minutes (17+/-6 versus 10+/-6 mm Hg; P = 0.4). Norepinephrine increased after H2O (P = 0.018) but not after NaCl-H2O (P = 0.195). Both oral water and salt water increase BP in patients with OH. Instead of augmenting the gastropressor response, the additional salt paradoxically attenuates the pressor response to water. These data suggest a potentially important role for gastrointestinal osmolality in the activation of the sympathetic nervous system leading to cardiovascular reflexes responsible for the gastropressor response.

Aged↗

Antiemetic therapy for chemotherapy-induced vomiting: metoclopramide, benztropine, dexamethasone, and lorazepam regimen compared with chlorpromazine alone.

Twenty-six children aged 4 to 15 years who were to receive cancer chemotherapy were enrolled in a double-blind, randomized, crossover trial that compared the antiemetic efficacy of a four-drug regimen (the MBDL regimen: metoclopramide, 8 mg/kg; benztropine, 0.04 mg/kg; dexamethasone, 0.7 mg/kg; lorazepam, 0.1 mg/kg), given over 24 hours, with the efficacy of chlorpromazine, 3.3 mg/kg, given in four doses over 24 hours. The MBDL regimen was more effective than chlorpromazine in both objective and subjective measures of antiemetic control. Of 26 children, 23 (89%) had less vomiting on the MBDL regimen, and 20 (77%) of 26 patients or parents preferred this regimen (p less than 0.01). The MBDL regimen reduced the number of vomiting episodes by a mean of 4.0 (p less than 0.01) and reduced the duration of vomiting by a mean of 3.7 hours (p less than 0.01). A moderate level of sedation was documented at some stage in the 24-hour period of observation in 27% on the MBDL regimen and in 35% receiving chlorpromazine. Dystonia was seen in 1 (4%) of 26 children. We conclude that the MBDL regimen is safe in children and more effective than chlorpromazine.

Adolescent↗

Bioavailability of magnesium diglycinate vs magnesium oxide in patients with ileal resection.

BACKGROUND: Patients who have undergone ileal resection are at risk for developing magnesium depletion/deficiency because of poor absorption and decreased intake as well as increased endogenous losses. Magnesium repletion is difficult to accomplish because of the cathartic action of most oral magnesium supplements at therapeutic doses. The results of in vitro and in situ studies show that magnesium diglycinate (chelate) represents a highly available form of magnesium that is absorbed in part as an intact dipeptide in the proximal small intestine. METHODS: We conducted a double-blind, randomized crossover trial with 12 patients who had ileal resections in order to compare the bioavailability of a 100-mg dose of 26Mg-labeled chelate with MgO in this patient population. RESULTS: For the patient group as a whole, 26Mg absorption was low but was not different for the two supplements (23.5% vs 22.8% for magnesium chelate and MgO, respectively). However, 26Mg absorption was substantially greater from the chelate (23.5% vs 11.8%; p < .05) in the four patients who showed the greatest impairment of magnesium absorption with MgO and was better tolerated by all patients. Peak isotope enrichment also occurred significantly earlier after 26Mg chelate than after 26MgO ingestion (mean difference 3.2 +/- 1.3 hours; p < .05), and the area under the enrichment vs time curve was greater after chelate ingestion (p < .05). CONCLUSIONS: Data from this study support the suggestion that some portion of magnesium diglycinate is absorbed intact, probably via a dipeptide transport pathway. Magnesium diglycinate may be a good alternative to commonly used magnesium supplements in patients with intestinal resection.

Administration, Oral↗

Nicotinic acid as therapy for dyslipidemia in non-insulin-dependent diabetes mellitus.

Recently, nicotinic acid has been recommended as a first-line hypolipidemic drug. To determine the effectiveness of nicotinic acid in dyslipidemic patients with non-insulin-dependent diabetes mellitus, 13 patients were treated in a randomized crossover trial. Patients received either nicotinic acid (1.5 g three times daily) or no therapy (control period) for 8 weeks each. Compared with the control period, nicotinic acid therapy reduced the plasma total cholesterol level by 24%, plasma triglyceride level by 45%, very-low-density lipoprotein cholesterol level by 58%, and low-density lipoprotein cholesterol level by 15%, and it increased the high-density lipoprotein cholesterol level by 34%. However, nicotinic acid therapy resulted in the deterioration of glycemic control, as evidenced by a 16% increase in mean plasma glucose concentrations, a 21% increase in glycosylated hemoglobin levels, and the induction of marked glycosuria in some patients. Furthermore, a consistent increase in plasma uric acid levels was observed. Therefore, despite improvement in lipid and lipoprotein concentrations, because of worsening hyperglycemia and the development of hyperuricemia, nicotinic acid must be used with caution in patients with non-insulin-dependent diabetes mellitus with dyslipidemia. We suggest that the drug not be used as a first-line hypolipidemic drug in patients with non-insulin-dependent diabetes mellitus.

Aged↗

Substituting milk for apple juice does not increase kidney stone risk in most normocalciuric adults who form calcium oxalate stones.

OBJECTIVE: Increasing intake of dietary calcium from less than 400 mg to 800 mg daily may decrease the absorption of dietary oxalate, which in turn would decrease urinary oxalate excretion. The effect of substituting milk for apple juice on urine composition and risk of calcium oxalate precipitability was studied. SUBJECTS: Twenty-one normocalciuric adults with a history of at least 1 calcium oxalate stone and urinary oxalate excretion exceeding 275 micromol/day on their self-selected diet. DESIGN: Randomized crossover trial. INTERVENTION: Each participant consumed two moderate-oxalate (2,011 micromol/day) study diets, which were identical except that one contained 360 mL milk and the other contained 540 mL apple juice as the beverage with meals. SETTING: Four days free-living then 2 days in the metabolic unit of a university nutrition department. MAIN OUTCOME MEASURE: Tiselius risk index for calcium oxalate precipitability calculated from urine composition. STATISTICAL ANALYSES: Paired t tests. RESULTS: Twenty-four hour urinary oxalate excretion was 18% lower (P<.0001) on the milk diet vs the juice diet: 423 vs 514 micromol, respectively. Calcium excretion was 17% higher (P<.05) on the milk vs juice diet: 4.7 vs 3.9 mmol, respectively. Urinary magnesium and citrate excretion, volume, and Tiselius risk index did not differ between diets. APPLICATIONS: Substituting 360 mL milk daily for apple juice with meals in a diet containing moderate amounts of dietary oxalate from whole grains, legumes, fruits, and vegetables does not increase the risk index of calcium oxalate precipitability in most normocalciuric adults who form stones.

Adult↗

Randomized crossover comparison of ProSeal Laryngeal Mask Airway with Laryngeal Tube Sonda during anaesthesia with controlled ventilation.

BACKGROUND: The Laryngeal Tube Sonda (LTS) is a supraglottic airway which, like the ProSeal Laryngeal Mask Airway (PLMA), incorporates a drain tube. We compared the performances of LTS and PLMA during controlled ventilation anaesthesia. METHODS: The devices were studied in 32 ventilated patients by randomized crossover trial. Primary outcome was airway seal pressure. Secondary outcomes included insertion success and time, manipulations required, ventilation quality, peak and plateau airway pressures, ability to pass a gastric tube and fibreoptic laryngeal view. RESULTS: The PLMA produced a higher seal pressure (median values, PLMA 26 cm H(2)O and LTS 24 cm H(2)O, P<0.01). First-attempt insertion succeeded with PLMA 28 times and LTS 22 times (P>0.05). The PLMA required fewer manipulations (P<0.05) in fewer patients (P<0.05) and took less time to insert (P<0.01). All PLMA patients and 22 LTS patients achieved optimal ventilation (P<0.01). Peak airway pressure was lower with the PLMA than with the LTS (P<0.01). The vocal cords were visible through the PLMA in 32 patients and through the LTS in nine patients (P<0.001). The laryngeal view was superior through the PLMA (P<0.001). CONCLUSION: The difference in seal pressure between devices was clinically unimportant. However, the LTS had an unexpectedly high failure rate. PLMA performance exceeded LTS performance in many clinically useful measures. The PLMA has greater clinical utility than the LTS during controlled ventilation.

Adult↗

Almonds and almond oil have similar effects on plasma lipids and LDL oxidation in healthy men and women.

Epidemiologic and clinical studies have shown that nut consumption is associated with favorable plasma lipid profiles and reduced cardiovascular risk. These effects may result from their high monounsaturated fat (MUFA) content but nuts contain constituents other than fatty acids that might be cardioprotective. We conducted a study to compare the effects of whole-almond vs. almond oil consumption on plasma lipids and LDL oxidation in healthy men and women. Using a randomized crossover trial design, 22 normolipemic men and women replaced half of their habitual fat (approximately 14% of approximately 29% energy) with either whole almonds (WA) or almond oil (AO) for 6-wk periods. Compliance was ascertained by monitoring dietary intake via biweekly 5-d food records, return of empty almond product packages and weekly meetings with a registered dietitian. Fat replacement with either WA and AO resulted in a 54% increase in percentage of energy as MUFA with declines in both saturated fat and cholesterol intake and no significant changes in total energy, total or polyunsaturated fat intake. The effects of WA and AO on plasma lipids did not differ compared with baseline; plasma triglyceride, total and LDL cholesterol significantly decreased, 14, 4 and 6% respectively, whereas HDL cholesterol increased 6%. Neither treatment affected in vitro LDL oxidizability. We conclude that WA and AO do not differ in their beneficial effects on the plasma lipid variables measured and that this suggests that the favorable effect of almonds is mediated by components in the oil fraction of these nuts.

Adult↗

Effect of a single dose of montelukast sodium on methacholine chloride PC20.

BACKGROUND: It is currently recommended that leukotriene modifiers (receptor antagonists and synthesis inhibitors) be withheld for a minimum of 24 h before direct bronchoprovocation testing, but there is little evidence to support this recommendation. OBJECTIVE: To examine the effect of a single oral dose of montelukast sodium 10 mg on airway response to methacholine chloride-induced bronchoconstriction. METHODS: A double-blind, placebo-controlled, randomized crossover trial was performed in 12 subjects with asthma whose methacholine chloride concentration causing a 20% decrease in the forced expiratory volume during the first second of exhalation (PC20) was 8 mg/mL or lower and a baseline forced expiratory volume during the first second of exhalation of 70% predicted or greater. Two-minute tidal breathing methacholine chloride inhalation challenges were performed 1 h and 25 h after both 10 mg montelukast sodium and identical-appearing placebo. RESULTS: There were no significant differences in the methacholine chloride PC20 between active treatment and placebo at 1 h post-10 mg montelukast sodium (1.0 mg/mL versus 1.3 mg/mL; n=12; P=0.17, respectively) or at 25 h post-10 mg montelukast sodium (1.4 mg/mL versus 1.9 mg/mL; n=11; P=0.15, respectively). CONCLUSION: A single dose of montelukast sodium did not affect methacholine chloride-induced bronchoconstriction measured after 1 h and 25 h.

Acetates↗

Moderate alcohol consumption and changes in postprandial lipoproteins of premenopausal and postmenopausal women: a diet-controlled, randomized intervention study.

Moderate alcohol consumption is associated with a reduced risk of coronary heart disease. Earlier studies in men have shown that moderate alcohol consumption affects lipoprotein metabolism and hemostasis. In this diet-controlled, randomized, crossover trial, we investigated the effect on lipoprotein metabolism of moderate consumption of red wine or red grape juice with evening dinner for 3 weeks in premenopausal women using oral contraceptives and in postmenopausal women. After 3 weeks, blood samples were collected 1 hour before dinner up to 19 hours after starting dinner at 2-hour or 4-hour intervals. Plasma triglyceride concentrations and very low density lipoprotein (VLDL) triglyceride levels peaked 3 hours after dinner with wine in both premenopausal and postmenopausal women. After wine consumption, the overall high-density lipoprotein (HDL) cholesterol level was increased in postmenopausal women (mean increase 0.17 mmol/L, or 12%, p = 0.03), and the plasma low-density lipoprotein (LDL) cholesterol level was reduced in premenopausal women (mean reduction 0.35 mmol/L, or 12%, p = 0.01) as compared with grape juice consumption. The findings suggest that postprandial lipoprotein metabolism after moderate alcohol consumption differs between oral contraceptive-using premenopausal women and postmenopausal women. The response of postmenopausal women to alcohol resembled the response found in earlier studies in men.

Adult↗

Comparison of transdermal versus oral estradiol on endometrial receptivity.

OBJECTIVE: To compare the effects of oral micronized E2 with transdermal E2 on endometrial receptivity in women undergoing oocyte donation. DESIGN: Prospective, randomized, crossover trial. Serum E2 and P concentrations were measured on cycle days 14 and 22 (luteal day +8). Endometrial biopsies were obtained on day 22 and read in a blinded fashion for histology and beta-3-integrin expression. SETTING: University-based donor oocyte program. PATIENTS: Twenty-seven patients presenting for donor oocytes. MAIN OUTCOME MEASURES: Endometrial histology and beta-3-integrin expression. RESULTS: The endometrial glandular histology in women given oral micronized E2 was delayed by a mean of 1.6 days in comparison to that of women given transdermal E2. Seventy percent of women given oral E2 displayed a lag > or = 4 days whereas 29.6% given transdermal E2 displayed a similar lag. Serum E2 levels were 1,194 +/- 108.8 pg/mL (mean +/- SEM; conversion factor to SI unit, 3.671) in women on oral micronized E2 and 117.4 +/- 14.0 pg/mL in those on transdermal E2. CONCLUSION: The supraphysiologic serum E2 levels associated with oral micronized E2 may have a deleterious impact on endometrial receptivity. The development of more physiologic hormone replacement protocols may enhance endometrial receptivity and lead to improved clinical pregnancy rates.

Administration, Cutaneous↗

Soy isoflavones improve plasma lipids in normocholesterolemic and mildly hypercholesterolemic postmenopausal women.

BACKGROUND: Soy-protein consumption is known to reduce plasma total and LDL cholesterol concentrations. However, the responsible soy component or components and the magnitude of effects in normocholesterolemic and mildly hypercholesterolemic subjects are unclear. OBJECTIVE: The present study examined the effects of soy isoflavone consumption on plasma concentrations of triacylglycerol, apolipoprotein (apo) A-I, apo B, lipoprotein(a), and total, LDL, and HDL cholesterol and on LDL peak particle diameter in normocholesterolemic and mildly hypercholesterolemic postmenopausal women. DESIGN: In a randomized crossover trial, fasting plasma samples were obtained from 18 postmenopausal women throughout three 93-d periods of daily isolated soy protein (ISP) consumption providing an average of 7.1 +/- 1.1 (control), 65 +/- 11 (low isoflavone), or 132 +/- 22 (high isoflavone) mg isoflavones/d. RESULTS: Compared with values measured during the control diet, the plasma LDL cholesterol concentration was 6.5% lower (P < 0.02) during the high-isoflavone diet and the ratio of LDL to HDL cholesterol was 8.5% and 7.7% lower during the low- and high-isoflavone diets, respectively (P < 0.02). Isoflavone consumption did not significantly affect plasma concentrations of total or HDL cholesterol, triacylglycerol, apo A-I, apo B, or lipoprotein(a) or the LDL peak particle diameter. CONCLUSIONS: Consumption of isoflavones as a constituent of ISP resulted in small but significant improvements in the lipid profile in normocholesterolemic and mildly hypercholesterolemic postmenopausal women. Although the effects were small, it is possible that isoflavones may contribute to a lower risk of coronary heart disease if consumed over many years in conjunction with other lipid-lowering strategies.

Aged↗

Protective effect of nedocromil sodium on the dual asthmatic response to bronchial antigen challenge.

The effects of nedocromil sodium and placebo on the asthmatic response to antigen bronchial provocation were studied in a double-blind, randomized, crossover trial. Twelve subjects sensitized to Dermatophagoides pteronyssinus were challenged with successive doubling doses of this allergen (1.25-80 x 10(-3) mg) on two separate occasions, at least 15 days apart. A single dose of either nedocromil sodium 4 mg, or, a matching placebo was given 30 min before challenge. Forced expiratory volume in 1 s (FEV1) was measured 5, 10 and 15 min after challenge. Early asthmatic response was analyzed using three indices: dose producing a 20% decrease in FEV1 (PD20), the slope of and area under the dose-response curve. Nedocromil sodium was significantly superior to placebo with respect to all three indices, providing significant inhibition of the early asthmatic responses. Seven of the 12 patients showed a late asthmatic response. There was no significant difference between the effects of nedocromil sodium and placebo treatments on the decline in peak expiratory flow rate (PEFR) during the late asthmatic response but it should be noted that when patients had been treated with nedocromil sodium they were receiving two to eight times the dose of allergen given after placebo treatment.

Adult↗

A new index of prognostic severity for chronic asthma.

OBJECTIVE: To develop a prognostic clinical index for adults with chronic stable asthma. DESIGN: Analysis of data from a 48-week randomized, crossover trial of regular vs as-needed inhaled beta-agonist therapy. PATIENTS: Eligible patients included 70 men and women between the ages of 15 and 64 years with asthma for > 1 year. OUTCOME MEASURE: Asthma deterioration within 20 weeks, defined as either a marked decline in FEV1 (> or = 1.0 L or > or = 30% from baseline) or initiation of systemic corticosteroid therapy for asthma exacerbation. RESULTS: Three baseline factors independently predicted asthma deterioration: frequent symptoms on waking in the 4 weeks before baseline, past hospitalization for asthma, and age 35 years or older. Based on cross-stratification and consolidation of these prognostic factors, an index was developed that stratified subjects into four risk groups with distinctive deterioration rates of 9%, 21%, 39%, and 67% (p<0.001). CONCLUSION: For adults with chronic stable asthma, three simple clinical factors can be combined to stratify effectively for risk of subsequent asthma deterioration.

Administration, Inhalation↗

Effects of ingestion of bicarbonate, citrate, lactate, and chloride on sprint running.

PURPOSE: Ingestion of sodium bicarbonate is known to enhance sprint performance, probably via increased buffering of intracellular acidity. The goal was to compare the effect of ingestion of sodium bicarbonate with that of other potential buffering agents (sodium citrate and sodium lactate) and of a placebo (sodium chloride) on sprinting. METHODS: In a double-blind randomized crossover trial, 15 competitive male endurance runners performed a run to exhaustion 90 min after ingestion of each of the agents in the same osmolar dose relative to body mass (3.6 mosmol x kg) on separate days. The agents were packed in gelatin capsules and ingested with 750 mL of water over 90 min. During each treatment we assayed serial finger-prick blood samples for lactate and bicarbonate. A familiarization trial was used to set a treadmill speed for each runner's set of runs. We converted changes in run time between treatments into changes in a time trial of similar duration using the critical-power model, and we estimated likelihood of practical benefit using 0.5% as the smallest worthwhile change in time-trial performance. RESULTS: The mean run times to exhaustion for each treatment were: bicarbonate 82.3 s, lactate 80.2 s, citrate 78.2 s, and chloride 77.4 s. Relative to bicarbonate, the effects on equivalent time-trial time were lactate 1.0%, citrate 2.2%, and chloride 2.7% (90% likely limits +/- 2.1%). Ingested lactate and citrate both appeared to be converted to bicarbonate before the run. There were no substantial differences in gut discomfort between the buffer treatments. CONCLUSION: Bicarbonate is possibly more beneficial to sprint performance than lactate and probably more beneficial than citrate or chloride. We recommend ingestion of sodium bicarbonate to enhance sprint performance.

Adult↗

The contrasting effects of dobutamine and dopamine on gastric mucosal perfusion in septic patients.

To test the hypothesis whether or not dobutamine or dopamine infusion increases gastric mucosal perfusion, a prospective randomized crossover trial was conducted on 10 septic patients in the intensive care unit of a university hospital. Systemic hemodynamic, oxygen transport, and gastric perfusion assessed by gastric intramucosal pH and laser Doppler flowmetry were measured at baseline and after administration of dobutamine or dopamine (5 micrograms/kg/min). Both increased oxygen transport. In response to dobutamine, gastric mucosal blood flow increased (+32 +/- 14% from baseline; p < 0.05), gastric tonometered PCO2 and gastric arterial PCO2 difference decreased (58 +/- 7 versus 52 +/- 7 mm Hg; p < 0.05; 16.8 +/- 7.0 versus 10.5 +/- 7.2 mm Hg; p < 0.05), and intramucosal pH increased (7.23 +/- 0.05 versus 7.29 +/- 0.06; p < 0.05). In response to dopamine, gastric mucosal blood flow decreased (-28 +/- 8% from baseline; p < 0.05), gastric tonometered PCO2, gastric-arterial PCO2 difference, and calculated intramucosal pH were unchanged (58 +/- 7 versus 61 +/- 9 mm Hg, ns; 16.8 +/- 7.0 versus 18.9 +/- 8.4 mm Hg, ns; 7.24 +/- 0.05 versus 7.21 +/- 0.06, ns). We speculated that despite an oxygen transport increase, dobutamine and dopamine have affected differently gastric mucosal perfusion in septic patients.

Acid-Base Equilibrium↗

Synthetic human parathyroid hormone 1-34 vs calcitriol and calcium in the treatment of hypoparathyroidism.

OBJECTIVE: To test the hypothesis that treatment with human parathyroid hormone 1-34 (PTH 1-34) can maintain normal serum calcium without hypercalciuria in patients with hypoparathyroidism. DESIGN: Randomized crossover trial lasting 20 weeks. Each 10-week arm consisted of a 2-week inpatient dose-adjustment phase followed by an 8-week outpatient phase. SETTING: Tertiary care center. PATIENTS: A total of 10 patients with hypoparathyroidism were enrolled consecutively over a 15-month period. Half of the patients were prior National Institutes of Health patients, and the other 5 patients were referred from outside physicians. INTERVENTIONS: A dose of PTH 1-34 was administered each morning by subcutaneous injection. Calcitriol was given orally twice daily with supplemental calcium carbonate. MAIN OUTCOME MEASURES: Serum and urine calcium and phosphorus levels. RESULTS: Once-daily treatment with PTH 1-34 maintained serum calcium in the normal range with decreased urine calcium excretion (P<.05 at 2 weeks and P<.Ol at 10 weeks) compared with calcitriol treatment. Biochemical markers of bone turnover increased significantly (P<.Ol at 10 weeks) during PTH 1-34 treatment. CONCLUSIONS: Treatment of hypoparathyroidism with PTH 1-34 reduces urine calcium excretion compared with treatment with calcitriol and calcium.

Adult↗

A comparison of hemodynamic effects of one-month oral captopril and enoximone treatment for severe congestive heart failure.

A double-blind, randomized, crossover trial was undertaken to compare the effect of enoximone (150 mg, 3 times daily) and captopril (25 mg, 3 times daily) added to conventional therapy with diuretics in the treatment of 13 patients with severe chronic heart failure. Each treatment was continued for 1 month. Heart failure was due to idiopathic dilated cardiomyopathy in 6 patients and coronary artery disease in 7. Hemodynamic measurements were made at rest and during exercise, on entry to the study and after each treatment period. The cardiac index at rest was 1.9 +/- 0.2 liters min-1 m2 (mean +/- 1 standard deviation) and did not change with either drug. Systemic vascular resistance at rest decreased with enoximone (p less than 0.05) and was unchanged with captopril. Systemic vascular resistance at peak exercise was not lowered by either drug. Both drugs caused an increase of cardiac index at peak exercise (p less than 0.04) and a prolongation of exercise time (p less than 0.05). No difference was detected between the hemodynamic response to the 2 drugs after 1 month treatment either at rest or during exercise.

Administration, Oral↗