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Results for “randomized crossover trial”

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PubMed1985

Quinidine-digoxin interaction: are the pharmacokinetics of both drugs altered?

An open randomized crossover trial to investigate quinidine-digoxin interactions under steady-state conditions with special attention to quinidine pharmacokinetics was performed in 6 healthy male volunteers. Coadministration of quinidine sulphate induces a prolongation of digoxin elimination half-life (means +/- SD) from 33.0 +/- 8.0 to 43.9 +/- 6.2 hours, causing an augmentation of 0/48 AUC (means +/- SD) from 37.8 +/- 14.1 to 100.2 +/- 30.4 ng/ml.h. This increase in serum digoxin concentration-time course was caused by a decrease of both renal clearance (means +/- SD) from 150.7 +/- 46.5 to 79.0 +/- 23.3 ml/min and of minor importance, total clearance (means +/- SD) from 198.8 +/- 66.4 to 91.7 +/- 21.9 ml/min. A decrease in apparent volume of distribution of digoxin (means +/- SD) from 520.1 +/- 115.2 to 344.5 +/- 78.2 l could also be observed: When digoxin was given additionally, two quinidine-pharmacokinetic parameters were altered: renal quinidine clearance decreased from (means +/- s) 61.2 +/- 11.5 to 45.7 +/- 13.7 ml/min, causing a prolongation of elimination half-life of quinidine (means +/- s) from 10.34 +/- 1.76 to 12.28 +/- 1.23 hours. These altered parameters induced an augmentation in 0/48 AUC of quinidine of 11% on the average but this change was not statistically significant because of the relatively large standard-deviation in serum quinidine concentrations. Considering the reduction of renal digoxin clearance, the mechanism mainly responsible for the quinidine-digoxin interaction, the decrease in renal quinidine clearance, appears to be most remarkable as well.

Acetyldigoxins↗

PubMed1987

Monotherapy with the calcium channel antagonist nisoldipine for systemic hypertension and comparison with diuretic drugs.

A comparative, double-blind, placebo-controlled, double-dummy, randomized, crossover trial was performed in 32 hypertensive patients (initial blood pressure [BP] 165/105 +/- 3/2 mm Hg), most of them obese women, to evaluate the antihypertensive efficacy and tolerability of the new calcium channel blocking drug nisoldipine, 10 mg once or twice daily, over 6 weeks compared with the diuretic hydrochlorothiazide-amiloride (hydrochlorothiazide, 25 mg, in combination with amiloride, 2.5 mg once or twice daily). Adequate 24-hour control of BP (supine diastolic BP less than 90 mm Hg) was achieved in 15 of 32 patients (47%) with monotherapy by 1 agent and in 23 of 32 patients (72%) when including those who responded to either agent. Both nisoldipine and the diuretic had a flat dose-response curve. The larger dose of diuretic yielded lower systolic and exercise BP values (erect and supine) than high-dose nisoldipine (p less than 0.05), with less headache (p less than 0.05). In the other 9 patients who did not respond, the combination of nisoldipine 10 mg plus hydrochlorothiazide (25 mg)-amiloride (2.5 mg) was administered and yielded a response in 8 patients (overall response including monotherapy 96%). Ten patients were given nisoldipine for an additional period of 6 months, and they required an average dose of 33 mg/day for BP control. In both the 6-week and 6-month studies, nisoldipine monotherapy caused frequent subjective adverse effects. In contrast, in the 6-week study the combination of low-dose nisoldipine and low-dose diuretic gave good BP control with no adverse effects.

Adult↗

PubMed2000

Rye bread improves bowel function and decreases the concentrations of some compounds that are putative colon cancer risk markers in middle-aged women and men.

Cereal fiber may reduce the risk of colorectal cancer by diluting colonic contents due to increased fecal output, by accelerating intestinal transit, by increasing fecal frequency and by altering bacterial metabolism. The effects of whole-meal rye bread on some putative colon cancer risk markers were investigated in 17 healthy Finnish subjects using a randomized crossover trial with two 4-wk bread consumption periods and a 4-wk washout period between the bread periods. White wheat bread was used as a control. Test breads covered a minimum of 20% of the daily energy intake (range, 4330-14, 033 kJ/d). Intestinal transit time, stool weight, fecal bacterial enzyme activities and short-chain fatty acid, ammonia, diacylglycerol (DAG) and bile acid concentrations in feces (expressed per gram wet feces) were measured. Whole-meal rye bread significantly increased fecal output and fecal frequency and shortened mean intestinal transit time compared with wheat bread in both women and men. Activities of beta-glucuronidase and beta-glucosidase (expressed per gram wet feces) were significantly lower in men and urease activity significantly higher in women during the rye bread period (RBP). Fecal butyrate concentration was higher during the RBP in men. Fecal ammonia and DAG concentrations did not differ between bread periods. Fecal total and secondary bile acid concentrations were significantly lower during RBP in both women and men. This study shows that whole-meal rye bread significantly improves bowel function in healthy adults and may decrease the concentration of some compounds that are putative colon cancer risk markers.

Adult↗

PubMed2004

Resource effects of training general practitioners in risk communication skills and shared decision making competences.

RATIONALE, AIMS AND OBJECTIVES: Involving patients more in decisions about their own care requires doctors to be trained in effective ways of communicating information and in developing competences to negotiate levels of patient involvement which are most appropriate for each case. The aim of this study was to determine the cost of such training and identify which service resource variables are subsequently affected. METHODS: An explanatory cluster randomized crossover trial was carried out which involved training general practitioners (GPs) in the use of risk communication (RC) tools, shared decision making (SDM) competences or both. Continuing care by GPs of patients with one of four chronic conditions (menopausal symptoms, menorrhagia, atrial fibrillation, prostatism) was reviewed before and after training. Cost of training was assessed by prospective monitoring of resources used. Data on prescribing, referrals and investigations were collected via questionnaires to participating practitioners. Data on follow-up GP consultations were extracted from medical records. Three two-level logistic models were performed to investigate the probability of training having an effect on prescribing, referrals and investigations ordered at the review consultation. RESULTS: Training cost pound 1218 per practitioner which increased the cost of a consultation by pound 2.89. Training in SDM or combined with RC significantly affected the probability of a prescription being issued to women with menopausal symptoms and menorrhagia (although RC on its own had no effect) but did not significantly affect prescribing for patients with prostatism or atrial fibrillation. It did not significantly affect the probability of investigations, referrals or follow-up GP visits for any of the conditions. CONCLUSION: Unless training has a major influence on consultation length, it is unlikely to have any major impacts on cost.

Chronic Disease↗

PubMed2001

Effect of sildenafil citrate (Viagra) on the ocular circulation.

PURPOSE: Sildenafil citrate induces vasodilation by enhancing the smooth muscle relaxant effects of nitric oxide. We have previously reported that nitrate compounds, a different group of nitric oxide-mediated vasodilators used mainly for the treatment of ischemic cardiac diseases, produce an increase in optic nerve head circulation and retinal venous vasodilation. The purpose of the present investigation was to evaluate the effect of sildenafil on ocular circulation. METHODS: In a double-blind, randomized, crossover trial, 15 healthy male volunteers received 100-mg doses of sildenafil citrate (Viagra; Pfizer, Inc, New York, New York) or matching placebo on 2 separate days. Laser Doppler flowmetry was used to assess foveolar choroidal and optic nerve rim circulatory parameters. Measurements were obtained in one eye at baseline, 1 hour, and 5 hours after dosing. Blood pressure and intraocular pressure were monitored, and perfusion pressure was calculated. RESULTS: Mean optic nerve head blood flow measurements at baseline, 1 hour, and 5 hours were 11.6 +/- 2.2 arbitrary units (+/- SD), 12.5 +/- 2.8, and 12.1 +/- 2.4 after sildenafil and 11.9 +/- 2.5, 12.6 +/- 3.1, and 13.0 +/- 3.0 after placebo, respectively. When compared with placebo, no significant change in mean blood pressure, intraocular pressure, perfusion pressure, or choroidal or optic nerve circulatory parameters were observed after sildenafil treatment. The power to detect a 20% change in optic nerve head and choroidal blood flow after sildenafil was approximately 90%. CONCLUSIONS: In comparison with placebo, no significant change in optic nerve rim or foveolar choroidal blood flow was observed after treatment with sildenafil. This suggests that nitrate compounds and sildenafil may differentially affect ocular circulation. Furthermore, no significant effects on intraocular pressure, systemic blood pressure, or ocular perfusion pressure were detected after sildenafil treatment.

Adult↗

PubMed2003

Reduction of sleep-disordered breathing after physostigmine.

The cholinesterase inhibitor physostigmine (PHYS) was investigated in a double-blind, placebo-controlled, randomized, crossover trial of 10 male patients with moderate to severe obstructive sleep apnea. PHYS (0.12 microg/minute/kg, 7-hour infusion) reduced mean apnea/hypopnea index (AHI) by 13.6 (95% confidence interval [CI], 2.2-25.1) corresponding to 21.4% (95% CI, -5.5 to 47.9) and increased minimum SaO2 by 8.7% (95% CI, -0.3 to 17.7) corresponding to 23.2% (95% CI, 4.8-41.3). During the last third of the night, coinciding with predicted plasma concentration steady state, non-REM sleep AHI decreased by 19.2 (95% CI, 0.1-38.3) or 14.9% (95% CI, -43.6 to 77.7) and REM AHI by 33.8 (95% CI, 13.7-54.0) or 67.5% (95% CI, 49.7-85.3). Mean total sleep time was reduced by 74 minutes (95% CI, 33.9-114.9), but patients with the least pronounced sleep shortening had the largest reduction of AHI (r = 0.73, p < 0.02). The nocturnal decline in heart rate was reduced by PHYS. Moreover, resting (early-night placebo heart rate) was positively correlated with proportional reduction of REM apnea index (r = 0.69, p < 0.02). Body mass index was negatively correlated with reduction of REM AHI (r = 0.77, p < 0.02). This, predominantly REM-related, reduction of obstructive sleep apnea after PHYS may provide a new treatment option if the effects are maintained in long-term studies.

Adult↗

PubMed1994

Eucapnic voluntary hyperventilation as a bronchoprovocation technique. Comparison with methacholine inhalation in asthmatics.

Methacholine inhalation challenge (MIC) is probably the most widely used and best standardized test for nonspecific bronchoprovocation challenge (BPC). There has been increasing interest in developing "physical" stimuli such as eucapnic voluntary hyperventilation (EVH) with dry gas to assess airway hyperreactivity (AHR), because of inherent problems with using a pharmacologic agent in epidemiologic surveys. To our knowledge, no studies exist that compare MIC with EVH in known asthmatics. We conducted a prospective, randomized, crossover trial with a group of subjects (n = 16) who met the American Thoracic Society definition of asthma with these objectives: (1) to compare the sensitivity of EVH with MIC; (2) to compare the quantitative response of one test with the response to the other challenge; and (3) to correlate the response of both tests with symptoms, serum IgE levels, and serum eosinophil counts. We found that (1) EVH was positive in 75 percent of cases and MIC was positive in 81 percent of cases; one subject reacted to EVH but not to MIC and vice-versa. (2) The quantitative response to one test correlated with the response to the other test (r = -0.60, p = 0.01). (3) There was a correlation between severity of asthma symptoms and the response to EVH (r = 0.62; p = 0.01), but not to MIC. (4) Response to MIC (log PD20), but not EVH, correlated with serum IgE level (r = -0.53, p = 0.04). We suggest that EVH may be used for the initial assessment of AHR in the evaluation of asthma. Eucapnic voluntary hyperventilation is a sensitive measure of AHR and it correlates well with symptoms. Furthermore, though these points were not addressed in our study, it is more physiologic than MIC, and it is easy and less expensive to perform.

Adult↗

PubMed1993

Evaluation of the bioequivalence of tablet and capsule formulations of granisetron in patients undergoing cytotoxic chemotherapy for malignant disease.

Granisetron is a novel, highly specific 5-hydroxytryptamine receptor antagonist given prophylactically to patients undergoing chemotherapy. An open, randomized, crossover trial was performed with 37 patients (24 females and 13 males) undergoing cytotoxic chemotherapy for malignant disease to compare an oral tablet (1-mg tablet given twice daily) with a clinical-trial capsule (1-mg capsule given twice daily). Complete pharmacokinetic data were determined for 24 patients (14 females and 10 males). The concentration of granisetron in plasma was measured by HPLC; the limit of quantitation was 0.2 ng/mL. The bioavailability evaluation was based mainly on the area under the curve (AUC) (mean values: 52.1 ng.h/mL for the capsule and 54.2 ng.h/mL for the tablet) and the maximum concentration (Cmax) (mean values: 7.42 ng/mL for the capsule and 8.18 ng/mL for the tablet) measured at the steady state after 7 days of continuous therapy. Wide interpatient variability in plasma granisetron levels after oral administration was observed. The 90% standard confidence interval for the geometric mean ratio overlapped the critical range, 0.8-1.25. Point estimates for AUC and Cmax based on two one-sided t tests and log-transformed data showed that the upper limit of the confidence interval was not within 20% of the mean for the capsule; the corresponding power analysis values for AUC and Cmax were 0.89 and 0.81, respectively. Despite bioequivalence not being proven, any differences that exist between the two formulations are likely to be small. There was no difference in efficacy or safety between the two formulations assessed.

Adolescent↗

PubMedDate not supplied

Absorption characteristics of three phenytoin sodium products after administration of oral loading doses.

The absorption characteristics of three phenytoin sodium products given orally as loading doses in five healthy men were studied. Extended phenytoin sodium capsules, prompt phenytoin sodium capsules, and phenytoin sodium injection were administered in a randomized, crossover trial as single 18-mg/kg doses and as divided doses of 6 mg/kg every three hours for three doses. Each dose was given with 200 ml of water, and a two-week washout period followed each treatment. The maximum plasma concentration (Cmax), time to reach maximum plasma concentration, time to reach the lower end (10 mg/liter) of the therapeutic range, time to reach a plasma concentration greater than 15 mg/liter, and time within the therapeutic range were determined for each loading-dose regimen. Prompt phenytoin sodium capsules (prompt PHT) given in divided doses produced a mean Cmax of 22.0 mg/liter, which was significantly higher than that observed with any of the other loading-dose regimens. In addition, all subjects receiving prompt PHT in divided doses had plasma phenytoin concentrations of 10 mg/liter within six hours; only this treatment produced plasma concentrations greater than 15 mg/liter at nine hours in all subjects. Plasma concentrations remained within the therapeutic range (10-20 mg/liter) for 81 and 78% of the first 24-hour period for prompt PHT in divided and single doses, respectively. Adverse effects were minimal in all regimens. The prompt-release phenytoin sodium capsules used in this study may provide an alternative means for rapidly achieving therapeutic phenytoin concentrations in situations where i.v. administration is not indicated or practical.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Oral↗

PubMed1986

Usefulness of PY 108-068, a new calcium channel blocker, for angina pectoris.

The efficacy of PY 108-068 (75 and 150 mg/day), a new dihydropyridine calcium antagonist, was compared with placebo for treatment of chronic stable angina. Twelve patients were studied in a placebo-controlled, double-blind, randomized, crossover trial of 2 weeks each. Antianginal efficacy was assessed by the number of episodes of angina and nitroglycerin tablets consumed during each 2-week period, as well as the number of episodes of ischemia during 48-hour ambulatory monitoring and the area and severity of ST-segment depression during 16-point precordial exercise mapping. Nitroglycerin consumption (mean +/- standard error of the mean) decreased from 6.1 +/- 2.9 with placebo to 1.8 +/- 1.5 with 75 mg/day of PY 108-068 (p less than or equal to 0.03) and to 3.6 +/- 2.3 with 150 mg/day of PY 108-068 (p less than or equal to 0.01 vs placebo, difference not significant vs 75 mg/day of PY 108-068), whereas episodes of angina were reduced significantly only by the high dose (p less than or equal to 0.03) (11.1 +/- 3.9 with placebo, 6.3 +/- 2.4 with 75 mg/day of PY 108-068 and 8.1 +/- 3.4 with 150 mg/day of PY 108-068). The low dose alone significantly reduced ST-segment depression during exercise testing (p less than or equal to 0.03) (29.6 +/- 3.6 with placebo, 23.1 +/- 5.6 with 75 mg/day of PY 108-068 and 24.4 +/- 5.0 with 150 mg/day of PY 108-068), whereas neither dose significantly altered the number of episodes of ischemia during ambulatory monitoring.(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗

PubMed1991

Benefit of single setting rate responsive ventricular pacing compared with fixed rate demand pacing in elderly patients.

In order to assess the value of a simple, single setting rate response option to VVI pacing, 12 patients (mean age 75.1 +/- 6.2, range 62-83 years, seven males, five females) with symptomatic complete heart block were entered into a double-blind, randomized crossover trial of VVI versus VVIR (single setting rate responsive) pacing using Medtronic Activitrax pacemakers. Assessment was by time taken in seconds (sec) and Borg scale symptom score (6-20) for simple activities (standing from chair x 30; walking 800 meters; 52 steps on stairs [slow and fast pace], and incremental, noninclined maximal treadmill exercise), performed after a 4-week period with the patient in each pacing mode. Times were significantly improved in VVIR mode for standing from chair [mean +/- SD] (78.7 +/- 22.5 vs 70.7 +/- 19.5 sec; P less than 0.05), for 800 m walk (1032 +/- 80 vs 885 +/- 59 sec; P less than 0.05), fast ascent of stairs (29.5 +/- 7.7 vs 26.5 +/- 5.6 sec; P less than 0.02), and treadmill exercise (626.7 +/- 189.5 vs 741.0 +/- 170.2 sec, P less than 0.005) although no difference in time for slow stair ascent was demonstrated. Symptom scores were significantly less in VVIR for standing from chair (12.7 +/- 2.8 vs 10.3 +/- 1.8; P less than 0.01), 800 m walk (10.9 +/- 2.7 vs 9.0 +/- 2.4; P less than 0.01), slow ascent of stairs (11.6 +/- 2.1 vs 10.0 +/- 2.0; P less than 0.01), and fast ascent of stairs (13.0 +/- 2.0 vs 11.7 +/- 1.9; P less than 0.02) but unchanged for treadmill exercise.(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗

PubMed1991

Influence of rifampin on the pharmacokinetics of pefloxacin.

Pefloxacin and rifampin are frequently associated in the antibiotic therapy of deep-seated, and especially bone-located, infections. The influence of rifampin, a potent drug metabolism enzyme inducer, on the pharmacokinetics of pefloxacin was studied in a randomized crossover trial involving eight young healthy male volunteers. Every volunteer received either pefloxacin alone (period A) or pefloxacin after a 10-day induction by rifampin (period B) given as a 900 mg daily oral dose, and both periods were separated by a 3-week washout period. During both periods, pefloxacin was given during 3 days as a 400 mg b.i.d. oral dose (six doses) followed by a 400 mg intravenous dose on the fourth day. The kinetics of pefloxacin are significantly influenced by rifampin: The minimum (12-hour) plasma concentration, area under the concentration-time curve, and elimination half-life decreased respectively from 4.26 +/- 1.57 to 2.70 +/- 1.00 mg/L, 78.91 +/- 22.82 to 57.81 +/- 16.69 mg.hr/L, 14.46 +/- 3.46 to 10.08 +/- 2.44 hours (p less than 0.05). The renal clearance of pefloxacin was unchanged, but the plasma clearance increased from 94.04 +/- 39.04 to 126.82 +/- 47.36 ml/min (p less than 0.05). The plasma clearance of N-demethyl and N-oxide metabolites were similar for both periods, but the cumulative renal excretion (0 to 96 hours) decreased significantly (p less than 0.01) for period B versus period A. This definite but moderate inductive effect of rifampin on the pharmacokinetics of pefloxacin does not suggest a dose modification of pefloxacin in therapeutic association with rifampin, but pefloxacin assay in plasma seems to be advisable.

Adult↗

PubMed1992

Transdermal nitroglycerin efficacy in patients with chronic stable angina pectoris as related to sympathetic and renin-angiotensin-aldosterone activity.

The aim of this study was to evaluate the acute effects of transdermal nitroglycerin on the sympathetic and renin-angiotensin-aldosterone systems activity, in a group of patients with stable exercise induced angina pectoris. Eighteen outpatients (15M, 3F, age range 47-65 years) were included in this double-blind, randomized, crossover trial comparing the antianginal effects of a transdermal system delivering 20 mg.day-1 of nitroglycerin to an identical placebo. Plasma renin activity, plasma aldosterone and catecholamine concentrations were measured in resting basal conditions and at 4, 8, 24, and 32 h post-dosing. Patients were subdivided in two groups according to the increase in exercise duration after patch application greater than 30% (responders, n = 8) and less or equal to 30% (non-responders, n = 10) in respect to placebo. In responders plasma norepinephrine was slightly increased during transdermal nitroglycerin administration in comparison to placebo while no change was observed in plasma adrenaline and aldosterone concentrations and in plasma renin activity. In non-responders plasma norepinephrine levels significantly increased during nitroglycerin treatment in comparison with placebo. Multiple comparisons showed that this increase was significant at 4, 8 and 24 h post-dosing. Plasma epinephrine and aldosterone concentrations and plasma renin activity were also increased after nitroglycerin administration. In the population as a whole, a significant inverse correlation was found between the percent increase in exercise duration (active drug vs placebo) and the absolute values of plasma norepinephrine and aldosterone, 4 h post-dosing.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Cutaneous↗

PubMed2001

Co-administration of the health food supplement, bovine colostrum, reduces the acute non-steroidal anti-inflammatory drug-induced increase in intestinal permeability.

Non-steroidal anti-inflammatory drugs (NSAIDs) are effective analgesics but cause gastrointestinal injury. Present prophylactic measures are suboptimal and novel therapies are required. Bovine colostrum is a cheap, readily available source of growth factors, which reduces gastrointestinal injury in rats and mice. We therefore examined whether spray-dried, defatted colostrum could reduce the rise in gut permeability (a non-invasive marker of intestinal injury) caused by NSAIDs in volunteers and patients taking NSAIDs for clinical reasons. Healthy male volunteers (n=7) participated in a randomized crossover trial comparing changes in gut permeability (lactulose/rhamnose ratios) before and after 5 days of 50 mg of indomethacin three times daily (tds) per oral with colostrum (125 ml, tds) or whey protein (control) co-administration. A second study examined the effect of colostral and control solutions (125 ml, tds for 7 days) on gut permeability in patients (n=15) taking a substantial, regular dose of an NSAID for clinical reasons. For both studies, there was a 2 week washout period between treatment arms. In volunteers, indomethacin caused a 3-fold increase in gut permeability in the control arm (lactulose/rhamnose ratio 0.36+/-0.07 prior to indomethacin and 1.17+/-0.25 on day 5, P<0.01), whereas no significant increase in permeability was seen when colostrum was co-administered. In patients taking long-term NSAID treatment, initial permeability ratios were low (0.13+/-0.02), despite continuing on the drug, and permeability was not influenced by co-administration of test solutions. These studies provide preliminary evidence that bovine colostrum, which is already currently available as an over-the-counter preparation, may provide a novel approach to the prevention of NSAID-induced gastrointestinal damage in humans.

Adult↗

PubMed1993

Studies on the bronchodilator, tremorogenic, cardiovascular and hypokalaemic effects of fenoterol dry powder in asthma.

1. The airway and tremor response and cardiovascular and hypokalaemic effects of single and cumulative doses of fenoterol given by dry powder capsules (DPC) and by metered dose inhaler (MDI) were studied in asthmatics in two randomized, crossover trials. 2. Single doses of fenoterol DPC and MDI (0.2 mg, 0.4 mg), investigated in 24 subjects, produced similar, dose-dependent increases in FEV1. Fenoterol DPC caused less tremor response and less hypokalaemic effects than fenoterol MDI. 3. Cumulative doses of fenoterol DPC and MDI (0.2, 0.6, 1.4, 3.0, 6.2 mg), investigated in 12 subjects, produced a comparable bronchodilatation (mean maximum increase in FEV1 was 0.53 +/- 0.06/0.52 +/- 0.081 for DPC/MDI) and a similar, dose-dependent rise in heart rate (35 +/- 3.81/41 +/- 2.25 beats min(-1)). The rise in tremor and the fall in plasma potassium were smaller after DPC than after MDI. The mean maximum changes were 51.58 +/- 6.41/95.83 +/- 6.75 cm s(-2) for tremor and -0.68 +/- 0.09/-0.96 +/- 0.10 mmol l(-1) for potassium. 4. Our findings may result from a difference in the pharmacokinetics of the dry powder and the aerosol formulation, particularly differences in distribution and absorption. 5. In conclusion, fenoterol DPC used in low therapeutic doses (0.2,0.4 mg), is preferable to the MDI. Fenoterol DPC used as rescue medication in high cumulative doses, do not suggest a greater safety margin than the MDI and the same restrictions should be considered for the fenoterol dry powder formulation as suggested for the MDI.

Administration, Inhalation↗

PubMed1987

Treating hypertensive diabetics: a comparison of verapamil and metoprolol in black and white patients.

Ca2+ antagonists may be particularly effective in "low-renin" patients, including black subjects and diabetics, as metabolically sound antihypertensive therapy. This paper reports a double-blind randomized crossover trial of verapamil SR (to 240 mg b.i.d.) versus metoprolol (to 100 mg b.i.d.) in 20 black and 15 Caucasian non-insulin-dependent patients with entry blood pressures (BP) greater than 160/90 mm Hg. Mean age was 61 +/- 4.8 years; duration of diabetes 5.8 +/- 4.9 years. Each subject took 4 weeks placebo, then two 6 week active phases, with an intervening 2 week washout. Erect (E)/lying (L) BP, weight, and fasting blood were taken at each visit with overnight urine collections. In blacks mean entry BP (L) +/- SD were 165.8 +/- 16/98.7 +/- 11 mm Hg. On verapamil BP (L) fell significantly by -12.6 +/- 16/-6.6 +/- 9.7 mm Hg (p less than 0.01), but there was no overall fall on metoprolol (+1.65 +/- 14.5/-1.3 +/- 9.7 mm Hg). Heart rates fell on both drugs from 76.1 +/- 18.3 to 68.4 +/- 11 and 59.4 +/- 7.6 beats/min, respectively, indicating tablet compliance. In whites, BP fell on both drugs, as did heart rates. Changes in HbA1c, plasma glucose, and renin were statistically insignificant. Change in BP was unrelated to initial renin levels in either blacks or whites. In blacks, mean entry urine Na, K, and Ca were 77.4 +/- 39.3, 20.9 +/- 10, and 2.35 +/- 1.5 mmol/l and in whites 84.1 +/- 42, 22 +/- 17.2, and 3.56 +/- 3.2 mmol/l, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

Albuminuria↗

PubMed1996

A moderate increase in daily protein intake causing an enhanced endogenous insulin secretion does not alter circulating levels or urinary excretion of dehydroepiandrosterone sulfate.

To study the effect of a moderate increase in insulin secretion produced by an increased daily protein intake on dehydroepiandrosterone sulfate (DHEAS), a balanced randomized crossover trial consisting of three strictly controlled dietary regimens was performed in six healthy male volunteers. The basic diet (B) contained 50 g protein/d; diets P and M (also basic diets) were enriched with either 32 g protein/d (P) or 10 mmol L-methionine/d (M). Methionine was given (as a specific nonprotein source of endogenously derived sulfate) to control for possible confounding effects on DHEAS due to an increased sulfate supply. At the end of each 4-day diet period, blood and 24-hour urine samples were collected. Fasting plasma levels of testosterone, cortisol, insulin-like growth factor-I (IGF-I), and insulin, as well as urinary output of total (hot acid-cleaved) testosterone conjugates and 3alpha-androstanediol glucuronide, did not show significant changes in response to dietary manipulations. Endogenous sulfate availability (as reflected by renal sulfate output per 24 hours) approximately doubled with diets P and M. However, plasma levels (6.3 +/- 1.5, 6.8 +/- 1.8, and 6.9 +/- 2.1 micromol/L for B, P, and M, respectively) and urinary excretion (8.8 +/- 9.8, 9.4 +/- 11.2, 8.0 +/- 8.3 micromol/d) of DHEAS remained unaffected. Considering the clear increments (P < .01) in urinary C-peptide excretion with diet P (20.4 +/- 10.3 nmol/d) versus diets B and M (12.6 +/- 5.1 and 13.2 +/- 3.6 nmol/d), respectively, our results suggest that a moderately strong diet-induced increase in daily insulin secretion does not alter urinary and plasma levels of DHEAS.

Adult↗

PubMed2005

Deleterious effects of omitting breakfast on insulin sensitivity and fasting lipid profiles in healthy lean women.

BACKGROUND: Breakfast consumption is recommended, despite inconclusive evidence of health benefits. OBJECTIVE: The study's aim was to ascertain whether eating breakfast (EB) or omitting breakfast (OB) affects energy intake, energy expenditure, and circulating insulin, glucose, and lipid concentrations in healthy women. DESIGN: In a randomized crossover trial, 10 women [x+/-SD body mass index (BMI; in kg/m2): 23.2+/-1.4] underwent two 14-d EB or OB interventions separated by a 2-wk interval. In the EB period, subjects consumed breakfast cereal with 2%-fat milk before 0800 and a chocolate-covered cookie between 1030 and 1100. In the OB period, subjects consumed the cookie between 1030 and 1100 and the cereal and milk between 1200 and 1330. Subjects then consumed 4 additional meals with content similar to usual at predetermined times later in the day and recorded food intake on 3 d during each period. Fasting and posttest meal glucose, lipid, and insulin concentrations and resting energy expenditure were measured before and after each period. RESULTS: Reported energy intake was significantly lower in the EB period (P=0.001), and resting energy expenditure did not differ significantly between the 2 periods. OB was associated with significantly higher fasting total and LDL cholesterol than was EB (3.14 and 3.43 mmol/L and 1.55 and 1.82 mmol/L, respectively; P=0.001). The area under the curve of insulin response to the test meal was significantly lower after EB than after OB (P<0.01). CONCLUSION: OB impairs fasting lipids and postprandial insulin sensitivity and could lead to weight gain if the observed higher energy intake was sustained.

Adult↗