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Results for “randomized crossover trial”

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PubMed2006

Beneficial impact of spironolactone on nephrotic range albuminuria in diabetic nephropathy.

Reduction of nephrotic range albuminuria is associated with markedly improved renal and cardiovascular outcome in patients with diabetic nephropathy. Aldosterone has been suggested to play a role in the progression of diabetic nephropathy. We therefore aimed to evaluate the short-term effect of aldosterone antagonism with spironolactone on nephrotic range albuminuria and blood pressure in diabetic nephropathy. Twenty Caucasian patients with diabetic nephropathy and nephrotic range albuminuria (>2500 mg/24 h) despite recommended antihypertensive treatment completed this double-masked, randomized crossover trial. Patients were treated in random order with spironolactone 25 mg once daily and matched placebo for 2 months, on top of ongoing antihypertensive treatment, including an angiotensin-converting enzyme inhibitor or an angiotensin II receptor blocker in maximally recommended doses. Median (range) number of antihypertensive drugs was 3 (2-5). After each treatment period, albuminuria, 24-h ambulatory blood pressure, and glomerular filtration rate (GFR) were determined. Spironolactone on top of recommended renoprotective treatment induced a 32% (95% confidence interval (CI): 21-42%) reduction in albuminuria from (geometric mean (95% CI)) 3718 (2910-4749) mg/24 h on placebo treatment (P<0.001). There was a significant reduction in 24-h blood pressure of 6 (2-10)/4 (2-6) mm Hg and day blood pressure of 7 (3-12)/5 (3-7) mm Hg (P<0.01), whereas night blood pressure remained unchanged. Spironolactone induced an insignificant reversible reduction in GFR of 3 ml/min/1.73 m2 from 64 (27) ml/min/1.73 m2. No patients were excluded due to adverse events. Our results suggest that spironolactone treatment on top of recommended renoprotective treatment including maximal renin-angiotensin system blockade may offer additional renoprotection in patients with diabetic nephropathy and nephrotic range albuminuria.

Adult↗

PubMed1988

Terbutaline and diaphragm function in chronic obstructive pulmonary disease: a double-blind randomized clinical trial.

We conducted a double-blind, randomized crossover trial to evaluate whether oral terbutaline (2.5 mg orally three times daily for a week) increased the force of diaphragmatic contraction in normocapnic patients with chronic obstructive pulmonary disease. Ten patients with moderate to severe airway obstruction completed the trail. Compared with placebo, terbutaline produced a mean increase of 5.8 cmH2O in peak inspiratory mouth pressure and a mean increase of 5.0 cmH2O in transdiaphragmatic pressure during a maximal inspiratory manoeuvre. These small changes with terbutaline failed to achieve statistical significance. Also, terbutaline failed to alter flow rates (FEV1, Vmax50) or patients' dyspnoea ratings using two separate clinical scales (Pneumoconiosis Research Unit Score and the Modified Dyspnoea Index). Because all observed changes in respiratory muscle strength were small and because the trial had power to detect small changes in inspiratory mouth pressures, we suggest that oral terbutaline at the dose administered in this study has little noteworthy effect on respiratory muscle strength in normocapnic patients with chronic obstructive pulmonary disease.

Aged↗

PubMed2001

Evaluation of selected-protein-source diets for management of dogs with adverse reactions to foods.

OBJECTIVE: To evaluate 3 commercially available selected-protein-source diets as maintenance diets in dogs with pruritus caused by adverse food reactions. DESIGN: Randomized crossover trial. ANIMALS: 40 dogs > 6 months of age with pruritus caused by adverse reactions to foods. PROCEDURE: Diagnosis was confirmed by use of diet elimination and provocation studies. Subsequently, dogs were fed 3 commercial diets for 3 weeks each in a randomized, blinded, crossover trial. Dogs were evaluated for pruritus, vomiting, diarrhea, and flatulence. RESULTS: Pruritus recurred in 52.5% of dogs fed a chicken-rice diet, 47.5% of dogs fed a catfish-rice diet, and 85% of dogs fed a venison-rice diet. Overall 95% of the dogs could be managed successfully with at least 1 of the 3 diets. CONCLUSIONS AND CLINICAL RELEVANCE: Results indicated that commercially available limited-allergen diets with selected protein sources may be appropriate for long-term management of pruritus caused by adverse food reactions. Testing of various protein sources is usually required.

Animal Feed↗

PubMed1999

Cholesterol reduction using manufactured foods high in monounsaturated fatty acids: a randomized crossover study.

In two separate studies, the cholesterol-lowering efficacy of a diet high in monounsaturated fatty acids (MUFA) was evaluated by means of a randomized crossover trial. In both studies subjects were randomized to receive either a high-MUFA diet or the control diet first, which they followed for a period of 8 weeks; following a washout period of 4-6 weeks they were transferred onto the opposing diet for a further period of 8 weeks. In one study subjects were healthy middle-aged men (n 30), and in the other they were young men (n 23) with a family history of CHD recruited from two centres (Guildford and Dublin). The two studies were conducted over the same time period using identical foods and study designs. Subjects consumed 38% energy as fat, with 18% energy as MUFA and 10% as saturated fatty acids (MUFA diet), or 13% energy as MUFA and 16% as saturated fatty acids (control diet). The polyunsaturated fatty acid content of each diet was 7%. The diets were achieved by providing subjects with manufactured foods such as spreads, 'ready meals', biscuits, puddings and breads, which, apart from their fatty acid compositions, were identical for both diets. Subjects were blind to which of the diets they were following on both arms of the study. Weight changes on the diets were less than 1 kg. In the groups combined (n 53) mean total and LDL-cholesterol levels were significantly lower at the end of the MUFA diet than the control diet by 0.29 (SD 0.61) mmol/l (P < 0.001) and 0.38 (SD 0.64) mmol/l (P < 0.0001) respectively. In middle-aged men these differences were due to a mean reduction in LDL-cholesterol of -11 (SD 12)% on the MUFA diet with no change on the control diet (-1.1 (SD 10)%). In young men the differences were due to an increase in LDL-cholesterol concentration on the control diet of +6.2 (SD 13)% and a decrease on the MUFA diet of -7.8 (SD 20)%. Differences in the responses of middle-aged and young men to the two diets did not appear to be due to differences in their habitual baseline diets which were generally similar, but appeared to reflect the lower baseline cholesterol concentrations in the younger men. There was a moderately strong and statistically significant inverse correlation between the change in LDL-cholesterol concentration on each diet and the baseline fasting LDL-cholesterol concentration (r -0.49; P < 0.0005). In conclusion, diets in which saturated fat is partially replaced by MUFA can achieve significant reductions in total and LDL-cholesterol concentrations, even when total fat and energy intakes are maintained. The dietary approach used to alter fatty acid intakes would be appropriate for achieving reductions in saturated fat intakes in whole populations.

Adult↗

PubMed2003

Effect of ciclesonide on allergen challenge in subjects with bronchial asthma.

BACKGROUND: The aim of this clinical trial was to investigate whether repeated inhalation of the new inhaled steroid ciclesonide reduces the early-phase (EAR) and late-phase (LAR) reactions after allergen challenge in patients with mild allergic asthma. Also, this study provides further data on safety and tolerance of ciclesonide. METHODS: The study was designed as a double-blind placebo-controlled randomized crossover trial. Following a baseline period, patients were randomized to either of two treatment sequences (ciclesonide/placebo, placebo/ciclesonide) each of which lasted for one week and were separated by 3-5 weeks from the alternate treatment sequence. Patients received 800 micro g ciclesonide twice daily by means of a Cyclohaler. At the end of each treatment patients were subjected to an allergen challenge. RESULTS: Thirteen asthmatic patients (mean FEV1 of 91% predicted) who experienced an EAR and LAR after allergen challenge participated in the study. The time-average FEV1 decreases 0-2 h (2-12 h) after allergen challenge as measure of the EAR (LAR) were significantly reduced (P < 0.05, one-sided) from 0.426 L to 0.233 L (EAR) and from 0.443 L to 0.213 L (LAR), respectively. Thus, the study results suggest that ciclesonide significantly lowered the extent of EAR and LAR compared to placebo. Ciclesonide was well tolerated and no drug-related adverse events were reported. Cortisol excretion in 24-h urine showed no significant difference between ciclesonide and placebo. CONCLUSIONS: The study supports the efficacy and safety of ciclesonide.

Administration, Inhalation↗

PubMed2007

Differential effect of pioglitazone (PGZ) and rosiglitazone (RGZ) on postprandial glucose and lipid metabolism in patients with type 2 diabetes mellitus: a prospective, randomized crossover study.

BACKGROUND: Postprandial metabolism is impaired in patients with type 2 diabetes (T2Dm). Two thiazolidinediones pioglitazone (PGZ) and rosiglitazone (RGZ) have similar effects on glycaemic control but differ in their effects on fasting lipids. This study investigated the effects of RGZ and PGZ on postprandial metabolism in a prospective, randomized crossover trial. METHODS: Seventeen patients with T2Dm were randomized to RGZ or PGZ for 12 weeks, with an 8-week wash-out period. Fasting blood samples were taken for glucose (FPG), insulin, HbA(1c), lipids, apolipoproteins (apo), lipoprotein (LPL) and hepatic lipase (HL), and cholesterol ester transfer protein (CETP) activity. A standardized breakfast was served and postprandial glucose, insulin, and lipid subfraction profiles were determined. RESULTS: RGZ and PGZ treatment resulted in a similar improvement in FPG, HbA(1c) and homeostasis model assessment. Fasting and postprandial triglyceride (TG) levels were significantly lower following PGZ therapy (fasting: -0.35 vs 0.44 mmol/L; p < 0.04; postprandial AUC-TG: -195.6 vs 127.9 mmol/L/min; p < 0.02) associated with changes in VLDL-2-TG (-0.10 vs 0.21 mmol/L; p = 0.23) and VLDL-3-TG (0.0 vs 0.34 mmol/L; p < 0.04). Fasting cholesterol increased with RGZ compared to PGZ (0.06 vs 0.59 mmol/L; p < 0.04), particularly in VLDL-2-C (-0.30 vs 0.59 mmol/L; p < 0.03) and VLDL-3-C (-0.85 vs 2.11 mmol/L; p < 0.02). Postprandial VLDL lipid and protein content increased after RGZ and decreased after PGZ. Fasting apoB, apoA-I, apoC-II/C-III-ratio, and LPL activity did not differ. CETP activity decreased after RGZ and increased after PGZ (-6.2 vs 4.2 p/mol/mL/min; p < 0.002). CONCLUSIONS: Both the glitazones had similar effects on glucose metabolism. The additional beneficial effect of PGZ on lipid metabolism may be related to its effects on insulin-independent VLDL production and CETP activity.

Blood Glucose↗

PubMedDate not supplied

Comparison of the intubating laryngeal mask airway versus laryngoscopy in the Bell 206-L3 EMS helicopter.

INTRODUCTION: The purpose of this study is to compare intubation success rate and time to intubation for the intubating laryngeal mask airway (I-LMA) versus direct laryngoscopy (DL) using a manikin model during a simulated in-flight scenario. SETTING: The setting for the study was a University hospital-based air medical program. METHODS: This was a prospective, randomized, crossover trial. Eight nurses and 7 paramedics were randomly assigned to perform 3 intubations with either the I-LMA or DL first and then 3 intubations using the alternate technique. Descriptive statistics, 95% confidence intervals (CIs) of means, and Fisher's Exact test were conducted for comparisons. RESULTS: Fifteen set-ups and 45 intubations were performed with each technique. Previous experience was 74 mm (95% CI 64-84) with DL and 18 mm (95% CI 9-27) with the I-LMA. Set-up time was 33 seconds (95% CI 26-40) for DL and 40 seconds (95% CI 29-50) for I-LMA. Time to intubation was 12 seconds (95% CI 10-14) for DL and 39 seconds (95% CI 31-48) for I-LMA. Success rate was 100% for DL and I-LMA placement and 98% for intubation through the I-LMA. Crew rated difficulty of DL 13 mm (95% CI 6-20), placing the I-LMA 23 mm (95% CI 13-32), and intubating through the I-LMA 17 mm (95% CI 10-24). CONCLUSION: Intubation success was very high for both DL and the I-LMA, despite less flight crew experience with the I-LMA. Total time to intubation was longer with the I-LMA but still less than 1 minute. The flight crews considered both techniques easy to perform. The I-LMA appears to be a useful adjunct for airway management in the Bell 206-L3 helicopter.

Air Ambulances↗

PubMedDate not supplied

Improved gastrointestinal tolerance and palatability of didanosine in adults by the use of pediatric power formulation.

Administration of didanosine (ddI) as buffered tablets is complicated by its poor palatability. The tolerance and palatability of pediatric powder ddI in an adult population of subjects with HIV infection as compared with buffered ddI tablets was compared. Twenty HIV-infected, were enrolled in a randomized crossover trial. Subjects took one of the two randomly assigned formulations for 4 weeks and then were crossed over to the alternative treatment. Twenty subjects were enrolled, and all of them completed the study. Of the 16 subjects, 10 reported that taking the ddI tablets affected the quality of their lives negatively. Of the participants, 18 (905) rated the pediatric formulation as 6 (better) or 2 (much better) than the buffered tablets. Preference was based on better taste and ease to swallow, although none of these 18 patients reported difficulties taking the pediatric formulation. In contrast, 19 of the 20 subjects reported difficulties taking the buffered tablets during the study period, including poor taste, trouble swallowing them, and diarrhea. Tolerance and palatability of ddI demonstrate marked improvement by the use of the pediatric powder, which suggests that the administration of ddI can markedly enhanced by the use of pediatric formulation.

Administration, Oral↗

PubMed1998

Efficacy of azithromycin in the treatment of cyclosporine-induced gingival hyperplasia in renal transplant recipients.

BACKGROUND: Gingival hyperplasia (GH) is a common side effect of cyclosporine . Azithromycin (Zithromax; AZI) is a macrolide antibiotic reported in case studies to reduce cyclosporine-induced gingival hyperplasia (CIGH) in renal transplant recipients (RTR). METHODS: The efficacy of AZI to treat CIGH in RTR was examined in a double-blind, randomized crossover trial. Patients (n=17) with CIGH were randomized to receive AZI and a matching placebo in alternate order for 5 days, separated by a 2-week washout period. Follow-up visits were conducted at week 6 and week 12. Changes in GH were evaluated by measuring the clinical gingival sulcus depths, tooth length, and the length of the interdental papillae to the cementum-enamel junction of two teeth in each of the four quadrants. RESULTS: Significant improvements were observed in all three types of periodontal measurements, representing reductions of gingival tissue above the medial aspect of the tooth, of the gingival sulcus depth, and of the length of the interdental papillae. Patients reported an improvement in gum bleeding. AZI was well tolerated, and 67% of the patients reported that the treatment was at least somewhat useful. CONCLUSIONS: AZI should be considered for RTR with CIGH.

Adult↗

PubMed2002

Additional lunchtime basal insulin during insulin lispro intensive therapy in a randomized, multicenter, crossover study in adults : a real-life design.

OBJECTIVE: This study was performed to evaluate whether an additional dose of NPH insulin at lunchtime might overcome the deleterious effects of waning basal insulinemia on pre-dinner and evening glucose values during insulin lispro intensive therapy with once daily basal insulin at night. RESEARCH DESIGN AND METHODS: The study was a 10-month multicenter, randomized, crossover trial. After a 2-month run-in period, subjects injected NPH insulin once (1 x NPH) or twice (2 x NPH) daily for 4 months in a randomized order. Adult patients were included if they had HbA(1c) levels <8.5%. Efficacy measures were HbA(1c) levels, 8-point glucose profiles, and the frequency of hypoglycemia. The statistical analysis included a within-patient comparison for crossover trials. RESULTS: In all, 104 patients completed the trial. The mean HbA(1c) level before randomization was 7.1 +/- 0.85%. The HbA(1c) levels did not change significantly within patients (t test, mean difference = 0.06%; 95% confidence interval [CI] -0.073 to 0.20). The pre-dinner blood glucose values were significantly lower during the 2 x NPH daily protocol, with a mean difference of 0.76 mmol/l (t test, P = 0.004; CI 0.25 to 1.3). In the evening, the frequency of hypoglycemia increased significantly during the 2 x NPH daily protocol with a median difference of 0.56 mild episodes/30 days (P = 0.001) and 6.9 severe episodes/patient year (P = 0.007), respectively. CONCLUSIONS: Equal HbA(1c) levels and increasing frequencies of hypoglycemia in the evening overshadow the slight improvement of the evening glucose profiles during a regimen with 2 x NPH daily insulin. Therefore, generalized use of a second injection of NPH insulin at lunchtime cannot be recommended to all adult patients with type 1 diabetes using intensive insulin lispro therapy.

Adult↗

PubMed2001

Effects of palm oil and dietary cholesterol on plasma lipoproteins: results from a dietary crossover trial in free-living subjects.

OBJECTIVE: To study the effects of palm oil (PO) and egg consumption (E) on plasma lipoproteins. DESIGN: Randomized crossover trial. SETTING: Free-living subjects. SUBJECTS: Twenty-eight healthy male students aged 20-34 y. INTERVENTIONS: Four typical Colombian diets (10 878 kJ/day; 57% energy in carbohydrates, 12% energy in proteins and 31% energy in fats) were consumed for 4 weeks. The HPOLC diet was high in PO (8.8% energy as palmitic acid, PA) and low in eggs (181.2 mg/kJ of dietary cholesterol, DC); the HPOHC diet was high in PO and high in eggs (866.1 mg/kJ of DC); the MPOMC diet was moderate in PO (6.3% energy as PA) and moderate in eggs (581.6 mg/kJ of DC); and the LOPOMC diet had no PO and was moderate in eggs (543.9 mg/kJ of DC). MAIN OUTCOME: Total (TC), low density (LDL-c), and high density lipoprotein cholesterol (HDL-c), and triacylglycerols (TAG) were measured on a pool of three fasting blood samples collected in consecutive days the last week of each diet. RESULTS: Comparison of the HPOHC and HPOLC diets showed increases in TC and LDL-c of 0.21 (P=0.01), and 0.16 mmol/l (P=0.05). Comparison of LOPOMC and MPOMC diets showed increases in TC and LDL-c of 0.39 (P<0.001), and 0.38 mmol/l (P<0.001), respectively. No significant changes in HDL-c or TAG were observed. CONCLUSIONS: Our findings suggest that non-extreme short-term changes in PO and DC consumption lead to significant elevations in plasma TC and LDL-c. SPONSORSHIP: CENIPALMA, Fundación Cardiovascular del Oriente Colombiano, Universidad Industrial de Santander.

Adult↗

PubMed1993

Successful treatment of the idiopathic restless legs syndrome in a randomized double-blind trial of oxycodone versus placebo.

In a double-blind randomized crossover trial, oxycodone or placebo was given in divided night-time doses to 11 patients with idiopathic restless legs syndrome (RLS) for 2 weeks prior to appropriate polysomnographic studies. Under double-blinded conditions, patients were asked to do daily ratings of their leg sensations, motor restlessness and daytime alertness on a 1-4 scale for the 2 weeks prior to the polysomnographic studies and for the nights of the polysomnographic studies as well. Leg sensations (p < 0.009), motor restlessness (p < 0.006) and daytime alertness (p < 0.03) were significantly improved on oxycodone as compared to baseline or placebo. Patients were studied polysomnographically under double-blinded conditions for 2 nights in each phase of the protocol. On an average dose of 15.9 mg oxycodone (equivalent to approximately three 5-mg tablets of commercial preparation), there was a statistically significant reduction in the number of periodic limb movements in sleep [(PLMS)/hour sleep (p < 0.004)] and in the number of arousals/hour sleep (p < 0.009) on drugs as compared to baseline or placebo. A statistically significant improvement was also noted in sleep efficiency (p < 0.006) and 10 of the 11 patients preferred oxycodone over placebo. We conclude that oxycodone is an effective treatment for RLS and PLMS.

Adult↗

PubMed2001

Effect of a single-use sterile catheter for each void on the frequency of bacteriuria in children with neurogenic bladder on intermittent catheterization for bladder emptying.

OBJECTIVE: The frequency of bacteriuria is high in children with neurogenic bladder on intermittent catheterization for bladder emptying. In an effort to decrease bacteriuria, we examined whether the method of catheter care was responsible for the high rate of bacteriuria. For this, the frequency of bacteriuria was examined in the same patient on single-use sterile catheters and on reused clean catheters. METHODS: A prospective, randomized, crossover trial was conducted with 10 patients who were randomized to 4 months of a new, sterile catheter for intermittent catheterization and 4 months of reuse of a clean catheter for intermittent catheterization. Each week, a urine sample was collected and symptoms of infection and medication use were recorded. RESULTS: A total of 158 urine samples were collected during 164 patient-weeks on the new catheter method for each void; 115 (73%) were positive for a pathogen. Of the 161 samples collected during 169 patient-weeks on the standard, reuse method for voiding, 123 (76%) were positive (115 [73%] of 158 vs 123 [76%] of 161). Escherichia coli was the most common pathogen detected during both method periods. CONCLUSION: A new, sterile catheter for each void did not decrease the high frequency of bacteriuria in patients with neurogenic bladder on intermittent catheterization.

Adolescent↗

PubMed2007

Calcium absorption in postmenopausal Chinese women: a randomized crossover intervention study.

The Ca intake and food sources of Chinese postmenopausal women are quite different from those of their Western counterparts. But, little information on Ca metabolism is available in Chinese populations. We determined true fractional calcium absorption (TFCA), true Ca absorption(= TFCA x Ca intake, Va), urinary Ca excretion (Vu,) and the difference between Va and Vu, (Va-u), in response to three dietary Ca intake levels. Twenty-one healthy postmenopausal Chinese women aged 49-64 years were recruited for this randomized crossover trial from a general community, Guangzhou, China. Subjects were randomly assigned to receive 0, 500 and 1000 mg Ca/d for 5 weeks separated by 2-week washout periods. TFCA using Ca stable isotopes, total urinary Ca excretion and Ca intake were determined after 4 weeks of adaptation. Mean values for total Ca intake (Vi) of the three phases were 391 (SD 197), 880 (SD 130) and 1382 (SD 160) mg/d. On usual diet, TFCA, Vu, Va, and Va-u were 0.57 (SD 0.12), 175 (SD 59) mg/d, 216 (SD 98) mg/d and 41 (SD 99) mg/d, respectively. With the supplementations of 500 and 1000 mg Ca/d, TFCAsignificantly decreased to 0.52 (SD 0.12) and 0.43 (SD 0.13) (P<0.001); whereas urinary Ca (P=0.003), Va and Va-u increased significantly (P< 0.001). Using a mixed-effects nonlinear regression model, it was estimated that Va-u was approaching a plateau when mean Ca intake reached 1300 mg/d. In conclusion, the present findings suggest postmenopausal Chinese women have high Ca absorption efficiency and a mean Ca intake of about 1300 mg/d is required to maximize the Va-u.

Biomarkers↗

PubMed2001

Flaxseed in lupus nephritis: a two-year nonplacebo-controlled crossover study.

OBJECTIVE: The objective of this study was to determine the renoprotective effects of ground flaxseed in patients with lupus nephritis. METHODS: Forty patients with lupus nephritis were asked to participate in a randomized crossover trial of flaxseed. Twenty-three agreed and were randomized to receive 30 grams of ground flaxseed daily or control (no placebo) for one year, followed by a twelve-week washout period and the reverse treatment for one year. At baseline and six month intervals, serum phospholipids, flaxseed sachet counts, serum creatinine, 12-hour urine albumin excretion and urine albumin to creatinine ratios, serum viscosity and plasma lipids were measured. RESULTS: There were eight drop-outs and of the 15 remaining subjects flaxseed sachet count and serum phospholipid levels indicated only nine were adherent to the flaxseed diet. Plasma lipids and serum viscosity were unaltered by the flaxseed supplementation whereas serum creatinine in the compliant patients during flaxseed administration declined from a mean of 0.97+/-0.31 mg/dL to a mean of 0.94+/-0.30 mg/dL and rose in the control phase to a mean of 1.03+/-0.28 mg/dL [p value <0.08]. Of the fifteen patients who completed the study, similar changes were noted [p value <0.1]. The nine compliant patients had lower serum creatinines at the end of the two-year study than the 17 patients who refused to participate [p<0.05]. Microalbumin at baseline declined in both control and flaxseed time periods, but there was a trend for a greater decline during flaxseed administration [p<0.2]. CONCLUSIONS: Flaxseed appears to be renoprotective in lupus nephritis, but this interpretation is affected by under powering due to poor adherence and potential Hawthorne effects.

Albuminuria↗

PubMed1989

A low molecular weight heparin ("fragmin") for routine hemodialysis: a crossover trial comparing three dose regimens with a standard regimen of commercial unfractionated heparin.

In 20 hemodialysis patients using mainly flat plate dialyzers, we have conducted a controlled randomized crossover trial of three dose regimens of a low molecular weight heparin (LMWH), "Fragmin" (Kabi 2165), in comparison with a standard dose regimen of commercial unfractionated heparin (UFH) that had previously been shown to provide effective anticoagulation. The aim of the present study was to find the lowest dosage regimen of the LMWH which would be as effective as the standard UFH regimen. The UFH regimen comprised a prime with heparinized saline, an initial intravenous bolus of 5,000 international units (IU) and an infusion of 1,500 IU/h. The three LMWH regimens comprised a LMWH-saline prime, an infusion of 750 anti-factor Xa (aXa) U/h and three different bolus doses: 1) LMWH-low: 3,000 aXa U. 2) LMWH-medium: 4,000 aXa U. 3) LMWH-high: 5,000 aXa U. With the UFH regimen, plasma heparin levels of around 1.0 IU/ml were maintained during the heparin infusion, declining to 0.71 IU/ml an hour after the infusion was terminated. The LMWH-medium regimen produced very similar plasma aXa levels. The LMWH-high regimen also produced similar plasma aXa levels: therefore, it had no advantage over the LMWH-medium regimen. The LMWH-low regimen produced significantly lower levels than the other regimens during the heparin infusion (0.81-0.85 aXa U/ml, p less than 0.025). Dialysis proceeded uneventfully at all times and plasma levels of fibrinopeptide A (FPA) were suppressed well with all 4 regimens (2.77-5.74 pmol/ml) but tended to rise after the infusion was switched off (5.52-8.45 pmol/ml).(ABSTRACT TRUNCATED AT 250 WORDS)

Clinical Protocols↗

PubMed2001

Oxcarbazepine, an antiepileptic agent.

BACKGROUND: Epilepsy is a common neurologic condition. Many of the currently approved pharmacologic agents for its treatment are associated with numerous adverse drug reactions and drug interactions. OBJECTIVE: This review describes the pharmacology and therapeutic use of oxcarbazepine, an analogue of the well-known antiepileptic agent carbamazepine. METHODS: Articles for review were identified through a search of MEDLINE, International Pharmaceutical Abstracts, and EMBASE for the years 1980 through 2000. The terms used individually and in combination were oxcarbazepine, carbamazepine, epilepsy, and seizures. RESULTS: Oxcarbazepine and its primary metabolite have been effective in animal models of epilepsy that generally predict efficacy in generalized tonic-clonic seizures and partial seizures in humans. The exact mechanism of action of oxcarbazepine is unknown, although as with carbamazepine, it is believed to involve blockade of voltage-gated sodium channels. The pharmacokinetic profile of oxcarbazepine is less complicated than that of carbamazepine, with less metabolism by the cytochrome P450 system, no production of an epoxide metabolite, and lower plasma protein binding. The clinical efficacy and tolerability of oxcarbazepine have been demonstrated in trials in adults, children, and the elderly. In a double-blind, randomized, crossover trial in adults, oxcarbazepine 300 mg was associated with a decrease in the mean frequency of tonic seizures (21.4 vs 30.5 seizures during steady-state periods) and tonic-clonic seizures (8.2 vs 10.4) compared with carbamazepine 200 mg (P = 0.05). A multinational, multicenter, double-blind, placebo-controlled, randomized, 28-week trial assessed the efficacy and tolerability of oxcarbazepine at doses of 600, 1200, and 2400 mg as adjunctive therapy in patients with uncontrolled partial seizures. All 3 oxcarbazepine groups demonstrated a reduction in seizure frequency per 28-day period compared with placebo (600 mg, 26% reduction; 1200 mg, 40% reduction; 2400 mg, 50% reduction; placebo, 7.6% reduction; all, P < 0.001). A trial in children assessed the efficacy and toxicity of oxcarbazepine (median dose, 31.4 mg/kg/d) as adjunctive therapy for partial seizures. Patients receiving oxcarbazepine experienced a 35% reduction in seizure frequency, compared with a 9% reduction in the placebo group (P < 0.001). The most common adverse effects associated with oxcarbazepine are related to the central nervous system (eg, dizziness, headache, diplopia, and ataxia) and the gastrointestinal system (eg, nausea and vomiting). Compared with carbamazepine, there is an increased risk of hyponatremia with oxcarbazepine. The frequency and severity of drug interactions are less with oxcarbazepine than with carbamazepine or other antiepileptic agents. CONCLUSIONS: Oxcarbazepine may be considered an appropriate alternative to carbamazepine for the treatment of partial seizures in patients who are unable to tolerate carbamazepine. Its use in nonseizure disorders remains to be examined in large-scale clinical trials, and pharmacoeconomic comparisons of oxcarbazepine with other antiepileptic agents, particularly carbamazepine, are needed.

Adolescent↗

PubMed2005

Effectiveness of female and male condoms in preventing exposure to semen during vaginal intercourse: a randomized trial.

OBJECTIVES: Comparison of male condom (MC) vs. female condom (FC) with respect to self-reported mechanical and acceptability problems and semen exposure using prostate-specific antigen (PSA) as an objective biological marker and evaluation of the effect of an educational intervention on self-reported problems and semen exposure, by condom type. DESIGN: Randomized crossover trial. METHODS: Four hundred women attending a family planning clinic in Brazil were randomized and either received in-clinic instruction or were encouraged to read the condom package insert; all used two FCs and two MCs. We measured the rates of self-reported user problems with MC and FC use and the rates of semen exposure during use (assessed by testing vaginal fluid for PSA). RESULTS: The educational intervention group reported fewer problems with either condom as compared with the control group (p = .0004, stratified by condom type). In both groups, self-reported problems were more frequent with FC use than with MC use (p < .0001, stratified by intervention). The educational intervention did not significantly reduce semen exposure. Overall, semen exposure occurred more frequently with FC use (postcoital PSA, > 1 ng/mL; 22%) than with MC use (15%); the difference, however, was small and nonsignificant for high PSA levels (> or = 150 ng/mL; 5.1% for FC vs. 3.6% for MC). CONCLUSIONS: In this study, the FC was less effective than the MC in preventing semen exposure during use and led more frequently to self-reported user problems. Both devices were highly protective against "high-level" semen exposure, as measured by postcoital PSA levels in vaginal fluid. In-clinic education may reduce user problems and increase acceptability and use of both devices.

Adult↗