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H Chrystyn

Publications and source records attributed to H Chrystyn.

At least 19 recordsLinked to original sources
PubMed2006

Validation of high-performance liquid chromatography assay for quantification of formoterol in urine samples after inhalation using UV detection technique.

A novel high-performance liquid chromatography (HPLC) assay for the estimation of formoterol in urine samples was developed and validated. A solid phase extraction (SPE) using Oasis HLB was optimised to isolate formoterol from a urine matrix followed by HPLC with UV detection. This extraction procedure concentrated the final analyte forty times so that UV detection can be used to determine even a low concentration of formoterol in urine samples. The urinary assay was performed in accordance with FDA and ICH regulations for the validation of bioanalytical samples. The samples were injected onto a C18 Spherisorb (250 mm x 4.6 mm x 5 microm) analytical column maintained at 30 degrees C. The mobile phase consisted of 5 mM of potassium dihydrogen orthophosphate buffer (adjusted to pH 3 with ortho phosphoric acid):acetonitrile (ACN) (70:30, v/v), and the formoterol peak was detected at wavelength 214 nm. The extraction recovery of formoterol from the urine sample was >95%. The calibration curve was linear (r2=0.99) over formoterol concentrations ranging from 1.5 to 25 ng/mL (n=6). The method had an accuracy of >92% and intra and inter-day precision CV% of <3.9% and <2.2%, respectively, at three different concentrations low, medium and high (10, 15, 20 ng/mL). The limit of quantification (LOQ) for formoterol was found to be 1.50 ng/mL. The accuracy and precision at the LOQ level were 95% and %CV <3.7% (n=10), respectively. The method reported is simple, reliable, precise, and accurate and has the capacity to be used for determination of formoterol in urine samples.

Administration, Inhalation↗
PubMed2005

High performance liquid chromatography assay method for simultaneous quantitation of formoterol and budesonide in Symbicort Turbuhaler.

A sensitive and rapid high performance liquid chromatography method has been developed and used for the simultaneous determination of formoterol and budesonide in Symbicort Turbuhaler when assessing the aerodynamic characteristics of the emitted dose using Pharmacopoeial methods. This capability results in both time and cost saving. The mobile phase composition was acetonitrile-5 mM sodium dihydrogen orthophosphate, pH 3 (60: 40% v/v), and was passed at 1.5 ml min(-1) through a C18 column with a UV detection (wavelength 214 nm). The method was shown to give good analytical performance in terms of linearity, precision (using phenylpropanolamine as an internal standard), sensitivity and solution stability. The intra-day precision for both formoterol and budesonide were 0.75% and 1.11%, respectively (n = 10). The limit of quantitation for formoterol was 10 microgL(-1) and for budesonide was 120 microgL(-1), and the limit of detection were 3 and 30 microgL(-1), for both formoterol and budesonide, respectively. The method has been applied to determine the content of the emitted dose and the fine particle dose of Symbicort Turbuhaler.

Acetonitriles↗
PubMed2005

Determination of the bioavailability of gentamicin to the lungs following inhalation from two jet nebulizers.

AIMS: To determine the bioavailability of gentamicin to the lung following inhalation from two jet nebulizers. METHODS: Serial urine samples were obtained from 10 volunteers after a 80 mg dose given orally, nebulized from a Pari LC + (PARI) and MicroNeb III (MN) devices, or after a 40 mg intravenous dose. In vitro aerodynamic characteristics of the nebulized doses were also determined. RESULTS: The mean (SD) absolute gentamicin lung bioavailalibility following delivery by PARI and MN devices was 1.4 (0.4) and 1.7 (0.5) %. The mass median aerodynamic diameter (MMAD) of the drug particles from the PARI and MN systems was 8.6 (0.6) and 6.7 (0.5) microm and the corresponding fine particle doses (FPD) were 10.2 (2.8) and 11.7 (1.5) mg. CONCLUSIONS: The MMAD and FPD data reflect the poor lung deposition of gentamicin identified by urinary excretion.

Administration, Inhalation↗
PubMed2005

Can patients use all dry powder inhalers equally well?

If patients are unable to use their inhaler, drug delivery may be unsatisfactory and the patients may fail to benefit from the prescribed medication. It is important to consider whether patients can use all dry powder inhalers equally well. Changing a patient from a dry powder inhaler used well to one that the patient is unable to operate effectively could compromise asthma control. The many marketed dry powder inhalers reflect differences in design decisions that could affect lung deposition. Studies using different dry powder inhalers have confirmed that different lung deposition patterns are observed. Furthermore, there may be considerable individual variability in lung deposition. Differences in lung deposition patterns could have clinical effects. Studies may show similar clinical effectiveness with two inhalers, because most products are used at the plateau phase of the dose-response curve, although there may be differences in the adverse event profile. The ideal inhaler does not yet exist. Different dry powder inhalers show some but not all features of the ideal inhaler; hence, patients may prefer some aspects of one inhaler while favouring a different inhaler for other features. The individual balance of features will govern the overall preference for one inhaler over others. The method for operation of dry powder inhalers varies. Ease of use is seen as an important consideration when selecting an inhaler device, which should be evaluated in real-life studies using unselected patient populations. In conclusion, the evidence suggests that patients cannot use all dry powder inhalers equally well.

Administration, Inhalation↗
PubMed2005

Do patients show the same level of adherence with all dry powder inhalers?

Poor adherence with inhaled therapy presents a considerable problem. In the UK, non-adherence is estimated to occur in 10-46% of those prescribed inhaled corticosteroids and may contribute to an estimated 18-48% of asthma deaths. Before dry powder inhalers can be considered interchangeable, it is important to check that adherence is unaffected by any switching of the device dispensed to patients. Numerous studies have shown that adherence with inhaled medication is a multifactorial issue. A number of evidence-based guidelines have concluded that there is no difference in the delivery of treatments from different inhaler devices. However, many studies comparing different devices are designed to show equivalence. It is therefore difficult to determine whether the studies on which the guidelines are based were conducted with treatments already being used at the top of a dose-response curve. Furthermore, studies use selected patient populations who consent to take part and consequently receive regular contact with healthcare professionals, with emphasis on using the correct inhaler technique and on compliance. These studies do not therefore necessarily reflect real life. It is possible that patient preferences or perceptions of differences in efficacy are behind complaints when devices are switched. Patients vary in their preference for different dry powder inhalers, as shown in numerous studies of patient attitudes. There is evidence to indicate that patient claims of differences between inhalers that contain the same molecule from different manufacturers may have an objective basis. Healthcare professionals increasingly recognise the impact of patient attitudes on adherence. Accepting that patients make choices about their therapy is an integral part of achieving the partnership in management recommended by guidelines. The most effective treatment will not achieve disease control if it is not used or if it is used incorrectly. It may be short-sighted to change a device that a patient has chosen to one that is just given without consent, as this may result in poor adherence to therapy with consequent loss of control.

Administration, Inhalation↗
PubMed2004

The relationship between the quality of prescribing and practice appointment rates with asthma management data in those admitted to hospital due to an acute exacerbation.

Specific targeting of patients with a previous asthma hospitalisation could be more focused if predictors could be identified. This study was an observational retrospective analysis using ridge and linear multivariate regression analysis. Patient asthma management data were extracted from the hospital and general practice notes of those that had been admitted with an acute exacerbation of their asthma over a 5-year period. From the prescribing data, the annual doses of preventer (P) and reliever (R) medication were converted to defined daily doses then divided to give a P:R ratio. Preliminary statistical analysis was used to identify any association between either the P:R ratio or for the number of general practitioner (GP) practice appointments (PA) and their asthma management data. Multivariate regression analysis was applied to the P:R ratio and to PA to determine a model between each of these and asthma management data/events. GPs gave consent to access the data of 115 (out of 440) asthmatics, age >5 years, admitted to a district general hospital for asthma exacerbations between 1994 and 1998. The multivariate analysis revealed that PA was associated with oral prednisolone rescue courses (PRCs) and age whilst the P:R ratio was associated to PRCs and more reliever usage but not preventers. Patients with low preventer usage with respect to their reliever medication should be targeted for medication review as these were the patients prescribed more prednisolone courses and their increased PAs reflect this. This could decrease visits to the doctor and acute exacerbations.

Acute Disease↗
PubMed2004

In-vitro intra- and inter-inhaler flow rate-dependent dosage emission from a combination of budesonide and eformoterol in a dry powder inhaler.

Some dry powder inhalers have profound inhalation flow rate-dependent dosage emission, and it has been suggested that there are links between the in vitro emitted dose, total lung deposition, and subsequent clinical response. We have measured the in vitro dosage delivery for a combination of budesonide and eformoterol in a new version of the Turbuhaler. At inhalation flow rates of 30, 60, and 90 Lmin(-1), the total dose emission for 10 separate inhalations from each of six inhalers was determined. The aerodynamic characteristics of the emitted dose using inhalation flow rates of 28.3 and 60 Lmin(-1) were measured using the Andersen Cascade Impactor. The mean (SD) emitted dose for budesonide, at 30, 60, and 90 Lmin(-1), was 37.5%(18.2%), 64.4%(16.6%), and 107.4%(36.0%) (of the nominal emitted dose), respectively, and for eformoterol were 38.0%(20.3%), 65.0%(16.8%), and 104.9%(36.2%) (of the nominal emitted dose), respectively. Variability of dose emission characteristics from each inhaler and between inhalers at each flow rate was found. The aerodynamic particle size characterization of the emitted dose at flow rates of 28.3 and 60 Lmin(-1) revealed a mean fine particle dose for budesonide of 11.9% and 28.6% of the nominal emitted dose, respectively, and similarly 10.0% and 26.3% for eformoterol. At 28.3 Lmin(-1), the majority of the emitted dose (54.8% for budesonide and 64.5% for eformoterol) was deposited in the throat and preseparator of the Andersen Cascade Impactor. The mass median aerodynamic diameters for budesonide and eformoterol at 28.3 Lmin(-1) were 3.2 and 3.6 microm, respectively, and similarly at 60 Lmin(-1) were 2.4 and 2.5 microm. The modified Turbuhaler containing a budesonide and eformoterol combined formulation shows intra- and inter-inhaler flow-dependent dosage emission. The clinical significance of the in vitro dose-dependent properties should be investigated.

Bronchodilator Agents↗
PubMed2003

Dose-response relationship and reproducibility of urinary salbutamol excretion during the first 30 min after an inhalation.

AIMS: To determine the reproducibility and dose-response relationship for urinary salbutamol excretion post inhalation. METHODS: Fifteen volunteers inhaled either one, two, three, four or five doses of 100 micro g salbutamol on separate days and then seven of these also repeated each of the one, three and five doses on five occasions. After each study dose urine was collected 30 min post inhalation. RESULTS: The mean (SD) 30 min urinary salbutamol after one, two, three, four and five doses was 2.61 (1.0.), 5.47 (1.59), 8.68 (2.73), 12.34 (3.96) and 15.99 (4.50) micro g, respectively. Statistical analysis revealed a linear relationship (P < 0.001). Mean (SD) coefficient of variation after one, three and five doses was 10.5 (3.6), 10.1 (2.7) and 9.4 (2.3)%. CONCLUSIONS: The 30 min salbutamol urinary excretion post inhalation pharmacokinetic method, to compare inhaled products, is linear with inhaled dose and reproducible.

Administration, Inhalation↗
PubMed2003

Is inhalation rate important for a dry powder inhaler? Using the In-Check Dial to identify these rates.

The fraction of the emitted dose from an inhaler that has the potential to be deposited into the lungs is known as the fine particle dose (also the respirable dose). During inhalation all dry powder inhalers require a 'force' to be created inside the device so that a fine particle dose is generated from the formulation in the metering chamber. This 'force' is formed by the inhalation rate used together with the resistance (and hence design) inside an inhaler. Studies have shown that the fine particle dose is related to the clinical effect whilst other studies have reported that this dose can be dependent on the inhalation rate used. The inhalation technique recommended by the manufacturer of an inhaled device should, therefore, be used. For those dry powder inhalers that demonstrate significant flow dependent dosage emission it is important that patients use the most desirable rate that has been reported. The In-Check Dial is a simple and ease to use meter that can be used to measure the inhalation rate of a patient when they use each of the commonly prescribed inhalers that are currently available. This meter can be used to identify the most suitable inhaler for each individual.

Administration, Inhalation↗
PubMed2003

A Cox regression analysis of covariates for asthma hospital readmissions.

BACKGROUND: Asthma hospital admissions and readmissions are unacceptably high, thus, a method to identify those at greatest risk could be helpful. METHODS: An observational retrospective study using a Cox regression to determine the relationship between the time interval between admissions and possible covariates of a readmission. The covariates were age, sex, ethnicity, smoking habit, history of allergy or eczema/hay fever, age of onset, Townsend index (TI), Jarman score (JS), and drugs on discharge. Those with p < 0.2, together with interacting covariates, from the preliminary analysis were eligible for the multivariate Cox regression analysis. RESULTS: Of the 523 patients admitted between 1994 and 1998 because of their asthma, complete data were available for 440. Of these, 112 were readmitted. Eligible covariates for the multivariate Cox regression analysis were sex, allergy status, history of eczema/hay fever, the JS and TI together with interactions between JS and TI, JS and allergy, and allergy with eczema/hay fever. There were 278 subjects (71 with a readmission) with complete data for these eligible covariates. The multivariate analysis revealed that female sex (odds ratio [OR] = 2.65, 95% confidence interval [CI] 1.42, 4.92), high JS (OR = 2.03, 95% CI 1.13-3.65), and history of allergy (OR = 1.88, 95% CI 1.06-3.32) formed the final model as significant predictors of readmission. CONCLUSION: Females with a history of allergy that were registered at a practice with a high workload (JS) had a higher risk of readmission. The analysis method used highlights how those at risk of readmission can be identified so that they can be targeted post discharge.

Adolescent↗
PubMed2002

Relative lung and total systemic bioavailability following inhalation from a metered dose inhaler compared with a metered dose inhaler attached to a large volume plastic spacer and a jet nebuliser.

OBJECTIVE: To compare the lung and systemic delivery of salbutamol following inhalation from a metered dose inhaler (MDI), a MDI attached to a spacer (MDI+SP) and a nebuliser (NEB) using a urinary pharmacokinetic method. METHOD: Twelve healthy subjects each provided urine samples at 0, 30 min and pooled up to 24 h after the start of 5 x 100 microg salbutamol inhaled from MDI and MDI + SP and after 2.5 mg was delivered by NEB. Following nebulisation, the amount of salbutamol trapped on an exhalation filter together with that remaining in the apparatus was determined. The amount left in the spacer and that leaving the MDI mouthpiece was also determined. Thus, for all the methods, the amount available for inhalation from each study dose was determined. RESULTS: The mean (+/- SD) 30-min urinary excretion amounts of salbutamol for MDI, MDI+SP and NEB were 12.6+/-3.5, 27.1+/-6.0 and 16.1+/-4.6 microg, respectively. The mean ratios (90% confidence intervals) for MDI+SP compared with MDI and NEB were 230.2 (186.7, 273.8) and 183.0 (146.4, 219.7) (both P values<0.001), respectively, while that between MDI and NEB was 134 (110.4, 159.1) (P < 0.05). The mean (+/-SD) 24-h urinary excretion values for salbutamol and its metabolite were 287.0+/-46.5, 198.1+/-34.7 and 253.4+/-138.3 microg, respectively. Following inhalation a mean of 202.9+/-51.5 microg was left in the spacer. Similarly, after nebulisation 1387.7+/-88.9 microg was left in the nebuliser chamber, 26.3+/-8.0 microg in the mouthpiece and 553.8+/-68.5 microg exhaled. The mean emitted dose from the MDI was 88.4+/-6.1 microg per actuation. When normalised for the amounts available for inhalation, the mean amounts of salbutamol excreted in the urine during the first 30 min were 2.86+/-0.78, 9.15+/-1.69 and 3.06+/-0.70% following MDI, MDI + SP and NEB, respectively. CONCLUSION: Five 100-microg doses inhaled from a metered dose inhaler attached to a spacer delivered more to the lungs and less to the systemic circulation than either the same doses from a metered dose inhaler used alone or five times the dose given via a jet nebuliser. Spacers should be routinely used instead of nebulisers to manage patients unless they are short of breath.

Adult↗
PubMed2002

Determination of the relative bioavailability of salbutamol to the lungs and systemic circulation following nebulization.

AIMS: Clinical studies comparing nebulized drug delivery systems could be flawed because of the high doses used. We have compared lung and total systemic delivery of salbutamol from a nebuliser with that from a metered dose inhaler by measuring urinary recovery of drug and its sulphate metabolite. METHODS: Twelve healthy volunteers provided urine samples at 0, 0.5, 1, 2, 4, 8, 12 and 24 h after the start of dosing. Formulations and doses were 5 x 100 microg oral solution (ORAL), 5 x 100 microg from a metered dose inhaler (MDI), 2.5 mg using a nebuliser (NEB) and NEB with 25 g oral charcoal (NEBC). Each study phase was separated by 7 days and the order of dosing was randomized. RESULTS: Mean (s.d.) 30 min urinary salbutamol excretion after ORAL, MDI, NEB and NEBC was 0.4 (0.7), 12.1 (3.7), 15.0 (3.9) and 18.2 (5.7) microg, respectively (all P<0.001 compared with ORAL). When normalized for the dose available for inhalation from MDI, NEB and NEBC, the mean (s.d.) 30 min urinary excretion of salbutamol was 2.4 (0.7), 2.9 (0.6) and 2.7 (0.6)%, respectively, with a mean ratio (90% confidence interval) between NEB and NEBC, of 95.3 (91.1, 99.5)%. The mean (s.d.) excretion of salbutamol plus its metabolite over 24 h post ORAL, MDI, NEB and NEBC dosing was 297.9 (38.3), 290.3 (41.4), 266.5 (44.6) and 151.7 (40.9) microg, respectively. The mean ratio (90% confidence interval) between MDI and ORAL, and NEB and ORAL were 97.5 (94.1, 101.0) and 90.7 (81.2, 100.2)%, respectively. The NEBC data indicate that 6.07 (1.04)% of the nominal nebulized dose was delivered to the lungs. CONCLUSIONS: The 30 min urinary recovery of salbutamol, an index of the relative systemic bioavailability of salbutamol following inhalation, can be used to compare the lung deposition of nebulized systems. Similarly, the urinary 24 h recovery of salbutamol plus its metabolite, an index of the relative systemic bioavailability of salbutamol following inhalation, can be used to compare the delivery of nebulized drug to the systemic circulation.

Administration, Inhalation↗
PubMed2002

The value of inpatient pharmaceutical counselling to elderly patients prior to discharge.

AIMS: The use of medication and information discharge summaries (MIDS) has become a standard procedure in many hospitals. We have evaluated if these summaries, together with in-patient pharmaceutical counselling backed up with a simple medicine reminder card, may help with the delivery of seamless pharmaceutical care. METHODS: Elderly patients prescribed more than four items discharged to their own home received the standard discharge policy including a recently introduced MIDS and medicine reminder card. Each patient's GP was sent a copy on discharge. Pre-discharge a pharmacist counselled study patients about their medicines and compliance. A research pharmacist visited patients in their home approximately 2-3 weeks and at 3 months post-discharge to determine their drug knowledge, compliance, home medicine stocks and any healthcare related events. RESULTS: Forty-three study and 40 control patients completed both visits. Their mean (s.d.) ages were 80.2 (5,7) and 81.1 (5,8) years and they were prescribed 7.1 (1.8) and 7.1 (2.3) items, respectively. At visit 1 knowledge (P < 0.01) and compliance (P < 0.001) was better in the study group. At visit 2 compliance had improved in the study group (P < 0.001). Unplanned visits to the GP and readmission to hospital amongst the study group were 19 and 5, respectively, which were both significantly less (P < 0.05) than 27 and 13 in the control group. At visit 2 for the study group the 24 unplanned GP visits and three re-admissions were significantly (P < 0.05) less than the respective 32 and 15 in the control group. At visit 1, two study group patients had altered their own medication compared with 10 control patients. At visit 2 these reduced to 0 and 4, respectively. CONCLUSIONS: In-patient pharmaceutical counselling, linked to a medication and information discharge summary and a medicine reminder card, contributed to better drug knowledge and compliance together with reduced unplanned visits to the doctor and re-admissions. A pharmaceutical domiciliary visit consolidated the improved healthcare outcomes.

Aged↗
PubMed2002

An investigation of in vitro/in vivo correlations for salbutamol nebulized by eight systems.

The choice of a nebulized system for a patient usually depends on the equipment available. To date, there is limited guidance on the selection and use of a nebulizer. We have conducted in vitro tests described within the draft European Standard for Nebulisers (BSEN13544-1; CEN) and correlated these to in vivo pharmacokinetic performance of relative lung and systemic deposition in healthy volunteers. Eight nebulizer systems have been tested. The in vitro analysis used the recommended CEN methods to quantify the total dose available for inhalation as well as the size distribution from which the respirable dose was determined. The draft European Standard methods were slightly modified to use salbutamol rather than a fluoride tracer. For the in vivo study, nine volunteers provided urine samples after 30 min and then pooled for 24 h after the start of each nebulized dose (2.5 mg of salbutamol). Amounts of salbutamol and its metabolite excreted in the urine samples were determined. There was a significant (p = 0.02) correlation between the in vitro respirable dose and the amount of salbutamol excreted in the urine 30 min after the start of nebulization (relative bioavailability of salbutamol to the lung). Also, there was a significant (p < 0.001) correlation between the in vitro dose available for inhalation and the total amount of salbutamol and its metabolites excreted over the 24 h after the start of nebulization (relative bioavailability of salbutamol to the body). The results demonstrate that in vivo/in vitro correlations exist and warrant further investigations. The in vitro methods require further validation with in vivo correlations using patients with different severities of airway obstruction.

Aerosols↗
PubMed2001

Relative lung bioavailability of generic sodium cromoglycate inhalers used with and without a spacer device.

The relative lung bioavailability of sodium cromoglycate following inhalation has been evaluated using urinary drug excretion in nine healthly volunteers. Each inhaled four 5 mg sodium cromoglycate doses from a generic metered dose inhaler (MDI) and when it was attached to large volume spacer (MDI + VOL). A breath-actuated MDI was also evaluated either used on its own (EB) or attached to a small volume spacer tube (EBO). The mean (SD) urinary excretion of sodium cromoglycate in the first 30 min post-inhalation was 34.1 (20.2), 211.7 (123.5), 29.3 (19.5) and 52.8 (36.0) microg following MDI, MDI+VOL, EB and EBO, respectively. The cumulative mean (SD) urinary excretion of sodium cromoglycate over the 24 h post-inhalation was 364.7 (266.2), 1227.1 (459.0), 280.2 (155.4) and 429.5 (176.7) microg. A metered dose inhaler attached to a large volume spacer delivers more sodium cromoglycate to the lungs than any other inhalation method.

Administration, Inhalation↗
PubMed2001

Measurement of peak inhalation rates with an in-check meter to identify an elderly patient's ability to use a turbuhaler.

Dry powder inhalers are designed with resistance to airflow so that a respirable cloud of particles is generated during inhalation. Some of these devices require a certain inhalation rate to produce a consistent dose of respirable particles. The aim of the study was to determine the inhalation rate of elderly patients with chronic obstructive pulmonary disease (COPD) when they inhale through a Turbuhaler and assess the potential of the In-Check Meter to identify inhalation rates. Their peak inhalation rate using a normal inhalation, pre- and post-counselling, was measured using a Turbuhaler Trainer and an In-Check Meter. Spirometry was also measured. Seventy-four COPD patients with a mean (SD) age of 79.7 (8.4) years and forced expiratory volume in 1 sec (FEV1) 41.9 (12.8)% predicted. Pre-counselling 14 obtained a rate of <30 l min(-1) with the Turbuhaler Trainer, 31 from 30 to 40 min(-1), 23 between 40-60 l min(-1) and 6 > 60 l min(-1). The median (range) peak inhalation rates with the In-Check Meter were 50 (50-70), 70 (50-130), 100 (60-200) and 225 (200-250) l min(-1). Post-counselling 7, 16,41 and 10 achieved the respective peak inhalation rates using the Turbuhaler Trainer Similarly the In-Check inhalation rates were 50 (50-60), 70 (50-130), 90 (60-200) and 250 (200-270) l min(-1). The results highlight the potential of the In-Check Meter to identify patients' inhalation rates through dry powder inhalers.

Aged↗
PubMed2000

Ondansetron therapy for uremic pruritus in hemodialysis patients.

Pruritus is a distressing symptom affecting up to 90% of dialysis patients. Conventional treatment with antihistamines is often ineffective and may have unacceptable side effects. Serotonin (5-hydroxytryptamine type 3 [5-HT(3)]) is known to enhance pain perception and pruritic symptoms through receptors on sensory nerve endings. Antagonism of 5-HT(3) receptors may be of use in treating uremic pruritus. We randomly assigned 16 hemodialysis patients with persistent pruritus to treatment with the 5-HT(3)-receptor antagonist, ondansetron (8 mg), or placebo three times daily for 2 weeks each in a prospective, placebo-controlled, double-blind crossover study. Patients scored their intensity of pruritus daily on a 0-to-10 visual analogue scale (0 = no pruritus, 10 = maximal pruritus), and daily use of antihistamines as escape medication was recorded. The median daily pruritus score did not change significantly during active or placebo treatment (preondansetron, 5. 3; interquartile range [IQR], 3.4 to 6.3; during ondansetron, 3.9; IQR, 2.7 to 5.0; P = not significant; preplacebo, 3.7; IQR, 3.0 to 4. 6; during placebo, 3.6; IQR, 2.4 to 4.8; P = not significant). The median daily percentage of escape medication use decreased from 21% (IQR, 9 to 61) to 9% (IQR, 0 to 33) with ondansetron (P = not significant) and from 53% (IQR, 0 to 88) to 5% (IQR, 0 to 31) with placebo (P = not significant). There was no difference in predialysis biochemistry test results or dialysis efficacy during treatment phases. Ondansetron does not improve pruritus in hemodialysis patients. Use of antihistamines decreased with both ondansetron and placebo.

Adult↗