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PubMed2003

Serum concentrations and effects of gabapentin and vigabatrin: observations from a dose titration study.

To explore possible concentration-effect relationships, gabapentin (GBP) and vigabatrin (VGB) serum concentrations were obtained from patients participating in an add-on dose-titration trial comparing GBP and VGB in partial epilepsy. Patients randomized to GBP started on 1800 mg/d and could have their dosage increased stepwise to 2400 and 3600 mg/d if seizures persisted. Those randomised to VGB started on 1000 mg/d, and the dose could be increased to 2000 and 4000 mg/d. Blood samples were obtained at steady state, at a nonstandardized time, from 27 patients randomized to GBP and from 36 randomized to VGB. Serum samples were analyzed using high-performance liquid chromatography. The treatment effect was expressed as percentage reduction in number of seizures from baseline. In addition, patients were classified as responders (>50% reduction in number of seizures from baseline) or nonresponders. There was no significant correlation between serum concentrations of GBP and seizure reduction at the lowest dosage, 1800 mg/d (r = -0.02, P = 0.94, Spearman-rank), nor between VGB serum levels and seizure reduction at 1000 mg/d of VGB (r = -0.14, P = 0.44). The serum GBP concentrations among responders to GBP 1800 mg/d were 26 +/- 12 micro mol/L (mean +/- SD), which was not different from serum concentrations in nonresponders, 28+/-13 micro mol/L. Nor was there a difference between serum concentrations of responders and nonresponders to VGB 1000 mg/d (32 +/- 23 and 44 +/- 36 micro mol/L, respectively). Hence, with the present study design we were unable to identify specific target ranges of GBP and VGB serum concentrations.

Acetates↗

PubMed2005

A modified critical test and its use in two dose titration trials to assess efficacy of praziquantel for Anoplocephala perfoliata in equids.

Aims of this study with 43 equids naturally infected with Anoplocephala perfoliata in two dose titration trials were to document (i) the usefulness of a critical test with a 48 h treatment to necropsy period, (ii) efficacy of an oral paste of 0.5-2.0 mg praziquantel/kg body weight, and (iii) when after treatment would fecal egg counts provide best estimates of the tapeworm's prevalence in a herd. All feces passed by an equid after treatment and collected in successive 12 h batches were examined for tapeworms. At necropsy, tapeworms were identified as attached to the mucosa or unattached. Tapeworms were examined with a stereoscope and identified as normal or abnormal. Fecal samples were taken for egg counts at treatment and at 6 h intervals thereafter. In 32 of 36 treated equids, efficacy was 100% and mean efficacies for 0.5, 1.0, 1.5 and 2.0 mg praziquantel/kg body weight were 85.5, 99.7, 100 and 100%, respectively. Two equids treated with 0.5 mg praziquantel/kg body weight had low efficacies (5.4 and 38.1%) and normal tapeworms were found attached in the ventral colon and in one equid also in the dorsal colon. In seven untreated equids, tapeworms were primarily in the cecum with 21.3% detached. "Major fragments" or worms without a scolex but otherwise nearly a complete worm were 20.5% of the number of intact worms; they were not included in the efficacy analysis but should be. If the two equids with low efficacy were eliminated and if the number of all tapeworms and major fragments are combined less than 0.5% were in feces within 12 h of treatment, about 20% were in the 12-24 h period, 42% in 24-36h, 24% in 36-48 h and 13.5% in the equids at necropsy. One horse passed all its tapeworms in 24 h. This 48 h test when compared with a 24 h one with no examination of feces was more efficient in use of trial animals and reduced underestimation and overestimation of efficacy. However, a protocol similar to the 48 h test but with a 24 or 36 h post-treatment period should be investigated. The mean egg count peaked 18-24 h after treatment and samples taken at that time would provide the best estimate of prevalence. The Cornell-Wisconsin centrifugal flotation technique had a specificity of 100% and at 18 and 24 h its sensitivity was 94%. A brief discussion on critical and controlled tests for assessing efficacy of an anthelmintic for A. perfoliata is presented.

Administration, Oral↗

PubMed1977

Dose-titrated, double-blind, cross-over comparison of a selective beta-blocker and methyldopa in the treatment of hypertension.

The efficacy and toxicity of tolamolol and methyldopa in hypertensive patients has been compared by a dose-titrated, double-blind, cross-over study. Thirteen patients completed the trial. Within the dose ranges investigated (tolamolol - 300 mg/day - 900 mg/day; methyldopa - 750 mg/day - 2250 mg/day)both drugs produced significant falls in laying and standing, systolic and diastolic blood pressures. Although the hypotensive effects of methyldopa were more marked than tolamolol, these only achieved conventional (P less than 0.05) levels of significance for lying blood pressure. There were no objective changes in haematological or biochemical indices during treatment with either drug, but patients complained of tiredness, weak limbs and mouth dryness significantly more during methyldopa treatment, than during either placebo or tolamolol therapy.

Adult↗

PubMed1999

A randomized, multicenter trial of weight-adjusted intravenous heparin dose titration and point-of-care coagulation monitoring in hospitalized patients with active thromboembolic disease. Antithrombotic Therapy Consortium Investigators.

BACKGROUND: Therapy with intravenous unfractionated heparin improves clinical outcome in patients with active thromboembolic disease, but achieving and maintaining a therapeutic level of anticoagulation remains a major challenge for clinicians. METHODS: A total of 113 patients requiring heparin for at least 48 hours were randomly assigned at 7 medical centers to either weight-adjusted or non-weight-adjusted dose titration. They were separately assigned to either laboratory-based or point-of-care (bedside) coagulation monitoring. RESULTS: Weight-adjusted heparin dosing yielded a higher mean activated partial thromboplastin time (aPTT) value 6 hours after treatment initiation than non-weight-adjusted dosing (99.9 vs 78.8 seconds; P =.002) and reduced the time required to exceed a minimum threshold (aPTT >45 seconds) of anticoagulation (10.5 vs 8.6 hours; P =.002). Point-of-care coagulation monitoring significantly reduced the time from blood sample acquisition to a heparin infusion adjustment (0.4 vs 1.6 hours; P <.0001) and to reach the therapeutic aPTT range (51 to 80 seconds) (16.1 vs 19.4 hours; P =.24) compared with laboratory monitoring. Although a majority of patients participating in the study surpassed the minimum threshold of anticoagulation within the first 12 hours and reached the target aPTT within 24 hours, maintaining the aPTT within the therapeutic range was relatively uncommon (on average 30% of the overall study period) and did not differ between treatment or monitoring strategies. CONCLUSIONS: Weight-adjusted heparin dosing according to a standardized titration nomogram combined with point-of-care coagulation monitoring using the BMC Coaguchek Plus System represents an effective and widely generalizable strategy for managing patients with thromboembolic disease that fosters the rapid achievement of a desired range of anticoagulation. Additional work is needed, however, to improve on existing patient-specific strategies that can more effectively sustain a therapeutic state of anticoagulation.

Adult↗

PubMed1995

Transdermal fentanyl in combination with initial intravenous dose titration by patient-controlled analgesia.

Two studies including a total of 70 patients evaluated the efficacy and side effects of a combination of initial patient-controlled analgesia (PCA) for dose finding with transdermal fentanyl administration. Patients, requiring strong opioids for severe cancer pain, received intravenous (i.v.) fentanyl on an on-demand basis over a 24 h period. The amount of fentanyl administered was then used for selecting a suitable transdermal therapeutic system (TTS), which remained in place for 72 h. The size of the second TTS was adjusted according to the amount of supplementary i.v. fentanyl required on day 3. Beginning on day 4, oral or subcutaneous morphine was made available as a rescue medication. The use of TTS fentanyl in combination with initial dose titration using PCA resulted in rapid and statistically significant pain relief in both studies. A respiratory rate below 8 per minute was observed in three patients. Due to adequate symptomatic treatment, other moderate and severe symptoms were relatively rare. TTS fentanyl was shown to be an effective, safe and simple method for long-term pain relief in cancer patients and presents an interesting novel option in the treatment of cancer pain.

Administration, Cutaneous↗

PubMed1994

A dose titration, and an open 6-week efficacy and safety study of desmopressin tablets in the management of nocturnal enuresis.

The efficacy and safety of 6 weeks of treatment with desmopressin tablets at doses of 200 to 400 micrograms.at bedtime were investigated in 33 children with monosymptomatic nocturnal enuresis. During an initial 1 to 2-week dose titration period 22 patients (67%) became either completely dry or showed improvement, 7 (21%) showed no response and 4 (12%) dropped out of therapy. During tablet treatment 17 patients on 400 micrograms.and 5 on 200 micrograms.at bedtime increased the number of weekly dry nights from 2.0 +/- 1.6 (standard deviation) during a 2-week observation period to 5.2 +/- 1.9 (p < 0.001). During a subsequent 2-week period 40 micrograms.intranasal desmopressin showed a similar overall efficacy, with a mean of 5.4 +/- 1.6 dry nights per week. In addition, intranasal treatment was able to increase the number of dry nights in 2 of the 7 nonresponders to tablet treatment.

Administration, Intranasal↗

PubMed2004

Dose titration of repaglinide in patients with inadequately controlled type 2 diabetes.

A total of 385 drug-therapy naïve patients, with inadequately controlled type 2 diabetes, were randomised into a multinational, parallel-group study to compare two strategies for dose titration of the oral hypoglycaemic agent repaglinide. Patients were allocated to either a fasting blood glucose (FBG) monitoring group with titration target 4.4-6.1 mmol/l or to a post-prandial blood glucose (PPBG) monitoring group with titration target 4.4-8.0 mmol/l. An initial titration period of up to 8 weeks was followed by a 12-week treatment period. Glycaemic control and hypoglycaemic outcomes were compared for the respective groups. HbA(1c) decreased significantly more in the FBG monitoring group by a mean of 1.38% compared to the PPBG group by a mean of 1.22% (P=0.03). The glycaemic control targets were met by fewer patients in the FBG group than in the PPBG group (57% versus 86% (P<0.001)) despite a higher mean dose of repaglinide in the FBG group. The within-patient blood glucose variability was significantly lower in the FBG group than in the PPBG group (P<0.001). In conclusion, repaglinide lowered the HbA(1c) effectively and safely in both groups and self-monitored FBG is a suitable parameter for titration of repaglinide. Whether a lower PPBG target might be as good a guide as FBG for titration of repaglinide should be addressed in a future study.

Adult↗

PubMed1989

Dose titration and confirmation tests for determination of cesticidal efficacy of epsiprantel in dogs.

Fifty-five dogs, naturally infected with Taenia sp or Dipylidium caninum or both, were assigned to the following treatment groups for dose titration studies with epsiprantel: nonmedicated control dogs (n = 14), medicated dogs given a dosage of 2.75 mg/kg of body weight (n = 15), medicated dogs given a dosage of 5.5 mg/kg (n = 16), and medicated dogs given a dosage of 8.25 mg/kg (n = 10). Medication was given orally in a tablet formulation. Feces were examined for cestodes passed and the gastrointestinal tract was examined at necropsy for retained cestodes. Efficacy of epsiprantel was 92.9% against Taenia and 44.8% against Dipylidium for a dosage of 2.75 mg/kg, 100% against Taenia and 99.8% against Dipylidium for a dosage of 5.5 mg/kg, and 94.6% against Taenia and 100% against Dipylidium for a dosage of 8.25 mg/kg. For dose confirmation, 36 dogs naturally infected with Taenia sp or D caninum or both were allotted to 2 treatment groups: nonmedicated control dogs (n = 16) and dogs medicated with epsiprantel at a dosage of 5.5 mg/kg (n = 20). Efficacy was 100% for both Taenia sp and D caninum.

Animals↗

PubMed1998

A dose titration study on the effect of virginiamycin on gilt/sow and piglet performance.

Virginiamycin (VM), a compound with proven performance-promoting properties in pigs, can also be considered as sow performance enhancer. The present dose titration study investigates the long-term effects of VM on gilt/sow and litter performance. A total of 140 healthy gilts, in 35 sets of 2 + 2 siblings each, were used in this trial; gilts in each set were randomly allocated to the four treatments (35 gilts per each treatment group): VM0 = negative control, virginiamycin 0 mg/kg, VM20 = virginiamycin 20 mg/kg, VM40 = virginiamycin 40 mg/kg and VM60 = virginiamycin 60 mg/kg of feed. VM was added to the gilt/sow feed for a period starting from 6 months of age up to conception of the fourth parity, covering three complete breeding cycles (pregnancy, lactation and weaning-to-conception interval). The feed given did not contain any other antibacterial agent or performance enhancer. Piglets were given exactly the same quantity of creep feed from the fifth day onwards; it did not contain any antibacterial agent or performance enhancer. The lactation period was the same in all gilts/sows (21 days). Results indicate that VM supplementation of the feed improved gilt/sow performance by: (i) increasing (P < 0.05) the mean body weight at each farrowing, (ii) decreasing (P < 0.05) the mean weight loss from farrowing to weaning, and (iii) decreasing (P < 0.05) the mean weaning-to-conception intervals. VM supplementation of gilt/sow feed also resulted in improved litter size and litter performance in terms of: (i) a higher (P < 0.05) mean number of piglets born alive at each birth, (ii) a higher (P < 0.05) mean number of piglets weaned, (iii) a higher (P < 0.05) mean piglet body weight at each birth, and (iv) a higher (P < 0.05) mean piglet body weight at each weaning. These beneficial effects of VM were more pronounced in the VM40 group.

Animals↗

PubMed2004

A dose titration of triamcinolone acetonide on insulin-like growth factor-1 and interleukin-1-conditioned equine cartilage explants.

REASONS FOR PERFORMING STUDY: Previous in vitro pilot studies have defined a potentially beneficial effect of insulin-like growth factor-1 (IGF-1) and triamcinolone acetonide (TA) on interleukin-1 (IL-1)-conditioned equine cartilage. Furthermore, an optimal dose for IGF-1 treatment alone has been documented previously using the same test system as in the current project. OBJECTIVES: To perform a dose titration of TA on IL-1-conditioned equine articular cartilage explants in the presence of an optimised IGF-1 dose, in order to optimise a triamcinolone concentration for use in combination with IGF-1 for future investigations. METHODS: Cartilage explants were harvested from the distal femur of a normal horse. The effect of a clinically relevant TA dose range was evaluated in the presence of IL-1 and IGF-1 through measurement of proteoglycan (PG) matrix metabolism (synthesis and degradation). RESULTS: TA and IGF-1 in combination inhibited the IL-1-induced release of PG matrix components (glycosaminoglycan or GAG) from the articular cartilage, as well as producing a significant increase in GAG synthesis. CONCLUSIONS: This experiment provided proof of principle that a combination treatment appears to be able to combat the IL-1-induced matrix depletion, while enhancing anabolic metabolism within the articular cartilage. POTENTIAL RELEVANCE: The use of IGF-1 in conjunction with TA in vivo has the potential to provide beneficial anabolic effects not seen with TA alone.

Animals↗

PubMed2002

Dose titration using the Disease Activity Score (DAS28) in rheumatoid arthritis patients treated with anti-TNF-alpha.

OBJECTIVE: Anti-tumour necrosis factor alpha (TNF-alpha) therapy yields high response rates shortly after institution of therapy in patients with rheumatoid arthritis (RA), and on theoretical grounds large differences in the effective dose between patients can be expected. Together with the high costs, these differences warrant new approaches to the way patients are dosed. METHODS: We used the Disease Activity Score (DAS28), a composite disease activity index, to titrate the dose of anti-TNF-alpha (adalimumab, D2E7; Knoll) in 21 patients with low disease activity in an open extension study lasting 40 weeks. The dose of anti-TNF-alpha was reduced stepwise and dosing intervals were kept stable. Disease activity and flares were assessed using the DAS28. Patients who flared received the previous effective dose. RESULTS: Dose reduction was accomplished in 15 patients. The total amount of anti-TNF-alpha given to the patients was reduced by 67%. At the end of the study the mean DAS28 had not changed and no patients dropped out because of persistent worsening of the RA. CONCLUSION: Dose titration of anti-TNF-alpha treatment using the DAS28 is feasible and leads to overall dose reduction while maintaining clinical efficacy. This approach will save costs and possibly prevent long-term side-effects.

Adalimumab↗

PubMed1990

Long-term suppression of severe recurrent genital herpes simplex infections with oral acyclovir: a dose-titration study.

Twenty immunocompetent patients, four females and 16 males, with severe recurrent genital herpes (median number of recurrences the previous year 16, range (8-24] entered an open continuous long-term suppressive treatment with oral acyclovir (ACV) for 12 months. The study included a dose-titration schedule: (ACV, 200 mg x 4/1-3 months, ACV, 400 mg x 2/4-6 months, ACV, 200 mg x 2/7-9 months, and ACV, 400 mg x 1/10-12 months). Patients with recurrences on steps two and three received an alternative dose of ACV, 200 mg x 3. Otherwise patients entered the previous dose-step. Five (20%) of patients were completely free of symptoms (recurrences and abortive lesions) during the four dose-reduction periods. A further nine patients (50%) could be dose-reduced to 200 mg x 3 without symptoms. Isolates from three patients showed a decrease in virus sensitivity after ceasing treatment. In conclusion, 14/20 of treated patients could be dose reduced to 200 mg x 2-3 without selection of HSV strains showing clinically important decreases in sensitivity towards ACV.

Acyclovir↗

PubMed2004

Oral transmucosal fentanyl citrate in the management of breakthrough pain in cancer: an open, multicentre, dose-titration and long-term use study.

Sixty-six patients with cancer-related pain entered an open multicentre study to examine the safety and efficacy of oral transmucosal fentanyl citrate (OTFC) in the treatment of breakthrough pain. Patients were eligible for the study if they were stabilized on a long-acting opioid but were experiencing up to four episodes of breakthrough pain a day and achieving at least partial relief from breakthrough pain using conventional medication (normal release oral morphine in the majority of patients). The efficacy of the conventional medication was documented in a run-in phase and patients then changed to OTFC. All patients were treated initially with a 200 mcg unit of OTFC and the dose was increased if necessary to a level that produced relief of breakthrough pain without troublesome adverse effects. Fifty-eight patients completed the run-in phase using their usual medication and entered the dose titration phase with OTFC and 57 patients received at least one dose of OTFC. Forty-two patients (72%) found a successful dose of OTFC. The primary outcome measures were the Summed Pain Intensity Differences (SPID) and Total Pain Relief (TOTPAR) scores at 60 min. There was a significant difference in both measures in favour of OTFC compared with conventional medication in these patients. Twenty-eight of the 42 patients (67%) preferred OTFC to their usual medication. The most common adverse effects attributed to OTFC were nausea, stomatitis, vomiting and dizziness but there were no unpredicted or severe problems. Thirty-seven patients continued into the long-term study and 12 of these completed six months treatment. Most drop-outs in this phase were associated with progression of the underlying disease. No patient stopped using OTFC because of dissatisfaction with the drug. OTFC appears to be a safe and effective treatment for breakthrough pain in cancer patients and may have advantages over currently available opioid formulations.

Administration, Buccal↗

PubMed1997

Dose titration of nebulized budesonide in young children.

We compared the clinical effect of the glucocorticoid budesonide delivered from two nebulizers Aiolos and Pari LL in 38 children less than 4 years of age (mean age, 20.2 months) with chronic wheeze. The design was a controlled, single-blind, randomized, cross-over, dose titration study. After a 1-week run-in, patients were randomized to treatment with 1 mg budesonide b.i.d. for 2 weeks from either an Aiolos or a Pari LL nebulizer. This was followed by a gradual dose reduction period during which the budesonide dose was reduced at 2-week intervals until unacceptable asthma symptoms appeared or the placebo level was reached. The patient was then switched to budesonide 1 mg b.i.d. from the other nebulizer for 2 weeks, after which the dose was reduced at 2-week intervals as described for the first period. Patients who completed the study on placebo for 2 weeks without deterioration of their asthma were not included in the statistical analysis. During Period #1 the minimum effective dose of budesonide was 2 mg/day in 9 patients, 1 mg/day in 10 patients, and 0.5 mg/day in 13 patients. In Period #2 the corresponding figures were 14, 5, and 13 patients. Six patients were excluded after the first period because their asthma control did not deteriorate during dose reduction and when finishing on placebo for 2 weeks. For both nebulizers the reduction in budesonide dose was associated with a small increase in symptoms and use of rescue terbutaline. The mean dose of budesonide delivered to the patient by the Aiolos was twice as large as that delivered by the Pari LL: 26% vs. 13% of the nominal dose assessed by the filter method. Nevertheless, no statistically significant difference in clinical effect or mean minimal effective dose (1.1 mg for Aiolos and 1.2 mg for Pari LL) could be detected between the two nebulizers. No serious adverse events were observed. We conclude that the minimal effective dose of nebulized budesonide varies from 0.5 to 2.0 mg/day in young children with asthma. A higher drug delivery, as assessed by the filter method, does not necessarily result in better clinical control or lower minimal effective dose. Further studies are needed to assess whether this is due to insufficient sensitivity of the study design in detecting a difference in clinical effect, or whether measurements of drug delivery by the filter method do not reflect lung deposition or clinical effect in young children with wheezing.

Asthma↗

PubMed1975

Dose titration of steroidal and non-steroidal topical anti-inflammatory agents.

Although there is a variety of animal models available, neither a single assay system nor the results of the various assays permit absolute protection of relative anti-inflammatory potency. Equally, current clinical dose titration studies, although more reliable, provide only gross estimates of therapeutic potency when conducted in certain clinical situations in a double-blind randomized fashion. This paper delineated clinical means to titrate more objectively and accurately therapeutic potency in the patient. Moreover, it has submitted considerations as to how to assess therapeutic anti-inflammatory activity in the complex multi-component process of inflammation accompanying most dermatologic diseases that eventually may permit titration of specific anti-inflammatory compounds on certain tissue components of the inflammatory process.

Administration, Topical↗

PubMed1999

Efficacy and tolerability of tasosartan, a novel angiotensin II receptor blocker: results from a 10-week, double-blind, placebo-controlled, dose-titration study. Tasosartan Investigators Group.

BACKGROUND: Angiotensin II receptor antagonists are selective blockers of the renin-angiotensin system and represent an alternative to angiotensin-converting enzyme inhibitors in the treatment of hypertension. Tasosartan is a newly developed nonpeptide AT1 receptor blocker. METHODS AND RESULTS: In this double-blind, randomized, dose-titration, multicenter trial, tasosartan and placebo were compared in patients with stage I and stage II hypertension. A prequalification washout period (antihypertensive medications withdrawn) and a 2-week qualification period (patients received single-blind placebo) preceded a 10-week, double-blind treatment period. The patients received either 50 mg tasosartan (n = 132) or placebo (n = 130) once per day and were evaluated once per week. The dose of tasosartan was increased at 3-week intervals to 100 mg and then to 200 mg if the mean sitting diastolic blood pressure (SiDBP) exceeded 90 mm Hg. Compared with placebo, tasosartan produced significantly (P <.05) greater reductions in both SiDBP (-9.4 +/- 0.7 vs -2.0 +/- 0.7 mm Hg) and sitting systolic blood pressure (SBP) (-12.2 +/- 1.2 vs +0.4 +/- 1.2 mm Hg). The rate of response (SiDBP </=90 mm Hg or a decrease from baseline of >/=10 mm Hg) was significantly (P <.05) greater in the tasosartan group than in the placebo group (55% vs 19%). The mean 24-hour blood pressure reduction with tasosartan was -12.6 +/- 0. 9/-8.1 +/- 0.6, significantly greater (P <.05) than the reduction with placebo (+0.6 +/- 0.9/+0.5 +/- 0.6 mm Hg). The trough-to-peak ratio (determined from the ambulatory data) was 0.66 for DBP and 0. 72 for SBP for the tasosartan treatment group, demonstrating 24-hour efficacy with once-a-day administration. The safety profile of tasosartan was similar to placebo. CONCLUSIONS: These results demonstrate that tasosartan at 50 to 200 mg given once a day over a titration period of 10 weeks was effective and safe in the treatment of essential hypertension.

Adult↗

PubMed2000

Seizure threshold in ECT: II. Dose titration vs age and half age methods.

Seizure threshold determination is of crucial importance in optimizing electrical stimulus dosage at electroconvulsive therapy (ECT). We measured initial seizure threshold by means of Srinakharinwirot University titration schedule in 106 patients with schizophrenia or schizoaffective disorder, receiving bilateral ECT. Seizure threshold was approximately 106 millicoulombs on average, and varied 5-fold across patients. Seizure threshold was directly related to age, but inversely related to motor seizure duration. Comparisons of stimulus charge were done with the Age and Half age methods. By using the Half age method, 68 per cent of patients would have seized at the first stimulation and resulted in a closer mean charge to dose-titration method than the Age method. The results may have important clinical implications for stimulus dosing strategy in ECT.

Adolescent↗

PubMed1997

Dose titration during anti-thymocyte globulin therapy: monitoring by CD3 count or total lymphocyte count?

Anti-thymocyte globulin (ATG) is extensively used for both prophylaxis and treatment of rejection episodes in renal transplantation, but it is expensive and potentially hazardous. We report the utility of therapeutic monitoring by the readily available total lymphocyte count, compared with the more complex and expensive assay of CD3 counts by flow cytometry in eight renal transplant patients receiving ATG. Aiming for an absolute CD3 count of 0.2-0.5 x 10(9)/l, it was possible to reduce the mean daily dose of ATG from the recommended 2.5 mg/kg/d to a mean of 1.6 mg/kg/d. Analysis of simultaneously taken total lymphocyte counts showed that the same dose reductions could have been made if the target for therapeutic effect had been a total lymphocyte count of < 0.3 x 10(9)/l. Anti-rejection therapy was successful in all cases, with satisfactory graft function at 6-9 months post-therapy. Lower than recommended doses of ATG proved effective prophylaxis and treatment of renal allograft rejection, with considerable cost savings. A simple protocol may be followed titrating dose against total lymphocyte count, provided it remains below 0.3 x 10(9)/l. CD3 estimation can be reserved for those times when the total lymphocyte count rises to 0.3 x 10(9)/l or above.

Antigens, CD19↗