One-year Treatment Research Articles

Efficacy of Valacyclovir vs Acyclovir for the Prevention of Recurrent Herpes Simplex Virus Eye Disease: A Pilot Study

To compare the efficacy of one-year treatment with valacyclovir vs acyclovir in preventing recurrence of the herpes simplex virus (HSV) eye disease. Prospective, randomized, clinical trial pilot study. Fifty-two immunocompetent patients with a history of recurrent ocular HSV disease were treated at the Ocular Immunology Service, San Raffaele Hospital, Milan, Italy. Twenty-six patients were randomized to the valacyclovir group (one 500 mg tablet daily), and 26 patients were randomized to the acyclovir group (one 400 mg tablet twice daily). The recurrence rate of ocular HSV disease during 12 months of treatment and drug-related side effects were monitored. Recurrence of any type of ocular HSV disease during the 12-month treatment period was 23.1% in the valacyclovir group, compared with 23.1% in the acyclovir group. No difference between the two groups was observed regarding the nature, frequency, or severity of adverse events. The most frequent adverse events were nausea and headache. One-year suppression therapy with oral valacyclovir (500 mg tablet daily) was shown to be as effective and as well tolerated as acyclovir (400 mg tablet twice daily) in reducing the rate of recurrent ocular HSV disease.

The role and the possibilities of natural interferon treatment for chronic hepatitis C: Our experiences with natural interferon treatment for patients debarred from combined antiviral treatment due to the STOP rule

The first choice, and the most efficient therapy for chronic hepatitis C is the pegylated interferon + ribavirin treatment. The introduction and application of the STOP rule (pegylated interferon + ribavirin treatment should be stopped in cases without sufficient virological answer for the therapy at the 12th or 24th week of the treatment) is motivated by the very high cost of this treatment. The greatest problem of the application of the STOP rule is that these patients are not coming in for the proven advantages of one-year interferon treatment (arrest or decrease the inflammation, decrease or prevent the progression to liver cirrhosis, decrease probability or prevent the development of hepatocellular carcinoma), which were observed almost in virologically slow-, partial-, or non-responder patients who received one-year interferon therapy. Based on these data, the official Hungarian treatment protocol allows and recommends the continuation of the antiviral treatment by natural interferon for patients whose pegylated interferon + ribavirin treatment should have been stopped because of the STOP rule. 15 patients whose pegylated interferon + ribavirin treatment should have been stopped because of the STOP rule (8 men, 7 women, age: 35-63, mean: 48.8 years, HCV genotype: 1b, HAI mean: 6.7, SD: +/-5.03; stage: mean: 1.75 SD: +/-0.9) treatment was continued with natural IFN for further 16-36 (mean 23.7) weeks. The total treatment duration was 48-52 weeks. The duration of follow-up was at least 6 months. 18 patients whose pegylated interferon + ribavirin treatment should have been stopped because of the STOP rule (7 men, 11 women, age: 32-63, mean: 48.7 years, HCV genotype: 1b, HAI mean: 10.1, SD: +/-4.8; stage mean: 2.0 SD: +/-0.6). The duration of follow-up was at least 6 months. There is no significant difference between the two groups. The ALT level significantly decreased (73.4 U/l SD: +/-25.5 versus 45.9 U/l SD: +/- 22.1) due to pegylated interferon + ribavirin treatment, and remained at this level during the natural interferon treatment and the follow up (45.7 U/l SD: +/-15.1, and 49.3 U/l SD: +/-19.4 U/l; p < 0.001). The difference is significant. The ALT level decreased (108.5 U/l SD: +/-69.8 versus 86.0 U/l SD: +/-82.8) due to pegylated interferon + ribavirin treatment, but increased after the cessation of the therapy (99.7 U/l SD: +/-60.9) in the control group. The biochemical response (significant reduction of ALT level) which was detected during the pegylated interferon + ribavirin treatment remained permanent during the continuation and after the cessation of the therapy in the natural interferon treated group, while relapse occurred in every case in the control group. The viral load increased at least 1 log 10 after cessation of the therapy in pegylated interferon + ribavirin treatment non-responder patients. The natural interferon treatment was able to control the viral replication (prevent the increasing of the viral load), but after the termination of natural interferon dosage, similar elevation of viral load was observed. The subjective side effects of natural interferon treatment were rarely and milder. Leucopenia and thrombopenia occurs rarely and was milder than that during the pegylated interferon + ribavirin therapy. The patients have no difficulty in the application of natural interferon; probably the positive psychic effect of the fact that they have not been barred from treatment compensated the technical hardness (three injections weekly). A wide range of the application of this therapeutic possibility, and further studies with larger number of patients are suggested.

Facteurs décisionnels céphalométriques dans les traitements précoces des classes III squelettiques

Many authors recommend early treatment for patients with Class III malocclusions in order to make their appearance more acceptable and also to re-channel the growth of basal bone into a normal pattern. However, the long-term effects and the stability of the results of this type of treatment have not been studied extensively. In the best interests of our patients, it would behoove us to know when early intervention is indicated and in what circumstances a strategy of watchful waiting and postponement of definitive treatment until the end of the growth period would be preferable. This retrospective study of a population of 30 patients from six to nine years old with skeletal and dental Class III malocclusions offers information on results obtained in early interceptive treatment, the potential for relapse, and the cephalometric criteria upon which a determination of the probable success or failure of treatment at this precocious stage can be made. A one-year treatment period began with rapid palatal expansion and was completed with alignment of the upper arch with a full-bonded appliance on the upper arch that was followed by orthopedic force delivered through an antero-posterior Delaire type facemask. In an evaluation eight years after the close of this early treatment, patients were separated into two groups, one of orthopedic success and the other of orthopedic failure. The inclination of the upper incisors proved to have descriptive value: the cases determined to be failures showed more inclination, a sign of early compensation. This meant that labio-version of upper incisors could be considered a predictive sign of relapse of an early treatment result. By means of a multiple regression analysis, we were able to discern three cephalometric components whose positive or negative readings would help to predict the probable prognosis for the success or failure of early treatment.

Follow-up of brain-derived neurotrophic factor (BDNF) during a one-year antidepressant treatment.

Follow-up of brain-derived neurotrophic factor (BDNF) during a one-year antidepressant treatment.

Clinical study on concurrent and sequential therapy of intensity modulated radiation therapy (IMRT) combined with NP regimen chemotherapy in the treatment of middle and advanced non-small cell lung cancer

To evaluate the clinical effects of concurrent and sequential therapy for middle and advanced stage non-small cell lung cancer (NSCLC) useing IMRT combined with NP regimen chemotherapy. Eighty patients with middle and advanced stage NSCLC were randomized into two groups. Forty patients were underwent sequential therapy and other 40 patients were underwent concurrent therapy. IMRT was used in radiotherapy and NP regimen of vinorelbine+cispatin (NP) was used in chemotherapy. (1) The overall response (CR+PR) rate was 75% in concurrent group and 45% in sequential group (P<0.05); (2) The treatment courses were 84 days and 140 days for concurrent group and sequential group respectively (P<0.05); (3) One-year survival rate in concurrent group was 72.4% and 52.3% in sequential group respectively; (4) The toxic effects can be tolerable by all of patients. The concurrent chemo-radiotherapy has better overall response, one-year survival rate and shorter treatment course than the sequential chemo-radiotherapy, so it is a better method for the treatment of middle and advanced stage NSCLC, but the long term survival rate will be studied.

Differences of therapeutic effects on regional bone mineral density and markers of bone mineral metabolism between alendronate and alfacalcidol in Japanese osteoporotic women

We studied the differences of therapeutic effects on regional bone mineral density (BMD) and markers of bone mineral metabolism between alendronate and alfacalcidol in Japanese osteoporotic women. Ninety-two Japanese women suffering from primary osteoporosis without osteoporotic fractures, aged 55 to 81 years, were divided into two groups: women treated orally with alendronate for one-year (5mg/day) (alendronate group, n=35) and women treated orally with alfacalcidol for one year (0.5 microg/day) (alfacalcidol group, n=57). The mean BMD of the 2nd to 4th lumbar vertebrae (L2-4BMD) and regional BMD were measured using dual energy X-ray absorptiometry. In the alendronate group, the percentage changes of L2-4BMD, lumbar spine BMD, thoracic spine BMD, pelvis BMD in the alendronate group were 106.3+/-4.6%, 104.2+/-6.6%, 107.1+/-10.4%, 107.1+/-10.5%, respectively. The percentage changes of L2-4BMD and regional BMD except for head BMD in the alendronate group were significantly greater than those in the alfacalcidol group. In the alfacalcidol group, L2-4BMD, thoracic spine BMD and lumbar spine BMD were maintained at respective pretreatment levels, whereas other regional BMD were decreased. Both serum bone-specific alkaline phosphatase and urinary type I collagen cross-linked N-telopeptide of the alendronate group were decreased, whereas these markers of bone mineral metabolism of alfacalcidol group were increased compared with the respective pre-treatment levels. The results suggest that one-year treatment with alendronate increased L2-4BMD, lumbar spine BMD, thoracic spine BMD and pelvis BMD, and that markers of both bone formation and bone resorption were decreased following one-year treatment with alendronate.

Cost-Effectiveness Analysis Comparing Methotrexate With PUVA Therapy for Moderate—Severe Psoriasis in the Sanitary Area of Badajoz

Objective To perform a cost-effectiveness analysis, by using a decision tree model, comparing methotrexate with PUVA therapy for moderate to severe chronic plaque psoriasis in the sanitary area of Badajoz (south-western Spain) over a one-year period. Material and methods The following variables and data sources were included: efficacy (a 50% reduction in the PASI) and safety. Data were retrieved from the dermatologic medical literature, mainly general reviews, systematic reviews and randomized clinical trials. Therapy schedules followed current guidelines from work task teams and consensus documents. Direct costs included unitary costs of medical consults, costs of laboratory tests, pharmacy, phototherapy sessions and costs derived from adverse reactions. Indirect costs included travel expenses and costs of lost productive work time. Results Unitary cost of methotrexate therapy would be 952,79 euros per treatment (direct cost: 796,48; indirect cost: 156,31). Unitary cost of PUVA therapy would be 899,70 euros per treatment (direct cost: 383,36; indirect cost: 516,34). Total cost of a one-year treatment with methotrexate would be 255,202.73 euros. Total cost of a one-year treatment with PUVA would be 266,406.88 euros. The average cost-effectiveness ratios per case successfully treated would be 1,519.06 euros for methotrexate therapy, and 1,085.18euros for PUVA therapy. The incremental cost-effectiveness ratio of PUVA/methotrexate would be 150,65euros for each additional case successfully treated. Conclusions One-year treatment for moderate to severe psoriasis in the sanitary area of Badajoz would be more expensive but also more cost-effective with PUVA than with methotrexate. However, indirect costs (borne by patients in the Spanish Health System), are higher for PUVA therapy, a fact that raises an issue of equity. The results should be interpreted taking into account the methodological limitations of a modelling study.

Combined treatment of vitamin K2and angiotensin-converting enzyme inhibitor ameliorates hepatic dysplastic nodule in a patient with liver cirrhosis

Although it is well known that the hepatocellular carcinoma (HCC) is an ominous complication in patients with liver cirrhosis, there has been no approved drug to prevent the development of HCC to date. We previously reported that the combined treatment of vitamin K2 (VK) and angiotensin-converting enzyme inhibitor (ACE-I) significantly suppressed the experimental hepatocarcinogenesis. A 66-year-old Japanese woman with hepatitis C virus (HCV)-related liver cirrhosis developed a dysplastic nodule in the liver detected by enhanced computed tomography along with elevation of the tumor markers, namely, alpha-fetoprotein (AFP) and lectin-reactive demarcation (AFP-L3), suggesting the presence of latent HCC. After oral administration of VK and ACE-I, the serum levels of both AFP and AFP-L3 gradually decreased without any marked alteration of the serum aminotransferase activity. After one-year treatment, not only the serum levels of AFP and AFP-L3 returned to the normal ranges, but also the dysplastic nodule disappeared. Since both VK and ACE-I are widely used without serious side effects, this combined regimen may become a new strategy for chemoprevention against HCC.

Análisis de coste-efectividad modelizado comparando metotrexato con fototerapia tipo PUVA para la psoriasis moderada-severa en el Área de Salud de Badajoz

Objective To perform a cost-effectiveness analysis, by using a decision tree model, comparing methotrexate with PUVA therapy for moderate to severe chronic plaque psoriasis in the sanitary area of Badajoz (south-western Spain) over a one-year period. Material and methods The following variables and data sources were included: efficacy (a 50 % reduction in the PASI) and safety (adverse reactions). Data were retrieved from the dermatologic medical literature, mainly general reviews, systematic reviews and randomized clinical trials. Therapy schedules followed current guidelines from work task teams and consensus documents. Direct costs included unitary costs of medical consults, costs of laboratory tests, pharmacy, phototherapy sessions and costs derived from adverse reactions. Indirect costs included travel expenses and costs of lost productive work time. Results Unitary cost of methotrexate therapy would be 952.79 euros per treatment (direct cost: 796.48; indirect cost: 156.31). Unitary cost of PUVA therapy would be 899.70 euros per treatment (direct cost: 383.36; indirect cost: 516.34). Total cost of a one-year treatment with methotrexate would be 255,202.73 euros. Total cost of a one-year treatment with PUVA would be 266,406.88 euros. The average cost-effectiveness ratios per case effectively treated would be 1,519.06 euros for methotrexate therapy, and 1,085.18 euros for PUVA therapy. The incremental cost-effectiveness ratio of PUVA/methotrexate would be 150.65 euros for each additional case effectively treated. Conclusions One-year treatment for moderate to severe psoriasis in the sanitary area of Badajoz would be more expensive but also more cost-effective with PUVA than with methotrexate. However, indirect costs (borne by patients), are higher for PUVA therapy, a fact that raises an issue of equity. The results should be interpreted taking into account the methodological limitations of a modelling study.

Long-term cost-effectiveness of clopidogrel in patients with acute coronary syndrome without ST-segment elevation in Germany

Patients with acute coronary syndrome without ST-segment elevation receiving clopidogrel in addition to acetylsalicylic acid (ASA) showed a 20% risk reduction in comparison to patients receiving ASA monotherapy (CURE trial). Economic models for assessing the impact on costs exist for several countries but not for Germany on a long-term basis. The objective of this model adaptation is to assess the long-term economic impact of clopidogrel taken in addition to ASA in Germany. A Markov model with six states [at risk, first year with stroke, following years with stroke, first year with new myocardial infarction (MI), following years with MI, and death] was adapted for Germany. Model outcome was life-years saved. Effects of 1-year treatment were calculated based on the CURE trial. Resource use for the different health states was based on published data, which included costs for drugs, outpatient care, hospitalization, rehabilitation and nursing. Risk data for MI and stroke were based on Swedish data and validated for the German adaptation. The model calculates lifetime costs and survival length. Costs were estimated from the payers' perspective. A series of one-way sensitivity analyses was conducted (follow-up costs, discount rates). The Markov analysis predicts a survival of 8.89years in the placebo treatment group and 9.02 years in the clopidogrel treatment group. The cumulated costs were euro 8,548 and euro 8,953, respectively. The incremental cost-effectiveness ratio (ICER) was euro 3,113 for each life-year saved. The model was robust regarding variations in key parameters in the sensitivity analysis, resulting in a range of ICER from euro 1,338 to euro 9,322. Our results are in line with the results for other healthcare systems. Adding clopidogrel to ASA for patients with acute coronary syndrome without ST-segment elevation generated an additional life-year saved at a comparably low value of euro 3,113. One-year treatment with clopidogrel is a cost-effective treatment option in patients with acute coronary syndrome from the perspective of a third-party payer in Germany.

Rituximab as an adjuvant therapy to immune tolerance in a haemophilia A boy with high inhibitor titre

We report a haemophilia A boy with high inhibitor titre (170 BU) who experienced five life-threatening bleeding episodes during a one-year period from 9 to 21 months. At the age of 22 months, he received rituximab (375 mg m(-2) per dose) at one- and three-week intervals, three courses each and alternative daily treatment with factor VIII concentrate at doses of 100 units kg(-1) for 24 weeks and 50 units kg(-1) for the following 28 weeks. Although the pretreatment inhibitor level of 4.5 BU showed an anamnestic response reaching the maximum level of 200 BU at the 9th week of treatment, it gradually declined to 30 BU at the 22nd week and was constantly maintained at 25-30 BU for the following 30 weeks. Only three bleeding episodes of two haematomas and one haemarthrosis were found during the one-year treatment period. No opportunistic infection occured during this period.

A retrospective study of compliance (adherence) with a care pathway in periodontal therapy in a primary care setting

Recently the issue of patient adherence with prolonged periodontal therapy and the importance of smoking and its influence as a significant co-factor in the outcome of treatment for patients with periodontal disease has been of interest to health care professionals. This paper is an audit of adherence in regard to both smoking cessation for those who admitted to a smoking habit at the initial examination and patient compliance with a periodontal treatment protocol. During the initial examination, patients referred to the practice with periodontal problems were photographed both with and without lip retractors as part of their clinical record, and a charting of the teeth made with any 5 mm or greater probing depths recorded. Tooth mobility and furcation involvement of molar teeth were also charted. Two separate time periods (Series 1 and Series 2) were audited in this study. Patients enrolled in Series 2 were routinely asked about their smoking habits at the initial examination. Two time periods were audited, as the initial purpose of the investigation was to audit the success of the practice in treating this group of patients, and to identify any improvements that could be made in care provision as each audit cycle was completed. Primary care setting. Patient adherence rates were high through all the various stages of periodontal therapy, even though the treatment protocol took over 18 months to complete. Approximately 55% of patients in both time periods presented for the one-year post treatment re-evaluation appointments. 56.5% of the patients reported they had smoked to within five years of their initial consultation, of which 38% reported that they had stopped by the time they had completed the initial hygiene phase of treatment. With a comprehensive and clearly defined supportive periodontal care programme (SPC), this paper demonstrates that high adherence levels can be achieved in a primary care setting. The results suggest that treatment should include not only the teaching of an effective oral hygiene regime, but also include giving advice in relation to smoking cessation for those patients who admit to a smoking habit at the initial examination. Patients who smoked and chose to have treatment for their periodontal condition went on to report good adherence with smoking cessation advice. Continuing supportive smoking cessation (SSC) advice should be part of any effective SPC programme. New methods of treating periodontal disease that become available to practitioners in the future should use established benchmarks against which to evaluate the success of any new treatment strategy.

Cost Effectiveness of Lenalidomide in the Treatment of Transfusion-Dependent Myelodysplastic Syndromes in the United States

Lenalidomide has been approved for the treatment of transfusion-dependent low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a chromosome 5q deletion with or without additional cytogenetic abnormalities. We evaluated the cost effectiveness of lenalidomide versus best supportive care (BSC) in these patients. We developed a decision analytic model to compare costs and outcomes of lenalidomide with BSC without recombinant erythropoietin (EPO) versus BSC with EPO over 1 year. Outcome measures were transfusion independence and quality-adjusted life years (QALYs) gained. The model incorporated costs of medications, transfusions, chelation, laboratory tests, office visits, and other resources associated with each therapy. Lenalidomide therapy was associated with an estimated incremental 0.53 transfusion-free and 0.25 QALY gain compared to BSC at 1 year. The costs of lenalidomide therapy were substantially offset by reduced blood transfusion and EPO costs. One-year total treatment costs were estimated at $63,385 for lenalidomide and $54,940 for BSC. The incremental cost-effectiveness ratio for lenalidomide vs BSC was estimated at $16,066 per transfusion-free year and $35,050 per QALY gained, values within the acceptable cost-effectiveness ranges for a new therapy. Results suggest that oral lenalidomide is cost effective in the United States in the treatment of transfusion-dependent, low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality. Confirmation of these findings awaits results of an ongoing randomized phase III trial (MDS-004 study).

Heat‐shock protein peptide DiaPep277 treatment in children with newly diagnosed type 1 diabetes: a randomised, double‐blind phase II study

Type 1 diabetes mellitus (T1DM) is a T-cell-mediated autoimmune disease that leads to the destruction of insulin-producing beta cells. Treatment with DiaPep277, a peptide derived from heat-shock protein 60 (hsp60), has been found to slow the deterioration of beta-cell function after clinical onset of diabetes in NOD mice and human adults. Our aim was to evaluate the efficacy and safety of DiaPep277 treatment in attenuating beta-cell destruction in children with recent-onset T1DM. A prospective, randomized, double-blind, phase II design was used. The sample included 30 children (19 males) aged 7-14 years who had been diagnosed with T1DM from 53 to 116 days previously, and had basal C-peptide concentrations above 0.1 nmol/L. The children were randomized to receive subcutaneous injections of 1 mg DiaPep277 (15 patients) or 40 mg mannitol (placebo) at entry and at 1, 6, and 12 months. The duration of follow-up was 18 months. The groups were compared for stimulated C-peptide level, exogenous insulin dose, and HbA1c concentration. C-peptide levels similarly decreased over time in the DiaPep277- and placebo-treated patients. There was no significant difference in insulin dose or HbA1c concentration between the groups at any time point. No serious drug-related adverse effects were recorded throughout the study period. One-year treatment with DiaPep277 at a dosage of 1 mg is safe for use and well tolerated in children with recent-onset T1DM. However, it appears to have no beneficial effect in preserving beta-cell function or improving metabolic control.

PD-02.01: The effects of one-year treatment with an isoflavone extract from red clover on prostate, liver, sexual function and quality of life in men

PD-02.01: The effects of one-year treatment with an isoflavone extract from red clover on prostate, liver, sexual function and quality of life in men

Evaluating the pharmacoeconomic effect of adding tiotropium bromide to the management of chronic obstructive pulmonary disease patients in Singapore

To perform a pharmacoeconomic analysis on the treatment of chronic obstructive pulmonary disease (COPD) with the addition of tiotropium bromide. Pharmacoeconomic modeling was performed utilizing the efficacy of tiotropium bromide from the literature on different settings and severity of COPD. Reductions in exacerbations, hospitalizations, and number of exacerbation days per year were derived from these studies. Cost of drug treatment, exacerbations, hospitalization, and loss of income were derived from local data in Singapore and reported in Singapore dollars (US$1=S$1.71). A model was constructed to calculate the impact of one-year treatment with tiotropium bromide, and the results were reported for the total incremental cost per year, cost per year needed to reduce one hospitalization in one year, and cost-savings from hospitalizations in one year. Sensitivity analysis were performed for different number of patients treated per year, differing cost of hospitalization, different cost for tiotropium bromide, different impact of tiotropium bromide on clinical outcomes, and the different amount of substitution drug utilized in the comparator group. Using the different clinical effects and looking at the impact on treating 1000, 2000, and 10,000 patients per year, most of the results showed a high level of decrease in overall cost per year that ranged from S$145.40 to S$840.37 per patient treated. Cost per year needed to reduce one hospitalization in one year ranged from S$3217.31 to S$18,148.92. Cost-savings from hospitalizations in one year per patient treated ranged from $57.16 to $322.49. This may contribute as high as 83% of the overall cost saving. Sensitivity analysis supports the cost savings finding. Adding tiotropium bromide for severe COPD patients would lead to a significant cost savings for the economy.

53 One-year treatment with clevudine demonstrated significant viral suppression and biochemical improvement

53 One-year treatment with clevudine demonstrated significant viral suppression and biochemical improvement

Cardiac Autonomic Control in Patients with Refractory Epilepsy before and during Vagus Nerve Stimulation Treatment: A One‐Year Follow‐up Study

To elucidate possible effect of vagus nerve stimulation (VNS) therapy on interictal heart rate (HR) variability in patients with refractory epilepsy before and after 1-year VNS treatment. A 24-hour electrocardiogram (ECG) was recorded at the baseline and after 12 months of VNS treatment in 14 patients with refractory epilepsy, and once in 28 healthy age- and sex-matched control subjects. Time and frequency domain measures, along with fractal and complexity measures of HR variability, were analyzed from the ECG recordings. The mean value of the RR interval (p=0.008), standard deviation of N-N intervals (SDNN) (p<0.001), very-low frequency (VLF) (p<0.001), low-frequency (LF) (p=0.001), and high-frequency (HF) (p=0.002) spectral components of HR variability, and the Poincaré components SD(1) (p=0.005) and SD(2) (p<0.001) of the patients with refractory epilepsy were significantly lower than those of the control subjects before VNS implantation. The nocturnal increase in HR variability usually seen in the normal population was absent in patients with refractory epilepsy. VNS had no significant effects on any of the HR-variability indexes despite a significant reduction in the frequency of seizures. HR variability was reduced, and the nocturnal increase in HR variability was not present in patients with refractory epilepsy. One-year treatment with VNS did not have a marked effect on HR variability, suggesting that impaired cardiovascular autonomic regulation is associated with the epileptic process itself rather than with recurrent seizures.

Biochemical response to lamivudine treatment in HBeAg negative chronic hepatitis B patients in Iran

To study the effect of a one-year lamivudine regimen in patients with chronic hepatitis B. Medical records of HBeAg negative hepatitis B patients who attended a hepatitis clinic in Tehran between March 2002-March 2004 were evaluated. The patients received 100 mg lamivudine tablets once daily for at least 12 mo. Liver enzymes and complete blood count were checked at baseline and the end of treatment (12th mo) and 6 mo after discontinuation of treatment. Of all patients, 24 were excluded. Of 71 patients left, 58 (81.7%) were men. Mean age of the patients was 38 +/- 14 years. Mean level of ALT in serum was 1437 +/- 205 nkat/L at baseline with a significant reduction at the end of treatment to a mean level of 723 +/- 92 nkat/L (P = 0.002). In 38 patients (53.5%), the ALT level was normal after one-year treatment. Five patients (7.3%) relapsed (biochemically) within 6 mo after discontinuing lamivudine therapy (the patients with good end of treatment response). Mean level of AST in serum was 1060 +/- 105 nkat/L at baseline which decreased significantly to 652 +/- 75 nkat/L at the end of treatment (P = 0.002). Over half (53.5%) of chronic hepatitis B patients with HBeAg negative have normal liver enzyme level at 12-mo lamivudine therapy.

Medical Consumption and Costs during a One-Year Follow-up of Patients with LUTS Suggestive of BPH in Six European Countries: Report of the TRIUMPH Study

ObjectiveTo determine the medical consumption and associated treatment costs of patients with LUTS suggestive of BPH. MethodsA prospective, cross-sectional, observational survey in six European countries: France, Germany, Italy, Poland, Spain and the United Kingdom, with a one-year follow-up of incident and prevalent patients. ResultsTreatment costs were estimated for 5,057 patients with a mean age of 66 years and a mean IPSS score at inclusion of 11.5. In 30% of patients watchful waiting was the therapy of choice for the full follow-up period, 57% were prescribed alpha-lockers, 11% finasteride and 10% phytotherapy at any moment during the follow-up (including switches and combination of treatment). Surgery rate was 4.9%. Mean one-year treatment costs were €858 per patient, three quarters of which concerned medication costs. Multivariate regression analysis showed that medication choice, complications and undergoing surgery were associated with higher costs. ConclusionsTreatment costs for patients with LUTS suggestive of BPH were moderate and largely consisted of medication costs. Daily practice and associated costs varied considerably across the six countries.