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At least 1,297 records · Page 72Linked to original sources
PubMed1999

Lamotrigine monotherapy in newly diagnosed untreated epilepsy: a double-blind comparison with phenytoin.

PURPOSE: Lamotrigine is an effective add-on therapy against a range of epileptic seizure types. Comparative studies with carbamazepine (CBZ) as monotherapy in newly diagnosed epilepsy suggest similar efficacy. In this study, lamotrigine (LTG) and phenytoin (PHT) are compared. METHODS: In a double-blind parallel-groups study, 181 patients with newly diagnosed untreated partial seizures or secondarily or primary generalised tonic-clonic seizures were randomised to two treatment groups. One group (n = 86) received LTG titrated over 6 weeks from a starting dose of 100 mg/day. The other (n = 95) received PHT titrated from 200 mg/day. Treatment continued for < or =48 weeks. RESULTS: The percentages of patients remaining on each treatment and seizure free during the last 24 and 40 weeks of the study, and times to first seizure after the first 6 weeks of treatment (dose-titration period), did not differ significantly between the treatment groups. These were measures of efficacy. Time to discontinuation, a composite index of efficacy and safety, likewise did not distinguish between treatments. Adverse events led to discontinuation of 13 (15%) patients from LTG and 18 (19%) from PHT. The adverse-event profile for LTG was dominated by skin rash [discontinuation of 10 (11.6%) patients compared with five (5.3%) from PHT] rather than central nervous system side effects: asthenia, somnolence, and ataxia were each significantly more frequent in the PHT group. The high rate of rash with LTG was probably due to the high starting dose and may be avoidable. A quality-of-life instrument, the SEALS inventory, favoured LTG. Patients taking PHT showed the biochemical changes expected of an enzyme-inducing drug, whereas those taking LTG did not. CONCLUSIONS: LTG and PHT monotherapy were similarly effective against these seizure types in patients with newly diagnosed epilepsy. LTG was better tolerated, more frequently causing rash, but with a lower incidence of central nervous system side effects.

Adolescent↗
PubMed2000

Multicenter double-blind, randomized, placebo-controlled trial of levetiracetam as add-on therapy in patients with refractory partial seizures. European Levetiracetam Study Group.

PURPOSE: To evaluate the efficacy and tolerability of levetiracetam (LEV, Keppra) as add-on therapy in patients with refractory partial seizures. METHODS: In this European multicenter, double-blind, randomized, placebo-controlled trial, LEV (500 or 1,000 mg twice daily) was compared with placebo as add-on therapy in 324 patients with uncontrolled simple or complex partial seizures, or both, with or without secondary generalization. After enrollment, three parallel groups were assessed during a baseline period of 8 or 12 weeks, followed by a 4-week titration interval and a 12-week evaluation period. RESULTS: LEV significantly decreased partial seizure frequency compared with placebo. A reduction in seizure frequency of > or =50% occurred in 22.8% of patients in the 1,000-mg group and 31.6% of patients in the 2,000-mg group, compared with 10.4% of patients in the placebo group. Administration of LEV did not affect plasma concentrations of concomitant antiepileptic drugs or alter vital signs or laboratory parameters. No significant difference in the incidence of adverse events was observed between treatment groups (70.8% for the 1,000-mg group and 75.5% for the 2,000-mg group), or between the LEV and placebo groups (73.2% for placebo group). The most commonly reported adverse effects in the LEV group were asthenia, headache, and somnolence. CONCLUSIONS: The antiepileptic efficacy and tolerability of LEV (1,000 mg/d and 2,000 mg/d, administered in two divided doses) as add-on therapy was established in patients with refractory partial seizures in this clinical study.

Anticonvulsants↗
PubMed2005

Hyponatremia associated with repeated use of levetiracetam.

Levetiracetam (LEV) is increasingly used as adjunctive anticonvulsant therapy because of apparent low toxicity. Somnolence, asthenia, headache, dizziness, and nervousness are the most frequently reported side effects (1). We describe a patient, predisposed to the development of the syndrome of inappropriate antidiuretic hormone secretion (SIADH), in whom hyponatremia developed after two challenges of LEV.

Aged↗
PubMed1988

Clinical course and prognosis of pseudotumor cerebri. A prospective study of 24 patients.

In a prospective study, 24 consecutive patients with pseudotumor cerebri were followed for an average of 49 months with regular neurologic and ophthalmologic examinations. At the first examination the intracranial pressure was between 18 and 45 mm Hg; several patients had pressure waves up to 70 mm Hg and decreased conductance to cerebrospinal fluid outflow. In the majority, medical treatment, usually with diuretics and acetazolamide, induced a rapid relief of symptoms, but about 25% had a more protracted disease course with persistent headache, asthenia and memory disturbances interfering with daily life. Five patients required a shunt operation. Chronic changes of the optic disc developed in nearly half the patients, and one had optic atrophy and severe visual impairment. Repeated measurements of the intracranial pressure and conductance to cerebrospinal fluid outflow showed that abnormalities can persist for a long time, even in cases without symptoms of intracranial hypertension.

Adolescent↗
PubMed1989

Long-term prognosis and quality of life after reversible cerebral ischemic attacks.

The long-term prognosis and quality of life of 201 patients admitted to hospital with reversible ischemic attacks (RIA) were estimated in a prospective study. The median follow-up time was 58 months. Further RIAs were reported by 91 patients (45%) and 48 (24%) suffered a stroke. The risk of stroke was markedly higher in the first 6 months after RIA, after which the annual stroke rate was rather constant with an average of 4.8%, about 8 times higher than expected. The average annual mortality rate for the RIA patients was 5.9%, which is significantly higher than expected. Cardiovascular deaths accounted for more than half of all deaths, stroke for one fourth. Life-table analysis of subgroups disclosed a much more favorable prognosis for women under 60 years. High systolic blood pressure, diabetes, and previous myocardial infarction were identified as risk factors. The occurrence of RIA had significantly influenced the quality of life and occupational status for the majority of the patients, even for those who did not suffer a subsequent stroke. Decreased working capacity, general asthenia and fatigue and impaired memory were the most common complaints. We conclude that RIA may be a more serious vascular event than generally believed. Apart from carrying a substantial risk of stroke and death, even a single RIA can cause permanent psychological dysfunction influencing the quality of life.

Actuarial Analysis↗
PubMed2006

Levetiracetam in a broad population of patients with refractory epilepsy: interim results of the international SKATE trial.

OBJECTIVE: To prospectively assess the safety and efficacy of levetiracetam in patients with uncontrolled focal epilepsy, in a common practice-based setting. PATIENTS AND METHODS: In this phase IV, open-label, 16-week community-based study, adult patients with focal seizures initially received levetiracetam 1,000 mg/day. Throughout the study, the dose was adjusted in increments of 1,000 mg (maximum 3,000 mg/day) to achieve seizure control and maintain tolerability. The outcome parameters were the percentage reduction in partial and total seizure frequency per week from historical baseline, global evaluation scale (GES), and adverse events (AE). RESULTS: Seven hundred and thirty-one patients were included in this analysis and 84.4% completed the study. The median percent reduction in all seizures was 47.8%, and 49.3% for all partial seizures. The 50% responder rate was 49%, and the seizure-free rate was 17.2% for all partial seizures. Approximately 60% of patients showed moderate to marked improvement on the GES. The majority of AE were of mild to moderate severity; the most commonly reported being asthenia, somnolence, headache, and dizziness. CONCLUSION: Levetiracetam is both efficacious and safe as an add-on therapy in patients with refractory epilepsy treated by clinicians in their daily practice.

Adult↗
PubMed1980

Clopenthixol and flupenthixol depot preparations in outpatient schizophrenics. II. Factor analysis of the CPRS sub-scale for schizophrenia.

Eleven factors were obtained by factor analysing the CPRS results from a longitudinal treatment process study in chronic schizophrenics during maintenance phase. Such factors may give more reliable information than the single item. Two factors--"anxiety-depression-asthenia" and "psychotic" (psychotic schizophrenic symptoms and signs)--nonpsychotic rating of anxiety and depressive symptoms as well as definite psychotic-schizophrenic symptoms, respectively--demonstrated special value for the clinical work, i.e. being relevant instrument for monitoring a treatment process.

Adult↗
PubMed1989

A combination of hypothalamic phospholipid liposomes with trazodone for treatment of depression. An open controlled study.

In an open controlled trial of 48 patients with major depression illness (according to DSM-III), the patients were randomly assigned to 2 groups. One group of 25 patients was treated with 200-300 mg/day of trazodone and a second group of 23 patients was treated with 200-300 mg/day trazodone plus 1 ampoule (corresponding to 1000 gamma of lipidic phosphorous) twice daily of hypothalamic phospholipids (HPL). The effectiveness of treatment was evaluated by the Hamilton Rating Scale for Depression (HRSD). Side effects of treatment with trazodone were looked for by measuring systolic and diastolic blood pressure and heart rate and from EEG made before and on the 7th and 30th days of treatment. Combination with HPL shortened the typical latency of action of the antidepressant trazodone, definitely improved the subjective symptoms, especially the psychosomatic symptoms, on the HRDS and decreased the incidence of such side effects of trazodone as hypertension, reflex tachycardia and asthenia.

Adult↗
PubMed1995

Interferon-alpha plus low-dose cytosine arabinoside in advanced phase chronic myelogenous leukaemia patients.

Twenty-nine late chronic and accelerated phase chronic myelogenous leukaemia (CML) patients were entered in a pilot study designed to test the therapeutic efficacy of treatment with interferon-alpha (IFN-alpha) and low-dose cytosine arabinoside (ARA-C). IFN-alpha was administered at a dose of 2-10 x 10(6) IU/day and ARA-C at 15 mg/m2/day for 14 days each month. The treatment was well tolerated by 73% of the patients. Side effects were mainly asthenia, anorexia, anaemia and piastrinopenia. Haematological and cytogenetic responses were evaluated in the 19 patients who received more than 6 cycles. Four complete haematological response, 7 partial haematological response, 6 minor haematological response, 2 stable disease were obtained in this patient group. Two complete cytogenetic responses and 2 minor cytogenetic responses were detected in these patients. Suppression of secondary Ph' positive clones which appeared during the previous IFN-alpha treatment was documented in 3 accelerated phase patients after ARA-C was added to their IFN-alpha treatment. It would therefore seem that late chronic and accelerated phase CML patients benefit from combined IFN-alpha/ARA-C treatment and achieve haematological and cytogenetic responses not obtained during previous treatment without being exposed to undue toxicity. However, we cannot judge whether it offers any advantage in terms of survival.

Adult↗
PubMed2004

Mycophenolate mofetil can be used as monotherapy late after liver transplantation.

We report our experience with calcineurin inhibitor (CNI) withdrawal and MMF monotherapy in 50 adult liver transplant (OLT) recipients with CNI-related toxicity. Thirty-four patients had chronic renal dysfunction (CRD) associated with arterial hypertension, 11 had only CRD and other five patients had hypertension. The mean time between OLT and introduction of MMF was 81 months. After the introduction of MMF, CNI was progressively reduced and withdrawn if possible. At the end of the follow up (mean time: 18 months) CNI was withdrawn in 39 patients (78%), and there was a significant decrease from baseline in serum creatinine (1.81-1.49 mg/dL; p < 0.0001), BUN (76.6-52.8 mg/dL; p < 0.0001) and uric acid (9-7.5 mg/dL; p < 0.0001) levels, and an increase in creatinine clearance (44.7-55.1 mL/min; p < 0.0001). Excluding patients who developed graft rejection and two patients who died, CRD improved in 32 of 40 patients (80%), and arterial hypertension improved in 22 of 29 patients (76%). Five patients (10%) developed acute rejection, and one patient (2%) chronic rejection. Twenty-six patients (52%) experienced side-effects, with asthenia, herpes virus infection, and diarrhea being the most common. Only eight patients (16%) required MMF dose reduction. In conclusion, MMF monotherapy late after OLT improves CRD and hypertension in most patients, is safe and well tolerated.

Adult↗
PubMedDate not supplied

Infectious mononucleosis-like syndromes in febrile travelers returning from the tropics.

Infectious mononucleosis (IM), resulting from Epstein-Barr virus (EBV) infection, and IM-like syndromes, mainly due to cytomegalovirus (CMV), Toxoplasma gondii, or human immunodeficiency virus (HIV), have been occasionally reported in travelers returning from the tropics. Our objective was to investigate the prevalence, outcome, and diagnostic predictors of these syndromes in febrile travelers. Between April 2000 and March 2005, all febrile travelers and migrants presenting at our referral centers within 12 months after a tropical stay were prospectively included. We identified all patients serologically diagnosed with IM or IM-like syndrome and compared them with the rest of the cohort. During the 5-year period, 72/1,842 patients (4%) were diagnosed with an IM-like syndrome, including 36 CMV, 16 T gondii, 15 EBV, and 5 HIV primary infections. All patients were western travelers or expatriates. Mean delay before consultation was 2 weeks. Most patients had consulted other practitioners and/or received presumptive treatment. A minority of patients presented with IM clinical features. Lymphocytosis > or =40% of the white blood cells (WBC) and reactive/atypical lymphocyte morphology were observed in 60 and 30% of the patients. The four diseases were indistinguishable. Protracted fever and asthenia were common but complications rarely occurred. IM-like syndromes were independently associated with fever >7 days, lymphadenopathy, elevated liver enzymes, and lymphocytosis > or =40% of WBC. Diagnostic probability increased to >20% if at least three of these predictors were present. Diagnosis of IM and IM-like syndrome is not uncommon in febrile travelers, with a higher proportion of primary CMV, T gondii, and HIV infections than in nonimported series. Consequently, classic IM clinical and laboratory features are often lacking. All four pathogens should be systematically considered because early diagnosis should avoid unnecessary investigations and treatment and allow early intervention in case of primary HIV infection.

Adult↗
PubMedDate not supplied

Cyclosporiasis: a point source outbreak acquired in Guatemala.

BACKGROUND: Cyclosporiasis is a disease due to Cyclospora cayetanensis, an emerging coccidian parasite first described in 1979. It is an orally transmitted disease that is more frequent in tropical and subtropical areas. Cyclospora cayetanensis has been mainly described as a cause of travelers' diarrhea. This pathogen has given rise to a number of epidemic outbreaks attributable to ingestion of imported foods, particularly from tropical areas. METHODS: Descriptive study of clinical and epidemiological data of a small epidemic outbreak of C cayetanensis-induced gastroenteritis. RESULTS: Seven confirmed cases of C cayetanensis among Spanish nationals who had traveled to Antigua Guatemala are described. The incubation period was 6 days. Diarrhea, asthenia, anorexia, borborygmi, flatulence, and abdominal distension were present in all cases. Fever and heart burn in 85.7%. Weight loss in 71.4%. Abdominal pain, rectal tenesmus, and nausea in 42.8%. Vomiting and eructation in 14.2%. Heart burn was a frequent symptom, a finding not often previously described. The infection was probably acquired from raspberry juice. All cases improved with trimethoprim/sulphametoxazol. CONCLUSIONS: Cyclosporiasis is a cause of travelers' diarrhea. Parasitology laboratories must be advised of clinical suspicion of cyclosporiasis so that they can conduct a suitable targeted study; otherwise, false negative results may arise.

Adult↗
PubMed2006

Lercanidipine is an effective and well tolerated antihypertensive drug regardless the cardiovascular risk profile: The LAURA study.

To determine whether the antihypertensive effectiveness of lercanidipine was independent of the different cardiovascular risk levels. Patients with treated or untreated mild-to-moderate essential hypertension were included in a multicentre, prospective, non-comparative, open-label study. Patients received lercanidipine (10 mg/day, uptitrated to 20 mg/day) during 6 months. A total of 3175 patients, age 63 +/- 10 years, 51% women, were included. The cardiovascular risk was low in 237 patients, medium in 1396, high in 722, and very high in 820. At baseline, blood pressure (BP) was 159.5 +/- 11.7/95.2 +/- 7.4 mmHg. BP was progressively higher according to increase in cardiovascular risk. After 6 months of treatment, BP was 136.0 +/- 9.7/79.7 +/- 6.8 mmHg. The decrease in systolic BP and diastolic BP at each follow-up visit compared with baseline was statistically significant both in the intergroup and intragroup comparisons (p < 0.001). Mean decreases of systolic blood pressure (SBP) and diastolic blood pressure (DBP) were -18.5/-13.8 mmHg in the low risk group, -23/-15.2 mmHg in the medium risk group, -24.4/-16.1 mmHg in the high risk group, and -27.4/-17.4 mmHg in the very high risk group. Most frequent side effects were oedema (5.1%), headache (3.3%), flushes (2.5%), and asthenia (1%). Only 1.7% of patients discontinued antihypertensive medication because of adverse events. Tolerability of lercanidipine was independent of the cardiovascular risk group. Lercanidipine was effective and well-tolerated in patients with mild-to-moderate hypertension in the daily practice. The effectiveness and safety of the drug were independent of the degree of cardiovascular risk.

Aged↗
PubMed2000

DX-8951f: summary of phase I clinical trials.

Exatecan mesylate (DX-8951f) is a new hexacyclic camptothecin analogue with favorable attributes compared to topotecan and CPT-11, including watersolubility, greater potency against topoisomerase I, lack of esterase-dependent activation, broad antitumor activity, and low cross-resistance against MDR-1 overexpressing tumors. In preclinical studies, the compound demonstrated a favorable toxicology profile with hematologic dose-limiting toxicity and moderate gastrointestinal toxicity, linear pharmacokinetics, P450 hepatic metabolism (CYP3A4 and CYP1A2), and predominately fecal excretion. The results of six U.S. and European phase I clinical trials as well as two Japanese studies are presented including total DX-8951 and lactone DX-8951 pharmacokinetics. The toxicity profile was similar for all schedules of administration. Hematologic toxicity was dose-dependent and reversible. Neutropenia was dose-limiting in minimally pretreated patients, whereas neutropenia and thrombocytopenia were dose-limiting in heavily pretreated patients. Non-hematologic toxicity included moderate gastrointestinal toxicity (nausea, vomiting > diarrhea), transient elevation of hepatic transaminases, asthenia, and alopecia. Two cases of acute pancreatitis not predicted by preclinical toxicology were also observed. Antineoplastic activity was detected in several solid tumor types: non-small cell lung cancer, extrapulmonary small cell cancer, colorectal cancer, hepatocellular cancer, and sarcoma. Antitumor activity was seen in CPT-11 and topotecan-resistant tumors. Pharmacokinetics were linear within the dose range tested. A pharmacokinetic/pharmacodynamic model predictive of DX-8951f-induced neutropenia in individual patients was developed. The daily x5, every 3-week schedule with the drug administered as a 30-minute intravenous infusion was selected for future phase II clinical trials based on its superior antitumor activity.

Animals↗
PubMed2002

Neurochemical changes and neurotoxic effects of an acute treatment with sydnocarb, a novel psychostimulant: comparison with D-amphetamine.

Sydnocarb [(phenylisopropyl)N-phenylcarbamoylsydnonimine; SYD] was introduced to clinical practice in Russia as a psychostimulant drug used for the treatment of asthenia and apathy, which accompany schizophrenia and manic depression. It has been described as a psychostimulant with addiction liability and toxicity less than amphetamine (AMPH). The precise cellular mechanisms by which sydnocarb elicits its psychostimulant effect are still unclear. At present its neurochemical and neurotoxic effects are compared to those of AMPH in the striatum, the main input structure of the basal ganglia. The expression of c-fos protein in striatal neurons was much more increased after a single injection of D-AMPH (5 mg/kg) than after an equimolar concentration of SYD (23.8 mg/kg) in both the anterior and the posterior part of the striatum. Using in situ hybridization on striatal slices, we observed that AMPH increased the striatal levels of preprodynorphin (PPDYN) mRNAs in both parts of the striatum, while SYD did not affect basal levels of PPDYN mRNAs. Furthermore, AMPH and SYD increased striatal preprotachykinin (PPT-A) and preproenkephalin (PPE) mRNA levels. The effects of AMPH and SYD on PPT-A-mRNA levels were similar. A differential effect of AMPH and SYD was observed only on the PPE-mRNA levels measured in the anterior striatum where SYD increased these levels more than AMPH. The acute neurotoxicity of these two psychostimulants was analyzed by measuring their effects on the parameters of oxidative stress, such as nitric oxide (NO) generation, as well as specific indices of lipid peroxidation (i.e., thiobarbituric acid reactive substances; TBARS), while, on the other hand, the alpha-tocopherol level was taken as an index of antioxidant defense processes. Measuring generation of NO directly by electron paramagnetic resonance, it was observed that AMPH shows a more pronounced increase in comparison to SYD, in the striatum and in cortex. TBARS levels in the striatum and cortex were significantly less enhanced than AMPH after a single injection of SYD. Similarly, the alpha-tocopherol level was decreased only by AMPH in the striatum, and neither AMPH nor SYD had any effect in the cortex. Results show that a single injection of a high dose of AMPH is able to induce several neurotoxic effects. The study also demonstrates that SYD has mild neurochemical effects as well as fewer neurotoxic properties than AMPH.

Animals↗
PubMed1999

Safety and pharmacokinetics of abacavir (1592U89) following oral administration of escalating single doses in human immunodeficiency virus type 1-infected adults.

Abacavir (1592U89) is a nucleoside analog reverse transcriptase inhibitor that has been demonstrated to have selective activity against human immunodeficiency virus (HIV) in vitro and favorable safety profiles in mice and monkeys. A phase I study was conducted to evaluate the safety and pharmacokinetics of abacavir following oral administration of single escalating doses (100, 300, 600, 900, and 1,200 mg) to HIV-infected adults. In this double-blind, placebo-controlled study, subjects with baseline CD4+ cell counts ranging from < 50 to 713 cells per mm3 (median, 315 cells per mm3) were randomly assigned to receive abacavir (n = 12) or placebo (n = 6). The bioavailability of the caplet formulation relative to that of the oral solution was also assessed with the 300-mg dose. Abacavir was well tolerated by all subjects; mild to moderate asthenia, abdominal pain, headache, diarrhea, and dyspepsia were the most frequently reported adverse events, and these were not dose related. No significant clinical or laboratory abnormalities were observed throughout the study. All doses resulted in mean abacavir concentrations in plasma that exceeded the mean 50% inhibitory concentration (IC50) for clinical HIV isolates in vitro (0.07 microgram/ml) for almost 3 h. Abacavir was rapidly absorbed following oral administration, with the time to the peak concentration in plasma occurring at 1.0 to 1.7 h postdosing. Mean maximum concentrations in plasma (Cmax) and the area under the plasma concentration-time curve from time zero to infinity (AUC0-infinity) increased slightly more than proportionally from 100 to 600 mg (from 0.6 to 4.7 micrograms/ml for Cmax; from 1.0 to 15.7 micrograms.h/ml for AUC0-infinity) but increased proportionally from 600 to 1,200 mg (from 4.7 to 9.6 micrograms/ml for Cmax; from 15.7 to 32.8 micrograms.h/ml for AUC0-infinity. The elimination of abacavir from plasma was rapid, with an apparent elimination half-life of 0.9 to 1.7 h. Abacavir was well absorbed, with a relative bioavailability of the caplet formulation of 96% versus that of an oral solution (drug substance in water). In conclusion, this study showed that abacavir is safe and is well tolerated by HIV-infected subjects and demonstrated predictable pharmacokinetic characteristics when it was administered as single oral doses ranging from 100 to 1,200 mg.

Adult↗
PubMed1978

Acute toxicity of 12,13-epoxytrichothecenes in one-day-old broiler chicks.

Acute toxic effects of several 12,13-epoxytrichothecenes were investigated in 1-day-old broiler chicks by single oral doses. The 7-day median lethal dose values of purified 8-acetylneosolaniol, diacetoxyscirpenol, T-2 toxin, HT-2 toxin, neosolaniol, deacetyl-HT-2 toxin, and T-2 tetraol were 3.22 +/- 0.26, 3.82 +/- 0.40, 4.97 +/- 0.44, 7.22 +/- 0.39, 24.87 +/- 2.64, 30.18 +/- 7.53 (incomplete value), and 33.79 +/- 5.39 mg/kg of body weight, respectively. Deaths occurred during the 8- to 60-h period after dosing with the tested trichothecenes. Within 4 to 10 h after dosing, inappetence, asthenia, diarrhea, and coma generally developed. Sublethal doses of each toxin decreased feed consumption and weight gain proportionally with the amounts of toxins administered. These results demonstrate that the toxic potency of 12,13-epoxytrichothecenes varies depending on the modification of side chains in the molecule.

Administration, Oral↗
PubMed2006

Etanercept and sulfasalazine, alone and combined, in patients with active rheumatoid arthritis despite receiving sulfasalazine: a double-blind comparison.

OBJECTIVE: To compare the efficacy and safety of etanercept and sulfasalazine, alone and in combination, in patients with active rheumatoid arthritis despite sulfasalazine treatment. METHODS: A double-blind, randomised study in adult patients with active rheumatoid arthritis despite stable sulfasalazine (2-3 g/day) treatment. The primary end point was a 20% response by the American College of Rheumatology (ACR) criteria at 24 weeks. RESULTS: At baseline, the three treatment groups (sulfasalazine, n = 50; etanercept, n = 103; etanercept and sulfasalazine, n = 101) were comparable for demographic variables and disease activity. Lack of efficacy was the primary reason for discontinuation (sulfasalazine, n = 12; etanercept, n = 1; etanercept and sulfasalazine, n = 4; p<0.001). Significantly more patients receiving etanercept, alone or in combination (74% for each), achieved ACR 20 responses at 24 weeks than those receiving sulfasalazine (28%; p<0.01). Similarly, more patients in the etanercept groups achieved ACR 50 and ACR 70 responses than those in the sulfasalazine group (p<0.01). In the groups receiving etanercept, significant differences in the ACR core components were observed by week 2 compared with those receiving sulfasalazine alone (p<0.01). The incidences of several common adverse events (headache, nausea, asthenia) were lower with etanercept alone than with the combination (p<0.05), but infections and injection site reactions were higher with etanercept alone (p<0.05). The safety profiles of both etanercept treatment groups were comparable with previous experience of etanercept. CONCLUSIONS: For all efficacy variables assessed, etanercept alone or in combination with sulfasalazine resulted in substantial and similar improvement in disease activity from baseline to week 24 compared with sulfasalazine alone in patients with active rheumatoid arthritis despite their sulfasalazine treatment. All three treatments were generally well tolerated.

Adult↗