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Low-dose flutamide (125 mg/day) as maintenance therapy in the treatment of hirsutism.

OBJECTIVE: To evaluate the safety and efficacy of a low dose of flutamide (125 mg/day) in maintaining the clinical results already obtained using a higher dose (250 mg/day), in women suffering from hirsutism. METHOD: Forty-three women suffering from hirsutism of varying origin received 250 mg/day of flutamide as an initial treatment for 12 months and, subsequently, 125 mg/day of flutamide for an additional 12 months as a maintenance treatment. Hirsutism was evaluated by the Ferriman-Gallwey score, and hair diameter and hair growth rate were determined by a special image analysis processor. Biochemical, clinical and hormonal parameters were evaluated in basal conditions and every 2-6 months. RESULTS: The significant decrease in the hirsutism score, hair diameter and hair growth rate during the initial treatment period was confirmed at the end of the maintenance treatment period. Androgen levels decreased up to the end of the initial treatment period and partially decreased during the maintenance treatment. During the initial treatment period, 4 subjects showed an increase of aspartate aminotransferase and alanine aminotransferase and dropped out. During the maintenance treatment period, no side effects or complications were observed. CONCLUSION: Satisfactory management of hirsutism with flutamide seems to be represented by an initial treatment period using 250 mg/day to achieve satisfactory results, followed by a long maintenance treatment period using 125 mg/day.

Adult↗

Prognostic factors for long-term maintenance of urinary continence in patients with incontinence managed by diapers or indwelling catheters.

OBJECTIVE: We examined the prognostic factors for longterm maintenance of continence following nonsurgical treatments in hospitalized patients with urinary incontinence. METHODS: 313 inpatients (average age: 64 years) in whom urinary incontinence had originally been managed with diapers (n = 158) or indwelling Foley catheters (n = 155) first received nonsurgical rehabilitative treatments. The patients who became continent with these treatments were then evaluated for being either continuously continent or recurrently incontinent during the 5-year follow-up period after discharge from hospital. A multivariate logistic regression analysis was then performed to determine significant risk factors for recurrent urinary incontinence. RESULTS: By initial treatments (mean duration: 144 days), 294 of the 313 patients (94%) were continent and free from diapers or catheters. After the 5-year follow-up period, urinary continence was maintained in 103 (66%) and 62 patients (45%) initially managed with diapers (n = 157) and catheters (n = 137), respectively. Multivariate logistic analysis revealed that in both patient groups, poor posttherapeutic activities of daily living or loss of home care service lowered the maintenance rate of continence. Dementia also lowered the maintenance rate in patients with catheters, but not in those with diapers. In addition, a long history of Foley catheter drainage for over 1 year prior to the initial treatment reduced the maintenance rate (highest odds ratio). CONCLUSIONS: Physical disability and poor therapeutic assistance at home are more prominent risk factors for long-term maintenance of urinary continence in elderly patients than problems within the urinary tract.

Aged↗

Maintenance hormone therapy with letrozole after first-line chemotherapy for advanced breast cancer.

OBJECTIVES: Maintenance hormone therapy after first-line chemotherapy is routinely used by many clinicians in advanced breast cancer patients with potentially hormone-sensitive tumors, although there are insufficient evidences in the literature to support this practice. We investigated the effects of the third-generation aromatase inhibitor letrozole as a maintenance therapy in postmenopausal patients who had responded or had stable disease with first-line chemotherapy. METHODS: Fifty-eight patients (median age 62 years, range 31-80) were recruited and received letrozole, 2.5 mg/day starting within 8 weeks since the last cycle of chemotherapy. Estrogen and/or progesterone receptor status was positive in 81% of the patients, unknown in 19%; 57% of the patients had visceral disease. First-line chemotherapy included anthracyclines and/or taxanes in 74% of cases. RESULTS: The median time to progression (TTP) from starting letrozole was 18.5 months. A shorter TTP was found in patients with abnormal CA 15-3 levels at the start of maintenance letrozole (median TTP, 9.9 months: p = 0.01), or with levels increasing >25% from baseline during the first 6 months of letrozole therapy (median TTP, 8.2 months: p < 0.0001). Response status improved during letrozole in 15.5% of patients who had obtained less than a complete response to chemotherapy. Maintenance treatment was well tolerated and had no significant impact on quality of life scores. CONCLUSIONS: This study provides evidence in support of the common clinical practice of maintenance hormone therapy after chemotherapy in suitably selected patients with advanced breast cancer.

Adult↗

Maintenance therapy for multiple myeloma with particular emphasis on thalidomide.

Treatment standards are changing as a result of new findings in the therapy of multiple myeloma. So far, prednisone, dexamethasone and interferon-a have mainly been used as maintenance therapy after achieving remission or stable disease. At present, thalidomide is being considered as a new therapeutic option in several studies investigating maintenance therapy. As a result of the dose dependence of adverse effects such as neuropathy, constipation, sedation/vertigo and bradycardia, individual adjustment of the thalidomide dose is recommended. Only isolated cases of thrombosis occurred in the maintenance phase of therapy, and discontinuation of therapy is generally not necessary. While important study results on the efficacy of thalidomide following conventional chemotherapy are still awaited, it is the best documented drug so far for maintenance therapy following autologous stem cell transplantation. An upgrade of the response was seen in 22-73% of patients, as well as a significant prolongation of progression-free survival. For the first time, maintenance therapy with thalidomide showed a significant improvement in overall survival in a phase III study published recently. The tolerability of thalidomide could be further improved by including the option of intermittent administration of the drug.

Angiogenesis Inhibitors↗

Maintenance after pulmonary rehabilitation in chronic lung disease: a randomized trial.

Pulmonary rehabilitation is beneficial for patients with chronic lung disease. However, long-term maintenance has been difficult to achieve after short-term treatment. We evaluated a telephone-based maintenance program after pulmonary rehabilitation in 172 patients with chronic lung disease recruited from pulmonary rehabilitation graduates. Subjects were randomly assigned to a 12-month maintenance intervention with weekly telephone contacts and monthly supervised reinforcement sessions (n = 87) or standard care (n = 85) and followed for 24 months. Except for a slight imbalance between sexes, experimental and control groups were equivalent at baseline and showed similar improvements after rehabilitation. During the 12-month intervention, exercise tolerance (maximum treadmill workload and 6-minute walk distance) and overall health status ratings were better maintained in the experimental group together with a reduction in hospital days. There were no group differences for other measures of pulmonary function, dyspnea, self-efficacy, generic and disease-specific quality of life, and health care use. By 24 months, there were no significant group differences. Patients returned to levels close to but above prerehabilitation measures. We conclude that a maintenance program of weekly telephone calls and monthly supervised sessions produced only modest improvements in the maintenance of benefits after pulmonary rehabilitation.

Aftercare↗

Budesonide/formoterol combination therapy as both maintenance and reliever medication in asthma.

Asthma control is improved by combining inhaled corticosteroids with long-acting beta2-agonists. However, fluctuating asthma control still occurs. We hypothesized that in patients receiving low maintenance dose budesonide/formoterol (bud/form), replacing short-acting beta2-agonist (SABA) reliever with as-needed bud/form would provide rapid symptom relief and simultaneous adjustment in antiinflammatory therapy, thereby reducing exacerbations. In this double-blind, randomized, parallel-group study, 2,760 patients with asthma aged 4-80 years (FEV1 60-100% predicted) received either terbutaline 0.4 mg as SABA with bud/form 80/4.5 microg twice a day (bud/form + SABA) or bud 320 microg twice a day (bud + SABA) or bud/form 80/4.5 microg twice a day with 80/4.5 microg as-needed (bud/form maintenance + relief). Children used a once-nocte maintenance dose. Bud/form maintenance + relief prolonged time to first severe exacerbation (p < 0.001; primary endpoint), resulting in a 45-47% lower exacerbation risk versus bud/form + SABA (hazard ratio, 0.55; 95% confidence interval, 0.44, 0.67) or bud + SABA (hazard ratio, 0.53; 95% confidence interval 0.43, 0.65). Bud/form maintenance + relief also prolonged the time to the first, second, and third exacerbation requiring medical intervention (p < 0.001), reduced severe exacerbation rate, and improved symptoms, awakenings, and lung function compared with both fixed dosing regimens.

Adolescent↗

Protective effects of imipramine maintenance treatment in panic disorder with agoraphobia.

OBJECTIVE: This study was designed to assess and compare the differential relapse rates of patients with panic disorder and agoraphobia after discontinuation of acute treatment (6 months) or acute plus maintenance treatment (18 months) with imipramine. METHOD: Sixteen patients with panic disorder and agoraphobia who had shown marked and stable response to 6 months of acute imipramine treatment and a comparable group of 14 patients who had been in remission during an additional year of half-dose imipramine maintenance treatment entered a 3-month, double-blind discontinuation study followed by a 3-month drug-free period. Assessments of the patients were made according to operationalized response/relapse criteria, and plasma drug concentrations were monitored. RESULTS: Survival analysis revealed significantly different cumulative probabilities of continued response 6 months after discontinuation of imipramine treatment between the patients who had received only acute treatment and those who had received acute and maintenance treatment. CONCLUSIONS: The results support the hypothesis that successful imipramine maintenance treatment of patients with panic and agoraphobia can have protective effects against relapse, at least in the first 6 months after the maintenance treatment period.

Adult↗

Methadone maintenance outcome as a function of detoxification phobia.

OBJECTIVE: Methadone maintenance outcome as a function of detoxification phobia was examined. METHOD: Opiate addicts (N = 271) in a 1983 random sample of methadone maintenance patients from three diverse populations were studied. Subjects from an individually assessed follow-up sample (N = 102) were compared on detoxification phobia. Logistic regression analysis yielded best predictors of the phobia. RESULTS: Phobic patients were more likely to be white, female, and abstinent; to have had fewer detoxification attempts and longer periods on maintenance; to show persistence of the phobia; to meet diagnostic criteria for depressive or anxiety disorders; and to have Addiction Severity Index scores above the 75th percentile for psychological problems. CONCLUSIONS: Detoxification phobia has a complex relationship to methadone maintenance outcome. It is associated with greater abstinence for patients in methadone maintenance treatment. However, for rehabilitated phobic patients it presents a barrier to successful detoxification and a drug-free adjustment that is often associated with other psychopathology but could be ameliorated by targeted assessment and treatment.

Adult↗

Innovations: Alcohol & drug abuse: Methadone maintenance in Europe and Hungary: degrees of sociocultural resistance.

Opiate substitution treatment, commonly referred to as maintenance treatment, was introduced in the United States and Europe in the 1960s. This column discusses approaches to opioid maintenance treatment in Europe and focuses on the introduction of methadone maintenance treatment in Hungary. Although persons have received methadone maintenance in Hungary since 1987, consensus guidelines were not adopted until 1998 and were not confirmed by the Hungarian parliament until 2000. Hungary encountered initial difficulties in introducing methadone maintenance, and it is hoped that Hungary's joining the European Union in 2004 will help to make opiate substitution treatment more widely available.

Attitude to Health↗

Rituximab maintenance improves clinical outcome of relapsed/resistant follicular non-Hodgkin lymphoma in patients both with and without rituximab during induction: results of a prospective randomized phase 3 intergroup trial.

We evaluated the role of rituximab (R) both in remission induction and maintenance treatment of relapsed/resistant follicular lymphoma (FL). A total of 465 patients were randomized to induction with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (every 3 weeks) or R-CHOP (R: 375 mg/m(2) intravenously, day 1). Those in complete remission (CR) or partial remission (PR) were randomized to maintenance with R (375 mg/m(2) intravenously once every 3 months for a maximum of 2 years) or observation. R-CHOP induction yielded an increased overall response rate (CHOP, 72.3%; R-CHOP, 85.1%; P < .001) and CR rate (CHOP, 15.6%; R-CHOP, 29.5%; P < .001). Median progression-free survival (PFS) from first randomization was 20.2 months after CHOP versus 33.1 months after R-CHOP (hazard ratio [HR], 0.65; P < .001). Rituximab maintenance yielded a median PFS from second randomization of 51.5 months versus 14.9 months with observation (HR, 0.40; P < .001). Improved PFS was found both after induction with CHOP (HR, 0.30; P < .001) and R-CHOP (HR, 0.54; P = .004). R maintenance also improved overall survival from second randomization: 85% at 3 years versus 77% with observation (HR, 0.52; P = .011). This is the first trial showing that in relapsed/resistant FL rituximab maintenance considerably improves PFS not only after CHOP but also after R-CHOP induction.

Adult↗

Maintenance therapy with thalidomide improves survival in patients with multiple myeloma.

Newer chemotherapeutic protocols as well as high-dose chemotherapy have increased the response rate in myeloma. However, these treatments are not curative. Effective maintenance strategies are now required to prolong the duration of response. We conducted a randomized trial of maintenance treatment with thalidomide and pamidronate. Two months after high-dose therapy, 597 patients younger than age 65 years were randomly assigned to receive no maintenance (arm A), pamidronate (arm B), or pamidronate plus thalidomide (arm C). A complete or very good partial response was achieved by 55% of patients in arm A, 57% in arm B, and 67% in arm C (P = .03). The 3-year postrandomization probability of event-free survival was 36% in arm A, 37% in arm B, and 52% in arm C (P < .009). The 4-year postdiagnosis probability of survival was 77% in arm A, 74% in arm B, and 87% in arm C (P < .04). The proportion of patients who had skeletal events was 24% in arm A, 21% in arm B, and 18% in arm C (P = .4). Thalidomide is an effective maintenance therapy in patients with multiple myeloma. Maintenance treatment with pamidronate does not decrease the incidence of bone events.

Aged↗

Day&#x2009;+&#x2009;30 detection of minimal residual FLT3-ITD by high-sensitivity PCR-NGS predicts relapse risk and guides post-transplant maintenance in AML.

BACKGROUND: Allogeneic hematopoietic stem cell transplantation (allo-HSCT) has improved outcomes in patients with acute myeloid leukemia (AML) harboring FLT3-internal tandem duplication (FLT3-ITD) mutations. However, relapse still occurs in 15-35% of these patients after transplantation. Therefore, early and highly sensitive detection methods are required to identify patients at risk of relapse and enable timely post-transplant intervention. METHODS: In this NICHE cohort study, a total of 136 patients were included, then we evaluated whether high-sensitivity polymerase chain reaction (PCR)-next-generation sequencing (NGS) for FLT3-ITD (limit of detection: 5&#x2009;&#xd7;&#x2009;10-6) on day&#x2009;+&#x2009;30 post-HSCT could identify patients at a high risk of relapse and inform decisions regarding maintenance therapy. RESULTS: Among the 136 patients, 37 patients (27.2%) had detectable FLT3-ITD clones on day&#x2009;+&#x2009;30. These patients exhibited a significantly higher cumulative incidence of post-HSCT multiparameter flow cytometry (MFC)-measurable residual disease (MRD) relapse (40.3% vs. 18.8%, p&#x2009;=&#x2009;0.001). Notably, FLT3-ITD-positive patients who received FLT3 inhibitor maintenance therapy had no relapses, while 6 out of the 13 patients who did not receive maintenance therapy relapsed. Conversely, FLT3-ITD-negative patients without high-risk factors (2022 European LeukemiaNet adverse-risk group, relapsed/refractory AML, MFC-MRD positivity pre-HSCT) showed limited benefit from maintenance therapy (MFC-MRD-free survival: hazard ratio (HR)&#x2009;=&#x2009;0.25 (0.03-2.11), p&#x2009;=&#x2009;0.204; OS: HR&#x2009;=&#x2009;0.20 (0.02-1.70), p&#x2009;=&#x2009;0.142). CONCLUSIONS: This is the first study to demonstrate that detection of minimal FLT3-ITD clones at the fixed time point of day&#x2009;+&#x2009;30 post-HSCT can reliably stratify relapse risk in AML patients and provide a rationale for individualized post-transplant maintenance therapy.

Humans↗

Interferon versus interferon plus prednisone remission maintenance therapy for multiple myeloma: a Southwest Oncology Group Study.

PURPOSE: We evaluated the vincristine, doxorubicin, and dexamethasone (VAD) regimen alone or with chemosensitizers for remission induction and interferon (IFN) versus IFN plus prednisone (IFN/P) for remission maintenance in previously untreated multiple myeloma. PATIENTS AND METHODS: Two hundred thirty-three patients were registered for remission-induction therapy with VAD or VAD plus the chemosensitizers verapamil and quinine. Patients who achieved remission were randomized to maintenance therapy with IFNalpha 3 MU in the evening three times weekly or IFN plus 50 mg of prednisone (IFN/P) on the morning after IFN until relapse. RESULTS: Two hundred twenty-nine patients were eligible for induction. Fatal toxicities in nine patients who received VAD plus verapamil and quinine led to closure of this arm after 47 registrations. Subsequently, all patients received VAD induction. Despite the high early mortality rate on VAD plus sensitizers, overall survival by induction arm did not differ for median or 5-year survival with approximately 40% of patients surviving 5 years. Eighty-nine eligible patients who achieved remission were randomized to maintenance. Patients who received IFN/P had improved progression-free survival (median, 19 v9 months for IFN; P = .008). After 48 months, progression-free survival on IFN/P was at the thirtieth percentile, whereas it was below the tenth percentile on IFN alone. Median survival from start of maintenance was long on both arms (57 months for IFN/P v 46 months for IFN; P = .36). CONCLUSION: IFN/Pwas more effective than IFN alone. Improved relapse-free survival may be attributable to IFN/P or to the use of prednisone for maintenance. This latter alternative is currently being studied.

Adult↗

Eastern Cooperative Oncology Group randomized trials of observation versus maintenance therapy for patients with metastatic breast cancer in complete remission following induction treatment.

PURPOSE: To investigate the value of maintenance treatment for patients with metastatic breast cancer whose disease is in complete remission (CR). PATIENTS AND METHODS: One hundred ninety-five women (141 eligible) whose disease was in CR or in CR except for bone metastases following six cycles (6 months) of doxorubicin-containing induction treatment were randomized to receive cyclophosphamide, methotrexate, fluorouracil, prednisone, tamoxifen, and halotestin [CMF(P)TH] or observation. In a previous pilot study, patients in CR after 24 months of induction treatment were randomized to continue chemotherapy for 4 more years or stop chemotherapy. RESULTS: Among patients randomized to CMF(P)TH, life-threatening toxicity included leukopenia in 3%, thrombocytopenia in 3%, cardiac in 2%, and diabetes in 1%. The median time to relapse from randomization was 18.7 months on CMF(P)TH and only 7.8 months on observation (P < .0001). The median time to death was 32.2 months on CMF(P)TH and 28.7 months on observation (P=.74). Similar results were seen in the pilot study (median time to relapse, 12.6 and 6.4 months; median survival, 37.7 and 24.2 months; study too small for statistical significance). Maintenance treatment was always the most significant covariate in time-to-relapse models. CONCLUSION: There is definite toxicity associated with CMF(P)TH maintenance treatment. When CR was obtained on induction, maintenance treatment with CMF(P)TH was never significant in survival models. However, maintenance treatment was always the most significant covariate in the time-to-relapse models, which motivates its consideration for appropriately informed patients.

Adult↗

Comparison of induction, maintenance, and recovery characteristics of sevoflurane-N2O and propofol-sevoflurane-N2O with propofol-isoflurane-N2O anesthesia.

Induction of, maintenance of, and recovery from sevoflurane anesthesia were compared with propofol and isoflurane anesthesia when administered with nitrous oxide to patients undergoing gynecologic surgery. Seventy-five healthy (ASA I or II), consenting patients were randomly assigned to receive either (I) propofol for induction of anesthesia and isoflurane-nitrous oxide for maintenance (control), (II) propofol for induction and sevoflurane-nitrous oxide for maintenance, or (III) sevoflurane-nitrous oxide for induction and maintenance of anesthesia. Inhaled induction of anesthesia with sevoflurane-nitrous oxide was rapid (109 +/- 25 s to loss of consciousness) and without any untoward hemodynamic changes or episodes of coughing and laryngospasm. Mean arterial blood pressure after induction of anesthesia with propofol (71 +/- 11, 73 +/- 12 mm Hg for groups I and II, respectively) was lower than when sevoflurane (80 +/- 14 mm Hg) was used. The emergence time after discontinuation of isoflurane-nitrous oxide (6.7 +/- 2.2 min) was significantly longer than after propofol-sevoflurane-nitrous oxide or sevoflurane-nitrous oxide alone (4.1 +/- 2.2 and 4.0 +/- 2.0 min for groups II and III, respectively). However, later recovery events did not differ between groups. Serum fluoride levels increased after administration of sevoflurane but not isoflurane. The levels of fluoride ions correlated with the degree of exposure to sevoflurane in MAC-hours. In conclusion, induction of anesthesia with either propofol or sevoflurane-nitrous oxide was rapid and without significant side effects. Emergence and early recovery after maintenance of anesthesia with sevoflurane-nitrous oxide was significantly faster than that after an isoflurane-nitrous oxide combination.

Adult↗

Desflurane anesthesia after sevoflurane inhaled induction reduces severity of emergence agitation in children undergoing minor ear-nose-throat surgery compared with sevoflurane induction and maintenance.

Emergence agitation may occur after general anesthesia with volatile anesthetics in children. We designed this study to examine the emergence behavior of children undergoing ear-nose-throat surgery after sevoflurane induction and desflurane maintenance versus both sevoflurane induction and maintenance using a recently published Pediatric Anesthesia Emergence Delirium (PAED) scale. In 38 premedicated children aged 12 mo to 7 yr mask induction with sevoflurane was performed and they were randomly assigned to receive either sevoflurane (n = 19) or desflurane (n = 19) for maintenance of general anesthesia. Time to tracheal extubation, modified Aldrete score, emergence behavior, recovery complications, and pain scores were assessed. The PAED scale showed a significant advantage for desflurane (6 [0-15] versus 12 [2-20], maximum total score of 20 for severe agitation). Time to extubation was significantly shorter with desflurane than with sevoflurane (5.4 +/- 1.4 versus 13.4 +/- 1.8 min). The modified Aldrete score on arrival in the postanesthesia care unit (PACU) was significantly lower in children receiving sevoflurane for maintenance. Time to discharge from PACU to normal ward and the incidence of adverse effects were not significantly different between the groups. In conclusion, the use of desflurane for maintenance of anesthesia after sevoflurane induction in children is associated with less severe emergence agitation and faster emergence times.

Anesthesia Recovery Period↗

Maintenance of ZPA signaling in cultured mouse limb bud cells.

The positional signal localized to the posterior (zone of polarizing activity or ZPA) region of the vertebrate limb is transiently expressed during development and a decline in ZPA signaling is accelerated when posterior cells are dissociated and cultured in vitro. The evidence that cultured posterior cells display a precocious decline in ZPA signaling when compared to in vivo studies suggests that a factor present in the limb bud maintains or stabilizes ZPA signaling during limb outgrowth and that this maintenance factor is lost and/or exhausted in in vitro studies. We have developed a new culture technique, 'microdissociation', which preserves extracellular components that we have found to be necessary for ZPA signal maintenance. Our data suggest that the limb bud ectoderm produces a maintenance activity that becomes stored in the extracellular matrix where it acts on limb bud cells to stabilize the activity of the ZPA signal. Using our initial characterization of this maintenance activity, we have identified a growth factor, FGF-2 (bFGF), that can replace all of the ZPA signaling maintenance activity observed in microdissociate cultures. The existence of various members of the FGF family in the developing limb strongly argues a role for FGF in stabilizing ZPA signaling in vivo.

Animals↗

Budesonide/formoterol in a single inhaler for maintenance and relief in mild-to-moderate asthma: a randomized, double-blind trial.

STUDY OBJECTIVE: To compare a novel asthma management strategy--budesonide/formoterol in a single inhaler for both maintenance therapy and symptom relief--with a higher dose of budesonide plus as-needed terbutaline. METHODS: This was a 6-month, randomized, double-blind, parallel-group study in patients with mild-to-moderate asthma (n = 697; mean age, 38 years [range, 11 to 79 years]; mean baseline FEV1, 75% of predicted; mean inhaled corticosteroid [ICS] dosage, 348 microg/d). Following a 2-week run-in period, all patients received two blinded, dry powder inhalers, one containing maintenance medication and one containing medication to be used as needed for the relief of symptoms. Patients were randomized to receive either budesonide/formoterol (80 microg/4.5 microg, two inhalations qd) for maintenance plus additional inhalations as needed for symptom relief, or budesonide (160 microg, two inhalations qd) for maintenance medication plus terbutaline (0.4 mg) as needed. The primary efficacy variable was morning peak expiratory flow (PEF). RESULTS: Patients receiving budesonide/formoterol showed greater improvements in morning PEF than patients receiving budesonide (increases of 34.5 L/min vs 9.5 L/min, respectively; p < 0.001). The risk of having a severe exacerbation (hospitalization/emergency department [ED] treatment, oral steroids for asthma, or a > or = 30% decrease from baseline in morning PEF on 2 consecutive days) was 54% lower with budesonide/formoterol vs budesonide (p = 0.0011). Budesonide/formoterol patients experienced 90% fewer hospitalizations/ED treatments due to asthma than budesonide patients (1 vs 10, respectively; p = 0.026). The increased efficacy with budesonide/formoterol was achieved with less ICS than was used in the budesonide group (mean dose, 240 microg/d vs 320 microg/d, respectively) and with 77% fewer oral steroid treatment days vs budesonide (114 days vs 498 days, respectively). Both treatments were well tolerated. CONCLUSIONS: Budesonide/formoterol for both maintenance and relief improves asthma control with a lower steroid load compared with a higher dose of budesonide plus terbutaline.

Administration, Inhalation↗