Randomized, 6-Week, Placebo-Controlled Study of Treatment for Adult Attention-Deficit/Hyperactivity Disorder: Individualized Dosing of Osmotic-Release Oral System (OROS) Methylphenidate With a Goal of Symptom Remission.

OBJECTIVE: To evaluate the efficacy and safety of individualized dosing within the approved dose range for osmotic-release oral system (OROS) methylphenidate hydrochloride in adults with attention-deficit/hyperactivity disorder (ADHD). METHODS: A double-blind, 6-week trial was conducted between July 2009 and February 2010 at 35 US sites. Adults with ADHD (DSM-IV diagnostic criteria) and a screening ADHD Investigator Symptom Rating Scale (AISRS) score > 24 were randomly assigned to OROS methylphenidate 18 mg or matching placebo. Treatment dose could be increased at 18 mg increments, up to 72 mg/d, until an optimal dose was achieved. AISRS score changes from baseline to end point (primary outcome) were analyzed using analysis of covariance. RESULTS: At baseline, the intent-to-treat population of 169 OROS methylphenidate and 172 placebo subjects (mean age = 35.8 years) had mean (standard deviation [SD]) AISRS scores of 37.8 (6.94) and 37.0 (7.51), respectively. OROS methylphenidate-treated subjects exhibited a significantly greater mean (SD) AISRS score improvement than placebo subjects (-17.1 [12.44] vs -11.7 [13.30]; P < .001). In general, OROS methylphenidate-treated subjects experienced greater improvements than placebo subjects in secondary measures of symptom frequency, cognitive function, work productivity, and quality-of-life. Little effect of OROS methylphenidate was observed in exploratory sleep assessments. The adverse event pattern was similar to previous reports of stimulants in adults with ADHD. CONCLUSIONS: OROS methylphenidate treatment with individualized doses titrated to achieve symptom remission demonstrated greater ADHD symptom reduction than placebo treatment. These data support the overall efficacy of OROS methylphenidate treatment in the management of adults with ADHD and provide new possibilities for additional intervention. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00937040.

Time course of treatment effect of OROS® methylphenidate in children with ADHD.

OBJECTIVE: The authors evaluated the time course of the treatment effect of Osmotic-Release Oral System methylphenidate (OROS(®) MPH) HCl (Concerta(®), Raritan, NJ) CII in children with ADHD. METHOD: Data were combined from two double-blind, randomized, placebo-controlled, cross-over, analog classroom studies in children (9-12 years) with ADHD. Participants received an individualized dose of placebo or OROS(®) MPH on two laboratory school days. Permanent Product Math Test and Swanson, Kotkin, Agler, M-Flynn, and Pelham scores were evaluated 0.5 hr before dosing and 1, 2, 4, 10, 11, and 12.5 hr post dose. Analysis used a repeated-measures mixed model. RESULTS: Treatment effects were present at all postdose assessment points (p < .0001 for all comparisons, n = 139). Adverse events were similar to previous reports for OROS(®) MPH. CONCLUSION: A robust treatment effect occurred with OROS(®) MPH; onset was at 1 hr and persisted for at least 12.5 hr after dosing.

Adrenergic control of vascular resistance varies in muscles composed of different fiber types: influence of the vascular endothelium.

The influence of the sympathetic nervous system (SNS) upon vascular resistance is more profound in muscles comprised predominately of low-oxidative type IIB vs. high-oxidative type I fiber types. However, within muscles containing high-oxidative type IIA and IIX fibers, the role of the SNS on vasomotor tone is not well established. The purpose of this study was to examine the influence of sympathetic neural vasoconstrictor tone in muscles composed of different fiber types. In adult male rats, blood flow to the red and white portions of the gastrocnemius (Gast(Red) and Gast(White), respectively) and the soleus muscle was measured pre- and postdenervation. Resistance arterioles from these muscles were removed, and dose responses to α1-phenylephrine or α2-clonidine adrenoreceptor agonists were determined with and without the vascular endothelium. Denervation resulted in a 2.7-fold increase in blood flow to the soleus and Gast(Red) and an 8.7-fold increase in flow to the Gast(White). In isolated arterioles, α2-mediated vasoconstriction was greatest in Gast(White) (∼50%) and less in Gast(Red) (∼31%) and soleus (∼17%); differences among arterioles were abolished with the removal of the endothelium. There was greater sensitivity to α(1)-mediated vasoconstriction in the Gast(White) and Gast(Red) vs. the soleus, which was independent of whether the endothelium was present. These data indicate that 1) control of vascular resistance by the SNS in high-oxidative, fast-twitch muscle is intermediate to that of low-oxidative, fast-twitch and high-oxidative, slow-twitch muscles; and 2) the ability of the SNS to control blood flow to low-oxidative type IIB muscle appears to be mediated through postsynaptic α1- and α2-adrenoreceptors on the vascular smooth muscle.

Academic, behavioral, and cognitive effects of OROS® methylphenidate on older children with attention-deficit/hyperactivity disorder.

OBJECTIVE: To assess the effect of Osmotic-Release Oral System (OROS) methylphenidate (MPH) on a variety of measures evaluating academic performance, cognition, and social behavior in children with attention-deficit/hyperactivity disorder (ADHD). METHODS: This double-blind, randomized, placebo-controlled, crossover laboratory school study enrolled 78 children aged 9-12 years with ADHD who responded to OROS MPH. After determining individualized OROS MPH dosing (18-54 mg/day), 71 subjects received blinded treatment (OROS MPH or placebo then vice versa) on each of 2 laboratory school days, separated by 1 week. Primary efficacy was measured by Permanent Product Measure of Performance at 4 hours after study drug administration. RESULTS: Treatment with OROS MPH resulted in statistically significant improvement in Permanent Product Measure of Performance and Swanson, Kotkin, Agler, M-Flynn, and Pelham scores, measures of response time, and of working memory compared to placebo. Other measures did not meet all pre-established criteria for significance (maintenance of the overall type I error rate at 5%). Adverse events were consistent with previous reports of stimulant medications used in the management of ADHD. There were no discontinuations due to adverse events, and no serious adverse events or deaths. CONCLUSIONS: OROS MPH dosed to reduce core symptoms of ADHD to within the normal range also improved performance on a variety of academic tasks in school-aged children compared to placebo. Adverse effects reported were consistent with prior studies. CLINICAL TRIAL REGISTRY INFORMATION: Double-Blind, Randomized, Placebo-Controlled, Crossover Study Evaluating the Academic, Behavioral and Cognitive Effects of Concerta on Older Children with ADHD, URL: http://clinicaltrials.gov/ct2/show/NCT00799409, unique identifier: NCT00799409.

Mouse plantar flexor muscle size and strength after inactivity and training.

INTRODUCTION: Losses in muscle mass and strength may affect an astronaut's safety; therefore, it is of utmost importance to optimize countermeasures to minimize atrophy and strength loss during spaceflight. The main purpose of this study was to determine if high force eccentric or isometric contractions performed by the plantar flexor group during hind limb suspension would preserve muscle mass and strength. METHODS: Plantar flexor muscles of mice were trained with either eccentric or isometric contractions every other day during a 10-d hind limb suspension period. Pre- and post-suspension stimulation frequency- and angular velocity-dependent measurements of torque of the plantar flexors, soleus twitch (Pt) and tetanic (Po) force, bodyweight, and muscle wet weight measurements were made. RESULTS: The 19 and 26% losses in gastrocnemius and soleus muscle wet weights, respectively, were not attenuated with eccentric or isometric contractions. Neither eccentric nor isometric contractions attenuated the soleus muscle's 30% isometric force loss after hind limb suspension. Despite losses in muscle mass, there was no decrease in the force produced by the plantar flexor muscle group after hind limb suspension. DISCUSSION: Hind limb suspension decreased both gastrocnemius and soleus mass, and in vitro soleus force production. However, in vivo force production of the plantar flexor muscle group did not decrease, which may be explained by a shift in the isometric torque: ankle angle relationship. The use of eccentric or isometric contractions as a countermeasure to offset muscle mass and strength requires further investigation as neither was capable of maintaining soleus muscle force production, or gastrocnemius and soleus muscle mass during hind limb suspension.

Long-term, open-label safety study of oral almotriptan 12.5 mg for the acute treatment of migraine in adolescents.

OBJECTIVES: This study evaluated the long-term safety of oral almotriptan 12.5 mg for the treatment of multiple migraine episodes in adolescents over a 12-month period. Efficacy outcomes were assessed as a secondary objective. METHODS: Adolescent migraineurs aged 12-17 years were enrolled in this 12-month, open-label study (Study ID CR002827). Patients were instructed to record their assessments on paper headache records whenever they experienced a migraine headache that they treated with study medication. Safety was assessed descriptively and assessments included adverse event (AE) recording, change in laboratory values, vital signs, and electrocardiogram parameters. Efficacy outcomes were assessed descriptively and outcomes included rates for 2- and 24-hour pain relief and sustained pain relief, 2- and 24-hour pain-free and sustained pain-free, and presence of migraine-associated symptoms of photophobia, phonophobia, nausea and vomiting. RESULTS: Overall, 67.1% of patients reported >or=1 AE over the course of the trial, 7.6% had an AE judged by the study investigator to be related to treatment with almotriptan, 2.4% discontinued because of an AE, and 1.9% reported serious AEs. The most commonly reported treatment-related AEs (occurring in >or=1% of patients) were nausea (1.4%) and somnolence (1.4%). Pain relief responses for treated migraines of moderate or severe intensity at baseline were 61.7% and 68.6%, at 2 and 24 hours, respectively; the sustained pain relief rate was 55.5%. Pain-free responses were reported for 40.5% of all treated migraines at 2 hours and 65.9% of treated migraines at 24 hours; the sustained pain-free rate was 38.4%. The proportion of migraines that achieved the pain relief, sustained pain relief, pain-free and sustained pain-free endpoints were similar in the 12- to 14-year and 15- to 17-year age groups. Treating with almotriptan 12.5 mg when headache pain was mild was associated with higher rates of pain relief and pain-free at 2 and 24 hours, and sustained pain relief and sustained pain-free, compared with treatment initiated when pain was severe. CONCLUSIONS: Almotriptan 12.5 mg was well tolerated in this adolescent population over a 12-month period. No unexpected safety or tolerability concerns were revealed over the course of this study. The results are consistent with almotriptan 12.5 mg being effective for the acute treatment of pain and symptoms associated with migraine in both younger and older adolescents.

Electronic medical records as a research tool: evaluating topiramate use at a headache center.

BACKGROUND: Electronic medical records (EMRs) are used in large healthcare centers to increase efficiency and accuracy of documentation. These databases may be utilized for clinical research or to describe clinical practices such as medication usage. METHODS: We conducted a retrospective analysis of EMR data from a headache clinic to evaluate clinician prescription use and dosing patterns of topiramate. The study cohort comprised 4833 unique de-identified records, which were used to determine topiramate dose and persistence of treatment. RESULTS: Within the cohort, migraine was the most common headache diagnosis (n = 3753, 77.7%), followed by tension-type headache (n = 338, 7.0%) and cluster or trigeminal autonomic cephalalgias (n = 287, 5.9%). Physicians prescribed topiramate more often for subjects with migraine and idiopathic intracranial hypertension (P < .0001) than for those with other conditions, and more often for subjects with coexisting conditions including obesity, bipolar disorder, and depression. The most common maintenance dose of topiramate was 100 mg/day; however, approximately 15% of subjects received either less than 100 mg/day or more than 200 mg/day. More than a third of subjects were prescribed topiramate for more than 1 year, and subjects with a diagnosis of migraine were prescribed topiramate for a longer period of time than those without migraine. CONCLUSIONS: Findings from our study using EMR demonstrate that physicians use topiramate at many different doses and for many off-label indications. This analysis provided important insight into our patient populations and treatment patterns.

Efficacy and safety of extended-release oxybutynin in combination with tamsulosin for treatment of lower urinary tract symptoms in men: randomized, double-blind, placebo-controlled study.

OBJECTIVE: To evaluate the efficacy and tolerability of extended-release oxybutynin in combination with the alpha1-blocker tamsulosin in reducing lower urinary tract symptoms in men. PATIENTS AND METHODS: In this multicenter, double-blind trial performed between March 29, 2004, and June 22, 2005, 420 men aged 45 years or older with a total International Prostate Symptom Score (IPSS) of 13 or more and IPSS for storage of 8 or more were randomized to receive tamsulosin (0.4 mg/d) with either extended-release oxybutynin (10 mg/d) or placebo for 12 weeks. Eligibility requirements included a maximum flow rate of 8 mL/s or more with voided volume of 125 mL or more and a postvoid residual volume of 150 mL or less on 2 occasions. Postvoid residual volume and peak flow rates at weeks 4, 8, and 12 were measured. The primary end point was change from baseline in total IPSS after 12 weeks of treatment. Secondary outcomes included change in IPSSs for storage and quality of life. RESULTS: Tamsulosin combined with extended-release oxybutynin resulted in significantly greater improvement in total IPSS compared with tamsulosin and placebo after 8 (P=.03) and 12 (P=.006) weeks of treatment, and improved IPSS for storage and quality of life at all assessment points (P<.01). The incidence of postvoid residual volume higher than 300 mL was 2.9% (6/209) in patients receiving combination therapy compared with 0.5% (1/209) in patients receiving tamsulosin alone (P=.12). Occurrence of peak flow rates below 5 mL/s was 3.8% (8/209) for combination therapy and 5.7% (12/209) for tamsulosin alone (P=.49). CONCLUSION: In men with substantial storage symptoms, combination therapy with tamsulosin and extended-release oxybutynin demonstrated greater efficacy than and comparable safety and tolerability to tamsulosin monotherapy.

Topiramate prescribing patterns among medicaid patients: diagnosis, comorbidities, and dosing.

BACKGROUND: Routine clinical practice data are useful for payers and formulary decision makers to make sound decisions regarding coverage policy. Based on a literature search, there has been scant research into topiramate prescribing patterns among Medicaid patients. OBJECTIVE: The aim of this study was to describe diagnoses, demographic characteristics, additional co-existing diagnoses, and dosing among Medicaid patients prescribed topiramate. METHODS: This descriptive, retrospective database analysis used data from South Carolina (SC) and Texas (TX) ambulatory Medicaid claims dated October 1, 2003, to December 31, 2004. Patients whose data were eligible for inclusion in the study were enrolled in Medicaid during the study period, had >or=2 topiramate prescriptions, were aged <65 years, and had evidence of a topiramate treatment-related diagnosis (possible diagnoses were identified through literature search and drug compendiums). Four cohorts were defined: (1) epilepsy only; (2) migraine only; (3) epilepsy and migraine; and (4) nonepilepsy/nonmigraine. Demographic characteristics, diagnoses, comorbidities, and daily dose of topiramate were summarized using descriptive statistics. The initial study analysis (period 1) was a 180-day window comprising the 90 days before and after the first available topiramate prescription claim was filed. A second, 360-day analysis (period 2) was completed comprising the 180 days before and after the index topiramate prescription date. RESULTS: In the 180-day analysis, 2216 SC and 4766 TX Medicaid patients met the selection criteria. Cohort classification percentages were 32.3% and 39.6% (epilepsy only), 29.7% and 16.4% (migraine only), 10.7% and 9.2% (epilepsy and migraine), and 27.3% and 34.9% (nonepilepsy/nonmigraine) for SC and TX, respectively. Mean (SD) ages were 29.9 (15.9) (SC) and 27.1 (16.1) (TX) years. In the nonepilepsy/nonmigraine cohort, the most common diagnoses were bipolar disorder and depression. The median daily doses in the epilepsy-only cohort were 175 mg/d in the SC group and 200 mg/d in the TX group. In the migraine-only cohort, the median daily dose was 100 mg/d in SC and TX. Results for the 360-day analysis were similar. CONCLUSIONS: In this descriptive study using data from 2 Medicaid populations, the majority of patients using topiramate had a diagnosis of epilepsy and/or migraine. Median dosages ranged from 175 to 200 mg/d in patients with epilepsy and 100 mg/d in those with migraine. Depression was a common comorbidity in the migraine cohort and the nonepilepsy/nonmigraine cohort.

Effect of pain intensity and time to administration on responsiveness to almotriptan: results from AXERT 12.5 mg Time Versus Intensity Migraine Study (AIMS).

OBJECTIVE: To determine whether time-based early treatment, independent of pain intensity, is superior to a pain intensity-based treatment, where patients are asked to treat at least moderate intensity headaches, resulting in a reduction of overall migraine headache duration. BACKGROUND: Retrospective and prospective trials have reported improved outcomes when triptans were used early or to treat mild migraine headache pain. However, tolerability as well as efficacy may be 2 of several key issues that have prevented this new treatment paradigm from becoming universally accepted. METHODS: In this multicenter, open-label, cluster-randomized study, patients with IHS-defined migraine were instructed to treat 2 sequential migraine headaches with almotriptan 12.5 mg using either Early Treatment (ET, ie, treat at earliest onset of headache pain, within 1 hour) or Standard Treatment (ST, ie, treat when headache pain intensity is moderate or severe). The novel trial design uses total migraine headache pain duration as the primary endpoint. RESULTS: Results are presented for the first headache and include an ITT population of 757 ET and 693 ST patients. Median headache duration (time from onset of headache pain until no pain) was significantly shorter in ET patients compared to ST patients (3.18 vs 5.53 hours, P < .001). An analysis of the ET subgroup treating headache pain within 1 hour of onset revealed pain intensity, ie, treating mild or moderate versus severe pain, was significantly correlated with treatment outcomes defined by total headache duration, 2-hour pain free, sustained pain free, and use of rescue medication. Multivariate analyses comparing ST subgroups that treated within 1 hour versus greater than 1 hour after headache onset, demonstrate that both pain intensity, ie, treating moderate versus severe headache pain, and treating early versus late, were significantly correlated with total headache duration, 2-hour pain free, sustained pain free, and use of rescue medication. The overall incidence of adverse events was low; nausea and dizziness were the only adverse events with an incidence > or =1% in either treatment group (nausea: 2.5% and 1.7% and dizziness 1.1% and 0.7%, in the ET and ST groups, respectively). CONCLUSION: Total headache duration was significantly shorter in the early treatment group compared to the standard treatment group. Considering time to treatment within a relatively early range of 1 hour or less, efficacy results when treating mild versus moderate pain were similar and both were associated with better outcomes than treatment of severe pain. When considering the prognostic variables of time to treatment and headache pain intensity (limited to moderate vs severe), both were independent predictors, with time to treatment a better predictor of headache duration and rescue medication use, and pain intensity a better predictor of 2-hour pain free and sustained pain free.

Safety and tolerability of extended-release oxybutynin once daily in urinary incontinence: combined results from two phase 4 controlled clinical trials.

Early studies of extended-release oxybutynin in patients with overactive bladder used adjusted-dose regimens ranging from 5 to 30 mg/day to achieve an optimal balance of efficacy and tolerability. The safety and tolerability of extended-release oxybutynin at a fixed dose of 10 mg once daily (commonly prescribed in clinical practice) is reported using pooled data from 2 multicenter, randomized, double-blind, parallel-group trials with a similar study design. One study compared extended-release oxybutynin with immediate-release tolterodine 2 mg bid. The other study compared extended-release oxybutynin with extended-release tolterodine 4 mg qd. In total, 576 patients received extended-release oxybutynin, 399 received extended-release tolterodine, and 193 received immediate-release tolterodine. The incidence of adverse events (AEs) was similar in the three treatment groups (extended-release oxybutynin, 70%; extended-release tolterodine, 64%; and immediate-release tolterodine, 79%). The most common adverse event was dry mouth (extended-release oxybutynin, 29%; extended-release tolterodine, 22%; and immediate-release tolterodine, 33%). Other AEs occurring in more than 5% of patients in any treatment group included constipation, diarrhea, headache, urinary tract infection, pain, dyspepsia, and peripheral edema, with no apparent difference across treatment groups. Most AEs (>90%) were mild or moderate in intensity in all treatment groups. The proportion of patients who discontinued study medication due to AEs was 6.1, 4.8, and 7.8% in the extended-release oxybutynin, extended-release tolterodine, and immediate-release tolterodine groups, respectively. In total, 1.2, 1.0, and 1.6% of patients in the extended-release oxybutynin, extended-release tolterodine, and immediate-release tolterodine groups, respectively, discontinued study medication due to dry mouth.

Perceptions and behaviours of women with bladder control problems.

OBJECTIVES: To evaluate women's perceptions about bladder control problems. METHODS: 757 Women with one or more bladder control symptoms (frequency, urgency, stress or urge urinary incontinence and nocturia) participated in an Internet-based survey. A separate study involved 12 focus groups including a total of 180 women with bladder control problems. RESULTS: Respondents in the survey reported multiple symptoms, e.g. stress urinary incontinence (72%), frequency (56%), nocturia (45%), urge urinary incontinence (43%) and urgency (33%). Women in both the survey and the focus groups revealed extensive use of coping mechanisms to manage their symptoms. The focus groups revealed that many women were not aware that overactive bladder (OAB) is a pathophysiological condition. Approximately 30% of respondents in the survey felt uncomfortable talking to their doctor about their condition. Among women who did speak with their doctor, stress-related symptoms were described more readily than urge-related symptoms. In the survey, only about half (56%) of the women felt their OAB medication was effective, and half (50%) stopped taking their medication at some point. Information from the focus groups suggested that some women may have unrealistic expectations of onset of efficacy or extent of benefit and may be unprepared for managing side effects. CONCLUSIONS: Feelings of embarrassment and limited understanding of the pathophysiology of OAB can contribute to miscommunication between a woman and her doctor. Patient education regarding reasonable expectations coupled with suggestions for coping with unwanted side effects will likely result in better management.

Efficacy and safety of extended release oxybutynin for the treatment of urge incontinence: an analysis of data from 3 flexible dosing studies.

PURPOSE: We assessed the efficacy and safety of extended release (ER) oxybutynin at individualized doses for urge urinary incontinence. MATERIALS AND METHODS: Data were combined from 3 flexible dosing studies of a total of 420 patients with urge urinary incontinence or mixed incontinence in whom ER oxybutynin dose adjustments were made to achieve the optimal balance between efficacy and tolerability, as judged by each participant. Individual doses were adjusted in 5 mg increments across a dose range of 5 to 30 mg daily. Efficacy was assessed during maintenance therapy using a 7-day diary. RESULTS: Data on 368 patients who completed dose adjustment were included in the analysis. In 47% of patients the preferred dose was greater than 10 mg daily. Individualized doses of ER oxybutynin produced a 79.3% decrease from baseline in the total of all incontinence episodes and an 83.2% decrease in urge episodes. Of patients 81% achieved a decrease of at least 70% in all incontinence episodes and 43% achieved total dryness. Moderate or severe dry mouth was reported by 23% of patients and it was cited as the cause for early withdrawal by 1.4% who completed dose adjustment. Therapy was well tolerated. In the pooled sample overall 6.7% of patients cited adverse events as the reason for discontinuing. CONCLUSIONS: Individualized dosing with ER oxybutynin was associated with highly effective and well tolerated control of urinary incontinence with more than 40% of patients achieving total dryness.

Comparison of dry mouth in women treated with extended-release formulations of oxybutynin or tolterodine for overactive bladder.

The incidence, severity and tolerability of dry mouth was compared in 790 women with overactive bladder who were treated with extended-release oxybutynin chloride 10 mg/day or extended-release tolterodine tartrate 4 mg/day for 12 weeks in a multicenter, double-blind, parallel-group study. Dry mouth was the most common adverse event associated with treatment, with an incidence rate of 28.1% in the oxybutynin group and 21.6% in the tolterodine group (P = 0.039). The majority of dry mouth events were mild in both treatment groups. Severe dry mouth occurred in 1.5% and 0.5% of patients in the oxybutynin and tolterodine groups, respectively (P = 0.173). Seven patients on extended-release oxybutynin and 4 patients on extended-release tolterodine discontinued treatment due to dry mouth (P = 0.380). The results of this analysis showed that dry mouth was common with both treatments, but most events were mild; there was no difference in the rate of severe dry mouth or in the rate of withdrawal due to dry mouth.

Pre- and post-season dietary intake, body composition, and performance indices of NCAA division I female soccer players.

Little published data describe the dietary and physiological profiles of intercollegiate female soccer players; therefore, the purpose of this investigation was to report baseline dietary data, anthropometrics, and performance indices of soccer women during rigorous pre-season training (2 sessions/day) and then during the post-competitive season. Members of a NCAA Division I women's soccer squad completed 3-day diet records, anthropometrics, and physical tests, including VO2peak. Average body mass was 62 kg with 16% body fat, and no significant pre to post differences were observed. Total energy, carbohydrate (CHO), protein, and fat intakes were significantly greater during the pre-season. Pre-season energy intake met the DRI for females with an "active" lifestyle (37 kcal/kg). While CHO intake failed to meet minimum recommendations to promote glycogen repletion (7-10 g/kg), protein and fat intakes were above minimum recommendations. Pre- and post-season intakes of several micronutrients were marginal (<75% of the DRI) including vitamin E, folate, copper, and magnesium. VO2peak significantly improved from pre- to post-season (42 and 50 ml/kg/min). In this study female soccer players appeared to meet caloric needs during periods of training but failed to meet minimum CHO and micronutrient recommendations. Foods higher in protein and fat displaced more CHO-rich and nutrient-dense foods within athletes' energy requirements and satiety limits.