Patient burden and healthcare resource utilization of regimens for ovarian stimulation.

RESEARCH QUESTION: Do women receiving corifollitropin alfa with a gonadotrophin-releasing hormone (GnRH) antagonist experience less emotional and/or physical exhaustion than women receiving standard of care gonadotrophin with daily administration of GnRH agonist or antagonist? DESIGN: The CoRifollitropin EvAluation in PracTicE (CREATE) study was a prospective observational study of fertility clinics in 17 countries in Europe and the Asia-Pacific region. Women undergoing IVF were categorized by treatment. Group A received single-dose corifollitropin alfa plus a GnRH antagonist; group B received usual care daily gonadotrophin regimens with a GnRH agonist or antagonist; and group B1i received daily GnRH agonist injections. For the primary analysis, two items from the Controlled Ovarian Stimulation Impact questionnaire were used to assess the level of emotional and physical exhaustion associated with ovarian stimulation. Secondary end-points included the impact of ovarian stimulation-related healthcare resource use. RESULTS: No statistical difference was found between the percentage of participants reporting emotional exhaustion in group A (11.6%) and B (13.1%) or the percentage reporting being 'often' or 'always' physically exhausted. More participants in group B1i (16.4%) reported being emotionally exhausted 'often' or 'always' during ovarian stimulation compared with group A (11.6%; P = 0.026). Patient questionnaire scores for psychological impact were higher in group A compared with group B, indicating less negative impact (72.7 versus 70.9; P = 0.004). Group A had fewer clinic visits, physician consultations, nurse contacts and transvaginal ultrasound scans (all P < 0.001) than group B1. CONCLUSIONS: Treatment with corifollitropin alfa resulted in similar or numerically small differences in psychological impact and lower clinic service use compared with daily gonadotrophin regimens.

Development of a patient-reported outcomes symptom measure for patients with nontransfusion-dependent thalassemia (NTDT-PRO© ).

ß-Thalassemia, a hereditary blood disorder caused by reduced or absent synthesis of the ß-globin chain of hemoglobin, is characterized by ineffective erythropoiesis, and can manifest as nontransfusion-dependent thalassemia (NTDT) or transfusion-dependent thalassemia (TDT). Many patients with NTDT develop a wide range of serious complications that affect survival and quality of life (QoL). Patient-reported outcomes (PRO), including health-related QoL (HRQoL), are important tools for determining patient health impairment and selecting appropriate treatment. However, there are currently no disease-specific PRO tools available to assess symptoms related to chronic anemia experienced by patients with NTDT. This study aimed to develop a new, US Food and Drug Administration (FDA)-compliant PRO of chronic anemia symptoms, the NTDT-PRO© tool, for use in patients with NTDT. Participants had a median age of 36 years (range, 18-47) and 60% were female. The initial development of the NTDT-PRO tool involved concept-elicitation interviews with 25 patients from 3 centers (in Lebanon, Greece, and Canada); subsequent interview discussions and clinical input resulted in the generation of 9 items for inclusion in the draft NTDT-PRO. Following a round of cognitive interviews involving 21 patients from 2 centers (in Lebanon and Greece), 4 items (Pain, Headaches, Ability to Concentrate, and Paleness) were removed from the draft NTDT-PRO. The final NTDT-PRO comprises 6 items that measure Tiredness, Weakness, and Shortness of Breath, with or without Physical Activity. The NTDT-PRO is a new disease-specific HRQoL tool for patients with NTDT, developed using a thorough methodology based on FDA 2009 PRO development guidelines.

Patterns of total cost and economic consequences of progression for patients with newly diagnosed multiple myeloma.

BACKGROUND: Few studies have addressed the cost patterns of patients with multiple myeloma (MM) before and after first relapse. This US claims analysis evaluated, from a US health plan perspective, patterns of total direct costs of care from treatment initiation to progression for patients with MM treated with novel agents, using time to next therapy (TTNT) as a proxy measure for progression. METHODS: A retrospective study was conducted using a large US claims database, evaluating patients with claims for MM between 2006 and 2013. Patients with claims for stem cell transplant (SCT) were excluded. The analysis focused on patients receiving lenalidomide (LEN) or bortezomib (BORT) based treatment, for whom complete claim history was available through initiation of subsequent treatment. Average patient monthly direct costs were determined, including medical and pharmacy costs, and total cost patterns over quarterly time periods were calculated. RESULTS: The study population comprised 2843 patients with newly diagnosed MM (NDMM) and 1361 with relapsed MM. Total monthly cost for patients with NDMM declined steadily, from $15,734 initially to $5082 at 18+ months after therapy. Upon initiation of second-line therapy, total monthly costs rose to $13,876 and declined to $6446 18 months later. Although NDMM cost levels for individual ordinal months were similar between the LEN and BORT groups, TTNT was longer for LEN-based treatments (37 months). The BORT-treated cohort had higher average monthly total costs for NDMM and for the common time period through 37 months after initiation of therapy ($7534 vs $10,763 for LEN and BORT, respectively). Key limitations of this study, in addition to the lack of mortality and staging information available from claims data, include the definition of TTNT based on change in treatment or a defined gap in therapy prior to retreatment, which may differ from actual time of progression in some patients. CONCLUSIONS: For patients with NDMM receiving either LEN- or BORT-based treatment without SCT, followed until TTNT, total direct monthly costs (drug + medical) declined steadily over time. Monthly costs returned to near initial levels when patients began second-line therapy and then followed a similar pattern of decline. Due to the longer TTNT for patients initiated on LEN and the associated longer period of below-average costs, patients initiated with LEN-based treatments had mean monthly total costs >$3200 lower than total costs for patients initiated on BORT during the first 3 years after starting treatment, cumulating to nearly $120,000 in lower costs for patients initiated on LEN.

Therapeutic practice patterns related to statin potency and ezetimibe/simvastatin combination therapies in lowering LDL-C in patients with high-risk cardiovascular disease.

BACKGROUND: Statin combination therapy and statin uptitration have been shown to be efficacious in low-density lipoprotein cholesterol (LDL-C) lowering and are recommended for patients with high-risk coronary heart disease (CHD) who do not reach guideline-endorsed LDL-C goals on statin monotherapy. OBJECTIVE: This analysis evaluated treatment practice patterns and LDL-C lowering for patients with CHD/CHD risk equivalent on statin monotherapy in a real-world practice setting in the United States. METHODS: In this retrospective, observational study, patients with CHD/CHD risk equivalent on statin therapy were identified during 2004 to 2008 in a US managed care database. Prescribing patterns and effect of switching from statin monotherapy to combination ezetimibe/simvastatin therapy vs uptitration to higher statin dose/potency level and no change from initial statin potency on LDL-C lowering were assessed. Percentage of change from baseline in LDL-C levels and odds ratios for LDL-C goal attainment were estimated with analyses of covariance and logistic regression. RESULTS: Of 27,919 eligible patients on statin therapy, 2671 (9.6%) switched to ezetimibe/simvastatin therapy, 11,035 (39.5%) uptitrated statins, and 14,213 (50.9%) remained on the same statin monotherapy. LDL-C reduction from baseline and attainment of LDL-C <100 and <70 mg/dL were substantially greater for patients who switched to ezetimibe/simvastatin therapy (-24.0%, 81.2%, and 35.2%, respectively) than for patients who titrated (-9.6%, 68.0%, and 18.4%, respectively) or remained on initial statin therapy (4.9%, 72.2%, and 23.7%, respectively). The odds ratios for attainment of LDL-C <100 and <70 mg/dL were also higher for patients who switched than for patients who uptitrated and had no therapy change than for patients who titrated vs no therapy change. Similarly, among a subgroup of patients not at LDL-C <100 mg/dL on baseline therapy, attainment of LDL-C <100 and <70 mg/dL was greater for patients who switched than for statin uptitration vs no change, as well as for patients who uptritrated statins vs no therapy change. CONCLUSION: In this study, LDL-C lowering and goal attainment rates improved substantially for patients with high-risk CHD on statin monotherapy who switched to combination ezetimibe/statin or uptitrated their statin therapies; however, approximately one-third of these patients still did not attain the optional recommended LDL-C goal of <70 mg/dL. Moreover, these higher efficacy lipid-lowering therapies were infrequently prescribed, indicating the need for further assessment of barriers to LDL-C goal attainment in actual practice settings.

Healthcare expenses associated with multiple vs singleton pregnancies in the United States.

OBJECTIVE: The purpose of this study was to document cost that is associated with multiple births vs singleton births in the United States. STUDY DESIGN: This was a retrospective cohort study that used a claims database. Women 19-45 years old with live-born infants from 2005-2010 were identified. Infant deliveries were identified by International Classification of Diseases, 9th Revision, Clinical Modification diagnosis codes. The cost entailed all payment made by insurers and patients. For mothers, the cost included expenses from 27 weeks before delivery to 1 month after delivery. For infants, the cost contained all expenses until their first birthday. Adjusted cost was estimated by generalized linear models after adjustment for the potential confounding variables with a gamma distribution and a log link. RESULTS: The analysis included 437,924 eligible deliveries. Of them, 97.02% were singletons; 2.85% were twins, and 0.13% was triplets or more. Women with multiple pregnancies had higher systemic and localized comorbidities compared with women with singleton pregnancies (P < .0001). Twins and triplets or more were more likely to have stayed in a neonatal intensive care unit than were singletons (P < .0001). On average, adjusted total all-cause health care cost was $21,458 (95% confidence interval [CI], $21,302-21,614) per delivery with singletons, $104,831 (95% CI, $103,402-106,280) with twins, and $407,199 (95% CI, $384,984-430,695) with triplets or more. CONCLUSION: Pregnancies with the delivery of twins cost approximately 5 times as much when compared with singleton pregnancies; pregnancies with delivery of triplets or more cost nearly 20 times as much.

Inappropriate use of combined hormonal contraceptives for birth control among women of reproductive age in the United States.

OBJECTIVE: To describe the extent of inappropriate use of combined hormonal contraceptives (CHC) according to the United States Medical Eligibility Criteria (U.S. MEC). METHODS: We analyzed Kantar Health's 2010 U.S. National Health and Wellness Survey data, which is an annual population-based survey of 75,000 U.S. adults via internet. A stratified random sampling framework was used to construct a sample that reflects the U.S. census by age, gender, and ethnicity. The analysis included nonpregnant females aged 18-44 years who used CHC, including oral, patch, or vaginal rings in the past 6 months. Women classified into category 3 (theoretical or proven risks usually outweigh the advantages of using the method) or 4 (unacceptable health risk) according to the U.S. MEC were defined as having high-risk conditions, or inappropriate CHC use. The proportions of women who had inappropriate CHC use were then projected to the U.S. population by diseases/conditions and demographic characteristics incorporating sampling weights. RESULTS: We identified 2963 adult females of reproductive age (mean 29.3±6.0) (i.e., 20.4% of all adult females of reproductive age in the database) as being CHC users. Among them, 23.7% (95% CI: 22.8%-24.5%) had at least one high-risk condition and 9.3% (95% CI: 9.2%-9.4%) had at least one condition of unacceptable risk. The three most common high-risk conditions were migraine (12.7%), multiple risk factors for arterial cardiovascular disease (9.3%), and hypertension (6.1%). Women with relatively higher proportions of inappropriate CHC use were age ≥35, not finished college, and Medicaid recipients. CONCLUSIONS: A large portion of women used CHC inappropriately. Hormone-free and progestin-only contraceptives are available options with potentially less risk for them.

Changes in prescription patterns before and after reporting of the Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression trial (ENHANCE) results and expected effects on low-density lipoprotein-cholesterol reduction.

BACKGROUND: Recent trends suggest a decreased use of ezetimibe/simvastatin combination and coadministered ezetimibe plus statin therapies. OBJECTIVE: This analysis evaluated changes in prescription patterns for ezetimibe/simvastatin, ezetimibe plus statins, and statin therapies and expected effects on low-density lipoprotein cholesterol (LDL-C) lowering during 2007 to 2008. METHODS: Prescription pattern changes were assessed by the use of patient-level data from the IMS Health Longitudinal Rx database during two time periods, July 14, 2007 to January 13, 2008 (n = 8,813,674) and January 14, 2008 to July 13, 2008 (n = 9,131,030), 6 months before and after reporting of the results of The Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression trial (ENHANCE) trial on January 14, 2008. Expected LDL-C reductions were estimated using data from previous controlled clinical trials. RESULTS: During 6 months post-ENHANCE, greater proportions of patients were switched from ezetimibe/simvastatin and ezetimibe plus statins to other lipid-lowering therapies by health care providers than 6 months pre-ENHANCE (21.1% vs 6.0% and 46.9% vs 38.5%, differences: -15.06% [95% confidence interval -15.14%, -14.97%] and -8.43% [95% confidence interval -8.70%, -8.17%], respectively). Greater proportions of these patients switched to statin monotherapy in the later than earlier period. Prescription patterns were similar for statins during both time periods, although fewer patients switched to ezetimibe/simvastatin and ezetimibe plus statin therapies post-ENHANCE. In both time periods, greater proportions of patients on ezetimibe/simvastatin and ezetimibe plus statins switched to less-than-equivalent LDL-C lowering efficacy doses of statins than those on statin therapy. On the basis of previous clinical data for these therapies, smaller LDL-C reductions would be expected in patients who switched from ezetimibe/simvastatin and ezetimibe plus statins to statins, despite a trend toward switching to greater statin doses in the later time period. CONCLUSIONS: More patients switched from ezetimibe/simvastatin and ezetimibe plus statin to statin monotherapy 6 months after the reporting of the ENHANCE trial, the majority of which were prescribed less potent, LDL-C-lowering therapies. On the basis of the known LDL-C lowering efficacies for these therapies, such changes would be expected to increase LDL-C levels in these patients and may reduce the proportion of patients who achieve guideline-recommended LDL-C goals.

Triptan persistency among newly initiated users in a pharmacy claims database.

OBJECTIVE: Our study was conducted to describe prescription refill patterns among patients newly treated with triptans. BACKGROUND: Although triptans are efficacious in treating migraine headache, the persistency of triptan use among newly initiated users has not been well described. METHODS: From a US pharmacy claims database, we identified patients receiving new triptan monotherapy prescriptions from 2001 to 2005. Prescription refill information was gathered for two years for each patient. Persistency was defined as sustained refills of the index triptan prescription, regardless of duration between refills. RESULTS: Of 40,892 patients receiving a new triptan prescription, 53.8% (N = 22031) did not persistently refill their index triptan. Of these, 25.5% discontinued prescription migraine therapy, 7.4% switched to a different triptan, and 67.1% switched to a non-triptan migraine medication at the time of their first refill. Only 46.2% of patients received at least one persistent refill. CONCLUSIONS: Migraine patients were more likely to discontinue their triptan after their index prescription than at any other time in their prescription refill history. The majority of patients did not persistently refill triptans, but filled prescriptions for non-specific migraine therapies such as opioids and non-steroidal anti-inflammatory drugs. Reasons for triptan discontinuation warrant further investigation.

EuroQol (EQ-5D) health utility scores for patients with migraine.

PURPOSE: Previous studies have reported health utilities for migraine patients as generally measured between migraine attacks, but health utility data for within a migraine attack are unavailable. We evaluated within-attack health utilities among acute migraine patients experiencing different grades of headache severity. METHODS: We examined data for 330 20-65-year-old adults, in good physical health, who had 1-6 moderate/severe migraine attacks per month in the 2 months prior to the screening visit. Data were collected from a multicenter, double-blind study of a treatment for acute migraine in the United States. The EQ-5D system was used to measure generic health status at baseline and 24 h post-treatment within an acute migraine attack, and patients were also asked to rate their pain level at these time points (no, mild, moderate, or severe pain). The D1 time-trade-off scoring algorithm for the U.S. population was applied. Confidence intervals were estimated by bootstrap methods. RESULTS: The study population was 88% women and 78% white ethnicity, with 60% of subjects over age 40. The disutility of mild migraine pain was estimated to be 0.140 (95% CI: 0.0848, 0.1940), with a disutility for moderate migraine pain of 0.186 (95% CI: 0.1645, 0.2053) and for severe migraine pain of 0.493 (95% CI: 0.4100, 0.5654). CONCLUSIONS: Within-attack disutilities estimated for migraine in this study are much greater than those reported for migraine when evaluated as a chronic health condition (e.g., valuations collected at random time points). These data can be of value in adapting results from clinical trials of migraine interventions to cost-utility policy analyses.

Switching from high-efficacy lipid-lowering therapies to simvastatin and low-density lipoprotein cholesterol goal attainment in coronary heart disease/coronary heart disease-equivalent patients.

BACKGROUND: The availability of generic simvastatin in 2006 has prompted substantial changes in formulary recommendations for lipid-management agents. OBJECTIVE: To assess the impact of switches from high-efficacy lipid-lowering therapy to simvastatin on low-density lipoprotein cholesterol (LDL-C) and goal attainment in coronary heart disease (CHD) or CHD risk-equivalent patients in a managed care setting. METHODS: In this retrospective observational study, we estimated the least squares mean difference in the percent change from baseline LDL-C and the odds ratios for LDL-C goal attainment rates (<100 mg/dL and <70 mg/dL) at follow-up for each baseline high-efficacy lipid-lowering therapy with the analysis of covariance and logistic regressions, respectively. RESULTS: We identified 18,061 patients who, between September 1, 2004 and October 31, 2008, were either switched from or remained on their initial high-efficacy LDL-C lowering therapy: ezetimibe/simvastatin fixed-dose combination (E/S), rosuvastatin, or atorvastatin. The difference in percent change in LDL-C levels from baseline were 25.2 (95% confidence interval 21.2-29.2), 13.0 (6.0-20.0), and 3.1 (0.3-5.9) greater in switchers to simvastatin in the E/S, rosuvastatin, and atorvastatin comparisons, respectively, after adjusting for age, sex, and starting dose of the initial therapy. For switchers, the percent of patients at LDL-C <100 mg/dL at follow-up decreased from 83.5% to 63.8% in the E/S, 67.7% to 52.7% in the rosuvastatin, and 65.1% to 60.2% in the atorvastatin cohorts. The percent of patients at LDL-C <70 mg/dL at follow-up was lower for all switcher groups compared with nonswitchers. CONCLUSIONS: Among CHD/CHD risk-equivalent patients, switching to simvastatin was associated with increases in LDL-C levels and lower LDL-C goal attainment rates. The public health impact of this phenomenon on population risk and CHD events remains to be determined.

Loss of early gains in low-density lipoprotein cholesterol goal attainment among high-risk patients.

BACKGROUND: Guidelines recommend a low-density lipoprotein cholesterol (LDL-C) measurement of <70 mg/dL as a reasonable goal in high-risk patients with coronary heart disease (CHD) or atherosclerotic vascular disease (AVD). METHODS: This retrospective, cross-sectional study examined LDL-C goal attainment monthly trends from January 1, 2004, to August 31, 2008, in a large, managed-care claims database in the United States. High-risk CHD or AVD patients who had at least one LDL-C test during that time period were included (N = 284,915). Average LDL-C values and percent of patients not achieving LDL-C goal (LDL-C ≥70 mg/dL) were obtained by averaging patient level LDL-C values for each month. A linear trend analysis with first-order autocorrelated errors was conducted. RESULTS: The proportion of patients treated with lipid-lowering therapy gradually increased from 58.5% in 2004 to 70.5% in 2008. Mean LDL-C values in patients treated with lipid-lowering therapy decreased from 100.4 to 96.4 mg/dL, whereas LDL-C remained relatively constant in untreated patients (114.3 mg/dL). In treated patients, the percentage with LDL-C ≥70 mg/dL decreased from 87.5% in January 2004 to 73.8% in December 2006 (P < .0001), then gradually declined between January 2007 (79.6%) and August 2008 (76.2%; P < .0001). Among untreated patients, 92.9% had LDL-C levels ≥70 mg/dL in January 2004 and 93.0% in August 2008. CONCLUSION: In conclusion, the percentage of high-risk patients with CHD or AVD treated with lipid-lowering therapy who achieve LDL-C <70 mg/dL levels has increased since 2004, although a large proportion of these patients still do not meet this goal. Additionally, 1 of 4 high-risk patients otherwise eligible for lipid-lowering therapy remains untreated. These data suggest the need for renewed efforts to support guideline-based LDL-C lowering in high-risk patients.

Projected cost-effectiveness of ezetimibe/simvastatin compared with doubling the statin dose in the United Kingdom: findings from the INFORCE study.

OBJECTIVE: To evaluate the incremental cost-effectiveness ratio (ICER) of switching to ezetimibe/simvastatin (Eze/Simva) compared with doubling the submaximal statin doses, in patients with acute coronary syndrome (ACS) events in the INFORCE study. METHODS: Lifetime treatment costs and benefits were computed using a Markov model. Model inputs included each patient's cardiovascular risk factor profile and actual lipid values at baseline and 12 weeks (endpoint). Cardiovascular event and drug costs were discounted at 3.5%. Age-specific utilities were based on UK literature values and non-coronary heart disease mortality rates on the Office of National Statistics data. In the INFORCE study, 384 patients taking statins at stable doses for ≥6 weeks before hospital admission were stratified by statin dose/potency (low, medium, and high) and then randomized to doubling the statin dose or switching to Eze/Simva 10/40mg for 12 weeks. RESULTS: The Eze/Simva group (n=195) had a higher mean baseline total cholesterol than the double-statin group (n=189). Analyses were adjusted for baseline characteristics. In the INFORCE study, Eze/Simva reduced low-density lipoprotein cholesterol (LDL-C) by ∼30% (vs. 4% with doubling statin doses) and significantly enhanced LDL-C goal attainment. In the cost-effectiveness analysis, Eze/Simva conferred 0.218 incremental discounted quality-adjusted life year (QALY) at a discounted incremental cost of £2524, for an ICER of £11,571/QALY (95% confidence interval=£8181-£18,600/QALY). The ICER was £13,552/QALY, £11,930/QALY, and £10,148/QALY in the low-, medium-, and high-potency strata, respectively. CONCLUSIONS: Switching to Eze/Simva 10/40 mg is projected to be a cost-effective treatment (vs. double-statin) in UK patients with ACS.

Predictability of future attacks by migraineurs: a prospective observational study.

OBJECTIVE: To determine the predictability of future migraine attacks and to describe the effect of migraine on daily life during and between migraine attacks. BACKGROUND: Migraine is associated with substantial economic and humanistic burden. There is growing evidence that early intervention with triptans results in better treatment outcomes. However, this is dependent on a patient's preparedness for an attack including having abortive medications readily accessible at headache onset. METHODS: Physician-diagnosed adult migraine sufferers, who treat with prescription or over-the-counter medications, completed 2 self-reported, Internet-based questionnaires, administered at baseline and following the resolution of the next migraine attack. The baseline questionnaire included the Migraine Disability Assessment questionnaire (MIDAS), questions about experiences on days between attacks, predictions of the date, time of day (5 time windows), and sufferer's location (4 places) at the start of their next migraine. At follow-up, information was collected in the similar fashion about the date, time of day, and sufferer's location at the start of their most recent migraine. RESULTS: A total of 1519 migraine sufferers completed the baseline questionnaire and 877 (57.7%) completed the follow-up. At baseline, 58.7% experienced moderate to severe disability from headache, based on MIDAS. Only 4.0% were able to predict the exact date of their next migraine; 21.24% predicted next migraine within 3 days. Larger proportions (46.6%) were able to accurately predict time of day or location (70.7%) of their next migraine. In the past 3 months, 92.6% reported that they were forced to change daily plans because of migraine. Because of fear of getting a migraine, 20.2% had avoided and 27.0% had changed a work commitment, and 27.3% had avoided and 28.2% had changed social plans. CONCLUSIONS: Migraine sufferers are generally unable to predict onset of the next migraine. Lack of predictability heightens the importance of education and preparedness for a migraine attack which may also reduce fear and anxiety between attacks.

GERD prevalence in migraine patients and the implication for acute migraine treatment.

The objective of this study is to estimate the prevalence of gastroesophageal reflux disease (GERD) and heartburn in migraine patients and examine their use of non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin-containing medications when treating acute migraine attacks. Responses from a web-based survey of migraine patients were matched to the same patient's responses on a general health survey. A total of 1,832 migraineurs (92.0%) were successfully matched. A total of 403 migraineurs (22.0%) reported having diagnosed GERD, 212 (11.6%) reported diagnosed heartburn, and 290 (15.8%) reported reflux symptoms but were undiagnosed. The most common prescription drugs used to treat migraines were triptans. First-line NSAID/aspirin medication use was 10.0% among diagnosed GERD and heartburn patients, 17.8% among undiagnosed patients, and 11.8% among GERD/heartburn-free migraineurs. In conclusion, almost half of migraineurs reported physician-diagnosed GERD and heartburn or symptoms of these conditions. Use of NSAID medications for migraine is fairly common among diagnosed GERD patients and more so for those with undiagnosed GERD symptoms. Physicians should minimize prescribing NSAIDs or NSAID-containing acute migraine medications in this population.

Acute migraine treatment with oral triptans and NSAIDs in a managed care population.

OBJECTIVE: To describe the use of oral triptans with or without nonsteroidal anti-inflammatory drugs (NSAIDs) for acute migraine treatment in a managed care population and its potential impact on functionality. BACKGROUND: Prescription or over-the-counter NSAIDs with or without oral triptans are commonly used for treatment of acute migraine pain. Little is known about patients' treatment strategy when they have had experiences using NSAIDs and oral triptan cotherapy and the relationship between treatment strategy and migraine symptoms and functionality. METHOD: Migraineurs identified from an administrative claims database were surveyed for their use of oral triptans and NSAIDs during their last attack in the screening phase and during the subsequent migraine attack in the follow-up phase of the study. Treatment regimens were classified into 6 categories: simultaneous coadministration of triptans and NSAIDs (T and N); triptans first followed by NSAIDs (T N); NSAIDs first followed by triptans (N T); triptans only (TRP only); NSAIDs only (NSAID only); and others. Headache experience, reasons for treatment regimens, and treatment satisfaction were cross-tabulated by treatment regimens. The log-rank test was used for the analysis of time-to-event data. RESULTS: Among 8440 oral triptan users surveyed during the screening phase, 2307 (27%) reported using triptans and NSAIDs combination therapy during their last migraine attack. Of those, 1502 experienced a subsequent migraine attack and completed the follow-up survey; 38% of these 1502 patients who used triptans and NSAIDs cotherapy during their last migraine attack continued to use combination therapy for their next attack. The most common treatment regimen, excluding "others" (n = 354, 24%), was TRP only (n = 403, 27%), followed by N T (n = 345, 23%), NSAID only (n = 170, 11%), T&N (n = 152, 10%), and T N (n = 75, 5.0%). More TRP only patients became nausea-free within 1 h after an initial dosing. TRP only, T&N, and N T had significantly shorter median hours of suffering from migraine and limited functioning, as compared with other treatment regimens. Substantially more patients taking TRP only (34.7%) were very satisfied with their current treatment regimen than other regimens. CONCLUSIONS: Migraine patients frequently change their treatment regimens in response to headache profiles. For patients with migraine associated nausea symptom, combination of therapy with triptan and NSAIDs appears to be less effective in relieving nausea than triptan monotherapy. Triptan montherapy remains a common and an effective migraine treatment strategy.

Does early migraine treatment shorten time to headache peak and reduce its severity?

OBJECTIVE: To explore whether early treatment would shorten the duration of headache from headache onset to its peak and reduce headache severity at peak. BACKGROUND: Prior clinical studies almost exclusively focused on headache relief after dosing. No data are available on whether early intervention affects the duration from headache onset to peak and headache severity at peak. METHODS: Adult migraineurs were enrolled in this observational study from multi-site headache clinics. Patients recorded their migraine experiences via an electronic diary over 1 month. Patients reported the time and pain severity at onset, dosing, and peak. We used a linear mixed model to evaluate the impact of the timing of treatment and to adjust for covariates and correlation of observations within subjects. RESULTS: A total of 182 patients reported 970 migraine episodes, 620 of which were treated before headaches progressed to peak. Mean time from headache onset to peak varied from 1.9 hours to 8.9 hours for patients treated within 15 minutes of onset and those who waited for 4 or more hours, respectively. However, early intervention was not associated with reduced headache severity at peak. In multivariate analysis, early treatment, use of triptans, and mild migraine headache in the past 3 months were significantly associated with shorter time from onset to headache peak. A separate model indicated that the timing of medication was not associated with the duration between dosing and headache peak, but use of triptans shortened the time from dosing to headache peak. CONCLUSIONS: Early treatment and use of triptans may lead to shorter duration from migraine headache onset to its peak but did not alleviate headache severity at peak. This could result in decreased migraine burden by reducing total migraine headache duration.

Can migraineurs accurately identify their headaches as "migraine" at attack onset?

BACKGROUND: While treating migraine early when the headache is mild is believed to link to improved treatment outcomes, it is not clear whether patients can correctly self-identify a headache as a migraine at onset in real-world settings. OBJECTIVE: This study aims to assess the likelihood that patients can correctly self-identify a headache as a migraine at onset, and to evaluate cues that patients use to correctly identify migraine attacks. METHODS: Adult migraineurs were recruited from 14 headache clinics across the United States. Patients recorded their headache experiences via an electronic diary daily over a period of 30 days. On days when they experienced headaches, patients were asked to recall the types of headache they experienced at both onset and peak. Patients also identified cues for deciding whether the headache was a migraine or not. Using identification of migraine at headache peak as the criterion, we examined the sensitivity and specificity of migraine identification at onset. We employed generalized estimating equation (GEE) to evaluate factors identified at headache onset that predicted migraine identified at headache peak. RESULTS: Of the 192 enrolled patients, 182 patients recorded a total of 1197 headache episodes over 30 days. At headache onset, 888 episodes were deemed by patients as migraine and 309 episodes not migraine; a majority (92%) of these early migraine identifications were confirmed at headache peak. Sensitivity and specificity of self-identification of migraine at onset were 91% and 97%, respectively. A number of factors at headache onset were predictive of a migraine identified at peak: sensitivity to light (OR = 3.1, 95% CI: 1.9-5.0), headache severity (OR = 2.0, 95% CI: 1.4-2.8), nausea symptoms (OR = 2.6, 95% CI: 1.5-4.5), and visual disturbance (OR = 2.3, 95% CI: 1.1-4.9). Patients who ruled out tension-type headache at onset were twice (OR = 2.0, 95% CI: 1.5-2.8) as likely to conclude a migraine at peak. CONCLUSIONS: Most migraineurs in tertiary care settings can correctly self-identify a headache as a migraine at onset. Factors such as headache severity, presence of nausea, visual disturbance, sensitivity to light, and no tension-type headache, appeared to augment the correct identification.

Time to pain freedom and onset of pain relief with rizatriptan 10 mg and prescription usual-care oral medications in the acute treatment of migraine headaches: a multicenter, prospective, open-label, two-attack, crossover study.

BACKGROUND: Patients and physicians consider rapid onset of pain relief and pain freedom among the most important attributes of migraine therapy. OBJECTIVE: This study compared the effectiveness of rizatriptan 10 mg and usual-care oral migraine medications in everyday clinical practice settings. METHODS: This was a multicenter, prospective, open-label study. Adult patients treated 2 sequential migraine attacks with rizatriptan 10 mg and a usual-care prescription migraine medication in a crossover manner. Patients chose which medication to take first. They recorded the treatment outcomes using a stopwatch and a treatment diary. End points included time to pain freedom (length of time from dosing to no pain) and time to onset of pain relief (mean time to onset of pain relief and proportion of patients reporting onset of pain relief at 30 minutes), satisfaction with treatment, and medication preference. Information on adverse events was collected through the normal post-marketing reporting mechanism. Comparisons were made using the paired t test and McNemar test for continuous and categorical variables, respectively. A mixed model, accounting for multiple observations per patient, was fitted for the time to pain freedom, controlling for age, sex, treatment period, medication, and headache severity. RESULTS: Of 2346 enrolled patients, 1489 treated 2 migraines in a crossover manner and were included in the analysis (86.8% women, 13.2% men; mean age, 41.7 years). A majority of patients (80.6%) treated both migraines with oral triptans. The most commonly used nontriptans were NSAIDs (5.4%), butalbital-containing combinations (4.3%), and isometheptene (3.4%). Over-the-counter medications were used by 22.3% of patients during rizatriptan-treated attacks and by 28.9% of patients during attacks treated with usual-care medications. The mean time to pain freedom was significantly shorter when an attack was treated with rizatriptan compared with usual-care medications (222 vs 298 minutes, respectively; P<0.001), and the onset of pain relief was significantly more rapid (85 vs 107 minutes; P=0.003), with significant differences noted as early as 15 minutes after dosing (P<0.001). The findings remained similar after adjustment for potential confounding factors. No significant sequence effect was detected. Significantly more patients reported being very satisfied or satisfied with rizatriptan compared with usual-care medications (65.4% vs 57.7%; P<0.001) and preferred rizatriptan (58.0% vs 42.0%; P<0.001). One female patient reported having hives and itchy skin the day after taking rizatriptan; the symptoms subsided after treatment with methylprednisolone. CONCLUSIONS: In this selected population, treatment of a migraine attack with rizatriptan 10 mg was associated with a faster time to pain freedom and onset of pain relief compared with treatment with usual-care oral migraine medications. Patients reported greater satisfaction with and preference for rizatriptan.

Postoperative nausea and vomiting following inpatient surgeries in a teaching hospital: a retrospective database analysis.

OBJECTIVE: To report the incidence of postoperative nausea and vomiting (PONV), to describe the use of anti-emetics both for the prophylaxis and treatment of PONV, and to assess resource utilization and duration of post-anesthesia care unit (PACU) stay. RESEARCH DESIGN AND METHODS: We retrieved data from the Duke Anesthesia Peri-operative database. We included adult patients, who underwent inpatient surgery under general anesthesia with inhaled agents between January 2004 and February 2005, and had two or more risk factors for PONV documented preoperatively (female, previous history of PONV or motion sickness, non-smoker or use of postoperative opioid). Data on the use of prophylactic anti-emetics, the incidence of PONV, nausea scores, pain scores, and the use of rescue anti-emetics in PACU and in the period between PACU discharge and 24 h after surgery were recorded. Resource utilization and cost assessment was performed from the perspective of the hospital and included length and direct cost of PACU stay, as well as the acquisition costs of rescue anti-emetics in PACU. Descriptive statistics were used to summarize the demographic characteristics of patients. For group comparisons, data were analyzed with the t-test for continuous data, and the Chi-square test for categorical data. Multiple linear regression models were used to evaluate the association between PONV and PACU length of stay adjusting for confounding factors. RESULTS: A total of 3641 patients were included in the analysis. Of those, 2869 (79%) received prophylactic anti-emetics. In the PACU, nausea and vomiting were reported in 16% and 3% of the patients, respectively. Rescue anti-emetics were given to 26% of all patients. The incidence of vomiting was significantly less in patients who received PONV prophylaxis (p = 0.03). In multiple linear regression models, the duration of PACU stay was longer by a mean of 25 min in patients who experienced PONV or received rescue anti-emetics in PACU (p < 0.0001) despite the fact that the duration of surgery was shorter by a mean of 24 min in this group of patients (p < 0.0001). Following PACU discharge, 40% of patients reported nausea, vomiting or needed rescue anti-emetics. PONV was associated with significantly increased resource utilization and costs of PACU stay (p < 0.0001). Emesis was associated with greater incremental cost (138 US dollars) than nausea (85 US dollars), mainly from the longer duration of PACU stay. CONCLUSIONS: PONV remain a significant problem postoperatively and often persists beyond PACU discharge. The presence of PONV is associated with increased length of PACU stay and greater resource utilization and costs.

Treating early versus treating mild: timing of migraine prescription medications among patients with diagnosed migraine.

INTRODUCTION: Although research suggests that early treatment of migraine headache when the pain is mild results in better outcomes for patients, many patients delay taking their acute-migraine medication until their headaches are moderate or severe. Understanding when and why patients use their migraine medications is an important first step to improve migraine management. METHODS: A prospective observational study, conducted at a major national retail pharmacy chain with stores across the United States between April 2001 and November 2002, enrolled men and women between 18 and 55 years of age with a physician diagnosis of migraine with or without aura. Baseline data on 690 patients included patient demographics, migraine history, medication use, tendency to avoid or delay treatment of a migraine attack, and reasons for delaying treatment. Reasons for delaying treatment were assessed via a checklist of nine potential reasons. In the follow-up survey completed after treatment of the next migraine attack, patients reported the timing of medication use in relation to pain onset and the severity of the migraine headache at the time they took the medication. RESULTS: Despite the severity of their typical migraine attacks, approximately 49% of the respondents answered, "yes" to the question, "Do you often avoid or delay taking your migraine medications when you start to experience a migraine attack?" The two most common rationales for avoiding or delaying treatment were "wanting to wait and see if it is really a migraine attack" (69%) followed by "only want to take medications if it is a severe attack" (46%). In the follow-up survey, regardless of medication used, about 85% of patients did not treat their next migraine attack until the headache pain was moderate or severe, although 74% treated within 1 hour of pain onset. CONCLUSION: These results suggest that patients with migraine often delay their treatment until they have identified their attack as a migraine. In addition, while many patients treated their follow-up headache early, they did not treat when the pain was mild. This suggests that there is an opportunity for physicians to educate their migraine patients on how to differentiate migraine from other headache types and about when and how to use their acute-migraine medication.