Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0018681 (headache)
 56,091 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Acetylsalicylic acid (ASA) and pseudoephedrine (PSE) are often administered together for the treatment of symptoms of the common cold, i.e., nasal congestion, runny nose, sore throat and headache. Based on this fact we developed a fixed combination of 500 mg ASA and 30 mg PSE, the recommended doses for both drugs for treating symptoms of the common cold, as granulate to be dissolved in water for administration. The purpose of this open, randomized, three-factorial (three-treatment, three-period, six-sequence) Latin Square clinical study was to investigate the relative bioavailability of ASA and PSE as well as the establishment of bioequivalence after single administration of the fixed combination (final formulation for approval) of 500 mg ASA/30 mg PSE*HCl and the preliminary formulation of this combination. Pharmacokinetic characteristics AUC(norm) and C(max,norm) of ASA, its metabolite SA, and PSE, were determined as measure of rate and extent of absorption of the two formulations. The treatment ratios final/preliminary formulation and their corresponding 90% confidence intervals were calculated to establish bioequivalence. Additionally, descriptive statistics were calculated for the parameters t(max), t((1/2)), and mean residence time (MRT). In total, data from 18 healthy male volunteers were included in the pharmacokinetic evaluation. The primary target parameters were analyzed using an analysis of variance (ANOVA) after logarithmic transformation of the data. Confidence intervals of 90% were calculated for the geometric means of ratios using the mean square error term of the ANOVA. Bioequivalence criteria were fulfilled for AUC(norm) and C(max,norm). Geometric means of individual ratios of AUC(norm) and of C(max,norm) showed equal bioavailability of the new formulation compared with the preliminary. Furthermore, a relative bioavailability of approximately 100% of the preliminary formulation was shown for the newly developed formulation for all parameters. The parameters t(max), t((1/2)), and MRT showed comparable results for ASA, SA, and PSE, respectively, in both formulations. The supplementary evaluation for the non-normalized original parameters AUC and C(max) also revealed bioequivalence. For the newly developed formulation, the arithmetic means of the parameters AUC and C(max) for PSE were 1040.66 mg/h*l and 134.52 mg/l, for SA 142.28 mg/h*l and 30.34 mg/l, respectively. The median t(max) values were 0.67 h for PSE and 0.92 h for SA. Both treatments were safe and well tolerated.
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PMID:Relative bioavailability and bioequivalence of a newly developed fixed combination sachet of acetylsalicylic acid and pseudoephedrine compared with a preliminary combination. 1467 81

This prospective randomized study compared unilateral and bilateral spinal anesthesia with respect to intraoperative and postoperative complications, and time to discharge from hospital for knee arthroscopies in outpatients. We studied 70 ASA I patients scheduled for elective outpatient knee arthroscopy. The patients were randomly allocated into two groups to receive either 3 ml (15 mg) 0.5% hyperbaric bupivacaine (bilateral group) or 1.5 ml (7.5 mg) 0.5% hyperbaric bupivacaine (unilateral group). The duration of motor and sensory block and the time to discharge from the hospital were all recorded. Perioperative complications such as hypotension, bradycardia, nausea, vomiting, urinary retention, if present, were recorded. The patients were interviewed by telephone 7 days later, and each patient was asked about headache or backache. The duration of motor and sensory block, and the time to discharge from hospital was shorter in the unilateral group than in the bilateral group. Three patients in the bilateral group were treated for hypotension. Bradycardia occurred in two patients in the bilateral group, and three patients required temporary bladder catheterization due to delay in recovery of spontaneous urination. Nausea and vomiting occurred in three patients in bilateral group. Nine patients in the bilateral group and six patients in the unilateral group developed postspinal headache. Backache occurred in five patients in the bilateral group and in six patients in the unilateral group. Our data indicate that the use of unilateral spinal block is a suitable technique for knee arthroscopies in outpatients.
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PMID:Bilateral vs. unilateral spinal anesthesia for outpatient knee arthroscopies. 1502 63

The importance of the use of analgesic medication for the symptomatic relief of pain has been underestimated in medical practice. The objective of this study was to determine the prevalence of tension-type and migraine-type headaches and the associated analgesic consumption for its treatment within elementary school students from Porto Alegre (Brazil). A systematic random sample of 538 students from 5th to 8th grades was produced to complete the cross-sectional delineation. Subjects were individually submitted to a structured interview on headache and to general physical and neurological examination. Lifetime prevalence for headaches was 93.3%, 82.9% of the students recalled having headaches during the last year and 31.4% reported headaches in the last week. The prevalence for headaches in the previous 24 h was 8.9%. There was a significant prevalence of headache in females. The prevalence of analgesic consumption was 84.1% throughout life, 85.7% in the last year, and 54% in the last 3 months. A significantly higher prevalence of headache medication consumption was also depicted for females. However, the small age differences within the sample did not appear to be an important factor in influencing analgesic use for headaches. Different agents composed the individual treatment of headaches, with predominant use of over-the-counter preparations. Acetylsalicylic acid, consumed by 58.3% of the children, was the drug most frequently used for both tension-type and migraine-type headache treatments. In spite of the verification that headache was very frequently experienced by the children composing this sample accompanied by a consequent use of analgesics, no medication abuse was diagnosed.
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PMID:Analgesic use for headache treatment by schoolchildren of southern Brazil. 1507 71

Studies suggest that a substantial proportion of headache sufferers presenting to headache clinics may overuse acute medications. In some cases, overuse may be responsible for the development or maintenance of a chronic daily headache (CDH) syndrome. The objectives of this study are to evaluate patterns of analgesic overuse in patients consulting a headache centre and to compare the outcomes in a group of patients who discontinued medication overuse to those of a group who continued the overuse, in patients with similar age, sex and psychological profile. We reviewed charts of 456 patients with transformed migraine (TM) and acute medication overuse defined by one of the following criteria: 1. Simple analgesic use (>1000 mg ASA/acetaminophen) > 5 days/week; 2. Combination analgesics use (caffeine and/or butalbital) > 3 tablets a day for > 3 days a week; 3. Opiate use > 1 tablet a day for > 2 days a week; 4. Ergotamine tartrate use: 1 mg PO or 0.5 mg PR for > 2 days a week. For triptans, we empirically considered overuse > 1 tablet per day for > 5 days per week. Patients who were able to undergo detoxification and did not overuse medication (based on the above definition) after one year of follow-up were considered to have successful detoxification (Group 1). Patients who were not able to discontinue offending agents, or returned to a pattern of medication overuse within one year were considered to have unsuccessful detoxification (Group 2). We compared the following outcomes after one year of follow-up: Number of days with headache per month; Intensity of headache; Duration of headache; Headache score (frequency x intensity). The majority of patients overused more than one type of medication. Numbers of tablets taken ranged from 1 to 30 each day (mean of 5.2). Forty-eight (10.5%) subjects took >10 tablets per day. Considering patients seen in the last 5 years, we found the following overused substances: Butalbital containing combination products, 48%; Acetaminophen, 46.2%; Opioids, 33.3%; ASA, 32.0%; Ergotamine tartrate, 11.8%; Sumatriptan, 10.7%; Nonsteroidal anti-inflammatory medications other than ASA, 9.8%; Zolmitriptan, 4.6%; Rizatriptan, 1.9%; Naratriptan, 0.6%. Total of all triptans, 17.8%. Of 456 patients, 318 (69.7%) were successfully detoxified (Group 1), and 138 (30.3%) were not (Group 2). The comparison between groups 1 and 2 after one year of follow-up showed a decrease in the frequency of headache of 73.7% in group 1 and only 17.2% in group 2 (P < 0.0001). Similarly, the duration of head pain was reduced by 61.2% in group 1 and 14.8% in group 2 (P < 0.0001). The headache score after one year was 18.8 in group 1 and 54 in group 2 (P < 0.0001). A total of 225 (70.7%) successfully detoxified subjects in Group 1 returned to an episodic pattern of migraine, compared to 21 (15.3%) in Group 2 (P < 0.001). More rigorous prescribing guidelines for patients with frequent headaches are urgently needed. Successful detoxification is necessary to ensure improvement in the headache status when treating patients who overuse acute medications.
Cephalalgia 2004 Jun
PMID:Transformed migraine and medication overuse in a tertiary headache centre--clinical characteristics and treatment outcomes. 1515 58

In pregnancy and in childhood, headache and migraine are challenging therapeutic problems.However, this review aims to give treatment recommendations for drug and non-drug therapy in both patient groups which are based on scientific evidence. Pregnant women often lose their migraine attacks which reappear during lactation. During pregnancy acute headache can be treated with paracetamol, in the middle trimenon also ASA and ibuprofen are allowed. Triptans for the acute treatment of migraine are contraindicated. As prophylactic agents, only metoprolol, fluoxetine, and magnesium are possible. In childhood, drug of first choice for acute headache treatment is ibuprofen. Migraine can also be treated by sumatriptan nasal spray. In migraine prophylaxis, flunarizine is drug of first choice, no prophylactic drugs are evaluated for tension-type headache in childhood. The problems of specific contraindications and of the off-label use of drugs in this particular life periods are discussed.
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PMID:[Difficult decisions: headache treatment in pregnancy and childhood]. 1531 64

Acetylsalicylic acid (ASA) in combination with metoclopramide has been frequently used in clinical trials in the acute treatment of migraine attacks. Recently the efficacy of a new high buffered formulation of 1000 mg effervescent ASA without metoclopramide compared to placebo has been shown. To further confirm the efficacy of this new formulation in comparison with a triptan and a nonsteroidal anti-inflammatory drug (ibuprofen) a three-fold crossover, double-blind, randomized trial with 312 patients was conducted in Germany, Italy and Spain. Effervescent ASA (1000 mg) was compared to encapsulated sumatriptan (50 mg), ibuprofen (400 mg) and placebo. The percentage of patients with reduction in headache severity from moderate or severe to mild or no pain (primary endpoint) was 52.5% for ASA, 60.2% for ibuprofen, 55.8% for sumatriptan and 30.6% for placebo. All active treatments were superior to placebo (P < 0.0001), whereas active treatments were not statistically different. The number of patients who were pain-free at 2 h was 27.1%, 33.2%, 37.1% and 12.6% for those treated with ASA, ibuprofen, sumatriptan or placebo, respectively. The difference between ASA and sumatriptan was statistically significant (P = 0.025). With respect to other secondary efficacy criteria and accompanying symptoms no statistically significant differences between ASA and ibuprofen or sumatriptan were found. Drug-related adverse events were reported in 4.1%, 5.7%, 6.6% and 4.5% of patients treated with ASA, ibuprofen sumatriptan or placebo. This study showed that 1000 mg effervescent ASA is as effective as 50 mg sumatriptan and 400 mg ibuprofen in the treatment of migraine attacks regarding headache relief from moderate/severe to mild/no pain at 2 h. Regarding pain-free at 2 h sumatriptan was most effective.
Cephalalgia 2004 Nov
PMID:Placebo-controlled comparison of effervescent acetylsalicylic acid, sumatriptan and ibuprofen in the treatment of migraine attacks. 1548 57

It was the aim of this clinical study to demonstrate the efficacy of 1000 mg acetylsalicylic acid (ASA, CAS 50-78-2) in combination with 60 mg pseudoephedrine (PSE, CAS 90-82-4), compared with placebo, in the symptomatic treatment of nasal congestion associated with the common cold. A further aim was to demonstrate the efficacy of 500 mg ASA + 30 mg PSE and of 1000 mg paracetamol (CAS 103-90-2) + 60 mg PSE (active control) in the symptomatic treatment of nasal congestion. The study was designed as a randomized, two-center, double-blind, double-dummy, placebo-controlled, parallel-group, single-dose efficacy and safety trial over 6 h and was carried out in the USA. In total, at two centers, 643 patients who had a history and diagnosis of acute upper respiratory tract infection (URTI), were included; they showed symptoms such as nasal congestion, scratchy/sore throat, headache, generalized muscle ache, earache, runny nose, fever, sneezing etc. The investigational drugs ASA and PSE were both provided as granules in sachets and the granules were dissolved in water before administration; the combined preparation of paracetamol + PSE was administered as commercially available tablets encapsulated for blinding. For all preparations, matching placebos were provided. The primary efficacy variable was the area under the curve for differences from baseline on a nasal congestion scale in the first 2 h after treatment. To be eligible for the study, otherwise healthy volunteers were to present with nasal stuffiness of recent onset that reached a score of at least 6 on the 11-point scale for nasal congestion (0 = not stuffy, 10 = very stuffy). The primary analysis of the primary efficacy variable was calculated by analysis of variance including treatment group, severity (moderate/severe) and center as main strata. The analysis was performed using the intent-to-treat population. All active treatments proved to be statistically significantly superior to placebo with regard to the primary efficacy variable. Significant superiority of active treatment compared with placebo could also be demonstrated for an interval of up to 6 h after intake of the drug and for the relief of nasal congestion. The lower dose did not reveal significant different results compared with placebo for relief of nasal congestion in patients with a severe nasal congestion score at baseline. As well in patients with moderate nasal congestion score (NCS) at start of the study the difference from baseline in the NCS compared with placebo was not statistically significant. Thus a trend towards better efficacy in the higher dose could be assumed. No difference was found between 1000 mg ASA + 60 mg PSE and the active control. There were no differences between the two centers. The treatment proved to be safe and well tolerated, without relevant differences between the four treatment groups. Main adverse events were found to be related to the upper respiratory tract infection or were of gastrointestinal nature. In conclusion, the combination of ASA with PSE can be considered as an effective and safe remedial for the symptomatic treatment of the nasal congestion during URTI.
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PMID:Clinical, double-blind, placebo-controlled study investigating the combination of acetylsalicylic acid and pseudoephedrine for the symptomatic treatment of nasal congestion associated with common cold. 1550 Jan 97

Acetaminophen, ibuprofen, and aspirin are the most commonly used drugs in the United States. Although the frequency of their use has been associated with hypertension, prospective data examining the dose of these drugs and risk of hypertension are lacking. Furthermore, whether certain indications for analgesic use, particularly headache, mediate the association is unclear. We conducted 2 prospective cohort studies among older women 51 to 77 years of age (n=1903) from the Nurses' Health Study I and younger women 34 to 53 years of age (n=3220) from the Nurses' Health Study II who completed detailed supplemental questionnaires pertaining to their analgesic use and who did not have hypertension at baseline. We analyzed incident hypertension according to categories of average daily dose of acetaminophen, nonsteroidal anti-inflammatory drugs, and aspirin. Information on indications for analgesic use as well as relevant confounders was also gathered prospectively. Compared with women who did not use acetaminophen, the multivariable adjusted relative risk for those who took >500 mg per day was 1.93 (1.30 to 2.88) among older women and 1.99 (1.39 to 2.85) among younger women. For nonsteroidal anti-inflammatory drugs, similar comparisons yielded multivariable relative risks of 1.78 (1.21 to 2.61) among older women and 1.60 (1.10 to 2.32) among younger women. These associations remained significant among women who did not report headache. Aspirin dose was not significantly associated with hypertension. Higher daily doses of acetaminophen and nonsteroidal anti-inflammatory drugs independently increase the risk of hypertension in women. Because acetaminophen and nonsteroidal anti-inflammatory drugs are commonly used, they may contribute to the high prevalence of hypertension in the United States.
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PMID:Non-narcotic analgesic dose and risk of incident hypertension in US women. 1610 74

Clinical and experimental data suggest that ergotamine compounds and triptans may contribute to vascular events such as myocardial infarction and stroke. The role of blood cell aggregation in this context is, however, not clarified. We aimed to evaluate the impact of different acute antimigraine compounds on platelet and erythrocyte aggregation in a human ex vivo experimental design. In 20 healthy subjects without migraine and in 20 healthy subjects with migraine without aura, platelet and erythrocyte aggregation were measured before and after intake of placebo, acetylsalicylic acid, ergotamine tartrate, zolmitriptan and sumatriptan. Platelet aggregation was measured by the so-called platelet reactivity index. Erythrocyte aggregation was measured by photometric assessment in an aggregometer. Ergotamine tartrate induced a significant increase of platelet aggregation, whereas acetylsalicylic acid induced a significant decrease in both subject groups. After placebo, after sumatriptan and after zolmitriptan, no significant changes of platelet aggregation were noted. Erythrocyte aggregation was affected by neither compound. We can conclude that platelet aggregation, but not erythrocyte aggregation, is increased after intake of ergotamine tartrate. This may in part contribute to vascular side-effects of this compound. Acetylsalicylic acid and the triptans appeared to be safe with respect to platelet and erythrocyte aggregation.
Cephalalgia 2006 Aug
PMID:The impact of different antimigraine compounds on platelet and erythrocyte aggregation. 1725 45

In this paper, summary narratives on the established and emerging uses of aspirin are presented. On the former, aspirin is used to treat conditions such as headache and also reduce the risks associated with cardiovascular disease and also with pre-eclampsia. On the latter, aspirin might be taken more widely by individuals over 50 years, used as a dietary supplement to possibly reduce cancer risk and used post-transplant to improve organ survival. Aspirin will continue to be an important therapeutic agent and to generate considerable interest among the research community for the foreseeable future.
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PMID:The established and emerging uses of aspirin. 1704 Feb 12


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