30 results on '"Diener, H-C"'
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2. The efficacy and tolerability of a fixed combination of acetylsalicylic acid, paracetamol, and caffeine in patients with severe headache: a post-hoc subgroup analysis from a multicentre, randomized, double-blind, single-dose, placebo-controlled parallel group study.
- Author
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Diener HC, Peil H, and Aicher B
- Subjects
- Acetaminophen adverse effects, Adolescent, Adult, Aged, Analgesics, Non-Narcotic administration & dosage, Analgesics, Non-Narcotic adverse effects, Anti-Inflammatory Agents, Non-Steroidal administration & dosage, Anti-Inflammatory Agents, Non-Steroidal adverse effects, Aspirin adverse effects, Caffeine adverse effects, Double-Blind Method, Drug Combinations, Female, Humans, Male, Middle Aged, Phosphodiesterase Inhibitors administration & dosage, Phosphodiesterase Inhibitors adverse effects, Placebos, ROC Curve, Severity of Illness Index, Treatment Outcome, Young Adult, Acetaminophen administration & dosage, Aspirin administration & dosage, Caffeine administration & dosage, Migraine Disorders drug therapy, Tension-Type Headache drug therapy
- Abstract
Background: We investigated efficacy and tolerability of two tablets of the fixed combination of 250 mg acetylsalicylic acid (ASA) + 200 mg paracetamol + 50 mg caffeine (Thomapyrin) in comparison to two tablets of placebo in a post-hoc analysis of a subgroup of patients with severe headache., Methods: Patients where included if they were used to treating their episodic tension-type headache or migraine attacks with non-prescription analgesics and reported a history of headache attacks characterized by at least severe pain and greatly impaired usual daily activities and treated headaches with pain intensity of at least 48 mm assessed on a 100-mm visual analogue scale and associated with greatly impaired usual daily activities., Results: For the primary endpoint 'time to 50% pain relief' in this intention-to-treat subset (n = 179 patients), the fixed combination of ASA, paracetamol, and caffeine was statistically significantly superior to placebo (p = 0.0008). The superior efficacy of the triple combination could also be shown for all secondary endpoints such as time until reduction of pain intensity to 10 mm, weighted sum of pain intensity difference (%SPIDweighted), extent of impairment of daily activities, and global assessment of efficacy. Both treatments were well tolerated. The incidence of adverse events observed was low. The results for this subgroup analysis are consistent with respect to all endpoints and to the patients with non-severe headache and the overall patient population. As with all post-hoc subgroup analyses, the findings are hypothesis generating only and must be interpreted with caution., Discussion: The results of this subgroup analysis confirm that the fixed combination of ASA (250 mg), paracetamol (200 mg), and caffeine (50 mg) is effective and well tolerated in a broad spectrum from mild to severe migraine and tension-type headache severity independently of the headache diagnosis.
- Published
- 2011
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3. Dipyridamole plus aspirin versus aspirin alone in secondary prevention after TIA or stroke: a meta-analysis by risk.
- Author
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Halkes PH, Gray LJ, Bath PM, Diener HC, Guiraud-Chaumeil B, Yatsu FM, and Algra A
- Subjects
- Drug Therapy, Combination, Humans, Risk Factors, Anti-Inflammatory Agents, Non-Steroidal therapeutic use, Aspirin therapeutic use, Dipyridamole therapeutic use, Ischemic Attack, Transient prevention & control, Platelet Aggregation Inhibitors therapeutic use, Stroke prevention & control
- Abstract
Objectives: To study the effect of combination therapy with aspirin and dipyridamole (A+D) over aspirin alone (ASA) in secondary prevention after transient ischaemic attack (TIA) or minor stroke of presumed arterial origin and to perform subgroup analyses to identify patients that might benefit most from secondary prevention with A+D., Data Sources: The previously published meta-analysis of individual patient data was updated with data from ESPRIT (n = 2,739); trials without data on the comparison of A+D versus ASA were excluded., Review Methods: A meta-analysis was performed using Cox regression, including several subgroup analyses and following baseline risk stratification., Results: A total of 7612 patients (five trials) were included in the analyses, 3800 allocated to A+D and 3812 to ASA alone. The trial-adjusted hazard ratio (HR) for the composite event of vascular death, non-fatal myocardial infarction and non-fatal stroke was 0.82 (95% confidence interval (CI) 0.72 to 0.92). HRs did not differ in subgroup analyses based on age, sex, qualifying event, hypertension, diabetes, previous stroke, ischaemic heart disease, aspirin dose, type of vessel disease and dipyridamole formulation, nor across baseline risk strata as assessed with two different risk scores. A+D were also more effective than ASA alone in preventing recurrent stroke; HR 0.78 (95% CI 0.68 to 0.90)., Conclusion: The combination of aspirin and dipyridamole is more effective than aspirin alone in patients with TIA or ischaemic stroke of presumed arterial origin in the secondary prevention of stroke and other vascular events. This superiority was found in all subgroups and was independent of baseline risk.
- Published
- 2008
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4. Clopidogrel versus aspirin in patients with atherothrombosis: CAPRIE-based calculation of cost-effectiveness for Germany.
- Author
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Berger K, Hessel F, Kreuzer J, Smala A, and Diener HC
- Subjects
- Aged, Aged, 80 and over, Atherosclerosis complications, Atherosclerosis economics, Atherosclerosis mortality, Clopidogrel, Cohort Studies, Coronary Thrombosis complications, Coronary Thrombosis economics, Coronary Thrombosis mortality, Cost-Benefit Analysis, Germany, Humans, Models, Econometric, Myocardial Infarction epidemiology, Myocardial Infarction mortality, Platelet Aggregation Inhibitors economics, Platelet Aggregation Inhibitors therapeutic use, Survival Analysis, Ticlopidine economics, Ticlopidine therapeutic use, Treatment Outcome, Aspirin economics, Aspirin therapeutic use, Atherosclerosis drug therapy, Coronary Thrombosis drug therapy, Ticlopidine analogs & derivatives
- Abstract
Objectives: To model the 2-year cost-effectiveness of secondary prevention with clopidogrel versus aspirin (acetylsalicylic acid) (ASS) in German patients with myocardial infarction (MI), ischaemic stroke (IS) or diagnosed with peripheral arterial disease (PAD), based on CAPRIE trial data and from the perspective of German third party payers (TPP)., Methods: An existing Markov model was adapted to Germany by using German cost data. The model was extended by using different datasets for cardiovascular event survival times (Framingham vs. Saskatchewan health databases) and in two separate scenarios., Results: The treatment with clopidogrel leads to a reduction of 13.19 vascular events per 1000 patients, of which 2.21 are vascular deaths. The overall incremental costs for the 2-year management of atherothrombotic patients with clopidogrel instead of ASS are calculated to be about euro1 241 440 per 1000 patients. The number of life-years saved (LYS) has been calculated as the difference in the number of life-years lost due to vascular death or events with ASS versus clopidogrel: it is 86.35 LYS when analysis is based on Framingham data and 66.07 LYS with Saskatchewan-based survival data. The incremental costs per LYS are euro14 380 and euro18 790, respectively. Cost-effectiveness is sensitive to changes in survival data, discounting and daily costs of clopidogrel, but stable against substantial (+/- 25%) changes in all other cost data., Conclusion: The findings for Germany are in line with published results for Belgium (euro13 390 per LYS) and also with results for Italy (euro17 500 per LYS), both based on Saskatchewan data, and with a French analysis based on Framingham data (euro15 907 per LYS). Even if no officially accepted cost-effectiveness threshold exists for Germany at present, incremental cost-effectiveness results of less than euro20 000 per LYS for the treatment with clopidogrel can be assumed to be acceptable for German third party payers.
- Published
- 2008
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5. Efficacy and safety of 1,000 mg effervescent aspirin: individual patient data meta-analysis of three trials in migraine headache and migraine accompanying symptoms.
- Author
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Lampl C, Voelker M, and Diener HC
- Subjects
- Administration, Oral, Adult, Anti-Inflammatory Agents, Non-Steroidal administration & dosage, Anti-Inflammatory Agents, Non-Steroidal adverse effects, Dose-Response Relationship, Drug, Drug-Related Side Effects and Adverse Reactions, Female, Humans, Male, Middle Aged, Migraine Disorders physiopathology, Nausea chemically induced, Pain Measurement drug effects, Placebo Effect, Randomized Controlled Trials as Topic statistics & numerical data, Serotonin Receptor Agonists administration & dosage, Serotonin Receptor Agonists adverse effects, Sumatriptan administration & dosage, Sumatriptan adverse effects, Time Factors, Treatment Outcome, Vomiting chemically induced, Aspirin administration & dosage, Aspirin adverse effects, Migraine Disorders drug therapy
- Abstract
Migraine is often associated with health consequences including impaired quality of life, and the cost of treating migraine headaches places a significant financial burden on patients who suffer from migraines. Nonsteroidal anti-inflammatory drugs (NSAIDs) and triptans are commonly used for the treatment of acute migraine attacks. Aspirin is widely accepted as a treatment option for migraine pain relief and could provide an alternative not only for treatment of moderate migraine attacks, but also for severe migraine attacks. The efficacy and safety of 1,000 mg effervescent aspirin (eASA) was evaluated in comparison to 50 mg sumatriptan and placebo in an individual patient data meta-analysis of three randomized, placebo-controlled, single- dose migraine trials. Pain-relief at 2 h, pain-free at 2 h and sustained pain-free up to 24 h were calculated. For eASA, the response rates were 51.5 % (95 % CI: 46.6-56.5 %), 27.1 % (95 % CI: 22.6-31.4 %), and 23.5 % (95 % CI: 19.3-27.7 %). For sumatriptan, the response rates were 46.6 % (95% CI: 40.0-53.2 %), 29% (95 % CI: 23.0-34.9 %), and 22.2 % (95 % CI: 16.7-27.6 %). The corresponding rates for placebo were 33.9 % (95% CI: 29.1-38.6 %), 15.1 % (95 % CI: 11.5-18.7 %), and 14.6 % (95 % CI: 11.0-18.1 %). The treatment effect of eASA and sumatriptan were significantly different from placebo (p < 0.001), but differences between eASA and sumatriptan were not significant. The remission of accompanying symptoms and the subgroup analyses of patients with moderate or severe migraine pain at baseline revealed no significant differences between eASA and sumatriptan. Safety was evaluated based on the frequency of reported adverse events, and treatment with eASA was associated with lower incidence of adverse events than was with sumatriptan. This individual patient data meta-analysis provided evidence that eASA 1,000 mg is as effective as sumatriptan 50mg for the treatment of acute migraine attacks and has a better side effect profile. This is also true for patients with moderate as well as severe headache at baseline. Patients therefore should be advised to use eASA first for migraine attacks and use a triptan in case of no response.
- Published
- 2007
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6. The fixed combination of acetylsalicylic acid, paracetamol and caffeine is more effective than single substances and dual combination for the treatment of headache: a multicentre, randomized, double-blind, single-dose, placebo-controlled parallel group study.
- Author
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Diener HC, Pfaffenrath V, Pageler L, Peil H, and Aicher B
- Subjects
- Acetaminophen administration & dosage, Analgesics, Non-Narcotic administration & dosage, Anti-Inflammatory Agents, Non-Steroidal administration & dosage, Double-Blind Method, Drug Administration Schedule, Drug Combinations, Drug Synergism, Germany epidemiology, Humans, Migraine Disorders diagnosis, Pain Measurement, Placebo Effect, Prognosis, Severity of Illness Index, Treatment Outcome, Aspirin administration & dosage, Caffeine administration & dosage, Migraine Disorders drug therapy, Migraine Disorders epidemiology, Tension-Type Headache drug therapy, Tension-Type Headache epidemiology
- Abstract
We investigated efficacy, safety, and tolerability of two tablets of the fixed combination of 250 mg acetylsalicylic acid (ASA) + 200 mg paracetamol + 50 mg caffeine (Thomapyrin) in comparison with two tablets of 250 mg ASA + 200 mg paracetamol, two tablets of 500 mg ASA, two tablets of 500 mg paracetamol, two tablets of 50 mg caffeine, and placebo in patients who were used to treating their episodic tension-type headache or migraine attacks with non-prescription analgesics. For the primary endpoint "time to 50% pain relief" in the intention-to-treat dataset (n = 1743 patients), the fixed combination of ASA, paracetamol and caffeine was statistically significantly superior to the combination without caffeine (P = 0.0181), the mono-substances ASA (P = 0.0398), paracetamol (P = 0.0016), caffeine (P < 0.0001) and placebo (P < 0.0001). All active treatments except caffeine differed significantly (P < 0.0001) from placebo. The superior efficacy of the triple combination could also be shown for all secondary endpoints such as time until reduction of pain intensity to 10 mm, weighted sum of pain intensity difference (%SPIDweighted), extent of impairment of daily activities, global assessment of efficacy. All treatments were well tolerated. The incidence of adverse events observed was low.
- Published
- 2005
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7. Placebo-controlled comparison of effervescent acetylsalicylic acid, sumatriptan and ibuprofen in the treatment of migraine attacks.
- Author
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Diener HC, Bussone G, de Liano H, Eikermann A, Englert R, Floeter T, Gallai V, Göbel H, Hartung E, Jimenez MD, Lange R, Manzoni GC, Mueller-Schwefe G, Nappi G, Pinessi L, Prat J, Puca FM, Titus F, and Voelker M
- Subjects
- Adult, Chemistry, Pharmaceutical, Chi-Square Distribution, Confidence Intervals, Cross-Over Studies, Double-Blind Method, Female, Humans, Male, Middle Aged, Migraine Disorders physiopathology, Aspirin therapeutic use, Ibuprofen therapeutic use, Migraine Disorders drug therapy, Sumatriptan therapeutic use
- Abstract
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.
- Published
- 2004
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8. Differences of anti-nociceptive mechanisms of migraine drugs on the trigeminal pain processing during and outside acute migraine attacks.
- Author
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Katsarava Z, Limmroth V, Baykal O, Akguen D, Diener HC, and Kaube H
- Subjects
- Adult, Blinking drug effects, Electrophysiology, Female, Humans, Male, Pain drug therapy, Pain Measurement methods, Trigeminal Nerve drug effects, Tryptamines, Anti-Inflammatory Agents, Non-Steroidal administration & dosage, Aspirin administration & dosage, Migraine without Aura drug therapy, Oxazolidinones administration & dosage, Serotonin Receptor Agonists administration & dosage
- Abstract
The aim of this study was to investigate central anti-nociceptive mechanisms of i.v. acetylsalicylic acid (ASA) and oral zolmitriptan (ZOL) in migraine patients and healthy subjects using the 'nociceptive' blink reflex (nBR). Twenty-eight migraine patients received ASA (n = 14, 1000 mg i.v) or ZOL (n = 14, 5 mg p.o) during the acute migraine attack and interictally. Thirty healthy subjects received either ASA or ZOL vs. placebo using a double blind cross over design. nBR was recorded in all patients and subjects before, 60 and 90 min after treatment. ASA and ZOL did not inhibit nBR responses in healthy subjects. Both ASA and ZOL suppressed nBR responses (ASA by 68%, ZOL by 78%) only during the acute attack but not interictally. The data suggest, that the anti-nociceptive effects of migraine drugs on the trigeminal nociceptive processing are different during and outside an acute migraine attack.
- Published
- 2004
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9. [For which patient ASS, clopidogrel or dipyridamole? (interview by Dr. Med. Dirk Einecke)].
- Author
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Diener HC
- Subjects
- Aspirin adverse effects, Clinical Trials as Topic, Clopidogrel, Dipyridamole adverse effects, Drug Therapy, Combination, Humans, Platelet Aggregation Inhibitors adverse effects, Secondary Prevention, Ticlopidine adverse effects, Treatment Outcome, Aspirin administration & dosage, Cerebral Infarction prevention & control, Dipyridamole administration & dosage, Ischemic Attack, Transient prevention & control, Platelet Aggregation Inhibitors administration & dosage, Ticlopidine administration & dosage, Ticlopidine analogs & derivatives
- Published
- 2004
10. Efficacy of 1,000 mg effervescent acetylsalicylic acid and sumatriptan in treating associated migraine symptoms.
- Author
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Diener HC, Eikermann A, Gessner U, Göbel H, Haag G, Lange R, May A, Müller-Schwefe G, and Voelker M
- Subjects
- Adolescent, Adult, Aged, Demography, Double-Blind Method, Female, Follow-Up Studies, Humans, Male, Middle Aged, Time Factors, Treatment Outcome, Aspirin analogs & derivatives, Aspirin therapeutic use, Migraine Disorders drug therapy, Sumatriptan therapeutic use, Vasoconstrictor Agents therapeutic use
- Abstract
Recently a new effervescent acetylsalicylic acid (ASA) tablet with high buffering capacity has been developed. In this double-blind, 3-arm, multicenter, parallel-group study, 433 patients were treated either with 1,000 mg effervescent ASA or 50 mg encapsulated sumatriptan or placebo. The primary endpoint was the percentage of patients with complete remission of the 3 accompanying symptoms nausea, photophobia and phonophobia within 2 h after intake of the study drug. 43.8% of patients treated with ASA, 43.7% of patients treated with sumatriptan and 30.9% of patients treated with placebo showed complete remission of all 3 accompanying symptoms (p < 0.05 for ASA and sumatriptan vs. placebo). Both active treatments were superior to placebo regarding the individual symptoms photophobia and phonophobia, but not for nausea. The percentage of patients with reduction in headache severity from moderate or severe to mild or no pain (secondary objective) was 49.3% for ASA, 48.8% for sumatriptan and 32.9% for placebo. All active treatments were superior to placebo (p < 0.05). 25.3, 24.4 and 14.5% of patients treated with ASA, sumatriptan or placebo were pain free at 2 h. Drug-related adverse events were reported in 3.9, 4.7 and 6.7% of patients treated with placebo, ASA or sumatriptan. The study showed that administration of effervescent ASA leads to remission of the migraine symptoms nausea, photophobia and phonophobia, reduces migraine headache and is comparable to sumatriptan., (Copyright 2004 S. Karger AG, Basel)
- Published
- 2004
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11. Abnormal habituation of 'nociceptive' blink reflex in migraine--evidence for increased excitability of trigeminal nociception.
- Author
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Katsarava Z, Giffin N, Diener HC, and Kaube H
- Subjects
- Adult, Analysis of Variance, Aspirin pharmacology, Aspirin therapeutic use, Blinking drug effects, Female, Follow-Up Studies, Habituation, Psychophysiologic drug effects, Humans, Lysine pharmacology, Lysine therapeutic use, Male, Middle Aged, Migraine Disorders drug therapy, Oxazolidinones pharmacology, Oxazolidinones therapeutic use, Pain Measurement drug effects, Trigeminal Nerve drug effects, Tryptamines, Aspirin analogs & derivatives, Blinking physiology, Habituation, Psychophysiologic physiology, Lysine analogs & derivatives, Migraine Disorders physiopathology, Pain Measurement methods, Trigeminal Nerve physiology
- Abstract
We studied the habituation of the 'nociceptive' blink reflex (nBR) in 15 healthy subjects and 17 migraine patients interictally as well as during unilateral migraine headache within six hours of onset and after treatment. In healthy volunteers the mean regression coefficient (MRC) was - 3.9 following right sided and - 4.9 left sided stimulation. This equals an amplitude loss of 19.5% (5 x -3.9) and 24.5% (5 x -4.9), respectively, across five consecutive sweeps. An augmentation of nBR responses was found in migraine patients interictally: MRC = 3.3 following stimulation of the headache side (HA) and MRC = 4.0 of the non-headache side (non-HA). The differences were statistically significant (anova: d.f. = 1, F = 25.8, P < 0.001). During the migraine attack MRCs were negative both before (-5.0, HA and - 4.0, non-HA) and after treatment (-2.6, HA and - 1.9 non-HA) and significantly differed from those outside the migraine attack (anova: d.f. = 2, F = 12.4, P < 0.001). The demonstrated lack of habituation of the nBR responses indicates an abnormal trigeminal nociceptive processing in migraine patients outside the migraine attack.
- Published
- 2003
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12. [Secondary prevention of ischemic insult and transient cerebral ischemia. Is ASS alone enough?].
- Author
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Diener HC
- Subjects
- Aspirin administration & dosage, Controlled Clinical Trials as Topic, Dipyridamole administration & dosage, Drug Therapy, Combination, Humans, Meta-Analysis as Topic, Phosphodiesterase Inhibitors administration & dosage, Placebos, Platelet Aggregation Inhibitors administration & dosage, Recurrence, Risk, Aspirin therapeutic use, Dipyridamole therapeutic use, Ischemic Attack, Transient prevention & control, Phosphodiesterase Inhibitors therapeutic use, Platelet Aggregation Inhibitors therapeutic use, Stroke prevention & control
- Published
- 2003
13. Low-dose aspirin for migraine prophylaxis in women.
- Author
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Diener HC
- Subjects
- Aspirin adverse effects, Clinical Trials as Topic, Dose-Response Relationship, Drug, Drug Administration Schedule, Female, Humans, Treatment Outcome, Aspirin administration & dosage, Migraine Disorders prevention & control
- Published
- 2001
- Full Text
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14. Cardiac safety in the European Stroke Prevention Study 2 (ESPS2).
- Author
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Diener HC, Darius H, Bertrand-Hardy JM, and Humphreys M
- Subjects
- Angina Pectoris prevention & control, Humans, Longitudinal Studies, Myocardial Infarction prevention & control, Treatment Outcome, Aspirin administration & dosage, Dipyridamole administration & dosage, Ischemic Attack, Transient prevention & control, Platelet Aggregation Inhibitors administration & dosage, Stroke prevention & control
- Abstract
The second European Stroke Prevention Study investigated the prevention of stroke and/or death in 6602 patients with transient ischaemic attack or stroke with aspirin (25 mg b.d.), dipyridamole (400 mg b.d.), the combination of aspirin and dipyridamole or placebo. This post hoc analysis investigated cardiac events in patients with coronary heart disease or myocardial infarction (MI) at entry. Dipyridamole did not result in a higher number of cardiac events, e.g. angina pectoris, MI, or death from all causes. The combination of aspirin plus dipyridamole was superior to either drug alone in the prevention of stroke.
- Published
- 2001
15. A comparative study of oral acetylsalicyclic acid and metoprolol for the prophylactic treatment of migraine. A randomized, controlled, double-blind, parallel group phase III study.
- Author
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Diener HC, Hartung E, Chrubasik J, Evers S, Schoenen J, Eikermann A, Latta G, and Hauke W
- Subjects
- Adolescent, Adult, Aged, Aspirin adverse effects, Female, Humans, Male, Metoprolol adverse effects, Middle Aged, Treatment Outcome, Aspirin administration & dosage, Metoprolol administration & dosage, Migraine Disorders drug therapy
- Abstract
This study was a multinational, multicentre, double-blind, active controlled phase III trial designed to investigate efficacy and safety of 300 mg acetylsalicyclic acid (ASA) (n = 135) vs. 200 mg metoprolol (n = 135) in the prophylaxis of migraine. In total 270 (51 male and 219 female) patients, aged 18-65 years, suffering between two and six migraine attacks per month were recruited. The main objective was to show equivalence with respect to efficacy, defined as a 50% reduction in the rate of migraine attacks. A run-in phase was carried out with placebo for 4 weeks, followed by a 16-week drug phase. In both treatment groups the median frequency of migraine attacks improved during the study period, from three to two in the ASA group and from three to one in the metoprolol group; 45.2% of all metoprolol patients were responders compared with 29.6% with ASA. Medication-related adverse events were less frequent in the ASA group (37) than in the metoprolol group (73). The findings from this trial show that metoprolol is superior to ASA for migraine prophylaxis but has more side-effects. Acetylsalicylic acid is better tolerated than metoprolol. Using a strict responder criterion ASA showed a responder rate comparable with the placebo rate in the literature.
- Published
- 2001
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16. Analgesics.
- Author
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Diener HC and Limmroth V
- Subjects
- Acetaminophen therapeutic use, Administration, Intranasal, Administration, Oral, Analgesics, Non-Narcotic therapeutic use, Anti-Inflammatory Agents, Non-Steroidal administration & dosage, Humans, Analgesics, Opioid therapeutic use, Anti-Inflammatory Agents, Non-Steroidal therapeutic use, Aspirin therapeutic use, Migraine Disorders drug therapy
- Abstract
Analgesics such as acetaminophen (paracetamol), acetylsalicyclic acid and non-steroidal anti-inflammatory drugs are effective in the treatment of migraine attacks. Comparative studies indicate that their efficacy is similar or slightly inferior to sumattriptan, a specific antimigraine drug. Few data on the efficacy of opioid drugs in the treatment of migraine are available. They seem to be effective but carry the risk of dependency and may cause drug-induced headache.
- Published
- 2001
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17. Aspirin in the prevention of strokes.
- Author
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Diener HC
- Subjects
- Anti-Inflammatory Agents, Non-Steroidal therapeutic use, Aspirin administration & dosage, Aspirin adverse effects, Cerebrovascular Disorders mortality, Clinical Trials as Topic, Hemorrhage chemically induced, Humans, Secondary Prevention, Time Factors, Aspirin therapeutic use, Cerebrovascular Disorders prevention & control
- Abstract
Aspirin leads to a moderate but significant reduction of stroke, myocardial infarction (MI), and vascular deaths in patients with transient ischemic attack (TIA) and ischemic stroke. Low doses are as effective as high doses but are better tolerated in terms of gastro-intestinal side-effects. The recommended daily aspirin dose is therefore between 50 and 325 mg. Bleeding complications are not dose dependent and occur with the lowest doses.
- Published
- 1999
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18. Acetylsalicylic acid in the treatment of headache.
- Author
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Limmroth V, Katsarava Z, and Diener HC
- Subjects
- Humans, Treatment Outcome, Anti-Inflammatory Agents, Non-Steroidal therapeutic use, Aspirin therapeutic use, Headache drug therapy, Migraine Disorders drug therapy
- Abstract
Acetylsalicylic acid (ASA) is used to treat a broad range of symptoms and disorders. Since its discovery in 1897, it has been used to treat fever and rheumatic pain, to inhibit the formation of thrombocytes, to prevent myocardial ischemia and strokes, and as preventive medication against neoplasms. ASA is best known, however, as a headache medication. For this function alone, ASA underwent an evolution: from powder to tablet to effervescent and chewable tablets. In addition to these oral formulations, an injectable form was developed in the 1970s for intravenous and intramuscular application. Furthermore, coated (slow-releasing) tablets are now used in the prophylactic treatment of migraine. The various forms of ASA used to treat headache are discussed and the controlled studies conducted to evaluate ASA's efficacy in headache treatment are summarized.
- Published
- 1999
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19. Efficacy and safety of intravenous acetylsalicylic acid lysinate compared to subcutaneous sumatriptan and parenteral placebo in the acute treatment of migraine. A double-blind, double-dummy, randomized, multicenter, parallel group study. The ASASUMAMIG Study Group.
- Author
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Diener HC
- Subjects
- Adult, Analgesics adverse effects, Aspirin administration & dosage, Aspirin adverse effects, Double-Blind Method, Female, Humans, Infusions, Intravenous, Injections, Subcutaneous, Lysine administration & dosage, Lysine adverse effects, Male, Middle Aged, Recurrence, Sumatriptan adverse effects, Treatment Outcome, Vasoconstrictor Agents adverse effects, Analgesics administration & dosage, Aspirin analogs & derivatives, Lysine analogs & derivatives, Migraine Disorders drug therapy, Sumatriptan administration & dosage, Vasoconstrictor Agents administration & dosage
- Abstract
Two-hundred-and-seventy-eight patients with acute migraine attacks with or without aura were treated in 17 centers with 1.8 g lysine acetylsalicylate i.v. (Aspisol; = 1 g acetylsalicylic acid), 6 mg sumatriptan s.c. or placebo using a double-blind, double-dummy, randomized, multicenter parallel group study design. Two-hundred-and-seventy-five of them fulfilled the criteria for efficacy analysis, corresponding to 119 patients treated with lysine acetylsalicylate (L-ASA), 114 with sumatriptan and 42 with placebo injections. Both treatments were highly effective compared to placebo (p < 0.0001) in decreasing headache from severe or moderate to mild or none (verbal rating scale, VRS, placebo = 23.8%). Sumatriptan showed a significantly (p = 0.001) better response (91.2%) compared to L-ASA (response 73.9%). Of the patients in the L-ASA-group, 43.7% were pain-free after 2 h; 76.3% after sumatriptan and 14.3% after placebo. It took patients on average 12.6 (L-ASA), 8.2 (sumatriptan), and 19.4 h (placebo) to be able to work again. There was no significant difference between treatment groups in recurrence of headache in responders within 24 h (18.2% L-ASA, 23.1% sumatriptan, 20% placebo). Accompanying symptoms (nausea, vomiting; photophobia, phonophobia, and visual disturbances) improved with both verum treatments to a similar extent. L-ASA was significantly better tolerated than sumatriptan (adverse events L-ASA 7.6%, sumatriptan 37.8%). In conclusion, subcutaneous sumatriptan and lysine acetylsalicylate i.v. are effective treatments for patients suffering from migraine attacks. Sumatriptan is more effective, but resulted in more adverse events.
- Published
- 1999
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20. Second European Stroke Prevention Study: antiplatelet therapy is effective regardless of age. ESPS2 Working Group.
- Author
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Sivenius J, Cunha L, Diener HC, Forbes C, Laakso M, Lowenthal A, Smets P, and Riekkinen P Sr
- Subjects
- Administration, Oral, Adult, Age Factors, Aged, Brain Ischemia epidemiology, Cerebrovascular Disorders epidemiology, Drug Therapy, Combination, Female, Humans, Incidence, Ischemic Attack, Transient epidemiology, Ischemic Attack, Transient prevention & control, Male, Middle Aged, Aspirin therapeutic use, Brain Ischemia prevention & control, Cerebrovascular Disorders prevention & control, Dipyridamole therapeutic use, Fibrinolytic Agents therapeutic use, Platelet Aggregation Inhibitors therapeutic use
- Abstract
Background: The Second European Stroke Prevention Study (ESPS2) was a randomized, placebo-controlled trial that investigated the efficacy of low-dose acetylsalicylic acid (ASA) and modified-release dipyridamole (DP), alone or in combination, in the secondary prevention of ischemic stroke. The trial demonstrated that the combination was significantly more effective than either agent used alone. The aim of the present study was to evaluate the influence of age on the efficacy of ASA and DP, alone or in combination, in the secondary prevention of stroke in the ESPS2 population., Methods and Results: A total of 6602 patients were recruited to the ESPS2 and there were 4 treatment groups: ASA (25 mg twice daily), DP (200 mg twice daily), ASA and DP in a combined formulation, or placebo. Primary endpoints were stroke, death, and stroke or death together. The endpoints evaluated in the present study were stroke, stroke and/or death, and vascular events. Stroke was the qualifying event in 76% of the patients, while 24% had a transient ischaemic attack. Patients were reviewed at 3-month intervals for 2 years. The study population consisted of 2565 (39%) patients aged less than 65 years, 2240 (34%) patients aged between 65 and 74 years, and 1797 (27%) patients aged 75 years and over. Advancing age was associated with an increased incidence of endpoints in all 4 treatment groups. The combination of ASA and DP significantly reduced the incidence of all endpoints, compared with placebo, in each age group. There was no influence of age on the efficacy of antiplatelet therapy for any of the evaluated endpoints. Relative risk reductions of treatment compared with placebo were 11.1-27.6% in the ASA group, 8.0-18.7% in the DP group, and 20.3-45.2% in patients receiving combination therapy., Conclusion: This study clearly demonstrates that combination therapy with DP and ASA is superior to either agent used alone in the secondary prevention of ischemic stroke, irrespective of the age of the patient.
- Published
- 1999
- Full Text
- View/download PDF
21. Aspirin dose in secondary prevention of stroke.
- Author
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Diener HC
- Subjects
- Humans, Aspirin administration & dosage, Cerebrovascular Disorders drug therapy, Cerebrovascular Disorders prevention & control, Fibrinolytic Agents administration & dosage
- Published
- 1998
22. European Stroke Prevention Study. 2. Dipyridamole and acetylsalicylic acid in the secondary prevention of stroke.
- Author
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Diener HC, Cunha L, Forbes C, Sivenius J, Smets P, and Lowenthal A
- Subjects
- Adult, Aged, Aspirin adverse effects, Cerebrovascular Disorders drug therapy, Cerebrovascular Disorders mortality, Demography, Dipyridamole adverse effects, Double-Blind Method, Female, Follow-Up Studies, Hemorrhage chemically induced, Humans, Ischemic Attack, Transient drug therapy, Ischemic Attack, Transient mortality, Ischemic Attack, Transient prevention & control, Male, Patient Compliance, Placebos, Platelet Aggregation Inhibitors adverse effects, Survival Analysis, Aspirin administration & dosage, Cerebrovascular Disorders prevention & control, Dipyridamole administration & dosage, Platelet Aggregation Inhibitors administration & dosage
- Abstract
In 1988, we undertook a randomized, placebo-controlled, double-blind trial to investigate the safety and efficacy of low-dose acetylsalicylic acid (ASA), modified-release dipyridamole, and the two agents in combination for secondary prevention of ischemic stroke. Patients with prior stroke or transient ischemic attack (TIA) were randomized to treatment with ASA alone (50 mg daily), modified-release dipyridamole alone (400 mg daily), the two agents in a combined formulation, or placebo. Primary endpoints were stroke, death, and stroke or death together. TIA and other vascular events were secondary endpoints. Patients were followed on treatment for two years. Data from 6,602 patients were analysed. Factorial analysis demonstrated a highly significant effect for ASA and for dipyridamole in reducing the risk of stroke (p < or = 0.001) and stroke or death combined (p < 0.01). In pairwise comparisons, stroke risk in comparison to placebo was reduced by 18% with ASA alone (p = 0.013); 16% with dipyridamole alone (p = 0.039); and 37% with combination therapy (p < 0.001). Risk of stroke or death was reduced by 13% with ASA alone (p = 0.016); 15% with dipyridamole alone (p = 0.015); and 24% with the combination (p < 0.001). The treatment had no statistically significant effect on the death rate alone. Factorial analysis also demonstrated a highly significant effect of ASA (p < 0.001) and dipyridamole (p < 0.01) for preventing TIA. The risk reduction for the combination was 36% (p < 0.001) in comparison with placebo. Headache was the most common adverse event, occurring more frequently in dipyridamole-treated patients. All-site bleeding and gastrointestinal bleeding were significantly more common in patients who received ASA in comparison to placebo or dipyridamole. We conclude that (1) ASA 25 mg twice daily and dipyridamole, in a modified-release form, at a dose of 200 mg twice daily have each been shown to be equally effective for the secondary prevention of ischemic stroke and TIA; (2) when co-prescribed the protective effects are additive, the combination being significantly more effective than either agent prescribed singly; (3) low-dose ASA does not eliminate the propensity for induced bleeding.
- Published
- 1996
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- View/download PDF
23. Low-dose ibuprofen in self-medication of mild to moderate headache: a comparison with acetylsalicylic acid and placebo.
- Author
-
Nebe J, Heier M, and Diener HC
- Subjects
- Adult, Aspirin administration & dosage, Case-Control Studies, Cross-Over Studies, Double-Blind Method, Female, Humans, Ibuprofen administration & dosage, Male, Placebos, Aspirin therapeutic use, Ibuprofen therapeutic use, Self Medication
- Abstract
A double-blind, threefold crossover, double-dummy trial was performed, investigating the efficacy of 200 mg ibuprofen compared with 500 mg acetylsalicylic acid and placebo in patients who usually treated their headaches with over-the-counter drugs. Ninety-five patients suffering from mild to moderate migraine or episodic tension-type headache were included. Seventy-seven patients entered the intention-to-treat analysis and 65 completed all three treatments. For the main response criterion, a minimum 50% decrease of headache intensity on a visual analogue scale at 1 h after treatment, ibuprofen was significantly superior to acetylsalicylic acid and placebo. This was true for migraine attacks and tension-type headache episodes. Towards the end of the observation period (150 min), the differences between ibuprofen and acetylsalicylic acid were no longer significant. In conclusion, ibuprofen was at least equivalent to acetylsalicylic acid and superior to placebo.
- Published
- 1995
- Full Text
- View/download PDF
24. [Acetylsalicylic acid in migraine].
- Author
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Diener HC
- Subjects
- Aspirin administration & dosage, Germany, Infusions, Intravenous, Migraine Disorders etiology, Societies, Medical, Aspirin therapeutic use, Migraine Disorders drug therapy
- Published
- 1991
25. Aspirin and Extended-Release Dipyridamole vs. Clopidogrel for Recurrent Stroke
- Author
-
Yusuf S, Diener H-C, and Sacco Rl
- Subjects
medicine.medical_specialty ,Aspirin ,business.industry ,Clopidogrel ,Dipyridamole ,Recurrent stroke ,Internal medicine ,medicine ,Cardiology ,Surgery ,Extended release ,business ,Cardiology and Cardiovascular Medicine ,medicine.drug - Published
- 2009
- Full Text
- View/download PDF
26. Management of atherothrombosis with clopidogrel in high-risk patients with recent transient ischaemic attack or ischaemic stroke (MATCH) study design and baseline data
- Author
-
Diener, H. C., Bogousslavsky, J, Brass, L. M., Cimminiello, C, Csiba, L, Kaste, M, Leys, D, MATIAS GUIU, J, ON BEHALF OF THE MATCH INVESTIGATORS, RUPPRECHT H. S., and Carolei, Antonio
- Subjects
medicine.medical_specialty ,Ticlopidine ,Arteriosclerosis ,MEDLINE ,Text mining ,Risk Factors ,Internal medicine ,Ischaemic stroke ,medicine ,Humans ,In patient ,cardiovascular diseases ,Stroke ,Randomized Controlled Trials as Topic ,High risk patients ,Aspirin ,business.industry ,Thrombosis ,Baseline data ,medicine.disease ,Clopidogrel ,Neurology ,Ischemic Attack, Transient ,Cardiology ,Neurology (clinical) ,Cardiology and Cardiovascular Medicine ,business ,Platelet Aggregation Inhibitors ,circulatory and respiratory physiology ,medicine.drug - Abstract
Background: The CAPRIE study showed the superiority of clopidogrel over acetylsalicylic acid (ASA) for reducing the combined risk of major atherothrombotic events in patients with recent myocardial infarction (MI), recent ischaemic stroke (IS) or established peripheral arterial disease. The benefit of clopidogrel over ASA is amplified in high-risk patients. Proof of concept for the benefit of clopidogrel in addition to ASA in patients with coronary manifestations of atherothrombosis was provided by the CURE trial. Methods: MATCH is a randomized, double-blind, placebo-controlled trial that compares clopidogrel and ASA versus clopidogrel alone in high-risk patients with recently symptomatic cerebrovascular disease. Eligible patients have experienced a transient ischaemic attack (TIA) or IS within the last 3 months and have evidence of at least 1 additional risk factor within the last 3 years (prior IS, MI, stable or unstable angina pectoris, diabetes or symptomatic peripheral arterial disease). Patients were randomized to receive ASA 75 mg once daily or placebo, with both groups receiving clopidogrel 75 mg once daily as part of standard therapy. The primary end point is the composite of IS, MI, vascular death and rehospitalization for an acute ischaemic event. The duration of treatment and follow-up is 18 months for each patient. Results: Enrolment was completed in April 2002, with 7,599 patients randomized to receive the study medication. The mean age at randomization was 66 years, and the qualifying event was IS in 78.9% of patients and TIA in 21.1%. The baseline features of the study cohort indicate a population that is at a high risk for atherothrombotic recurrence. Conclusion: MATCH is a major ongoing trial that will provide important data on the benefit of clopidogrel and ASA compared with clopidogrel alone for reduction of vascular ischaemic events in patients with recent TIA or IS who are at high risk of atherothrombotic event recurrence.
- Published
- 2004
27. Efficacy and safety of 1,000mg effervescent aspirin: individual patient data meta-analysis of three trials in migraine headache and migraine accompanying symptoms.
- Author
-
Lampl, Christian, Voelker, M., and Diener, H. C.
- Subjects
ASPIRIN ,MIGRAINE complications ,HEADACHE ,DRUG side effects ,META-analysis ,NONSTEROIDAL anti-inflammatory agents ,SUMATRIPTAN ,INDOLE alkaloids - Abstract
Migraine is often associated with health consequences including impaired quality of life, and the cost of treating migraine headaches places a significant financial burden on patients who suffer from migraines. Nonsteroidal anti-inflammatory drugs (NSAIDs) and triptans are commonly used for the treatment of acute migraine attacks. Aspirin is widely accepted as a treatment option for migraine pain relief and could provide an alternative not only for treatment of moderate migraine attacks, but also for severe migraine attacks. The efficacy and safety of 1,000 mg effervescent aspirin (eASA) was evaluated in comparison to 50 mg sumatriptan and placebo in an individual patient data meta-analysis of three randomized, placebo-controlled, single- dose migraine trials. Pain-relief at 2 h, pain-free at 2 h and sustained pain-free up to 24 h were calculated. For eASA, the response rates were 51.5 % (95 % CI: 46.6–56.5 %), 27.1 % (95 % CI: 22.6–31.4 %), and 23.5 % (95 % CI: 19.3–27.7 %). For sumatriptan, the response rates were 46.6 % (95% CI: 40.0–53.2 %), 29% (95 % CI: 23.0–34.9 %), and 22.2 % (95 % CI: 16.7–27.6 %). The corresponding rates for placebo were 33.9 % (95% CI: 29.1–38.6 %), 15.1 % (95 % CI: 11.5–18.7 %), and 14.6 % (95 % CI: 11.0–18.1 %). The treatment effect of eASA and sumatriptan were significantly different from placebo (p < 0.001), but differences between eASA and sumatriptan were not significant. The remission of accompanying symptoms and the subgroup analyses of patients with moderate or severe migraine pain at baseline revealed no significant differences between eASA and sumatriptan. Safety was evaluated based on the frequency of reported adverse events, and treatment with eASA was associated with lower incidence of adverse events than was with sumatriptan. This individual patient data meta-analysis provided evidence that eASA 1,000mg is as effective as sumatriptan 50mg for the treatment of acute migraine attacks and has a better side effect profile. This is also true for patients with moderate as well as severe headache at baseline. Patients therefore should be advised to use eASA first for migraine attacks and use a triptan in case of no response. [ABSTRACT FROM AUTHOR]
- Published
- 2007
- Full Text
- View/download PDF
28. TREATING MIGRAINE EFFECTIVELY.
- Author
-
Diener, H.-C.
- Subjects
- *
MIGRAINE , *THERAPEUTICS , *ASPIRIN , *SUMATRIPTAN , *PLACEBOS , *DRUG efficacy - Abstract
The article discusses the treatment of migraine. Acetylsalicylic acid has been used as an analgesic, anti-pyretic and anti-inflammatory drug. The results of an individual patient data meta-analysis of trials with effervescent aspirin in comparison with sumatriptan and placebo in acute migraine attacks showed comparable efficacy for effervescent aspirin and sumatriptan.
- Published
- 2006
29. USING ASPIRIN INTRAVENOUSLY.
- Author
-
Diener, H.-C.
- Subjects
- *
ASPIRIN , *INJECTIONS , *MIGRAINE , *SUMATRIPTAN , *PLACEBOS , *DRUG side effects - Abstract
The article discusses research on the efficacy and safety of intravenous lysine acetyl salicylate (iLAS) in the acute treatment of migraine. It references a study by H. C. Diener published in a previous issue of "Cephalalgia." Findings indicated that both iLAS and sumatriptan were superior to placebo. Adverse events were reported in some patients treated with iLAS.
- Published
- 2006
- Full Text
- View/download PDF
30. Pain measurement: Visual Analogue Scale (VAS) and Verbal Rating Scale (VRS) in clinical trials with OTC analgesics in headache.
- Author
-
Aicher, B, Peil, H, Peil, B, and Diener, H-C
- Subjects
- *
ACETAMINOPHEN , *ANALGESICS , *ASPIRIN , *CAFFEINE , *COMBINATION drug therapy , *COMPARATIVE studies , *HEADACHE , *RESEARCH methodology , *MEDICAL cooperation , *PHARMACOKINETICS , *RESEARCH , *EVALUATION research , *PAIN measurement , *RECEIVER operating characteristic curves , *STANDARDS ,RESEARCH evaluation - Abstract
Aim: The aim was to assess the performance of the Visual Analogue Scale (VAS) in patients recruited in a clinical trial with over the counter analgesics in headache.Methods: The Thomapyrin Study showed the significant superiority of the fixed combination of acetylsalicylic acid + paracetamol + caffeine over the combination without caffeine, the single preparations, and placebo in the treatment of headache. Patients enrolled into the study were trained in the handling of the VAS by naming categories of a 6-point Verbal Rating Scale (VRS). These data were used to evaluate the level of order consistency between the VAS and VRS, to deduce cut-off points for rescaling the continuous VAS into a discrete ordinal scale using the receiver operating characteristic methodology, and to assess the test-retest performance.Results: Approximately 75% of the patients recorded the pain intensity on the VAS in the same order as given on the VRS. However, in 12.6% of patients, the German terms 'leicht' (mild) and 'mäßig' (moderate) were mixed up regarding their order on the VAS. Substantial overlapping of the frequency distributions of the VAS assessment were found for the VRS categories mild and moderate pain as well as severe and very severe pain. Grouping of the VAS assessments into a discrete ordinal scale necessitated a non-equidistant rescaling based on the categories of the VRS. By means of analysis of the receiver operating characteristic curves, the following cut-off points were determined on a 100 mm VAS: no pain 0-2 mm, mild pain 2-17 mm, moderate pain 17-47 mm, severe pain 47-77 mm, very severe pain 77-96 mm, most severe pain imaginable 96-100 mm. Repeated assessment up to several months after the first assessment demonstrated a test-retest agreement on the VAS in 61.0-91.4% of the patients, depending on the VRS category.Conclusions: This study shows that the VRS categories cannot be presented in an equidistant manner on the VAS, and that contrary to previous assumptions, the pain intensity descriptors are less clear and can have different meanings in different languages. Therefore, both in the 3rd edition of the International Headache Classification (ICHD-III) and in the guidelines for clinical trials of patients with headache illnesses, rather than a 4-grade VRS, a 6-grade or higher level VRS or a VAS should be recommended, with correspondingly broadly defined anchor points. [ABSTRACT FROM AUTHOR]- Published
- 2012
- Full Text
- View/download PDF
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