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Biomedical subjects

C G Dahlöf

Publications and source records attributed to C G Dahlöf.

At least 19 recordsLinked to original sources
PubMed2006

Efficacy, speed of action and tolerability of almotriptan in the acute treatment of migraine: pooled individual patient data from four randomized, double-blind, placebo-controlled clinical trials.

A meta-analysis of pooled individual patient data from four randomized, placebo-controlled, double-blind trials comparing several doses of almotriptan (n = 1,908) with placebo (n = 386) was used to investigate the efficacy, speed of onset and tolerability of almotriptan in the acute treatment of migraine. As early as 30 min after dosing, almotriptan 12.5 mg was significantly more effective than placebo for pain relief (14.9% vs. 8.2%; P < 0.05) and pain free (2.5% vs. 0.7%; P < 0.05). At 2 h, pain-relief rates were 56.0%, 63.7% and 66.0% for almotriptan 6.25, 12.5 and 25 mg, respectively, compared with 35% for placebo; 2-h pain-free rates were 26.7%, 36.4% and 43.4% compared with 13.9% for placebo. All almotriptan dosages were significantly more effective than placebo in eliminating migraine-associated symptoms (P < 0.05) and in achieving sustained pain relief up to 24 h (P < 0.05). The incidence of adverse events after almotriptan 6.25 mg and 12.5 mg was not significantly different from that of placebo. This meta-analysis confirms the findings of individual clinical trials, while demonstrating for the first time, significant pain-free efficacy at 30 min compared with placebo.

Acute Disease↗
PubMed2005

Focus on trial endpoints of clinical relevance and the use of almotriptan for the acute treatment of migraine.

Almotriptan is a 5-HT(1B/1D) receptor agonist, or triptan, indicated for the acute treatment of migraine. It has been shown to be effective and well tolerated for the treatment of acute migraine in approximately 5000 patients enrolled in short-term placebo- and active-controlled trials and long-term open-label trials. A recent meta-analysis reported that almotriptan has the highest sustained pain-free (SPF) rate and lowest adverse-event (AE) rate of all oral triptans. Sustained pain free is a composite endpoint of pain freedom at 2 h, no recurrence of moderate-to-severe headache and no use of rescue medication from 2 to 24 h after dosing. Patient surveys have indicated that migraine sufferers consider complete pain relief, no recurrence, rapid onset and no side-effects to be the most important attributes of their acute treatment. Composite endpoints such as SPF and SPF with no AEs (SNAE) contain the attributes that migraine sufferers express as being the most important elements of an acute migraine therapy, and their use in future clinical trials should aid in the selection of agents that can offer patients the highest likelihood of consistent treatment success.

Acute Disease↗
PubMed2001

Sumatriptan: pharmacological basis and clinical results.

Sumatriiptan was the first selective serotonin (5-HT)1B/1D agonist for the acute treatment of migraine attacks. Apart from the subcutaneous and oral formulation, it is also available as nasal spray and suppository. In placebo-controlled clinical trials, sumatriptan, administered subcutaneously, orally, intranasally or rectally was significantly more effective than placebo in relieving migraine headache and in producing relief or resolution of other symptoms associated with migraine, including nausea, photophobia and phonophobia. For patients who desire particularly rapid relief that cannot be provided by a tablet form, sumatriptan injection with a 10-minute onset of action may be an appropriate choice. Patients with very severe attacks and those with vomiting may also benefit from the injection. For patients with nausea who do not wish to take tablets or who fear injections, a sumatriptan nasal spray or a suppository may be appropriate options. New triptans, zolmitriptan, rizatriptan, and naratriptan began entering the market in 1997 but in clinical practice, in particular after dose adjustments have been made, all triptans appear to be very similar with respect to efficacy and tolerability as well as safety.

Administration, Inhalation↗
PubMed2000

Within-patient consistency of response of rizatriptan for treating migraine.

OBJECTIVE: To determine the within-patient consistency of response for rizatriptan, a 5-HT(1B/1D) receptor agonist for the acute treatment of migraine. METHODS: Post hoc analysis was performed on data from a randomized, double-blind, placebo-controlled clinical trial. Four hundred seventy-three patients with migraine diagnosed according to the criteria of the International Headache Society were randomly assigned to one of five sequence groups in which each patient was scheduled to treat four separate moderate or severe migraine attacks. Patients in four groups received 10 mg of rizatriptan for three of four attacks and placebo for the remaining attack; patients in the fifth group received 10 mg of rizatriptan for all four attacks. Headache severity, functional disability, and associated migraine symptoms were measured immediately before dosing and at regular intervals up to 4 hours after the dose. The analysis was based on efficacy at 2 hours after dosing, the last time point before escape medications were allowed. The percentages of patients who responded in a specified number of attacks after treatment with rizatriptan were calculated. The analysis was descriptive, and no formal statistical testing was performed. RESULTS: Of the evaluable patients who treated three migraine attacks with 10 mg of rizatriptan (with an additional interspersed placebo-treated attack in most patients), 216 of 252 (86%) had pain relief (reduction of pain to mild or none), 122 of 252 (48%) were pain free, 211 of 250 (84%) had no nausea, 163 of 251 (65%) had no photophobia, 182 of 252 (72%) had no phonophobia, 136 of 249 (55%) had no functional disability, and 233 of 252 (92%) had no need for escape medications at 2 hours after dosing in at least two of three attacks. CONCLUSION: The response to 10 mg of oral rizatriptan within individual patients was consistent over three attacks on a range of measures.

Adolescent↗
PubMed1998

[New triptan preparations can help the migraine patient. Pharmacodynamic and pharmacokinetic progresses].

Migraine is an idiopathic, recurrent neurovascular headache disorder characterised by attacks of debilitating pain associated with photophobia, phonophobia, nausea and vomiting. It is apparently a global disorder, occurring in all races, cultures and geographical locations. Migraine has a hereditary component, and its life-time prevalence is about 16%. About a third of migraine patients in Sweden seem to be particularly sorely afflicted having 1-6 severe attacks a month and accounting for more than 80 per cent of the annual total of about 14 million attacks in the country as a whole. In general, these migraine sufferers do not obtain satisfactory relief from simple analgesice or NSAIDs (non-sterodial antiinflammatory drugs only), and thus require additional migraine-specific treatment. Selective 5-HT1B/1D-agonists, the so-called triptans, have become an invaluable addition to the therapeutic arsenal for treating this category of patients.

Analgesics↗
PubMed1998

How does sumatriptan nasal spray perform in clinical practice?

Migraineurs (94F, 24M) with previous experience of subcutaneous sumatriptan and/or sumatriptan tablets were asked their opinion on sumatriptan nasal spray treatment particularly with respect to onset of action, total efficacy, tolerability, and user friendliness. The information was obtained by means of a self-administered questionnaire handed out at the time of prescription of the nasal spray. The results are based on the patients' cumulative experience of having treated at least two migraine attacks with the spray (20 mg). Sumatriptan nasal spray (20 mg) was perceived to have a faster onset of action and, with the exception of a bad taste, to have a better tolerability than the tablets. Compared with subcutaneous sumatriptan, the nasal spray was claimed to be less effective in reducing symptoms of migraine attacks but to cause fewer adverse events. A bitter taste was the most commonly reported side effect of sumatriptan nasal spray--reported by 68% (80 out of 118) of the migraineurs. The user friendliness of sumatriptan nasal spray was rated better than that of subcutaneous sumatriptan and/or sumatriptan tablets. The overall impression of sumatriptan nasal spray was reported to be better or equal to that of the tablet and the injection by 57% and 46%, respectively. It is concluded that the results obtained in clinical practice are very much in line with those obtained in controlled clinical trials. The overall impression of sumatriptan nasal spray is that it is user friendly and useful in the acute treatment of migraine attacks of moderate intensity.

Administration, Intranasal↗
PubMed1998

Safety trial with the 5HT1B/1D agonist avitriptan (BMS-180048) in patients with migraine who have experienced pressure, tightness, and/or pain in the chest, neck, and/or throat following sumatriptan.

We investigate whether symptoms of pressure, tightness, and/or pain in the chest, neck, and/or throat after administration of the 5HT1B/1D agonist avitriptan were associated with objective impairment of the myocardial function on 12-lead electrocardiogram (ECG), continuous ECG (Holter) monitoring, and echocardiography. Migraine sufferers who in two-thirds of all attacks treated with sumatriptan had experienced chest/throat/neck symptoms were chosen for study. Baseline measures included vital signs, a 12-lead ECG and an echocardiogram. Patients (n = 51) who had no clinically significant abnormality at baseline received a high dose (150 mg) of avitriptan orally outside of a migraine attack. If pressure, tightness, and/or pain in the chest, neck, and/or throat occurred, an ECG was obtained, and a repeat echocardiogram was done while the symptoms were present in order to monitor for impairment of myocardial function. If symptoms of these types did not occur within 60 min after administration of the study drug, a second echocardiogram was obtained. Forty-five patients (88%) reported at least one adverse event and 23 (45%) experienced pressure, tightness, and/or pain in the chest, neck, and/or throat after administration of avitriptan. No clinically significant myocardial abnormalities were observed in any patients, even in those who had experienced the targeted symptoms. No other serious adverse event occurred. We concluded that the typical 5HT1B/1D agonist-induced chest/throat/neck symptoms are most unlikely to be of cardiovascular origin.

Adult↗
PubMed1998

Pathophysiology and pharmacology of migraine. Is there a place for antiemetics in future treatment strategies?

This article reviews the pathophysiology and pharmacology of emesis in relation to migraine pathogenesis. Also, the place of antiemetic and gastrointestinal prokinetic agents in current and future acute migraine treatment strategies is reviewed. The mechanisms of action of current and novel acute migraine therapies are considered with respect to the neurogenic and vascular hypothesis. Control of migraine-associated nausea and vomiting is often achieved with the benzamide dopamine D2 receptor antagonist metoclopramide. This drug also has 5HT3 receptor antagonist activity and reproducibly stimulates gastric motility to increase the availability of orally administered drugs. Other antiemetic and gastroprokinetic agents with potential value for the treatment of migraine-associated nausea and vomiting could speed absorption of oral antimigraine therapies without central nervous system side effects. Domperidone, a dopamine D2 receptor antagonist that does not cross the blood brain barrier is relatively free of the central side-effect liability of metoclopramide. Cisapride, a benzamide 5HT4 receptor agonist gastrointestinal prokinetic drug, lacks dopamine antagonist activity. A controlled comparison of these agents as migraine co-therapies could provide information on the importance of peripheral and central mechanisms in migraine-associated nausea and vomiting and improve antimigraine treatment options.

Antiemetics↗
PubMed1996

Ketoprofen, paracetamol and placebo in the treatment of episodic tension-type headache.

The aim of the study was to assess the efficacy and tolerability of a single oral dose of ketoprofen 25 mg in comparison with single doses of ketoprofen 2 x 25 mg, paracetamol 500 mg and 1,000 mg, and placebo in the treatment of episodic tension-type headache. The study was conducted as a single centre, double-blind, randomized, placebo-controlled, five-period, within-patient comparative trial in outpatients with episodic tension-type headache according to the International Headache Society's diagnostic criteria. Each patient had to treat five attacks of episodic tension-type headache with a single dose of each of the tested medications with a minimum interval of 72 h between two attacks. Details of the attack and response to treatment were recorded on a diary card. Altogether 30 patients treated 5 attacks and 2, 3, 1 and 4 patients treated 4, 3, 2 and 1 attack, respectively. The primary variable was decrease in headache pain intensity from baseline to 2 h after intake, evaluated by means of a 100 mm visual analogue scale. Ketoprofen 50 mg was significantly better than placebo and paracetamol for this main criterion. Neither of the paracetamol groups differed from the placebo group. Only a few adverse events were reported, usually of mild or moderate severity, with no difference between the treatments. Ketoprofen 50 mg may be considered an effective and well tolerated analgesic in the treatment of episodic tension-type headache of moderate or severe intensity.

Acetaminophen↗
PubMed1996

Alniditan in the acute treatment of migraine attacks: a subcutaneous dose-finding study. Subcutaneous Alniditan Study Group.

Alniditan is a new 5HT1D receptor agonist, belonging to a different chemical class from sumatriptan and other indole derivatives used or being developed for the treatment of acute migraine. In a multinational double-blind randomized parallel-groups dose-finding trial, alniditan was given subcutaneously in hospital to patients with migraine headache of moderate or severe intensity at doses of 0.8 mg (n = 44), 1.0 mg (n = 42), 1.2 mg (n = 46) and 1.4 mg (n = 39). Efficacy, tolerability and safety of each dose were compared with those of placebo (n = 41). At 2 h after injection, headache was absent or mild in 83% and 82% of patients receiving alniditan 1.2 and 1.4 mg respectively compared with 39% for placebo (p < or = 0.002). Complete relief from headache was achieved in 72% (1.4 mg). Time to onset of relief decreased with increasing alniditan dose, and there was a dose-dependent reduction in headache recurrence rate: 25% of patients receiving 1.4 mg had responded by 15 min and headache recurred within 24 h in only 16% of the patients who initially responded to alniditan 1.4 mg, significantly less than for placebo (p = 0.018). Alniditan was superior to placebo in reducing the associated symptoms of nausea, phonophobia and photophobia, and in increasing patients' functional ability. The use of rescue medication was reduced when compared with placebo, and up to 87% of patients said that they would use the drug again if available. No clinically relevant cardiovascular effects were seen, nor consistent changes in clinical laboratory findings. Adverse effects, mainly head pressure, paraesthesia, and hot flushes, were reported by 34% of placebo-treated patients and up to 70% of patients receiving alniditan, but all doses were very well tolerated and no clear relationship with dose was established. Comparison with published findings suggests that alniditan 1.4 mg sc may have advantages over sumatriptan 6 mg sc in providing complete relief from acute migraine headache, and may be associated with fewer headache recurrences within 24 h. Both of these suggestions warrant further and larger trials of alniditan in acute migraine.

Adult↗
PubMed1995

Migraine patients experience poorer subjective well-being/quality of life even between attacks.

The aim of the present study was to compare the general well-being of migraine patients between attacks with that of an age- and sex-matched control group. One hundred and forty-five consecutive and eligible patients at the Gothenburg Migraine Clinic were asked about their well-being and their complaints. Using three self-administered standardized questionnaires, the Minor Symptoms Evaluation Profile (MSEP), Subjective Symptoms Assessment Profile (SSAP) and the Psychological General Well-Being (PGWB) Index, evaluable responses were obtained from 138 migraine patients. Compared with control subjects, migraineurs perceived more symptoms and greater emotional distress as well as disturbed contentment, vitality and sleep. It is concluded that the general well-being of the migraine patient is impaired, even between the attacks.

Adult↗
PubMed1995

Health-related quality of life under six months' treatment of migraine--an open clinic-based longitudinal study.

Health-related quality of life (HQL) assessment in the clinical setting have distinguished subjective perceptions (e.g., well-being), signs/symptoms of the disease and functional capacity as three major components. The impact of short-term treatment for migraine attacks on these variables was evaluated in an open prospective 6-month study at the Gothenburg Migraine Clinic. Socio-economic factors, subjective symptoms, and general well-being/quality of life were evaluated by self-administered questionnaires in 99 patients with migraine with or without aura in accordance with the classification of the International Headache Society. Short-term treatment comprising conventional therapy or subcutaneous sumatriptan reduced number of days per month with migraine and absenteeism from work, migraine-associated symptoms, but did not significantly improve general well-being between attacks. Future assessment of the patients' HQL in accordance with this approach would enable us to consider all the advantages and disadvantages of current therapies of particular interest in the field of migraine.

Adrenergic beta-Antagonists↗
PubMed1995

How does sumatriptan perform in clinical practice?

The patient's opinion on sumatriptan treatment has been obtained from 351 migraineurs (299F and 52M) by means of a telephone survey. The results are based on the patient's cumulative experience of more than 20,000 subcutaneous injections and more than 2,000 tablet doses. The average period during which subcutaneous sumatriptan (12 mg/ml, 0.5 ml) was used was 19.1 +/- 0.4 months and 84% of the patients had used more than 10 injections. The average number of migraine attacks per month was 3.0 +/- 0.1, injections per attack 1.7 +/- 0.1, and number of tablets (100 mg) per attack 1.8 +/- 0.2. Attack duration was decreased from on average 38.4 +/- 2.1 h to 2.3 +/- 0.5 h by subcutaneous sumatriptan and to 3.4 +/- 1.0 by orally administered sumatriptan. The average degree of efficiency at work with migraine was 76.3 +/- 1.9% on sumatriptan compared with 26.6% on other treatment options; 85% said that sumatriptan was much better than previous conventional therapies tested. During their experience with sumatriptan, 89% of the migraineurs reported altogether 1,058 adverse events (average 3.6 +/- 01, range 1 to 12) in connection with subcutaneous sumatriptan treatment. The three most frequent were drowsiness/sedation (49%), chest symptoms (40%) and injection site symptoms (37%). Among the table users, 87% reported altogether 122 adverse events (average 2.6 +/- 0.3, range 1 to 11). Seventy-eight percent of the responders responded to subcutaneous sumatriptan sometimes (22% always, 15% every second attack, 40% seldom) experienced a recurrence of their headache within 24 h. The average number of recurrences was 1.7 +/- 0.1 and the average time to recurrence 13.0 +/- 0.6 h (range 1.5-24 h). It is concluded that the selected group of migraineurs found sumatriptan to be very effective in reducing the symptoms of their migraine attacks, but also to cause several adverse events, in many cases, with short-lasting effect.

Administration, Oral↗
PubMed1990

Subjective symptoms and pharmacokinetics/dynamics of metoprolol CR in elderly subjects--a comparison with atenolol.

In a double-blind, randomised, cross-over study, the pharmacokinetic/dynamic effects and subjective symptoms of a new controlled-release (CR) formulation of metoprolol (50 and 100 mg) have been compared with atenolol (50 mg) and placebo in 20 elderly healthy subjects. The metoprolol CR formulation displayed an even plasma concentration-time profile over the dosage interval while atenolol produced a peak at 2-4 h. All three active treatments produced significant beta 1-blockade at 24 h compared to placebo. Four hours after dose intake, the degree of beta 1-blockade was significantly greater with conventional atenolol 50 mg than with either dose of metoprolol CR. Subjective well-being was examined with a self-administered questionnaire (MSE-profile), including three dimensions: Contentment, Vitality and Sleep. No significant differences were detected between placebo and either dose of metoprolol CR. At 2 h, following atenolol, a deterioration in Vitality was observed compared to placebo and metoprolol CR 100 mg. At the end of the dosage interval there was no longer any significant difference between the treatments. Perceived leg fatigue during exercise, evaluated 4 h after dosing, was more pronounced during treatment with atenolol than metoprolol CR 50 mg. The results suggest that the metoprolol CR formulation was not associated with significant effects on subjective well-being, whereas atenolol caused a deterioration at the time of the peak plasma concentration of the drug.

Aged↗
PubMed1990

Defining quality of life in medicine.

In recent years, there has been increasing interest in incorporating the concept of "Quality of Life" in the evaluation of medical interventions. The lack of a general definition which can function as a basis for the scientific evaluation of medical treatment is, however, a problem. The definition proposed in this paper contains three main factors: Subjective well-being, Health and Welfare. "Subjective well-being" is the central component in the evaluation of Quality of Life, referring to the individual's perception of his life situation, "Health" is a subjective as well as objective evaluation of physical and mental status, while "Welfare" reflects the objective environmental factors. Thus, the evaluation of Quality of Life in medicine should ideally address these three main factors. Although the importance of any particular component may vary, subjective well-being and health should always be included.

Delivery of Health Care↗
PubMed1989

Differences in the subjective well-being and symptoms of normotensives, borderline hypertensives and hypertensives.

In this study, previously untreated subjects were randomly recruited from a blood pressure screening programme. After repeated measurement of blood pressure levels, the subjects were divided into three major groups: normotensives (n = 95), borderline hypertensives (n = 69) and hypertensives (n = 30). Three self-administered standardized questionnaires were used to measure different aspects of subjective well-being and symptoms: the Nottingham Health Profile (NHP), the Subjective Symptoms Assessment Profile (SSAP) and the Minor Symptoms Evaluation Profile (MSEP). The results indicate gradual differences between the three groups, the most pronounced symptoms being seen among the hypertensives. Statistically significant differences were found for cardiac and gastrointestinal symptoms as well as for emotional reactions, home life, social life, sex life and sleep. The differences in well-being and subjective symptoms noted between the groups are important in the evaluation of new antihypertensive agents. Self-administered questionnaires of the type used in this study could also be valuable in identifying symptoms and disturbances in subjective well-being related to the antihypertensive medication per se.

Adult↗