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Biomedical subjects

M J Gawel

Publications and source records attributed to M J Gawel.

At least 19 recordsLinked to original sources
PubMed2001

A systematic review of the use of triptans in acute migraine.

OBJECTIVE: A systematic review of the literature was undertaken, to consolidate evidence concerning the efficacy and safety of triptans currently available in Canada (sumatriptan, rizatriptan, naratriptan, zolmitriptan), and to provide guidelines for selection of a triptan. METHODS: Data from published, randomized, placebo-controlled trials were pooled and a combined number needed to treat (NNT) and number needed to harm (NNH) was generated for each triptan. Direct comparative trials of triptans were also examined. RESULTS: The lowest NNT for headache response/pain-free at one/two hours is observed with subcutaneous sumatriptan. Among the oral formulations, the lowest NNT is observed with rizatriptan and the highest NNT with naratriptan. The lowest NNH is observed with subcutaneous sumatriptan. CONCLUSIONS: Triptans are relatively safe and effective medications for acute migraine attacks. However, differences among them are relatively small. Considerations in selecting a triptan include individual patient response/tolerance, characteristics of the attacks, relief of associated symptoms, consistency of response, headache recurrence, delivery systems and patient preference.

Acute Disease↗
PubMed2001

Eletriptan.

Eletriptan (Relpax, Pfizer) is one of a group of anti-migraine medications commonly referred to as 'triptans'. It is a potent serotonin agonist at the 5-HT(1B/1D) receptor and is indicated for the acute treatment of migraine headaches. Eletriptan is administered orally. It is rapidly absorbed and has a bioavailability of 50% compared to 14% for sumatriptan. The relatively high lipophilicity of eletriptan compared to sumatriptan may explain its faster oral absorption and shorter time to onset of action. Results from comparative studies between oral eletriptan and sumatriptan indicate that eletriptan 80 mg was superior to sumatriptan 100 mg in onset of action, headache response rate, pain free response rate and relief of associated migraine symptoms at the 1 or 2 h time intervals. Although there was a modest increase in adverse events with eletriptan 80 mg than with sumatriptan 100 mg, eletriptan received a high patient acceptability rating (84%).

Clinical Trials as Topic↗
PubMed2000

Oral zolmitriptan is effective in the acute treatment of cluster headache.

OBJECTIVE: To evaluate the efficacy and tolerability of oral zolmitriptan 5 mg and 10 mg and placebo in cluster headache. METHODS: A multicenter, double-blind, randomized, three-period, crossover, outpatient study. Adult patients received placebo and zolmitriptan 5 mg and 10 mg orally for the acute treatment of episodic or chronic cluster headache. Headache intensity was rated by a five-point scale: none, mild, moderate, severe, or very severe. Patients only treated moderate to very severe headaches. The primary efficacy measure was headache response (two-point or greater reduction from baseline in the cluster headache rating scale) at 30 minutes. Secondary efficacy measures included proportion of patients with initial headache relief within 15 and 30 minutes, mild or no pain at 30 minutes, meaningful headache relief, and use of escape medication. RESULTS: A total of 124 patients took at least one dose of study medication, with 73% having episodic and 27% chronic cluster headache. For the primary endpoint, there was a treatment-by-cluster-headache-type interaction (p = 0.0453). Therefore, results are presented separately for chronic and episodic cluster headache. In patients with episodic cluster headache, the difference between zolmitriptan 10 mg and placebo at 30 minutes reached significance (47% versus 29%; p = 0.02). Mild or no pain at 30 minutes was reported by 60%, 57%, and 42% patients treated with zolmitriptan 10 mg, zolmitriptan 5 mg, and placebo (both p </= 0.01 versus placebo). For all other secondary endpoints, zolmitriptan 10 mg was significantly superior to placebo in episodic cluster headache patients, whereas zolmitriptan 5 mg was significantly superior to placebo for three of the four secondary endpoints. In patients with chronic cluster headache, response rates following zolmitriptan 5 mg or 10 mg were not significantly different from placebo at any endpoint. Zolmitriptan 5 mg and 10 mg were well tolerated. CONCLUSION: Oral zolmitriptan is efficacious in episodic cluster headache.

Acute Disease↗
PubMed1999

Measurement of health-related quality of life in patients with amyotrophic lateral sclerosis in clinical trials of new therapies.

OBJECTIVES: Recent trials of amyotrophic lateral sclerosis (ALS) therapies have included the Sickness Impact Profile (SIP) to evaluate health-related quality of life (HQL). The purpose of this study was to assess the feasibility, psychometric properties, and interpretation of the Sickness Impact Profile in this setting. METHODS: The Sickness Impact Profile was administered at baseline, 3, 6, and 9 months during a double-blind, placebo-controlled study of recombinant human insulin-like growth factor I. The frequency of missing Sickness Impact Profile data and administration time were recorded. Patients' scores on the Appel ALS (AALS) Rating Scale were used to identify a stable subgroup for reliability testing and clinically distinct groups for validity testing. Internal consistency reliability and reproducibility were evaluated using Cronbach's alpha and intraclass correlation coefficients, respectively. Analysis of variance (ANOVA) models and t tests were used to assess validity. Effect sizes and the responsiveness index were used to assess responsiveness. RESULTS: At baseline, 259 (97%) patients completed a 30-minute Sickness Impact Profile interview. At subsequent assessments, response rates ranged from 92% to 97% and mean administration times ranged from 25 to 27 minutes. The overall Sickness Impact Profile score demonstrated alpha reliability and 3-month stability coefficients of 0.94 and 0.80, respectively. Baseline overall Sickness Impact Profile scores discriminated between patients in the two AALS-defined groups with a mean of 13.0+/-7.8 and 24.0+/-11.7 in the better and worse AALS groups, respectively. Similarly, mean overall SIP change scores discriminated patients progressing at different rates (slow to moderate = 4.00+/-7.97; rapid = 10.74+/-8.76). With few exceptions, dimension and category scores met similar criteria. Responsiveness statistics for the physical and overall Sickness Impact Profile scores were lower at 3 months and higher at 6 and 9 months. CONCLUSIONS: The feasibility, psychometric, and interpretive findings support the validity of the Sickness Impact Profile for assessing outcomes of amyotrophic lateral sclerosis and its treatment. Based on these findings, we recommend including the Sickness Impact Profile in future amyotrophic lateral sclerosis clinical trials.

Activities of Daily Living↗
PubMed1999

The new triptans.

In the past 10 years, new compounds have been developed for the acute treatment of migraine. Studies of a group of compounds called the triptans are summarized. The triptans are derived from the serotonin molecule and act on the 5-hydroxytryptamine 1B/1D receptors. The receptors are on the blood vessels, trigeminal neurons and trigeminal nucleus caudalis. Activation of these receptors causes constriction of extracerebral intracranial vessels, abolition of the dural extravasation and neurogenic inflammation, and inhibition of trigeminal neuronal discharge. The drugs are sumatriptan, zolmitriptan, naratriptan, rizatriptan and eletriptan. Their pharmacology and clinical properties are reviewed and compared.

Humans↗
PubMed1998

Guidelines for the nonpharmacologic management of migraine in clinical practice. Canadian Headache Society.

OBJECTIVE: To provide physicians and allied health care professionals with guidelines for the nonpharmacologic management of migraine in clinical practice. OPTIONS: The full range and quality of nonpharmacologic therapies available for the management of migraine. OUTCOMES: Improvement in the nonpharmacologic management of migraine. EVIDENCE AND VALUES: The creation of the guidelines followed a needs assessment by members of the Canadian Headache Society and included a statement of objectives; development of guidelines by multidisciplinary working groups using information from literature reviews and other resources; comparison of alternative clinical pathways and description of how published data were analysed; definition of the level of evidence for data in each case; evaluation and revision of the guidelines at a consensus conference held in Ottawa on Oct. 27-29, 1995; redrafting and insertion of tables showing key variables and data from various studies and tables of data with recommendations; and reassessment by all conference participants. BENEFITS, HARMS AND COSTS: Augmentation of the use of nonpharmacologic therapies for the acute and prophylactic management of migraine is likely to lead to substantial benefits in both human and economic terms. RECOMMENDATIONS: Both the avoidance of migraine trigger factors and the use of nonpharmacologic therapies have a part to play in overall migraine management. VALIDATION: The guidelines are based on consensus of Canadian experts in neurology, emergency medicine, psychiatry, psychology and family medicine, and consumers. Previous guidelines did not exist. Field testing of the guidelines is in progress.

Acupuncture Therapy↗
PubMed1997

Guidelines for the diagnosis and management of migraine in clinical practice. Canadian Headache Society.

OBJECTIVE: To provide physicians and allied health care professionals with guidelines for the diagnosis and management of migraine in clinical practice. OPTIONS: The full range and quality of diagnostic and therapeutic methods available for the management of migraine. OUTCOMES: Improvement in the diagnosis and treatment of migraine, which will lead to a reduction in suffering, increased productivity and decreased economic burden. EVIDENCE AND VALUES: The creation of the guidelines followed a needs assessment by members of the Canadian Headache Society and included a statement of objectives; development of guidelines by multidisciplinary working groups using information from literature reviews and other resources; comparison of alternative clinical pathways and description of how published data were analysed; definition of the level of evidence for data in each case; evaluation and revision of the guidelines at a consensus conference held in Ottawa on Oct. 27-29, 1995; redrafting and insertion of tables showing key variables and data from various studies and tables of data with recommendations; and reassessment by all conference participants. BENEFITS, HARMS AND COSTS: Accuracy in diagnosis is a major factor in improving therapeutic effectiveness. Improvement in the precise diagnosis of migraine, coupled with a rational plan for the treatment of acute attacks and for prophylactic therapy, is likely to lead to substantial benefits in both human and economic terms. RECOMMENDATIONS: The diagnosis of migraine can be improved by using modified criteria of the International Headache Society as well as a semistructured patient interview technique. Appropriate treatment of symptoms should take into account the severity of the migraine attack, since most patients will have attacks of differing severity and can learn to use medication appropriate for each attack. When headaches are frequent or particularly severe, prophylactic therapy should be considered. Both the avoidance of migraine trigger factors and the application of nonpharmacological therapies play important roles in overall migraine management and will be addressed at a later date. VALIDATION: The guidelines are based on consensus of Canadian experts in neurology, emergency medicine, psychiatry, psychology, family medicine and pharmacology, and consumers. Previous guidelines did not exist. Field testing of the guidelines is in progress.

Adrenergic beta-Antagonists↗
PubMed1997

Effect of recombinant human insulin-like growth factor-I on progression of ALS. A placebo-controlled study. The North America ALS/IGF-I Study Group.

The objective of this study was to investigate the safety and efficacy of recombinant human insulinlike growth factor-I (rhIGF-I) in the treatment of sporadic ALS. A double-blind, placebo-controlled, randomized study of 266 patients was conducted at eight centers in North America. Placebo or rhIGF-I (0.05 mg/kg/day or 0.10 mg/kg/day) was administered for 9 months. The primary outcome measure was disease symptom progression, assessed by the rate of change (per patient slope) in the Appel ALS rating scale total score. The Sickness Impact Profile (SIP), a patient-perceived, health-related quality of life assessment, was a secondary outcome variable. Progression of functional impairment in patients receiving high-dose (0.10 mg/kg/day) rhIGF-I was 26% slower than in patients receiving placebo (p = 0.01). The high-dose treatment group was less likely to terminate the study due to protocol-defined markers of disease symptom progression, and members in this group exhibited a slower decline in quality of life, as assessed by the SIP. Patients receiving 0.05 mg/kg/day of rhIGF-I exhibited trends similar to those associated with high-dose treatment, suggesting a dose-dependent response. The incidence of clinically significant adverse experiences was comparable among the three treatment groups. Recombinant human insulin-like growth factor-I slowed the progression of functional impairment and the decline in health-related quality of life in patients with ALS with no medically important adverse effects.

Amyotrophic Lateral Sclerosis↗
PubMed1997

Strategies for diagnosing and managing medication-induced headache.

PROBLEM ADDRESSED: Headache is a common clinical disorder. Nearly 50% of patients with headaches use prescription medications, and 90% regularly use nonprescription drugs. Medication-induced headaches (MIH) are chronic daily headaches caused by overuse of medicine. OBJECTIVES: To summarize the diagnostic criteria for MIH, to determine the investigations necessary to confirm the diagnosis and exclude other possible diagnoses, and to establish recommendations for managing MIH. MAIN FINDINGS: Diagnosis of MIH is based on patient's history and the clinical characteristics of the headache. Treatment includes patient education and support, withdrawal of offending medications, relief of withdrawal symptoms, and specific treatment of residual headache. When migraine and other causes of headache are adequately addressed, patients will not seek additional pain relief. CONCLUSION: Medication-induced headache is preventable. The key to prevention is appropriate drug therapy to relieve the primary headache. All patients with MIH can be treated and most cured.

Analgesics↗
PubMed1995

Amyotrophic lateral sclerosis: correlation of clinical and MR imaging findings.

PURPOSE: To determine the magnetic resonance (MR) imaging characteristics of amyotrophic lateral sclerosis (ALS) and to evaluate possible correlations between the disease severity and the MR imaging findings. MATERIALS AND METHODS: The authors retrospectively reviewed MR images of the head in 17 patients with ALS (14 men and three women) and 17 age-matched control subjects. The corticospinal tract (CST) was analyzed for the following features: size, signal intensity, and number of sections and regions in which the CST could be seen. RESULTS: Patients with ALS demonstrated sharp, well-defined, round, symmetric lesions that were hyperintense to gray matter within the CST. The lesions were best seen at the level of the middle or lower internal capsule on T2-weighted images. Visualization of the CST on proton-density-weighted images (which occurred in eight ALS patients) is the most reliable MR finding. Low signal intensity was identified within the motor cortex in six patients. Positive MR findings correlated with average or rapid progression of the disease. CONCLUSION: Increased signal intensity in the CST on proton-density-weighted MR images is diagnostic for motor neuron disease and correlates with the rate of disease progression. Subtle ALS changes can be differentiated from the normal CST. Low signal intensity in the motor cortex on T2-weighted images is a useful finding.

Adult↗
PubMed1993

Subcutaneous sumatriptan in the treatment of acute episodes of posttraumatic headache.

Seven patients with posttraumatic headaches refractory to other medical treatment were treated with sumatriptan, 6 mg subcutaneously, at the peak of a headache. In all, the throbbing temporal part of the headache disappeared leaving a persistent occipital pain. It is postulated that involvement of the trigeminovascular system is involved in part of the pain of posttraumatic headache, making it amenable to treatment with sumatriptan.

Adult↗
PubMed1992

Central-nervous-system dysfunction after warm or hypothermic cardiopulmonary bypass.

The increasing popularity of warm heart surgery led us to assess the effect of temperature during cardiopulmonary bypass (CPB) on neuropsychological function after coronary surgery. 34 patients enrolled in a randomised trial of normothermic versus hypothermic CPB were subjected to a battery of psychomotor and memory tests before and after their operations. The mean nasopharyngeal temperature for warm CPB was 34.7 (SD 0.5) degrees C and that for hypothermic CPB was 27.8 (2.0) degrees C. In all seven neuropsychological tests the postoperative scores were better in the warm CPB than in the hypothermic group, although only one difference achieved significance (trial-making test A; p less than 0.023). Thus, neurological function after normothermic CPB seems to be no worse than that after hypothermic procedures.

Body Temperature↗
PubMed1992

Occipital nerve block in the management of headache and cervical pain.

The origins of chronic headache and the role of the greater occipital nerve in headache syndromes are reviewed. The anatomical pathways and physiological basis of these headaches are discussed with a view to synthesizing some current concepts of headache generation. Studies of occipital nerve blockade for treatment of headaches of various types are assessed and a retrospective analysis of our own experience is presented.

Head↗
PubMed1992

Comparison of the efficacy and safety of flunarizine to propranolol in the prophylaxis of migraine.

This study was designed to compare flunarizine, a cerebro-specific calcium channel antagonist, and propranolol in the prophylaxis of migraine with or without aura. Following a 1 month single-blind placebo baseline period, 94 patients were equitably randomised under double-blind conditions to take flunarizine 10 mg daily or propranolol 80 mg twice daily for 4 months. Both treatments led to a significant reduction in the frequency of migraines and use of rescue analgesics with a significantly greater decrease in number of attacks for flunarizine after 1 and 4 months. Neither treatment affected the severity nor duration of migraines. Overall, 67% of flunarizine patients and 51% of propranolol patients responded positively. Propranolol significantly reduced blood pressure and heart rate; flunarizine had no effect on cardiovascular function. Weight gain was noted with both treatments. Flunarizine is at least as effective as propranolol in the prophylactic treatment of migraine and may have a better safety profile.

Adolescent↗
PubMed1990

Diffuse Lewy body disease with dementia and oculomotor dysfunction.

The case is presented of an elderly patient who had dementia, axial rigidity, and bradykinesia with limitation of horizontal and vertical gaze. Pathological examination disclosed Lewy and Lewy-like bodies in the substantia nigra, locus ceruleus, and neocortex, leading to a final diagnosis of diffuse Lewy body disease. Similar inclusions were found in areas of the pons and midbrain believed to be associated with gaze control. Moderate numbers of neuritic plaques, but no neurofibrillary tangles, were present in limbic cortex and neocortex. Review of the literature has not shown previous association of diffuse Lewy body disease with both horizontal and vertical gaze anomalies.

Aged↗
PubMed1990

Evaluation of analgesic agents in recurring headache compared with other clinical pain models.

The efficacy of three preparations (placebo, analgesic agent, and analgesic plus antihistaminic agent) were compared in a double-blind crossover study in subjects with recurring headaches. It was confirmed that headache as a pain model does not show the usual return of pain with as the effects of a single analgesic dose wear off. Consequently, there is no "peak effect," and the rationale for comparing treatments by "area under the curve" calculations is weakened. Greater efficacy was demonstrated for the analgesic over the placebo and for the analgesic and antihistaminic combined over the analgesic alone in several parameters. Slopes of straight lines derived as a quadratic function of pain versus time data proved to be a more effective discriminator between treatments than area under the curve calculations from the same data.

Acetaminophen↗