Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0027497 (nausea)
 23,468 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Rizatriptan is a novel 5-HT1B/1D agonist which is rapidly absorbed after oral administration. The efficacy and tolerability of oral rizatriptan (5 mg and 10 mg) were examined in this multicenter, double-blind, outpatient study of 1473 migraineurs which featured randomized, placebo-controlled treatment of migraine recurrences. On experiencing moderate or severe migraine headaches, patients rated headache severity prior to dosing and at 30-minute intervals for 2 hours after dosing. Onset of effect was seen as early as 30 minutes after dosing with rizatriptan 10 mg. At 2 hours postdose, the percentage of patients with pain relief was significantly higher after rizatriptan 5 mg (62%) or 10 mg (71%) compared with placebo (35%). Complete relief was also significantly higher after rizatriptan 5 mg (33%) and 10 mg (42%) compared with placebo (10%). In patients experiencing headache recurrence after initial benefit, further relief was obtained in 71% with rizatriptan 5 mg (placebo 54%) and in 82% with rizatriptan 10 mg (placebo 44%). Complete relief of recurrent headache was obtained in 36% with rizatriptan 5 mg, 49% with rizatriptan 10 mg, and 15% with placebo (P < 0.05). The most common drug-related adverse experiences were dizziness, somnolence, asthenia/fatigue, and nausea (the incidences of which were low and dose related). There was no increase in the incidence of adverse experiences after use of up to three doses of rizatriptan within 24 hours. We conclude that both doses of rizatriptan are effective and well tolerated in the acute treatment of migraine and migraine recurrence, with the 10-mg dose preferred as it is more effective with a faster onset of action.
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PMID:Rizatriptan (MAXALT) for the acute treatment of migraine and migraine recurrence. A placebo-controlled, outpatient study. Rizatriptan 022 Study Group. 1239 Jun 57

During the past 10 years there have been major changes in the management of the most common symptoms of terminal cancer. Opioid agonists remain the mainstay in the management of cancer pain. Slow-release preparations are currently available for several of these agents. The increased use of opioids has led to the recognition of opioid-induced neurotoxic effects and to the development of effective adjuvant drugs and other strategies to counteract these side effects. A number of drugs are available for the management of symptoms of cachexia, including corticosteroids and progestational drugs. Prokinetic drugs, either alone or in combination with other agents such as corticosteroids, are highly effective in the treatment of chronic nausea. For patients with asthenia, it should first be determined whether there are any reversible causes; if not, corticosteroids and psychostimulants may diminish the symptoms. Haloperidol, other neuroleptics and benzodiazepines may be required to manage hyperactive delirium. Oxygen and opioids are effective in treating dyspnea, whereas there is limited evidence that benzodiazepines provide any relief of this symptom. More research on the assessment and management of these devastating clinical symptoms of cancer is badly needed.
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PMID:Management of specific symptom complexes in patients receiving palliative care. 986 Dec 20

The safety, antiretroviral activity, and pharmacokinetic profile of nelfinavir, a potent and specific inhibitor of human immunodeficiency virus (HIV) protease, were assessed in a small open-label phase I/II dose-ranging study in protease inhibitor-naive HIV-positive men. A total of 22 patients with baseline plasma HIV RNA > or = 20,000 copies/mL and CD4+ counts between 200 and 500 cells/mm3 were enrolled in the study. Of the 22 patients, 20 were evaluated for activity; 10 patients assigned to 771 mg/day base equivalent (300 mg three times daily) and 10 patients assigned to 1,026 mg/day base equivalent (600 mg twice daily) given monotherapy. A capsule formulation of nelfinavir was used. The initial study period was 28 days; patients showing a virologic response of 1 log10 reduction were eligible for enrollment in an extension phase and addition of nucleoside analogues. A maximally tolerated dose of nelfinavir was not established. A dose-response relationship was observed for four (40%) patients in the 771-mg group and six (60%) patients in the 1,026-mg group experiencing a reduction from baseline in plasma HIV RNA of at lest 1 log during the 28-day study. Of these patients, five sustained the reduction in plasma HIV RNA beyond day 28 (2 patients receiving 771 mg/day and 3 patients receiving 1,026 mg/day). Median increases from baseline in CD4+ counts at day 28 were 216 cell/mm3 and 86 cell/mm3 in the 771-mg and 1,026-mg groups, respectively. After oral administration, median nelfinavir plasma concentrations on day 28 reached a maximum at 1 hour (2,966 ng/mL) in the 771-mg group and at 3 hours (3,157 ng/mL) in the 1,026-mg group. Data for 22 patients were included in the safety analysis; 12 patients (55%) reported at least one grade 2 or worse (moderate, severe, or very severe) adverse event. The most common grade 2 or worse adverse event was diarrhea, reported by two patients (20%) receiving 771 mg/day and seven patients (70%) receiving 1,026 mg/day; followed by nausea, flatulence, asthenia, and headache (each reported in 1 patient [10%] in the 771-mg group) and dizziness (reported in 1 patient [10%] receiving 1,026 mg/day). In the small subgroup (n = 6) who continued taking nelfinavir for longer periods (between 8 and 15 months), virologic responses were sustained in the majority of patients with good tolerability. Nelfinavir is an active HIV-protease inhibitor with favorable pharmacokinetics, good tolerability, and sustained antiviral effects. Results of this early phase I/II dose-ranging study provided data for the safety and antiretroviral activity of nelfinavir and led to the selection of higher doses for phase II/III trials to further optimize virologic and immunologic responses.
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PMID:Safety, pharmacokinetics, and antiretroviral activity of the potent, specific human immunodeficiency virus protease inhibitor nelfinavir: results of a phase I/II trial and extended follow-up in patients infected with human immunodeficiency virus. 972 50

Opioid analgesics are widely acknowledged as the most important drugs for the treatment of chronic cancer pain. Although these drugs can in most cases control severe pain, even when they are used appropriately, they may produce new symptoms or exacerbate preexisting symptoms, most notably nausea and somnolence. The combination of severe pain, anorexia, chronic nausea, asthenia, and somnolence is a frequent finding in patient with advanced cancer. An adjuvant drug should meet at least one of the following criteria: 1) to increase the analgesic effect of opioids; 2) to decrease their toxicity; 3) to improve others symptoms associated with terminal cancer. Many drugs, such as nonsteroidal antiinflammatory agents, tricyclic antidepressants, corticosteroids, benzodiazepines, amphetamines, antiemetics, oral local anesthetics and bisphosphonates have been suggested to have adjuvant analgesic effects. Unfortunately, most of the evidence for the effects of these drugs is anedoctal. Controlled clinical trials are badly needed to precise the indications and the risk/benefit ratios of these agents, some of which have significant toxicity and could potentially aggravate narcotics toxicity.
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PMID:[Treatment of cancer pain: the role of co-analgesics]. 980 65

To evaluate the toxicity of zidovudine (ZDV) prophylaxis in human immunodeficiency virus (HIV)-exposed healthcare workers (HCWs) in Italy, a national protocol for postexposure prophylaxis has been implemented and a national registry has been established. All Italian clinical centers licensed to dispense ZDV participate. As of December 1995, data from 674 individuals who received ZDV prophylaxis have been collected. In three cases ZDV was used in combination with either didanosine (DDI) or dideoxycytidine (DDC). In 556 cases (82%), the daily dose of ZDV was 1,000 mg/day; 21 HCWs (3%) were treated with 300-800 mg/day, and in 72 persons (11%) the dose was 1,200-3,000 mg/day. A total of 332 (49%) HCWs reported at least one adverse effect; 132 (20%) discontinued prophylaxis because of side effects (40% of those reporting side effects). Nausea was reported in 243 cases; other side effects included vomiting, gastric pain, diarrhea, asthenia, and headache. Most constitutional adverse effects were reported during the first week of prophylaxis. Grade 1 anemia (hemoglobin 9.5-11 g/dL) occurred in 10 cases (3%); in 2 cases, the neutrophil count decreased to <1,000 cells/mm3. A transient increase of serum alanine aminotransferase to three times the upper limit of normal was observed in 7 persons. All side effects were reversible after the prophylaxis was stopped. Among those reporting at least one side effect the mean duration of treatment was 22 days; for HCWs reporting hematologic or liver adverse effects the mean length of treatment was 34 days. A total of 351 HCWs (54.6%) ceased the treatment before the scheduled 1-month period. In the 132 persons who discontinued treatment because of side effects, the mean length of prophylaxis was 8 days. One HCW seroconverted after conjunctival exposure to blood. The short-term toxicity of ZDV prophylaxis is frequent, mild, dose related, and reversible. Further studies are needed to assess the risk of long-term sequelae of this treatment as well as of prophylaxis with combinations of antiretroviral drugs.
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PMID:Zidovudine toxicity in uninfected healthcare workers. Italian Registry of Antiretroviral Prophylaxis. 984 98

A bibliographic review of the safety profile of 311C90 or zolmitriptan is performed in the present study showing the large number of clinical trials carried out in both healthy volunteers and patients with migraine. The molecule, a potent, selective agonist for the 5HT1B/1D receptors with central and peripheral activity does not appear to have significant influence on arterial pressure. ECG and Holter ECG studies did not show any alterations in healthy volunteers. In migraine patients, the ECG did not demonstrate ischemic alterations at any of the dosages of zolmitriptan used. In patients who had undertaken treatment for months, the hemogram and biochemical follow up did not show any changes. This new triptan was well tolerated in a wide spectrum of patients and healthy volunteers. Complaints of subjective side effects usually increase according to an increase in dosage. The most frequent adverse effects were nausea and dizziness. Other discomforts are: dryness of the mouth, sensation of heat, paresthesia, asthenia, drowsiness, and dizziness. The sensation of heaviness, tightness or pressure of the throat and chest have also been reported. The adverse effects reported with 5 mg of zolmitriptan are similar to those found with 100 mg of sumatriptan. The adverse side effects are usually mild, last a short time and remit without therapy. Zolmitriptan used together with the other most often used drugs in migraine patients did not show any important clinical interactions. However, it seems reasonable to limit the daily administration of zolmitriptan with monoaminoxidase inhibitors (MAOI-A) since a possible increase of the levels of zolmitriptan and its metabolites may be detected in the presence of one (moclobemide). At a dose of 2.5 mg, zolmitriptan appears to provide the best relationship between benefits and risk.
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PMID:[Safety profile of 311C90 (zolmitriptan)]. 985 92

Symptoms can markedly influence the hemodialysis patients well-being and quality of life. The aim of this paper is to study the frequency of symptoms at home and how these relate to biochemical and treatment variables. Seventy-three hemodialysis patients were questioned on the absence, occasional presence or daily recurrence (score = 0, 1, 2) of 14 symptoms and a record was made of their biochemical parameters, age, time on treatment and KtIV as a function of each symptom. The following relationships were detected: thirst with high Osm and BUN; asthenia with old age and hypoalbuminemia; insomnia with hypercalcemia; hypersomnia with hypoxemia and hypernatremia; anorexia with hypokalemia; dyspnea with old age, hypernatremia and hypokalemia; dysgeusia with hypoxemia; nausea with alkalemia, hypoxemia and low BUN; vomiting with alkalemia. Pruritus, arthralgia, restless legs syndrome, cramp and tremor showed no relationships. Monitoring acid-base balance and plasma electrolytes could help to alleviate symptoms and ameliorate quality of life of hemodialysis patients.
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PMID:Symptoms in hemodialysis patients and their relationship with biochemical and demographic parameters. 998 55

Paroxysmal supraventricular tachycardia (SVT) may have numerous electro-physiologic mechanisms. The most common type of SVT is AV-nodal reentry tachycardia (60%) followed by the bypass tract-mediated SVT (preexcitation. 30%) and a smaller group (10%) comprising paroxysmal atrial flutter or fibrillation and atrial ectopic tachycardia. In persons with otherwise normal hearts symptoms are usually mild and include palpitations or an uneasy feeling in the chest. But some describe precordial pain. Weakness, dizziness, nausea, vomiting, and even syncope. Whenever possible a 12-lead-ECG during an episode of SVT should be obtained. If not possible the use of several Holter-ECG or of an event-recorder may be helpful. Conversion of a SVT can be accomplished by vagal maneuvers or intravenous adenosine (6-18 mg bolus injection). Further diagnostic procedures should prove or rule out a significant structural heart disease. Therapeutic options (expectative, pharmacological prophylaxis, invasive electrophysiologic testing and catheter-mediated modification or ablation) are chosen according to the objective threat (e.g. ventricular fibrillation due to 1:1 conducted atrial fibrillation in a preexcitation syndrome) and the subjective complaints. Definitive healing of the AV-nodal reentry tachycardia and the bypass tract-mediated SVT can be achieved by use of catheter-mediated modification or ablation in 95 to nearly 100%.
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PMID:[Modern therapy of paroxysmal supraventricular tachycardia]. 1009 47

Amplification of the human epidermal growth factor receptor 2 protein (HER2) in primary breast carcinomas has been shown to correlate with poor clinical prognosis for certain patients. Trastuzumab (Herceptin, Genentech, Inc., South San Francisco, California) is a highly purified recombinant DNA-derived humanized monoclonal immunoglobulin G1 kappa antibody that binds with high affinity and specificity to the extracellular domain of the HER2 receptor. In vitro and in vivo preclinical studies have shown that administration of trastuzumab alone or in combination with paclitaxel or carboplatin significantly inhibits the growth of breast tumor-derived cell lines that overexpress the HER2 gene product. At therapeutic doses in breast cancer patients, the mean half-life of trastuzumab is 5.8 days. Trastuzumab serum concentrations reach steady state with mean trough and peak concentrations of 79 microg/mL and 123 microg/mL, respectively. In a 222-patient, single-arm clinical study, treatment with a loading dose of trastuzumab 4 mg/kg administered IV followed by weekly IV doses of 2 mg/kg produced an overall response rate of 14% (2% complete remission and 12% partial remission). The beneficial effects were greatest in patients with the greatest degree (3+) of HER2 protein overexpression. In another clinical study, 469 women with metastatic breast carcinoma were randomized to a paclitaxel or anthracycline-plus-cyclophosphamide regimen with or without trastuzumab. The overall response rate was significantly greater in the trastuzumab-plus-chemotherapy group than in the chemotherapy-alone cohort. The magnitude of observed effects was greatest with pacli taxel plus trastuzumab. The most common adverse effects attributed to trastuzumab in clinical studies were fever and chills, pain, asthenia, nausea, vomiting, increased cough, diarrhea, headache, dyspnea, infection, rhinitis, and insomnia. Trastuzumab in combination with chemotherapy can lead to cardiotoxicity, leukopenia, anemia, diarrhea, abdominal pain, and infection. Trastuzumab has been approved by the US Food and Drug Administration as a single agent for the treatment of patients who have metastatic breast cancer involving overexpression of the HER2 protein and who have received 1 or more chemotherapy regimens; in combination with paclitaxel, it has been approved for the treatment of such patients who have not received chemotherapy.
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PMID:Trastuzumab, a recombinant DNA-derived humanized monoclonal antibody, a novel agent for the treatment of metastatic breast cancer. 1021 34

This study was designed to evaluate the activity, safety and tolerance of docetaxel (D) in a selected population with metastatic squamous cell carcinoma of the head and neck (SCCHN). Twenty-four patients with no prior palliative therapy were enrolled and received D 100 mg m(-2) by 1 h of infusion, every 3 weeks. All but two patients had been evaluated for efficacy on lung metastatic sites. No prophylactic administration of anti-emetics or growth factors was given. A pharmacokinetic study was performed in 22 patients. Twenty-one patients were assessable for response and 24 for toxicity. One hundred and four cycles were administered with a median of 4.5 (range 1-9) per patient. The median cumulative dose was 449 mg m(-2). Partial responses were achieved in five patients with a median duration of 18.7 weeks (range 13.1-50.3). The overall response rate was 20.8% with a median duration of 11.0 weeks (range 2.4-52.6). The most frequent side-effect was neutropenia (79.2% grade IV) but with a short duration (median 4 days) and no febrile neutropenia. The incidence of moderate/severe fluid retention was 29.2% with one treatment discontinuation. Other toxicities (all grades) were common (skin 75%, asthenia 50%, infection 29.2%, nausea 16.7%, diarrhoea 12.5%, stomatitis 16.7%, vomiting 8.3% and HSR 8.3%). A mean clearance of 19.6 l h(-1) m(-2) and an area under the curve of 6.00 microg ml(-1) h(-1) was found in the pharmacokinetic analysis. Docetaxel is active in this selected population with metastatic SCCHN, with a good tolerance.
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PMID:A phase II study of docetaxel in patients with metastatic squamous cell carcinoma of the head and neck. 1050 70


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