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 51,768 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

More than 1200 patients who received pindolol for the treatment of hypertension, angina pectoris, and various arrhythmias in studies conducted in the United States were included in the New Drug Application submitted to the FDA. Nearly 1000 of these patients received pindolol as monotherapy. The side effects reported were generally transient and of mild or moderate severity. The most frequently reported side effects seen after pindolol administration, compared to those seen after placebo, were in decreasing order of incidence: headache, dizziness, insomnia, muscle pain, fatigue, weakness, nervousness, joint pain, edema, nausea, and muscle cramps. Other side effects that occurred more frequently with pindolol than with placebo but at a rather low incidence induced weight gain, bizarre dreams, visual disturbances, lethargy, and diarrhea. Nasal congestion, throat discomfort, nocturia, impotence, pruritus, anxiety, hypotension, bradycardia, and heart failure occurred only rarely. Of the 323 patients who received pindolol alone for the treatment of mild to moderate hypertension, only 20 (6.2%) were withdrawn from the study because of side effects. Overall, 3.4% of the patients treated with pindolol were withdrawn because of side effects, most of which involved the central nervous system, that is, insomnia, anxiety, dizziness, and headache. However, a few patients manifested some edema and weight gain while receiving pindolol alone. Review of the side effects data did not reveal a tendency for the incidence of side effects to be dose related. One placebo-controlled, double-blind study designed to evaluate the fixed dosages of 15, 30, and 60 mg in the treatment of mild to moderate hypertension suggested that only the incidences of insomnia and nervousness increased with increasing doses. However, these side effects were generally transient and of mild or moderate severity. The evidence indicates that pindolol has an acceptable safety profile and that any side effects that appear are generally well tolerated and disappear with continued treatment.
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PMID:Adverse reactions to pindolol administration. 704 82

A double-blind, randomized, parallel-group, placebo-controlled study involving 130 patients was conducted at 9 centres in the U.K. to assess the effect of 6 weeks of treatment with azelastine nasal spray (azelastine) and beclomethasone dipropionate nasal spray (BDP) on the symptoms of perennial rhinitis. Efficacy was assessed by patients recording daily the severity of the symptoms of rhinitis on 10-cm visual analogue scales. Analysis of this diary data showed significant reductions in sneezing, blocked nose, running nose, and itching nose during azelastine treatment. Patients on BDP recorded a consistent reduction in rhinitis symptoms, but these reductions were significant only for sneezing on treatment day 7. When rhinitis symptoms were assessed by clinical investigators on a 4-point scale, the scores obtained following treatment with the 2 study medications showed little change from baseline or "active" treatment scores. There was no evidence of a consistent change in nasal airway resistance, measured using anterior rhinomanometry, following treatment with either BDP or azelastine. Azelastine nasal spray and BDP nasal spray were well tolerated by the patients and the relative incidence of adverse events was similar in the azelastine and placebo/azelastine treatment groups, except that taste perversion occurred more frequently during azelastine treatment than during placebo/azelastine treatment. There was no evidence of an increased incidence of somnolence or fatigue in patients who received azelastine nasal spray. Overall, the results of this study indicate that azelastine administered twice daily as an intranasal spray is a safe and efficacious treatment for the symptoms of rhinitis in patients suffering from mild to moderate perennial rhinitis.
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PMID:The effect of intranasal azelastine and beclomethasone on the symptoms and signs of nasal allergy in patients with perennial allergic rhinitis. 790 44

A double-blind, randomized, placebo-controlled, parallel trial was conducted to compare the efficacy and safety of terfenadine, 60 mg (immediate-release)/pseudoephedrine hydrochloride, 120 mg (controlled-release) (T/Ps) and clemastine fumarate, 1.34 mg (immediate-release)/phenylpropanolamine, 75 mg (sustained-release) (C/Ph) in a combination tablet b.i.d. in 178 patients (12-59 years of age) with symptoms of seasonal allergic rhinitis. After seven days of treatment, the total symptom scores recorded in the diaries of 175 patients showed that both therapies had a highly significant overall treatment effect when compared with placebo (P < or = .02). The overall level of improvement, as well as improvement of individual symptoms, was similar with the two therapies. Total symptom scores assigned by physicians to 170 patients showed significant and similar levels of improvement with both therapies when compared with placebo (P < .01). The two therapies were also similar on physicians' evaluations of overall effectiveness. Both therapies relieved most histamine-mediated symptoms as well as nasal congestion, although only T/Ps showed improvement of the latter symptom in both the patients' diaries and physicians' evaluations. Among 178 patients, drowsiness and fatigue occurred more often in the C/Ph group (25% and 11.7% for the two adverse events, respectively) than in the T/Ps group (10.2% and 1.7%, respectively). The incidence of insomnia and dry mouth/nose/throat was higher with T/Ps (23.7% and 11.9%, respectively) than with C/Ph (6.7% and 3.3%, respectively). No serious or unexpected adverse events were reported. These results indicate that T/Ps and C/Ph are both superior to placebo and equally effective in the treatment of symptoms of seasonal allergic rhinitis.(ABSTRACT TRUNCATED AT 250 WORDS)
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PMID:Safety and efficacy of terfenadine/pseudoephedrine versus clemastine/phenylpropanolamine in the treatment of seasonal allergic rhinitis. 849 30

Perennial and seasonal allergic rhinitis affect many million Americans and account for close to $2 billion annually in medical costs and lost productivity. The symptoms of allergic rhinitis, including sneezing, rhinorrhea, nasal congestion, and pruritus are, at best, very annoying and may be quite debilitating in some patients, causing irritability, insomnia, and fatigue. Moreover, allergic rhinitis is often not self-limiting and can contribute to serious medical complications such as sinusitis and otitis. Aggressive medical management of allergic rhinitis is important in the therapy for chronic sinusitis and otitis media and may prevent progression to more serious disease. Accurate diagnosis and initiation of environmental control measures to reduce exposure to causative factors should accompany initiation of pharmacotherapy. Antihistamines form the cornerstone of pharmacologic therapy, and use of the newer nonsedating antihistamines such as loratadine, terfenadine, and astemizole is not associated with the sedation produced by the classic antihistamines. Both loratadine and terfenadine are available in combination with a decongestant. Topical intranasal corticosteroids are another important component of pharmacologic management of allergic rhinitis. Allergen immunotherapy (hyposensitization) is used in those patients not adequately managed with pharmacotherapy. The relative safety and convenient dosing schedule of the newer medications should be accompanied by enhanced patient compliance and, hence, better control of allergic symptoms, halting progression of allergic rhinitis to serious medical complications.
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PMID:Treatment strategies designed to minimize medical complications of allergic rhinitis. 912 50

We performed a phase II, Southwest Oncology Group (SWOG) clinical trial of recombinant human interleukin-4 (rhuIL-4) in patients with previously treated non-Hodgkin's lymphoma (NHL). We studied 18 eligible patients with low-grade and 21 patients with intermediate- or high-grade NHL. All patients had received prior chemotherapy. A protocol amendment after the first four patients reduced the frequency of s.c. rhuIL-4 administration from daily to 3 times per week at 3 microg/kg and limited the number of prior chemotherapy regimens allowed. We documented no complete or partial responses in the low-grade NHL group [0%; 95% confidence interval (CI) 0-19%]. One patient in the intermediate/high-grade NHL group developed a partial response lasting longer than 15 months (5%; 95% CI 0-24%). Median survivals for the low- and intermediate/high-grade NHL groups were 15 and 13 months, respectively. Common toxicities included: arhralgia/myalgia, fatigue/malaise/lethargy, fever, headache, nausea and rigors/chills. Cardiac toxicity, gastrointestinal ulceration and nasal congestion due to rhuIL-4 were not prominent toxicities in our patients. Our previously treated NHL patients tolerated s.c. rhuIL-4 at a dose of 3 microg/kg given 3 times per week, but objective response rarely occurred. Further evaluation of rhuIL-4 in these patient populations does not appear warranted.
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PMID:Phase II evaluation of interleukin-4 in patients with non-Hodgkin's lymphoma: a Southwest Oncology Group trial. 1112 30

It is critical to take HIV medications, particularly protease inhibitors, exactly as prescribed to reduce the risks of developing resistance. The Food and Drug Administration (FDA) recently approved a new drug, Combivir, a combination of 3TC (lamivudine) and AZT in one tablet. Combivir works by interfering with the HIV life cycle to prevent it from replicating, and is taken twice a day with or without food. Patients with low body mass, hepatitis, or liver or kidney disease should not take Combivir. Blood counts need to be monitored regularly when taking this drug. Potential side effects include headache, nausea, fatigue, diarrhea, nasal congestion, or flu-like symptoms. A phone number is provided for more information on Combivir.
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PMID:What you need to know about Combivir. 1136 67

Allergic rhinitis (AR) is a heterogeneous disorder that despite its high prevalence is often undiagnosed. It is characterized by one or more symptoms including sneezing, itching, nasal congestion, and rhinorrhea. Many causative agents have been linked to AR including pollens, molds, dust mites, and animal dander. Seasonal allergic rhinitis (SAR) is fairly easy to identify because of the rapid and reproducible onset and offset of symptoms in association with pollen exposure. Perennial AR is often more difficult to detect than SAR because of the overlap with sinusitis, respiratory infections, and vasomotor rhinitis. SAR can result in hyperresponsiveness to allergens such as cigarette smoke, once pollen season is over. Perennial AR is defined as occurring during approximately 9 months of the year. AR affects an estimated 20 to 40 million people in the United States alone, and the incidence is increasing; an estimated 20% of cases are SAR; 40% of cases are perennial rhinitis; and 40% of cases are mixed. The pathophysiology of SAR is complex. There is a strong genetic component to the allergic response, which is driven through mucosal infiltration and action on plasma cells, mast cells, and eosinophils. The allergic response occurs in two phases, which are considered the "early" and "late" phase responses. Early phase response occurs within minutes of exposure to the allergen and tends to produce sneezing, itching, and clear rhinorrhea; late phase response occurs 4 to 8 hours after allergen exposure and is characterized by congestion, fatigue, malaise, irritability, and possibly neurocognitive deficits. The key to diagnosis of AR is awareness of signs and symptoms. IgE antibody tests to detect specific allergens are the standard method used today; however, in addition, diagnosis must be confirmed with a positive history and demonstration that the symptoms are the result of IgE-mediated inflammation.
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PMID:Allergic rhinitis: definition, epidemiology, pathophysiology, detection, and diagnosis. 1144

Recent data suggested that daytime somnolence in patients with allergic rhinitis was secondary to disrupted sleep caused by nasal congestion. Medications, which decreased congestion, would be expected to improve sleep and daytime somnolence. Previously, we showed that nasal steroids improved all three symptoms. Presently, we have not performed objective sleep testing to determine if there is a correlation between subjective improvement of congestion, sleep, and daytime somnolence. The objective of this 8-week, double-blind, placebo-controlled study was to determine if topical nasal fluticasone is effective at decreasing subjective congestion and daytime somnolence and improving sleep and if this improvement correlated with a change in overnight sleep testing (polysomnography). We recruited 32 subjects with perennial allergic rhinitis and randomized them in a double-blinded, cross-over fashion, to receive placebo or fluticasone (50 micrograms a spray), 2 sprays each side everyday, using Balaam's design. Questionnaires, quality of life instruments, daily diary, Epworth Sleepiness Scale, and an overnight sleep test with polysomnograms were used as tools. The last 2 weeks of each 4-week treatment period were summarized, scored, and compared by PROC MIXED in SAS. Correlations between arousals on sleep tests and subjective tests were performed. Fluticasone improved subjective sleep when compared with placebo (p = 0.04); however, there was no difference in the apnea/hypopnea index in those that were treated. Daytime sleepiness and fatigue were decreased by > 10% in the treated group; however, this was not statistically significant. However, fluticasone used at approved doses improves subjective sleep in patients with perennial allergic rhinitis without a change in the apnea/hypopnea index.
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PMID:The effect of topical nasal fluticasone on objective sleep testing and the symptoms of rhinitis, sleep, and daytime somnolence in perennial allergic rhinitis. 1263 78

Patients with allergic rhinitis frequently present with symptoms of nasal congestion, runny nose, sneezing, daytime somnolence and fatigue associated with decreased cognitive performance and impaired quality of life. Recent research has suggested that daytime somnolence in allergic rhinitis can be attributed to chronic inflammation of the nasal mucosa leading to nasal congestion and obstructed nasal passageways resulting in disturbed sleep. Treating daytime somnolence due to allergic rhinitis requires a reduction in obstruction caused by nasal congestion. Currently available therapy for allergic rhinitis includes topical corticosteroids, sedating and nonsedating antihistamines, topical cromolyn sodium (sodium cromoglycate), decongestants, immunotherapy and topical ipratropium bromide. The effectiveness of antihistamines in patients with allergic rhinitis has long been established. However, results of placebo-controlled trials investigating the effects of azelastine on sleep and daytime somnolence have produced conflicting results. Sleep improved with azelastine therapy, but there was a lack of evidence that azelastine significantly affected daytime sleepiness, sleep severity and nasal congestion. Sedating antihistamines exacerbate daytime somnolence and should be avoided in patients with allergic rhinitis. In a separate study, desloratadine failed to benefit sleep, but did not worsen daytime somnolence. Topical nasal cromolyn sodium is inconvenient to use and is unlikely to have a major effect on nasal congestion. Decongestants do decrease nasal congestion but the effect this has on sleep has not been adequately studied. Recent research has shown that topical corticosteroids are an effective treatment for alleviating nasal congestion secondary to allergic rhinitis. However, few studies have assessed the effect of topical corticosteroids on daytime fatigue and sleep. In 20 patients with allergic rhinitis and symptoms of daytime sleepiness, flunisolide significantly improved sleep quality and congestion but daytime sleepiness was not significantly improved. A similar study with fluticasone propionate showed improvement in nasal congestion and sleep but there was no significant change in objective sleep measurements recorded on polysomnography. Further research involving objective measures of sleep quality is necessary to determine the efficacy of medications in the treatment of allergic rhinitis associated with fatigue and daytime somnolence.
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PMID:Poor sleep and daytime somnolence in allergic rhinitis: significance of nasal congestion. 1472 57

Noninvasive positive-pressure ventilation (NPPV) should be considered a standard of care to treat COPD exacerbations in selected patients, because NPPV markedly reduces the need for intubation and improves outcomes, including lowering complication and mortality rates and shortening hospital stay. Weaker evidence indicates that NPPV is beneficial for COPD patients suffering respiratory failure precipitated by superimposed pneumonia or postoperative complications, to allow earlier extubation, to avoid re-intubation in patients who fail extubation, or to assist do-not-intubate patients. NPPV patient-selection guidelines help to identify patients who need ventilatory assistance and exclude patients who are too ill to safely use NPPV. Predictors of success with NPPV for COPD exacerbations have been identified and include patient cooperativeness, ability to protect the airway, acuteness of illness not too severe, and a good initial response (within first 1-2 h of NPPV). In applying NPPV, the clinician must pay attention to patient comfort, mask fit and air leak, patient-ventilator synchrony, sternocleidomastoid muscle activity, vital signs, hours of NPPV use, problems with patient adaptation to NPPV (eg, nasal congestion, dryness, gastric insufflation, conjunctival irritation, inability to sleep), symptoms (eg, dyspnea, fatigue, morning headache, hypersomnolence), and gas exchange while awake and asleep. For severe stable COPD, preliminary evidence suggests that NPPV might improve daytime and nocturnal gas exchange, increase sleep duration, improve quality of life, and possibly reduce the need for hospitalization, but further study is needed. There is consensus, but without strong supportive evidence, that COPD patients who have substantial daytime hypercapnia and superimposed nocturnal hypoventilation are the most likely to benefit from NPPV. Adherence to NPPV is problematic among patients with severe stable COPD.
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PMID:Noninvasive ventilation for chronic obstructive pulmonary disease. 1473 24


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