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Comparative Efficacy (comparative + efficacy)
Selected AbstractsComparative efficacy of rapid-release nicotine gum versus nicotine polacrilex gum in relieving smoking cue-provoked cravingADDICTION, Issue 11 2005Raymond Niaura ABSTRACT Aims Most relapse episodes occur when smokers are confronted with craving provoked by situational cues. Current nicotine gum can help relieve cue-provoked cravings, but faster effects may result in more rapid relief. We tested a prototype formulation of a new rapid-release nicotine gum (RRNG) that provides more rapid release and absorption of nicotine, for its ability to provide faster and better craving relief compared to current nicotine polacrilex gum (NPG). Design Random assignment to RRNG or NPG, used during a smoking cue provocation procedure. Participants and setting A total of 319 smokers were exposed to a smoking cue in the laboratory by being asked to light but not smoke a cigarette of their preferred brand. Subjects then chewed a piece of 2 mg RRNG (n = 159) or 2 mg NPG (n = 160) according to randomized assignment. Measurements Craving assessments were completed at regular intervals before and after cue exposure (baseline, pre-cue, and 3, 6, 9, 12, 15, 18, 21, 25, 30 and 35 minutes after the cue). Findings Smokers chewing RRNG showed significantly lower craving than NPG subjects starting with the first assessment at 3 minutes (P < 0.025). Repeated-measures ANOVA revealed a significant treatment × time interaction (P < 0.05),craving scores dropped more rapidly in RRNG subjects compared to NPG subjects. Survival analyses also indicated superiority of RRNG in achieving more rapid self-reported meaningful relief (P < 0.05) and complete relief (P < 0.05) of craving. Conclusions Rapid-release nicotine gum reduced cue-provoked craving more rapidly compared to NPG, and thus merits further study in cessation efficacy trials. [source] Comparative efficacy of two nit combs in removing head lice (Pediculus humanus var. capitis) and their eggsINTERNATIONAL JOURNAL OF DERMATOLOGY, Issue 12 2007Rick Speare BVS Background, Fine tooth lice combs fall into two classes based on the material from which their teeth are made: plastic or metal. Metal combs are further divided into those that are made from a flat sheet of metal, and hence have rectangular teeth, and those that have cylindrical teeth embedded in a plastic base. Methods, The efficacy of two fine tooth combs [Lice Meister comb (metal) and Lady Jayne comb (plastic)] in removing head lice (Pediculus humanus var. capitis) and their eggs from the hair of children was evaluated after treatment with a viscous head lice product (Lice Blaster; Emerald Forest Pharmaceuticals Pty Ltd, Currumbin, Qld, Australia). The hair of 27 children was divided into two sections sagitally, and each comb was randomly assigned to one half of the hair, and the lice and eggs removed by the combs were counted. Results, In 96% of subjects, the Lice Meister comb removed more eggs than the Lady Jayne comb, with an average of three to four times more hatched, dead, and live eggs removed. The Lice Meister comb removed more lice than the Lady Jayne comb in 10 subjects, the same in eight subjects, and less in nine subjects. Conclusion, Overall, the Lice Meister comb is recommended as a more effective comb for use in controlling head lice infestations, whether employed with conditioner or with insecticide treatment. This appears to be the first study investigating the efficacy of nit combs in vivo. Further research is needed to determine which characteristics of fine tooth combs are the most important in removing head lice eggs. [source] Comparative efficacy of the Schistosoma mansoni nucleic acid vaccine, Sm23, following microseeding or gene gun deliveryPARASITE IMMUNOLOGY, Issue 4 2002Akram A. Da'dara Summary Sm23 is an integral membrane protein expressed widely in the human parasitic worm Schistosoma mansoni. Sm23 has already been shown to elicit protective immune responses following immunization with peptides or DNA constructs. In this study, we evaluated the immunogenicity and the protective efficacy of the Sm23 DNA vaccine using two different intradermal DNA delivery methods: microseeding and gene gun. Using both techniques, all mice immunized with the Sm23-pcDNA construct generated Sm23-specific immunoglobulin (Ig)G antibody, while mice immunized with the control plasmid, pcDNA, did not. Antibody isotypes analysis revealed that microseeding elicited mainly IgG2a and IgG2b antibodies, with relatively low levels of IgG1 and IgG3. The relative IgG1/IgG2a ratio was 0·03, indicative of a Th1 type immune response. In contrast, gene gun immunization resulted in significantly higher levels of IgG1 and IgG3. The relative IgG1/IgG2a ratio in this case was 11, indicative of a Th2 type immune response. No significant difference in the levels of IgG2b was observed. Coimmunization with plasmid DNA encoding either interleukin (IL)-12 or IL-4 by microseeding did not affect the levels of IgG1, while the levels of IgG2a and IgG2b were reduced. On the other hand, the levels of IgG3 were significantly increased by IL-4, but unchanged by IL-12. Importantly, in all experiments, the Sm23-pcDNA vaccine provided statistically significant levels of protection against challenge infection. Microseeding immunizations resulted in higher levels of protection (31,34% protection) than gene gun immunization (18% protection). This suggests that the Th1 type immune response elicited by microseeding immunization was responsible for the higher protection levels. However, the protective effect of the vaccine was not affected by coadministering plasmids encoding either IL-12 or IL-4 using the microseeding technique. [source] Comparative efficacy of MS-222 and benzocaine as anaesthetics under simulated transport conditions of a tropical ornamental fish Puntius filamentosus (Valenciennes)AQUACULTURE RESEARCH, Issue 2 2010Padinhare Kattil Pramod Abstract There is a growing commercial interest in the fish, Puntius filamentosus, in the ornamental fish trade in India and elsewhere. The trade is, however, hampered by severe mortalities during transport of the fish owing to insufficient data available on the use of anaesthetics. To resolve this problem, we evaluated the efficacy of two anaesthetics, MS-222 and benzocaine, in sedating P. filamentosus in simulated transportation experiments and used stress response parameters such as cortisol and blood glucose levels to perform assessments. We observed that MS-222 at 40 mg L,1 and benzocaine at 20 mg L,1 were sufficient to induce sedation for 48 h. Above these concentrations, both the anaesthetics adversely affected the fish and resulted in mortalities. Both anaesthetics significantly lowered the blood cortisol and glucose levels compared with the unsedated controls. Importantly, the anaesthetics treatment significantly lowered the post-transport mortality in the fish. The results of the study show that MS-222 and benzocaine could be used as sedatives to alleviate transport-related stress in P. filamentosus to improve their post-transport survival and hence reduce economic loss. [source] Comparative efficacy of thalidomide and prednisolone in the treatment of moderate to severe erythema nodosum leprosum: A randomized studyAUSTRALASIAN JOURNAL OF DERMATOLOGY, Issue 3 2009Inderjeet Kaur ABSTRACT The present study was undertaken to compare the efficacy and safety of thalidomide to that of oral prednisolone in the treatment of moderate to severe type 2 lepra reaction. Sixty patients with a histologically confirmed diagnosis of erythema nodosum leprosum with a clinical score of 4 or more (i.e. moderate to severe type 2 reaction) were randomly allocated to two groups comprising 30 patients each. Group 1 patients were given thalidomide at a dose of 300 mg/day for 1 week and the dose was gradually reduced, and Group 2 received prednisolone 40 mg daily for 2 weeks, which was tapered by 10 mg every 2 weeks. Thalidomide induced a faster clinical response (cutaneous as well as systemic) compared with prednisolone. Patients taking thalidomide had fewer relapses and a longer period of remission than those receiving prednisolone. [source] Comparative efficacy of two ,1 -adrenoreceptor antagonists, doxazosin and alfuzosin, in patients with lower urinary tract symptoms from benign prostatic enlargementBJU INTERNATIONAL, Issue 6 2004T.M. De Reijke OBJECTIVES To compare doxazosin and alfuzosin in patients with moderate to severe lower urinary tract symptoms (LUTS) suggestive of bladder outlet obstruction. PATIENTS AND METHODS In all, 210 men with LUTS were randomized to receive doxazosin 1,8 mg once daily or alfuzosin 5,10 mg divided in two or three daily doses in a 14-week, multicentre, double-blind, baseline-controlled, dose-titration study. The International Prostate Symptom Score (IPSS) and maximum urinary flow rate were used to assess the efficacy of the treatment. RESULTS At study completion, the mean dose of doxazosin was 6.1 mg/day and alfuzosin 8.8 mg/day. The least squares mean (se) change from baseline in total IPSS was ,9.23 (0.6) for doxazosin and ,7.45 (0.6) (both P < 0.001) for alfuzosin. The respective mean change from baseline in irritative symptoms was ,3.5 (0.2) and ,2.8 (0.3) (both P < 0.001). The differences between the treatment groups were statistically significant in favour of doxazosin (total IPSS, P = 0.036; irritative symptoms, P = 0.049). The improvement between groups was also significantly different for postvoid residual urine volume, at ,29.19 (8.6) and +,9.59 (8.9) mL for doxazosin and alfuzosin, respectively (P = 0.002). Improvements in mean and maximum urinary flow rates were similar for both treatments, at +,1.5 and +,1.2, and +,2.8 and +,2.5 mL/s, respectively. Doxazosin and alfuzosin were both well tolerated, with most all-cause adverse events reported as mild or moderate. CONCLUSIONS The mean doses of doxazosin and alfuzosin used in this study were not equipotent. Doxazosin 6.1 mg/day produced significantly greater improvements than alfuzosin 8.8 mg/day in total and irritative urinary symptom scores and postvoid residual urine volume in men with moderate to severe LUTS. Changes in maximum and mean flow rates were comparable. Doxazosin and alfuzosin were both well tolerated. [source] A systematic review on the diagnosis and treatment of primary (idiopathic) dystonia and dystonia plus syndromes: report of an EFNS/MDS-ES Task ForceEUROPEAN JOURNAL OF NEUROLOGY, Issue 5 2006A. Albanese chairman To review the literature on primary dystonia and dystonia plus and to provide evidence-based recommendations. Primary dystonia and dystonia plus are chronic and often disabling conditions with a widespread spectrum mainly in young people. Computerized MEDLINE and EMBASE literature reviews (1966,1967 February 2005) were conducted. The Cochrane Library was searched for relevant citations. Diagnosis and classification of dystonia are highly relevant for providing appropriate management and prognostic information, and genetic counselling. Expert observation is suggested. DYT-1 gene testing in conjunction with genetic counselling is recommended for patients with primary dystonia with onset before age 30 years and in those with an affected relative with early onset. Positive genetic testing for dystonia (e.g. DYT-1) is not sufficient to make diagnosis of dystonia. Individuals with myoclonus should be tested for the epsilon-sarcoglycan gene (DYT-11). A levodopa trial is warranted in every patient with early onset dystonia without an alternative diagnosis. Brain imaging is not routinely required when there is a confident diagnosis of primary dystonia in adult patients, whereas it is necessary in the paediatric population. Botulinum toxin (BoNT) type A (or type B if there is resistance to type A) can be regarded as first line treatment for primary cranial (excluding oromandibular) or cervical dystonia and can be effective in writing dystonia. Actual evidence is lacking on direct comparison of the clinical efficacy and safety of BoNT-A vs. BoNT-B. Pallidal deep brain stimulation (DBS) is considered a good option, particularly for generalized or cervical dystonia, after medication or BoNT have failed to provide adequate improvement. Selective peripheral denervation is a safe procedure that is indicated exclusively in cervical dystonia. Intrathecal baclofen can be indicated in patients where secondary dystonia is combined with spasticity. The absolute and comparative efficacy and tolerability of drugs in dystonia, including anticholinergic and antidopaminergic drugs, is poorly documented and no evidence-based recommendations can be made to guide prescribing. [source] The 40-mg dose of eletriptan: comparative efficacy and tolerability versus sumatriptan 100 mgEUROPEAN JOURNAL OF NEUROLOGY, Issue 2 2004Hans-Christoph Diener Meta-analysis provides valuable information regarding relative efficacies of triptans, but head-to-head comparator studies remain the gold standard. Three similar head-to-head trials comparing eletriptan 40 mg (E40) with sumatriptan 100 mg (S100) provide a rare opportunity and sufficient power, for robust comparisons of efficacy. Data were combined from three double-blind, placebo-controlled, first-dose, first-attack acute migraine treatment studies comparing E40 (n = 1132), S100 (n = 1129), and placebo (n = 645). The primary outcome was headache response at 2 h. Secondary outcomes included headache response at 1 h, pain-free and functional responses, and sustained headache and pain-free responses. Odds ratios were calculated for summary estimates of probability of response. There were higher headache response rates with eletriptan versus sumatriptan at 2 h (67% vs. 57%; P < 0.0001) and 1 h (34% vs. 26%; P < 0.0001). Eletriptan also had higher 2 h pain-free (35% vs. 25%; P < 0.0001) and functional responses (67% vs. 58%; P < 0.0001). Sustained headache (42%) and pain-free (22%) response rates were higher for eletriptan versus sumatriptan (34%, P < 0.0001; 15%, P < 0.0001). The probability of response for eletriptan versus sumatriptan ranged from 36% higher (relief of nausea) to 64% higher (sustained pain-free rate). Combined analysis demonstrates that E40 has superior efficacy versus S100 across all clinically relevant outcomes. [source] Meta-Analysis Examining the Efficacy and Safety of Almotriptan in the Acute Treatment of MigraineHEADACHE, Issue 8 2007Li-Chia Chen PhD Objective.,To evaluate the comparative efficacy and safety of oral almotriptan in treating acute migraine attacks. Background.,Almotriptan is an oral selective sertonin1B/1D receptor agonist (triptan) with a high bioavailability and short half-life, developed for the treatment of migraine. In recent years, a number of randomized controlled trials have been published examining the efficacy and safety of almotriptan in the acute treatment of migraine. Methods.,Systematic review and meta-analysis of randomized controlled trials (RCTs) using a random-effects model to estimate the pooled rate ratios (RRs) and 95% confidence intervals (95%CI) for the proportions of patients achieving headache relief and pain-free responses at 1 or 2 hours post-dose, sustained pain-free response at 2,24 hours post-dose, and safety outcomes (proportions of patients experiencing any adverse events, dizziness, somnolence, asthenia, and chest tightness) comparing almotriptan against placebo, other triptans, and different dosages of almotriptan. Absolute rate differences (ARDs) for 2-hour headache relief, pain free, and sustained pain free responses between almotriptan and placebo were also calculated. Results.,Eight RCTs involving 4995 patients were included in the analysis. Almotriptan 12.5 mg was significantly more effective than placebo for all efficacy outcomes (RRs ranged from 1.47 to 2.15; ARDs ranged from 0.01 to 0.28) and there were no significant differences in any of the safety outcomes. There were also no significant differences in efficacy outcomes comparing almotriptan 12.5 mg against sumatriptan 100 mg and zolmitriptan 2.5 mg, but almotriptan 12.5 mg was associated with significantly fewer adverse events than sumatriptan 100 mg (RR: 0.39, 95%CI: 0.23, 0.67). However, there was no significant difference between almotriptan and sumatriptan in terms of clinically important adverse effects, such as dizziness, somnolence, asthenia, and chest tightness. Almotriptan 12.5 mg was significantly less effective than almotriptan 25 mg for 1-hour pain-free response (RR: 0.45, 95%CI: 0.21, 0.95), but associated with significantly fewer patients experiencing adverse events (RR: 0.61, 95%CI: 0.41, 0.91) than almotriptan 25 mg. Conclusions.,Almotriptan 12.5 mg is an effective treatment for acute attacks of migraine, in particular, it has been found to be as effective as sumatriptan 100 mg and zolmitriptan 2.5 mg. The risk of adverse events associated with almotriptan 12.5 mg was similar to placebo and significantly lower than sumatriptan 100 mg. Further research is required to assess the comparative efficacy of almotriptan against other triptans. [source] Comparison of carbamazepine and lithium in treatment of bipolar disorder: A systematic review of randomized controlled trials,HUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 1 2009Daniela Ceron-Litvoc Abstract Objectives To review data from randomized controlled trials (RCTs) assessing the comparative efficacy of carbamazepine and lithium in treatment of acute manic and maintenance phase of bipolar disorder (BD). Design RCTs were identified through a search strategy that included: electronic databases, reference cross-checking, hand search of non-indexed publications, and book chapters on the treatment of BD comparing carbamazepine with lithium. Outcomes investigated were antimanic effect, trial withdrawal, relapse, hospitalization, need for rescue medication, and presence of adverse effects. Selection of studies and data analysis were performed independently by authors. Whenever possible, data from trials were combined through meta-analyses. Relative risks (RR) were estimated for dichotomous data. Results In acute mania, carbamazepine was similar to lithium on the following outcomes: trial withdrawal due to adverse effects, number of participants with at least one adverse effect, improvement in the Clinical Global Impression (CGI). In acute mania, carbamazepine was associated with fewer trial withdrawals. In maintenance treatment, carbamazepine was similar to lithium in relapses and hospitalization, but there were fewer trial withdrawals due to adverse effects on lithium. Conclusion This review suggests that carbamazepine might be comparable to lithium in terms of efficacy and safety, and therefore a valuable option in the treatment of both manic and maintenance phases. Copyright © 2008 John Wiley & Sons, Ltd. [source] Scintigraphy can be used to compare delivery of sore throat formulationsINTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 4 2009M. Limb Summary Aims:, Sore throat (pharyngitis) is commonly treated with over-the-counter lozenges, tablets, sprays and gargles. While the efficacy of the active ingredients has been examined, less is known about the comparative efficacy of the different delivery formats. Methods:, A pilot study was initially performed, followed by an open-label, four-way crossover study in healthy volunteers to quantitatively assess the delivery efficacy of a lozenge, tablet, spray and gargle, using technetium-99m and scintigraphy as a marker of deposition and clearance of the active ingredients. Results:, Initial deposition in the mouth and throat combined was significantly greater for the solid dose forms (lozenge and tablet) than for the spray or gargle. Rates of clearance were initially similar for the tablet and lozenge with low levels of radioactivity present at up to 2 h. At 10 and 20 min, significantly more of the dose remained for the lozenge than for the tablet. The mouth appeared to act as a reservoir for continued clearance to the throat. Discussion and Conclusion:, Scintigraphy is an effective means of quantifying the delivery efficiency, and hence availability, of sore throat medications. The results presented here suggest that both lozenges and tablets offer considerable advantages over sprays or gargles, both in terms of proportion of the dose delivered to the mouth and throat, combined, and clearance from these regions. These delivery formats provide fast, effective and prolonged delivery of active ingredients, highlighting their potential benefits for sore throat medication. [source] Once-Daily Cefepime Versus Ceftriaxone for Nursing Home,Acquired PneumoniaJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 5 2007Joseph A. Paladino PharmD OBJECTIVES: To compare once-daily intramuscular cefepime with ceftriaxone controls. DESIGN: Double-blind study. SETTING: Six skilled nursing facilities. PARTICIPANTS: Residents aged 60 and older with nursing home,acquired pneumonia. INTERVENTION: Cultures were obtained, and patients were randomized to cefepime or ceftriaxone 1 g intramuscularly every 24 hours. MEASUREMENTS: Clinical success: cure or improvement. Cure was defined as complete resolution of all symptoms and signs of pneumonia or a return to the patient's baseline state. Improvement was defined as clear improvement but incomplete resolution of all pretherapy symptoms or signs or incomplete return to the patient's usual baseline status. Safety and pharmacoeconomics were also assessed. RESULTS: Sixty-nine patients were randomized; 61 were evaluable: (32 to cefepime, 29 ceftriaxone). Patients were predominately female (76%). They had a mean age±standard deviation of 85±6, with a mean 5.8±1.9 comorbidities; they had age-appropriate renal dysfunction, with a mean estimated creatinine clearance of 35±7 mL/min. Clinical success occurred in 78% of cefepime- and 66% of ceftriaxone-treated patients (P=.39). Fifty-seven patients (93%) were switched to oral antibiotics after 3 days. Antibiotic-related adverse events occurred in 5% of patients. Seven patients (11.5%) were hospitalized. The overall mortality rate was 8%. Mean antibiotic costs were $117±40 for cefepime- and $215±68 for ceftriaxone-treated patients (P<.001). Cost-effectiveness analysis of total costs showed that cefepime would cost $597 and ceftriaxone $1,709 per expected successfully treated patient. One- and two-way sensitivity analyses using a generic price for ceftriaxone and improving its comparative efficacy revealed that the results were robust. CONCLUSIONS: Once-daily cefepime was a cost-effective alternative to ceftriaxone for the treatment of elderly nursing home residents who developed pneumonia and did not require hospitalization. [source] Treatment of acute otitis media in patients with a reported penicillin allergyJOURNAL OF CLINICAL PHARMACY & THERAPEUTICS, Issue 3 2000Falconer Otitis media occurs commonly in children, and is usually treated with an antibiotic. In this case report, amoxicillin was prescribed for a 6-year-old boy suffering from acute otitis media. As he had previously experienced a rash after the administration of a penicillin, the medication order was switched from amoxicillin to trimethoprim/sulfamethoxazole (TMP/SMX). In an effort to determine whether or not this intervention was appropriate, references were found using Medline, International Pharmaceutical Abstracts and the Cochrane Library. Issues to be addressed included the need for antibiotics in acute otitis media, the comparative efficacy and tolerability of antimicrobial agents and the reliability of reported penicillin allergies. Amoxicillin and TMP/SMX were found to be first-line agents in the treatment of acute otitis media owing to their efficacy, safety and cost, with neither drug being significantly better than the other. The need to treat otitis media with antibiotics remains controversial. Reported penicillin allergies were found to be an unreliable indicator of a potentially serious reaction. In conclusion, it was found that treatment with TMP/SMX was an appropriate intervention. [source] Aminoglycoside dosing in diabetesJOURNAL OF CLINICAL PHARMACY & THERAPEUTICS, Issue 2 2000Axworthy Studies have evaluated the comparative efficacy, toxicity and costs associated with extended-interval vs. standard multiple daily dosing of aminoglycosides. In this case, an elderly man with diabetes and good renal function at baseline was switched from standard to extended-interval dosing. During the course of therapy there was evidence of decreased renal function. Pertinent literature was searched for, uncovered and critically evaluated to determine if and what evidence supports using extended dosing of aminoglycosides in this population. No data were found specifically evaluating the different dosing strategies in diabetic patients. However, there were many trials and several meta-analysis located that compared the two dosing strategies, most suggesting at least a cost advantage and possibly less toxicity with extended-interval dosing. Further information is needed to determine whether there is a differential risk for toxicity between these dosing regimens in patient with diabetes. [source] Facilitating eyewitness memory in adults and children with context reinstatement and focused meditationJOURNAL OF INVESTIGATIVE PSYCHOLOGY AND OFFENDER PROFILING, Issue 2 2006Laura Hammond Abstract This study examined the comparative efficacy of two brief techniques for facilitating eyewitness memory in police investigations. Adult and child participants (N = 126; 64 children and 62 adults) who had viewed a videotape of a crime were subsequently tested for their memory of the event following either a focused meditation procedure (FM, derived from hypnotic interviewing techniques), a context reinstatement procedure (CR, a component of the cognitive interview), or a control procedure (no memory facilitation instructions). For both adults and children, the FM and CR procedures enhanced performance on both open-ended and closed questions to levels above those achieved by controls, although those in the CR condition produced significantly more correct responses than those in the FM condition. However, only those in the CR group displayed elevated levels of confidence in relation to incorrect responses on closed questions. Implications for the possible use of such procedures are discussed. Copyright © 2006 John Wiley & Sons, Ltd. [source] Naratriptan for the treatment of acute migraine: meta-analysis of randomised controlled trials,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 2 2004Darren M. Ashcroft PhD Abstract Objective To evaluate the comparative efficacy and tolerability of naratriptan in the treatment of acute attacks of migraine. Design Meta-analysis of randomised controlled trials using a random effects model. Subjects A total of 4499 patients suffering from moderate or severe attacks of acute migraine reported in ten trials. Main outcome measures Response rate ratios for headache relief, pain-free response and sustained relief (4,24 hours). Adverse events were estimated with the rate ratio (RR), risk difference and number needed to harm. Results Pooled RRs relative to placebo for pain-free response at 2 and 4 hours for naratriptan 2.5,mg were 2.52 (95%,CI: 1.78,3.57) and 2.58 (1.99,3.35). Naratriptan 2.5,mg was more effective than naratriptan 1,mg; the corresponding RRs for pain-free response at 2 and 4 hours were 1.54 (95%,CI: 1.28,1.86) and 1.35 (1.20,1.51). In contrast, naratriptan 2.5,mg was less effective in pain-free response than either rizatriptan 10,mg at 4,hours (RR: 0.68; 95%,CI: 0.55,0.85) or sumatriptan 100,mg at 4,hours (RR: 0.79; 95%,CI: 0.67,0.93). However, significantly fewer patients experienced adverse effects with naratriptan 2.5,mg than with rizatriptan 10,mg (RR: 0.73; 95%,CI: 0.56,0.97) or sumatriptan 100,mg (RR: 0.68; 95%,CI: 0.55,0.86). Conclusions Naratriptan is an effective and well-tolerated treatment for acute attacks of migraine. Head-to-head comparisons suggest that naratriptan 2.5,mg is significantly more effective than the 1,mg dose. Rizatriptan 10,mg and sumatripatn 100,mg were superior to naratriptan in terms of headache relief, while zolmitriptan 2.5,mg seemed to have comparable efficacy. Randomised controlled trials have shown that at licensed doses (1 and 2.5,mg), naratriptan is associated with a lower incidence of adverse effects than rizatriptan, sumatriptan and zolmitriptan. The incidence rates of adverse effects were similar to placebo. Copyright © 2003 John Wiley & Sons, Ltd. [source] Dronedarone: Current Evidence and Future QuestionsCARDIOVASCULAR THERAPEUTICS, Issue 1 2010Jeremy A. Schafer Atrial fibrillation (AF) is the most common sustained arrhythmia, affecting more than 2.2 million Americans. ACC/AHA/ESC guidelines for the management of patients with AF recommend amiodarone for maintaining sinus rhythm. Dronedarone is a derivative of amiodarone indicated for the treatment of AF. To provide an overview of dronedarone with a focus on the phase III trials and discuss unresolved questions of dronedarone. A literature search was conducted via the PubMed database using the keyword "dronedarone." Search was limited to human trials in english. The FDA website was searched for briefing documents and subcommittee meetings on dronedarone. Clinicaltrials.gov was searched with the keyword dronedarone for upcoming or unpublished clinical trials. Five phase III trials are available for dronedarone: ANDROMEDA, EURIDIS/ADONIS, ATHENA, ERATO, and DIONYSIS. EURIDIS/ADONIS and ATHENA demonstrated a reduction AF recurrence with dronedarone compared to placebo. The ANDROMEDA trial recruited patients with recent hospitalization for heart failure and was terminated due to an excess of deaths in the dronedarone group. The DIONYSIS trial was a comparative effectiveness trial that demonstrated less efficacy for dronedarone but improved tolerability compared to amiodarone. Dronedarone represents an option in the management of AF in select patients. Dronedarone is not appropriate in patients with recently decompensated heart failure or those treated with strong CYP3A4 inhibitors or medications prolonging the QT interval. Dronedarone appears to have improved tolerability at the expense of decreased efficacy when compared to amiodarone. Questions remain on the long-term safety, use in patients with heart failure, retreatment after dronedarone or amiodarone failure, and comparative efficacy with a rate control strategy. [source] |