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Granisetron/dexamethasone combination for reducing nausea and vomiting during and after spinal 2 anesthesia for cesarean section buy generic seroflo 250mcg line. Prophylactic therapy with granisetron in the prevention of vomiting after paediatric surgery purchase 250 mcg seroflo with visa. A randomized seroflo 250mcg, double-blind comparison 2 with droperidol and metoclopramide. Comparison of granisetron, droperidol, and metoclopramide for prevention of postoperative vomiting in children with a 2 history of motion sickness undergoing tonsillectomy. Comparison of granisetron and ramosetron for the prevention of nausea and vomiting after thyroidectomy. Ramosetron compared with granisetron for the prevention of vomiting following strabismus surgery in children. Treatment of vomiting after paediatric strabismus surgery with granisetron, droperidol, and metoclopramide. Antiemetics Page 95 of 136 Final Report Update 1 Drug Effectiveness Review Project Exclusion Excluded Studies code # Fujii Y, Tanaka H, Kawasaki T. Randomized clinical trial of granisetron, droperidol and metoclopramide for the treatment of nausea and vomiting 2 after laparoscopic cholecystectomy. A comparison of granisetron, droperidol, and metoclopramide in the treatment of established nausea and vomiting after 2 breast surgery: A double-blind, randomized, controlled trial. Benefits and risks of granisetron versus ramosetron for nausea and vomiting after breast surgery: a randomized, 2 double-blinded, placebo-controlled trial. Prevention of nausea and vomiting after middle ear surgery: Granisetron versus ramosetron. Granisetron, droperidol, and metoclopramide for preventing postoperative nausea and vomiting after 2 thyroidectomy. The effects of dexamethasone on antiemetics in female patients undergoing gynecologic surgery. Granisetron reduces the incidence and severity of nausea and vomiting after laparoscopic cholecystectomy. Prevention of nausea and vomiting with granisetron, droperidol and metoclopramide during and after spinal 2 anaesthesia for caesarean section: A randomized, double-blind, placebo- controlled trial. Prevention of nausea and vomiting in female patients undergoing breast surgery: A comparison with granisetron, 2 droperidol, metoclopramide and placebo. Prevention of PONV granisetron, droperidol and metoclopramide in female patients with history of motion sickness. Prophylactic antiemetic therapy with a combination of granisetron and dexamethasone in patients undergoing 2 middle ear surgery. A granisetron-droperidol combination prevents postoperative vomiting in children. Granisetron-droperidol combination for the prevention of postoperative nausea and vomiting in female patients 2 undergoing breast surgery. Antiemetics Page 96 of 136 Final Report Update 1 Drug Effectiveness Review Project Exclusion Excluded Studies code # Fujii Y, Toyooka H, Tanaka H. Prevention of postoperative nausea and vomiting with a combination of granisetron and droperidol. Prevention of postoperative nausea and vomiting in female patients during menstruation: Comparison of droperidol, 2 metoclopramide and granisetron. Prophylactic anti-emetic therapy with granisetron, droperidol and metoclopramide in female patients undergoing 2 middle ear surgery. Double-blind, randomized comparison of ondansetron and intraoperative propofol to prevent 2 postoperative nausea and vomiting. Progress in the control of acute and delayed emesis induced 2 by cisplatin. Gebbia V, Testa A, Valenza R, Cannata G, Tirrito ML, Gebbia N. Oral granisetron with or without methylprednisolone versus metoclopramide plus methylprednisolone in the management of delayed nausea and vomiting 2 induced by cisplatin-based chemotherapy: A prospective randomized trial. Substance P (neurokinin-1) antagonist prevents postoperative vomiting after abdominal hysterectomy 2 procedure. Antiemetic effects of granisetron, droperidol and dexamethasone in otologic surgery. Goldschmidt H, Salwender H, Egerer G, Kempe R, Voigt T. Comparison of oral itasetron with oral ondansetron: Results of a double- blind, active- controlled phase II study in chemotherapy-naive patients receiving 2 moderately emetogenic chemotherapy. Ondansetron is no more effective than supplemental intraoperative oxygen for prevention of postoperative nausea 2 and vomiting. Comparison of cyclizine and ondansetron for the prevention of postoperative nausea and vomiting in 2 laparoscopic day-case gynaecological surgery. Grond S, Lynch J, Diefenbach C, Altrock K, Lehmann KA. Comparison of ondansetron and droperidol in the prevention of nausea and vomiting after 2 inpatient minor gynecologic surgery. The effect of ginger and ondansetron on nausea and vomiting after middle ear surgery. Antiemetics Page 97 of 136 Final Report Update 1 Drug Effectiveness Review Project Exclusion Excluded Studies code # Hahlen K, Quintana E, Pinkerton CR, Cedar E. A randomized comparison of intravenously administered granisetron versus chlorpromazine plus 2 dexamethasone in the prevention of ifosfamide-induced emesis in children. A single-blind comparison of intravenous ondansetron, a selective serotonin antagonist, with intravenous metoclopramide in the prevention of nausea and vomiting associated with 2 high-dose cisplatin chemotherapy. Handberg J, Wessel V, Larsen L, Herrstedt J, Hansen HH. Randomized, double-blind comparison of granisetron versus granisetron plus prednisolone 2 as antiemetic prophylaxis during multiple-day cisplatin- based chemotherapy.

Anderson RU order seroflo without prescription, Mobley D order 250mcg seroflo amex, Blank B seroflo 250mcg for sale, Saltzstein D, Susset J, Brown JS. Once daily controlled versus immediate release oxybutynin chloride for urge urinary incontinence. Prospective randomized controlled trial of extended-release oxybutynin chloride and tolterodine tartrate in the treatment of overactive bladder: results of the OBJECT Study. A randomized, double-blind, parallel-group comparison of controlled- and immediate-release oxybutynin chloride in urge urinary incontinence. A randomized controlled trial comparing the efficacy of controlled-release oxybutynin tablets (10 mg once daily) with conventional oxybutynin tablets (5 mg twice daily) in patients whose symptoms were stabilized on 5 mg twice daily of oxybutynin. Comparison of darifenacin and oxybutynin in patients with overactive bladder: assessment of ambulatory urodynamics and impact on salivary flow. Chapple CR, Arano P, Bosch JHR, De Ridder D, Kramer A, Ridder A. Solifenacin appears effective and well tolerated in patients with symptomatic idiopathic detrusor overactivity in a placebo- and tolterodine-controlled phase 2 dose-finding study. A comparison of the efficacy and tolerability of solifenacin succinate and extended release tolterodine at treating overactive bladder syndrome: Results of the STAR trial. Chu FM, Dmochowski RR, Lama DJ, Anderson RU, Sand PK. Extended-release formulations of oxybutynin and tolterodine exhibit similar central nervous system tolerability profiles: a subanalysis of data from the OPERA trial. A short-term, multicenter, randomized double- blind dose titration study of the efficacy and anticholinergic side effects of transdermal compared to immediate release oral oxybutynin treatment of patients with urge urinary incontinence. Prospective, randomized, double-blind study of the efficacy and tolerability of the extended-release formulations of oxybutynin and tolterodine for overactive bladder: Results of the OPERA trial. Comparative efficacy and safety of transdermal oxybutynin and oral tolterodine versus placebo in previously treated patients with urge and mixed urinary incontinence. Overactive bladder Page 45 of 73 Final Report Update 4 Drug Effectiveness Review Project 33. Drutz HP, Appell RA, Gleason D, Klimberg I, Radomski S. Clinical efficacy and safety of tolterodine compared to oxybutynin and placebo in patients with overactive bladder. Controlled, double-blind, multicentre clinical trial to investigate long-term tolerability and efficacy of trospium chloride in patients with detrusor instability. Health-related quality of life of Japanese patients with overactive bladder treated with extended-release tolterodine or immediate-release oxybutynin: a randomized, placebo-controlled trial. Homma Y, Paick JS, Lee JG, Kawabe K, Japanese, Korean Tolterodine Study G. Clinical efficacy and tolerability of extended-release tolterodine and immediate-release oxybutynin in Japanese and Korean patients with an overactive bladder: a randomized, placebo-controlled trial. Tolterodine: As effective but better tolerated than oxybutynin in Asian patients with symptoms of overactive bladder. A randomized controlled trial of tolterodine and oxybutynin on tolerability and clinical efficacy for treating Chinese women with an overactive bladder. Madersbacher H, Stohrer M, Richter R, Burgdorfer H, Hachen HJ, Murtz G. Trospium chloride versus oxybutynin: a randomized, double-blind, multicentre trial in the treatment of detrusor hyper-reflexia. Double-blind crossover comparison of flavoxate and oxybutynin in women affected by urinary urge syndrome. Nilsson CG, Lukkari E, Haarala M, Kivela A, Hakonen T, Kiilholma P. Comparison of a 10-mg controlled release oxybutynin tablet with a 5-mg oxybutynin tablet in urge incontinent patients. Radomski S, Caley B, Reiz JL, Miceli PC, Harsanyi Z, Darke AC. Preliminary evaluation of a new controlled-release oxybutynin in urinary incontinence. A comparison of extended-release oxybutynin and tolterodine for treatment of overactive bladder in women. Treatment of overactive bladder with once-daily extended-release tolterodine or oxybutynin: The Antimuscarinic Clinical Effectiveness Trial (ACET). Swift S, Garely A, Dimpfl T, Payne C, Tolterodine Study G. A new once-daily formulation of tolterodine provides superior efficacy and is well tolerated in women with overactive bladder. Van Kerrebroeck P, Kreder K, Jonas U, Zinner N, Wein A, Tolterodine Study G. Tolterodine once-daily: superior efficacy and tolerability in the treatment of the overactive bladder. Overactive bladder Page 46 of 73 Final Report Update 4 Drug Effectiveness Review Project 47. Versi E, Appell R, Mobley D, Patton W, Saltzstein D. Dry mouth with conventional and controlled-release oxybutynin in urinary incontinence. Conservative therapy of frequency, urgency and urge incontinence: A double-blind clinical trial of flavoxate hydrochloride, oxybutinin chloride, emepronium bromide and placebo. The efficacy, tolerability and safety profile of tolterodine in the treatment of overactive/unstable bladder. Randomized, double-blind placebo- and tolterodine-controlled trial of the once-daily antimuscarinic agent solifenacin in patients with symptomatic overactive bladder. Health-related quality of life issues in urinary urge incontinence. Expert Review of Pharmacoeconomics & Outcomes Research. Quality-of-life aspects of the overactive bladder and the effect of treatment with tolterodine. The comparative tolerability and efficacy of tolterodine 2 mg bid versus oxybutynin 2.

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These can be divided into 2 groups: those relating to generalizability of the results and those relating to methodology within the scope of this review buy seroflo 250mcg fast delivery. The generalizability of the results are limited by the scope of the key questions and inclusion criteria and by the generalizability of the studies included buy seroflo online now. Most studies included narrowly defined populations of patients who met strict criteria for case definition discount seroflo express, had fewer comorbidities, and used fewer concomitant medications than many neuropathic pain patients not participating in trials. Minorities, young adults, and the least healthy were under represented as were patients whose pain was less severe or unrelated to diabetes. Methodological limitations of the review within the defined scope included the exclusion of studies published in languages other than English and lack of a specific search for unpublished studies. Few direct head-to-head comparisons of many of the included drugs have been conducted, which limited our conclusions to indirect comparison of placebo-controlled trials for many of the outcomes. This also limited the strength of the evidence due to heterogeneity of trial populations, interventions, and outcomes assessment. One potential limitation to the applicability of this review is it relates to a narrower range of drugs than are available in clinical practice. Applicability Based on the scope of this review the evidence presented and synthesized here is applicable to a somewhat limited group of patients. Patients in direct comparison trials included in this review were most often from Europe or Asia, female (53%), 60 years old, and had diabetes or postherpetic neuralgia for 7 years (mean range 4-13 years). Only 1 trial was based in the United States; this trial consisted of 26 United States military veterans who included 25 males and 23 Caucasians. Therefore, it is difficult to know whether the results presented here apply equally well to African Americans, Hispanics, or to Caucasians in the United States. The selection of drugs included in this review was influenced by the specific programmatic interests of the organizations participating in the Drug Effectiveness Review Project and were not meant to be read as a usage guideline. Of the drugs studied, trials differed with respect to dosing regimens limiting any conclusions about optimal dose. While evidence on how the drugs compared directly was the goal, the evidence with direct comparison is limited; much of the evidence consisted of placebo-controlled trials. Given that neuropathic pain is a chronic condition, the applicability of results from short-term trials such as those included in this report may be limited. Outcomes studied were primarily measures of pain, with multiple methods used to assess pain response. Neuropathic pain may impact a patient’s life in other ways as well, such as causing Neuropathic pain 47 of 92 Final Update 1 Report Drug Effectiveness Review Project fatigue, depression, lack of ability to have full employment, or reduced quality of life. These outcomes were not well studied, and the evidence does not provide insight here. Studies Pending Review The following unpublished studies were identified just after completion of this report (summaries of these studies can be found at http://clinicaltrials. Summary of the evidence by key question Key question Strength of evidence Conclusion Key Question 1. What is the comparative effectiveness of anticonvulsants, tricyclic antidepressants, SNRIs, and the lidocaine patch for neuropathic pain? Diabetic neuropathy and Gabapentin, pregabalin, No difference in rate of response defined postherpetic neuralgia lamotrigine vs. What are the comparative harms of anticonvulsants, tricyclic antidepressants, SNRIs, and the lidocaine patch for neuropathic pain? Diabetic neuropathy and Gabapentin, pregabalin, No difference in withdrawals due to postherpetic neuralgia lamotrigine vs. Gabapentin/pregabalin cause less dry tricyclic antidepressants: mouth than the tricyclic antidepressants Moderate Gabapentin/pregabalin vs. Gabapentin/pregabalin combined cause tricyclic antidepressants: more ataxia than the tricyclic Low antidepressants Duloxetine vs. Fewer withdrawals due to adverse events topiramate, oxcarbazepine: in gabapentin and lamotrigine when Low compared to either topiramate or oxcarbazepine Other types of neuropathic Insufficient Among 3 head-to-head trials, 1 reported pain no withdrawals due to adverse events with either amitriptyline or carbamazepine, and the others reported similar proportions of patients withdrawing due to adverse events for amitriptyline or imipramine compared to gabapentin Key Question 3. Are there differences in effectiveness or harms of anticonvulsants, tricyclic antidepressants, SNRIs, and the lidocaine patch based on demographics, socioeconomic status, comorbidities, or drug-drug interactions, when used to treat neuropathic pain? Low Age: Post hoc analyses have not found older age to have an impact on response or treatment emergent adverse events with duloxetine Combination therapy: Combinations of duloxetine and pregabalin; lidocaine patch and pregabalin; or gabapentin with imipramine, nortriptyline, or venlafaxine have a potential benefit compared to monotherapy, but increased adverse events occurred Demographics, socioeconomic status, comorbidities or cointerventions: no evidence Neuropathic pain 49 of 92 Final Update 1 Report Drug Effectiveness Review Project CONCLUSIONS Overall, the strength of evidence evaluating the comparative benefits or harms of these drugs to treat neuropathic pain was low to moderate. Based on a small number of short-term trials directly comparing the drugs in patients with painful diabetic neuropathy and postherpetic neuralgia, the evidence did not support a statistically significant difference in response (50% reduction in pain) or withdrawal due to adverse events with gabapentin, pregabalin, and lamotrigine compared with tricyclic antidepressants. Oral pregabalin was similar to lidocaine 5% medicated patch in rate of response, but resulted in more patients withdrawing due to an adverse event. Adjusted indirect comparisons of placebo-controlled trials suggested that duloxetine, pregabalin, and gabapentin were superior to lacosamide and lamotrigine, but no difference in withdrawal from study due to adverse events was found. In these analyses, differences were not found between pregabalin, duloxetine, and gabapentin or comparisons of 5% lidocaine patch and amitriptyline or gabapentin. Tricyclic antidepressants caused more dry mouth than pregabalin or gabapentin while gabapentin and pregabalin resulted in higher rates of ataxia. In patients with cancer-related neuropathic pain who were taking opioids, there was no difference in pain relief with low-dose gabapentin compared with low-dose imipramine. Monotherapy with either drug was insufficient for pain relief. In patients with spinal cord injury, gabapentin was more effective for pain relief than amitriptyline. The difference was significant only in the subgroup of patients with the highest levels of depression. In patients with central poststroke pain, there was no difference between amitriptyline and carbamazepine. There was no direct evidence in patients with HIV-associated neuropathic pain, multiple sclerosis, complex regional pain syndrome, postmastectomy pain syndrome, phantom limb pain, or traumatic nerve injury pain. Evidence for comparative effectiveness in patients with types of neuropathic pain other than diabetic or postherpetic was insufficient to assess comparative safety. Post hoc analyses have not found older age to have an impact on response or treatment- emergent adverse events with duloxetine. Combination therapy with duloxetine and pregabalin; lidocaine patch and pregabalin; or gabapentin with imipramine, nortriptyline, or venlafaxine may have had a potential benefit compared with monotherapy, but there was an increased risk of adverse events. Neuropathic pain 50 of 92 Final Update 1 Report Drug Effectiveness Review Project REFERENCES 1.

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Other parasite factors can tip the balance between clearance and widespread 132 CHAPTER 9 infection of a secondarily inoculated host proven 250mcg seroflo. For example discount seroflo uk, the number of parasites in the inoculum frequently influences whether an infection is cleared quickly or spreads widely order seroflo 250 mcg. These various parasite attributes and the rate parameters that gov- ern parasite birth and death within hosts must be measured against the kinetics of immunological memory and the response to secondary infection. The quantitative outcome influences the selective pressure imposed on various parasite epitopes by host memory. Such selective pressure, in turn, shapes the distribution of antigenic variation in para- site populations. First, which parasite variants have infected that host in the past? Third, to which of the primary epitopes has the host retained memory? The immunological profile of each host and the variation of profiles between hosts influence the selective pressures imposed on parasite antigens. For the profile of each host, consider as a simple measure of immunodominance the number of epitopes to which a host retains protective antibody. If a host retains protection against n epitopes, then avariantparasite strain must differ in at least n sites to avoid all mem- ory. If the mutationratepersiteisµ,thenthe probability is µn that aprogenyoftheoriginal strain is an escape variant with all of the n necessary differences. Several laboratory experiments of influenza have studied the origin of escape variants when neutralizing antibody pressure is imposed against viral epitopes (Yewdell et al. For anti- bodies against only a single epitope, escape variants arise often because only a single mutation is needed. The mutation rate of influenza is on the order of µ = 10−5 per nucleotide per generation. Thus, a moderate- size population of viruses likely has at least a few escape mutants. By contrast, antibody selection against two or more epitopes rarely yields escape mutants, because the probability of multiple mutations, µn,be- comes small relative to the effective size of the population. IMMUNOLOGICAL VARIABILITY OF HOSTS 133 These laboratory experiments show that a broader antibody response against multiple epitopes impedes the origin of new variants. By con- trast, a more focused immunodominant response allows the rapid evo- lution of escape variants. Similarly, persistent viral infections within hosts respond differently to narrowversus broad CTL pressure (Wodarz and Nowak 2000). A highly immunodominant CTL response allows rapid evolution of escape mutants and continuing change within hosts. By contrast, a broad CTL response against multiple epitopes impedes the origin of escape variants and leads to relatively slow evolution of viruses within a host. To determine the selective pressures imposed on parasite popula- tions, the immunodominance of each host’s memory profile must be placed in the context of variationinmemoryprofiles between hosts. Suppose, for example, that a parasite has two distinct antigenic sites. A parasite with genotype A/B at the two sites sweeps through the popula- tion, infecting all hosts. One-half ofthe host population maintains mem- ory against both antigens, one-quarter has immunodominant memory against A only, and one-quarter has immunodominant memory against B only. Now consider how this distribution of memory profiles influences the success of antigenic variants. A mutation at a single site, for example B,yieldsanaltered parasite, A/B. Thism utant can attack the quar- ter of the host population with memory only against B. Asthepara- site spreads, a second mutation to A /B allows attack of the remaining hosts. This example shows that strongly immunodominant host profiles lim- ited to one or a few sites allow parasite mutants with few changes to succeed. Once the variant parasite begins to spread between suscepti- ble hosts, additional mutations allow attack against hosts with different immunodominant profiles or against hosts that developed broader im- munity against multiple antigenic sites. Influenza evolution may proceed by this sort of sequential accumula- tion of variation, with new epidemic strains differing from the previous epidemic strain at several sites (Natali et al. Surveys of human popula- tions and laboratory studies of mice and rabbits support this hypoth- esis by showing that individuals often have narrowly focused antibody 134 CHAPTER 9 responses and that individuals vary in the antigenic sites to which they develop antibodies. In the laboratory, studies show that individual mice infected with hu- man influenza often produce antibody responses focused on a limited number of antigenic sites—probably just one or two sites (Staudt and Gerhard 1983; Underwood 1984; Thomas et al. Individual mice differed in the antigenic sites to which they raised antibodies. Individ- ual variation in antibody response probably occurs because stochastic recombinational and mutational processes generate antibody specificity (Staudt and Gerhard 1983). Surveys of human populations find that individuals previously ex- posed to influenza vary in antibody memory profiles (Natali et al. For samples collected from the early years of the Hong Kong influenza subtype epi- demics (1969 and 1971), 33% of individuals had antibodies to all three sites, 50% had antibodies for two sites, and 17% hadantibodies for only one site. Approximately equal numbers of individuals lacked antibody to any particular site, suggesting that each site was equally likely to stim- ulate an antibody response. Most individuals sampled in 1978 had anti- bodies for all three sites. It appears that after several years of repeated exposure to various strains of the Hong Kong subtype, individuals had acquired a wider repertoire of antibodies. Human children tend to have particularly narrowly focused antibody profilesagainst influenza (Natali et al. This may occur either because of children’s relatively smaller number of exposures or because of their narrower response per infection. Theseobservations on mice and humans support the hypothesis that individuals have narrowly focused antibody memory and that individu- als vary in the antigenic sites to which they respond.

Fewer atorvastatin patients needed to have their dose doubled; nevertheless a greater percentage of atorvastatin patients reached the low-density lipoprotein cholesterol target after 52 weeks (61% compared with 41%; P<0 order discount seroflo online. However buy seroflo 250mcg with visa, the simvastatin 80 mg dose buy generic seroflo 250 mcg online, which was approved later, was not evaluated in the study. In the Evaluation to Compare Lipid-lowering effects of rosuvastatin and atorvastatin (ECLIPSE) study, a 24-week, open-label, randomized, multicenter and multinational, head-to- 20 head trial, compared rosuvastatin 10 mg to atorvastatin 10 mg. The doses were then sequentially doubled every 6 weeks until the patient was receiving rosuvastatin 40 mg or atorvastatin 80 mg, the maximal dose of each drug. Also analyzed was the percentage of very high-risk patients achieving a low-density lipoprotein cholesterol goal of <70 mg/dL (1. In a meta-analysis of three 12-week randomized trials of rosuvastatin compared with atorvastatin, 76% of patients taking rosuvastatin 10 mg reached their Adult Treatment Panel III 97 goal compared with 53% of those taking atorvastatin 10 mg. In the same publication, in a pooled analysis of 2 trials of rosuvastatin compared with simvastatin and pravastatin, percentages of patients reaching their goal were 86% for rosuvastatin 10 mg, 64% for simvastatin 20 mg, and 49% for pravastatin 20 mg. Results for rosuvastatin 5 mg are not reported in this meta-analysis. The only 1-year head-to-head study of rosuvastatin compared with 69 atorvastatin was conducted in 3 phases: a 6-week run-in period, a 12-week fixed-dose comparison of rosuvastatin (5 mg or 10 mg) or atorvastatin (10 mg), and a 40-week titration period in which the dose of rosuvastatin or atorvastatin could be doubled until the National Cholesterol Education Program-II goal or a dose of 80 mg was reached. At 52 weeks, the percentage of patients meeting their goal was 88% for patients starting at rosuvastatin 5 mg, 98% of those starting at rosuvastatin 10 mg, and 87% of those starting at atorvastatin 10 mg (no statistical analysis was performed). Excluding results for 80 mg of rosuvastatin, results were similar (89% of those starting at rosuvastatin 5 mg and 98% of those starting at rosuvastatin 10 mg reached their goal). In other studies of atorvastatin lasting 1 year or longer, percentages of patients meeting their National Cholesterol Education Program goal ranged from 46% to 61% for 10 mg to 40 mg atorvastatin and 51% to 95% for 10 mg to 80 mg atorvastatin. Fixed-dose combination products containing a statin and another lipid-lowering drug Eight trials measured the percentage of patients meeting their National Cholesterol Education Program low-density lipoprotein cholesterol treatment goals. Seven of these evaluated ezetimibe 100, 101, 103-107 and simvastatin (Vytorin) fixed-dose combination and 1 evaluated the efficacy of Statins Page 30 of 128 Final Report Update 5 Drug Effectiveness Review Project 110 niacin extended-release and simvastatin (Simcor) fixed-dose combination. Fewer studies reported the percentage achievement of the optional goal of <70 mg/dL low-density lipoprotein cholesterol for very high-risk patients. There was a significant difference in the ezetimibe- simvastatin fixed-dose compared to all statins at all comparable doses except for rosuvastatin, which had equal efficacy in achieving National Cholesterol Education Program Adult Treatment Panel III low-density lipoprotein cholesterol goals at all doses except rosuvastatin 10 mg (Table 103 8). There was no statistically significant difference in the ability of the niacin extended-release and simvastatin fixed-dose combination compared to simvastatin alone in achieving the National Cholesterol Education Program Adult Treatment Panel III low-density lipoprotein cholesterol 110 goals based on 1 study. Achievement of National Cholesterol Education Program low-density lipoprotein cholesterol goals of fixed-dose combination products Fixed-dose combination LDL-C < 100 mg/dL or LDL-C < 70 mg/dL or product 2. A comparative effectiveness review and meta-analysis was recently conducted by the Agency for Healthcare Research and Quality. Its conclusions regarding combination lipid- 115 lowering products are consistent with the results of this review. How do statins and fixed-dose combination products containing a statin and another lipid-lowering drug compare in their ability to increase high- density lipoprotein cholesterol? Summary of findings • When statins are provided in doses that reduce low-density lipoprotein cholesterol by equivalent amounts, a similar percent increase in high-density lipoprotein cholesterol can be achieved. Statins Page 31 of 128 Final Report Update 5 Drug Effectiveness Review Project • Some studies found greater increases in high-density lipoprotein cholesterol with low- dose rosuvastatin compared with atorvastatin, while other studies found no difference. Are there doses for each statin or fixed-dose combination product containing a statin and another lipid-lowering drug that produce similar percent increase in high-density lipoprotein cholesterol between statins? Statins A previous meta-analysis of placebo-controlled trials estimated that, on average, statins increased high-density lipoprotein cholesterol by 3 mg/dL (0. In our review of 77 head-to-head trials, statins raised high-density lipoprotein cholesterol levels from 0% to 19%, with the great majority between 5% and 9% (Evidence Table 1). While most found no significant difference in high- density lipoprotein cholesterol-raising among the statins, there were some exceptions. In 6 head-to-head studies of low-density lipoprotein cholesterol lowering, simvastatin 38, 41, 52, 55, 58, 68 increased high-density lipoprotein cholesterol more than atorvastatin 10 to 80 mg, 26, 29, 30, 39, 42, 48, but in 14 others, there was no significant difference between the 2 on this measure. Patients were then randomized to simvastatin 40 mg or atorvastatin 40 mg for 8 weeks, when the atorvastatin dose was increased to 80 mg while the simvastatin dose remained the same. The non-equivalent dosing and patient inclusion criteria limited the utility of this finding. There was 1 meta-analysis of randomized controlled trials of atorvastatin and simvastatin which demonstrated that simvastatin was generally associated with greater increases in high-density lipoprotein cholesterol than atorvastatin, with the greatest significance at the 12 higher doses of atorvastatin. Two studies that compared atorvastatin to simvastatin were designed to measure high- 33, 59 density lipoprotein cholesterol raising as a primary outcome. A 24-week study of 917 patients randomized to atorvastatin 80 mg or simvastatin 80 mg reported only an average of the 33 increase at weeks 18 and 24, separately, by baseline high-density lipoprotein cholesterol level. The average increase was the same in patients with baseline high-density lipoprotein cholesterol above and below 40 mg/dL: 2. These differences were not statistically significant. In the other study Statins Page 32 of 128 Final Report Update 5 Drug Effectiveness Review Project 59 reporting high-density lipoprotein cholesterol as a primary outcome, 826 patients were randomized to atorvastatin (20 mg daily for 6 weeks, then 40 mg daily) or simvastatin (40 mg daily for 6 weeks, then 80 mg daily) for 36 weeks. The primary endpoint was the average of results from weeks 6 and 12. The mean percent increase in high-density lipoprotein cholesterol was greater in the simvastatin group (9. High-density lipoprotein cholesterol increased by 9. At lower doses, the difference was not significant (percent change not reported). Nine head-to-head trials (in 11 publications) reported high-density lipoprotein cholesterol 14, 17, 20, 36, 43, 56, 69, 92-94, 98 increases with rosuvastatin compared with atorvastatin. Five studies reported greater increases in high-density lipoprotein cholesterol with rosuvastatin 5 or 10 mg 20, 36, 43, 93, 94 than with atorvastatin 10 mg. A sixth study of fair quality reported no difference 69 between the 2 drugs at the same doses. Two studies reported greater increases with rosuvastatin 10 mg than with atorvastatin 20 mg (with one showing a decrease in high-density lipoprotein 17, 98 cholesterol).

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Effectiveness studies conducted in primary care or office-based settings use less stringent eligibility criteria purchase genuine seroflo online, more often assess health outcomes order seroflo line, and have longer follow-up periods than most efficacy studies purchase seroflo 250 mcg on line. The results of effectiveness studies are more applicable to the “average” patient than results from the highly selected populations in efficacy studies. Examples of effectiveness outcomes include quality of life, frequency or duration of hospitalizations, social function, and the ability to work. These outcomes are more important to patients, family, and care providers than surrogate or intermediate measures, such as scores based on psychometric scales. For example, a study might use very narrow inclusion criteria like an efficacy study, but, like an effectiveness study, might examine flexible dosing regimens, have a long follow-up period, and measure quality of life and functional outcomes. For this report we sought evidence about outcomes that are important to patients and would normally be considered appropriate for an effectiveness study. However, many of the studies that reported these outcomes were short-term and used strict inclusion criteria to select eligible patients. For these reasons, it was neither possible nor desirable to exclude evidence based on these characteristics. Labeling a study as either an efficacy or an effectiveness study, although convenient, is of limited value; it is more useful to consider whether the patient population, interventions, time frame, and outcomes are relevant to one’s practice or to a particular patient. Neuropathic pain 11 of 92 Final Update 1 Report Drug Effectiveness Review Project Studies anywhere on the continuum from efficacy to effectiveness can be useful in comparing the clinical value of different drugs. Effectiveness studies are more applicable to practice, but efficacy studies are a useful scientific standard for determining whether characteristics of different drugs are related to their effects on disease. Systematic reviews thoroughly cover the efficacy data in order to ensure that decision makers can assess the scope, quality, and relevance of the available data. This thoroughness is not intended to obscure the fact that efficacy data, no matter how large the quantity, may have limited applicability to practice. Clinicians can judge the relevance of study results to their practice and should note where there are gaps in the available scientific information. Unfortunately, for many drugs there exist few or no effectiveness studies and many efficacy studies. Yet clinicians must decide on treatment for patients who would not have been included in controlled trials and for whom the effectiveness and tolerability of the different drugs are uncertain. Systematic reviews indicate whether or not there exists evidence that drugs differ in their effects in various subgroups of patients, but they do not attempt to set a standard for how results of controlled trials should be applied to patients who would not have been eligible for them. With or without an evidence report, these decisions must be informed by clinical judgment. In the context of development of recommendations for clinical practice, systematic reviews are useful because they define the strengths and limits of the evidence, clarifying whether assertions about the value of an intervention are based on strong evidence from clinical studies. Judgment, reasoning, and applying one’s values under conditions of uncertainty must also play a role in decision making. Users of an evidence report must also keep in mind that not proven does not mean proven not; that is, if the evidence supporting an assertion is insufficient, it does not mean the assertion is untrue. The quality of the evidence on effectiveness is a key component, but not the only component, in making decisions about clinical policy. Additional criteria include acceptability to physicians and patients, potential for unrecognized harm, applicability of the evidence to practice, and consideration of equity and justice. Scope and Key Questions The Oregon Evidence-based Practice Center wrote preliminary key questions, identifying the populations, interventions, and outcomes of interest, and based on these, the eligibility criteria for studies. These were reviewed and revised by representatives of organizations participating in Drug Effectiveness Review Project. The participating organizations of Drug Effectiveness Review Project are responsible for ensuring that the scope of the review reflects the populations, drugs, and outcome measures of interest to both clinicians and patients. The participating organizations approved the following key questions to guide this review: 1. What is the comparative effectiveness of anticonvulsants, tricyclic antidepressants, serotonin–norepinephrine reuptake inhibitors (SNRIs), and the lidocaine patch for neuropathic pain? What are the comparative harms of anticonvulsants, tricyclic antidepressants, SNRIs, and the lidocaine patch for neuropathic pain? Neuropathic pain 12 of 92 Final Update 1 Report Drug Effectiveness Review Project 3. Are there differences in effectiveness or harms of anticonvulsants, tricyclic antidepressants, SNRIs, and the lidocaine patch based on demographics, socioeconomic status, comorbidities, or drug-drug interactions, when used to treat neuropathic pain? METHODS Inclusion Criteria Populations Adults with neuropathic pain, including: • Painful diabetic neuropathy • Post herpetic neuralgia • Trigeminal neuralgia • Cancer related neuropathic pain • HIV-related neuropathic pain • Central/poststroke neuropathic pain • Neuropathy associated with low back pain • Peripheral nerve injury pain • Phantom limb pain • Guillain-Barre syndrome • Polyneuropathy • Spinal cord injury related pain • Complex Regional Pain Syndrome (also known as Reflex Sympathetic Dystrophy) Drugs ® • Gabapentin (Neurontin ) ® • Pregabalin (Lyrica ) ® ®a ® ® ® b ® • Carbamazepine (Equetro , Carbatrol , Tegretol , Tegretol XR, Tegretol CR , Epitol [generic]) ® ® • Topiramate (Topamax , Topamax Sprinkle ) ® • Oxcarbazepine (Trileptal ) ® • Lacosamide (Vimpat ) ® ® ® ™ ® ™ • Lamotrigine (Lamictal , Lamictal CD , Lamictal ODT , Lamictal XR ) ® ™ • Levetiracetam (Keppra , Keppra XR ) ®a ®a ® ®b • Valproic acid/divalproex (Depakote , Depakote ER , Depakene , Epival ECT , ®a ®a Depacon , Stavzor ) ® • Duloxetine (Cymbalta ) ®a ® • Venlafaxine (Effexor , Effexor XR ) ® • Desvenlafaxine (Pristiq ) ®a • Lidocaine (Lidoderm ) ®b • Amitriptyline (Elavil [generic]) Neuropathic pain 13 of 92 Final Update 1 Report Drug Effectiveness Review Project ® • Desipramine (Norpramin ) ® ®a • Nortriptyline (Aventyl , Pamelor ) ® • Imipramine (Tofranil [generic]) ®b ™a • Doxepin (Sinequan , Silenor ) ® • Milnacipran (Savella ) ® • Protriptyline (Vivactil ) ® • Phenytoin (Dilantin ) a Not available in Canada, available in the United States. Effectiveness Outcomes • Response (including patient reported pain relief, patient reported global impression of clinical change, any other pain related measure) • Use of rescue analgesics • Speed and duration of response • Relapse • Functional capacity (quality of life, work productivity) Harms Outcomes • Overall adverse effects • Withdrawals • Withdrawals due to adverse effects • Serious adverse events (including mortality, arrhythmias, seizures, overdose) • Specific adverse events or withdrawals due to specific adverse events (including, but not limited to, hepatic, renal, hematologic, dermatologic, sedation/drowsiness, and other neurologic side effects) Study Designs For effectiveness: • Controlled clinical trials • Recent, good quality systematic reviews • Comparative observational studies of at least 1 year’s duration, reporting functional outcomes For harms: • Controlled clinical trials • Comparative observational studies (cohort or case-control) with a well-defined neuropathic pain population • Noncomparative observational studies only if the duration is 1 year or longer, and if serious harms are reported; a serious harm is one that results in long-term health effects or mortality Neuropathic pain 14 of 92 Final Update 1 Report Drug Effectiveness Review Project Literature Search ® To identify relevant citations, we searched Ovid MEDLINE (1966 to November Week 3 2010), ® the Cochrane Database of Systematic Reviews (4th Quarter 2010), the Cochrane Central ® Register of Controlled Trials (4th Quarter 2010), and the Database of Abstracts of Reviews of Effects (4th Quarter 2010), using terms for included drugs, indications, and study designs (see Appendix C for complete search strategies). Electronic database searches were supplemented by hand searches of reference lists of included studies and reviews. In addition, we searched the US Food and Drug Administration Center for Drug Evaluation and Research, the Canadian Agency for Drugs and Technology in Health, and the National Institute for Health and Clinical Excellence web sites for medical or statistical reviews and technology assessments. Finally, we searched dossiers of published and unpublished studies submitted by pharmaceutical companies. Study Selection All citations were reviewed for inclusion using the prespecified criteria detailed above. Two reviewers independently assessed titles and abstracts of citations identified from literature searches. Full-text articles of potentially relevant citations were retrieved and again were assessed for inclusion by 2 reviewers. In addition, results of studies can change substantially between initial presentation at a conference and final journal 17 18-25 publication. We also did not include the IMMPACT recommendations as these articles, although important in the field of chronic pain by providing guidance for future research, represent consensus statements rather than a controlled trial. Data Abstraction We constructed evidence tables showing the study characteristics, quality ratings, and results for all included studies. The following data were abstracted by 2 independent reviewers from included trials: population characteristics (including gender, age, ethnicity, diagnosis); eligibility; interventions (dose and duration); comparisons; numbers enrolled, lost to follow-up, and analyzed; and results for each outcome and funding. We considered methods to meet criteria for intent-to-treat analysis if outcomes for at least 95% of participants were analyzed according to the group to which they were originally assigned. In cases where only per-protocol results were reported, we calculated intent-to-treat results if the data to perform these calculations were available.

Female circumcision or genital mutilation is still widely practiced in over 30 countries in the world cheap seroflo online american express. WHO estimates that over 120 million women have been circumcised and several thousand more are circumcised each day cheap seroflo 250mcg without prescription. Due to population move- Figure 1 Prevalence of female genital mutilation in ments women and girls living in western nations Africa purchase generic seroflo. The practice has become an issue for most healthcare providers, particularly History and practice midwives and obstetricians who may, however, not be aware of the consequences. All health workers Female sexuality has been repressed in a variety of who are involved in caring for the mutilated ways in all parts of the world throughout history up patient have an important role to play: they to the present time. Female slaves in ancient Rome must recognize the sensitive nature and com- had one or more rings put through their labia to plexity of the issues related to FGM, and should prevent them from becoming pregnant. Chastity have knowledge on the possible complications in belts were brought to Europe by the crusaders dur- childbirth. Caregivers should avoid becoming ing the 12th century. In the 19th century the re- tion particularly the sexual problems and the moval of the clitoris was performed as a surgical possible serious gynecological and obstetric remedy against masturbation in Europe and in the complications. FGM may be viewed upon as one of the 275 GYNECOLOGY FOR LESS-RESOURCED LOCATIONS extreme forms of female oppression seen across • Type III: excision of part or all of the external centuries. FGM is found across many African coun- genitalia and stitching/narrowing of the vaginal tries (Figure 1) and some countries in Asia and the opening, or infibulation (may be known as Middle East such as Malaysia, Indonesia and the pharaonic circumcision of infibulation). It is traditional in many • Type IV: pricking, piercing or incising of the different groups and faiths, including Christians and clitoris and/or labia; stretching of the clitoris Muslims. Although there is no clear obligatory and/or labia; cauterization by burning of the statement in the Qur’an for this practice, it is still clitoris and surrounding tissue; scraping of tissue carried out in the name of religion, although the surrounding the vaginal orifice (angurya cuts) or practice is not exclusive to Muslims. It varies from a few days’ old baby to cause bleeding, or for the purpose of tighten- (e. Mali, the Jewish Flashas in Ethiopia and the ing or narrowing it – and any other procedure Nomads of the Sudan) to about 7 years old (as in that falls under the definition given above. Egypt and many countries of Central Africa), or to adolescents (among the Ibo of Nigeria) where exci- Cultural issues sion takes place shortly before marriage or before the first child (as among the Ahols in mid-Western Several theories exist about its origin: Nigeria). Most experts agree, however, that the age • To control women’s sexuality or an attempt to of mutilation is becoming younger and has less and obtain control of women’s magic power. The excision Most frequently, FGM is performed by an of the clitoris would decrease sexual desire and old woman of the village (known as ‘Noumou pleasure of the women before marriage. Mousso’ in Mali, ‘Gadda’ in Somalia) or traditional • To ensure a secure future for a female child in a birth attendants (called Daya in Egypt and the society ‘that requires infibulated wives, and since Sudan). In northern Nigeria and in Egyptian a girl has no other choice in life but to marry, villages barbers carry out the task and on rare occa- she must undergo the operation’. Anesthetics • As a protection against rape for young girls who are never used and the child is usually held down take the animals out to pasture. Herb mix- • For hygienic and esthetic reasons because a tures, earth, cow dung or ashes are rubbed into woman’s genitalia were considered unclean and the wound to stop bleeding. Needles, thorns, catgut or thread are Mossi in Burkina Faso believe that contact used to stitch the wound. There is no attempt at between the clitoris and child’s head during asepsis. In FGM is practiced on thousands or hundreds of other cases it is believed that removal of the thousands of newborn and small girls worldwide. These girls have the most awful experiences and the degree of post-traumatic stress will never be fully assessed in most individuals. Continuation of the practice Forms of female genital mutilation3 Why does the practice continue when the personal, 4 psychological and heath complications are so Figure 2 illustrates the types of FGM : severe? A study in 1984 of 300 women in Sierra • Type I: excision of the prepuce (a retractable Leone found that of the 90% who were circum- piece of skin covering part of the clitoris), with cised the reasons cited were tradition (85. Leone woman who practices FGM in a village 276 Female Genital Mutilation (a) (c) (b) (d) Figure 2 Different types of female genital mutilation (FGM). ISBN: 2–913326–49–8 explains ‘If the women of our village stop this prac- Acute complications tice, life will be meaningless to us all. It is our cul- These may include the immediate ones such as ture, and nobody has the right to take it away from shock due to pain, infection or severe hemor- us’. Acute infection with tetanus and general- WHO has taken a stand against genital mutila- ized septicemia is a frequent problem due to tion but has acknowledged that in the African the conditions in which FGM is carried out. The mortality rate of sition from both men and women and an insistence girls as a result of bleeding after FGM is unknown that westerners should not interfere with the cul- because these deaths are rarely reported to the tural practices of another nation. HEALTH COMPLICATIONS Health complications of FGM for women and Chronic complications children are serious, many and varied. They are acute or These include chronic urinary retention, obstruc- chronic. There is a broad range of complications tion to menstrual flow and consequences of infec- due to genital mutilation which women can suffer tion can lead to the following frequent occurring from during their entire life: complications: 277 GYNECOLOGY FOR LESS-RESOURCED LOCATIONS • Chronic urinary tract infections (UTI). Full sexual intercourse may take some weeks to achieve. The presenting part can compress the bladder and the rectum due to the fetus being retained in the vagina Figure 3 Excessive keloid after female genital mutila- through infibulation itself or scar tissue of tion. If the situation lasts for many hours, tissue necrosis of bladder and rectum will develop which will lead to a vesico- vaginal (VVF) or recto-vaginal fistula (RVF) once the necrotic tissue falls off (for more information about fistula see Chapter 21). In most cases the fetus will die (Figure 5) and the mother, if she survives may suffer from serious injuries (Figure 6) and become a social outcast due to the permanent stench of urine. FGM and the resulting scar tissue causes rigidity of vaginal tissue. At childbirth the level of elasticity of the vagina cannot be expected to be normal due to scarring. In the absence of surgical interventions severe tears of the vaginal wall Figure 4 Obstructed labor due to female genital or perineum can arise with the risk of major mutilation. Dyspareunia (pain during intercourse) and trauma can lead to vaginismus and other sexual problems. One can as- sume that these problems have a high incidence among women suffering from FGM but there are hardly any statistics or studies available on this issue. In addition many victims are Figure 5 Stillborn baby due to obstructed labor caused not even aware of the fact that their symptoms by female genital mutilation.