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Neuropsychopharmacology Vol 28(7) Jul 2003 buy triamcinolone 40 mg free shipping treatment yeast infection women, 1374- 1382 purchase triamcinolone 15mg without prescription symptoms 3 dpo. Calabrese JR buy generic triamcinolone 10 mg line treatment naive definition, Rapport DJ 40 mg triamcinolone free shipping treatment 2015, Youngstrom EA, Jackson K, Bilali S, Findling RL. New data on the use of lithium, divalproate, and lamotrigine in rapid cycling bipolar disorder. Antiepileptic drugs Page 59 of 117 Final Report Update 2 Drug Effectiveness Review Project European Psychiatry: the Journal of the Association of European Psychiatrists. Revicki DA, Hirschfeld RMA, Ahearn EP, Weisler RH, Palmer C, Keck PE, Jr. Effectiveness and medical costs of divalproex versus lithium in the treatment of bipolar disorder: results of a naturalistic clinical trial. Relationship of mania symptomatology to maintenance treatment response with divalproex, lithium, or placebo. Carbamazepine versus lithium in the prophylaxis of bipolar affective disorder. Denicoff KD, Smith-Jackson EE, Disney ER, Ali S, Leverich GS, Post RM. Comparative prophylactic efficacy of lithium, carbamazepine, and the combination in bipolar disorder. Journal of Clinical Psychiatry Vol 58(11) Nov 1997, 470-478. Hartong EG, Moleman P, Hoogduin CA, Broekman TG, Nolen WA. Prophylactic efficacy of lithium versus carbamazepine in treatment-naive bipolar patients. Journal of Clinical Psychiatry Vol 64(2) Feb 2003, 144-151. Carbamazepine vs lithium in the treatment and prophylaxis of mania. The comparative efficacy of carbamazepine low and high serum level and lithium carbonate in the prophylaxis of affective disorders. Long-term double-blind prospective study on carbamazepine versus lithium in bipolar and schizoaffective disorders: Preliminary results. Placidi GF, Lenzi A, Lazzerini F, Cassano GB, Akiskal HS. The Comparative Efficacy and Safety of Carbamazepine Versus Lithium: A Randomized, Double-Blind 3-Year Thai in 83 Patients. Watkins SE, Callender K, Thomas DR, Tidmarsh SF, Shaw DM. The Effect of Carbamazepine and Lithium on Remission from Affective Illness. Lithium versus carbamazepine in the maintenance treatment of bipolar II disorder and bipolar disorder not otherwise specified. The comparative prophylactic efficacy of lithium and carbamazepine in patients with bipolar I disorder. Greil W, Kleindienst N, Erazo N, Muller-Oerlinghausen B. Differential response to lithium and carbamazepine in the prophylaxis of bipolar disorder. Journal of Clinical Psychopharmacology Vol 18(6) Dec 1998, 455-460. Lithium versus carbamazepine in the maintenance treatment of bipolar disorders--a randomised study. Inter-episodic morbidity and drop-out under carbamazepine and lithium in the maintenance treatment of bipolar disorder. Antiepileptic drugs Page 60 of 117 Final Report Update 2 Drug Effectiveness Review Project 79. A preliminary double-blind study on the efficacy of carbamazepine in prophylaxis of manic-depressive illness. Lithium vs cambamazepine in the maintenance treatment of schizoaffective disorder: A randomised study. European Archives of Psychiatry and Clinical Neuroscience 1997;247(1):42-50. Prophylactic effect of phenytoin in bipolar disorder: a controlled study. A placebo-controlled 18-month trial of lamotrigine and lithium maintenance treatment in recently manic or hypomanic patients with bipolar I disorder. A double-blind, randomized, placebo-controlled, prophylaxis study of adjunctive gabapentin for bipolar disorder. Long-term randomized clinical trial on oxcarbazepine vs lithium in bipolar and schizoaffective disorders: Preliminary results. Case studies on prophylactic long-term effects of Oxcarbazepine in recurrent affective disorders. International clinical Psychopharmacology 1990;5 (suppl 1):89-94. Calabrese JR, Bowden CL, Sachs GS, Ascher JA, Monaghan E, Rudd GD. A double- blind placebo-controlled study of lamotrigine monotherapy in outpatients with bipolar I depression. Lamotrigine in the acute treatment of bipolar depression: Results of five double-blind, placebo-controlled clinical trials. A Multicenter, Double-Blind, Placebo- Controlled, Fixed-Dose, 8-Week Evaluation of the Efficacy and Safety of Lamotrigine in the Treatment of Bipolar Disorder Patients Currently Experiencing a Major Depressive Episode. A Multicenter, Double-Blind, Placebo- Controlled, Fixed-Dose Evaluation of the Safety, Efficacy, and Tolerability of LAMICTAL (Lamotrigine) in the Treatment of a Major Depressive Episode in Patients with Type I Bipolar Disorder. A Multicenter, Double-Blind, Placebo- Controlled, Fixed-Dose, 8-Week Evaluation of the Efficacy and Safety of Lamotrigine in the Treatment of Major Depression in Patients with Type II Bipolar Disorder. A Multicenter, Double–Blind, Placebo– Controlled, Flexible Dose (100–400mg) 10 Week Evaluation Of the Safety and Efficacy of LAMICTAL (Lamotrigine) in the Treatment of a Major Depressive Episode in Patients with Bipolar Disorder. A 7-week, randomized, double-blind trial of olanzapine/fluoxetine combination versus lamotrigine in the treatment of bipolar I depression. Antiepileptic drugs Page 61 of 117 Final Report Update 2 Drug Effectiveness Review Project 93. Randomized, double-blind pilot trial comparing lamotrigine versus citalopram for the treatment of bipolar depression. A single blind comparison of lithium and lamotrigine for the treatment of bipolar II depression. Treatment-resistant bipolar depression: a STEP-BD equipoise randomized effectiveness trial of antidepressant augmentation with lamotrigine, inositol, or risperidone. Clinical predictors of response to lamotrigine and gabapentin monotherapy in refractory affective disorders. Divalproex in the treatment of bipolar depression: a placebo-controlled study. Divalproex in the treatment of acute bipolar depression: a preliminary double-blind, randomized, placebo-controlled pilot study. Practice guidelines for the treatment of patients with bipolar disorder: Second Edition. McIntyre RS, Mancini DA, McCann S, Srinivasan J, Sagman D, Kennedy SH. Topiramate versus bupropion SR when added to mood stabilizer therapy for the depressive phase of bipolar disorder: a preliminary single-blind study.

Moderate Greater reduction in HbA1c with liraglutide than with placebo purchase triamcinolone 40mg on-line treatment diabetes type 2, both when added to various oral agents and as monotherapy (liraglutide 0 generic triamcinolone 40mg without a prescription medications you cant drink alcohol with. Moderate There was no statistically significant weight loss for liraglutide 0 order triamcinolone 4 mg online treatment sciatica. TZDs: Moderate Meta-analysis of 8 head-to-head RCTs found no statistically significant difference Pioglitazone between pioglitazone and rosiglitazone for their ability to improve glycemic vs discount triamcinolone 4mg with amex symptoms 8 dpo bfp. Rosiglitazone Prior systematic reviews found both drugs appear to have similar effects on HbA1c, producing a decrease of approximately 1%, similar to the change Key Question 1. What is the comparative efficacy and effectiveness of newer diabetes medications, TZDs, and drug combinations (administered as fixed dose combination products or dual therapy) for children and adults with diabetes mellitus? Strength of a Drugs evidence Conclusion produced with other oral agents (including metformin, glibenclamide, or glimepiride). Effect of both pioglitazone and rosiglitazone appears to be similar when used in either monotherapy or combination therapy. Insufficient None of the included head-to-head trials reported comparative efficacy/effectiveness of health outcomes or utilization outcomes. TZDs: Evidence in children Pioglitazone Insufficient No data on children were reported. Evidence in adults Moderate Overall, no significant difference in reduction in HbA1c between pioglitazone and sulfonylureas. High No significant difference in 7 trials for reduction in HbA1c between pioglitazone and metformin. TZDs: Evidence in children Rosiglitazone Insufficient No data on children were reported. Evidence in adults Moderate No significant difference in reduction in HbA1c between rosiglitazone and sulfonylureas. Moderate No significant difference in reduction in HbA1c between rosiglitazone and metformin. Low One trial comparing the addition of rosiglitazone with the addition of liraglutide (to ongoing glimepiride treatment) reported greater reduction in HbA1c with liraglutide (−1. Low Thiazolidinedione plus metformin compared with a second-generation sulfonylurea plus metformin (4 randomized controlled trials) did not show a consistent effect favoring 1 of the combinations, nor did an RCT comparing thiazolidinediones with repaglinide. Moderate No significant difference in reduction in HbA1c between rosiglitazone and sitagliptin in two randomized controlled trials. FDCPs and Evidence in children Dual Therapy: Insufficient We did not find any evidence Avandamet Actoplus Met Evidence in adults Avandaryl Insufficient We found no studies that focused on health outcomes as the primary outcomes Duetact for any available FDCP. Two studies reported health outcomes among other Janumet secondary outcomes or in the adverse events section. Metformin + Rosiglitazone Insufficient We found no head-to-head trials that compared HbA1c control between any 2 Metformin + FDCPs Pioglitazone Glimepiride + Insufficient We found no trials that evaluated the following FDCPs: Duetact , Janumet Rosiglitazone Glimepiride + Moderate Greater reduction in HbA1c with Avandamet or dual therapy with metformin and Pioglitazone rosiglitazone than with component monotherapy in trials of 24 to 32 weeks Metformin + (treatment difference range 0. What is the comparative efficacy and effectiveness of newer diabetes medications, TZDs, and drug combinations (administered as fixed dose combination products or dual therapy) for children and adults with diabetes mellitus? Strength of a Drugs evidence Conclusion Sitagliptin Moderate Greater reduction in HbA1c with Avandaryl or dual therapy with rosiglitazone and glimepiride than with component monotherapy in trials from 20 to 28 weeks (treatment difference range 0. What is the comparative tolerability and frequency of adverse events for newer diabetes medications, TZDs, and drug combinations (administered as fixed dose combination products or dual therapy) for children and adults with diabetes mellitus? Strength of a Drugs evidence Conclusion Amylin Evidence in children agonists: Insufficient No data on children were reported, although people as young as 16 years were 19, 20 Pramlintide for eligible for study enrollment in 2 included trials. Type 1 diabetes Evidence in adults Moderate Greater withdrawals due to adverse effects for pramlintide-treated subjects than for insulin-treated subjects (ranges across trials were 5% to 20% vs. Moderate Gastrointestinal adverse events including nausea, vomiting, anorexia, and reduced appetite were more commonly reported with the use of pramlintide plus insulin than with placebo plus insulin. Moderate Severe hypoglycemia occurred more frequently with pramlintide plus insulin during the first 4 weeks of treatment compared with placebo plus insulin. Rates of severe hypoglycemia declined once pramlintide doses stabilized but continued to remain slightly higher than with placebo plus insulin at up to 52 weeks of follow- up. Amylin Evidence in children agonists: Insufficient Children and adolescents ≤ 18 years were not included in any of the published Pramlintide for studies on efficacy or effectiveness. Type 2 diabetes Evidence in adults Moderate The most commonly reported adverse event was nausea, which occurred more frequently with pramlintide plus insulin than with placebo plus insulin especially during the first 4 weeks of treatment, but declined thereafter. Moderate Severe hypoglycemia occurred more frequently with pramlintide compared with placebo. Low Hypoglycemia occurred less frequently in subjects taking pramlintide than those taking rapid acting insulin analogs (RAIA) in one 24 week study. DPP-IV inhibitors: Insufficient We found no head-to-head studies of sitagliptin and saxagliptin meeting inclusion Sitagliptin vs. What is the comparative tolerability and frequency of adverse events for newer diabetes medications, TZDs, and drug combinations (administered as fixed dose combination products or dual therapy) for children and adults with diabetes mellitus? Strength of a Drugs evidence Conclusion DPP-IV Not graded The most commonly reported adverse events across treatment groups were inhibitors: hypoglycemia, nausea, vomiting, diarrhea, and abdominal pain. Sitagliptin Moderate The rates of withdrawal due to adverse events were not significantly different between sitagliptin and placebo (pooled RR 0. Moderate Hypoglycemia was generally more frequent with glipizide than with sitagliptin (17. Low Hypoglycemia was not significantly different in subjects taking sitagliptin 100 mg and those taking placebo (pooled RR 1. Moderate Rates of gastrointestinal side effects were higher with metformin than with sitagliptin. Low Gastrointestinal side effects were not significantly different between sitagliptin and placebo treated subjects (nausea pooled RR 1. Low Upper respiratory infections and urinary tract infections were not significantly different between patients taking placebo and those taking sitagliptin (pooled RR 1. DPP-IV Not graded The most commonly reported adverse effects were nasopharyngitis, upper inhibitors: respiratory infections, headache, and urinary tract infections. Saxagliptin Moderate Rates for total withdrawal were lower with saxagliptin 2. Moderate Rates of withdrawal due to adverse events were not significantly different with saxagliptin 2. Low The incidence of hypoglycemia was not significantly different with saxagliptin 2. Low There were no significant differences in infections between saxagliptin and placebo. GLP-1 Low In the 1 head-to-head randomized-control trial, withdrawal rates were not agonists: significantly different between groups. The proportion of patients who reported minor hypoglycemia was significantly less in the liraglutide group than the exenatide group (26% vs. There was no significant difference in change in total cholesterol, LDL cholesterol, or HDL cholesterol between the Key Question 2. What is the comparative tolerability and frequency of adverse events for newer diabetes medications, TZDs, and drug combinations (administered as fixed dose combination products or dual therapy) for children and adults with diabetes mellitus? Strength of a Drugs evidence Conclusion exenatide and the liraglutide treatment arms. Reduction in triglycerides was significantly greater in the liraglutide group than the exenatide group (−15. Exenatide Moderate Nausea and vomiting were the most frequent adverse events among exenatide- treated patients, and rates of these symptoms were significantly higher in the exenatide group than insulin and placebo groups. Moderate Rates of hypoglycemia were similar between insulin and exenatide groups.

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Lower extremity and pulmonary edema The prevalence of edema was the primary outcome in a retrospective chart review of 99 patients 245 receiving thiazolidinediones in combination with insulin 4mg triamcinolone sale treatment juvenile arthritis. Among patients taking pioglitazone buy generic triamcinolone 10mg on-line medicine 4839, there was an increase in edema with increasing dose (1 15 mg triamcinolone otc symptoms rectal cancer. There was 1 case of pulmonary edema in a patient taking rosiglitazone cheap triamcinolone 10mg overnight delivery treatment 197 107 blood pressure. Four of these had existing congestive heart 247 failure treated with diuretics. Another study reported edema in patients with documented heart failure. Fluid retention was seen with the use of both pioglitazone (15. Two patients (11%) had physical signs of pulmonary edema, but the study does not report which drug the patients were taking. Macular edema The manufacturer of rosiglitazone issued a warning letter in December 2005 regarding post- marketing reports of new onset and worsening diabetic macular edema for patients receiving 248 rosiglitazone. The incidence is not reported, but the warning letter states that reports were very rare. In the majority of these cases, the patients also reported concurrent peripheral edema. We identified no reports of macular edema in placebo-controlled trials or observational studies. Heart failure A retrospective cohort study used claims data to assess the risk of developing heart failure in 249 patients taking pioglitazone (N=1347) or rosiglitazone (1882) for up to 40 months. Compared with a control group of patients who did not take thiazolidinediones, the hazard ratio for pioglitazone was 1. There was no significant difference in the risk of developing heart failure between these 2 drugs (P=0. A retrospective database study designed to assess the prevalence of edema found no documentation of new-onset heart failure or exacerbations of existing heart failure in patients 245 initiating thiazolidinediones therapy plus insulin. The study authors caution, however, that documentation of heart failure was poor and that the data may be unreliable. Weight gain Seven comparative observational studies reported weight gain in follow-up periods ranging from 244, 246, 250-255 8 weeks to 1 year (Table 64). There was no difference in the amount of weight gain in patients taking pioglitazone compared with rosiglitazone in any study. Range of weight gain reported in comparative observational studies Weight gain with Weight gain with a Study Duration pioglitazone (kg) rosiglitazone (kg) 255 King 2000 16 weeks 0. Evidence comparing pioglitazone or rosiglitazone to active controls: Harms Ten observational studies reported adverse events associated with thiazolidinediones compared 243, 256-264 with other active drugs (Table 65, Evidence Table 21). The adverse events they examined included mortality, coronary heart disease events, heart failure, cancer or adenoma incidence, edema, weight gain and progression to insulin use. Because these studies did not report results separately for pioglitazone and rosiglitazone or they included only 1 of the thiazolidinediones, they do not provide information about the comparative safety of the thiazolidinediones. They do provide information about thiazolidinediones as a class compared with other antidiabetic agents. In 2 studies, thiazolidinediones were not associated with increased mortality compared 258, 261 with other oral hypoglycemic agents. In 1 study, pioglitazone was associated with reduced 243 all-cause mortality compared with other oral antidiabetic medications. In older patients with heart failure thiazolidinediones, either alone or combined with metformin, were associated with a lower risk of death over a 15-month period compared with patients not treated with an insulin 261 sensitizer. Two studies reported the incidence of coronary heart disease events (myocardial infarction or revascularization) with thiazolidinediones compared with metformin or sulfonylureas. A good-quality study using United States health insurance data found no increased risk of coronary heart disease events in patients initiating thiazolidinedione monotherapy 257 compared with those initiating metformin plus sulfonylurea combination therapy. The other found similar risks with rosiglitazone compared with sulfonylureas, metformin, or insulin, either 262 alone or in combination. Both studies also found no increased risk in the individual components of the composite outcome with thiazolidinedione use. Observational studies comparing adverse events associated with thiazolidinediones to adverse events associated with active controls Author, Year Data source, Sample Size Population (Quality) Comparison description Main outcomes Main results Adjusted odds ratio (95% CI) TZD vs. HR with propensity 243 2009 Rosiglitazone integrated All-cause adjustment, each compared to 19,717 vs. Lewis Nested case- Adjusted OR (95% CI) of any 263 2008 control; Kaiser adenoma on first colonoscopy, TZD vs. Hospital admission for congestive heart failure was the main outcome in a fair-quality 259 cohort study that used data from a Kaiser Permanente diabetes registry. Relative to patients initiating therapy with sulfonylureas, patients initiating therapy with thiazolidinediones were no more likely to experience a hospitalization for heart failure after an average of 10. A case-control study based on Oregon Medicaid claims data, in contrast, found a trend suggesting increased risk of hospitalization for heart failure associated with exposure to 265 thiazolidinediones within the previous 60 days. Increased risk was also found with exposure to insulin and to the combination of insulin plus thiazolidinediones, but not for other oral antidiabetic agents. A series of nested case-control studies found no difference in the incidence of breast, colon, or prostate cancer associated with exposure to thiazolidinediones compared with other 260 oral diabetic medications or insulin. A case-control study found a slightly higher odds of having an adenoma on first colonoscopy for subjects with type 2 diabetes exposed to TZDs 263 compared with those not exposed to TZDs. A study conducted in 500 primary care patients in Germany found fewer patients 256 progressed to insulin therapy when taking pioglitazone than when taking a sulfonylurea. However, because this study did not control for confounders and did not clearly report its recruitment strategy and other methods, these results may have a high risk of bias. The previous Drug Effectiveness Review Project TZDs report identified 43 additional 266-303 uncontrolled studies of adverse events associated with individual thiazolidinediones. The results of these studies were consistent with evidence from randomized controlled trials and comparative observational studies. Conclusions that can be drawn from this body of evidence are limited because the studies do not provide information about comparative harms. Fixed-dose Combination Products (FDCPs) or Dual Therapy Summary of findings for Fixed Dose Combination Products or Dual Therapy: Harms Harms in children • We did not find any evidence meeting inclusion/exclusion criteria for children. Harms in adults • We found no head-to-head trials that compared harms between any 2 FDCPs (insufficient strength of evidence). Rates of gastrointestinal adverse effects with Avandamet or dual therapy were high (28 to 47%), but were the same or slightly lower than those with metformin monotherapy (moderate strength of evidence). The 2 included trials were a 28 week trial (N=874) comparing 2 dosages of Avandaryl with glimepiride monotherapy and rosiglitazone monotherapy, and a 20 week trial (N=40) comparing concurrent use of rosiglitazone and glimepiride with rosiglitazone monotherapy. Evidence was limited to 1 trial (N=1,091, with outcomes reported at 24 and 54 weeks) including dual 31, 32 therapy with sitagliptin and metformin. Rates were slightly higher for sitagliptin 100 plus metformin 1000 compared with sitagliptin 100 monotherapy or with metformin 1000 monotherapy at 24 weeks (17. Detailed assessment for FDCPs and Dual Therapy: Harms We identified studies that have been conducted specifically using fixed-dose combination tablets 183, 185 comprised of rosiglitazone/metformin (Avandamet ), , rosiglitazone/glimepiride 186 139 (Avandaryl ), and pioglitazone/metformin (Actoplus Met ). Two of these were new since 139, 183 the 2007 Drug Effectiveness Review Project report on FDCPs. No studies were identified that used the fixed-dose combination tablets comprised of 189 190 pioglitazone/glimepiride (Duetact ) or sitagliptin/metformin (Janumet ). The safety of Duetact and Janumet have been established based on trials using the co-administration of their separate components. More detailed descriptions and summary tables for the studies in this section are provided in the corresponding section of Key Question 1 (Detailed assessment for FDCPs and Dual Therapy) related to efficacy. Details of included studies are found in Tables 37, 39, 41, and 43 and in Evidence Tables 5, 11.

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Although the International genetic modifiers of this phenotype has just begun purchase 15mg triamcinolone fast delivery treatment vertigo. One well- Society on Thrombosis and Haemostasis (ISTH) has now developed documented contributor to quantitative variation of VWF is the a widely used BAT 10mg triamcinolone mastercard treatment questionnaire, it is increasingly recognized that one BAT may ABO blood group cheap triamcinolone 15mg visa treatment dvt, with VWF levels being 25% lower in group not be suitable in all bleeding situations and that discount triamcinolone 40mg mastercard medications and breastfeeding, in these “O” subjects. This latter analysis currently involves testing genes encode lectin or scavenger clearance receptors (scavenger for VWF:RCo, but this test is notoriously difficult to standardize receptor class A member 5, stabilin 2, and C-type lectin type 4 and is relatively insensitive at VWF levels 10%. Further evidence confirming the involvement of these 37 recent development of assays to quantify direct binding of VWF to proteins in regulating VWF levels is just now beginning to appear. Diagnostic approaches to VWD Another complicating issue that has arisen in the interpretation of The diagnosis of VWD continues to involve the constellation of the platelet-dependent functional assay for VWF is the interference clinical symptoms of excessive mucocutaneous bleeding, coagula- in the VWF:RCo assay with a polymorphism at codon 1472 tion studies consistent with quantitative and /or qualitative VWF (D1472H). Furthermore, the nature and severity of bleeding in type 1 VWD is variable and is not distinguishable from other mucocutaneous bleeding disorders. In the laboratory, it is important to remember that VWF is an acute-phase protein prone to the transient fluctuations inherent with this group of proteins. Therefore, in patients with clear clinical evidence of a bleeding phenotype, quantification of VWF levels should be evaluated at least twice to ensure that true baseline values are obtained. Second, the gradual increase of VWF levels with age also complicates the interpretation of results from individuals with Figure 2. Figure illustrating the location of mutations resulting in mildly reduced plasma VWF levels, in whom protein levels are the various VWD subtypes. Types 1 and 3 VWD are caused by different likely to increase into the normal range over several years. Although types of mutation throughout the VWF sequence. In contrast, the type 2 many (most) of these mild-type 1 VWD patients will have corrected VWD mutations are localized to distinct functional domains of VWF, their VWF levels by age 50, it remains unclear whether their affecting multimer structure (2A), binding to FVIII (2N), platelets (2B and original bleeding tendencies are also rescued. In addition to determining the platelet-binding function of VWF, there is now good reason to add a specific assay to quantify the In contrast to the utility of genetic testing in type 2 and 3 VWD, the collagen-binding potential of the protein. Several families have now rationale for incorporating VWF genotyping as an adjunctive been described in whom the only defect in VWF function is reduced diagnostic strategy in type 1 disease is much less clear. With collagen binding, so these cases will be missed with the standard candidate VWF mutations not being found in 35% of type 1 VWD VWF testing panel. The question remains as to whether testing index cases and with a growing appreciation of problems in the should be performed with type I and III collagen only (assessing differentiation between pathogenic mutations and neutral polymor- phisms,28 the routine use of genetic analysis to evaluate diagnosti- binding through the A3 domain) or if binding to collagen type VI (mediated by the A1 domain) should also be evaluated. Most of of this dilemma will require larger study populations and additional these missing mutations are in cases with mild phenotypes in whom genetic analysis of the A1 and A3 domains. In the meantime, addi- tional research needs to be performed to identify other genetic The most demanding diagnostic test for VWD is the VWF multimer factors with an influence on plasma VWF levels that may be of analysis, an investigation that challenges even the most seasoned sufficient importance to incorporate into genetic testing algorithms laboratory technologist. Robust evidence of the loss of HMWMs is for this phenotype. Unfortunately, the inevitable fact remains that important in the diagnosis of type 2A and 2B VWD, but the VWF borderline cases of VWF deficiency will continue to challenge the multimer profile cannot be used to differentiate between these 2 definitive assignment of disease status. This must involve the demonstration of hypersensitivity to low-dose ristocetin for type 2B mutants in the ristocetin-induced Advances in the treatment of VWD platelet agglutination test. This diagnostic consideration should also Little has changed in the landscape of VWD therapies over the past take into account the type 2B genocopy, platelet-type VWD, in 2 decades (Table 3). In many cases of type 1 VWD, and in some which the gain-of-function causative mutations are located in the cases of type 2A disease, the use of desmopressin will provide GPIBA gene. All patients thought to be potential candidates for the use presence of HMWMs and thus further supports the rationale for of desmopressin should undergo a therapeutic trial with measurements performing this assay. Adjunctive therapy with Now, 28 years since the cloning of the VWF gene, there is a growing antifibrinolytic agents (ideally tranexamic acid) is also of significant role for the integration of genetic testing in VWD. The best benefit in VWD; in women with VWD experiencing menorrhagia, the examples of the utility of genetic diagnosis are in type 2 and 3 use of an oral contraceptive or the levonorgestrel-releasing intrauterine disease. In light of the fact that the mutations responsible for types device (Mirena) often produces excellent results. Similarly, given the severe phenotype of type 3 concentrates available for protein replacement therapy. All but one VWD, genetic prenatal diagnosis of this variant provides results for of these products represent plasma-derived VWF-FVIII concen- families and their physicians to make informed decisions about trates with various VWF:FVIII ratios and multimer profiles that family planning and obstetric management issues. VWD therapeutic management Future of VWD clinical management VWD treatment considerations Although recent advances in our understanding of the pathophysiol- ogy of VWD have been significant, the diagnostic and therapeutic Is desmopressin likely to be effective? The increasing use of BATs and the incorporation of (IV, SC, IN) molecular analysis into laboratory testing algorithms for some ●Test VWF:Ag, VWF:RCo, and FVIII:C levels at 1, 2, and 4 VWD subtypes will enhance diagnostic capabilities, but aside from hours the introduction of the new rVWF concentrate, the therapeutic ●Positive response both FVIII approaches for the treatment and prevention of bleeding have not and VWF 50% after changed since the 1990s. Although preclinical successes of gene administration therapy for VWD have been reported,54 there is no clear clinical Addition of adjunctive therapies ●Antifibrinolytics rationale for the development of this therapeutic modality in this ●For menorrhagia: oral condition. What may be of more interest to both the VWD and contraceptive or hemophilia A communities would be the development of VWF levonorgestrel-releasing IUD molecules that exhibit longer half-lives. However, to achieve this VWF concentrates ●If desmopressin response is goal, more basic information about normal VWF clearance mecha- inadequate nisms is required, a goal that might simultaneously provide more ●If desmopressin is required for knowledge concerning factors that contribute to the qualitative trait several consecutive days ●Dosing/product considerations of type 1 VWD. VWF/FVIII ratio VWF multimer profile Acknowledgments Dosing by VWF:RCo or D. His studies of VWD are supported by the Canadian Potential for prophylactic Institutes of Health Research, the National Institutes of Health, and schedule the Canadian Hemophilia Society. Rare development of VWF alloantibodies Disclosures Conflict-of-interest disclosure: The author has received research relating to the clinical efficacy and safety of these products, they all funding from Biogen-Idec, CSL-Behring, Baxter, and Bayer. Off- appear to provide satisfactory hemostasis and are not accompanied label drug use: None disclosed. The use of VWF concentrates with very low FVIII content should be accompanied by the coinfusion of recombinant FVIII to enhance the treatment of acute bleeding Correspondence episodes and to optimize surgical hemostasis. Any variances in Dr David Lillicrap, Department of Pathology and Molecular multimer content of the products have not resulted in obvious Medicine, Richardson Laboratory, Queen’s University, Kingston, differences in the clinical outcomes and the optimal dosing rationale ON, K7L 3N6, Canada; Phone: 613-548-1304; Fax: 613-548-1356; and schedule for these concentrates is still not reconciled defini- e-mail: dpl@queensu. Although dosing in FVIII:C units for surgical hemostasis is recommended by some, there may be more justification for using References VWF:RCo–based dosing to treat or prevent mucocutaneous bleeding. Human von Willebrand factor (vWF): isolation of complementary DNA The use of VWF-FVIII products for bleeding prophylaxis has been (cDNA) clones and chromosomal localization. Molecular musculoskeletal and mucosal bleeding, there is no consensus on the cloning of cDNA for human von Willebrand factor: authentica- concentrate dose and administration schedule. Bowman M, Hopman WM, Rapson D, Lillicrap D, James P. The prevalence of symptomatic von Willebrand disease in primary care practice. The clinical trial of this new concentrate has demonstrated excellent 6. Epidemiological investiga- hemostatic efficacy and safety, with effective bleeding control and tion of the prevalence of von Willebrand’s disease. Update on the 258 American Society of Hematology pathophysiology and classification of von Willebrand disease: a spectrum of type 1 von Willebrand disease: results from a report of the Subcommittee on von Willebrand Factor. Sequence and structure genotype of a cohort of families historically diagnosed with relationships within von Willebrand factor. Intersection of mecha- Type 1 von Willebrand Disease (MCMDM-1VWD). Use of a mouse model to have type 1 von Willebrand disease. Willebrand factor mutations and new sequence variations 12. Clinical and identified in healthy controls are more frequent in the African- molecular predictors of thrombocytopenia and risk of bleeding American population. Mutation and promoter of the von Willebrand factor gene in type 1 von ADAMTS13-dependent modulation of disease severity in a Willebrand disease. Willebrand factor mutations identified in patients with type 1 14. Mutation-specific von Willebrand disease from the MCMDM-1VWD study.

Atomoxetine resulted in higher rates of vomiting and somnolence order triamcinolone 15mg with visa medications qt prolongation, similar rates of nausea and anorexia generic triamcinolone 40 mg free shipping treatment 1st metatarsal fracture, and lower rates of insomnia than stimulants 10mg triamcinolone with visa symptoms hypoglycemia. Extended-release formulations of other nonstimulant drugs (clonidine order triamcinolone 4mg otc medicine cabinet shelves, guanfacine) have no comparative evidence to date. Immediate-release clonidine was similar to immediate-release methylphenidate. Comparative evidence in adults was limited and provided low-strength evidence of no significant differences in efficacy between switching to methylphenidate OROS compared with continuing with immediate-release methylphenidate or between immediate-release guanfacine or modafinil compared with immediate-release dextroamphetamine. Evidence was insufficient to assess the comparability of adverse events between switching to methylphenidate OROS or continuing with immediate-release methylphenidate, but low-strength evidence found no significant differences between immediate-release guanfacine or modafinil compared with immediate-release dextroamphetamine. Evidence on the risk of serious harms was primarily indirect, and indicated atomoxetine has increased risk of suicidal behavior compared with placebo. Differences in risk for sudden death was unclear, cardiac adverse events were not different between stimulants, and cerebrovascular adverse events in adults did not differ between stimulants and atomoxetine. Dextroamphetamine immediate-release caused more inhibition of growth than other stimulants, but the difference was influenced by dose and resolved after 2 years of treatment. Atomoxetine caused similar inhibition of weight gain that lasted up to 5 years. Evidence on abuse, misuse, and diversion was limited, but indicated that stimulant use during childhood is not associated with increased risk of substance use later. Misuse and diversion rates varied by age and were highest among college students, and rates of diversion were highest with amphetamine-based products but similar among methylphenidate products. Evidence of effects in important subgroups of patients with ADHD (e. Attention deficit hyperactivity disorder 123 of 200 Final Update 4 Report Drug Effectiveness Review Project REFERENCES 1. NIH Consensus Statement: Diagnosis and treatment of attention deficit hyperactivity disorder. Historical Definitions and Nomenclatures of the Label ‘ADHD’: An Investigating into Attention-deficit and Hyperactive Behavior through Time. Menomonie: The Graduate School, University of Wisconsin-Stout; 2002. Diagnosis and treatment of attention- deficit/hyperactivity disorder in children and adolescents. Council on Scientific Affairs, American Medical Association. Diagnostic and statistical manual of mental disorders : DSM-IV. Washington, DC: American Psychiatric Association; 1994. Summary of the practice parameters for the assessment and treatment of children, adolescents, and adults with ADHD. Journal of the American Academy of Child & Adolescent Psychiatry. The prevalence and correlates of adult ADHD in the United States: results from the national comorbidity survey replication. Diagnosis of Attention- Deficit/Hyperactivity Disorder (Technical Review #3). Rockville, MD: Agency for Health Care Policy and Research. Lincoln, NE: Buros Institute of Mental Measurements; 1985 v2. Lincoln, NE: Buros Institute of Mental Measurements; 1989. Lincoln, NE: Buros Institute of Mental Measurements; 1995. Lincoln, NE: The University of Nebraska-Lincoln; 1998. Lincoln, NE: Buros Institute of Mental Measurements; 1992. Lincoln, NE: Buros Institute of Mental Measurements; 1985 v1. Lincoln, NE: The University of Nebraska-Lincoln; 2001. Lincoln, NE: Buros Institute of Mental Measurements; 2003. The unpredictability paradox: review of empirical comparisons of randomised and non-randomised clinical trials. Attention deficit hyperactivity disorder 124 of 200 Final Update 4 Report Drug Effectiveness Review Project 19. Randomized, controlled trials, observational studies, and the hierarchy of research designs. A comparison of observational studies and randomized, controlled trials. Grading the strength of a body of evidence when comparing medical interventions-Agency for Healthcare Research and Quality and the Effective Health Care Program. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. Subcommittee on Attention-Deficit/Hyperactivity Disorder, Steering Committee on Quality Improvement and Management. ADHD: Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents. Practice parameter for the assessment and treatment of child and adolescents with attention deficit hyperactivity disorder. American Academy of Child and Adolescent Psychiatry. National Institute for Health and Clinical Excellence. Attention deficit hyperactivity disorder: Diagnosis and Management of ADHD in children, young people and adults. London (UK): The British Psychological Society and The Royal College of Psychiatrists; 2009. Schleifer M, Weiss G, Cohen N, Elman M, Cvejic H, Kruger E. Hyperactivity in preschoolers and the effect of methylphenidate. The effects of methylphenidate on the interactions of preschool ADHD children with their mothers. Journal of the American Academy of Child & Adolescent Psychiatry. Musten LM, Firestone P, Pisterman S, Bennett S, Mercer J. Effects of methylphenidate on preschool children with ADHD: cognitive and behavioral functions. Journal of the American Academy of Child & Adolescent Psychiatry. Firestone P, Musten LM, Pisterman S, Mercer J, Bennett S. Short-term side effects of stimulant medication are increased in preschool children with attention- deficit/hyperactivity disorder: a double-blind placebo-controlled study.

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N onerosive gastroesoph agealreflux disease sh ort-term trials A uth or N umberscreened/ Y ear Population eligible/ (Q uality rating) Setting Inclusioncriteria Exclusioncriteria enrolled M onikesetal order 10mg triamcinolone mastercard medicine cabinets. Proton pump inhibitors Page 108 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 3 order 15 mg triamcinolone mastercard treatment 1860 neurological. N onerosive gastroesoph agealreflux disease sh ort-term trials A uth or N umberwith drawn/ Y ear lostto followup/ (Q uality rating) analyzed Results Results M onikesetal buy cheap triamcinolone 10mg line symptoms concussion. N onerosive gastroesoph agealreflux disease sh ort-term trials A uth or Y ear W ith drawals Due to (Q uality rating) A dverse Events M onikesetal triamcinolone 15 mg low cost treatment 4s syndrome. N onerosive gastroesoph agealreflux disease sh ort-term trials A uth or N umberscreened/ Y ear Population eligible/ (Q uality rating) Setting Inclusioncriteria Exclusioncriteria enrolled Placebo- controlled trials Peuraetal. E x cludedthosewithanactivegastric parallelgroup during the3monthsbeforethestudy. Proton pump inhibitors Page 111 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 3. N onerosive gastroesoph agealreflux disease sh ort-term trials A uth or N umberwith drawn/ Y ear lostto followup/ (Q uality rating) analyzed Results Results Peuraetal. N onerosive gastroesoph agealreflux disease sh ort-term trials A uth or Y ear W ith drawals Due to (Q uality rating) A dverse Events Peuraetal. N onerosive gastroesoph agealreflux disease sh ort-term trials A uth or N umberscreened/ Y ear Population eligible/ (Q uality rating) Setting Inclusioncriteria Exclusioncriteria enrolled A ctive-controlled trials vanZyletal. Historyof keyGE RD andpatientswhohadrecentlytakenorwerestillreceiving symptoms(oneepisode/monthforatleast3 PPI therapyoragentslikelytoaffectgastricacidsecretionor months)priortoentryintothestudy. Proton pump inhibitors Page 114 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 3. N onerosive gastroesoph agealreflux disease sh ort-term trials A uth or N umberwith drawn/ Y ear lostto followup/ (Q uality rating) analyzed Results Results vanZyletal. N onerosive gastroesoph agealreflux disease sh ort-term trials A uth or Y ear W ith drawals Due to (Q uality rating) A dverse Events vanZyletal. H ead-to-h ead trials ofprotonpum pinh ibitors forpreventionofesoph agitis relapse A uth or Esoph agitis G rade (grading criteria),oth er N um berscreened,eligible,enrolled, Y ear Population,setting ch aracteristics with drawn,lostto followup Caos O f 497enrolledpatients,261patientscom pleted(Phase N R N R /N R /497/236(Phase1)/N R 2005 1)and205patientscom pleted(Phase2. H ead-to-h ead trials ofprotonpum pinh ibitors forpreventionofesoph agitis relapse A uth or Esoph agitis G rade (grading criteria),oth er N um berscreened,eligible,enrolled, Y ear Population,setting ch aracteristics with drawn,lostto followup D evault2007 IntheU S at143centers;twogroupsincluded-patients L A classification,% 4015screened,1026random iz edtotrm t, with healedE E from atrialof patientswith L A gradesC or GradeA 37% 1001ITT D E E whoweretreatedwith esom epraz ole40m g once GradeB38% dailyorlansopraz ole30m g oncedailyforup to8weeks. GradeC 20% Thesecondgroup of patientsincludedthosewith L A GradeD 4. Theyreceivedopen-labeltreatm entwith esom epraz ole40m g oncedailyforup to8weeks. Those whoseE E wasconsideredhealedonthebasisof an esophagogastroduodenoscopy(E GD )atweek4andwho reportednoheartburnoracidregurgitationsym ptom s during theprevious7dayswereeligibleforrandom iz ation intothism aintenancetrial. M eanage48years 41% fem ale 78% white 6% black 16% other J asperson 30patientsinGerm anywhoseesophagitishealedafter6- AllGrade4(Savary-M iller) 36treated,6didnotheal,30included. Proton pump inhibitors Page 118 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 4. H ead-to-h ead trials ofprotonpum pinh ibitors forpreventionofesoph agitis relapse A uth or Esoph agitis G rade (grading criteria),oth er N um berscreened,eligible,enrolled, Y ear Population,setting ch aracteristics with drawn,lostto followup L abenz etal2005 2766patients(63% m en;m eanage50years)were L A grade D iscontinuationsduetoadverseevents requiredtohaveE E [photographicallydocum entedat A:32. Proton pump inhibitors Page 119 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 4. H ead-to-h ead trials ofprotonpum pinh ibitors forpreventionofesoph agitis relapse A uth or Esoph agitis G rade (grading criteria),oth er N um berscreened,eligible,enrolled, Y ear Population,setting ch aracteristics with drawn,lostto followup L auritsenetal. A:38% (89%)random iz edform aintenance B:45% treatm ent. ITT = 1224(615 M eanage:49 C:14% esom epraz ole,609lansopraz ole). Proton pump inhibitors Page 120 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 4. H ead-to-h ead trials ofprotonpum pinh ibitors forpreventionofesoph agitis relapse A uth or Esoph agitis G rade (grading criteria),oth er N um berscreened,eligible,enrolled, Y ear Population,setting ch aracteristics with drawn,lostto followup R ichteretal. H ead-to-h ead trials ofprotonpum pinh ibitors forpreventionofesoph agitis relapse A uth or Esoph agitis G rade (grading criteria),oth er N um berscreened,eligible,enrolled, Y ear Population,setting ch aracteristics with drawn,lostto followup Thjodleifssonet 243patientsat21centersinE uropewith aprevious Grade0:77% 210/243com pletedoneyear;13 al. Proton pump inhibitors Page 122 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 4. H ead-to-h ead trials ofprotonpum pinh ibitors forpreventionofesoph agitis relapse A uth or F unding source Y ear R esults Q uality rating and role offunder Caos Primary endpoint: R elapseratesat5yrswere F air SupportedbyE isaiInc and 2005 11% forrabepraz ole20m g,23% forrabepraz ole J anssenPharm aceuticals 10m g and63% forplacebo(p<0. Secondary endpoints: D aytim eheartburnrelapse lowerwith both dosesof rabepraz olevplacebo (p<0. Symptomaticrelapse by 48 weeks: lansopraz ole30m g:0. H ead-to-h ead trials ofprotonpum pinh ibitors forpreventionofesoph agitis relapse A uth or F unding source Y ear R esults Q uality rating and role offunder D evault2007 E stim atedrem issionratesthrough 6m onths,% F air SupportedbyAstraZeneca (95% CI) esom epraz olevslansapraz ole E ndoscopic/sym ptom atic rem issionrate 84. H ead-to-h ead trials ofprotonpum pinh ibitors forpreventionofesoph agitis relapse A uth or F unding source Y ear R esults Q uality rating and role offunder L abenz etal2005 Primary endpoint: E ndoscopic plussym ptom atic Supportedbyagrantfrom rem issionforallpatientsat6m oswas74. Secondary endpoint: E som epraz ole20m g was significantlym oreeffectivethanpantopraz ole20 m g form aintaining pureendoscopic healing of E E (6-m onth lifetableestim ates:88. Proton pump inhibitors Page 125 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 4. H ead-to-h ead trials ofprotonpum pinh ibitors forpreventionofesoph agitis relapse A uth or F unding source Y ear R esults Q uality rating and role offunder L auritsenetal. F air:sm alldifferencesatbaseline(slightly>m aleson SponsoredbyAstraZeneca 2003 esom epraz ole84% vs. Proton pump inhibitors Page 126 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 4. H ead-to-h ead trials ofprotonpum pinh ibitors forpreventionofesoph agitis relapse A uth or F unding source Y ear R esults Q uality rating and role offunder R ichteretal. Secondary endpoints: N oSS differenceof healing m aintenancebasedonh. H ead-to-h ead trials ofprotonpum pinh ibitors forpreventionofesoph agitis relapse A uth or F unding source Y ear R esults Q uality rating and role offunder Thjodleifssonet Endoscopicrelapse at13 weeks: F air:allocationconcealm entnotreported,notclearif F undedbyE isai,L td,U K al. N on-erosive gastroesoph agealreflux disease relapse prevention A uth or N um berscreened,eligible,enrolled, Y ear Population,setting H eartburnseverity,oth erch aracteristics with drawn,lostto followup By tz eretal. Proton pump inhibitors Page 129 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 5. N on-erosive gastroesoph agealreflux disease relapse prevention A uth or F unding source Y ear R esults Q uality rating and role offunder By tz eretal. Proton pump inhibitors Page 130 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 6. R andom iz ed controlled trials ofesoph agitis treatm entinch ildren A uth or A ge,G ender,R ace, N um berScreened/ Y ear O th erPopulation Eligible/ Setting C h aracteristics Interventions C ontrol Enrolled M oore M eanage5. R andom iz ed controlled trials ofesoph agitis treatm entinch ildren A uth or Y ear Setting O utcom es reported (results) N um berofadverse effects Q uality rating M oore Parentdaily diary m eanscores ofcry/fuss tim e inm in/24h : N onereported F air 2003 Baseline:O :246vsplacebo:287 South Australia Period 1 (2 weeks): O :203vsplacebo:204 Period 2 (2 weeks): O :179vsplacebo:198 VisualA nalog Scale m eanscores ofinfantirritability: Baseline:O :7. R andom iz ed controlled trials ofduodenalulcertreatm ent:Protonpum pinh ibitorcom pared with protonpum p inh ibitor A uth or Y ear Setting O utcom es R eported (R esults) N um berofA dverse Effects Q uality R ating Beker H ealing: 21patientsreportedadverseevents(10pantopraz ole,11 F air 1995 (PP analysis) om epraz ole),with atotalof 23eventsreported. D iarrheawas M ulticenter 2 weeks:71% pantopraz ole,65% om epraz ole(p= 0. Theother2wereG I 2 weeks:81% pantopraz ole,82% om epraz ole(p = 0. Serum gastrinlevelsroseinboth groupsatboth 2and4 weeks,thechangewasstatistically significantwithinbutnot betweengroups. Capurso H ealingrates: 8adverseeffectsreported:3rabepraz ole, F air 1995 2 weeks:58% lansopraz ole,57% om epraz ole 3lansopraz ole,and2om epraz ole.

Prophylactic efficacy of lithium versus carbamazepine in treatment-naive bipolar patients triamcinolone 15 mg on line medicine 0552. Journal of Clinical Psychiatry Vol 64(2) Feb 2003 cheap 40 mg triamcinolone with amex treatment synonym, 144-151 purchase triamcinolone 40 mg mastercard medicine x pop up. Carbamazepine vs lithium in the treatment and prophylaxis of mania order triamcinolone 40mg on-line treatment without admission is known as. The comparative efficacy of carbamazepine low and high serum level and lithium carbonate in the prophylaxis of affective disorders. Long-term double-blind prospective study on carbamazepine versus lithium in bipolar and schizoaffective disorders: Preliminary results. Placidi GF, Lenzi A, Lazzerini F, Cassano GB, Akiskal HS. The Comparative Efficacy and Safety of Carbamazepine Versus Lithium: A Randomized, Double-Blind 3-Year Thai in 83 Patients. Watkins SE, Callender K, Thomas DR, Tidmarsh SF, Shaw DM. The Effect of Carbamazepine and Lithium on Remission from Affective Illness. Lithium versus carbamazepine in the maintenance treatment of bipolar II disorder and bipolar disorder not otherwise specified. The comparative prophylactic efficacy of lithium and carbamazepine in patients with bipolar I disorder. Greil W, Kleindienst N, Erazo N, Muller-Oerlinghausen B. Differential response to lithium and carbamazepine in the prophylaxis of bipolar disorder. Journal of Clinical Psychopharmacology Vol 18(6) Dec 1998, 455-460. Lithium versus carbamazepine in the maintenance treatment of bipolar disorders--a randomised study. Inter-episodic morbidity and drop-out under carbamazepine and lithium in the maintenance treatment of bipolar disorder. Antiepileptic drugs Page 60 of 117 Final Report Update 2 Drug Effectiveness Review Project 79. A preliminary double-blind study on the efficacy of carbamazepine in prophylaxis of manic-depressive illness. Lithium vs cambamazepine in the maintenance treatment of schizoaffective disorder: A randomised study. European Archives of Psychiatry and Clinical Neuroscience 1997;247(1):42-50. Prophylactic effect of phenytoin in bipolar disorder: a controlled study. A placebo-controlled 18-month trial of lamotrigine and lithium maintenance treatment in recently manic or hypomanic patients with bipolar I disorder. A double-blind, randomized, placebo-controlled, prophylaxis study of adjunctive gabapentin for bipolar disorder. Long-term randomized clinical trial on oxcarbazepine vs lithium in bipolar and schizoaffective disorders: Preliminary results. Case studies on prophylactic long-term effects of Oxcarbazepine in recurrent affective disorders. International clinical Psychopharmacology 1990;5 (suppl 1):89-94. Calabrese JR, Bowden CL, Sachs GS, Ascher JA, Monaghan E, Rudd GD. A double- blind placebo-controlled study of lamotrigine monotherapy in outpatients with bipolar I depression. Lamotrigine in the acute treatment of bipolar depression: Results of five double-blind, placebo-controlled clinical trials. A Multicenter, Double-Blind, Placebo- Controlled, Fixed-Dose, 8-Week Evaluation of the Efficacy and Safety of Lamotrigine in the Treatment of Bipolar Disorder Patients Currently Experiencing a Major Depressive Episode. A Multicenter, Double-Blind, Placebo- Controlled, Fixed-Dose Evaluation of the Safety, Efficacy, and Tolerability of LAMICTAL (Lamotrigine) in the Treatment of a Major Depressive Episode in Patients with Type I Bipolar Disorder. A Multicenter, Double-Blind, Placebo- Controlled, Fixed-Dose, 8-Week Evaluation of the Efficacy and Safety of Lamotrigine in the Treatment of Major Depression in Patients with Type II Bipolar Disorder. A Multicenter, Double–Blind, Placebo– Controlled, Flexible Dose (100–400mg) 10 Week Evaluation Of the Safety and Efficacy of LAMICTAL (Lamotrigine) in the Treatment of a Major Depressive Episode in Patients with Bipolar Disorder. A 7-week, randomized, double-blind trial of olanzapine/fluoxetine combination versus lamotrigine in the treatment of bipolar I depression. Antiepileptic drugs Page 61 of 117 Final Report Update 2 Drug Effectiveness Review Project 93. Randomized, double-blind pilot trial comparing lamotrigine versus citalopram for the treatment of bipolar depression. A single blind comparison of lithium and lamotrigine for the treatment of bipolar II depression. Treatment-resistant bipolar depression: a STEP-BD equipoise randomized effectiveness trial of antidepressant augmentation with lamotrigine, inositol, or risperidone. Clinical predictors of response to lamotrigine and gabapentin monotherapy in refractory affective disorders. Divalproex in the treatment of bipolar depression: a placebo-controlled study. Divalproex in the treatment of acute bipolar depression: a preliminary double-blind, randomized, placebo-controlled pilot study. Practice guidelines for the treatment of patients with bipolar disorder: Second Edition. McIntyre RS, Mancini DA, McCann S, Srinivasan J, Sagman D, Kennedy SH. Topiramate versus bupropion SR when added to mood stabilizer therapy for the depressive phase of bipolar disorder: a preliminary single-blind study. A placebo-controlled 18-month trial of lamotrigine and lithium maintenance treatment in recently depressed patients with bipolar I disorder. A double-blind placebo-controlled study of lamotrigine in rapid cycling bipolar disorder. Gabapentin in the treatment of fibromyalgia: a randomized, double-blind, placebo-controlled, multicenter trial. Pregabalin for the treatment of fibromyalgia syndrome: results of a randomized, double-blind, placebo-controlled trial. A 14-week, Randomized, Double-Blinded, Placebo-Controlled Monotherapy Trial of Pregabalin in Patients With Fibromyalgia. A randomized double blind placebo controlled phase III trial of pregabalin in the treatment of patients with fibromyalgia. Fibromyalgia relapse evaluation and efficacy for durability of meaningful relief (FREEDOM): A 6-month, double-blind, placebo- controlled trial with pregabalin Pain. Antiepileptic drugs Page 62 of 117 Final Report Update 2 Drug Effectiveness Review Project 109. Millan-Guerrero RO, Isais-Millan R, Barreto-Vizcaino S, et al.

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