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By Y. Tragak. The College of Insurance. 2018.

After preliminary studies of progesterone and testoster- one demonstrated decreased sickling order etodolac 400 mg with amex, investigators performed a Sexuality and reproductive choices in women with SCD crossover study in 28 women treated with progesterone and 16 Information on sexuality in women with SCD is limited etodolac 300mg sale. Although results were prelimi- the well-described data on delayed puberty and adverse outcomes nary discount etodolac 300mg without a prescription, they reported an 80% reduction in pain in the treated group. However, attitudes regarding contraception and unplanned placebo either before or after depot medroxyprogesterone acetate pregnancy suggest that women with SCD are interested in avoiding (DMPA). In addition, hemoglobin, fetal hemoglobin, and general population. This led to the Unplanned pregnancy and SCD conclusion that improved RBC survival may be due to the Unplanned pregnancy remains high globally and contraceptive use increased survival of RBCs containing higher concentrations of varies widely by country, age, and race/ethnicity. Finally, de Abood et al reported 43 women SCD, unplanned pregnancy rates have been high historically and with SCD who had pain in the last year and were nonrandomly remain high. Hematology 2014 419 Use of implantable progesterone-only containing compounds has although 2 women had successful pregnancies, 1 after preimplanta- been reported in small prospective studies in women with SCD. In 2004, the World unpredictable risk of infertility, patients may opt for procedures to Health Organization released recommendations on the use of preserve fertility before HSCT regardless of conditioning regimens. Although experience is limited, patients with IUDs outweighed the risks associated with the increased morbidity SCD have success with procedures and therapies that preserve and mortality associated with pregnancy. Cryopreservation options have expanded and depend Eligibility Criteria for Contraceptive Use 2010 continues to support 49 on stage of pubertal development. Combined hormonal contraceptives are pubertal males is standard and improvement of sperm banking classified as level 2, meaning that “the advantages of using the techniques and increased use of intracytoplasmic sperm injection method generally outweigh the theoretical or proven risks. Cryopreservation of testicular terone-only containing pills are classified as level 1, meaning that tissue, considered experimental, is an option in prepubertal boys, these agents can be used without restrictions. However, it is but is waiting for the development of technology and procedures for concerning that these recommendations are based primarily on the 63 restoring human fertility. It should be noted, however, that reduced SCD-related morbidity. However, as utilization of these women with SCD are at risk for thromboses67 and increased acute therapies increases, more attention is drawn to their associated pain while being exposed to increased estrogen levels during adverse effects and toxicities. Issues have been raised regarding HU ovarian stimulation. Successful oocyte preservation after controlled use, abnormal sperm production, and teratogenic effects. In addi- ovarian stimulation in a 19-year-old woman with SCD has been tion, fertility preservation after HSCT and the endocrine abnormali- described using a protocol to avoid hyperstimulation and incorporat- ties associated with transfusional iron overload remain concerns. In addition, successful pregnan- contraception counseling is paramount to decreasing unplanned cies in women with SCD after ovarian tissue preservation have been pregnancies. Hormonal contraceptive use is controversial in SCD 61,62 reported. For girls who are 18 years of age, particularly those primarily due to the theoretical increased risk for venous thrombo- 12 years, ovarian tissue preservation is an option, although embolism and risk for acute pain events. When counseling pediatric 68 outcomes in SCD are not clear. Transfusional iron overload and infertility Patterns of transfusional iron overload in patients with SCD seem to HSCT and fertility preservation be different from those in patients with thalassemia. HSCT remains the sole cure for SCD, with event- free survival rates averaging 85%–90% for allogeneic transplanta- Transfusional iron overload, if untreated, may lead to infertility tions. Gonadal failure in patients with SCD on outcomes such as endocrine dysfunction and impaired fertility are chelation therapy occurs at similar rates in those with SCD without iron overload. If the toxicity of conditioning regimens could be decreased while maintaining low rates of graft rejection, delayed in patients with SCD receiving chronic transfusion therapy HSCT may be considered more often in patients with SCD before compared with patients with thalassemia major. Generally, focus is severe acute complications and major end-organ damage occur. In women with Myeloablative conditioning regimens before HSCT for SCD cause thalassemia major, biomarkers have been used to assess reproduc- infertility, particularly in females. Young children who receive SCD receiving HU is impressive. Its impact on reducing acute HU appear to have normal growth,75 but information on pubertal complications and improving survival suggests that HU may development is less clear. However, 2 reproductive issues loom have a positive effect at limiting SCD-related organ dysfunction with the use of HU in both the pediatric and adult populations: long term.

Only for the section on ocular hypertension and open-angle glaucoma were we unable to find direct evidence for patients with asthma; thus we included two studies that included more broad populations of subjects taking ICSs cheap etodolac 300mg on line. Bone density/osteoporosis We found two fair quality systematic reviews with meta-analyses that studied the effect of ICSs 244 generic etodolac 200mg fast delivery, 245 on markers of bone function and metabolism etodolac 300mg sale. One included 14 studies (2,302 subjects) of 244 patients with asthma or COPD (both RCTs and prospective cohort studies) assessing BMD. The other included six studies of asthmatic subjects with median duration of ICS use of at least 245 three years. Pooled results from both meta-anlyses showed no statistically significant difference in BMD between patients taking ICSs and controls. The one that included patients with asthma and COPD reported that asthma patients treated with ICSs showed a slight increase in BMD (0. We excluded the remainder of studies from these two reviews because of wrong population (COPD patients), insufficient sample size, and/or 255, 256 251-253 poor quality. In total we include one good-rated RCT, three fair-rated RCTs, and five 259-262, 269 observational studies. All nine studies assessed BMD, facture risk, or both (Table 25). In total, four studies 252, 260, 261, 269 evaluated the risk of fracture and seven measured BMD as an intermediate 251-253, 255, 256, 259, 262, 269 251, 252 outcome. Two studies compared one ICS to another, three compared 253, 255, 256, 262 one ICS to placebo, and four studies compared one ICS or any ICS to a population Controller medications for asthma 146 of 369 Final Update 1 Report Drug Effectiveness Review Project 259-261, 269 that did not use an ICS. Most studies evaluated the risk of bone weakening over two to six years. Two of the trials were head-to-head RCTs comparing one ICS with another ICS in adult 251, 252 subjects. One 24-month open-label trial measuring BMD and vertebral fractures 252 randomized 374 adult patients with asthma to beclomethasone, budesonide, or placebo. Patients were titrated to the minimal effective dose following a pre-specified management plan; subjects who required more than three courses of oral corticosteroids were withdrawn. At two years, no significant differences in BMD were reported between the three treatment groups. A smaller trial reporting BMD randomized 69 asthmatic patients to medium and high doses of 251 beclomethasone or fluticasone. At one year, no significant differences in bone mass or metabolism were noted between the two treatment groups. Seven studies (three of them in pediatric populations) comparing an ICS-treated population to a population not treated with ICSs provided mixed evidence of an association 253, 255, 256, 259-262, 269 between ICS use and loss of BMD or osteoporosis; three of these studies 260, 261, 269 measured bone fractures. The studies conducted in pediatric populations reported no difference in BMD between ICS- and placebo-treated subjects and no difference in risk of osteoporosis or time to first fracture between ICS-treated subjects and those not treated with 255, 256, 262, 269 ICS. Of the remaining studies, one reported a dose-related decline in BMD with 259 ICS-treated subjects, one reported a dose-related increase in the risk of vertebral and 261 260 nonvertebral fractures with ICS, and two reported no difference in nonvertebral fracture or 253 BMD between ICS-treated subjects and controls (Table 25). Summary of studies on bone density or fractures Author Quality Year N Design Population Results rating Adult populations premenopausal TAA associated with dose-related 259 Prospective women with decline in BMD (total hip and Israel et al. Nested case- Asthma & the total group of subjects or for 260 18,942 Fair 2005 control COPD (adults) either of the separate respiratory disease categories (asthma or COPD) No difference in BMD between 253 Kemp et al. No difference in BMD between BDP- 251 69 RCT Asthma (adult) Fair 2000 and FP-treated patients over 1 year No difference in BMD/fractures Tattersfield et al. RCT Asthma 252 374 between BDP, BUD, and placebo Fair 2001 (open label) (adult) over 2 years Statistically significant dose-related Van Staa et al. Retrospective Asthma & 261 450,422 increase in risk of vertebral and Fair 2001 cohort COPD (adult) nonvertebral fractures with ICS Pediatric populations Childhood Asthma No difference in bone density Management Asthma 1041 RCT between BUD- and placebo-treated Good Program Research (pediatric) 255, 256 patients Group, 2000 Controller medications for asthma 147 of 369 Final Update 1 Report Drug Effectiveness Review Project Table 25. Summary of studies on bone density or fractures Author Quality Year N Design Population Results rating Agertoft & Cross- Asthma No difference between BUD and 262 157 Fair Pedersen, 1998 sectional (pediatric) placebo (3-6 years use) in BMD Cohort study 269 Asthma ICS use was not related to time to Kelly, 2008 877 (CAMP Fair (pediatric) first fracture or to risk for osteopenia subjects) Abbreviations: BDP = beclomethasone dipropionate; BUD = Budesonide; COPD= chronic obstructive pulmonary disease; ICS = Inhaled Corticosteroids; NA= not applicable; RCT= randomized controlled trial; TAA = Triamcinolone Acetonide. Symbol use: Drug X > Drug Y = statistically significant difference in outcomes favoring Drug X; Drug X > Drug Y trend = point estimate favors Drug X, but the difference is not statistically significant or tests of statistical significance were NR; No difference = no statistically significant difference or tests of statistical significance were not reported and outcomes are similar. Growth 31 Four head-to-head RCTs comparing fluticasone to beclomethasone, , fluticasone to 44, 249 62 budesonide, , or ciclesonide to budesonide assessed differences in growth.

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A meta-analysis comparing the effect of thiazolidinediones on cardiovascular risk factors order 300mg etodolac visa. Czoski-Murray C buy etodolac 200 mg visa, Warren E etodolac 200mg fast delivery, Chilcott J, Beverley C, Psyllaki MA, Cowan J. Clinical effectiveness and cost-effectiveness of pioglitazone and rosiglitazone in the treatment of type 2 diabetes: a systematic review and economic evaluation. Thiazolidinediones and the risk of edema: a meta- analysis. Benefits and harms of antidiabetic agents in patients with diabetes and heart failure: systematic review. Congestive heart failure and cardiovascular death in patients with prediabetes and type 2 diabetes given thiazolidinediones: a meta-analysis of randomised clinical trials. Factors associated with the effect-size of thiazolidinedione (TZD) therapy on HbA(1c): a meta-analysis of published randomized clinical trials. Thiazolidinediones and risk of repeat target vessel revascularization following percutaneous coronary intervention: a meta-analysis. Richter B, Bandeira-Echtler E, Bergerhoff K, Clar C, Ebrahim SH. Effect of thiazolidinedione therapy on restenosis after coronary stent implantation: a meta-analysis of randomized controlled trials. Thiazolidinediones Page 95 of 193 Final Report Update 1 Drug Effectiveness Review Project 53. Long-term risk of cardiovascular events with rosiglitazone: a meta-analysis. Thiazolidinediones and heart failure: a teleo-analysis. Dipeptidyl peptidase-4 (DPP-4) inhibitors for type 2 diabetes mellitus. A randomized, placebo-controlled trial assessing the effects of rosiglitazone on echocardiographic function and cardiac status in type 2 diabetic patients with New York Heart Association Functional Class I or II Heart Failure. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. Rosiglitazone evaluated for cardiovascular outcomes--an interim analysis. Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events): a randomised controlled trial. Efficacy of rosiglitazone and pioglitazone compared to other anti-diabetic agents: systematic review and budget impact analysis (Structured abstract). Pioglitazone and risk of cardiovascular events in patients with type 2 diabetes mellitus: a meta-analysis of randomized trials. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. Padwal R, Majumdar SR, Johnson JA, Varney J, McAlister FA. A systematic review of drug therapy to delay or prevent type 2 diabetes. Metabolic effects of pioglitazone and rosiglitazone in patients with diabetes and metabolic syndrome treated with glimepiride: a twelve- month, multicenter, double-blind, randomized, controlled, parallel-group trial. A comparison of the effects of pioglitazone and rosiglitazone combined with glimepiride on prothrombotic state in type 2 diabetic patients with the metabolic syndrome. A comparison of lipid and glycemic effects of pioglitazone and rosiglitazone in patients with type 2 diabetes and dyslipidemia. A prospective, randomized comparison of the metabolic effects of pioglitazone or rosiglitazone in patients with type 2 diabetes who were previously treated with troglitazone.

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Lin SR purchase 200mg etodolac visa, Ke MY order 300 mg etodolac overnight delivery, Luo JY discount 300 mg etodolac fast delivery, Yuan YZ, Wang JY, diTommaso S, et al. A randomized, double- blind, placebo-controlled trial assessing the efficacy and safety of tegaserod in patients from China with chronic constipation. Quigley EM, Wald A, Fidelholtz J, Boivin M, Pecher E, Earnest D. Safety and tolerability of tegaserod in patients with chronic constipation: pooled data from two phase III studies. Sullivan KL, Staffetti JF, Hauser RA, Dunne PB, Zesiewicz TA. McRorie JW, Daggy BP, Morel JG, Diersing PS, Miner PB, Robinson M. Psyllium is superior to docusate sodium for treatment of chronic constipation. Attar A, Lemann M, Ferguson A, Halphen M, Boutron MC, Flourie B, et al. Comparison of a low dose polyethylene glycol electrolyte solution with lactulose for treatment of chronic constipation. Wang HJ, Liang XM, Yu ZL, Zhou LY, Lin SR, Geraint M. A Randomised, Controlled Comparison of Low-Dose Polyethylene Glycol 3350 plus Electrolytes with Ispaghula Husk in the Treatment of Adults with Chronic Functional Constipation. A randomised, controlled comparison of low-dose polyethylene glycol 3350 plus electrolytes with ispaghula husk in the treatment of adults with chronic functional constipation. Voskuijl W, de Lorijn F, Verwijs W, Hogeman P, Heijmans J, Makel W, et al. PEG 3350 (Transipeg) versus lactulose in the treatment of childhood functional constipation: a double blind, randomised, controlled, multicentre trial. Nyhlin H, Bang C, Elsborg L, Silvennoinen J, Holme I, Ruegg P, et al. A double-blind, placebo-controlled, randomized study to evaluate the efficacy, safety and tolerability of tegaserod in patients with irritable bowel syndrome. Kellow J, Lee OY, Chang FY, Thongsawat S, Mazlam MZ, Yuen H, et al. An Asia-Pacific, double blind, placebo controlled, randomised study to evaluate the efficacy, safety, and tolerability of tegaserod in patients with irritable bowel syndrome. Muller-Lissner SA, Fumagalli I, Bardhan KD, Pace F, Pecher E, Nault B, et al. Tegaserod, a 5-HT(4) receptor partial agonist, relieves symptoms in irritable bowel syndrome patients with abdominal pain, bloating and constipation. Constipation Drugs Page 77 of 141 Final Report Drug Effectiveness Review Project 50. Novick J, Miner P, Krause R, Glebas K, Bliesath H, Ligozio G, et al. A randomized, double- blind, placebo-controlled trial of tegaserod in female patients suffering from irritable bowel syndrome with constipation. Tack J, Muller-Lissner S, Bytzer P, Corinaldesi R, Chang L, Viegas A, et al. A randomised controlled trial assessing the efficacy and safety of repeated tegaserod therapy in women with irritable bowel syndrome with constipation. A dose-ranging, double-blind, placebo- controlled study of lubiprostone in subjects with irritable bowel syndrome and constipation (c- ibs) [Abstract 131]. Effect of a laxative with and without tegaserod in adolescents with constipation predominant irritable bowel syndrome.

However 200mg etodolac, study groups in this trial were not similar at baseline with respect to recurrent depression (paroxetine 76 buy cheap etodolac 300mg on-line. We conducted a meta-analysis of five of these studies (excluding studies that did not report data on HAM-D or were conducted in elderly populations) comparing the effects of 69 etodolac 300mg with mastercard, 70, 72-74 fluoxetine to paroxetine on HAM-D scores at the end of follow-up. A “response” was Second-generation antidepressants 24 of 190 Final Update 5 Report Drug Effectiveness Review Project defined as an improvement of 50 percent or more on the HAM-D scale. Results (Exhibit 3) show that the response rate did not differ significantly between fluoxetine and paroxetine (RR: 1. Funnel plot, Kendell’s test, and L’Abbe plot did not indicate major biases. However, given the small number of component studies, results of these tests must be viewed cautiously. Fluoxetine compared with sertraline 54, 55, 73, 75-77 Six studies compared fluoxetine to sertraline. The top-level evidence consisted of two 54, 55 78 effectiveness trials and one efficacy trial with long periods of follow-up. Two fair-rated, multicenter trials from France were conducted in office settings (private 54, 78 psychiatrists and general physicians [GPs]). The psychiatrists’ study randomized 238 patients for 24 weeks and the GP study 242 patients for nearly 26 weeks (180 days) to fluoxetine (20-60 mg/d) or sertraline (50-150 mg/d). The majority of patients had concomitant medical conditions. Both studies assessed quality of life as a secondary outcome measure (Sickness Impact Profile [SIP], Functional Status Questionnaire [FSQ]). Exclusion criteria were less stringent in the GP trial than the psychiatrist trial. In the GP trial, researchers conducted outcome assessments only at day 120 and day 180, but patients could choose to consult the physician at any time. Intention-to-treat analyses in both studies did not reveal any statistically significant differences in any primary (MADRS, HAM-D, CGI) or secondary (Covi Anxiety Scale, HAD, SIP, Leeds Sleep Evaluation) efficacy measures or in the incidence of adverse events. The ARTIST trial was an open-label RCT designed as an effectiveness study and carried 55 out in a primary care setting (primary care physicians) over 9 months. This study enrolled 601 patients at 76 primary care sites. Initial diagnosis for enrollment was not based on diagnostic criteria but rather on the judgment of the treating physician. Criteria-based evaluation classified 74 percent of patients as having MDD, 18 percent dysthymia, and 8 percent minor depression. Patients’ treatments could be switched among study drugs or to other antidepressive medications as needed. Intention-to-treat analysis maintained the original randomization. Outcome measures assessing changes in depression and health-related quality of life measures (work, social and physical functioning, concentration and memory, sexual functioning) were administered over the telephone by a blinded third party. Range of dosage and loss to follow-up were incompletely reported. Results did not reveal any significant differences among drugs in any outcome measures at either 3 or 9 months. All treatment groups significantly improved during the study compared to baseline. Subgroup analyses did not show different effectiveness for patients with MDD or for those older than 60 years. Three additional fair-rated trials did not find any significant differences in primary 73, 75, 77, 79 outcome measures (HAM-D, MADRS, CGI-S). Treatment durations varied from 6 to 77, 79 16 weeks. One study was conducted in 236 participants older than 60 years.

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