By J. Thorald. Medical College of Ohio.
It is also unclear whether the men in this study were allowed to take an alpha-blocker 200mg cialis extra dosage overnight delivery venogenic erectile dysfunction treatment, although the use of 5-alpha- reductase inhibitors was excluded generic cialis extra dosage 50 mg without a prescription erectile dysfunction doctors san antonio. No studies looked thoroughly at the effect of non-urological comorbidity. The head-to- head trials allowed inclusion of patients with comorbidities other than renal, hepatic, and psychiatric illnesses, and some allowed a broader range of comorbidity, but none of the trials analyzed the effect of comorbidity on efficacy or adverse events in a comparative way. One 38 study reported that coexisting illness was significantly associated with withdrawal from the study but did not stratify by drug. This study randomized patients to a 2-week treatment of oxybutynin immediate-release 5 mg 3 times daily or trospium 20 mg twice daily with a placebo at midday. The overall rate of side effects including dry mouth was similar in the two groups. Severity of dry mouth was graded on a 4-point scale. Overactive bladder Page 41 of 73 Final Report Update 4 Drug Effectiveness Review Project Withdrawal occurred more commonly with oxybutynin immediate-release (16%) than trospium (4%). There were differences in demographic and urodynamic variables between the 2 groups at baseline and the numbers of randomized patients were unbalanced (more in one group than the other). While small differences in the number of patients randomized to each group is to be expected, large differences indicate a problem with the randomization process. Type or level of spinal cord injury was not provided, nor was information about other medications. Summary of the evidence Key question Quality of body of Findings a evidence Key question 1: Comparative efficacy In head-to-head trials what is the Oxy IR vs Tol IR: Fair Four studies of Oxy IR vs Tol IR found no comparative efficacy of Tros IR vs Oxy IR: Fair difference in efficacy. One study of Tros IR vs anticholinergic incontinence Tros IR vs Oxy ER: Fair Oxy IR found no difference in efficacy. Tros ER vs Oxy ER: results were found with Oxy ER vs Tol ER; the Poor better study found them equal. Flav: Poor Sol showed greater efficacy over Tol (IR and ER) Sol vs Tol IR: Fair for some outcomes in 2 short-term studies. No Sol vs Tol ER: Fair difference in efficacy found between Dar and Dar vs Oxy IR: Fair Oxy IR. What is the comparative efficacy Fair Four studies of Oxy ER vs Oxy IR and 1 of Tol of long-acting vs short-acting ER vs Tol IR found no difference in efficacy. One anticholinergic incontinence study of Oxy ER vs Tol IR found Oxy superior, drugs? Key question 2: Adverse events Long-term studies: Poor One comparative study assessing the discontinuation rate of Tol and Oxy over a 6- month period found a higher rate and earlier withdrawal with Oxy, but rates for both drugs were high. Uncontrolled studies reported dry mouth as the most common adverse event and found similar rates of adverse events and withdrawals between the drugs. Short-term studies: Fair Head-to-head trials indicate a higher incidence of adverse events overall and specifically dry mouth with Oxy. The ER form had less frequent adverse events overall and, specifically, less dry mouth than the IR form. Tros less often causes severe dry mouth than Oxy, although overall incidence of dry mouth and short-term adverse events are similar to those of Oxy IR. A Sol vs Tol ER trial found a lower rate of dry mouth for Tol ER. The difference between drugs based on withdrawals is less clear: 2 Sol vs Tol trials found similar rates of adverse events overall. What is the difference in adverse Tol IR vs Tol ER: Fair A short-term head-to-head comparison of Tol IR events between long-acting and Oxy IR vs Oxy ER: Fair vs Tol ER found a higher rate of dry mouth with short-acting formulations of the IR form. Withdrawal due to adverse event anticholinergic incontinence was similar for both. Short-term head-to-head comparison of Oxy IR vs Oxy ER found a higher rate of dry mouth with the IR form. Withdrawal due to adverse event was similar for both. Overactive bladder Page 42 of 73 Final Report Update 4 Drug Effectiveness Review Project Key question Quality of body of Findings a evidence Key question 3: Subpopulations Gender: Poor Evidence limited to 5 studies was not consistent (inconsistent) in identifying differences between men and Age: Fair women in response to tolterodine.
Antiemetics Page 87 of 136 Final Report Update 1 Drug Effectiveness Review Project Exclusion Excluded Studies code # Aksoylar S cheap 100 mg cialis extra dosage with visa erectile dysfunction at age 31, Akman SA buy 100 mg cialis extra dosage with mastercard impotence sentence, Ozgenc F, Kansoy S. Comparison of tropisetron and granisetron in the control of nausea and vomiting in children receiving 2 combined cancer chemotherapy. Comparison of ondansetron, metoclopramide and placebo as premedicants to reduce nausea and vomiting after major surgery. Comparison of ondansetron and droperidol in reducing postoperative nausea and vomiting associated 2 with patient-controlled analgesia. Comparative efficacy of a single oral dose of ondansetron and of buspirone against cisplatin-induced emesis in cancer 2 patients. Alkaissi A, Gunnarsson H, Johnsson V, Evertsson K, Ofenbartl L, Kalman S. Disturbing post-operative symptoms are not reduced by prophylactic 2 antiemetic treatment in patients at high risk of post-operative nausea and vomiting. Ondansetron in the treatment of postoperative vomiting: A randomized, double-blind comparison with droperidol and 2 metoclopramide. Randomized trial to compare the effect of ondansetron versus metopromide plus dexamethasone in controlling delayed 2 emesis after high-dose cisplatin. Persistence of efficacy of three antiemetic regimens and prognostic factors in patients undergoing moderately emetogenic 2 chemotherapy. Delayed emesis induced by moderately emetogenic chemotherapy: do we need to treat all patients? Ondansetron versus metoclopramide, both combined with dexamethasone, in the prevention of cisplatin-induced delayed emesis. An international multicenter protocol to assess the single and combined benefits of antiemetic interventions in a 2 controlled clinical trial of a 2x2x2x2x2x2 factorial design (IMPACT). A factorial trial of six interventions for the prevention of postoperative nausea and vomiting. Antiemetics Page 88 of 136 Final Report Update 1 Drug Effectiveness Review Project Exclusion Excluded Studies code # Arechevala E, Aulitzky W, Boeckmann W, Butcher ME, Dearnaley DP, Droz JP. A randomised, double-blind comparative study of ondansetron (OND) plus dexamethasone (DEX) with metoclopramide (MCP) plus dex as anti- 2 emetic prophylaxis during multi-day cisplatin chemotherapy. Tropisetron vs ondansetron for prevention of postoperative nausea and vomiting after laparoscopic 2 cholecystectomy: A randomized double-blind, placebo-controlled study. Ascaso FJ, Ayala I, Carbonell P, Castro FJ, Palomar A. Prophylactic intravenous ondansetron in patients undergoing cataract extraction under 2 general anesthesia. Badaoui R, Pouilly A, Yagoubi A, Carpentier F, Riboulot M, Ossart M. Comparison of ondansetron and droperidol in the prevention of postoperative 2 nausea and vomiting. Ondansetron (OND) vs metoclopramide (MTC) both combined with dexamethasone (DEX) in the prevention of 2 cisplatin (CDDP)-induced delayed emesis. Cisplatin-induced delayed emesis: Pattern and prognostic factors during three subsequent cycles. Comparison of ondansetron with metoclopramide in prevention of acute emesis associated with low dose & 2 high dose cisplatin chemotherapy. Randomized cross-over trial of ondansetron (OND) and metoclopramide (MET) in the treatment of emesis induced by 2 chemotherapy. Randomized study comparing the efficacy of ondansetron and metoclopramide in the control of emesi induced by 2 chemotherapy. A randomized double-blind comparison of ondansetron and metoclopramide in the prophylaxis of emesis 2 induced by cyclophosphamide, fluorouracil, and doxorubucin or epirubicin chemotherapy. Bonneterre J, Clavel M, the Ondansetron Breast Cancer Study G. Comparison between ondansetron (OND) tablet and alizapride (ALI) injection 2 in the prevention of emesis induced by cytotoxic regimens in breast cancer patients. Ondansetron versus chlorpromazine for preventing emesis in bone marrow transplant recipients: A double-blind 2 randomized study. Antiemetics Page 89 of 136 Final Report Update 1 Drug Effectiveness Review Project Exclusion Excluded Studies code # Bosi A, Guidi S, Saccardi R, Vannucchi AM, Messori A, Rossi Ferrini P. Bosnjak SM, Neskovic-Konstantinovic ZB, Radulovic SS, Susnjar S, Mitrovic LB.
One aorta patient developed abnormality in ALT % of patients achieving LDL-c goals at 6 cheap cialis extra dosage 40mg without prescription erectile dysfunction age 50, 12 cialis extra dosage 60 mg low cost erectile dysfunction doctors in cincinnati, and 18 weeks (p vs aorta): (>3X ULN) Patients reaching LDL-c <100. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Funding Source Wolffenbuttel et al. Supported by 2005 AstraZeneca R, Open-label, MC 263 patients randomized (N=263) 18 week treatment period Statins Page 179 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 1. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Inclusion Criteria/ Patient Clinical Trial Population Exclusion criteria Intervention Rosuvastatin vs Simvastatin Laks, 2008 Men and women aged 18 or older Familial hypercholesterolemia, secondary dysliidemia of any cause, Rosuvastatin 10 mg vs simvastatin 20 mg Open-label, multicenter with primary hypercholesterolemia history of serious adverse effect or hypersensitivity to othe statins, for 12 weeks and a 10-year CV risk >20% or a pregnancy, breastfeeding, and women of childbearing potential not history of CHD or other established using contraception, malignancy, use of disallowed concomitant atherosclerotic disease and fasting medications, history of alcohol or drug dependence, active liver triglycrides <=4. All were statin-naïve (not diabetes, unstable angina, uncontrolled hypertension, unexplained received a statin in the past 6 serum creatine kinase >3 times ULN, serious or unstable medical or months) or subjects on a start dose psychological conditin that compromises safety or participation in the or other lipid lowering therapy, trial. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Results (mean changes in lipoprotein levels) Harms/Comments Laks, 2008 Least squares mean percent change (SE) from baseline, rosuvastatin vs rosuvastatin vs simvastatin: Open-label, multicenter simvastatin: Overall withdrawals: 9. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Funding Source Laks, 2008 AstraZeneca Open-label, multicenter Statins Page 182 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 1. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Inclusion Criteria/ Patient Clinical Trial Population Exclusion criteria Intervention Switching statins Kai T et al, 2008 Men and women aged 41–87 years Familial hypercholesterolemia, severe liver dysfunction (transaminase > Switching from simvastatin 10mg/day to Open-label, single-center with mild hypertension and 100 IU/l), severe renal failure (creatinine > 2. Statins Page 183 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 1. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Results (mean changes in lipoprotein levels) Harms/Comments Kai T et al, 2008 Change in mean levels (baseline vs 6 months of treatment) NR Open-label, single-center Total cholesterol (mg/dl): 194 vs 193 (P=0. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Funding Source Kai T et al, 2008 None Open-label, single-center 27 patients 6 month treatment period Statins Page 185 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 2. Trials with primary coronary heart disease endpoints Author Mean Mean Year Study Baseline Study Name Study Characteristics Study Population Intervention Duration LDL-c Studies in outpatients ALLHAT Officers and Randomized, open- 10,355 people age 55+ with stage 1 Pravastatin 40 mg/day or 4. Asselbergs et al Randomized, active 864 residents of one city in the Pravastatin 40 mg or 46 + 7 174 + 37 2004 and placebo-controlled, Netherlands, ages 28-75 with matching placebo and months Prevention of Renal and double-blind, single persistent microalbuminuria, blood fosinopril 20 mg or matching Vascular Endstage Disease center pressure <160/100 mm Hg, and no placebo. Intervention Trial use of antihypertensive medication, (PREVEND IT ) and a total cholesterol level <309 mg/dL, or <193 mg/dL in case of previous myocardial infarction, and no use of lipid-lowering medication. Statins Page 186 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 2. Trials with primary coronary heart disease endpoints Author Percent Year LDL-c Reduction from Myocardial Infarction Coronary Heart Disease (new Cardiovascular or CHD Study Name Baseline (active vs. Trials with primary coronary heart disease endpoints Author Year Study Name All Cause Mortality Major Coronary Events Stroke Studies in outpatients ALLHAT Officers and 6-Year Rate 6-Year Rate 6-Year Rate Coordinators RRR= 1% (3% Heart failure (hospitalized or fatal) Fatal & nonfatal 2002 calculated) RRR= 1% (3% calculated) RRR= 9% Antihypertensive and Lipid- ARR= 0. Trials with primary coronary heart disease endpoints Author Year Need for Revascularization (CABG, PTCA, Study Name Stenting) Comments/Conclusions Studies in outpatients ALLHAT Officers and NR Coordinators 2002 Antihypertensive and Lipid- Lowering Treatment to Prevent Heart Attack Trial (ALLHAT-LLT) Asselbergs et al Not reported 2004 Prevention of Renal and Vascular Endstage Disease Intervention Trial (PREVEND IT ) Statins Page 189 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 2. Trials with primary coronary heart disease endpoints Author Year Study Name Funding Source Studies in outpatients ALLHAT Officers and National Heart, Lung, and Blood Institute; Pfizer; Coordinators AstraZeneca; Bristol-Myers Squibb 2002 Antihypertensive and Lipid- Lowering Treatment to Prevent Heart Attack Trial (ALLHAT-LLT) Asselbergs et al Dutch Kidney Foundation, Netherlands Heart 2004 Foundation, and Bristol-Myers Squibb Prevention of Renal and Vascular Endstage Disease Intervention Trial (PREVEND IT ) Statins Page 190 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 2. Trials with primary coronary heart disease endpoints Author Mean Mean Year Study Baseline Study Name Study Characteristics Study Population Intervention Duration LDL-c Colhoun 2004 Randomized, double- 2838 men and women with no Atorvastatin 10 mg/day or median 3. Randomized, double- 6605 healthy men (43-73 yrs) & Lovastatin 20 mg qpm or 5. Statins Page 191 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 2. Trials with primary coronary heart disease endpoints Author Percent Year LDL-c Reduction from Myocardial Infarction Coronary Heart Disease (new Cardiovascular or CHD Study Name Baseline (active vs. Prevention Study 95% CI 17-57% 95% CI 5-51% (AFCAPS/TexCAPS) NNT=86 NNT=122 Heart Protection Study 29. Trials with primary coronary heart disease endpoints Author Year Study Name All Cause Mortality Major Coronary Events Stroke Colhoun 2004 4. Trials with primary coronary heart disease endpoints Author Year Need for Revascularization (CABG, PTCA, Study Name Stenting) Comments/Conclusions Colhoun 2004 1. RRR=33% Lovastatin reduced the incidence of first acute major coronary 1998 ARR=1. Atherosclerosis 95% CI 15-48% Prevention Study NNT=65 (AFCAPS/TexCAPS) Heart Protection Study RRR=24% Coronary or vascular death, nonfatal MI, stroke and need for Collaborative Group ARR=2. Subanalysis of Heart Protection Study 95% CI 17-30 patients at LDL-c levels <100 mg/dl showed a reduction of to 65 (HPS) NNT=38 mg/dl (mean) produced a reduction in risk about as great as those at higher LDL-c. Simvastatin reduced incidence of the primary endpoint of total mortality, with a CHD death reduction of 42% vs. Simvastatin reduced incidence of major coronary events. The risk for these events was reduced in women and in those over 60 years.
Head-to-head trial comparisons in adults with seasonal allergic rhinitis purchase cialis extra dosage 60 mg fast delivery erectile dysfunction medication otc. quality cialis extra dosage 50 mg erectile dysfunction after drug use................................ Rhinitis symptom assessment outcomes in adults with seasonal allergic rhinitis................... Efficacy outcomes in trials of ciclesonide compared with placebo.......................................... Efficacy outcomes in trials of fluticasone furoate compared with placebo.............................. Main results in placebo-controlled trials in children with seasonal allergic rhinitis.................. Reductions in nasal symptom scores in head-to-head trials of perennial allergic rhinitis patients................................................................................................................................................... Outcomes in head-to-head trials of perennial allergic rhinitis patients.................................. Placebo-controlled trials in children/adolescents with perennial allergic rhinitis................... Funding: Washington State Preferred Drug Program selected the topic, had input into the Key Questions, and funded this review. The content and conclusions of the review are entirely determined by the Evidence-based Practice Center researchers. The authors of this report have no financial interest in any company that makes or distributes the products reviewed in this report. NCS Page 4 of 71 Final Report Update 1 Drug Effectiveness Review Project INTRODUCTION Allergic rhinitis is a condition characterized by sneezing, watery rhinorrhea, nasal 1 itching, congestion, itchy palate, and itchy, red, and watery eyes. The prevalence of allergic rhinitis has increased significantly over the last 15 years and the disease currently affects twenty 2 to forty million Americans. It is estimated that in 2002, approximately 14 million medical office 2 visits were attributed to allergic rhinitis. Many suffering from allergic rhinitis are children and 3 young adults, whom, if treated early, may avoid later stage complications. If left untreated, this condition could lead to the development or worsening of comorbidities including chronic or 4, 5 recurrent sinusitis, asthma, otitis media, an respiratory infections. Moderate to severe allergic 3, 5 rhinitis may also lead to sleep disorders, fatigue, and learning problems. Rhinitis can be divided into 2 broad categories: allergic and non-allergic. Allergic rhinitis consists of seasonal and perennial rhinitis. Seasonal allergic rhinitis, also called hay fever, is characterized by symptoms that occur in response to specific seasonally occurring allergens. Allergens may include pollen from trees, grasses, and weeds. Perennial allergic rhinitis occurs throughout the year and is caused by allergens such as house dust mites, animal dander, cockroaches, and molds. In some geographic locations, pollen can play a role in perennial rhinitis. Patients are often sensitized to both seasonal and perennial allergens, which can be 6 termed mixed allergic rhinitis. There is a prominent genetic component involved in the development of allergic rhinitis. Individuals with both parents suffering from atopic disease have a 50% or greater chance of 5 affliction with allergic disease. The symptoms of allergic rhinitis are caused by an IgE-mediated immune response to a particular allergen. An antibody, called immunoglobulin E (IgE), represents a major component of this immunologic reaction. The binding of the allergen to IgE molecules leads to a chain of events that includes the release of mediators such as histamine and leukotrienes and culminates in the arrival of inflammatory cells to the region. These inflammatory cells are responsible for the clinical symptoms of allergic rhinitis. In contrast, non-allergic rhinitis is often a diagnosis of exclusion and represents a diverse group of disorders. There are several different types of non-allergic rhinitis: drug induced, gustatory, hormonal, infectious, non-allergic rhinitis with eosinophilia syndrome, occupational, 7 anatomic, and vasomotor.
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