By O. Elber. College of New Rochelle. 2019.
Vasomotor rhinitis: clinical 5 efficacy of azelastine nasal spray in comparison with placebo buy penegra 50 mg line prostate oncology jacksonville. Orl; Journal of Oto-Rhino- Laryngology & its Related Specialties cheap penegra 100 mg amex prostate biopsy results. A randomized discount 50mg penegra with amex prostate 24 ingredients, double blind, placebo controlled study for evaluation of 7 the efficacy and safety of cetirizine dry syrup (CTZ DS) (2. The efficacy of short-term 6 administration of 3 antihistamines vs placebo under natural exposure to Japanese cedar pollen. Placebo controlled pilot study on the efficacy of 7 levocetirizine 5 mg in reducing symptoms, airway resistance, and sleep impairment in patients with persistent allergic rhinitis [completed]. Cintinuous intake of levocetirizine for 6 months has no relevant effect on 5 laboratory values: the XPERT trial. A placebo-controlled evaluation of 6 butterbur and fexofenadine on objective and subjective outcomes in perennial allergic rhinitis. Meltzer E, Banov C, Halverson P, Weiler J, Woehler T, Hemsworth G. Comparison of 4 azelastine, clemastine fumarate and placebo for treatment of perennial allergic rhinitis. Randomized, double-blind, placebo-controlled study of 3 montelukast for treating perennial allergic rhinitis. Histamine skin test reactivity following single and 2 multiple doses of azelastine nasal spray in patients with seasonal allergic rhinitis. A single-center, randomized, double-blind, placebo-controlled, two-way 7 crossover study designed to evaluate the efficacy of fexofenadine HCl 180 mg for preventing and controlling cat allergy symptoms [completed]. Improvements in simulated real-world relevant 6 performance for patients with seasonal allergic rhinitis: impact of desloratadine. Schering Plough, Double-blind, randomized, placebo-controlled, parallel-group, 6 multicenter/multinational, efficacy and safety study of desloratadine 5 mg in the treatment of subjects with allergic rhinitis who meet the criteria for intermittent allergic rhinitis (IAR) [completed]. High-dose desloratadine 6 decreases wheal volume and improves cold provocation thresholds compared with standard-dose treatment in patients with acquired cold urticaria: a randomized, placebo- controlled, crossover study. Clinical pharmacology of the H1-receptor antagonists 6 cetirizine and loratadine in children. Torkildsen GL, Gomes P, Welch D, Gopalan G, Srinivasan S. Evaluation of desloratadine 4 on conjunctival allergen challenge-induced ocular symptoms. A multi-center, randomized, double-blind, placebo-controlled, parallel-A multi-center, 5 randomized, double-blind, placebo-controlled, parallel-group study evaluating the efficacy and impact on health-related quality of life of levocetirizine 5 mg once daily given for 2 weeks in subjects 18 yr of age and older with seasonal allergic rhinitis [completed]. A multi-center, randomized, double-blind, placebo-controlled, parallel-group study 5 evaluating the efficacy and impact on health-related quality of life of levocetirizine 5 mg once daily given for 2 weeks in subjects 18 yr of age and older with seasonal allergic rhinitis [completed]. A multi-center, randomized, double blind, placebo controlled parallel group study of 5 the safety of levocetirizine dihydrochloride oral liquid formulation b. Antihistamines Page 64 of 72 Final Report Update 2 Drug Effectiveness Review Project Appendix E. Reporting of adverse events a Adverse events from head-to-head and active control trials in adults (Original Report) Author Withdrawals from Year Adverse events Total withdrawals AEs Head-to-head trials 29 Ciprandi 1997 No significant AEs reported Total: 0 0 L: loratadine 10 mg qd C: cetirizine 10 mg qd Total AEs: 16. L: loratadine 10 mg qd NR NR Considered treatment related F: fexofenadine 120 mg in F 8. A2: 4% chest pain, D: desloratadine 5 mg D: Headache 3%, pharyngitis A1: 2% lightheadedness) A1: azelastine nasal 4% D: 1% D: 1% (headache A2: azelastine nasal + P: headache 7% P: 1% and nausea) loratadine Somnolence: P: 1% (rash) P: placebo A1: 2%; A2: 1%; D: 1%; P: 1% More AEs (considered probably or possibly 56 Dockhorn 1987 treatment-related) in C C: 37% L: loratadine 10 mg L: 21% NR NR C: clemastine 2 mg P: 20% (p<0. Abbreviations: bid, twice daily; mg, milligrams; NSD, no significant difference; NR, not reported; qd, once daily; tid, 3 times daily. Adverse events from studies in adults (includes only studies from update 2003- a 2005) Adverse Type of AE event Cetirizine Fexofenadine Loratadine NEUROLOGICAL MAJOR 6. Abdominal MINOR fexofenadine cetirizine 0%, pain 75 75 2. MINOR Cough fexofenadine fexofenadine, 55 75 75 rupatadine 20 mg 5. Feet fexofenadine, cetirizine 0%, swelling 75 75 NSD NSD OR of hypospadias with loratadine 167 exposure: 1. Abbreviations: mg, milligrams; NR, not reported; NSD, no significant difference; OR, odds ratio QT, cardiac output; QTc, corrected QT interval for heart rate. There were no data on desloratadine identified in update 1. Somnolen 95 placebo 0% dexchlorphenira ce 102 NSD vs. Nausea chlorpheniramin 101 e 0% HEMATOLOGICAL Neutropenia MAJOR (asymptomatic 100 ) in 1 child NSD vs. MAJOR 156 92 interval NSD QT placebo placebo cetirizine vs. Abbreviations: NSD, no significant difference; QT, cardiac output; QTc, corrected QT interval for heart rate. Antihistamines Page 70 of 72 Final Report Update 2 Drug Effectiveness Review Project Appendix F. Poor-quality studies Original Report and Update 1 Author Agents Characteristics Placebo-controlled trials Fexofenadine 60, 120, 240 mg SAR, mc, r db, pc, 57 pts late Bernstein 1997 bid summer 2 wks Casale 1999 Fexofenadine 120 or 180 mg qd SAR mc, r, pc, 861 pts. Wasserman 1991 Cetirizine 10 mg and 5mg qd SAR, db, pc, 88 pts spring 2 wks Zuberbier 1995 Cetirizine 10 or 20 mg qd CIU, r, db, 24 pts 3wks Zuberbier 1996 Cetirizine 20 mg qd CIU, db, pc, 11 pts. Update 2 Amat P, Novella A, Roma J, Valero A, Lluch M, Malet A. Treatment of perennial allergic rhinitis with cetirizine. Berlin JM, Golden SJ, Teets S, Lehman EB, Lucas T, Craig TJ. Efficacy of a steroid nasal spray compared with an antihistamine nasal spray in the treatment of perennial allergic rhinitis. Double-blind, placebo controlled comparison of cetirizine 2HC1 and terfenadine in atopic perennial rhinitis. Desloratadine and levocetirizine improve nasal symptoms, airflow, and allergic inflammation in patients with perennial allergic rhinitis: a pilot study. Efficacy and tolerability of azelastine nasal spray in patients with allergic Antihistamines Page 71 of 72 Final Report Update 2 Drug Effectiveness Review Project rhinitis compared to placebo and budesonide. Improved quality of life among seasonal allergic rhinitis patients treated with olopatadine HCl nasal spray 0. Levocetirizine modulates lymphocyte activation in patients with allergic rhinitis. Efficacy and safety of levocetirizine on symptoms and health-related quality of life of children with perennial allergic rhinitis: a double-blind, placebo-controlled randomized clinical trial.
In a British cohort buy 50 mg penegra free shipping prostate 74, the rel- ative risk in the early years of the HIV epidemic was similar to that of the normal population and has now risen by a factor of 8 (Bower 2003) purchase penegra 100mg on-line prostate cancer youtube. In other cohorts generic penegra 50mg line prostate 8k springfield, rela- tive risk remained constant between 3–10 (Engels 2006, Cadranel 2006, Dal Maso 2009). Overall risk seems to rise as immunodeficiency increases (Guiguet 2009, Reekie 2011). In our own retrospective study of 72 patients developing lung cancer during the last decade, most cases occurred in the setting of limited immune deficiency and a long-lasting sufficient viral suppression (Hoffmann 2011). This increase can partly be explained by simple reasons: first, HIV+ patients live longer and have more time to develop lung cancer and second, HIV+ patients smoke more than non-infected patients. In some HIV outpatient clinics, up to 60–70% of the patients are smokers. Smoking remains the main risk factor for developing lung cancer (Hoffmann 2011, Clifford 2012). Thus, one should discuss the issue of smoking: “It’s time to quit” – there are possibilities to cease smoking (Niaura 2000). Apart from age and nicotine abuse, other factors also seem determine an increased risk (Kirk 2007, Chaturvedi 2007). This is underlined by the fact that the most fre- quent subtype found in HIV+ patients, adenocarcinoma, is the subtype that is least associated with nicotine consumption (Cadranel 2006). Because often immune defi- ciency is not present, other factors, such as specific lung infections and a resulting scarring, are assumed, but also increased proinflammatory cytokines in the lungs or reduced glutathione levels are found frequently in HIV+ individuals. These factors can worsen the damage caused by smoking. Generally, HIV+ patients seem to be more sensitive towards carcinogenesis (Engels 2006, Kirk 2007, Chaturvedi 2007). In the US veterans cohort, an increased risk for HIV+ patients remained significant, even after adjusting for smoking, age, ethnicity and COPD (Sigel 2010). There is also some evidence for a genetic predisposition (Engsig 2011). From a diagnostic-therapeutic view, patients always stand a better chance when the lung cancer has been diagnosed early. Symptoms are unspecific and when they present, it is often too late. In the case of HIV+ patients, diagnosis is seldom early enough. In our own cohort of 72 cases of lung cancer diagnosed 2000-2010, only 34% of the patients were in stages I-IIIa which are considered to be curable (Hoffmann 2011). Patients in early tumor stages should undergo surgery with curative intention since chemotherapy only suspends further progression for a few months (Cadranel 2006, Lavolé 2009). In our own cohort, median estimated overall survival (OS) was 450 AIDS 1. Clinical stage was highly predictive and long-term OS could only be achieved in very limited disease stages (Hoffmann 2011). If chemotherapy is indicated, patients with non-small cell lung carcinoma (NSCLC) in otherwise good condition should receive standard therapy beginning with cis- or carboplatin plus either taxane (paclitaxel), gemcitabine or navelbine. Carboplatin/ gemcitabine seem to be tolerated well (Bridges 2008). A second choice is pemetrexed or erlotinib, an inhibitor of epidermal growth factor receptor (EGFR) kinase. Preliminary data suggest an EGFR mutation status similar to that of the general pop- ulation (Okuma 2015). A large study recently found no significant difference in clinical outcome between HIV+ patients and uninfected controls with lung cancer. Survival after curative sur- gical resection in early-stage patients was similar. Thus, HIV status should not affect therapeutic decision making in lung cancer (Rengan 2012). HIV doctors should talk with and convince the oncologist not to expect the worst just because HIV-infection is involved and that HIV is not a contraindication for any drug. If general condition is poor, however, a well-tolerated combination of gemcitabine and navelbine can be given, which has been known to stop progression for a short time. References Alfa-Wali M, Allen-Mersh T, Antoniou A, et al. Chemoradiotherapy for anal cancer in HIV patients causes pro- longed CD4 cell count suppression. Colorectal cancer in HIV positive individuals: the immunological effects of treatment. A randomized, placebo-controlled, dose-escalation study to determine the safety, tolerability, and immunogenicity of an HPV-16 therapeutic vaccine in HIV-positive participants with onco- genic HPV infection of the anus. Risk factors for anal cancer in persons infected with HIV: a nested case- control study in the Swiss HIV Cohort Study. Screening colonoscopy for the detection of neoplastic lesions in asymptomatic HIV- infected subjects. Blazy A, Hennequin C, Gornet JM, Furco A, Gerard L, Lemann M, Maylin C. Anal carcinomas in HIV-positive patients: high-dose chemoradiotherapy is feasible in the era of HAART. High Rates of Endoscopic Findings and Histologic Abnormalities in Routine Colonoscopy of HIV Patients: German HIV Cohort. Changes in cancer mortality among HIV-infected patients: the Mortalité 2005 Survey. Phase II trial of gemcitabine/carboplatin followed by paclitaxel in patients with performance status=2,3 or other significant co-morbidity (HIV infection or s/p organ transplantation) in advanced non-small cell lung cancer. Lung Cancer 2008; 61:61-6 Bruyand M, Ryom L, Shepherd L, et al. Cancer risk and use of protease inhibitor or nonnucleoside reverse tran- scriptase inhibitor-based combination antiretroviral therapy: the D: A: D study. Cadranel J, Garfield D, Lavole A, Wislez M, Milleron B, Mayaud C. Lung cancer in HIV infected patients: facts, questions and challenges. Human immunodeficiency virus-associated adenocarci- noma of the colon: clinicopathologic findings and outcome. Chaturvedi AK, Pfeiffer RM, Chang L, Goedert JJ, Biggar RJ, Engels EA. Elevated risk of lung cancer among people with AIDS. HIV-associated squamous cell cancer of the anus: epidemiol- ogy and outcomes in the highly active antiretroviral therapy era. The impact of HIV viral control on the incidence of HIV-asso- ciated anal cancer. Lung cancer in the Swiss HIV Cohort Study: role of smoking, immun- odeficiency and pulmonary infection.
For trials including both types purchase penegra 50mg on-line prostate 90 diet, the data was not separately reported so comparisons could not be made trusted penegra 100mg prostate cancer outside the prostate. Hormone therapy Page 43 of 110 Final Report Update 3 Drug Effectiveness Review Project Table 9 50mg penegra overnight delivery prostate cancer karyotype. Placebo controlled trials with bone density outcomes (new for Update #3) Study Design; Study/year Number; Population (quality) Duration characteristics Interventions Main outcomes/results Oral estrogens Conjugated equine estrogen Reid, 2004 Double-blind Postmenopausal; CEE 0. Femoral neck: No change from baseline in placebo group. Trend for increased BMD in E2 or E2 + MPA groups, but not significant All 3 progestin treatments were similar to placebo Hormone therapy Page 44 of 110 Final Report Update 3 Drug Effectiveness Review Project Study Design; Study/year Number; Population (quality) Duration characteristics Interventions Main outcomes/results Warming, Double-blind; Postmenopausal; E2 1 mg + 1mg Difference between HRT and placebo after 2 years: 2004 N=240; 0/240 drospirenone, Spine: 7% (p<0. At 36 months, combination therapy had a significantly greater increase in total hip BMD than those on either ALN or HRT alone (p<. Conjugated synthetic estrogen combination Lindsay, Double-blind Postmenopausal Conjugated estrogens % of patients who did not lose >2% of spine BMD at 2005 Multicenter; Mean age 51. Placebo: 30%; 27% who did not lose >2% in 12 months lost >2% at 24 months. Transdermal estrogens Estradiol patch Ettinger, 2004 Double-blind Postmenopausal; estradiol patch releasing Lumbar spine BMD: Increased 2. N=417; Mean 67 ±5 years; (replaced once/week) Between group difference at 2 years: 2. Hormone therapy Page 45 of 110 Final Report Update 3 Drug Effectiveness Review Project Study Design; Study/year Number; Population (quality) Duration characteristics Interventions Main outcomes/results Estradiol patch/levonorgestrel Warming, Double-blind Postmenopausal, 45 micrograms estradiol Difference in BMD, HRT vs. One trial did not report treatment and placebo group differences, but stated that forearm bone density in the treatment group was statistically 125 significantly increased from baseline while the placebo group showed no change. Another trial reported a trend in E2 groups towards increased bone density, however statistical 126 significance was not reached for between group comparisons. All 15 trials of transdermal E2 reported statistically significant improvements in bone 127-139 density compared to placebo. Only three trials did not use concomitant 129, 134, 138, 140, 141 progestin/progesterone. Five trials of E2V with concomitant progestin/progesterone reported bone density 111, 142-145 outcomes. Four of the five trials noted improvement in treatment groups compared to 111, 142-144 145 placebo, and one did not. All trials reported significant within-group changes in bone density at multiple sites for various doses with higher doses showing greater changes. In a good-quality trial comparing combination treatment with CEE (with or without medroxyprogesterone) plus alendronate to either treatment alone, patients on combination therapy had a significantly greater increase in total hip BMD than those 170, 171 151 on either ALN or HRT alone after 3 years (p<. A more recent substudy of the Women’s HOPE trial found that most women on lower doses of CE with or without medroxyprogesterone (0. Similar improvements were found in the lumbar spine. In subjects with 6-year follow-up BMD data (n=443), the percentage increase in lumbar spine BMD was 7. The CEE-only study of the WHI produced modest but consistent positive effects on bone 173 mineral density. Hormone therapy Page 46 of 110 Final Report Update 3 Drug Effectiveness Review Project 174 One study of esterified estrogen examined dosages of 0. Effect of discontinuation of estrogen on bone density Two studies reported the effect on bone density after discontinuing the use of estrogen to determine if bone density gains were sustained after discontinuation, or if there was evidence that bone loss was accelerated in women who had used estrogen therapy when compared with 175, 176 those who had not used it. Both studies found the rate of bone loss after stopping estrogen was similar to that of women who did not receive estrogen treatment, as described below. Further bone density gains were not observed in women after discontinuation of estrogen therapy, but there was also no evidence of accelerated bone loss when compared with those who had taken placebo. The second study reported the effect on bone mineral density of discontinuation of estrogen therapy for one year after 5 years of treatment in women enrolled in a randomized placebo-controlled trial of raloxifene and estrogen for 176 prevention of postmenopausal bone loss. This study also found that changes in bone density after one year of discontinuation were not significantly different in women using CEE compared with women randomized to placebo. Comparison with other meta-analyses A Cochrane review and meta-analysis published in 2002 on estrogen and bone density 7 and fractures was reviewed for this report. Fifteen of the trials included in the Cochrane review did not meet inclusion criteria for this review because they used ineligible estrogen 177-191 preparations. Results of the Cochrane meta-analysis included: • The pooled percent change in bone density was statistically significantly increased with estrogen compared to placebo at all measurement sites when combining results for all prevention and treatment trials and for both opposed and unopposed regimens. Hormone therapy Page 47 of 110 Final Report Update 3 Drug Effectiveness Review Project o For high-dose estrogen (equivalent to 0. For the lumbar spine, the differences between estrogen and placebo groups were: o 5. This study was restricted to placebo-controlled trials of at least 2 year’s duration and enrollment of at least 60 subjects. Although the study did not report a systematic assessment of the quality of the trials selected for review, the number of dropouts in each trial and use of intention-to-treat results were assessed. The 2-year mean changes in lumbar spine BMD (weighted for the ratio of sample size/dropouts) are summarized as follows: o 7. Fractures Head-to-head comparisons No head-to-head trials were found. Placebo comparisons We identified 11 studies of estrogen that included outcome data on fractures (Evidence 128, 135, 144, 155, 156, 168, 193 7 Table 6). Seven were included in a recent Cochrane meta-analysis, and 4, 117, 149, 194 the remainder were more recently published. Only one study of oral E2 evaluated fracture outcomes and found a statistically significant risk reduction for forearm fractures (RR=0. Both studies of transdermal E2 indicated no 128, 135 128 significant improvement in vertebral and non-vertebral fractures. One trial of E2V in early postmenopausal women reported a significant decrease in nonvertebral (RR=0. Although some of these studies showed a trend toward reduction of fractures at various sites in the treatment groups, only 4 the WHI showed a significant result. When compared with the placebo group, total fractures for 4 women on CEE were significantly reduced (HR=0. Risks were also reduced for site-specific fractures of the hip and vertebra, although confidence intervals adjusted for multiple comparisons included 1. This effect did not differ in women stratified by age, body mass index, smoking status, history of falls, personal and family history of fracture, total calcium intake, past use of hormone therapy, bone density, or summary fracture risk score. Hip fractures and clinical vertebral fractures were also decreased, although 95% confidence intervals adjusted for multiple comparisons overlapped a HR of 1. Additional data on fractures recorded 173 through the study termination (average 7. These positive effects occurred largely irrespective of baseline risk factors for osteoporosis or fracture. The global index of overall health risks and benefits was balanced, however, with no evidence of overall benefit or risk noted even for women in the highest tertile of risk for fracture. Comparison with Cochrane meta-analysis 128, 135, 144, 155, 156, 168, 193 Seven studies reporting fracture outcomes were included in a 7 Cochrane review published in 2002.
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