Valid Treatment Options for Osteoporosis and Osteopenia in HIV-Infected Persons

2008 ◽  
Vol 42 (5) ◽  
pp. 670-679 ◽  
Author(s):  
Patrick G Clay ◽  
Laura E Voss ◽  
Charlott Williams ◽  
Eric C Daume
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Calcium Supplementation ◽  
Data Extraction ◽  
Treatment Options ◽  
Relevant Information ◽  
Mineral Density ◽  
Safety And Efficacy ◽  
Additional Information ◽  
Study Selection

Objective: To review clinical data on bone ossification agents that may be considered for use in the treatment of osteoporosis and osteopenia in HIV-infected patients. Data Sources: A literature search was performed using MEDLINE (1950-January 2008), EMBASE, PubMed, and abstracts from major HIV conferences (February 2001-October 2007). These searches were limited to human data published in English and used the key words bisphosphonates, calcitonin, raloxifene. teriparatide, HAART, osteopenia, osteoporosis, and HIV/AIDS. Additional articles were retrieved from citations of selected references. Study Selection and Data Extraction: Relevant information on the pharmacology, pharmacokinetics, safety, and efficacy of available treatment with hormonal and nonhormonal agents was selected. Greater emphasis was placed on randomized clinical trials than on retrospective studies. Data Synthesis: Osteoporosis in HIV-infected persons is at least as prevalent as in postmenopausal women, yet this population is not listed in primary care guidelines as one that should be considered for screening. In addition to bisphosphonates, calcitonin, raloxifene, and teriparatide are used to treat bone disorders. Three clinical trials to date have evaluated the use of a bisphosphonate in HIV-infected persons. The trials showed a marked increase in bone mineral density in patients taking alendronate versus those in the control groups (with/without calcium, exercise, and/or vitamin D in 1 or both arms). Dosing restrictions complicate the use of these agents; diet, exercise, and calcium supplementation remain the foremost recommended strategies to prevent bone loss. The use of estrogen, testosterone, calcitonin, and teriparatide is less studied in HIV-positive patients, but may be considered in select cases. There are some investigational drugs and agents not available in the US; however, there are not enough data to support their use. Conclusions: Alendronate appears to be a promising treatment option for HIV-infected patients with osteoporosis and osteopenia. Further research is required to determine the safety and efficacy of other available drugs. Until additional information is provided, and with available knowledge on the metabolism profiles of antiretroviral and bone ossification agents, alendronate appears to be the preferred agent to use in this population.

scholarly journals The Efficacy of Retention Appliances after Fixed Orthodontic Treatment: A Systematic Review and Meta-Analysis

2020 ◽  
Vol 10 (9) ◽  
pp. 3107 ◽  
Author(s):  
Antonino Lo Giudice ◽  
Gaetano Isola ◽  
Lorenzo Rustico ◽  
Vincenzo Ronsivalle ◽  
Marco Portelli ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Orthodontic Treatment ◽  
Randomized Clinical Trials ◽  
Data Extraction ◽  
Meta Analysis ◽  
Mean Difference ◽  
Anterior Crowding ◽  
Study Selection ◽  
Statistical Heterogeneity ◽  
Fixed Retainers

The purpose of this article is to evaluate the amount of the relapse of anterior crowding and the efficacy of retention appliances by reviewing the best available scientific evidence. A survey of articles published up to November 2019 about the stability of dental alignment and retention after fixed orthodontic treatment was performed using seven electronic databases. Study Selection: Only randomized clinical trials investigating patients previously treated with multi-bracket appliances with a follow-up period longer than 6 months were included. Data Extraction: Two authors independently performed the study selection, data extraction, and risk of bias assessment. All pooled data analyses were performed using a random-effects model. Statistical heterogeneity was evaluated. In total, eight randomized clinical trials (RCTs) were included, grouping data from 987 patients. The ages of the patients varied across the studies, ranging between 13 and 17 years. The observation period ranged between 6 and 24 months. The data showed no significant intercanine width modifications during the retention period with both fixed and removable retainers. A significant modification of Little’s Index was found for the mandibular removable retainers with a mean difference of 0.72 mm (95% Cl, 0.47 to 0.98) and for the maxillary removable retainers with a mean difference of 0.48 mm (95% Cl, 0.27 to 0.68). No significant changes were found by evaluating Little’s Index modification for the mandibular fixed retainers. The results of this meta-analysis showed that all the considered retainers were effective in maintaining dental alignment after fixed orthodontic treatment. However, fixed retainers showed greater efficacy compared to removable retainers.

Glecaprevir/Pibrentasvir: The First 8-Week, Pangenotypic HCV Treatment Regimen for Patients 12 Years of Age and Older

2019 ◽  
Vol 54 (3) ◽  
pp. 262-276
Author(s):  
Jamie Huff ◽  
Rebecca Andersen
Keyword(s):  
Clinical Trials ◽  
Hepatitis C ◽  
English Language ◽  
Data Extraction ◽  
Treatment Options ◽  
Safety Data ◽  
Hcv Treatment ◽  
Cost Information ◽  
Additional Information ◽  
Compensated Cirrhosis

Objective: To review the pharmacology, pharmacokinetics, efficacy, safety, dosing, and cost information of glecaprevir/pibrentasvir in the treatment of hepatitis C virus (HCV). Data Sources: A literature search was conducted between September 2018 and July 2019 using PubMed and Google Scholar with the search terms glecaprevir, pibrentasvir, Mavyret, Maviret, and hepatitis C. Clinicaltrials.gov was searched using the same terms. References of published articles were assessed for additional information. Study Selection and Data Extraction: English-language preclinical and clinical studies on the chemistry, pharmacology, pharmacokinetics, safety, and efficacy of glecaprevir/pibrentasvir were evaluated. Data Synthesis: Food and Drug Administration–approved glecaprevir/pibrentasvir is considered both safe and efficacious for the treatment of HCV genotypes 1 to 6 and in several patient populations, such as those with treatment-naïve or treatment-experienced HCV; with or without compensated cirrhosis, HIV-1 coinfection, or renal impairment; post–liver or post–kidney transplant; and ≥12 years of age. Sustained virological response rates ranged from 83% to 100% in clinical trials, and safety outcomes appear similar to other guideline-recommended HCV treatment options. Relevance to Patient Care and Clinical Practice: This review discusses the pharmacological, efficacy, and safety data found in glecaprevir/pibrentasvir clinical trials and relates this to guideline recommendations and the practical use of this medication for treatment of HCV. Conclusions: With HCV infection rates remaining elevated, it is important to have safe and efficacious treatment options. Glecaprevir/pibrentasvir is a safe and efficacious guideline-recommended, 8-week treatment for HCV in several patient populations, with these populations likely growing in the near future given ongoing and future studies.

Flibanserin

2016 ◽  
Vol 30 (2) ◽  
pp. 256-260 ◽  
Author(s):  
Ximena Vallejos ◽  
Christine Wu
Keyword(s):  
Clinical Trials ◽  
Sexual Desire ◽  
English Language ◽  
Human Subjects ◽  
Data Extraction ◽  
Premenopausal Women ◽  
Relevant Information ◽  
Time Frame ◽  
Double Blind ◽  
Study Selection

Objective: To review pivotal clinical trials, pharmacology, contraindications, precautions, and key patient education points of flibanserin for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. Data Sources: A literature search of PubMed using the key words flibanserin and HSDD was conducted in September 2015. There was no time frame to exclude relevant clinical trials. All trials referenced were published between March 2012 and June 2014. Other relevant information was obtained from the Food and Drug Administration (FDA) Web site, press releases, prescribing information from the manufacturer, and ClinicalTrials.gov . Study Selection/Data Extraction: All articles in the English language and involving human subjects were reviewed. Data Synthesis: There are three 24-week, multicenter, randomized, double-blind, placebo-controlled trials that evaluated the efficacy of flibanserin in North American premenopausal women with HSDD. There was 1 trial that studied the effects of flibanserin in postmenopausal women. In all of the trials, the investigators found statistical significant improvements in Female Sexual Function Index (FSFI) desire domain score and satisfying sexual events (SSEs). The most frequently reported adverse events in all flibanserin arms of treatment were somnolence, dizziness, and nausea. Conclusion: Flibanserin, a novel, nonhormonal agent that modulates excitatory and inhibitory neurotransmitters was studied in premenopausal women and has shown efficacy in improving sexual desire and SSEs.

Romosozumab: A Novel Injectable Sclerostin Inhibitor With Anabolic and Antiresorptive Effects for Osteoporosis

2020 ◽  
pp. 106002802095276
Author(s):  
Kimberly Lovin Nealy ◽  
Kira B. Harris
Keyword(s):  
Clinical Trials ◽  
Lumbar Spine ◽  
Data Extraction ◽  
Osteoporotic Fractures ◽  
Mineral Density ◽  
High Fracture ◽  
Study Selection ◽  
Humanized Monoclonal Antibody ◽  
Monthly Injection ◽  
Meta Analyses

Objective: To review the clinical pharmacology, efficacy, and safety of romosozumab, a humanized monoclonal antibody with a novel mechanism of action for monthly injection, and its place in the management of osteoporosis. Data Sources: PubMed, MEDLINE, and ClinicalTrials.gov searches (1966 to July 2020) were conducted using the keywords romosozumab and osteoporosis. Study Selection and Data Extraction: Published phase 2 and 3 clinical trials and 2 meta-analyses in patients with osteoporosis were included. Data Synthesis: Romosozumab increased bone mineral density (BMD) at the lumbar spine (12.1%-13.3%), femoral neck (2.2%-5.9%), and total hip (2.5%-6.9%) in patients with osteoporosis. After 12 months, romosozumab provided greater BMD gains at the lumbar spine and hip than teriparatide. However, teriparatide is likely to further increase BMD if continued for up to 24 months. In postmenopausal women at a high fracture risk, 1 year of romosozumab followed by 1 year of alendronate resulted in lower vertebral, nonvertebral, clinical, and hip fractures than alendronate alone for 2 years. Although absolute event rates were low, serious cardiovascular and cerebrovascular events were numerically higher in 2 clinical trials when compared with alendronate (2.5% vs 1.9%, respectively) and placebo (4.9% vs 2.5%, respectively). Relevance to Patient Care and Clinical Practice: This review discusses the place in therapy for romosozumab in osteoporosis management as a novel agent. Conclusions: Romosozumab offers an alternative for patients with a high risk of osteoporotic fractures. Clinicians should avoid romosozumab in patients with a history of myocardial infarction or stroke in the past 12 months.

Recent Advances: Antiinfectives

1995 ◽  
Vol 29 (10) ◽  
pp. 1035-1040 ◽  
Author(s):  
Laurie L Briceland ◽  
John D Cleary ◽  
Courtney V Fletcher ◽  
Daniel P Healy ◽  
Charles A Peloquin
Keyword(s):  
Infectious Diseases ◽  
English Language ◽  
Data Extraction ◽  
Information Service ◽  
Ulcer Disease ◽  
Additional Information ◽  
Study Selection ◽  
Enterococcus Spp ◽  
Scientific Meetings ◽  
Clinically Significant

Objective: To update readers on the significant changes in infectious diseases pharmacotherapy. Data Sources: An Index Medians and Iowa Drug Information Service search (1993–1994) of English-language literature pertaining to the selected topic areas was performed. Additional information from abstracts presented at scientific meetings were identified by the authors. Study Selection and Data Extraction: All identified studies were screened and those judged relevant to the update were evaluated. Data Synthesis: New or clinically significant data since 1992 that related to peptic ulcer disease, microbial resistance (e.g., Enterococcus spp., Streptococcus pneumoniae, Mycobacterium tuberculosis, Candida albicans), immunomodulators, and AIDS were evaluated and compared with previous data. Conclusions: There have been several exciting and significant changes in infectious diseases pharmacotherapy evident from this review.

Treatment Options for Rheumatoid Arthritis: Celecoxib, Leflunomide, Etanercept, and Infliximab

2000 ◽  
Vol 34 (6) ◽  
pp. 743-760 ◽  
Author(s):  
Brigitte T Luong ◽  
Barbara S Chong ◽  
Dionne M Lowder
Keyword(s):  
Rheumatoid Arthritis ◽  
English Language ◽  
Data Extraction ◽  
Treatment Options ◽  
Nonsteroidal Antiinflammatory Drugs ◽  
Antiinflammatory Drugs ◽  
Safety And Efficacy ◽  
Medline Search ◽  
Pertinent Data

OBJECTIVE: To review new pharmacologic agents approved for use in the management of rheumatoid arthritis (RA). DATA SOURCES: A MEDLINE search (1966–January 2000) was conducted to identify English-language literature available on the pharmacotherapy of RA, focusing on celecoxib, leflunomide, etanercept, and infliximab. These articles, relevant abstracts, and data provided by the manufacturers were used to collect pertinent data. STUDY SELECTION: All controlled and uncontrolled trials were reviewed. DATA EXTRACTION: Agents were reviewed with regard to mechanism of action, efficacy, drug interactions, pharmacokinetics, dosing, precautions/contraindications, adverse effects, and cost. DATA SYNTHESIS: Traditional pharmacologic treatments for RA have been limited by toxicity, loss of efficacy, or both. Increasing discoveries into the mechanisms of inflammation in RA have led to the development of new agents in hopes of addressing these limitations. With the development of celecoxib, a selective cyclooxygenase-2 inhibitor, the potential exists to minimize the gastrotoxicity associated with nonsteroidal antiinflammatory drugs. Leflunomide has been shown to be equal to or less efficacious than methotrexate, and may be beneficial as a second-line disease-modifying antirheumatic drug (DMARD). The biologic response modifiers, etanercept and infliximab, are alternatives that have shown benefit alone or in combination with methotrexate. However, they should be reserved for patients who fail to respond to DMARD therapy. Further studies should be conducted to evaluate the long-term safety and efficacy of these agents as well as their role in combination therapy. CONCLUSIONS: Celecoxib, leflunomide, etanercept, and infliximab are the newest agents approved for RA. Clinical trials have shown that these agents are beneficial in the treatment of RA; however, long-term safety and efficacy data are lacking.

Abstract P476: Safety and Efficacy of Balloon Mounted Drug-Eluting Stent in the Treatment of Symptomatic Intracranial Atherosclerotic Disease Multicenter International Experience

Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Mahmoud Mohammaden ◽  
Raul G Nogueira ◽  
WONDWOSSEN TEKLE ◽  
farhan siddiq ◽  
Diogo C Haussen ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Endovascular Treatment ◽  
Medical Management ◽  
Randomized Clinical Trials ◽  
Atherosclerotic Disease ◽  
Drug Eluting Stent ◽  
Safety And Efficacy ◽  
Intracranial Atherosclerotic Disease ◽  
Drug Eluting

Introduction: Intracranial atherosclerotic disease (ICAD) is a common cause of refractory stroke. Randomized clinical trials failed to prove the safety and efficacy of the endovascular treatment options of symptomatic ICAD (sICAD). However, there are many concerns regarding inclusion criteria in these trials which made them less effective than standard medical management. Herein, we aim to study the safety and efficacy of drug-eluting balloon mounted stents (DES) in the treatment of sICAD. Methods: A retrospective review of endovascular database from 10 comprehensive stroke centers inside and outside the USA from January 2017 to January 2020 was reviewed. Patients were included if they had symptomatic intracranial stenosis ≥70% in the target vessel, failed best medical management, and underwent intracranial stenting with DES. The primary outcome was the occurrence of ischemic stroke, hemorrhage, or mortality within 72 hours of the procedure. Secondary outcomes included rates of symptomatic and angiographic recurrence within 6 months of the procedure. Results: There was a total of 129 patients, the median age was 65 [58-72] years, 40 (31%) were females. The intracranial stenotic lesions were located in anterior circulation in 74 (57.4%) of cases [24 (18.6%) supraclinoid ICA, 5 (3.9%) cavernous ICA, 17 (13.2%) petrous ICA, 5 (19.4%) MCA-M1, and 3 (2.3%) M2] and in posterior circulation in 55 (42.6%) of cases [36 (27.9) vertebral artery V4 segment, 18 (14%) basilar and 1 (0.7%) PCA]. Recurrent stroke was the qualifying event in 101 (78.3%) while transient ischemic attacks (TIA) were identified in 28 (21.7%) of cases. The median time from the qualifying event to stenting was 6 [2-24] days. Strokes were reported within 72 hours of the procedure; 2 (1.6%) ischemic, 2 (1.6%) hemorrhagic strokes and 2 (1.6%) patients suffered inpatient mortality. The median follow-up time was 6 [3-6.75] months. Among 99 patients who had clinical follow up 2 (2%) had TIA and 6 (6.1%) had strokes. Fifty-one patients had follow-up imaging of whom symptomatic ISR was reported in 8 (15.7%). Conclusion: Our study has shown that in appropriately selected patients with sICAD, endovascular treatment using DES is safe and effective. Prospective randomized clinical trials are warranted.

scholarly journals Countermeasures to Coronavirus Disease 2019: Are Immunomodulators Rational Treatment Options—A Critical Review of the Evidence

2020 ◽  
Vol 7 (7) ◽  
Author(s):  
Daniel B Chastain ◽  
Tia M Stitt ◽  
Phong T Ly ◽  
Andrés F Henao-Martínez ◽  
Carlos Franco-Paredes ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Acute Respiratory Distress Syndrome ◽  
Respiratory Failure ◽  
Distress Syndrome ◽  
Treatment Options ◽  
Immune Dysregulation ◽  
Lung Damage ◽  
Safety And Efficacy ◽  
Rational Treatment ◽  
Immunomodulatory Therapies

Abstract Severe acute respiratory syndrome coronavirus 2 is associated with higher concentrations of proinflammatory cytokines that lead to lung damage, respiratory failure, and resultant increased mortality. Immunomodulatory therapy has the potential to inhibit cytokines and quell the immune dysregulation. Controversial data found improved oxygenation after treatment with tocilizumab, an interleukin-6 inhibitor, sparking a wave of interest and resultant clinical trials evaluating immunomodulatory therapies. The purpose of this article is to assess potential proinflammatory targets and review the safety and efficacy of immunomodulatory therapies in managing patients with acute respiratory distress syndrome associated with coronavirus disease 2019.

scholarly journals Effects of Composite Attachments on Orthodontic Clear Aligners Therapy: A Systematic Review

Materials ◽  
2022 ◽  
Vol 15 (2) ◽  
pp. 533
Author(s):  
Riccardo Nucera ◽  
Carolina Dolci ◽  
Angela Mirea Bellocchio ◽  
Stefania Costa ◽  
Serena Barbera ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Data Extraction ◽  
Risk Of Bias ◽  
Bias Assessment ◽  
Bodily Movement ◽  
Study Selection ◽  
Medium Risk ◽  
Clear Aligner ◽  
Anterior Root

This systematic review aims to highlight the differences between different clear aligner therapies that differ in the presence of attachments or in attachment configuration. Eight electronic databases were searched up to March 2020. Two authors independently proceeded to study selection, data extraction, and risk of bias assessment. The analysis of the results was carried out examining six groups of movements (mesio-distal tipping/bodily movement; anterior bucco-lingual tipping/root torque; posterior bucco-lingual tipping/expansion; intrusion; extrusion; rotation). Five clinical trials were selected and all of them showed a medium risk of bias. Literature showed that attachments mostly increase the effectiveness of orthodontic treatment with clear aligners, improving anterior root torque, rotation, and mesio-distal (M-D) movement; they are also important to increase posterior anchorage. However, some articles showed contradictory or not statistically significant results. Attachments also seem to improve intrusion, but the evidence about this movement, as well as extrusion, is lacking. No studies evaluated posterior bucco-lingual tipping/expansion. Further clinical trials are strongly suggested to clarify the influence of attachments and their number, size, shape, and position on each orthodontic movement.

Asthma: Anti-Immunoglobulin E Therapy with Omalizumab for Asthma

2007 ◽  
Vol 41 (9) ◽  
pp. 1397-1410 ◽  
Author(s):  
Leslie Hendeles ◽  
Christine A Sorkness
Keyword(s):  
Clinical Trials ◽  
Cost Effectiveness ◽  
Randomized Clinical Trials ◽  
Inhaled Corticosteroids ◽  
Immunoglobulin E ◽  
Data Extraction ◽  
Symptom Control ◽  
High Dose ◽  
Search Term ◽  
Ige Mediated

Objective: To evaluate data on anti-immunoglobulin E (anti-IgE) therapy for asthma. Data Sources: Information was selected from PubMed from 1989 to May 2007 using the search term omalizumab and included randomized, controlled trials. These studies evaluated asthma treatment with omalizumab and focused on its efficacy, tolerability, and cost-effectiveness in this population. Study Selection and Data Extraction: All randomized clinical trials were reviewed (23 were identified and 19 were included; 3 were not relevant and 1 contained duplicative data). Other articles using the search words anti-IgE therapy and cost-effectiveness were evaluated; relevant information was extracted. Data Synthesis: IgE-dependent mechanisms play an important role in the development and maintenance of airway inflammation in asthma. Omalizumab is a subcutaneously administered monoclonal anti-IgE antibody that reduces unbound IgE concentrations and promotes down-regulation of IgE receptors. Results from clinical trials in adults, adolescents, and children with poorly controlled IgE-mediated asthma have shown that omalizumab improves symptom control and allows patients to be managed with lower doses of inhaled corticosteroids (ICS). It has been well tolerated in clinical trials lasting as long as 52 weeks, but injection-site reactions are common (45% in omalizumab group vs 43% in placebo group) and anaphylaxis has occurred in 0.2% of patients. A consensus expert panel has recommended that omalizumab should be considered for patients 12 years of age or older with allergic asthma who are inadequately controlled on guideline-based therapy and require maintenance therapy with systemic corticosteroids or high-dose ICSs, or who have poor adherence to ICS therapy. Conclusions: Anti-IgE therapy provides an effective and generally safe approach to the treatment of patients with IgE-mediated asthma who are not adequately controlled by conventional guideline-based medications. However, the potential benefit must be weighed against the cost and inconvenience of this new therapy.

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