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Biomedical subjects

Denise R Kockler

Publications and source records attributed to Denise R Kockler.

10 recordsLinked to original sources
PubMed2006

Topiramate for binge-eating disorder associated with obesity.

OBJECTIVE: To review the use of topiramate for the treatment of binge-eating disorder (BED) associated with obesity. DATA SOURCES: MEDLINE (1966-July 2006) and the Cochrane Database (2006, issue 3) were used to conduct an English-language literature search. Key search terms included eating disorder, binge-eating, and topiramate. Bibliographies of identified articles were examined for additional references. DATA SYNTHESIS: BED is characterized by excessive food intake with lack of control during eating episodes, but without subsequent compensatory weight loss mechanisms, and is often associated with obesity and psychiatric disorders. Evidence suggests that topiramate may have mood-stabilizing properties and cause decreased appetite and weight. One case series, 1 case report, 2 open-label studies, and 1 placebo-controlled trial have described the use of topiramate for BED associated with obesity. Doses ranging from 50 to 1400 mg/day were stated to be effective in these reports. Adverse reactions included paresthesias, cognitive impairment, somnolence, and gastrointestinal distress. Although these adverse effects were transient, they may interfere with patients' tolerability of topiramate therapy. CONCLUSIONS: Albeit limited, evidence suggests that topiramate may be a viable short- and long-term treatment alternative for BED associated with obesity for patients with limited options. Further controlled trials are necessary to establish topiramate's place in therapy, optimal dosing, and length of treatment for this eating disorder.

Anti-Obesity Agents↗
PubMed2006

Human papillomavirus vaccines.

OBJECTIVE: To review the pharmacology, efficacy, safety, tolerability, and pharmacoeconomics of Cervarix and Gardasil, 2 human papillomavirus (HPV) vaccines. DATA SOURCES: English-language articles were obtained by MEDLINE search (1966-February 2006) using the key words human papillomavirus vaccine, Cervarix, and Gardasil. Bibliographies of selected articles were used to identify additional sources. STUDY SELECTION AND DATA EXTRACTION: All available published articles or abstracts reporting the results of human studies of HPV vaccines were reviewed for inclusion in this article. Additional information about ongoing clinical trials was obtained from manufacturers' Web sites. DATA SYNTHESIS: Cervarix and Gardasil are recombinant vaccines against HPV. Cervarix targets HPV-16 and -18, which are responsible for 70% of cervical cancers. Gardasil also targets HPV-16 and -18, plus the HPV-6 and -11 types responsible for more than 80% of genital warts. Both vaccines have been effective in preventing persistent infection with targeted HPV types and in preventing cervical intraepithelial lesions, while Gardasil has also been effective in preventing vulvar and vaginal neoplasia and genital warts. Both vaccines have been well tolerated, with the most common adverse effects occurring at the injection site. Phase III trials are ongoing to further evaluate vaccine efficacy. CONCLUSIONS: Cervarix and Gardasil are effective for prevention of HPV infection and cervical lesions. Issues remaining to be addressed include duration of protection, efficacy for prevention of cervical cancer, optimal age for vaccination, feasibility of application to the developing world, the ideal combination of HPV subtypes, and the most efficient combination of vaccination and cervical cancer screening.

Clinical Trials as Topic↗
PubMed2006

Fondaparinux for thromboembolic treatment and prophylaxis of heparin-induced thrombocytopenia.

OBJECTIVE: To review literature evaluating the use of fondaparinux for thromboembolic treatment and prophylaxis in patients with heparin-induced thrombocytopenia (HIT). DATA SOURCES: A MEDLINE search (1966-February 2006) was conducted using the search terms fondaparinux, heparin, low-molecular-weight heparin, and thrombocytopenia to identify English-language articles. Additional sources were identified from bibliographies of select articles and the manufacturer. DATA SYNTHESIS: Fondaparinux, a pentasaccharide that selectively inhibits factor Xa, has been reported to have negligible or no cross-reactivity in vitro with HIT antibodies. Thromboembolic treatment and prophylaxis with fondaparinux in patients with HIT has been described. Three cases reported patients who were successfully treated for thromboembolic events with fondaparinux after developing HIT during therapy with unfractionated heparin (UFH) or low-molecular-weight heparin (LMWH). Another report showed positive outcomes using fondaparinux for prophylaxis in a patient who had previously developed HIT after receiving UFH. Moreover, 2 case series, one using fondaparinux for prophylaxis in patients with a previous diagnosis of HIT and the other using fondaparinux for treatment in patients who developed HIT while receiving UFH or LMWH, reported normal platelet counts during fondaparinux treatment. Finally, results of a retrospective review demonstrated that fondaparinux prevented thromboembolic events or recurrent thrombocytopenia in patients with a prior HIT diagnosis. CONCLUSIONS: Limited data support the use of fondaparinux for thromboembolic treatment or prophylaxis in patients with antibody assay-confirmed HIT who do not have a contraindication for fondaparinux use. Randomized controlled trials have not been published; therefore, questions remain regarding efficacy, safety, optimal doses, treatment duration, and incidence of thromboembolic events when fondaparinux is used in this setting. Prospective trials evaluating the efficacy and safety of fondaparinux in this patient population need to be conducted to answer these questions.

Anticoagulants↗
PubMed2006

Mycophenolate mofetil treatment of myasthenia gravis.

OBJECTIVE: To review published literature evaluating the effectiveness of mycophenolate mofetil for the treatment of myasthenia gravis (MG). DATA SOURCES: Searches of MEDLINE (1966-August 2005) and Cochrane Database (1993-August 2005) were conducted. Studies conducted in humans and published in English were retrieved. Additional data were identified through subsequent bibliographic reviews. DATA SYNTHESIS: Interruption of T- and B-lymphocyte proliferation in various autoimmune diseases has been investigated. Mycophenolate is known to inhibit lymphocyte proliferation and has shown improved clinical responses in several autoimmune diseases including lupus erythematosus, rheumatoid arthritis, and systemic vasculitis. Data suggesting similar benefits in MG treatment have been reported in case reports, retrospective analyses, an open-label trial, and a randomized, double-blind trial. CONCLUSIONS: Limited evidence from retrospective analyses and clinical trials suggests that mycophenolate is a possible treatment option for patients with MG. Improvement in clinical symptoms and a steroid-sparing effect have been reported when mycophenolate is used in this patient population. Larger, randomized, controlled, and comparative trials are needed to establish optimal dose, time to effect, specific therapeutic role, and long-term safety for mycophenolate when used for treating MG.

Clinical Trials as Topic↗
PubMed2005

Rituximab treatment of refractory rheumatoid arthritis.

OBJECTIVE: To review published literature using rituximab for treatment of refractory rheumatoid arthritis (RA). DATA SOURCES: An English-language literature search was conducted using MEDLINE (1966-May 2005) and EMBASE (1980-May 2005). References of identified articles were subsequently reviewed for additional data. DATA SYNTHESIS: Evidence suggests that B lymphocyte depletion in patients suffering from refractory RA may be a key component in the interruption of the disease pathogenesis. Successful depletion of B lymphocytes with rituximab in patients with RA has been reported in case reports, open-label pilot studies, and a randomized, double-blind, placebo-controlled trial. CONCLUSIONS: Based on the limited published data, rituximab, when used in combination with other agents (ie, cyclophosphamide or methotrexate), appears to be a reasonable treatment option for refractory RA. However, additional controlled trials need to be conducted to further define optimal dosing, response rates, comparative long-term efficacy, and RA treatment algorithm placement of rituximab in this patient population.

Algorithms↗
PubMed2005

Darbepoetin alfa therapeutic interchange protocol for anemia in dialysis.

BACKGROUND: Erythropoiesis-stimulating proteins, such as erythropoietin alfa and darbepoetin alfa, have positively impacted anemia management. These medications improve patient outcomes and quality of life. Their costs, however, remain a major barrier for health systems. OBJECTIVE: To evaluate the development, implementation, and cost-effectiveness of an inpatient therapeutic interchange protocol for erythropoiesis-stimulating proteins at a large, tertiary care, university-affiliated health system. METHODS: Virginia Commonwealth University Health System (VCUHS) developed and implemented a therapeutic interchange program to convert therapy for all inpatients undergoing dialysis from erythropoietin alfa to darbepoetin alfa for treatment of chronic kidney disease-related anemia. An evaluation of the economic impact of this program on drug expenditures over a fiscal quarter (2003) was conducted using historical comparator data (2002). RESULTS: Preliminary evaluation of the program demonstrated cost-savings and reduced drug utilization of erythropoiesis-stimulating proteins in hospitalized dialysis patients. For the first quarter of 2003 compared with the first quarter of 2002, VCUHS realized a cost-savings of nearly 10,000 US dollars, which was related to the program's aggressive screening procedure. When these data were normalized for equal numbers of patients in each group receiving one of the drugs, the actual cost-savings was over 2000 US dollars. These cost-savings are largely due to reduced utilization of these expensive biotechnology products with implementation of a dosing protocol. CONCLUSIONS: VCUHS has successfully developed and implemented a darbepoetin alfa therapeutic interchange protocol for hospitalized dialysis patients. This has translated into reduced use of erythropoiesis-stimulating proteins, resulting in cost-savings for the health system.

Anemia↗
PubMed2004

Trivalent intranasal influenza vaccine, live.

OBJECTIVE: To review human data on the efficacy, safety, and clinical use of trivalent intranasal influenza vaccine, live (TIIVL). DATA SOURCES: A MEDLINE search (1966-3rd week of January 2004) using the terms influenza vaccine, intranasal administration, and FluMist was conducted. References from pertinent articles were also reviewed. STUDY SELECTION AND DATA EXTRACTION: Studies conducted in humans and published in English were selected. Double-blind, controlled trials evaluating the efficacy and safety of TIIVL were evaluated. DATA SYNTHESIS: Administration of TIIVL results in mucosal and humoral immunity to influenza. Results of clinical trials in children and adults have demonstrated that TIIVL reduces the incidence of influenza. In children, TIIVL was also associated with a decrease in febrile illness and febrile otitis media. In adults, reductions in workday absences and medical visits due to febrile upper respiratory tract illness were also documented. TIIVL is well tolerated, with rhinorrhea or nasal congestion and sore throat occurring more frequently than with placebo. CONCLUSIONS: TIIVL is an alternative to intramuscular inactivated influenza vaccine in healthy individuals between 5 and 49 years of age. However, the vaccine is contraindicated in the majority of patient populations for whom annual influenza vaccination is recommended.

Administration, Intranasal↗
PubMed2003

Clopidogrel-associated leukopenia.

OBJECTIVE: To report a case of leukopenia in a patient receiving clopidogrel following intracoronary stent placement. CASE SUMMARY: A 58-year-old white man presented to the emergency department (ED) with fever and chills. Seven days prior to presentation, he underwent intracoronary stent placement and clopidogrel 75 mg once daily was initiated. In the ED, laboratory evaluation revealed leukopenia with negative blood and urine cultures. The patient was released but returned the following day with fever and sweating. Infectious complications were ruled out, and clopidogrel was discontinued. Leukopenia resolved within 7 days, and the patient has experienced no further hematologic complications. Based on the Naranjo probability scale, the leukopenia was rated as a probable reaction to clopidogrel. DISCUSSION: Ticlopidine and clopidogrel are the 2 commercially available thienopyridine antiplatelet agents. Risk of myelotoxicity with ticlopidine is well known and requires frequent hematologic monitoring. Clopidogrel is better tolerated, less toxic, and has more extensive indications, including use in acute coronary syndrome. These factors have resulted in the replacement of ticlopidine by clopidogrel. The 4 previously published reports of clopidogrel-associated white blood cell (WBC) toxicity are described. The mechanism of myelotoxicity with clopidogrel is not known. CONCLUSIONS: Better tolerability, reduced toxicity (particularly hematologic), and the convenience of once-daily dosing have resulted in the replacement of ticlopidine with clopidogrel. WBC toxicity associated with clopidogrel therapy is very infrequent and has occurred weeks to months following therapy initiation. Clinicians should be aware of the potential for this adverse effect.

Aged↗
PubMed2003

Desloratadine: a nonsedating antihistamine.

OBJECTIVE: To review information on desloratadine, a nonsedating antihistamine. DATA SOURCES: An English-language MEDLINE search was conducted (1966-July 2002). References of identified articles were subsequently reviewed for additional data. Schering Corporation provided unpublished information. STUDY SELECTION/DATA EXTRACTION: Articles and abstracts pertaining to desloratadine were considered for inclusion, with emphasis on randomized, placebo-controlled, double-blind trials. DATA SYNTHESIS: Desloratadine is approved for the treatment of symptoms associated with seasonal allergic rhinitis (SAR), perennial allergic rhinitis (PAR), and chronic idiopathic urticaria (CIU) in patients aged > or =12 years. In placebo-controlled trials, desloratadine demonstrated superior efficacy as a once-daily treatment of SAR, PAR, and CIU. Data suggest that desloratadine has antiinflammatory and decongestant activity. CONCLUSIONS: Desloratadine appears to be a "me-too" agent, with no major differences compared with other second-generation antihistamines.

Adult↗