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Biomedical subjects

Russell D Cohen

Publications and source records attributed to Russell D Cohen.

At least 19 recordsLinked to original sources
PubMed2006

Management of refractory ulcerative colitis.

A physician's approach to patients with ulcerative colitis (UC) who are refractory to standard first-line therapies must be thoughtful and systematic and include the individual's physical and emotional state as the physician examines the various dietary, medical, and surgical options currently available. It is of foremost importance to confirm that the refractory patient's symptoms are not simply due to dietary indiscretion, concomitant bowel infection (especially with Clostridium difficile), an incorrect diagnosis (eg, colitis due to infection, NSAIDs, ischemia, diverticulitis, or Crohn's disease), or even a concomitant diagnosis (eg, celiac sprue, pancreatic insufficiency, functional bowel disorder, laxative or sorbitol intake). The ability to quickly assess the status of the colonic mucosa with flexible sigmoidoscopy aids in the ability to distinguish patients with refractory inflammation from those with other diagnoses. The initiation and optimization of the long-term purine analogues azathioprine (AZA) or 6-mercaptopurine (6-MP) remain the backbone of medical therapy for patients with refractory UC. For those unresponsive to corticosteroids, quicker induction of remission may necessitate infliximab, cyclosporine, or tacrolimus. Successful induction and maintenance with AZA, 6-MP, and/or infliximab should be followed by long-term therapy with these agents. Cessation of therapy often leads to relapse. Novel therapies under investigation hold the promise of offering more options for both the induction and maintenance of remission in refractory UC patients. Discussions of surgical intervention should not be put off as a last resort but rather included in the overall treatment plan offered to the patient.

Journal Article↗
PubMed2006

Serious infections and mortality in association with therapies for Crohn's disease: TREAT registry.

BACKGROUND & AIMS: Long-term safety data for infliximab and other therapies in Crohn's disease (CD) are needed. METHODS: We prospectively evaluated patients for prespecified safety-related outcomes. RESULTS: As of August 2004, 6290 patients were enrolled; 3179 received infliximab (5519 patient-years), 87% of whom received at least 2 infusions, and 3111 received other therapies (6123 patient-years). The mean length of follow-up evaluation was 1.9 years. More infliximab-treated patients had moderate-to-severe (30.8% vs 10.3%) or severe-fulminant (2.5% vs .6%) CD, and had surgical (17.5% vs 13.8%) or medical (14.4% vs 9.1%) hospitalizations in the previous year. More patients were taking prednisone (27.4% vs 16.1%), immunomodulators (49.4% vs 32.2%), or narcotic analgesics (9.8% vs 5.4%) when compared with those receiving other therapies (P<.001, all comparisons). The mortality rates were similar for infliximab- and non-infliximab-treated patients (.53 per 100 patient-years vs .43; relative risk, 1.24; 95% confidence interval [CI], .73-2.10). In multivariate logistic regression analysis, only prednisone was associated with an increased mortality risk (odds ratio [OR], 2.10; 95% CI, 1.15-3.83; P=.016). Although the unadjusted analysis showed an increased risk for infection with infliximab use, multivariate logistic regression analysis suggested that infliximab was not an independent predictor of serious infections (OR, .99; 95% CI, .64-1.54). Factors independently associated with serious infections included prednisone use (OR, 2.21; 95% CI, 1.46-3.34; P<.001), narcotic analgesic use (OR, 2.38; 95% CI, 1.56-3.63; P<.001), and moderate-to-severe disease activity (OR, 2.11; 95% CI, 1.10-4.05; P=.024). CONCLUSIONS: Mortality rates were similar between infliximab- and non-infliximab-treated patients. The increased risk for serious infection observed with infliximab likely was owing to disease severity and prednisone use.

Adult↗
PubMed2006

Economics of the use of biologics in the treatment of inflammatory bowel disease.

The introduction of the biologic therapies into the therapeutic regiment for IBD, coupled with the vast changes seen in health care delivery within the past decade, have turned previous economic assumptions and models on their head, and opened up a new opportunity to redefine what is truly the cost of a disease, and of its' interventions. Pundits and pencil-pushers are quick to point to the high drug cost as a threat to the economic stability of the health care system, without first doing a carefully planned, balanced analysis of the overall impact that such a therapy will make on the entire cost-structure of the system. This is also true outside of the United States, where those who must budget and pay for the therapies do not pay for the use of health care services, and simply enter the drug costs on an accountant's debit sheet. Such analyses are complicated, because they must calculate the impact that such therapies have on the direct costs of health care and the indirect costs for both the patient and their families or health care support system. Realizing what impact these therapies might have on altering the natural history of these previously relentless chronic debilitating conditions, and redefining how normal quality of life can actually get on these therapies, should be the focus of future studies as clinicians try to calculate truly whether these agents are cost savings for society overall.

Biological Products↗
PubMed2006

Medical management of left-sided ulcerative colitis and ulcerative proctitis: critical evaluation of therapeutic trials.

BACKGROUND: The goal of this work was to critically evaluate the published studies on the treatment of ulcerative proctitis (UP) and left-sided ulcerative colitis (L-UC). The results of this review provided the content for the accompanying treatment guidelines, Clinical Guidelines for the Medical Management of Left-sided Ulcerative Colitis and Ulcerative Proctitis: Summary Statement. METHODS: All English language articles published between 1995 and September 2005 were identified through a comprehensive literature search using OVID and PubMed. The quality of the data supporting or rejecting the use of specific therapies was categorized by a data quality grading scale. An "A+" grade was assigned to treatment supported by multiple high-quality randomized controlled trials with consistent results, whereas a "D" grade was given to therapy supported only by expert opinion. The therapeutic efficacy of a treatment was defined by its success in treating UP and L-UC compared with placebo. A medication was ranked as "excellent" if it was specifically studied for UP and L-UC and had consistently positive results compared with placebo or another agent. Quality and efficacy scores were agreed on by author consensus. RESULTS: For the acute treatment of UP or L-UC, the rectally administered corticosteroids and mesalazine (5-ASA), either alone or in combination with oral 5-ASAs, are the most effective therapy: evidence quality, A+; efficacy, excellent. Only rectally administered 5-ASA received an A+/excellent rating for maintenance of remission. Infliximab received an A+ grade for induction and maintenance of remission but only a "good" rating because the studies were performed in all UC, not specifically UP or L-UC. CONCLUSIONS: This critical evaluation of treatment provides a "report card" on medications available for the management of patients with UP and L-UC. The guidelines should provide a useful reference and supplement for physicians treating UC patients.

Adrenal Cortex Hormones↗
PubMed2006

Clinical guidelines for the medical management of left-sided ulcerative colitis and ulcerative proctitis: summary statement.

There are few published guidelines for the treatment of inflammatory bowel disease. Physicians choose therapy based on evidence-based data, peer and expert opinion, and personal experience. This article provides treatment guidelines for the induction and maintenance of ulcerative proctitis and left-sided colitis and the management of disease refractory to 5-aminosalicylic acid (5-ASA) compounds and corticosteroids The guidelines are derived from evidence-based data and, when lacking, expert opinion or the authors' experience. The comprehensive review of the literature is presented in the accompanying article, "The Medical Management of Left-Sided Ulcerative Colitis and Ulcerative Proctitis: Critical Evaluation of Therapeutic Trials". Rectally administered 5-ASA and corticosteroid suppositories are effective treatment for most ulcerative proctitis patients. Corticosteroid and 5-ASA enemas, which reach the splenic flexure of the colon, are recommended for patients with left-sided ulcerative colitis. The combination of rectally administered 5-ASA enemas and oral 5-ASA agents may afford better treatment of left-sided colitis and possibly prevent proximal extension of disease. Patients refractory to 5-ASAs and corticosteroids may require an immunomodulator or biological response modifier therapy. Those who have ongoing signs and symptoms of ulcerative proctitis and left-sided ulcerative colitis despite maximal medical therapy require a proctocolectomy.

Adrenal Cortex Hormones↗
PubMed2006

Factors associated with the development of intestinal strictures or obstructions in patients with Crohn's disease.

OBJECTIVE: Theoretical concern exists that rapid luminal healing in Crohn's disease (CD) with therapies like infliximab increases the risk of intestinal stenosis, stricture, or obstruction (SSOs). METHODS: Data were analyzed from the ongoing observational TREAT (the Crohn's Therapy, Resource, Evaluation, and Assessment Tool) Registry and ACCENT I (A Crohn's Disease Clinical Trial Evaluating Infliximab in a New Long-Term Treatment Regimen) study. Investigators reported SSOs as adverse events or serious adverse events. RESULTS: In TREAT, SSOs occurred at a significantly higher rate in patients treated with infliximab compared with patients who received other treatments only (1.95 events/100 patient-years vs 0.99 events/100 patient-years; p < 0.001). Using multivariable analyses, however, infliximab therapy was not associated with SSO development. CD severity at the time of event onset (hazard ratio (HR) = 2.35, 95% confidence internal (CI) 1.35-4.09); CD duration (HR = 1.02, 95% CI 1.00-1.04); ileal disease (HR = 1.56, 95% CI 1.04-2.36); and new corticosteroid use (HR = 2.85, 95% CI 1.23-6.57) were associated with SSOs. In ACCENT I, no increase in SSOs was reported in patients who received infliximab maintenance therapy compared with those who received episodic therapy, despite higher median cumulative infliximab exposure. Additionally, there was no increase in SSO development with rapid mucosal healing (healing at week 10). CONCLUSIONS: Although unadjusted analyses suggested that patients who received infliximab were twice as likely to develop SSOs, multivariable analysis adjusting for other factors demonstrated that only disease duration, disease severity, ileal disease, and new corticosteroid use were significantly associated with SSO development.

Adolescent↗
PubMed2005

Mesalamine delivery systems: do they really make much difference?

Sulfasalazine's role as the first-line of therapy in patients with inflammatory bowel disease has led to the development of other "designer" aminosalicylates, which eliminate the sulfa-moiety, and attempt to target the topically active mesalamine to the inflamed bowel. Olsalazine sodium and balsalazide disodium utilize the same azo-bond structure as sulfasalazine, requiring release of active mesalamine by colonic bacteria, and thus targeting these agents to the colon. Other mesalamine delivery systems use pH-dependant- or moisture-release to liberate the active mesalamine in both the large and small bowel. Direct application of mesalamine via enema or suppository is also effective in patients with distal colitis. The pharmacology and thus the undesirable drug absorption rates differ between drugs, although the clinical importance of these characteristics is debatable. Differences in release-systems, the impact of the fed and fasting state, and unique patient intolerances to individual agents demand an understanding of each of these products, and their application to patient therapy.

Animals↗
PubMed2005

Postoperative management of ulcerative colitis and Crohn's disease.

Approximately 10% to 30% of patients with ulcerative colitis and up to 70% of patients with Crohn's disease will undergo surgery at some point during their lifetime. Although patients with ulcerative colitis are considered "cured" by surgery, patients who have undergone an ileal pouch anal anastomosis may develop pouchitis, cuffitis, pouch irritability, or even Crohn's disease. Various therapies have shown success, including probiotics, in the prevention of pouchitis onset or relapse. Crohn's disease historically recurs following surgery; prophylaxis against disease recurrence has been attempted with a variety of agents, with variable success. Innovative therapies holding promise for the future treatment or prevention of these conditions are under exploration.

Colitis, Ulcerative↗
PubMed2004

Medical therapy for ulcerative colitis: the state of the art and beyond.

Ulcerative colitis (UC) is an idiopathic inflammatory condition of the large intestine. Recent advances in our understanding of the pathogenesis of UC have led to the development of novel treatments for this often debilitating condition. Aside from aminosalicylates and corticosteroids, drugs that have been used for decades in the treatment of UC, biologic agents, in addition to medications targeting specific effector mechanisms involved in the inflammatory cascade, have been used in patients with UC with varying degrees of success. Clinicians have never had as many therapeutic options for UC as they do today. Herein we review the variety of treatment options, both standard and investigational, that are available for patients with UC.

Antibodies, Monoclonal↗
PubMed2004

Medical management of severe ulcerative colitis.

The medical management of patients with severe ulcerative colitis requires initial stabilization, careful and repeated evaluations to exclude confounding or coexisting diagnoses, and timely delivery of appropriate medications. Medical therapies for these patients are potent but may be toxic, and administration must be done by experienced medical professionals, with adequate access to appropriate laboratory, radiographic, endoscopic, and surgical facilities. Patients who fail to respond to high-dose intravenous corticosteroids in a timely basis should be evaluated for cyclosporin therapy, or proceed to surgery. The promise of newer, investigational therapies to induce and maintain remission must be borne out by large controlled trials.

Adrenal Cortex Hormones↗
PubMed2004

Postoperative maintenance of Crohn's disease remission with 6-mercaptopurine, mesalamine, or placebo: a 2-year trial.

BACKGROUND & AIMS: No therapy has been shown to reliably prevent the evolution of postoperative recurrence of Crohn's disease. The aim of the current trial was to compare 6-mercaptopurine (6-MP) and mesalamine with placebo for the prevention of clinical, endoscopic, and radiographic recurrence of Crohn's disease after resection and ileocolic anastomosis. METHODS: Five centers randomized 131 patients to receive 6-MP (50 mg), mesalamine (3 g), or placebo daily in a double-blind, double-dummy trial. Patients had clinical assessments at 7 weeks and then every 3 months; colonoscopy at 6, 12, and 24 months; and small bowel series at 12 and 24 months. End points were clinical, endoscopic, and radiographic recurrence rates at 24 months. RESULTS: Clinical recurrence rates (intent to treat) by life-table analysis at 24 months were 50% (95% confidence interval [CI], 34%-68%), 58% (95% CI, 41%-75%), and 77% (95% CI, 61%-91%) in patients receiving 6-MP, mesalamine, and placebo, respectively. Endoscopic recurrence rates were 43% (95% CI, 28%-63%), 63% (95% CI, 47%-79%), and 64% (95% CI, 46%-81%), and radiographic recurrence rates were 33% (95% CI, 19%-54%), 46% (95% CI, 29%-66%), and 49% (95% CI, 30%-72%), respectively. 6-MP was more effective than placebo ( P < 0.05) at preventing clinical and endoscopic recurrence over 2 years. Patient withdrawals resulted in 69% of the study population evaluable for the clinical recurrence end point. CONCLUSIONS: 6-MP, 50 mg daily, was more effective than placebo at preventing postoperative recurrence of Crohn's disease and should be considered as a maintenance therapy after ileocolic resection.

Adult↗