The clinical and economic burden of illness in the first two years after ostomy creation: a nationwide Danish cohort study.

BACKGROUND: Living with an ostomy is often associated with costly complications. This study examined the burden of illness the first two years after ostomy creation. METHODS: Data from Danish national registries included all adult Danes with an ostomy created between 2002 and 2014. RESULTS: Four cohorts consisted, respectively, of 11,385 subjects with a colostomy and 4,574 with an ileostomy, of which 1,663 subjects had inflammatory bowel disease (IBD) and 1,270 colorectal cancer as cause of their ileostomy. The healthcare cost was significantly higher for cases versus matched controls for all cohorts. In the first year, the total healthcare cost per person-year was €27,962 versus €4,200 for subjects with colostomy, €29,392 versus €3,308 for subjects with ileostomy, €15,947 versus €2,216 when IBD was the underlying cause, and €32,438 versus €4,196 when it was colorectal cancer. Healthcare costs decreased in the second year but remained significantly higher than controls. Hospitalization and outpatient services were primary cost drivers, with ostomy-related complications comprising 8-16% of hospitalization expenses. CONCLUSION: Compared to controls, subjects with an ostomy bear a significant health and financial burden attributable to ostomy-related complications, in addition to the underlying disease, emphasizing the importance of better ostomy care to enhance well-being and reduce economic strain.

Burden of illness among intermittent catheter users with non-neurogenic urinary retention in Denmark.

BACKGROUND: Urinary retention (UR) caused by non-neurogenic conditions is a frequent disorder often requiring the use of intermittent catheterization (IC). This study examines the burden of illness among subjects with an IC indication due to non-neurogenic UR. METHODS: Health-care utilization and costs were extracted from Danish registers (2002-2016) related to the first year after IC training and compared to matched controls. RESULTS: A total of 4,758 subjects with UR due to benign prostatic hyperplasia (BPH) and 3,618 subjects with UR due to other non-neurological conditions were identified. Total health-care utilization and costs per patient-year were significantly higher compared to matched controls (BPH: 12,406 EUR vs 4,363, p < 0.000; other non-neurogenic causes: 12,497 EUR vs 3,920, p < 0.000) and driven mainly by hospitalizations. Urinary tract infections (UTIs) were the most frequent bladder complications often requiring hospitalization. The inpatient costs per patient-year for UTIs were significantly higher for cases than controls (BPH: 479 EUR vs 31, p < 0.000; other non-neurogenic causes: 434 EUR vs 25, p < 0.000). CONCLUSIONS: The burden of illness caused by non-neurogenic UR with need for IC was high and essentially driven by hospitalizations. Further research should clarify if additional treatment measures may reduce the burden of illness in subjects suffering from non-neurogenic UR using IC.

Using peristomal body profile assessment to improve leakage-related quality of life for individuals with an ostomy.

BACKGROUND: Improper fitting between peristomal body profile and ostomy product(s) is one of the main reasons for leakage among individuals with an ostomy. AIM: To evaluate clinical usability of the Body Assessment Tool developed by Coloplast that is available free of charge. The aim was also to study how changing to product(s) that were best suited to an individual, guided by peristomal body profile, affected the number of leakages and individuals' quality of life. METHODS: The study consisted of questionnaires administered before and after the study, which spanned 4-5 weeks. A total of 22 nurses and 68 individuals with an ostomy participated in four Nordic countries. FINDINGS: Of the 22 nurses, 21 recommended use of the tool. A shift to best fitting ostomy product(s) resulted in a significant decrease in the number of leakages (from 5.9 to 1.8 per 7 days) and a substantial improvement in quality of life. CONCLUSION: The findings support the use of the Body Assessment Tool in clinical practice and the results showed that optimally fitting ostomy product(s) reduced the number of leakages and increased individuals' quality of life.

Burden of illness the first year after diagnosed bladder dysfunction among people with spinal cord injury or multiple sclerosis - a Danish register study.

BACKGROUND: People with spinal cord injury (SCI) or multiple sclerosis (MS) are often living with some degree of bladder and/or bowel dysfunction due to acquired neurogenic damage. The objective was to estimate the burden of illness of SCI and MS the first year after diagnosed bladder dysfunction. METHODS: Data were extracted from registers covering all Danish citizens. People with SCI or MS were indexed at diagnosis of bladder dysfunction. Inclusion period was 2002-2015 and cases and matched controls were followed for one year. RESULTS: A total of 2,132 subjects with SCI and 1,887 subjects with MS were identified. Healthcare utilization and societal costs per patient-year were significantly higher for cases compared to controls driven primarily by inpatient care. Cases with urinary tract infection had significantly higher inpatient costs per patient-year compared to controls (SCI: 544 EUR vs 23, p < 0.05; MS: 497 EUR vs 6, p< 0.05) and medication for constipation was significantly more costly per patient-year (SCI: 178 EUR vs 3, p < 0.05; MS: 78 vs 1, p < 0.05). CONCLUSIONS: The study demonstrates heavy societal and personal costs in the first year after bladder dysfunction in people with SCI or MS. This emphasizes the need for medical and social interventions to reduce the burden of illness.

Efficacy and safety of low dose subcutaneous diclofenac in the management of acute pain: a randomized double-blind trial.

OBJECTIVE: Diclofenac is an effective and well-tolerated nonsteroidal anti-inflammatory drug (NSAID) frequently used in the treatment of acute pain. Marketed formulations for parenteral administration usually contain 75 mg/3 mL of diclofenac sodium, which provide limited dosing flexibility, and are usually given intramuscularly. METHODS: We present a randomized, double-blind, active comparator- and placebo-controlled, parallel-group phase III multicenter study, investigating efficacy and tolerability of a new 1 mL-volume formulation of diclofenac sodium (25, 50 or 75 mg) containing hydroxypropyl-ß-cyclodextrin (HPßCD) as a solubility enhancer. This low-volume formulation allows subcutaneous (SC), in addition to intramuscular (IM) administration. Patients developing moderate-to-severe pain (≥ 50 mm on Visual Analogue Scale) after third molar extraction under local anesthesia were randomized to one of the 4 SC injections: 25 mg diclofenac HPßCD (n = 77), 50 mg diclofenac HPßCD (n = 76), 75 mg diclofenac HPßCD (n = 78), or placebo (n = 75). RESULTS: Mean pain intensity difference at 1.5 hours postdose (primary endpoint) was higher in all diclofenac-treated groups than placebo group. The adjusted means (95% CI) were 36.5 (31.7 to 41.2) in diclofenac 25 mg group, 37.3 (32.6 to 42.1) in diclofenac 50 mg group, 37.7 (33.0 to 42.4) in diclofenac 75 mg group, and 12.3 (7.44 to 17.1) in placebo group. Both 25 and 50 mg doses of diclofenac produced significantly greater pain relief than placebo (P < 0.001 in both comparisons). CONCLUSION: Single SC doses of diclofenac HPßCD of 25 and 50 mg are effective and well tolerated for relieving pain compared with placebo.

Diclofenac epolamine (Flector) patch: evidence for topical activity.

This review focuses on previously unpublished clinical and pharmacokinetic data with the diclofenac epolamine (diclofenac hydroxyethylpyrrolidine) patch supporting the hypothesis of a topical effect of this formulation. Previous studies have shown that 1 or 2 weeks of treatment with diclofenac epolamine provides pain relief for various localized musculoskeletal conditions such as ankle sprains, epicondylitis and knee osteoarthritis. The reduction in pain after application of the first patch in 155 patients with painful knee osteoarthritis was significant at the 1-hour time point and was superior to placebo at the 3-hour time point and at all time points thereafter. Comparable results were found in a study of 274 patients with acute ankle sprains, in which pain relief was also significantly superior to placebo at the 3-hour time point. Corresponding single-dose (patch) application for 12 hours in ten healthy volunteers demonstrated that diclofenac first appears in plasma at a mean of 4.5 hours after application (range 2-8 hours). Hence, the patch provided pain relief at a time point at which no diclofenac is assumed to be in plasma, which demonstrates local action in terms of tissue diclofenac accumulation under the patch. This is further supported by an apparent plasma diclofenac half-life of 9-12 hours after patch application, which implies the presence of a tissue reservoir, as the half-life after oral intake of diclofenac is 1-2 hours.Steady-state plasma diclofenac concentrations are present before 3 days' application (two patches/day) and are in the order of 1-3 ng/mL. The bioavailability in terms of systemic exposure from the patch compared with oral intake (75 mg/day) is in the order of 1%. Such low diclofenac concentrations are without systemic effects, as demonstrated by the fact that no drug-related gastrointestinal bleeding, ulcers or cutaneous events characteristic of Steven-Johnson syndrome have been reported during 15 years of diclofenac epolamine patch use.These data provide support for the notion that diclofenac epolamine patch provides pain relief through accumulation of diclofenac under the site of application, without any evidence of systemic effects.