Hospitalization and surgical rates in patients with Crohn's disease treated with infliximab: a matched analysis.

PURPOSE: The majority of subjects with Crohn's Disease (CD) will be hospitalized and will receive surgery for their disease. These interventions account for most of the direct costs of the disease. We sought to explore the association between infliximab use and CD-related surgery and hospitalizations. METHODS: We obtained patient-level health claims between 1996 and 2007 from the Régie de l'Assurance Maladie du Québec (RAMQ), a Canadian provincial health care insurer. Subjects who were i) enrolled in the RAMQ for at least 2 years, ii) received prescription drug benefits for each year of enrolment and iii) were identified as having CD using a validated algorithm were eligible for the study. For each subject treated with infliximab, up to two closely matched comparison subjects were selected using propensity score methods. We compared time to first CD-related intra-abdominal surgery or hospitalization in infliximab users and non-users. RESULTS: We matched 338 infliximab users (mean age 34, 45% male) to at least one comparison subject using propensity score matching. Subjects who received infliximab had a significantly lower risk of experiencing a CD-related intra-abdominal surgery (hazard ratio [HR] = 0.64; 95% confidence interval [CI] 0.51-0.81) or hospitalization (HR = 0.73; 95% CI 0.63-0.85). Infliximab users also experienced lower rates of hospitalized days (Rate Ratio = 0.69; 95% CI 0.49-0.97). CONCLUSIONS: Our results support the real world effectiveness of infliximab therapy in reducing CD-related surgeries and hospitalizations.

The fetal safety of hydrocortisone-pramoxine (Proctofoam-HC) for the treatment of hemorrhoids in late pregnancy.

OBJECTIVE: Fetal safety has never been studied for any drug used in the treatment of hemorrhoids. Proctofoam-HC is a combination of a corticosteroid and a local anaesthetic that is proven effective for the treatment of hemorrhoids. The objective of this study was to assess prospectively the fetal safety of third trimester exposure to Proctofoam-HC. METHODS: In a multicentre study, 204 [corrected] women exposed to Proctofoam-HC in the third trimester and a similar number of control pregnant women were followed up postnatally. RESULTS: When compared to controls exposure to Proctofoam-HC was not associated with any adverse fetal effects on birth weight, gestational age, rates of prematurity, or pre- or postnatal complications. CONCLUSION: Proctofoam-HC is safe to use in the treatment of hemorrhoids in late pregnancy.

Methods for quantification of exposure to cigarette smoking and environmental tobacco smoke: focus on developmental toxicology.

Active and passive smoking have been associated with an array of adverse effects on health. The development of valid and accurate scales of measurement for exposures associated with health risks constitutes an active area of research. Tobacco smoke exposure still lacks an ideal method of measurement. A valid estimation of the risks associated with tobacco exposure depends on accurate measurement. However, some groups of people are more reluctant than others to disclose their smoking status and exposure to tobacco. This is particularly true for pregnant women and parents of young children, whose smoking is often regarded as socially unacceptable. For others, recall of tobacco exposure may also prove difficult. Because relying on self-report and the various biases it introduces may lead to inaccurate measures of nicotine exposure, more objective solutions have been suggested. Biomarkers constitute the most commonly used objective method of ascertaining nicotine exposure. Of those available, cotinine has gained supremacy as the biomarker of choice. Traditionally, cotinine has been measured in blood, saliva, and urine. Cotinine collection and analysis from these sources has posed some difficulties, which have motivated the search for a more consistent and reliable source of this biomarker. Hair analysis is a novel, noninvasive technique used to detect the presence of drugs and metabolites in the hair shaft. Because cotinine accumulates in hair during hair growth, it is a unique measure of long-term, cumulative exposure to tobacco smoke. Although hair analysis of cotinine holds great promise, a detailed evaluation of its potential as a biomarker of nicotine exposure, is needed. No studies have been published that address this issue. Because the levels of cotinine in the body are dependent on nicotine metabolism, which in turn is affected by factors such as age and pregnancy, the characterization of hair cotinine should be population specific. This review aims at defining the sensitivity, specificity, and clinical utilization of different methods used to estimate exposure to cigarette smoking and environmental tobacco smoke.

Effect of iron content on the tolerability of prenatal multivitamins in pregnancy.

BACKGROUND: Gastrointestinal irritability can deter pregnant women from starting or continuing prenatal multivitamin supplementation. In a previous study, suboptimal tolerability was observed among pregnant women taking a large tablet (18 mm x 8 mm x 8 mm) multivitamin with high elemental iron content (60 mg as ferrous fumarate). The objective of the present study was to compare rates of adherence and reported adverse events among pregnant women who were randomized to commence supplementation with a small-tablet prenatal multivitamin, containing either low or high iron content. METHODS: Pregnant women who called the Motherisk Program (Hospital for Sick Children, Toronto) and had not started taking or had discontinued any multivitamin due to adverse events were included in this prospective, randomized, open-label, 2-arm study. Women were randomized to take a small-size (16 mm x 9 mm x 4 mm), low elemental iron content (35 mg as ferrous fumarate) multivitamin ('35 mg' group); or a small-size (5 mm radius, 5 mm thickness), high elemental iron content (60 mg as ferrous sulphate) multivitamin ('60 mg' group). Follow-up interviews documented pill intake and adverse events. Rates of adherence and adverse events were compared between groups using chi-squared tests and Kaplan-Meier survival curves. RESULTS: Of 167 randomized women, 92 in the '35 mg' group and 75 in the '60 mg' group were included in the analysis. Despite ideal conditions and regular follow-ups, mean adherence based on pill intake recall, in both groups was approximately 50%. No statistically significant difference was detected in proportions of women who actually started taking either multivitamin. Among those who started, no difference was detected in rates of adherence or reported adverse events. CONCLUSION: The present results suggest that iron content is not a major determinant of adherence to prenatal multivitamins. Combined with our previous study, tablet size may be the more definitive factor affecting adherence.

Long-Term Neurodevelopmental Risks in Children Exposed in Utero to Cocaine: The Toronto Adoption Studya.

Children exposed in utero to cocaine are at risk for long-term neurobehavioral damage not just because of the drug itself, but also because of clustering of other health determinants, including low socioeconomic status, low maternal education, and maternal addiction, to mention a few. One methodologic approach to separate the direct neurotoxic effects of cocaine from these synergistic insults is to follow up a cohort of children exposed in utero to cocaine and given up for adoption to middle-upper class families. The Toronto Adoption Study, supported by Health Canada, has proven the direct neurotoxic effects of cocaine on IQ and language. These effects are mild to moderate as compared to those measured in children exposed in utero to cocaine and reared by their natural mothers.