Analysis of Pregnancy Outcomes Following Exposure to Intramuscular Interferon Beta-1a: The AVONEX® Pregnancy Exposure Registry.

BACKGROUND AND OBJECTIVES: There is a lack of well-controlled US studies of intramuscular (IM) interferon beta (IFNß)-1a use in pregnant women with multiple sclerosis; however, in the European Medicines Agency region, IFNß formulations may be considered during pregnancy if clinically needed based on data from European Union cohort registries. The AVONEX Pregnancy Exposure Registry was established to prospectively study the effects of IM IFNß-1a on the risk of birth defects and spontaneous pregnancy loss in a US population. METHODS: Pregnant women with multiple sclerosis exposed to IM IFNß-1a within ~ 1 week of conception or during the first trimester were included. Participants were followed until there was a pregnancy outcome, live-born infants were followed until age 8-12 weeks. Data were collected on IM IFNß-1a exposure, demographics, patient characteristics, medical history, and pregnancy outcomes, including live births (with or without birth defect), spontaneous abortions/miscarriages and fetal death/stillbirth, elective abortions (with and without birth defect), and ectopic pregnancies. A population-based birth defect surveillance program, the Metropolitan Atlanta Congenital Defects Program (MACDP), served as the primary external control group for evaluating the risk of birth defects. RESULTS: Three-hundred and two patients with a median (range) age of 31.0 (16-48) years and a median (range) gestational age at the time of enrollment of 10.1 (4-39) weeks were evaluable. Most patients (n = 278/302; 92%) reported IM IFNß-1a exposure in the week before conception and most (n = 293/302; 97%) discontinued treatment before the end of the first trimester. Of 306 pregnancy outcomes, there were 272 live births, 28 spontaneous abortions of 266 pregnancies enrolled before 22 weeks' gestation (rate 10.5%; 95% confidence interval 7.2-15.0), five elective abortions, and one stillbirth. There were 17 adjudicator-confirmed major birth defects of 272 live births (rate 6.3%; 95% confidence interval 3.8-10.0); the pattern of birth defects observed was not suggestive of a relationship to prenatal IM IFNß-1a exposure. CONCLUSIONS: This large US registry study suggests IM IFNß-1a exposure during early pregnancy was not clinically associated with adverse pregnancy outcomes in women with multiple sclerosis. These findings help inform clinicians and patients in weighing the risks and benefits of IM IFNß-1a use during pregnancy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT00168714, 15 September, 2005.

Use of nonsteroidal anti-inflammatory drugs in the older adult.

PURPOSE: Annually, approximately 90 million prescriptions are filled for nonsteroidal anti-inflammatory drugs (NSAIDs) with the number prescribed for older adults approximately three times higher than for younger adults. This article examines the benefits and risk of NSAID use in older adults. DATA SOURCES: Electronic data collection of research studies, evidence-based reviews, consensus statements, and guidelines related to the purpose of this article were analyzed if published between 2000 and 2013 in English from Ovid, MEDLINE, and PubMed databases. CONCLUSIONS: While NSAIDs are commonly used to treat pain and inflammation in older adults, strong consideration must be given to the potential adverse effects. A lack of consistency in the guidelines regarding NSAID use poses further challenges for clinicians in the selection of the best pharmacological approach. When prescribing NSAIDs, adverse events, polypharmacy, comorbidities, and treatment guidelines must be considered. NSAIDs are an appropriate option for pain management in select older adults, often after a trial of acetaminophen and if benefits outweigh risks. Alternative pharmacological and nonpharmacological therapies may be more appropriate in many older adults. IMPLICATIONS FOR PRACTICE: The challenge for clinicians prescribing NSAIDs in the treatment of pain in older adults is to utilize safe, individualized, and evidenced-based pain management regimens.

Recommended routine vaccinations for older adults.

A goal of primary prevention is to avoid the development of disease. Immunizations are one of several strategies used by clinicians in primary prevention. Influenza and pneumococcal disease--both preventable--cause significant morbidity and mortality in older adults who have an altered immune system, often have several chronic health problems, and are at higher risk for complications. Tetanus, while not as common in older adults, carries a high mortality rate in those 65 and older. These infections are associated with significant disability that results from hospitalizations for congestive heart failure, hip fracture, stroke, and pneumonia. The goal of immunizing older adults is to decrease functional decline and disability, as well as potential hospital admissions linked to these preventable diseases, which often exacerbate underlying health problems. Age-defined recommendations are available to guide clinicians on the appropriate vaccinations and schedules for administration to older adults.

Vitamin D.

There is growing awareness and evidence that vitamin D plays a pivotal role in maintaining health beyond its major biological function of enhancing calcium absorption and improving bone mineral density. Research findings suggest a strong relationship among a number of chronic diseases and vitamin D deficiency. Although vitamin D deficiency can occur across the age continuum, older adults with chronic diseases are particularly at risk. This article focuses on the role of vitamin D in maintaining health, current evidence linking vitamin D deficiency with chronic illness, and the importance of vitamin D supplementation.

Regulatory components for treating persistent pain in long-term care.

Persistent or chronic pain is frequently reported by older adults and has the potential to dramatically influence quality of life. Estimates indicate that 25% to 50% of community-dwelling older adults experience this kind of pain. This rate is even higher in long-term care facilities, where 50% to 75% of residents have chronic pain syndromes that are untreated or undertreated. To promote optimal pain management and enumerate the responsibilities of skilled nursing facilities to effectively treat and prevent pain, the Centers for Medicare & Medicaid Services released a new pain management surveyor guidance, F-Tag 309, which endorses the presence of an interdisciplinary team approach to pain management that involves the resident. The guidance delineates pain management principles, the need for ongoing professional education in all components of pain management, and emphasizes the important role of appropriate pharmacological treatment in conjunction with nonpharmacological interventions to aggressively manage pain. This directive will help skilled nursing facilities achieve optimal pain management for their residents.

Strategies for reducing polypharmacy in older adults.

Polypharmacy is a major concern in the care of older adults. Multiple factors contribute to this problem, and recognizing these factors is an initial step in addressing the problem. Further, identifying those individuals at risk for medication problems, as well as implementing specific strategies in practice to reduce the problem, will enable clinicians to develop safe and evidence-based medication regimens that minimize the risk of adverse drug reactions. The key to treating older adults is not necessarily to find a set number of medications and try to stay below it, but to find the right medication at the right dosage and for the shortest possible duration on a case-by-case basis. This individualized approach to treating patients will provide a much safer and effective means of practicing and will improve patients' quality of life.

Benefits of continuous subcutaneous insulin infusion in children with type 1 diabetes.

OBJECTIVE: To examine the effect of continuous subcutaneous insulin infusion (CSII) therapy on parameters affecting long-term outcome in type 1 diabetes. Study design Height, weight, body mass index, insulin dose, glycosylated hemoglobin (HbA(1C)), and blood glucose data from home meter downloads were collected prospectively for analysis in 51 children (age, 10.7+/-3.1 years, mean+/-SD) throughout the 12 months before and after introducing CSII. RESULTS: Before pump initiation, HbA(1C) was relatively stable, but it fell to 7.7+/-0.2% (P<.001) within 3 months of CSII and remained decreased (7.9+/-0.1%) at 12 months (P<.01). In contrast, weight standard deviation score increased before CSII (from 0.50+/-0.13 to 0.60+/-0.13, P<.05), but remained unchanged (0.61+/-0.11) in the year thereafter. Although severe hypoglycemia (<50 mg/dL) was reduced in the entire cohort, HbA(1C) improved primarily in young children and teenagers. Comparison of glycemic responders (HbA(1C) <7.5, or a decrease >1% on CSII, n=23) with nonresponders demonstrated no differences with respect to gender, socioeconomic status, weight standard deviation score, body mass index, initial HbA(1C), frequency of hypoglycemia, or number of education visits before CSII. CONCLUSION: Continuous subcutaneous insulin infusion is effective in lowering HbA(1C) and the occurrence of severe nocturnal hypoglycemia without excessive weight gain in most children with type 1 diabetes. HbA(1C) response to CSII is poorer in preadolescents than in young children or teenagers.