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A Systematic Review of Adherence With Medications for Diabetes Joyce A. Cramer Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut Address correspondence and reprint requests to Joyce A. Cramer, Yale University School of Medicine, 950 Campbell Ave. (Room 7-127, G7E), West Haven, CT 06516-2770. E-mail: joyce.cramer{at}yale.edu Abstract OBJECTIVE —The purpose of this study was to determine the extent to which patients omit doses of medications prescribed for diabetes. RESEARCH DESIGN AND METHODS —A literature search (1966–2003) was performed to identify reports with quantitative data on adherence with oral hypoglycemic agents (OHAs) and insulin and correlations between adherence rates and glycemic control. Adequate documentation of adherence was found in 15 retrospective studies of OHA prescription refill rates, 5 prospective electronic monitoring OHA studies, and 3 retrospective insulin studies. RESULTS —Retrospective analyses showed that adherence to OHA therapy ranged from 36 to 93% in patients remaining on treatment for 6–24 months. Prospective electronic monitoring studies documented that patients took 67–85% of OHA doses as prescribed. Electronic monitoring identified poor compliers for interventions that improved adherence (61–79%; P < 0.05). Young patients filled prescriptions for one-third of prescribed insulin doses. Insulin adherence among patients with type 2 diabetes was 62–64%. CONCLUSIONS —This review confirms that many patients for whom diabetes medication was prescribed were poor compliers with treatment, including both OHAs and insulin. However, electronic monitoring systems were useful in improving adherence for individual patients. Similar electronic monitoring systems for insulin administration could help healthcare providers determine patients needing additional support. MEMS, Medication Event Monitor Systems MUSE-P, Medication Usage Skills for Effectiveness Program OHA, oral hypoglycemic agent Footnotes J.C. is a member of an advisory panel of Novo Nordisk and has received honoraria or consulting fees from Novo Nordisk. Accepted January 18, 2004. Received August 18, 2003. DIABETES CARE

Antiepileptic drugs (AEDs) are the only neurotherapeutics for which regulatory approval is consistently separated into monotherapy or adjunctive-therapy indications. Because head-to-head comparisons of AEDs (used in the European Union to approve drugs for monotherapy) have not shown substantial differences in efficacy between drugs, FDA approval for use of an AED as monotherapy has typically been based on trials with novel designs that have been criticised for reasons of ethics and clinical relevance. Many new-generation AEDs have not been approved for monotherapy, causing drug labelling and real-world use to be increasingly inconsistent, with negative consequences for patients. The regulatory requirement for separate monotherapy and adjunctive-therapy indications in epilepsy is unnecessarily restrictive. We recommend that regulatory agencies approve AEDs for the treatment of specific seizure types or epilepsy syndromes, irrespective of concomitant drug use.

Alcoholism is a devastating illness that is difficult to treat. Naltrexone, an opioid-receptor antagonist, has been approved by the Food and Drug Administration for the treatment of alcohol dependence, but its effectiveness is uncertain. This study of veterans (mostly men) found no evidence that naltrexone, combined with attendance at Alcoholics Anonymous meetings and other psychosocial treatment, was more effective than placebo for chronic and severe alcohol dependence. This study found no evidence that naltrexone was effective for chronic alcohol dependence. Alcoholism is a devastating medical illness with a profound public health impact. 1 In 1995, because of its extensive record for safety when administered for other indications, the Food and Drug Administration (FDA) approved naltrexone, an opioid-receptor antagonist, for the treatment of ethanol dependence, in part on the basis of two well-designed single-site studies. 2 – 4 The initial studies suggested that naltrexone substantially increased sobriety and reduced ethanol consumption when combined with psychosocial treatment. Naltrexone was incorporated into the treatment of alcoholism on the premise that stimulation of the μ opioid receptor contributed to the rewarding effects of alcohol. 5 – 7 Data from . . .

Background The U.S. Food and Drug Administration (FDA) recently linked antiepileptic drug (AED) exposure to suicide-related behaviors based on meta-analysis of randomized clinical trials. We examined the relationship between suicide-related behaviors and different AEDs in older veterans receiving new AED monotherapy from the Veterans Health Administration (VA), controlling for potential confounders. Methods VA and Medicare databases were used to identify veterans 66 years and older, who received a) care from the VA between 1999 and 2004, and b) an incident AED (monotherapy) prescription. Previously validated ICD-9-CM codes were used to identify suicidal ideation or behavior (suicide-related behaviors cases), epilepsy, and other conditions previously associated with suicide-related behaviors. Each case was matched to controls based on prior history of suicide-related behaviors, year of AED prescription, and epilepsy status. Results The strongest predictor of suicide-related behaviors (N = 64; Controls N = 768) based on conditional logistic regression analysis was affective disorder (depression, anxiety, or post-traumatic stress disorder (PTSD); Odds Ratio 4.42, 95% CI 2.30 to 8.49) diagnosed before AED treatment. Increased suicide-related behaviors were not associated with individual AEDs, including the most commonly prescribed AED in the US - phenytoin. Conclusion Our extensive diagnostic and treatment data demonstrated that the strongest predictor of suicide-related behaviors for older patients newly treated with AED monotherapy was a previous diagnosis of affective disorder. Additional, research using a larger sample is needed to clearly determine the risk of suicide-related behaviors among less commonly used AEDs.

All medications have some adverse effects, ranging from mild to acute and serious or chronic. Antiepileptic drugs (AEDs) differ in the type and severity of adverse effects, mostly during initiation and early treatment. Some concerns are related to pharmacodynamic tolerance often affected by the dose and rate of initiation, while other concerns are idiosyncratic responses to the drug (rare and not predictable). Thus, lack of tolerability is a common reason for changing medication, quantified in studies as treatment retention. Although adverse effects can occur with all AEDs, and CNS effects are most prevalent, selected effects are hallmarks of specific drugs. The failure of an AED regimen may be the result of unacceptable adverse effects (intolerance), inadequate seizure control (inefficacy) or a combination of both. Although some diminution in adverse effects is typical when a drug is used in monotherapy, the potential for most issues remains if they are dose-related or idiosyncratic. This article describes three categories of prevalent adverse effects (CNS, behavioral and general medical issues) comparing profiles of second- and third-generation AEDs.

ABSTRACT Objective: Poor compliance and persistence with bisphosphonates is a concern in postmenopausal osteoporosis due to its negative impact on fracture risk and healthcare costs as well as quality of life. Reducing oral bisphosphonate dosing frequency is one measure available to increase therapy convenience and practicality, with the hope of improving compliance and persistence. This study compared compliance and persistence with weekly and daily bisphosphonate regimens for postmenopausal osteoporosis. Methods: Administrative claims data (1997–2002) from 30 health plans were used to identify postmenopausal women (> 45 years) with osteoporosis, who had been newly prescribed a once-weekly (QW alendronate 35 mg or 70 mg) or once-daily (QD alendronate 5 mg or 10 mg or risedronate 5 mg) bisphosphonate. QW and QD cohorts were followed for 12 months from initial prescription. Medication possession ratios (MPRs) measured refill compliance during follow-up. Persistence was calculated as the number of days from the initial prescription to a lapse of > 30 days after completion of the previous refill. Results: Data were available for 2741 women (QW, N = 731, QD, N = 2010). QW users had significantly higher medication compliance than QD users (69.2% vs. 57.6% MPR, p ≤ 0.0001). QW users persisted with therapy significantly longer than QD users ( p < 0.0001) and had higher rates of retention on treatment at 12 months than QD users (44.2% QW; 31.7% QD). Dosing frequency was the strongest predictor of time to discontinuation ( p < 0.0001). Conclusions: Postmenopausal women prescribed a weekly bisphosphonate had significantly better compliance and persistence than those taking more frequent, daily bisphosphonate doses. However, compliance and persistence rates for both regimens were suboptimal, suggesting that less frequent dosing intervals may provide an opportunity to further improve the consistent use of bisphosphonate therapy.

OBJECTIVE:--The purposes of this study were to determine the relationship between insulin self-management and glycemic control and to identify patient characteristics associated with better control. RESEARCH DESIGN AND METHODS--A Department of Veterans Affairs regional database was used to identify patients with diabetes on chronic insulin therapy (n = 6,222) with dose defined as number of units and doses. The rate of insulin use during a 2-year period was calculated using pharmacy data. Regression analyses were used 1) to predict compliance with prescribed insulin regimens using demographic variables, HbA[subscript 1c] levels, and a measure of diabetes management intensity and 2) to predict HbA[subscript 1c] levels using demographic variables and rates of insulin use. RESULTS:--Insulin use was 77.44 ± 17% of prescribed amounts, including wastage; HbA[subscript 1c] levels were 7.98 ± 1.66%. Concomitant oral hypoglycemic agent use (84.89 ± 16%) was higher than insulin use (P < 0.0001) but correlated with insulin use (r = 0.189, P < 0.0001). Ordinary least-squares regression showed that race, HbA[subscript 1c] levels, and intensity of diabetes management were significant predictors of insulin use. Age, race, and insulin use were significant predictors of HbA[subscript 1c] levels. CONCLUSIONS:--Adults prescribed a specific insulin regimen averaged using 77% of prescribed doses, demonstrating good intention to follow the prescription. However, HbA[subscript 1c] higher than the recommended level suggested that the rate of insulin use, the prescribed regimen, or both were inadequate to achieve good glycemic control in patients with long-term insulin use.

The aim of this study was to determine the effect of dose frequency on compliance and persistence with bisphosphonate therapy in postmenopausal women and to compare findings from 3 different health care systems. Three independently performed retrospective cohort analyses were performed using observational data sources. In the United States, bisphosphonatenaive postmenopausal women were identified from a database providing information on health plan prescription drug claims; in the United Kingdom and France, bisphosphonate-naive postmenopausal women were identified from a database of medical records supplied by general practice physicians. The women were grouped into 2 cohorts: those who were initiated on a weekly regimen of alendronate 70 mg or risedronate 35 mg and those initiated on a daily regimen of alendronate 5 or 10 mg or risedronate 5 mg. Compliance was measured in terms of the medication possession ratio (MPR), which was defined as the proportion of days in the 12-month follow-up period for which patients were covered by prescriptions for bisphosphonates. Persistence was measured as the number of days from the date of the index prescription to the last day of prescription coverage within the followup period. Women were classified as nonpersistent if the gap between prescriptions was > 30 days. The study included 2741 postmenopausal women with osteoporosis from the United States, 7567 from the United Kingdom, and 5332 from France. The mean (SD) age of the women was 73.0, 71.7, and 69.7 years in the 3 countries, respectively. The overall MPR was 61% in the United States, 74% in the United Kingdom, and 58% in France. In all 3 countries, women on a weekly regimen had a significantly greater MPR than women on a daily regimen (69% vs 58%, respectively, in the United States; 76% vs 64% in the United Kingdom; and 59% vs 53% in France; all, P 0.001). Women on a weekly regimen of bisphosphonates persisted with treatment significantly longer than women on a daily regimen (227 vs 185 days, respectively, in the United States; 249 vs 208 in the United Kingdom; and 179 vs 155 in France; all, P < 0.001). A significantly greater proportion of the women on a weekly regimen persisted with treatment for 12 months compared with those on a daily regimen (44% vs 32%, respectively, in the United States; 52% vs 40% in the United Kingdom; and 51% vs 44% in France; all, P < 0.001). In all 3 countries, postmenopausal women prescribed a weekly regimen of bisphosphonates had significantly greater rates of compliance than women prescribed a daily regimen, and they persisted longer with treatment. However, compliance and persistence rates were suboptimal for both regimens.

[...]our comments about the ethical difficulties of this trial design pertain to the subsequent evolution of our understanding of optimal epilepsy treatment.