Increased Regimen Complexity Research Articles

Clinical Use of IDegLira: Initiation to Titration After Basal Insulin.

Delayed treatment intensification is common in U.S. patients with type 2 diabetes uncontrolled on basal insulin. Concerns about weight gain, hypoglycemia, increased regimen complexity, and additional copayments may lead to reluctance to initiate prandial insulin. IDegLira is a titratable, fixed-ratio coformulation that combines the advantages of insulin degludec and the glucagon-like peptide 1 receptor agonist liraglutide in a single once-daily injection and mitigates the side effects associated with each component. Clinical trials have demonstrated that IDegLira improves glycemic control without the increased risk of hypoglycemia and weight gain observed with basal insulin up-titration and the addition of prandial insulin, and this is achieved using twice-weekly titration. Clinical trials and real-world studies have also shown that IDegLira has the potential to reduce therapeutic and titration inertia. However, better outcomes could be achieved with IDegLira initiation in suitable patients with timely titration and by providers sharing their experience with this combination product. This review describes considerations for initiation, titration, and intensification of IDegLira in patients previously receiving basal insulin.

Association between medication regimen complexity and pharmacotherapy adherence: a systematic review.

The purpose of this study was to systematically review evidence regarding the association between regimen complexity and adherence. Articles were searched in MEDLINE, LILACS, Cochrane, CINAHL, PsycINFO and references of included studies. Search terms included medication regimen complexity, medication adherence and their synonyms. Randomized clinical trials, cross-sectional, cohort or case-control studies published until March 2016 in English, Portuguese or Spanish were eligible if quantitatively examined the association between complexity and adherence in patients of any age and sex, under any type of medication therapy. Complexity was defined according to the strategy used to assess it in the individual studies. All types of instruments used to assess complexity and adherence were considered. Data extraction was performed using an electronic spreadsheet. Quality assessment was conducted independently using standard scales. The data were qualitatively synthesized. Fifty-four studies were included: 37 cross-sectional and 17 cohorts. Most were conducted in outpatient setting. Most frequently, studies were carried out with HIV-infected individuals or patients with chronic conditions. The most frequent methods used to assess complexity and adherence were complexity index (19) and self-report (27), respectively. Complexity was associated with adherence in 35 studies. Most of them (28) identified that participants with more complex regimens were less likely to adhere to pharmacotherapy; seven studies found a direct correlation. The others found inconclusive results or no association between complexity and adherence. The studies had low to moderate-methodological quality. Although there was variability regarding the association between complexity and adherence, most studies showed that an increased regimen complexity reduces medication adherence.

Insulin degludec and insulin aspart: novel insulins for the management of diabetes mellitus.

Patients with type 2 diabetes mellitus require insulin as disease progresses to attain or maintain glycaemic targets. Basal insulin is commonly prescribed initially, alone or with one or more rapid-acting prandial insulin doses, to limit mealtime glucose excursions (a basal-bolus regimen). Both patients and physicians must balance the advantages of improved glycaemic control with the risk of hypoglycaemia and increasing regimen complexity. The rapid-acting insulin analogues (insulin aspart, insulin lispro and insulin glulisine) all have similar pharmacokinetic and pharmacodynamic characteristics and clinical efficacy/safety profiles. However, there are important differences in the pharmacokinetic and pharmacodynamic profiles of basal insulins (insulin glargine, insulin detemir and insulin degludec). Insulin degludec is an ultra-long-acting insulin analogue with a flat and stable glucose-lowering profile, a duration of action exceeding 30 h and less inter-patient variation in glucose-lowering effect than insulin glargine. In particular, the chemical properties of insulin degludec have allowed the development of a soluble co-formulation with prandial insulin aspart (insulin degludec/insulin aspart) that provides basal insulin coverage for at least 24 h with additional mealtime insulin for one or two meals depending on dose frequency. Pharmacokinetic and pharmacodynamic studies have shown that the distinct, long basal glucose-lowering action of insulin degludec and the prandial glucose-lowering effect of insulin aspart are maintained in the co-formulation. Evidence from pivotal phase III clinical trials indicates that insulin degludec/insulin aspart translate into sustained glycaemic control with less hypoglycaemia and the potential for a simpler insulin regimen with fewer daily injections.

Perspectivas futuras del tratamiento de la hepatitis C, ¿sin interferón y sin ribavirina?

The hepatitis C virus is an important health problem worldwide. Currently, the standard treatment of genotype 1 chronic hepatitis C is the combination of pegylated interferon, ribavirin and a first-generation protease inhibitor: telaprevir or boceprevir. This triple therapy has improved the efficacy of treatment but has also increased regimen complexity, costs, and the number of adverse effects (mainly hematological and cutaneous). Unfortunately, viral response rates are still suboptimal in patients with cirrhosis, particularly those with a prior null response. Moreover, studies carried out in clinical practice have shown that the presence of advanced fibrosis confers a high risk of developing severe adverse effects during treatment (infection, decompensation and even death). It is therefore essential to select candidates for triple therapy according to their risk of complications and possibilities for cure. In this scenario, interferon (and ribavirin)-free combinations are very safe and well tolerated first-line treatments.This review describes the current treatment of hepatitis C as well as the latest results of studies combining distinct direct antiviral agents without interferon. It is hoped that these drugs will be available shortly, although their cost may be high. Consequently, it is essential to identify those patients who could derive the greatest benefit from these treatments.

OP-239 Impact of Number of Medications on Anticoagulation Control in Patients Receiving Warfarin Therapy

Patients on chronic warfarin therapy who have poor anticoagulation control are at increased risk for adverse events. Increasing regimen complexity is generally assumed to result in lower medication adherence, but there is conflicting evidence. The aim of this study was to examine the relationship between the number of medications prescribed alongside warfarin and anticoagulation control as measured by ‘International Normalized Ratio’ (INR).

PIN57 Public Expenditure for Antiretroviral Treatment and Projected Cost-Savings After the Entry of Generic Antiretrovirals in the Italian Pharmaceutical Market

Aims of this study were to quantify the expenditure for antiretroviral (ARV) treatment in Italy, and to estimate the potential impact of the introduction of generic antiretrovirals in the Italian pharmaceutical market. Using a data-set of pharmaceutical expenditure in Italy, we analysed the total expenses for ARVs at national level. Since in the near future generic zidovudine (AZT), lamivudine (3TC), nevirapine (NVP) and efavirenz (EFV) will be available in Italy, we calculated the potential cost-saving, modeling scenarios with price reduction between 20%-60% of the originators prices. In sensitivity analyses, we assumed that branded emtricitabine could be substituted by generic 3TC, and that fixed dose combinations (FDC) could be partially substituted by single components with generic medicines. In 2010, €500.689.927 were spent for antiretroviral therapies (total ARV use: 1.91 DDIs/1000 inhabitants/day), with an increase of 12.6% compared with the 2009 expenditure. The most relevant proportion was attributable to FDC, accounting for €238.826.599 (47.7% of total costs). The total percentage of costs for ARVs related to the use of AZT, 3TC, NVP and EFV was 7.33% (€36.713.056). Assuming the prescriptions of these drugs to be constant in next years, different scenarios of price reduction (from 20% to 60%) for generic drugs showed an estimated cost-saving ranging from €7.342.611 (1.47% of total ARV costs) to €22.027.833 (4.40%). When including emtricitabine substitution by 3TC, cost-saving rises to €7.435.738-22.307.213 (1.49-4.46%) and to €26.832.726-80.498.178 (5.36-16.08%) considering the unbundling of branded FDC. The forthcoming availability of some antiretroviral generics could be an option for safely and effectively cost-saving. However, in our study, the greater reduction of costs has been estimated by FDC substitution, raising the potential dilemma of increasing regimen complexity. Further studies will be needed to evaluate safety and efficacy of FDC substitution with generics incorporating both treatment adherence and pharmacoeconomic outcomes.

Reducing medication regimen complexity for older patients prior to discharge from hospital: feasibility and barriers

Older hospital inpatients are often prescribed complex multi-drug regimens; increased regimen complexity is associated with poorer medication adherence and treatment outcomes. There has been little research into methods for reducing regimen complexity. The objective of this study was to explore the feasibility of incorporating medication regimen simplification into routine clinical pharmacist care for older hospital inpatients and identify barriers to regimen simplification at a major teaching hospital. Following an educational intervention, clinical pharmacists were encouraged to minimize regimen complexity for their patients by identifying potential simplifications during routine medication regimen reviews (e.g. medication chart reviews, discharge prescription reviews) and discussing these changes with hospital doctors and patients. Pharmacists completed a data collection form for patients aged 60 years or above discharged from their wards during the study period (n = 205; mean age, 81.3 years), indicating whether they had reviewed the patient's medication regimen complexity (and if not why), whether any changes to simplify the regimen were identified, and whether changes were successfully implemented (and if not why). Pharmacists reviewed medication regimen complexity for 173/205 (84.4%) patients and identified 149 potential changes to reduce regimen complexity for 79/173 (45.7%) reviewed patients. Ninety-four (63.1%) changes were successfully implemented in 54/205 (26.3%) patients. Regimens were simplified more often for patients discharged from subacute aged care (geriatric assessment and rehabilitation) wards compared with acute general medicine wards. The most commonly cited reason for not reviewing regimen complexity and not implementing identified simplification-related changes was 'lack of time'. Non-acceptance of pharmacist recommendations by patients or doctors were other common reasons for not implementing changes. This is the first study to explore pharmacist-led medication regimen simplification and barriers to regimen simplification in the hospital setting. It demonstrates that simplification of older inpatients' regimens is feasible when training in regimen simplification is provided. The main barrier to regimen simplification appears to be lack of pharmacist time.

Impact of Hospitalisation on the Complexity of Older Patients' Medication Regimens and Potential for Regimen Simplification

ABSTRACTAimTo investigate the impact of hospitalisation on the complexity of older patients' medication regimens; and to determine whether discharge medication regimens could be simplified.MethodMedication Regimen Complexity Index (MRCI) scores were calculated on admission and discharge for 186 consecutive patients (mean age 80 years) discharged from 2 acute general medicine and 2 subacute aged care wards. A random sample of 40 discharge medication regimens were retrospectively simplified by clinical pharmacists and proposed changes reviewed by a clinical pharmacologist to determine feasibility of the changes and likelihood of equivalent therapeutic outcomes.ResultsOn average, 1.2 regularly scheduled long‐term medications/patient were ceased in hospital and 2.5 added. 0.6 regularly scheduled short‐term (defined duration) medications were commenced. MRCI scores increased by 22% (18 to 22; p < 0.0001) for regularly scheduled long‐term medications and 32% (21 to 27; p < 0.0001) for all medications. In multivariate analysis, using fewer medications prior to admission and being discharged from a subacute aged care ward were associated with increased regimen complexity. For the 40 discharge medication regimens reviewed, 90 simplifications to regularly scheduled long‐term medications were proposed, and 84 (93%) were rated by the clinical pharmacologist as feasible and likely to have the same or similar therapeutic outcomes to the complex regimens. These changes, if implemented, could have reduced medication regimen complexity at discharge by an average of 14%.ConclusionHospitalisation resulted in multiple medication changes and increased regimen complexity. Most medication regimens had the potential to be simplified.

Glycemic control and quality of life in diabetes mellitus

Purpose This study sought to evaluate the association between quality of life (QOL) and changes in hemoglobin A1c (HbA1c) levels in diabetic patients over a 1-year period. Methods Diabetic patients were identified from clinic databases using International Classification of Diseases (ICD-9) codes. Patients were asked to complete Short Form 36 (SF-36), which measures health-related QOL, and were invited to attend monthly diabetes education workshops. From December 2000 to December 2001, data were collected on multiple parameters, including HbA1c. SF-36 surveys were again collected at project termination. Regression analysis was used to correlate change in HbA1c with change in QOL scores while controlling for potential confounders. Results Of 1679 eligible patients identified, 380 completed SF-36 at project initiation; 243 of those also completed SF-36 at project termination. Pre- and postproject HbA1c data were available for 170 of the 243 patients who completed SF-36 at both time points. After adjusting for baseline SF-36 scores and changes in SF-36's physical component scores, a 5% decrease in HbA1c values was associated with a 1% increase in mental component scores of SF-36. No association between changes in HbA1c levels and physical QOL scores was observed. Conclusion The association between better HbA1c levels and improved mental, but not physical, QOL may reflect physical inconvenience associated with increased regimen complexity as well as mental empowerment from proactive disease management. Large experimental studies are needed to elucidate the long-term relationship between glycemic control and QOL before clinical recommendations can be made.

Effect of number of medications on cardiovascular therapy adherence.

Increasing regimen complexity is generally assumed to result in lower medication adherence, but there is conflicting evidence. This study determined the relationship between the number of medications dispensed and adherence with chronic cardiovascular regimens. A survey was administered to 367 patients who had taken an angiotensin-converting enzyme inhibitor or lipid-lowering medication for at least 3 consecutive months. Information was collected on nonprescription drug use, demographics, adverse effects, and use of adherence aids. Prescription drug use data over the previous 12 months were obtained for each subject from the British Columbia prescription claims database. Adherence for each prescription medication was calculated based on prescription fill dates and number of days supplied. Univariate and multivariate analyses were used to identify predictors of nonadherence (<80%) with cardiovascular medications. Forty-five subjects (12%) were categorized as nonadherent. Nonadherent subjects took fewer regularly scheduled prescription medications per day (4.1 +/- 2.7 vs. 5.9 +/- 3.4; p = 0.001), fewer pills per day (5.3 +/- 3.6 vs. 9.2 +/- 7.1; p < 0.001), and had fewer administration times per day (1.8 +/- 0.7 vs. 2.4 +/- 0.9; p = 0.001). A multivariate logistic regression model adjusting for age, gender, reported adverse effects, reported nonprescription drug use, and use of adherence aids identified fewer regularly scheduled prescription drugs as an independent predictor of nonadherence with chronic cardiovascular medications (OR = 0.85 per medication, 95% CI 0.74 to 0.94; p = 0.01). Contrary to popular belief, taking fewer medications was associated with lower adherence with chronic cardiovascular regimens.

Antiretroviral regimen complexity, self-reported adherence, and HIV patients' understanding of their regimens: survey of women in the her study.

Research regarding treatment adherence in chronic diseases, such as hypertension, suggests that increasing complexity in the medication regimen is associated with decreasing patient adherence. However, less is known about the relationship between regimen complexity and adherence in the treatment of HIV/AIDS. To examine the relationship between antiretroviral (ART) regimen complexity and patient understanding of correct regimen dosing to adherence (missing doses in the past 1 and 3 days). Cross-sectional survey of a cohort of women living with HIV/AIDS and enrolled in the HER (HIV Epidemiologic Research) Study. Seventy-five percent of patients correctly understood the dosing frequency of their ART medications, 80% understood the food-dosing restrictions, whereas only 63% understood both. The percentage of patients with a correct understanding of dosing decreased with increasing regimen complexity (increased dosing frequency and food-dosing restrictions). Patients were more likely to have missed doses in the previous 3 days if they were taking ART medications three or more times per day or had to take one or more antiretrovirals on an empty stomach. A multivariate logistic regression model demonstrated that patients with less complex regimens (twice daily or less in frequency, no food-dosing restrictions) who correctly understood the dosing and food restrictions of their ART regimen were less likely to have skipped doses in the past three days (odds ratio [OR], 0.4; 95% confidence interval [CI], 0.2-0.7) than those with more complex regimens. Younger age and higher CD4 count were also associated with a reduced likelihood of skipping doses. No association was found between adherence and race/ethnicity, current or past injection drug use, or education. Self-reported adherence is better among patients with less complex ART regimens. This is in part because patients' understanding of regimen dosing decreases as regimen complexity increases. Therefore, simplifying antiretroviral regimens may have an important role in improving patients' adherence.

Antiretroviral Regimen Complexity, Self-Reported Adherence, and HIV Patients' Understanding of Their Regimens: Survey of Women in the HER Study

Background: Research regarding treatment adherence in chronic diseases, such as hypertension, suggests that increasing complexity in the medication regimen is associated with decreasing patient adherence. However, less is known about the relationship between regimen complexity and adherence in the treatment of HIV/AIDS. Objective: To examine the relationship between antiretroviral (ART) regimen complexity and patient understanding of correct regimen dosing to adherence (missing doses in the past 1 and 3 days). Methods: Cross-sectional survey of a cohort of women living with HIV/AIDS and enrolled in the HER (HIV Epidemiologic Research) Study. Results: Seventy-five percent of patients correctly understood the dosing frequency of their ART medications, 80% understood the food-dosing restrictions, whereas only 63% understood both. The percentage of patients with a correct understanding of dosing decreased with increasing regimen complexity (increased dosing frequency and food-dosing restrictions). Patients were more likely to have missed doses in the previous 3 days if they were taking ART medications three or more times per day or had to take one or more antiretrovirals on an empty stomach. A multivariate logistic regression model demonstrated that patients with less complex regimens (twice daily or less in frequency, no food-dosing restrictions) who correctly understood the dosing and food restrictions of their ART regimen were less likely to have skipped doses in the past three days (odds ratio [OR], 0.4; 95% confidence interval [CI], 0.2-0.7) than those with more complex regimens. Younger age and higher CD4 count were also associated with a reduced likelihood of skipping doses. No association was found between adherence and race/ethnicity, current or past injection drug use, or education. Conclusions: Self-reported adherence is better among patients with less complex ART regimens. This is in part because patients' understanding of regimen dosing decreases as regimen complexity increases. Therefore, simplifying antiretroviral regimens may have an important role in improving patients' adherence.