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Recommendations for Improving Adherence to Type 2 Diabetes Mellitus Therapy- Focus on Optimizing Insulin-Based Therapy
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Recommendations for Improving Adherence to Type 2 Diabetes Mellitus Therapy- Focus on Optimizing Insulin-Based Therapy

R. Keith Campbell, RPh, MBA, CDE
Despite its unsurpassed efficacy in the management of diabetes, insulin has been resisted and feared for its risk of side effects (ie, weight gain, hypoglycemia). Many patients and providers have perceived insulin as a last resort therapy given to patients with a poor prognosis, and some patients even as a form of punishment for poor self-management. Also, fear of needles is a constant concern. Fortunately, these challenges to insulin use may be overcome via patient education as well as new developments in insulin therapy. Insulin formulations have been developed that possess pharmacokinetic profiles better adapted to the physiologic needs of patients with type 2 diabetes mellitus (T2DM), including rapid- and long-acting insulin analogues, as well as premixed formulations. Appropriate use of these agents is associated with improved glycemic control, higher levels of adherence to treatment, and lower healthcare costs. A variety of pen delivery systems for insulin delivery are available that allow for easier, more discreet, and more accurately dosed insulin therapy. Patients generally prefer pen delivery systems, and they are associated with greater adherence and better glycemic control as compared with vial and syringe use. In addition to the ever-increasing variety of insulin formulations and delivery systems, educational initiatives are absolutely vital in order to overcome the limited knowledge about diabetes, self-management, and coping skills that can be seen in a large proportion of people with T2DM. Improved adherence to treatment, better outcomes, and reduced costs are contingent upon the appropriate use of, and full access to, appropriate treatment and patient education.

(Am J Manag Care. 2012;18:S55-S61)
While insulin was once regarded as a last resort for the treatment of type 2 diabetes mellitus (T2DM), to be initiated only after the failure of oral therapies, this is no longer the case. The Standards of Medical Care in Diabetes—2012, produced by the American Diabetes Association (ADA), states that insulin should be considered as initial treatment, with or without additional agents, for newly diagnosed patients with T2DM whose blood glucose or glycated hemoglobin (A1C) levels are markedly elevated and/or who are highly symptomatic.1 Notably, however, initiation of insulin therapy is frequently delayed despite inadequate glycemic control.2

Patients and healthcare providers may resist the initiation and intensification of insulin therapy for a variety of reasons. Patient resistance to insulin is premised around several concerns, including anxiety about treatment complications such as hypoglycemia, fear of needles, and inconvenient dosing schedules.3 These concerns have been addressed in recent years with the development of new formulations and modes of insulin delivery that help lower the risk of complications while alleviating needle fear and improving dosing convenience. However, the existence of these newer options does not, alone, overcome patient resistance, and formal as well as informal patient education is necessary to address patient concerns regarding insulin therapy. For example, educating patients about forms of insulin that reduce the risk of hypoglycemia and that are more easily integrated into their lifestyles can help lessen anxieties. Similarly, patients should be assured that needles are much smaller and less invasive than they once were, and that insulin pens are easy to use, convenient, and not associated with significant pain.

This article will focus on strategies for improving adherence to insulin treatment, and will review available formulations and newer forms of insulin that can help improve treatment adherence, potentially improving outcomes and lowering healthcare costs. The article will also include a discussion of the role of education in improving adherence.

Resistance to Insulin Therapy and Concerns Regarding Treatment Complications

Patients’ concerns about insulin take several forms. For many patients, resistance to insulin is also a result of their perception that insulin is only used for “serious” cases, and that it is socially embarrassing to have to use insulin. Some patients regard the use of insulin as a kind of punishment imposed by the healthcare provider for patients’ inability to properly control their disease, or as a sign of their personal failure, and an indication that their disease has entered a new, more dire stage.3,4 Patients with T2DM—whether they are taking insulin or are being treated with other kinds of hypoglycemic agents—also express high levels of concern about balancing glycemic control with the need to avoid side effects. Concerns about weight gain as well as heart attack risk due to medication in particular may be associated with poorer adherence.5

Needle anxiety is very common among patients who require insulin.3 A number of recent developments have helped to address some of patients’ concerns regarding needles by making the administration of insulin simpler and more discreet. Needles have become smaller and narrower in design, which helps reduce the fear and pain associated with injections. Studies of patients with diabetes have demonstrated greater satisfaction with and acceptance of smaller diameter needles.6,7

The advent of pen devices has also had a large impact on the acceptability of injections in diabetes and on adherence.8,9 Pen devices incorporate a variety of design elements that make them particularly convenient and discreet to use, while maximizing portability and dosing accuracy as compared with vial and syringe. Pen devices include both disposable prefilled devices and durable devices with prefilled replacement cartridges.9 Moreover, manufacturers continue to refine the design of pen devices. For example, newer designs that are easier to use for patients with limited dexterity have been developed.10 The design of pen devices has also been refined to improve the readability of dosing scales.11

Pen Devices for Insulin Delivery

Issues of safety and efficacy obviously precede questions of adherence, and both safety and efficacy have been shown to be comparable for insulin delivery by pen devices versus syringe delivery.11 At the same time, data from the medical literature largely support the advantages of insulin delivery via pen devices for improving adherence, and in most cases also support a concurrent lowering of healthcare utilization and costs.12

Lee et al analyzed claims data from 57 managed care organizations (MCOs) and identified 1156 patients newly initiating the use of a pen device who had previously used syringes for insulin delivery, and who represented a national cross-section based on demographics and insurance plan type. The claims analysis showed that patients with T2DM who switched to a prefilled insulin analogue pen device exhibited significantly better medication adherence based on medication possession ratio (MPR) (69% vs 62%; P <.01); 64% fewer claims for hypoglycemic events (P <.05); fewer hypoglycemia-related emergency department (ED) and physician visits (both P <.05); and lower overall annual treatment costs (P <.01), including lower costs for ED visits, physician visits, hospitalization, and pharmacy expenditures (all P <.01).13

Baser et al undertook a retrospective claims analysis using data from one of the largest US health plans, and found that over the course of the study period (5 years and 3 months), those who had been using a vial and syringe for insulin delivery and continued to do so (n = 532) experienced a 0.13 increase in adherence based on MPR compared with a 0.22 increase in adherence for those who switched from vial and syringe to a pen device (n = 532), a difference that was highly statistically significant (P = .0011).14

Pawaskar et al compared adherence and costs for North Carolina Medicaid patients with T2DM in 2 separate patient cohorts: 1) patients switching from syringe-delivered to pen-delivered insulin versus those remaining on syringe-delivered insulin, and 2) patients initiating syringe-delivered insulin versus those initiating pen-delivered insulin as an add-on to oral antidiabetic drugs (OADs).15 In the first patient cohort (patients switching from syringe-delivered to pen-delivered insulin versus those remaining on syringe-delivered insulin), diabetes medication adherence based on MPR was lower for those switching to pen devices compared with those who stayed with syringes (45% vs 56%; P <.05), although overall medication adherence (ie, adherence to all medications, including diabetes medications) improved among patients using pen delivery (92% vs 90%; P <.05). Total healthcare costs were somewhat lower in the pen delivery group, although not significantly so. In the second cohort (patients initiating syringe-delivered insulin versus those initiating pen-delivered insulin as an add-on to OADs), patients receiving insulin via pen were slightly more adherent (53% vs 50%), but not to the point of statistical significance. Overall treatment costs, however, were significantly lower for patients in the pen delivery group (P <.05), including lower total diabetes-related costs, as well as lower hospitalization costs, outpatient costs, and insulin prescription costs (all P <.05).15

A recent study employing data from a large nationwide database, which included information from a wide variety of managed care plans, focused on the relative clinical effects of initiating insulin therapy with disposable pen delivery compared with initiating therapy with syringe delivery in 3842 patients with T2DM (n = 1921 for each group).8 The study period consisted of a 6-month period of baseline data and a 12-month follow-up period starting at the initiation of insulin therapy. With regard to glycemic control, patients using the pen device (whose mean baseline A1C levels were higher than those using a syringe) experienced a significantly greater A1C decrease than those in the syringe group. After 12 months, A1C levels were similar in both groups, as were the numbers of patients achieving an A1C less than 7%. Healthcare utilization and healthcare costs were also similar in both groups, while adherence was significantly better among patients using the pen device.8

The clinical utility and impact on adherence of a biphasic insulin pen device was analyzed in 486 patients with T2DM who had converted from syringe delivery, using data drawn from the PharmaMetrics database.9 Adherence was significantly improved (P <.01) compared with the study subjects’ previous experience with syringes, while hypoglycemic events were reduced by 74% (P <.05), as were hypoglycemia-related ED and physician visits (both P <.05). In addition, all-cause annual costs, hypoglycemia-related costs, and other diabetes-attributable costs were all significantly lower with biphasic pen use (all P <.01).9

Finally, a literature review identified 5 studies comparing syringe- with pen-delivered insulin for adherence, hypoglycemic events, and costs. While the studies were heterogeneous in design, they overwhelmingly observed improvements in adherence and reductions in both healthcare utilization and costs associated with pen device use (Table 1).9,12,13,15-17

Evolving Varieties and Formulations of Insulin

The development of purified short- and intermediate-acting human insulins has helped address limitations inherent in earlier insulin formulations, and the more recent introduction of various formulations and novel varieties of insulin analogues has helped improve outcomes and adherence while also contributing to lower overall costs.18-21

Insulin analogues have been developed with characteristics (ie, onset of effect, peak effect, and duration of effect) that are more suited to the physiologic needs of patients with T2DM. Insulin analogues are available in rapid-acting and long-acting formulations. The rapid-acting insulin analogues reach peak levels more rapidly than human insulin, while long-acting basal analogues are designed to have a relatively flat plasma concentration profile.22 Premixed formulations combining rapid- and intermediate-acting insulin are also available; these formulations offer some of the advantages of the ideal insulin control seen with basal-bolus administration but with a simpler dosing schedule. This approach offers a middle ground between dosing convenience and optimal control.23

 
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