Topically Applied therapies for the treatment of skin disease : Past Present and Future.

The purpose of this review is to summarize essential biological, pharmaceutical and clinical aspects in the field of topically applied medicines that may help scientists when trying to develop new topical medicines. After a brief history of topical drug delivery, a review of the structure and function of the skin, routes of drug absorption and their limitations is then provided. The most prevalent diseases and current topical treatment approaches are then detailed, the organization of which reflects the key disease categories of autoimmune and inflammatory, microbial infections, skin cancers and genetic skin diseases. The complexity of topical product development through to large scale manufacture along with recommended risk mitigation approaches is then highlighted. As such topical treatments are applied externally patient preferences along with the challenges they invoke are then described and finally the future of this field of drug delivery is discussed with the emphasis on areas that are more likely to yield significant improvements over the topical medicines in current use or would expand the range of medicines and diseases treatable by this route of administration. Significance Statement This review of the key aspects the skin, its associated diseases and current treatments along with the intricacies of topical formulation development should be helpful in making judicious decisions about the development of new or improved topical medicines. These aspects include the choices of the active ingredients, formulations, the target patient populations preferences and limitations and the future with regards to new skin diseases and topical medicine approaches.

Skin permeation and penetration of mometasone furoate in the presence of emollients: An ex vivo evaluation of clinical application protocols.

Background: Topical corticosteroids (TCS) and emollients are developed independently by the pharmaceutical industry but are often used together in practice. There is potential for the TCS and emollient formulations to interact on the skin surface affecting TCS absorption into the skin. Clinical guidelines acknowledge this issue but lack an evidence base and differ in their recommendations. There is a current clinical need to establish whether the application protocol employed for TCS and emollient products can impact delivery of TCS to the skin. Objectives: To investigate whether the sequence of application of a TCS and emollient and the time between their application can affect TCS skin absorption. Methods: The delivery of mometasone furoate (MF) to ex vivo human skin was evaluated following the application of Elocon cream either 5 or 30 min, before and after three different emollients. Mechanistic explanation of the changes in drug absorption was provided by modelling the skin permeation data and Raman microscopy of mixed Elocon cream and emollient formulations. Results: A circa fivefold difference in MF absorption was observed depending on the emollient and application protocol. Applying Elocon cream at short intervals in relation to Hydromol intensive significantly increased MF absorption regardless of the application protocol. In contrast, applying Elocon cream after Diprobase cream or ointment significantly reduced MF absorption relative to Elocon cream alone or when Elocon cream was applied before these emollients. The changes in drug absorption observed were attributed to the presence of emollients altering Elocon cream formulation performance through different mechanisms, including introduction of penetration enhancing excipients and inducing drug crystallization in the mixed TCS emollient layer on the skin surface. Conclusions: Emollients can affect MF absorption in different ways depending on the emollient and sequence of administration. Using a 30 min gap between product applications may not be sufficient to mitigate emollient effects on TCS absorption.

Polymer Architecture Effects on Poly(N,N-Diethyl Acrylamide)-b-Poly(Ethylene Glycol)-b-Poly(N,N-Diethyl Acrylamide) Thermoreversible Gels and Their Evaluation as a Healthcare Material.

Thermoreversible gels which transition between liquid-like and solid-like states when warmed have enabled significant novel healthcare technologies. Poly(N,N-diethyl acrylamide) (PDEA) is a thermoresponsive polymer which can be used as a trigger to form thermoreversible gels, however its use in these materials is limited and crucial design principles are unknown. Herein ABA copolymers with the structure PDEA-b-poly(ethylene glycol) (PEG)-b-PDEA are synthesized to give four block copolymers with varied molecular weight of PDEA and PEG blocks. Rheometry on solutions of the block copolymers reveals that high molecular weight PEG blocks are required to form thermoreversible gels with predominantly solid-like behavior. Furthermore, small-angle X-ray scattering elucidates clear differences in the nanostructure of the copolymer library which can be linked to distinct rheological behaviors. A thermoreversible gel formulation based on PDEA (20 kDa)-b-PEG (10 kDa)-b-PDEA (20 kDa) is designed by optimizing the polymer concentration and ionic strength. It is found that the gel is mucoadhesive, stable, and non-toxic, as well as giving controlled release of a hydrophobic drug. Overall, this study provides insight into the effect of polymer architecture on the nanostructure and rheology of PDEA-b-PEG-b-PDEA and presents the development of a highly functional thermoreversible gel with high promise for healthcare applications.

The use of polymer blends to improve stability and performance of electrospun solid dispersions: The role of miscibility and phase separation.

Solid dispersion-based nanofiber formulations of poorly soluble drugs prepared by electrospinning (ES) with a water-soluble polymer, can offer significant improvements in drug dissolution for oral drug administration. However, when hygroscopic polymers, such as polyvinylpyrrolidone (PVP) are used, environmental moisture sorption can lead to poor physical stability on storage. This study investigated the use of polymer blends to modify PVP-based ES formulations of a model poorly soluble drug, fenofibrate (FF), to improve its physical stability without compromising dissolution enhancement. FF-PVP ES dispersions demonstrated clear dissolution enhancement, but poor storage stability against high humidity. Polymer blends of PVP with Eudragit E, Soluplus and hypromellose acetate succinate (HPMCAS), were selected because of the low intrinsic moisture sorption of these polymers. The drug-polymer and polymer-polymer miscibility study revealed that FF was more miscible with Eudragit E and Soluplus than with PVP and HPMCAS, and that PVP was more miscible with HPMCAS than Eudragit E and Soluplus. This led to different configurations of phase separation in the placebo and drug-loaded fibres. The in vitro drug release data confirmed that the use of PVP-Eudragit E retained the dissolution enhancement of the PVP formulation, whereas PVP-Soluplus reduced the drug release rate in comparison to FF-PVP formulations. The moisture sorption results confirmed that moisture uptake by the polymer blends was reduced, but formulation deformation occurred to phase-separated blend formulations. The data revealed the importance of miscibility and phase separation in understanding the physical stability of the ES fibre mats. The findings provide insight into the design of formulations that can provide dissolution enhancement balanced with improved storage stability.

Easy to Swallow "Instant" Jelly Formulations for Sustained Release Gliclazide Delivery.

It is a challenge to safely administer sustained release medicines to patients with dysphagia. Sustained release tablets must not be crushed and multiparticulates with large particle sizes cause gritiness reducing patient acceptability. The aim of this study was to develop "instant" jellies as delivery vehicles incorporating sustained release microparticles for patients with dysphagia. Dry powder mixtures containing gelling agents such as sodium alginate and calcium ions were hydrated in 20 mL of water and formed a jelly texture within 10 min. The "instant" jellies demonstrated comparable properites to commercial "read-to-eat" jellies in appearance, rheological/textural properties and in vitro swallowing performance in an artificial throat model. Gliclazide sustained release microparticles were produced by fluidized bed coating using Eudragit® NM 30 D and achieved 99% production yield and final coated particle size (D50) of 198 ± 4.3 µm. Sustained gliclazide release was achieved over 15 h and the incorporation of the particles into the jellies significantly decreased the drug release rate. This novel drug delivery system offers a patient-centric solution to the long-standing challenge of administering sustained release medicines to patients with dysphagia and can potentially be used for paediatric patients.

The Swallowing Characteristics of Thickeners, Jellies and Yoghurt Observed Using an In Vitro Model.

Drinks and foods may be thickened to improve swallowing safety for dysphagia patients, but the resultant consistencies are not always palatable. Characterising alternative appetising foods is an important task. The study aims to characterise the in vitro swallowing behaviour of specifically formulated thickened dysphagia fluids containing xanthan gum and/or starch with standard jellies and yoghurt using a validated mechanical model, the "Cambridge Throat". Observing from the side, the model throat can follow an experimental oral transit time (in vitro-OTT) and a bolus length (BL) at the juncture of the pharynx and larynx, to assess the velocity and cohesion of bolus flow. Our results showed that higher thickener concentration produced longer in vitro-OTT and shorter BL. At high concentration (spoon-thick), fluids thickened with starch-based thickener showed significantly longer in vitro-OTT than when xanthan gum-based thickener was used (84.5 s ± 34.5 s and 5.5 s ± 1.6 s, respectively, p < 0.05). In contrast, at low concentration (nectar-like), fluids containing xanthan gum-based thickener demonstrated shorter BL than those of starch-based thickener (6.4 mm ± 0.5 mm and 8.2 mm ± 0.8 mm, respectively, p < 0.05). The jellies and yoghurt had comparable in vitro-OTT and BL to thickeners at high concentrations (honey-like and spoon-thick), indicating similar swallowing characteristics. The in vitro results showed correlation with published in vivo data though the limitations of applying the in vitro swallowing test for dysphagia studies were noted. These findings contribute useful information for designing new thickening agents and selecting alternative and palatable safe-to-swallow foods.

Heat Enhanced Follicular Delivery of Isotretinoin to the Skin.

PURPOSE: The aim of this work was to evaluate the use of short durations of externally applied heat with chemical penetration enhancers to improve delivery of isotretinoin to the skin and in particular via the follicular route. METHODS: A range of chemical penetration enhancers were screened for their ability to improve isotretinoin delivery into human skin with heat using infinite dose, Franz cell experiments conducted in a water bath at a higher temperature to simulate heated conditions. Following this a prototype external heating system was developed that provided short durations of heat and its ability to improve delivery of finite doses into the skin and hair follicles was assessed. RESULTS: The magnitude of the effect of heat on drug delivery was influenced by the choice of vehicle with changes in isotretinoin flux across skin ranging from not statistically significant to 25 fold increases with heat in the infinite dose studies. The prototype heating system provided significant increases in the total delivery of isotretinoin into the skin from an optimised vehicle. Drug distribution in the skin revealed significant increases in isotretinoin delivery to the hair follicles, and deeper skin layers, but not to the stratum corneum, providing strong evidence that the enhancement in delivery occurred mainly via the hair follicles. CONCLUSION: These data indicate that the use of short durations of heat combined with chemical penetration enhancers offers a valuable strategy for improving the delivery of drugs such as isotretinoin to the skin via the hair follicles. Graphical Abstract Schematic illustration of the sodium thiosulphate heating system on a Franz diffusion cell and the subsequent impact of a short burst of heat on the delivery of isotretinoin into human skin.

Effect of transdermal magnesium cream on serum and urinary magnesium levels in humans: A pilot study.

BACKGROUND: Oral magnesium supplementation is commonly used to support a low magnesium diet. This investigation set out to determine whether magnesium in a cream could be absorbed transdermally in humans to improve magnesium status. METHODS AND FINDINGS: In this single blind, parallel designed pilot study, n = 25 participants (aged 34.3+/-14.8y, height 171.5+/-11cm, weight 75.9 +/-14 Kg) were randomly assigned to either a 56mg/day magnesium cream or placebo cream group for two weeks. Magnesium serum and 24hour urinary excretion were measured at baseline and at 14 days intervention. Food diaries were recorded for 8 days during this period. Mg test and placebo groups' serum and urinary Mg did not differ at baseline. After the Mg2+ cream intervention there was a clinically relevant increase in serum magnesium (0.82 to 0.89 mmol/l,p = 0.29) that was not seen in the placebo group (0.77 to 0.79 mmol/L), but was only statistically significant (p = 0.02)) in a subgroup of non-athletes. Magnesium urinary excretion increased from baseline slightly in the Mg2+ group but with no statistical significance (p = 0.48). The Mg2+ group showed an 8.54% increase in serum Mg2+ and a 9.1% increase in urinary Mg2+ while these figures for the placebo group were smaller, i.e. +2.6% for serum Mg2+ and -32% for urinary Mg2+. In the placebo group, both serum and urine concentrations showed no statistically significant change after the application of the placebo cream. CONCLUSION: No previous studies have looked at transdermal absorbency of Mg2+ in human subjects. In this pilot study, transdermal delivery of 56 mg Mg/day (a low dose compared with commercial transdermal Mg2+ products available) showed a larger percentage rise in both serum and urinary markers from pre to post intervention compared with subjects using the placebo cream, but statistical significance was achieved only for serum Mg2+ in a subgroup of non-athletes. Future studies should look at higher dosage of magnesium cream for longer durations. TRIAL REGISTRATION: ISRCTN registry ID No. ISRTN15136969.

Disc-shaped polyoxyethylene glycol glycerides gel nanoparticles as novel protein delivery vehicles.

Disc-shaped nanoparticles with high aspect ratios have been reported to show preferential cellular uptake in vitro by mammalian cells. However, engineering and producing such disc-shaped nanoparticles are often complex. This study reports for the first time the use of a single, approved pharmaceutical excipient to prepare stable disc-shaped nanoparticles with a high aspect ratio via a simple, organic solvent free process. These disc-shaped nanoparticles were formed by fragmentation of stearoyl macrogol-32 glycerides (Gelucire 50/13) hydrogels. The nanoparticles showed good physical stability as a result of their outer coating of polyethylene glycol (PEG) that is a part of Gelucire composition. Using lysozyme as a model hydrophilic protein, these nanoparticles demonstrated a good loading capacity for hydrophilic macromolecules, mainly via surface adsorption. As a result of the higher hydrophobicity of the core of the nano-discs, the loading efficiency of hydrophobic model components, such as Coumarin-6, was significantly increased in comparison to the model hydrophilic compound. These Gelucire nano-discs exhibited no cytotoxicity at the tested level of 600µg/ml for Caco-2 cells. Rapid in vitro cellular uptake of the disc-shaped nanoparticles by Caco-2 cells was observed. This rapid internalisation was attributed to the high aspect ratio of the disc-shape nanoparticles which provides a high contact surface area between the particles and cells and may lower the strain energy required for membrane deformation during uptake. The results of this study demonstrate the promising potential of Gelucire nano-discs as effective nanocarriers for drug delivery and which can be manufactured using a simple solvent-free process.

Physical stabilization of low-molecular-weight amorphous drugs in the solid state: a material science approach.

Use of the amorphous state is considered to be one of the most effective approaches for improving the dissolution and subsequent oral bioavailability of poorly water-soluble drugs. However as the amorphous state has much higher physical instability in comparison with its crystalline counterpart, stabilization of amorphous drugs in a solid-dosage form presents a major challenge to formulators. The currently used approaches for stabilizing amorphous drug are discussed in this article with respect to their preparation, mechanism of stabilization and limitations. In order to realize the potential of amorphous formulations, significant efforts are required to enable the prediction of formulation performance. This will facilitate the development of computational tools that can inform a rapid and rational formulation development process for amorphous drugs.

Access to bereavement services in hospice.

Hospice bereavement services, though often overlooked in hospice research, are an important area of study due not only to the potential value of bereavement support but also the emphasis placed on such services by the Centers for Medicare and Medicaid Services. Moreover, access to these services is seldom understood or researched. Therefore, using the patient public use file of the 2007 National Home and Hospice Care Survey, we explored the relationships between patient, informal caregiver, and agency characteristics as well as discharges from hospice to gain perspective into bereavement service access to informal caregivers. Findings suggested that death at discharge from hospice may be an important moderator variable between access to hospice bereavement support and many other factors. However, even under controls for death at discharge, two agency characteristics remain significantly associated with access. Bereavement access tends to be more likely in agencies that provide only hospice care as opposed to other services, and in micropolitan agencies. Furthermore, death at discharge is less likely among African Americans, suggesting the value of enhanced culturally-appropriate and more targeted hospice care and hospice bereavement support for this population. Future research should explore the strategies used to effectively deliver bereavement services and how these strategies may benefit from targeted and culturally sensitive approaches.

Stabilisation of amorphous drugs under high humidity using pharmaceutical thin films.

In this study, the stabilization effects of three polymers on four model drugs (felodipine, fenofibrate, carbamazepine, and celecoxib) under saturated humidity were investigated. Three different types of thin films (solid dispersions, drug films with a polymer film coating and drug films laid on top of polymer coated surfaces) were prepared and compared with films containing the drug alone. ATR-FTIR spectroscopy, polarised light microscopy (PLM), scanning electron microscopy (SEM) and nano-thermal analysis (nano-TA) were performed on the model systems after storage under saturated humidity. The recrystallisation tendency of the drug in the drug containing thin films was found to be strongly related to the intrinsic crystallization tendency of the drug film alone and the strength of drug-polymer interactions. Additionally, under high humidity, the glass transition temperature of the polymer is no longer an indicator of its drug stabilization capability. Instead, it is the hygroscobicity of the polymer that appears to be the most important parameter. Amongst the polymers tested in this study, EUDRAGIT E PO was found to have the greatest inhibitory effect on crystallization, whilst PVP K30 was found to have the least protective effect; presumably because of its hygroscopic nature.

Moisture uptake of polyoxyethylene glycol glycerides used as matrices for drug delivery: kinetic modelling and practical implications.

PURPOSE: Gelucire 50/13, a polyoxyethylene glycol glyceride mixture, has been widely used in drug delivery, but its moisture uptake behaviour is still poorly understood. In this study, the effects of relative humidity, temperature, and drug incorporation on the moisture uptake of Gelucire are reported in relation to their practical implications for preparation of solid dispersions using this material. METHODS: DVS combined with kinetics modelling was used as the main experimental method to study the moisture uptake behaviour of Gelucire. Thermal and microscopic methods were employed to investigate the effect of moisture uptake on the physical properties of the material and drug loaded solid dispersions. RESULTS: The moisture uptake by Gelucire 50/13 is temperature and relative humidity dependent. At low temperatures and low relative humidities, moisture sorption follows a GAB model. The model fitting indicated that at high relative humidities the sorption is a complex process, potentially involving PEG being dissolved and the PEG solution acting as solvent to dissolve other components. CONCLUSION: Careful control of the storage and processing environmental conditions are required when using Gelucire 50/13. The incorporation of model drugs not only influences the moisture uptake capacity of Gelucire 50/13 but also the solidification behaviour.

The influence of home-delivered dietary approaches to stop hypertension meals on body mass index, energy intake, and percent of energy needs consumed among older adults with hypertension and/or hyperlipidemia.

BACKGROUND: It is unclear whether participation in home-delivered meal programs similar to the Older Americans Act home-delivered meals program influence weight status among older adults with hypertension and/or hyperlipidemia. OBJECTIVE: To examine the influence of a home-delivered Dietary Approaches to Stop Hypertension (DASH) meal intervention on body mass index (BMI), energy consumed, and percent of energy needs consumed. DESIGN: A 1-year randomized control trial of home-delivered DASH meals and medical nutrition therapy conducted from 2003 through 2005. Participants who received DASH meals were compared with those who did not receive meals. Data were collected in participants' homes at baseline, 6 months, and 12 months. PARTICIPANTS/SETTING: The study sample was composed of 298 adults aged >60 years with hypertension and/or hyperlipidemia residing in a county in the southeastern part of North Carolina. INTERVENTION: Participants in the meals intervention group received seven frozen meals per week for 1 year. The meals were designed to meet one third of participants' energy and nutrient needs and to comply with the DASH diet. MAIN OUTCOME MEASURES: Change in BMI, energy consumed, and percent of energy needs consumed. STATISTICAL ANALYSES PERFORMED: Difference-in-differences models were used to estimate the effects of the meal intervention on BMI, energy consumed, and percent of daily energy needs consumed. Analyses were conducted among the full sample and by subgroup (ie, race, income, and baseline obesity status). RESULTS: In the full sample, receipt of meals did not have a significant effect on BMI, energy consumed, or percent of daily energy needs consumed. Among those living at or above the 165% poverty threshold, receipt of home-delivered meals was significantly associated with a decrease in energy consumed and, therefore, percent of daily energy needs consumed. CONCLUSIONS: Participation in a home-delivered DASH meal program did not lead to weight gain or weight loss in a group of mostly overweight or obese older adults with hypertension and/or hyperlidemia.

Organizational factors associated with the use of telehospice.

We investigated organizational factors associated with the use of telehospice (defined as the use of video technology by hospices). The investigation was based on the 2007 National Home and Hospice Care Survey. There were 695 hospice agencies, of which 6% used telehospice. Logistic regression was used to examine the relation between use of hospice and a number of organizational factors. The dependent variable was the use/non-use of video technology in patient monitoring or consultations with professionals. Most of the variables that were significantly associated with the use of telehospice were related to characteristics of the agency director. If the director had at least a Masters degree or had a longer tenure as director of the agency, there was a higher likelihood that the agency used telehospice. If the director was a nurse, the likelihood that telehospice was used was considerably lower. Organizations with inter-agency contracts were less likely to use telehospice. Providing financial, training and organizational support to agencies that recognize the potential benefits of telehospice would probably assist in its future introduction.

Cost-effectiveness of medical nutrition therapy and therapeutically designed meals for older adults with cardiovascular disease.

BACKGROUND: Many older adults experience hyperlipidemia and hypertension, but there is little information about whether medical nutrition therapy (MNT) or therapeutic meals have independent or joint beneficial effects on older adults with these diagnoses. OBJECTIVE: To assess the cost-effectiveness of MNT and therapeutic meals for older adults with hyperlipidemia and/or hypertension. DESIGN: A 1-year prospective four-arm controlled randomized community-based clinical trial. SUBJECTS/SETTING: Participants were people ages 60 years or older residing in community settings who were medically diagnosed with either hypertension or hyperlipidemia. They were recruited through a number of venues beginning in May 2003. INTERVENTION: The 321 eligible individuals were assigned to one of four arms: (a) a literature control group, (b) a therapeutic meal group that received seven diagnosis-appropriate therapeutic meals a week, (c) an MNT group, and (d) an MNT-plus-therapeutic meal group. MAIN OUTCOME MEASURE: The outcome measure was quality-adjusted life-years (QALYs). Costs included both intervention and medical costs. STATISTICAL ANALYSES: Estimations of separate models of costs and QALYs facilitated the construction of incremental cost-effectiveness ratios. Net benefit analysis produced the probability that each intervention was cost-effective given different values for society's willingness to pay for a QALY. RESULTS: Therapeutic meals are cost-effective. Using the net benefit approach and a willingness to pay of $109,000 per QALY, the probability that the therapeutic meal delivery program is cost-effective is 95% and for MNT the probability is 90%. However, the combination of MNT and therapeutic meals did not have an independent significant effect on QALYs. CONCLUSIONS: Results inform the debate about extending Medicare funding for MNT to individuals with hypertension and hyperlipidemia. Future research should include more individuals who are not currently receiving medications for these diseases.

Oncology nurses' personal understandings about palliative care.

PURPOSE/OBJECTIVES: To examine how oncology nurses define palliative care, views about who should and should not receive palliative care, and beliefs about palliative care decision making, including who should be involved and how decisions should be managed. DESIGN: Qualitative interviews and analysis. SETTING: Preferred location of each respondent. SAMPLE: 12 nurses representing different aspects of oncology nursing. METHODS: An interview guide was employed to ensure that specific topics were covered. Interviews were transcribed verbatim. Qualitative analysis consisted of independent, multiple reviews of the transcripts to share initial findings and identify, refine, and reach consensus on major themes and subthemes. MAIN RESEARCH VARIABLES: Nurses' definitions of palliative care, views about who should and should not receive palliative care, and beliefs about palliative care decision making. FINDINGS: Nurses' perceptions of palliative care focused on symptom management. Most did not distinguish between palliative care and hospice and believed that only patients who were near the end of life should receive palliative care. They viewed their role in decisions regarding palliative care to be limited and indirect. CONCLUSIONS: Although oncology nurses should be at the cutting edge with regard to palliative care, these nurses' personal understandings could serve to limit care for many patients with cancer who could benefit from it. IMPLICATIONS FOR NURSING: Education and clinical experience embedded in a continuous quality-improvement model are needed to ensure sustained change that will overcome the multiple, interwoven barriers to providing appropriate palliative care.

The effect of home-delivered Dietary Approach to Stop Hypertension (DASH) meals on the diets of older adults with cardiovascular disease.

BACKGROUND: Many older adults with hyperlipidemia or hypertension participate in the Older Americans Act Nutrition Program, which serves meals in community settings and delivers meals to homes. However, there is little information regarding whether therapeutic meals designed around Dietary Approach to Stop Hypertension (DASH) principles have a beneficial effect on the diets of these older adults. OBJECTIVE: The objective of this study was to determine the degree to which dietary change is influenced by providing 7 home-delivered therapeutic meals weekly to adults aged > or = 60 y. DESIGN: We conducted a 1-y randomized controlled trial in 298 persons with hyperlipidemia or hypertension, in which 50% of participants received 7 therapeutic meals per week for 12 mo. Those in need of dietary change at baseline (n = 210) were examined. Changes in intermediate DASH accordance, DASH accordance, and the nutrients that make up the DASH diet were measured by using 24-h food recalls at baseline, 6 mo, and 12 mo. Chi-square tests, t tests, and multiple regression were used to examine the association between receipt of meals and dietary change over time. RESULTS: Participants who received meals were 20% (P = 0.001) more likely to reach intermediate DASH accordance at 6 mo and were 18% (P = 0.007) more likely to meet saturated fat accordance at 12 mo than were those who did not receive meals. When stratified by race and income, gains were marginally larger for whites and higher-income individuals. CONCLUSION: Delivery of 7 DASH meals per week was found to increase compliance with dietary recommendations among noncompliant older adults with cardiovascular disease.