Human mouthfeel panel investigating the acceptability of electrospun and solvent cast orodispersible films.

A human panel study was performed to investigate the acceptability of orodispersible electrospun and solvent cast films. 50 healthy volunteers took two drug-free samples of polyvinyl alcohol films prepared by the two methods. On a 5-point hedonic scale, the volunteers assessed the films' perceived size, stickiness, thickness, disintegration time, thickening effect on saliva, and handling. The films manufactured by both methods were similar in their end-user acceptability. The modal values of perceived size, thickness, disintegration time, saliva thickening effect, and handling were high (4 or 5). However, for both, the stickiness mode was 2 (strongly sticky) and the only negative attribute. Both films were reported to take approximately 30 s to disintegrate completely in the mouth. Electrospun films scored similarly high to solvent cast orodispersible films in most attributes of end-user acceptability. Electrospun films were marginally preferred, with 27 out of 50 participants picking electrospinning when presented with a forced choice test of both fabrication methods. This is the first study to show that electrospinning enables the fabrication of orodispersible films that are acceptable to adult human participants in terms of handling and mouthfeel and suggests that the potential for clinical translation of such formulations is high.

Acceptability and performance of a nonwoven device for vaginal drug delivery among women and their male partners in KwaZulu-Natal, South Africa.

Background: Multipurpose prevention technologies are needed to provide protection against HIV and sexually transmitted infections. Gel-based vaginal microbicides inserted via an applicator are prone to leakage. A novel device for vaginal drug delivery was developed to contain gel-based formulations, aiming to improve gel retention and reduce leakage. The objectives of this study were to assess acceptability and performance of a nonwoven vaginal delivery device. Methods: A nonwoven vaginal delivery device was prepared, pre-saturated with a commercially available water-based lubricant, with a finger pocket for insertion and string for removal. Quantitative and qualitative methods were used to collect data from interviews with 40 women and 10 male partners recruited from a sexual and reproductive health clinic in Durban, KwaZulu-Natal, South Africa. Women wore one device in the clinic and one device overnight or with their partner during intercourse. The primary endpoint was acceptability including comfort, ease of insertion and removal, and opinions on device attributes. Results: Most women said the device was 'easy' to insert and remove. Six women reported leakage after insertion and 34 reported having sexual intercourse while wearing the device. One woman was lost-to-follow-up and five women only wore the device overnight because their partners did not agree to intercourse with the inserted device. The best-liked attribute was the device's lubrication (22 women, 7 men); the least-liked was the removal string (9 women, 8 men). Conclusions: Data are promising for further development of this nonwoven device for vaginal drug delivery. Plain English summary Multipurpose prevention technologies (MPTs) that protect against HIV and sexually transmitted infections (STIs) are urgently needed. A variety of vaginal gel-based products are actively being researched; however, these products can often have challenges with vaginal leakage and retention. This research investigates the acceptability and performance of a nonwoven device to deliver vaginal gel formulations. The gel used in this study was a currently available marketed personal lubricant. In South Africa, 40 women (and 10 male partners) were recruited and given the opportunity to comment on various device attributes after insertion, overnight wear and sexual intercourse with their male partners. Generally, participants found the device easy to use and acceptable, where many factors possibly contributed to the device's acceptability (i.e., similarity to tampons, saturation with lubricant, minimal leakage, ease of insertion, comfort during intercourse and the male partners' willingness to have vaginal intercourse with the device in place). Further studies of the vaginal delivery device for acceptability, safety and efficacy using a gel-based formulation with an active ingredient are warranted.

Impact of patient choice for different postcesarean delivery analgesic protocols on opioid consumption: a randomized prospective clinical trial.

BACKGROUND: Choice of postcesarean delivery analgesic protocol may improve pain experience and reduce analgesic requirements. METHODS: Cesarean delivery patients were randomly assigned either to choose their postcesarean delivery analgesia protocol or to have no choice and receive routine care. Choices were low (50 µg intrathecal morphine), medium (identical to routine care: 150 µg intrathecal morphine), or high (300 µg intrathecal morphine with 600 mg oral gabapentin). All groups received scheduled acetaminophen and ibuprofen. The primary outcome was oxycodone requirements 0-48 hours postdelivery in those offered versus not offered a choice. RESULTS: Of 160 women enrolled, 120 were offered a choice and 40 were not offered a choice. There was no difference in oxycodone requirements or pain associated with choice, but those who had a choice expressed more satisfaction than those who did not have a choice (mean (95% CI) difference 5% (0% to 10 %), p=0.005). In the choice group, the high dose group required more oxycodone (5 (0 to 15) mg 0-24 hours after delivery and 15 (10 to 25) mg at 24-48 hours; p=0.05 and p=0.001) versus the low and medium groups. The low dose group had less pruritus (p=0.001), while the high dose group had more vomiting (p=0.01) requiring antiemetic treatment (p=0.04). CONCLUSION: Having a choice compared with no choice routine care did not reduce oxycodone requirements or pain scores. However, women have insight into their analgesic needs; women offered a choice and who chose the higher dose analgesic protocol required more oxycodone, and women who chose the lower dose protocol required less oxycodone. Despite providing additional analgesic (six times more intrathecal morphine plus gabapentin in high dose vs low dose protocols), we still did not equalize postcesarean oxycodone requirement differences between groups. TRIAL REGISTRATION NUMBER: NCT02605187.

Patient Acceptance of Sustained Glaucoma Treatment Strategies.

PURPOSE: To assess patient acceptance of different methods for delivering sustained-release, intraocular pressure (IOP)-lowering medications. METHODS: Electronic surveys were administered to 150 patients at 2 glaucoma clinics. Participants were questioned on their willingness to accept: (1) drug-eluting contact lenses, (2) ring inserts (3) punctal plugs, and (4) subconjunctival injections as alternatives to IOP-lowering eye drops based on various success levels. Multivariable logistic regression models determined the association between device type and treatment acceptance adjusting for age, sex, study site, cost burden of drops, and previous contact lens use. RESULTS: The majority (69%) of participants were 55 to 74 years of age, and white (65%), and half were female. The majority of participants would accept contacts (59%), rings (51%), plugs (57%), and subconjunctival injections (52%) if they obviated glaucoma surgery; fewer would accept these devices if they reduced (23% to 35%) or eliminated (27% to 42%) drops. Most participants would also accept contacts (56%), plugs (55%), and subconjunctival injections (53%) if they were more effective than eye drops, whereas only 47% would accept a ring; fewer would accept any device if it were equally or less effective than drops. Participants were also 36% (95% confidence interval=0.44-0.92; P=0.02) less likely to accept rings and 32% (95% confidence interval=0.47-0.98; P=0.04) less likely to accept subconjunctival injections as compared with contacts. CONCLUSION: Most glaucoma patients considered sustained drug-delivery modalities acceptable alternatives to IOP-lowering eye drops, but only when they were said to obviate surgery or demonstrate greater efficacy than eye drops.

Key acceptability attributes of orodispersible films.

The features rendering orodispersible films (ODFs) patient-centric formulations are widely discussed in the scientific literature. However there is a lack of research studies exploring ODF characteristics with a potential impact on end-user acceptability. The aim of this study was to identify the key ODF characteristics affecting end-user acceptability by developing in vitro test methods for the prediction of ODFs acceptability and correlate these formulation characteristics with the data obtained from a human panel study. Four drug-free single-polymer films were prepared by solvent casting. Solutions of poly(vinyl) alcohol (PVOH) 39 KDa (P1), PVOH 197 KDa (P2), carboxymethylcellulose (CMC) 395 KDa (C1), and CMC 725 KDa (C2) were prepared. Texture analysis and Dynamic Mechanical Analysis (DMA) were used to assess film tack. Petri dish and drop methods were used to assess disintegration time. A human panel of 24 healthy young adults was employed to identify end-user acceptability criteria of the four study film samples. Texture analysis data of ODF tack were not found to be in agreement with the in vivo perceived stickiness in the mouth. However, measurement of the area under the adhesive force curve obtained by DMA correlated with in vivo perceived stickiness data for all samples. The disintegration times obtained by drop method were more comparable to human panel data than the petri dish method. Hence DMA and drop methods proved to be promising methodologies for the prediction of the end-user acceptability. The type and molecular weight of the film-forming polymer had a strong influence on stickiness perception, whereas only polymeric molecular weight influenced perceived disintegration time. The human panel study showed that Participant Reported Outcomes (PROs) for the perceived stickiness in the mouth and disintegration time of test films received significantly different scores between samples, and thus were identified as the key attributes with the potential to affect the end-user acceptability. ODF stickiness and disintegration time should therefore be evaluated at an early stage of the drug product design.

An update on the pharmacotherapeutic interventions for smoking cessation.

INTRODUCTION: Cigarette smoking can damage every organ in the body and is the leading known preventable cause of death globally. It is estimated that 70% of patients want to quit, and about 50% report a quit attempt in the past year, yet only 4-7% are successful. These low quit rates represent the importance of appropriate treatment for smoking cessation through behavioral and pharmacotherapeutic means. AREAS COVERED: Pharmacotherapy approximately doubles patients' chances of quitting, and the first-line approved pharmacotherapetuic options include nicotine gum, lozenge, patch, nasal spray, and inhaler, sustained-release bupropion, and varenicline. Second-line therapies include nortriptyline and clonidine. Recent evidence suggests a potential role for cytisine and naltrexone. Healthcare providers play an important role in helping patients quit smoking; therefore, a clear understanding of appropriate dosing, regimen, technique, disadvantages, advantages, warnings/precautions, and contraindications for available pharmacotherapeutic options is essential. EXPERT OPINION: To improve chances of success, providers should consider patient preferences and prior experiences with quitting, provide medication-specific counseling for the selected therapy, and encourage adherence with the behavioral and pharmacotherapeutic treatment regimen.

Patient and Physician Perspectives on Mode of Administration of the PCSK9 Monoclonal Antibody Alirocumab, an Injectable Medication to Lower LDL-C Levels.

PURPOSE: Clinical trials of the PCSK9 inhibitor alirocumab, an every 2 week injectable monoclonal antibody, have shown significant reductions in LDL-cholesterol. However, many patients requiring lipid-lowering therapy are not experienced with self-injected medication. This study assessed patient and physician perceptions of 2 alirocumab delivery devices. METHODS: 400 participants (200 physicians, 200 patients) were included from 6 countries. Physicians (99 primary care physicians [PCPs]; 101 specialists) had mean practice experience of 17.8 years and an average of 797 hypercholesterolemic patients. Participating patients had LDL-C levels above their goal and at least one of the following: familial hypercholesterolemia, statin intolerance, high cardiovascular risk, and/or diabetes. Mean patient age was 58.5 years, 51% were female, and 25.5% had injectable medication experience. Following device instruction and demonstration, participants tested either a pre-filled pen or pre-filled syringe, using both 75 and 150 mg doses of single-blinded placebo into a prosthetic pad. Data were collected by self-administered questionnaire. FINDINGS: Participant acceptance of both devices was positive, with 83-100% agreeing with ease-of-use statements. After testing, physicians estimated that 66% (pen) and 58% (syringe) of their patients would be willing to self-inject using the device (relative increases from pre-testing of 22% and 16%, respectively; both P<0.05). Specialist estimates were higher than PCP estimates: for the pen, 60% versus 47% (pre-testing), respectively, and 72% versus 61% (post-testing); for the syringe, 57% versus 43% (pre-testing), 63% versus 54% (post-testing; all P<0.05, specialist vs PCP). After testing, 72% (pen) and 63% (syringe) of patient-participants were very willing to self-inject (relative increases from pre-testing of 26% [P<0.05] and 11%, respectively); 96% (pen) and 93% (syringe) were either very willing or somewhat willing to self-inject. The proportion of patients aged <60 years who were very willing to self-inject with either device was numerically (but not statistically) higher compared with those ≥60 years. Initially, patients with injectable medication experience were generally more willing to use the pen than injection-naive patients; after testing there was no difference between groups. No significant differences were observed in responses to the 2 different doses. IMPLICATIONS: Responses from physicians and patients to pre-filled pen and syringe devices were positive. Devices were considered easy to operate, with most patients willing to use and accept self-injection. Patient willingness to self-inject increased after demonstration and testing. Results suggest that, in clinical practice, alirocumab administration by either pre-filled pen or syringe would not deter most physicians from prescribing or most patients from self-administering.

Recent genetic findings in schizophrenia and their therapeutic relevance.

Over 100 loci are now associated with schizophrenia risk as identified by single nucleotide polymorphisms (SNPs) in genome-wide association studies. These findings mean that 'genes for schizophrenia' have unquestionably been found. However, many questions remain unanswered, including several which affect their therapeutic significance. The SNPs individually have minor effects, and even cumulatively explain only a modest fraction of the genetic predisposition. The remainder likely results from many more loci, from rare variants, and from gene-gene and gene-environment interactions. The risk SNPs are almost all non-coding, meaning that their biological significance is unclear; probably their effects are mediated via an influence on gene regulation, and emerging evidence suggests that some key molecular events occur during early brain development. The loci include novel genes of unknown function as well as genes and pathways previously implicated in the pathophysiology of schizophrenia, e.g. NMDA receptor signalling. Genes in the latter category have the clearer therapeutic potential, although even this will be a challenging process because of the many complexities concerning the genetic architecture and mediating mechanisms. This review summarises recent schizophrenia genetic findings and some key issues they raise, particularly with regard to their implications for identifying and validating novel drug targets.

A pilot study to examine the tolerability and device preference in type 1 diabetes of insulin aspart administered by InsuJet compared with subcutaneous injection.

BACKGROUND: Jet injectors allow needle-free insulin delivery. The study objective was to compare the tolerability and device preference of subcutaneous insulin aspart delivery by jet injector (InsuJet™; European Pharma Group, Schiphol-Rijk, The Netherlands) with pen injection in an open-label, randomized, crossover pilot study. SUBJECTS AND METHODS: Ten participants with type 1 diabetes underwent two meal tolerance tests 1 week apart. Plasma glucose and serum insulin levels were sampled from 10 min preceding to 240 min after insulin aspart administration by InsuJet or FlexPen(®) (Novo Nordisk Pharmaceuticals Pty. Ltd., Baulkham Hills, NSW, Australia). Insulin dose was calculated using participants' insulin-to-carbohydrate ratios. Immediately after insulin administration, participants drank 500 mL of Ensure(®) (Abbott Australasia Pty. Ltd., Botany, NSW, Australia) (providing 2,240 kJ of energy, 18.6 g of protein, 96 g of carbohydrate, and 3 g of fat). RESULTS: In this small pilot study, the devices were similar in glucose excursion (median [quartile 1, quartile 3], InsuJet vs. FlexPen, 9.4 [4.8, 12.8] vs. 8.1 [5.4, 10.6] mmol/L; P=0.43), in the area under the glucose concentration-time curve for 0-240 min corrected for baseline glucose level (InsuJet vs. FlexPen, 1,230 [623, 2,012] vs. 1,175 [91, 1,774] mmol · min/L; P=0.4), and in insulin absorption over the 240-min period. Devices were similar for participant preference and relative injection pain. CONCLUSIONS: Subcutaneous jet injection of aspart insulin was well tolerated.

Does pen help? A real-world outcomes study of switching from vial to disposable pen among insulin glargine-treated patients with type 2 diabetes mellitus.

OBJECTIVE: The study was designed to evaluate real-world data on clinical and economic outcome differences between patients with type 2 diabetes mellitus (T2DM) who use insulin glargine with vial-and-syringe delivery and those who switch to pen administration. SUBJECTS AND METHODS: This retrospective study analyzed medical and pharmacy claims information from the national managed-care IMPACT(®) database (Ingenix Inc., Salt Lake City, UT). Adults with T2DM treated with insulin glargine were evaluated. Clinical and economic outcomes over 1 year were compared between individuals who had converted from administering glargine via vial-and-syringe to the SoloSTAR(®) (sanofi-aventis U.S., Bridgewater, NJ) pen (Switchers) and patients who continued to use vial-and-syringe administration (Continuers). Patients from each cohort were matched using propensity score matching for a comparison sample. RESULTS: In total, 3,893 eligible patients were identified (665 Switchers and 3,228 Continuers), with a matched cohort with 603 patients in each group. Baseline characteristics were similar between groups. One-year treatment persistence was significantly higher with Switchers versus Continuers (65.3% vs. 49.8%; P<0.0001). Medication possession ratio was also significantly higher among Switchers (0.79 vs. 0.76; P=0.0173). Insulin use and glycemic control were similar between groups. Healthcare utilization and total costs were also similar between groups. Higher prescription costs among Switchers were offset by lower overall and diabetes-related outpatient and inpatient costs. CONCLUSIONS: Switching from insulin glargine vial-and-syringe administration to pen delivery resulted in improved treatment adherence and persistence, with comparable clinical and economic outcomes.

Preference between precoital and daily use of Duet® and BufferGel in Zimbabwe.

Duet® is a microbicide-delivery system and cervical barrier for use daily or precoitally. We conducted a crossover study among 80 Zimbabwean women to explore factors associated with use-regimen preference. Women were assigned in random order to 14 days of precoital and 14 days of daily Duet and BufferGel use. About 51 % of women preferred precoital use, 39 % preferred daily use, and 10 % liked both equally. Overall product adherence during sex was similar for both use-regimens. In multivariable analysis, diaphragm experience was associated with preference for precoital use (AOR 2.80, 95 % CI 1.01-7.76). Reasons for preferring precoital use included use only when needed, cleanliness, and discomfort with daily use. Daily use preference included convenience, discreetness, and being prepared for "sex-on-demand." Different personal and life circumstances may result in varying use-regimen preferences. Methods that can accommodate both coitally-related and daily use may be advantageous by providing more choice to users.

Targeting the BH3-interacting domain death agonist to develop mechanistically unique antidepressants.

The BH3-interacting domain death agonist (Bid) is a pro-apoptotic member of the B-cell lymphoma-2 (Bcl-2) protein family. Previous studies have shown that stress reduces levels of Bcl-2 in brain regions implicated in the pathophysiology of mood disorders, whereas antidepressants and mood stabilizers increase Bcl-2 levels. The Bcl-2 protein family has an essential role in cellular resilience as well as synaptic and neuronal plasticity and may influence mood and affective behaviors. This study inhibited Bid in mice using two pharmacological antagonists (BI-11A7 and BI-2A7); the selective serotonin reuptake inhibitor citalopram was used as a positive control. These agents were studied in several well-known rodent models of depression-the forced swim test (FST), the tail suspension test (TST), and the learned helplessness (LH) paradigm-as well as in the female urine sniffing test (FUST), a measure of sex-related reward-seeking behavior. Citalopram and BI-11A7 both significantly reduced immobility time in the FST and TST and attenuated escape latencies in mice that underwent the LH paradigm. In the FUST, both agents significantly improved duration of female urine sniffing in mice that had developed helplessness. LH induction increased the activation of apoptosis-inducing factor (AIF), a caspase-independent cell death constituent activated by Bid, and mitochondrial AIF expression was attenuated by chronic BI-11A7 infusion. Taken together, the results suggest that functional perturbation of apoptotic proteins such as Bid and, alternatively, enhancement of Bcl-2 function, is a putative strategy for developing novel therapeutics for mood disorders.

Uncoupling the dopamine D1-D2 receptor complex: a novel target for antidepressant treatment.

Depression, or major depressive disorder (MDD), is a serious mental illness that causes substantial worldwide disability. Current antidepressant medications mostly target the serotonin and norepinephrine neurotransmitter systems. These drugs are ineffective in many patients, and there are limited options for treatment-resistant depression. The dopamine neurotransmitter system has recently been identified as another modulator of mood and depressive symptoms, and a recently discovered interaction between the dopamine D1 and D2 receptor may be a novel antidepressant target.

Development of oral food-grade delivery systems: current knowledge and future challenges.

In recent years there has been an increasing interest in the development of new and efficient oral food delivery systems as tools to prevent disease and promote human health and well-being. Such vehicles are sought to protect bioactive ingredients added to food while controlling and targeting their release as they pass through the human gastrointestinal tract (GIT). This review aims to summarize the key concepts of food delivery systems, their characterization and evaluation. Particularly, evaluation of their performance within the human GIT is discussed. To this end an overview of several in vivo and in vitro methods currently applied for the study of such systems is given. Although considered to be still in its infancy, this promising field of research is likely to infiltrate into real products through rational design. In order for such efforts to materialize into real products some challenges still need to be met and are discussed herein. Overall, it seems that adopting a comprehensive pharmacological approach and relevant cutting edge tools are likely to facilitate innovations and help elucidate and perhaps tailor delivery systems' behavior in the human GIT.

Epigenetic regulation of the BDNF gene: implications for psychiatric disorders.

Abnormal brain-derived neurotrophic factor (BDNF) signaling seems to have a central role in the course and development of various neurological and psychiatric disorders. In addition, positive effects of psychotropic drugs are known to activate BDNF-mediated signaling. Although the BDNF gene has been associated with several diseases, molecular mechanisms other than functional genetic variations can impact on the regulation of BDNF gene expression and lead to disturbed BDNF signaling and associated pathology. Thus, epigenetic modifications, representing key mechanisms by which environmental factors induce enduring changes in gene expression, are suspected to participate in the onset of various psychiatric disorders. More specifically, various environmental factors, particularly when occurring during development, have been claimed to produce long-lasting epigenetic changes at the BDNF gene, thereby affecting availability and function of the BDNF protein. Such stabile imprints on the BDNF gene might explain, at least in part, the delayed efficacy of treatments as well as the high degree of relapses observed in psychiatric disorders. Moreover, BDNF gene has a complex structure displaying differential exon regulation and usage, suggesting a subcellular- and brain region-specific distribution. As such, developing drugs that modify epigenetic regulation at specific BDNF exons represents a promising strategy for the treatment of psychiatric disorders. Here, we present an overview of the current literature on epigenetic modifications at the BDNF locus in psychiatric disorders and related animal models.

Patient preference for a new growth hormone injection device: results of an open-label study in Japanese pediatric patients.

BACKGROUND: Growth hormone deficiency (GHD) in children is treated with daily subcutaneous injections of GH. Poor adherence, resulting in suboptimal treatment outcomes, is common due to long-term treatment. Injection devices that are considered easy to use by patients or guardians could improve adherence. OBJECTIVE: This study assessed the usability of the Norditropin FlexPro pen injector and NovoTwist needles (both Novo Nordisk A/S, Bagsvaerd, Denmark) in Japanese children and adolescents with GHD. METHODS: This open-label, uncontrolled usability test included patients aged 6 to < or = 18 years with GHD currently receiving daily injections of GH with pen injectors. Patients performed repeated injections of test medium into a foam cushion. Patients or guardians completed a questionnaire on pen handling. RESULTS: A total of 73/74 patients (99%) rated Norditropin FlexPro easy to handle, reporting no technical complaints. In total, 60 (81%) preferred Norditropin FlexPro over their current device, with 12% preferring their current device and 7% not sure. CONCLUSIONS: Norditropin FlexPro was perceived as easy to use and reliable, and was well accepted and preferred over the current device for the administration of GH in children and adolescents. Patients were more confident that Norditropin FlexPro delivered the right dose compared with their current device.

Acceptability of vaginal film, soft-gel capsule, and tablet as potential microbicide delivery methods among African women.

BACKGROUND: Vaginal microbicides are in development for the prevention of HIV transmission to women via sexual intercourse. Acceptability of the microbicide delivery method in the targeted population is important to product adherence and, therefore, product effectiveness. It is anticipated that multiple delivery methods will be required to satisfy personal preferences among future microbicide users. METHODS: A total of 526 sexually active women aged 18-30 years participated in a consumer product preference study in Burkina Faso, Tanzania, and Zambia. Screened women who had given consent were instructed to use each of the three products (placebo formulations of a vaginal tablet, film, and soft-gel capsule) once daily for 7 consecutive days for a total of 21 days. Women were interviewed about their impressions of the product at the completion of each 7-day trial period. RESULTS: Over 80% of women reported they liked using each dosage form, and over 85% said they would definitely use it. The film and soft-gel capsule were chosen significantly more often than the tablet as the preferred dosage form (39% and 37% vs. 25%, respectively) mainly because of faster dissolving time and easier insertion. Women in Burkina Faso and Tanzania preferred the soft-gel capsule (42%-46%), whereas Zambian women preferred the film (51%). Age, socioeconomic status, and marital status did not significantly affect product preference. CONCLUSIONS: All three dosage forms were acceptable to the women surveyed. Preferred dosage forms varied by country. These data suggest that the availability of microbicides in multiple dosage forms may increase acceptability, adherence, and, therefore, effectiveness.

Needle with a novel attachment versus conventional screw-thread needles: a preference and usability test among adults with diabetes and impaired manual dexterity.

BACKGROUND: NovoTwist(®) (Novo Nordisk A/S, Bagsværd, Denmark) is an insulin pen needle that features a novel attachment and detachment system. The aim of this test was to assess overall preference and handling of NovoTwist compared with conventional screw-thread needles in people with type 1 or type 2 diabetes. METHODS: One hundred twenty adults with type 1 or type 2 diabetes and manual dexterity dysfunction who were currently self-injecting with an insulin pen were included in this open-label, randomized, crossover test. Participants were stratified according to the impact that manual dexterity problems had on their ability to inject insulin (1 = no effect at all; 4 = a lot), and those rated as 1 were excluded from subanalyses because of low numbers. Following instruction, participants attached the needle to Next Generation FlexPen(®) (Novo Nordisk A/S), made an injection into a foam cushion, and detached the needle; this process was repeated three times with NovoTwist and the participant's current screw-thread needle (or NovoFine(®) [Novo Nordisk A/S]) in a random order. Responses to questions on user experience with each needle were subsequently recorded on a 6-point rating scale (1 = very difficult; 6 = very easy). RESULTS: Significantly more respondents had a preference for NovoTwist (79%) compared with the conventional screw-thread needles (21%, P < 0.001). Significantly more respondents preferred NovoTwist for both ease of attachment (80%, P < 0.001) and ease of detachment (74%, P < 0.001). Most respondents found NovoTwist the most appropriate needle for performing everyday injections (71%, P < 0.001). CONCLUSIONS: Such preference by patients has a positive impact on the treatment of diabetes as NovoTwist may alleviate the burden of performing everyday injections through its ease of use.

Perceptions and attitudes are primary contributors to insulin delivery system satisfaction in people with type 2 diabetes.

BACKGROUND: This study identifies factors that influence satisfaction with an insulin delivery system (IDS). Knowledge of such factors could help identify individuals who would benefit from innovative IDS. METHODS: Individuals with type 2 diabetes who use insulin, recruited from a general and chronic illness panel, participated in a web-based survey that included questions about demographics, self-reported diagnoses and hemoglobin A1c (HbA1c), current IDS used, insulin therapy attitudes, current IDS features, and satisfaction with IDS. Univariate analyses identified variables associated with IDS satisfaction (P < 0.05); those variables were entered into stepwise linear regression analyses with IDS satisfaction as the dependent variable. RESULTS: Six hundred sixty-seven individuals with type 2 diabetes participated (mean age, 57 years; 52% female; 88% Caucasian; 73% vial/syringe users, 27% insulin pen users). IDS satisfaction was associated (P < 0.05) with gender, health status, HbA1c, self-reported comorbidity, insulin therapy attitudes, IDS type, and evaluation of IDS features. Among individuals who reported their HbA1c (n = 438), the best predictors of IDS satisfaction were perceived effectiveness and value of insulin therapy, evaluation of IDS activity interference, and commitment to insulin therapy (R2 = 0.49, P < 0.001). Among all participants (n = 667), a second regression analysis that employed a variable representing report of HbA1c found the best predictors of IDS satisfaction included those in the first analysis with the addition of gender, report of HbA1c, and evaluation of IDS ease of use. These variables provided additional variance (R2 = 0.56, P < 0.001). CONCLUSIONS: In people with type 2 diabetes, positive perceptions and attitudes about insulin therapy have greater influence than the type of IDS used on IDS satisfaction.