Effectiveness of a family nurse-led programme on accuracy of blood pressure self-measurement: A randomised controlled trial.

AIMS AND OBJECTIVES: To evaluate the effectiveness of a Family Nurse Practitioner (FNP)-led programme on the degree of adherence of current recommendations on home blood pressure self-measurement (HBPM) as compared to routine care and management. BACKGROUND: HBPM plays an important role for monitoring hypertensive patients; however, patients' adherence to current guidelines is unsatisfactory. A nurse-led training programme in the community setting could be an effective strategy to achieve high level of patients' adherence to recommendations. DESIGN: A multicentre randomised controlled trial was carried out from September 2016 to September 2017. METHODS: In total, 170 patients were randomly allocated into the intervention group (n = 83) and the usual care (n = 87). All participants received usual care (written and verbal information on HBPM recommendations); subjects in the intervention group also received 1-hour training session on how to correctly self-measure BP. Clinical trial registration was done (ClinicalTrials.gov.: NCT04681703). The CONSORT checklist for randomised controlled trials was used in this study. RESULTS: At baseline, the level of adherence to the recommendation was similar in the two groups (p < .05). After 1 month, the adherence significantly increased in the intervention group, where patients were more likely to measure BP at the same hour and from the same arm, in a quiet environment, with the back and uncovered arm supported and the legs uncrossed; recording BP more than once in each measurement session; keeping a diary of blood pressure measurements; use of the appropriate cuff and proper placement of the cuff; and resting for >5 min before performing the measurement (all p < .05). CONCLUSIONS: The FNP-led programme is effective in improving patients' adherence to guidelines on the correct technique to self-measure BP at home. RELEVANCE TO CLINICAL PRACTICE: This programme may be added to the existing interventions in the community setting or considered into specifically nurse-led hypertension management models.

Evaluation of Omeprazole Limited Sampling Strategies to Estimate Constitutive Cytochrome P450 2C19 Activity in Healthy Adults.

BACKGROUND: Limited sampling strategy (LSS) is a validated method to estimate pharmacokinetic (PK) parameters from a reduced number of samples. Omeprazole is used to phenotype in vivo cytochrome P450 (CYP) 2C19 activity. This study examined an LSS using 2 estimation methods to determine apparent oral clearance (CL/F) and thus CYP2C19 activity. METHODS: Data from 7 previously published studies included healthy subjects receiving a single, oral dose of omeprazole with intensive PK sampling. CL/F was estimated using noncompartmental analysis (NCA) and population PK modeling. LSS was simulated by selecting the 1, 2, 4, and/or 6-hour postdose time points. Linear regression was performed to assess whether CL/F estimated from limited sampling could accurately predict CL/F from the full PK profile. RESULTS: Median CL/F was 23.7 L/h by NCA and 19.3 L/h by population PK modeling. In comparing the LSS NCA estimated versus observed CL/F, all evaluated linear regression models had unacceptable coefficients of determination (r, range: 0.14-0.81). With the population PK approach, 737 plasma concentrations (n = 71) and CYP2C19 genotype data were described with a 1-compartment structural model with mixed zero and first-order absorption and lag time. In comparing the population PK LSS estimated versus observed CL/F, all evaluated linear regression models had unacceptable r (range: 0.02-0.74). Post hoc comparison of CYP2C19 poor metabolizers versus CYP2C19 extensive metabolizers resulted in significantly lower CL/F in poor metabolizers versus extensive metabolizers. CONCLUSIONS: Omeprazole LSS performed poorly in estimating CL/F using 2 separate estimation approaches and does not seem to be a suitable method for determining CYP2C19 activity.

A New Approach to the Treatment of Uncomplicated Cystitis: Results of a Randomized Placebo-Controlled Clinical Trial.

OBJECTIVE: To assess the efficacy and safety of a new medical device (MD; a capsule whose main component is a cross-linked protein) in the prevention of uncomplicated cystitis recurrences. METHODS: Adult women with acute cystitis symptoms and a ciprofloxacin-susceptible isolate in urine culture were included in a randomized, double-blind clinical trial. Patients were treated with ciprofloxacin 500 mg/day and 1 capsule/day or matched placebo for 5 days, 1 capsule/day or placebo for 15 additional days, and 2 additional cycles of 1 capsule/day or placebo for 15 days on months 1 and 2 after initial treatment. RESULTS: No recurrence was observed after the first month of follow-up in the MD-treated group. In addition, symptomatic recurrence was reduced by 19.4% compared with placebo after 6 months. CONCLUSIONS: The new MD can help prevent the recurrence of uncomplicated cystitis as well as help to reduce antibiotic use in management of urinary tract infection in women.

An observational study of family caregivers' quality of life caring for patients with a stoma.

The management of stomas following surgical resection often falls to family caregivers. The purpose of this observational survey was to investigate the family caregivers' quality of life caring for a patient with ostomy. Between August 2008 and July 2009, 144 eligible Italian family members caring for a patient with ostomy were evaluated using two questionnaires: the Caregiver Quality of Life Cancer survey and the Caregiver Burden Inventory. Both questionnaires have similar capabilities to explore the burden of caregiving. The Caregiver Quality of Life Cancer reported a total Quality of Life score of 97.11 (SD = 14.36), whereas the Caregiver Burden Inventory score for the sample was 51.95 (SD = 10.72). Variables of interest included health, self-perception, nationality, society and territory in which the person lives, education, job, standard of living, house, family, relations with partner, and friendship. Only those who provided complete data (n = 123) were included in the analyses. Data show that generally the family caregiver is married (92%), female (97%), and aged 55.15 years (SD = 16.5). The burden of assistance is higher in younger single caregivers, whereas those with children or who are aged have economic concerns. Loss of spirituality is reported in people aged 30-49 and 71-90 years. Family Caregivers' Quality of Life is poor. Further research is needed to determine the effectiveness of social and economic interventions to help family caregivers in the management of long-term assistance.

A randomized controlled trial comparing a xyloglucan-based nasal spray with saline in adults with symptoms of rhinosinusitis.

BACKGROUND: This study assessed the efficacy, safety and tolerability of a xyloglucan-based nasal spray in the treatment of symptoms of rhinosinusitis. METHODOLOGY: In this randomized, double-blind study, 40 patients with itching, nasal congestion or continuous sneezing and a Total Nasal Symptom Score (TNSS) of ≥8 were randomized to 2 weeks' treatment with a xyloglucan-based nasal spray ("xyloglucan") or a physiological saline nasal spray ("saline"). Assessments included the TNSS, rhinosinusitis severity index, nocturnal awakenings, use of rescue medication, safety and tolerability. RESULTS: Baseline symptom scores were similar between groups. At treatment end, improvements from baseline were observed in both groups for TNSS (xyloglucan 58%; saline 35%, both p < .05) and number of nocturnal awakenings (p < .05). A significant improvement in the rhinosinusitis severity index was observed only with xyloglucan (p < .05). At treatment end, mean [SD] scores were significantly lower in the xyloglucan group versus the saline group for TNSS (3.60 [2.16] vs. 5.40 [2.64], p < .05), rhinosinusitis severity index (7.55 [1.19] vs. 6.45 [1.40], p < .05), and rhinorrhea and itching (both p < .05). No rescue medication was used. Both treatments were well tolerated. CONCLUSIONS: A xyloglucan-based nasal spray provided greater relief of rhinosinusitis symptoms than a physiological saline spray and was well tolerated. Trial registration number (EUDRACT): 2014-000143-32.

Bioequivalence study of two tablet formulations of ramipril in healthy volunteers.

This study was conducted in order to assess the bioequivalence of a test and reference tablet formulation containing 10 mg of ramipril ((1S,5S,7S)-8-[(2S)-2-[[(1S)-1-ethoxycarbonyl-3-phenyl-propyl]amino]propanoyl]-8-azabicyclo[3.3.0] octane-7-carboxylic acid, CAS 87333-19-5). Forty healthy male and female volunteers were treated in a single-centre randomised, single-dose, open-label, 2-way crossover study, with a washout period of 35 days between treatments. Plasma samples were collected up to 168 h post-dosing for the determination of ramipril and its active metabolite, ramiprilat, by LC-MS/MS. The evaluation of bioequivalence was based on the following pharmacokinetic parameters that were calculated by standard non-compartmental methods: the area under the plasma concentration-time curve from zero to the time of the last quantifiable concentration (AUCt) and that extrapolated to infinity (AUC) and the maximum observed concentration (Cmax). The 90% confidence interval of the ratios (test/reference) (obtained by analysis of variance, ANOVA) were 0.83-1.20 for Cmax of ramipril, 0.90-1.10 for Cmax of ramiprilat, 0.95-1.23 for AUC(0-48) of ramipril, 0.97-1.11 for AUC(0-168) of ramiprilat, 0.96-1.23 for AUC of ramipril and 0.98-1.15 for AUC of ramiprilat, i.e. within the predefined acceptable range for the conclusion of bioequivalence. Tmax of the test formulation was 0.67 +/- 0.33 h for ramipril and 2.28 +/- 0.74 h for ramiprilat; Tmax of the reference formulation was 0.71 +/- 0.32 h for ramipril and 2.40 +/- 0.88 for ramiprilat. The ramipril and ramiprilat Tmax values estimated for the test and the reference formulations were not significantly different (p-value > 0.05). The study indicated that the test and reference formulations containing 10 mg of ramipril were equivalent in terms of both the rate and extent of bioavailability.

Fast HPLC method for the determination of ketoprofen in human plasma using a monolithic column and its application to a comparative bioavailability study in man.

A fast, specific, accurate, precise and reproducible high-performance liquid chromatography (HPLC) method with diode-array detector (DAD) was developed and validated for the determination of ketoprofen (CAS 22071-15-4) in human plasma using flubiprofen (CAS 5104-49-4) as an internal standard. The chromatographic separation was achieved on an onyx monolithic C18 (100 x 4.6 mm) analytical column with an isocratic mobile phase consisting of acetonitrile/potassium dihydrogen phosphate (KH2PO4) 0.01 M, (40:60, v/v) adjusted to pH 3.5. The flow was set at 5 ml x min(-1) and the wavelength at 254 nm. The total analysis time was less than 5 min. The ratio of peak area of analyte to internal standard was used for quantification. The limit of detection was defined as the ketoprofen concentration that produced a signal-to noise ratio greater than 3. The lower limit of quantification (LLOQ) was 10 ng x m(-1). At this level, the relative standard deviation (RSD) was lower than 13%. The calibration curve was linear over the concentration range 1-500 ng x ml(-1) with a minimum detectable limit of 10 ng x ml(-1). The coefficients of variation for the inter-day and intra-day assay were found to be less than 11%. The present method was successfully applied to the routine analysis of human plasma samples collected from healthy volunteers after dermal application of two topical formulations containing ketoprofen in order to assess the relative bioavailability and to demonstrate that the systemic bioavailability of ketoprofen administered topically is low enough to ensure a low incidence of gastrointestinal adverse events.

Efficacy and safety of piroxicam patch versus piroxicam cream in patients with lumbar osteoarthritis. A randomized, placebo-controlled study.

UNLABELLED: In order to assess the efficacy and safety of a new patch containing 14 mg of piroxicam (CAS 36322-90-4) 1%, applied once daily, in comparison with a reference marketed formulation, piroxicam 1% cream applied three times a day, placebo patch applied once daily, a randomized, placebo-controlled, parallel-group clinical trial was carried out by general practitioners in patients with lumbar osteoarthritis aged between 18 and 75 years. Pain during daily activities scored on a 100 mm visual analogue scale was the primary outcome measure. Other secondary outcome measures were pain on isometric contraction, on full passive motion, and on pressure, and functional disability. Statistical analysis was performed on the differences between the three groups in the intention-to-treat population (ITT). One hundred and eighty patients were enrolled. The available ITT population comprised 179 patients. The compliance was very good. Decrease in pain score during daily activities after the eight days of study treatment (at the final visit, Vf) was 42.2%, 41.7% and 25.8% in the piroxicam patch, piroxicam cream and placebo groups, respectively. The difference between the pain scores in two active treatments arms was not statistically significant at the Vf whereas the differences between the pain scores of two active treatment arms vs the placebo arm were statistically significant validating the study design. All efficacy measures improved during the study, for both the active treatment groups, and the results for the secondary efficacy variables were generally consistent with those concerning the main efficacy criterion. The difference between the two active treatments in pain during daily activities were statistically significant at the final visit; in fact the 95% CI of the difference between the mean of responder rate of the piroxicam patch and piroxicam cream was -18.3%, +24.4% indicating a trend of superiority of the piroxicam patch versus the cream (per-protocol analysis). The data obtained during the intermediate visit (V2, day 4) allow us to assess that the piroxicam patch was on average better than the piroxicam cream in terms of fast pain reduction (change from baseline: - 29.1% for piroxicam patch in comparison to -24.6% for piroxicam cream). Moreover the piroxicam patch proved to be on average more effective than the piroxicam cream in terms of secondary efficacy endpoints. Safety was considered satisfactory in all groups. CONCLUSIONS: The piroxicam patch is effective in the treatment of lumbar osteoarthritis and has demonstrated to be well tolerated and it improves patients compliance. The piroxicam patch offers a comparable alternative to the marketed piroxicam cream for the treatment of lumbar osteoarthritis with the advantage of a better compliance with the once a day application of the patch compared to three daily applications for the piroxicam cream.

Bioequivalence study of two capsule formulations of omeprazole in healthy volunteers.

The study was conducted in order to assess the bioequivalence of two capsule formulations (test and reference) containing 20 mg of omeprazole (5-methoxy-2-[[4-methoxy-3,5-dimethyl-2-pyridinyl) methyl]sulfinyl]-1H-benzimidazole, CAS 73590-58-6). Fifty healthy male and female volunteers were treated in a single-centre, randomised, repeated-dose (once daily for six consecutive days), open-label, two-way crossover study, with a washout period of at least 9 days between treatments. Plasma samples were collected up to 12 h post-dosing for the determination of omeprazole by HPLC with photodiode array detector (DAD). The evaluation of bioequivalence was based on the following pharmacokinetic parameters that were calculated by standard non-compartmental methods: area under the plasma concentration-time curve from zero to the time of the last quantifiable concentration (AUCt) and that extrapolated to infinity (AUC) and the maximumobserved concentration (Cmax). The 90% confidence interval around the ratios (test/reference) (obtained by analysis of variance, ANOVA) were 0.92-1.04 forCmax, 0.88-1.05 for AUCt, and 0.88-1.05 for AUC, i.e., within the predefined acceptable range for the conclusion of bioequivalence. The study indicated that the test and reference formulations containing 20 mg of omeprazole are bioequivalent in terms of both the rate and extent of bioavailability.