Pill Burden Research Articles

Drug box: A novel stratergic tool to minimize pill burden and polypharmacy in geriatric population

Longevity and graceful ageing is what every elderly yearns for. With advances in better health care, better standards and newer modalities of medical expertise the elderly population is in a phase three of demographic transition and the number of elderly in India are on the rise. With increasing age comes the prospect of multiple morbidities. The current medical practice guidelines often require multiple medications to treat each chronic disease state for optimal clinical benefit and poly-pharmacy is inevitable. The multiple drugs when consumed in excess or in lesser dosage can in turn result in adverse drug reactions. An elders body responds in a different manner from the adult body mechanism especially with respect to drug-drug interactions, reduced organ functional capacities and most importantly medication non compliance due to morbidities of ageing viz. dementia, blindness, etc. Also there is accumulation of toxic products of drug metabolism due to pharmacokinetic and pharmacodynamics changes occurring with advancing age. A Novel substitute for pill burden and poly pharmacy3 is the drug box.3 A simple, cost-effective tool for the elderly, which helps in appropriate storage of medicines having compartments which coincide with the number of days in a week or a month, with divisions as per doses. Few boxes even show the time of the day during which the drug must be taken. Drug dispensers are high tech pill boxes keep the medications locked till the time it needs to be taken, and dispenses it at the right time thus prevents drug over dosage. This is very helpful for the elderly patients who suffer from dementia and those who are on multiple drug therapies. Keywords: Drug box, Novel tool, Pill burden.

Study of utilisation pattern of fixed dose drug combinations used in pediatric patients at a tertiary care teaching hospital of Eastern India

Introduction: Fixed dose combinations (FDC) enhance the efficacy of individual drugs, decrease the chances of drug resistance, improve patient compliance and also decrease the pill burden on the patients. Irrational prescribing of FDCs is a major health concern. Aims & Objectives: To study the utilisation pattern of fixed dose drug combinations used in paediatric patients Materials and Methods: The study was conducted during September 2014 to October 2015 in paediatric patients visiting the OPD of a tertiary care teaching hospital of eastern India. After obtaining informed consent, prescriptions were collected from OPD every Thursday from 10 A.M. to 1P.M. and data analyzed and evaluated as per W. H. O. prescribing indicators. Results: 1380 prescriptions were collected and analysed. It was found that most FDCs were antibiotics, multivitamins formulations, analgesic-antipyretic combinations, cough and cold preparations. Conclusion: There is an increasing trend towards prescribing FDCs. Many of the FDCs are not included in the WHO Model list of essential medicines and the National List of Essential Medicines. Assessment of prescribing pattern in medical care facilities helps in identifying problems regarding rational use and to propose interventions. Keywords: Fixed dose combinations (FDC).

Распространенность полипрагмазии в педиатрической практике: обзор российских исследований

Foreign publications regularly demonstrate a high level of prevalence of polypharmacy among various population groups. However, the scale of polypharmacy among the Russian children is poorly understood. This article is an attempt to generalize and systematize Russian studies about the prevalence of pediatric polypharmacy. Purpose of the review was to identify the prevalence of polypharmacy in the children's population of Russian Federation. The search for articles was conducted in April 2020 in online databases eLIBRARY.ru, cyberleninka.ru, as well as GoogleScholar (the first hundred search results). The Search queries ‘polypharmacy in children’, ‘polypharmacy in pediatrics’, ‘pill burden in children’, ‘pill burden in pediatrics’ was carried out by the title of the articles, abstracts and keywords, with subsequent exclusion of duplicates. We sought to consider original studies that evaluated the prevalence polypharmacy in children aged 0 to 18 years. A total of 635 publications were identified, after deleting duplicates – 255. Further full-text screening excluded 247 publications, so 8 articles were included in the review. The selected articles were distributed equally depending on the type of the medical documentation being analyzed (outpatient records or inpatient). Only two articles indicated the average number of drugs per case of disease. The prevalence of polypharmacy in the treatment of acute respiratory infections in children in outpatient settings was 2.01–24% (min – max). Polypharmacy inpatient settings was 18.8–78% (min – max). The prevalence of pediatric polypharmacy in Russian Federation is variable and depends on research methodology

The real-world effectiveness of sucroferric oxyhydroxide in European hemodialysis patients: a 1-year retrospective database analysis

BackgroundThe iron-based phosphate binder (PB), sucroferric oxyhydroxide (SFOH), demonstrated its effectiveness for lowering serum phosphate levels, with low daily pill burden, in clinical trials of dialysis patients with hyperphosphatemia. This retrospective database analysis evaluated the real-world effectiveness of SFOH for controlling serum phosphate in European hemodialysis patients.MethodsDe-identified patient data were extracted from a clinical database (EuCliD®) for adult hemodialysis patients from France, Italy, Portugal, Russia and Spain who were newly prescribed SFOH for up to 1 year as part of routine clinical care. Serum phosphate and pill burden were compared between baseline (3-month period before starting SFOH) and four consecutive quarterly periods of SFOH therapy (Q1−Q4; 12 months) in the overall cohort and three subgroups: PB-naïve patients treated with SFOH monotherapy (mSFOH), and PB-pretreated patients who were either switched to SFOH monotherapy (PB → mSFOH), or received SFOH in addition to another PB (PB + SFOH).Results1096 hemodialysis patients (mean age: 60.6 years; 65.8% male) were analyzed, including 796, 188 and 53 patients in, respectively, the PB + SFOH, mSFOH, and PB → mSFOH groups. In the overall cohort, serum phosphate decreased significantly from 1.88 mmol/L at baseline to 1.77–1.69 mmol/L during Q1–Q4, and the proportion of patients achieving serum phosphate ≤1.78 mmol/L increased from 41.3% at baseline to 56.2–62.7% during SFOH treatment. Mean PB pill burden decreased from 6.3 pills/day at baseline to 5.0–5.3 pills/day during Q1–Q4. The subgroup analysis found the proportion of patients achieving serum phosphate ≤1.78 mmol/L increased significantly from baseline during SFOH treatment in the PB + SFOH group (from 38.1% up to 60.9% [Q2]) and the mSFOH group (from 49.5% up to 75.2% [Q2]), but there were no significant changes in the PB → mSFOH group. For the PB + SFOH group, serum phosphate reductions were achieved with a similar number of PB pills prescribed at baseline prior to SFOH treatment (6.5 vs 6.2 pills/day at Q4). SFOH daily pill burden was low across all 3 subgroups (2.1–2.8 pills/day).ConclusionIn this real-world study of European hemodialysis patients, prescription of SFOH as monotherapy to PB-naïve patients, or in addition to existing PB therapy, was associated with significant improvements in serum phosphate control and a low daily pill burden.

Association between pill burden and interdialytic weight gain in patients with hemodialysis: A multi-center cross-sectional study.

High daily pill burden affects quality of life and mortality. High interdialytic weight gain (IDWG) is associated with increased mortality. We examined the association between pill burden and IDWG in hemodialysis patients. This cross-sectional study was conducted in six dialysis centers in Japan in June 2017. The exposure was the number of daily tablets, and outcome was defined as 1 day of relative IDWG divided by post-dialysis weight from the previous session. Among 188 outpatients (mean age, 68.7 [SD, 10.3] years; men, 67.0%; median dialysis vintage, 76.0 [interquartile range, 36.5, 131.5] months), the mean number of daily tablets was 19.7 ± 9.9, and mean relative weight gain was 3.5 ± 1.2%. Multiple linear regression analysis showed a regression coefficient of 0.021 (95% confidence interval: 0.004-0.039), indicating that one additional tablet prescription increased the IDWG by 0.021%. In hemodialysis patients, the daily pill burden was a significant, independent risk for increased relative IDWG.

Association between Adherence with an Atypical Antipsychotic and with Other Psychiatric Drugs in Patients with Bipolar Disorder.

Using U.S. pharmacy and medical claims, medication adherence patterns of patients with serious mental illness suggest that adherence to atypical antipsychotics may be related to adherence to other prescription drugs. This study investigated whether adherence to an atypical antipsychotic was related to adherence to other prescribed psychiatric drugs using self-reported data from patients with bipolar disorder. Daily self-reported medication data were available from 123 patients with a diagnosis of bipolar disorder receiving treatment as usual who took at least 1 atypical antipsychotic over a 12-week period. Patients took a mean of 4.0±1.7 psychiatric drugs including the antipsychotic. The adherence rate for the atypical antipsychotic was compared to that for other psychiatric drugs to determine if the adherence rate for the atypical antipsychotic differed from that of the other psychiatric drug by at least ±10%. Of the 123 patients, 58 (47.2%) had an adherence rate for the atypical antipsychotic that differed from the adherence rate for at least 1 other psychiatric drug by at least±10%, and 65 (52.8%) patients had no difference in adherence rates. The patients with a difference took a larger total number of psychiatric drugs (p<0.001), had a larger daily pill burden (p=0.020) and a lower adherence rate with the atypical antipsychotic (p=0.007), and were more likely to take an antianxiety drug (p<0.001). Adherence with an atypical antipsychotic was not useful for estimating adherence to other psychiatric drugs in about half of the patients with bipolar disorder.

GBT021601 Inhibits HbS Polymerization, Prevents RBC Sickling and Improves the Pathophysiology of Sickle Cell Disease in a Murine Model

Sickle cell disease (SCD) is a genetic disorder caused by inheritance of two alleles bearing a single nucleotide change in the β globin gene coding sequence. The pathophysiologic mechanism of SCD involves polymerization of intracellular hemoglobin S (HbS) following deoxygenation in the microvasculature, leading to decreased red blood cell (RBC) deformability, morphologic sickling of RBCs, decreased RBC survival, microvascular obstruction, and clinical complications (Bunn H, N Engl J Med, 1997). Voxelotor, a hemoglobin S polymerization inhibitor recently approved for the treatment of SCD, is an allosteric modifier of Hb that increases the proportion of oxygenated Hb in all RBCs. In clinical studies in subjects with SCD, voxelotor has demonstrated that doses of up to 1500 mg daily achieved Hb modifications of ~27%, was well tolerated, and resulted in reduced hemolytic anemia (Howard J et al., Blood, 2019; Vichinsky E et al., N Engl J Med, 2019). GBT021601 is a potent second generation HbS polymerization inhibitor with the potential to achieve even higher Hb modification in subjects with SCD at lower doses and therefore with less pill burden. To evaluate its effect on the pathophysiology of SCD, GBT021601 was administered at 20, 40, 75, and 150 mg/kg QD via oral dosing for 21 days in Townes SCD mice (SS mice). At steady state, GBT021601-treated SS mice achieved Hb occupancies (at Cmin) of 6%, 12%, 21%, and 29% corresponding to 20, 40, 75, and 150 mg/kg doses, respectively. This resulted in a dose-dependent reduction in p50 of SS mouse blood from ~28 mm Hg (vehicle-treated) to 11 mm Hg at the highest dose tested. Consequently, GBT021601 significantly reduced in vivo circulating sickled cells and ex vivo sickling of SS mouse blood under hypoxic conditions (20 mmHg). Consistent with its anti-polymerization activity, GBT021601 reduced hemolysis as demonstrated by 1) an increase in hemoglobin of up to 6.7 g/dL (Figure 1A), thereby achieving the normal range for wildtype mice, and 2) a reduction in the percentage of reticulocytes of up to 58% relative to vehicle-treated SS mice (Figure 1B). Additionally, GBT021601 treatment increased the percentage of mature RBCs and reduced the percentage of mitochondria-containing RBCs indicating an overall improvement in RBC health. Consistent with improved hemoglobin, reduced hemolysis, and improved RBC health, GBT021601 dose-dependently increased RBC half-life from 1.3 days in vehicle-treated SS mice to 7.4 days in SS mice treated with 150 mg/kg GBT021601 (Figure 1C). Furthermore, treatment of SS mice with GBT021601 for 21 days led to a significant reduction in spleen weight, indicating an improvement in splenic blood flow and organ function. Together, these data demonstrate that GBT021601, a next generation HbS polymerization inhibitor, normalized hemoglobin, reduced hemolysis and significantly improved RBC health, RBC half-life and organ function in a mouse model of SCD. These data support clinical development of GBT021601 as a potential best-in-class HbS polymerization inhibitor for SCD patients. Disclosures Dufu: Global Blood Therapeutics: Current Employment, Current equity holder in publicly-traded company. Alt:Global Blood Therapeutics: Current Employment, Current equity holder in publicly-traded company. Strutt:Global Blood Therapeutics: Current Employment, Current equity holder in publicly-traded company. Tang:Global Blood Therapeutics: Current Employment, Current equity holder in publicly-traded company. Liao-Zou:Global Blood Therapeutics: Current Employment, Current equity holder in publicly-traded company. Yuan:Global Blood Therapeutics: Current Employment, Current equity holder in publicly-traded company. Cathers:Global Blood Therapeutics: Current Employment, Current equity holder in publicly-traded company. Oksenberg:Global Blood Therapeutics: Current Employment, Current equity holder in publicly-traded company.

Optimizing Care: Discontinuing Medications Prior to Daratumumab and Hyaluronidase-Fihj Subcutaneous Injection (OMIT)

Introduction Intravenous daratumumab (DARA IV) is generally well tolerated, but it is commonly associated with infusion-related reactions (IRRs). Per prescribing information (PI), the manufacturer recommends pre-infusion medications with diphenhydramine, acetaminophen, and a corticosteroid prior to each infusion to prevent IRRs (Darzalex™ [PI]; 2019, DarzalexFaspro™ [PI]; 2020). However, in our experience the incidence of IRRs is significantly lower after the first three infusions, if they were well tolerated. Therefore, to decrease pill burden and overmedicating the patient at Cedars-Sinai Medical Center (CSMC), the pre-infusion medications for the fourth and subsequent infusions are discontinued. The new subcutaneous (SQ) formulation daratumumab and hyaluronidase- fihj (DARA SQ) has an even lower incidence of IRRs compared to the IV formulation, 12.7% versus 34.5%, of all grades and 1.5% versus 5.4% of grade 3 respectively (Mateos MV., et al. Lancet; 2020). Given the lower risk of IRRs, CSMC recommends discontinuing pre-medications after the third DARA SQ injection, or never starting them if the patient had previously tolerated three or more DARA IV infusions and is now being switched to the SQ formulation. This strategy has been our approach and to date our patients have tolerated their infusions and/or injections. Unfortunately, there is no published literature to guide clinicians, so institutions have different approaches based upon their own anecdotal experiences or hearsay. Methods A single-center, retrospective chart review was performed on patients from a single physician who have received at least one dose of DARA SQ from June 1 through July 22, 2020 at CSMC. A total of 63 patients were screened, one patient was excluded because she required diphenhydramine with each treatment. Data collected included number of DARA SQ doses given without pre-medications, diagnosis, previous treatment with DARA IV, time since last DARA IV treatment, previous IRRs to DARA IV (graded as per CTCAE version 5.0), IRRs to DARA SQ, number of SQ doses, corticosteroids use, and if the patients had any pre-existing pulmonary conditions. The primary objective was to review the incidence of IRRs in our patients following the omission of pre-medications after the third DARA SQ injection. Results A total of 81 doses of DARA SQ were administered to 62 patients. All treatments were well tolerated, and no systemic IRRs were documented. Only one patient had a localized reaction, characterized as erythema around the injection site. Most of the patients were diagnosed with multiple myeloma (94%), one patient had smoldering myeloma, and three patients were diagnosed with amyloidosis. Most patients were previously treated with DARA IV (77%) with a median time since last IV dose of 28 days (range, 7 - 59 days). 15 of these patients had a history of mild to moderate IRRs to DARA IV: 4 were grade 1 and 11 were grade 2. The most common corticosteroid treatment was dexamethasone 20 mg weekly, ranging from 4 mg twice weekly to 40 mg weekly. 18 patients did not receive corticosteroids as part of their treatment regimen, nor as a pre-treatment medication. The majority of the patients (85%) did not have a pre-existing documented pulmonary condition. Conclusion All our patients were able to safely receive DARA SQ without pre-medications with acetaminophen and diphenhydramine beginning with the fourth dose. Furthermore, 18 patients stopped corticosteroids with subsequent injections and were able to tolerate treatment without any IRRs. Clinicians should take into consideration that corticosteroids are given not solely as pre-medication, but also as a treatment for multiple myeloma. Therefore, if the only purpose of corticosteroids is the prevention of IRRs, their administration can be avoided. A previous reaction to DARA IV did not increase the risk of IRRs to DARA SQ. Diphenhydramine can cause drowsiness which can impair a patient's ability to drive home after their treatment; corticosteroids can cause insomnia, stomach upset, and hyperglycemia. By omitting unnecessary pre-medications, these unwanted adverse drug effects can be avoided. This study demonstrates that we can safely discontinue DARA SQ pre-medications if a patient tolerates the initial three treatments of IV or SQ daratumumab. Disclosures No relevant conflicts of interest to declare.

Social support, gender and pill burden influence viral load suppression among HIV-infected adolescents and young adults in rural south-western Uganda

ABSTRACT Adolescents and young adults (AYA) carry a significantly higher risk for HIV infection compared to the general population. HIV-infected AYA also have poorer adherence and viral load (VL) suppression compared to older adult patients. Social support may provide an avenue for interventions to improve adherence and VL suppression in this population. We conducted a cross-sectional study in rural southwestern Uganda to examine the association between social support and VL suppression. We measured family cohesion and various sources of social support namely parent/guardian, teachers, classmates and friend using validated scales, and reliability of the scales using Cronbach’s alpha was at least 0.70 on all of them. We defined VL suppression as having less than 1000 copies per ml. We used logistic regression analysis to calculate odds ratios (OR) for the association and to adjust for potential confounders. We enrolled 255 AYA, age range 12–24 years and 50.6% of them were male. Viral load suppression was present in 72.9% of them. In the multiple regression analysis, friend social support was associated with a 10% increase in the odds of VL suppression for every unit increase on the social support scale (OR = 1.10 95% CI 1.05, 1.14). Waiting for more than 15 minutes to see the doctor at the clinic was associated with an almost 2.5-fold increase in the odds of VL suppression (OR = 2.46, 95% CI (1.23–4.92). Males had 48% lower odds of having VL suppression (OR = 0.52, 95% Cl, 0.27–0.98) compared to females. Experiencing side effects on antiretroviral therapy (OR = 0.46 95% CI 0.22–0.95), and taking two or more pills per dose (OR = 0.21 95% CI 0.06–0.75) were associated with lower odds of VL suppression. In conclusion, social support is positively associated with VL suppression, and interventions to enhance social support should be developed and tested among HIV-infected AYA.

Cardiovascular Health and Transition From Controlled Blood Pressure to Apparent Treatment Resistant Hypertension: The Jackson Heart Study and the REGARDS Study.

Almost 1 in 5 US adults with hypertension has apparent treatment resistant hypertension (aTRH). Identifying modifiable risk factors for incident aTRH may guide interventions to reduce the need for additional antihypertensive medication. We evaluated the association between cardiovascular health and incident aTRH among participants with hypertension and controlled blood pressure (BP) at baseline in the Jackson Heart Study (N=800) and the Reasons for Geographic and Racial Differences in Stroke study (N=2316). Body mass index, smoking, physical activity, diet, BP, cholesterol and glucose, categorized as ideal, intermediate, or poor according to the American Heart Association's Life's Simple 7 were assessed at baseline and used to define cardiovascular health. Incident aTRH was defined by uncontrolled BP, systolic BP ≥130 mm Hg or diastolic BP ≥80 mm Hg, while taking ≥3 classes of antihypertensive medication or controlled BP, systolic BP <130 mm Hg and diastolic BP <80 mm Hg, while taking ≥4 classes of antihypertensive medication at a follow-up visit. Over a median 9 years of follow-up, 605 (19.4%) participants developed aTRH. Incident aTRH developed among 25.8%, 18.2%, and 15.7% of participants with 0 to 1, 2, and 3 to 5 ideal Life's Simple 7 components, respectively. No participants had 6 or 7 ideal Life's Simple 7 components at baseline. The multivariable adjusted hazard ratios (95% CIs) for incident aTRH associated with 2 and 3 to 5 versus 0 to 1 ideal components were 0.75 (0.61-0.92) and 0.67 (0.54-0.82), respectively. These findings suggest optimizing cardiovascular health may reduce the pill burden and high cardiovascular risk associated with aTRH among individuals with hypertension.

Determinants of antiretroviral therapy adherence among older adolescents living with HIV in Kenya during the transition to adult care; An observational study.

Lower levels of adherence to antiretroviral therapy (ART) among older adolescents as compared to adults are influenced by individual, psychosocial, and treatment-related factors. Successful transition of older adolescents into HIV adult care from paediatric & adolescent focused care requires an understanding of barriers to ART adherence. This study aimed at determining individual factors affecting ART adherence among older HIV positive adolescents transitioning to adult care. Between December 2018 and January 2019, we conducted a cross-sectional study among 82 perinatally infected adolescents aged 16-19 years in an HIV care and treatment clinic in Nairobi, Kenya. We used completed structured questionnaires and abstracted data from clinical charts. We performed multivariate logistic regression to identify factors independently associated >95% self-reported ART adherence (7-day recall). The study participants had a median age of 17 (IQR 16,18) on ART for a median duration of 11 years (IQR 7,13). Sixty-four per cent (52) of the adolescents reported optimal adherence was of >95%, and 15% reported missing doses for three or more months. Self -reported adherence had a high correlation with viral loads of <1000 copies ml (Kappa= 0.087). Adolescents with high self-efficacy were eight times more likely to report adherence of >95% [OR 8.1, 95% CI (2.31- 28.18)]. Once a day, dosing was also independently associated with adherence [OR 1.58, 95 %CI [0.62-4.08]. The reduction of ART pill burden and the inclusion of assessment of ART self -efficacy may contribute to transition preparedness among adolescents.

Safety and efficacy of sucroferric oxyhydroxide in pediatric patients with chronic kidney disease

BackgroundPediatric patients with advanced chronic kidney disease (CKD) are often prescribed oral phosphate binders (PBs) for the management of hyperphosphatemia. However, available PBs have limitations, including unfavorable tolerability and safety.MethodsThis phase 3, multicenter, randomized, open-label study investigated safety and efficacy of sucroferric oxyhydroxide (SFOH) in pediatric and adolescent subjects with CKD and hyperphosphatemia. Subjects were randomized to SFOH or calcium acetate (CaAc) for a 10-week dose titration (stage 1), followed by a 24-week safety extension (stage 2). Primary efficacy endpoint was change in serum phosphorus from baseline to the end of stage 1 in the SFOH group. Safety endpoints included treatment-emergent adverse events (TEAEs).ResultsEighty-five subjects (2–18 years) were randomized and treated (SFOH, n = 66; CaAc, n = 19). Serum phosphorus reduction from baseline to the end of stage 1 in the overall SFOH group (least squares [LS] mean ± standard error [SE]) was − 0.488 ± 0.186 mg/dL; p = 0.011 (post hoc analysis). Significant reductions in serum phosphorus were observed in subjects aged ≥ 12 to ≤ 18 years (LS mean ± SE − 0.460 ± 0.195 mg/dL; p = 0.024) and subjects with serum phosphorus above age-related normal ranges at baseline (LS mean ± SE − 0.942 ± 0.246 mg/dL; p = 0.005). Similar proportions of subjects reported ≥ 1 TEAE in the SFOH (75.8%) and CaAc (73.7%) groups. Withdrawal due to TEAEs was more common with CaAc (31.6%) than with SFOH (18.2%).ConclusionsSFOH effectively managed serum phosphorus in pediatric patients with a low pill burden and a safety profile consistent with that reported in adult patients.

Outcomes in unilateral primary aldosteronism after surgical or medical therapy.

Studies find surgery superior to medications in the treatment of primary aldosteronism (PA). It would be ideal to compare surgical and medical therapy in patients with unilateral PA only, who have the option between these treatment modalities. However, this is challenging as most patients with unilateral PA on adrenal vein sampling (AVS) undergo surgery. To compare outcomes of surgery and medications in patients with confirmed or likely unilateral PA. Retrospective cohort study of 274 patients with PA managed at two referral centres from 2000 to 2019. 154 patients identified with unilateral PA using AVS and a validated clinical prediction model were treated with surgical (n=86) or medical (n=68) therapy. Primary outcome was a composite incident cardiovascular event comprising acute myocardial infarction, coronary revascularization, stroke, atrial fibrillation or congestive cardiac failure. Secondary outcomes were clinical and biochemical control. Cardiovascular outcomes were comparable, with the surgery group having an adjusted hazard ratio of 0.93 (95% CI: 0.32-2.67), p=.89. Both treatments improved clinical and biochemical control, but surgery resulted in better systolic blood pressure, 133.0±11.7mmHg versus 137.9±14.6mmHg, p=.02, and lower defined daily dosages of antihypertensive medications, 1.0 (IQR 0.0-2.0) versus 2.6 (IQR 0.8-4.3), p<.001. In addition, 12 of 86 patients in the surgery group failed medical therapy before opting for surgery. In patients with unilateral PA who can tolerate medications, medical therapy improves clinical and biochemical control, and may offer similar cardiovascular protection. However, surgery reduces pill burden, may cure hypertension and is recommended for unilateral PA.

Evaluation of Changes Over Time in the Drug Burden and Medication Regimen Complexity in ESRD Patients Before and After Renal Transplantation

BackgroundMedication regimen complexity (MRC) has not been characterized in detail in patients with end-stage renal disease (ESRD). The objective of the present study was to quantify changes over time in the prescription drug burden and MRC in patients with ESRD (before transplantation, on discharge after kidney transplantation [M0], and 4 months [M4] and 12 months [M12] afterward).MethodsWe retrospectively studied adult patients having undergone kidney transplantation. The number and types of drug prescribed, the pill burden, and the MRC index (MRCI) at 4 different time points (before transplantation, M0, M4, and M12) were extracted from the patients’ medical records. MRCI was calculated by adding each drug score (calculated according to its formulation, dosing frequency, and additional instructions concerning administration). Hence, the MRCI took account of all prescription drugs. A logistic regression model was used to identify factors associated with an elevated MRCI at M12.ResultsThe median (interquartile range) age of the 354 study participants was 52 years (42–62). Respectively 21%, 42%, 53%, and 38% of the patients were taking 10 or more drugs before transplantation and at M0, M4, and M12. At M12, the 3 most frequently prescribed drug classes were immunosuppressants, cardiovascular system drugs, and drugs acting on the alimentary tract and metabolism. The pill burden and MRCI before transplantation were significantly lower (P < 0.001) than at each time point after transplantation. Diabetes and dyslipidemia were independently associated with an elevated MRCI at M12.ConclusionIn kidney transplant recipients, the drug burden and MRCI were greater at all time points after transplantation than before transplantation. The impact of the drug burden and MRC on medication adherence and clinical outcomes in these patients requires further evaluation.

A retrospective cohort study exploring diltiazem as a pharmaco‐enhancer for tacrolimus, in a post–heart transplant setting

A significant proportion of heart transplant-associated expenditure are attributable to immunosuppressants. Post-transplant hypertension adds to the pill burden and subsequent costs. In this study, we describe the effect of diltiazem-the antihypertensive and pharmaco-enhancer-on reducing the required oral dose of tacrolimus. We included 17 recipients who had successfully undergone heart transplants but later developed post-transplant hypertension and were treated with diltiazem. Serum trough levels of the immunosuppressant tacrolimus were measured every 2weeks. Required doses before and after the introduction of diltiazem were compared. Patients were assessed at each follow-up visit for any evidence of toxicity. Medication-related expenditure was estimated based on government-mandated standardized retail price. The power of the study was 98.92% at α=0.05. The mean tacrolimus dose required prior to initiation of diltiazem was 5.85±1.55mg. After initiating diltiazem, the mean required doses reduced to 2.88±1.24mg (p<.0001). Relatively, the required doses reduced by 52.4±10.9%-independently of age, sex, and dose of diltiazem. Medication-related monthly expenditure reduced by 50.3±10.4%. No patient demonstrated evidence of toxicity. Concomitant use of diltiazem and tacrolimus can safely, effectively, and predictably reduce the required dose of tacrolimus and significantly reduce corresponding costs.

Changes in Serum Phosphorus and Pill Burden in Peritoneal Dialysis (PD) Patients Treated with Sucroferric Oxyhydroxide (SO) as Part of Routine Clinical Care: A Contemporary Cohort

Changes in Serum Phosphorus and Pill Burden in Peritoneal Dialysis (PD) Patients Treated with Sucroferric Oxyhydroxide (SO) as Part of Routine Clinical Care: A Contemporary Cohort

Expert Opinion: Exploring the Effectiveness and Tolerability of Capsaicin 179 mg Cutaneous Patch and Pregabalin in the Treatment of Peripheral Neuropathic Pain.

Background and ObjectiveTreatment of peripheral neuropathic pain (PNP) remains a challenge. In the absence of clear predictors of response, clinical decision-making involves trial and error. While many classes of pharmacological agent are used and have shown efficacy, one of the most commonly used first-line treatments is pregabalin. However, in the 60% of PNP cases in which the pain is localized, a local treatment may be more suitable. This article will summarize the evidence for the relative effectiveness and tolerability of the capsaicin 179 mg patch and pregabalin in the treatment of PNP and highlight the expert opinion of the authors based on their own clinical experiences.ResultsWhen compared in a head-to-head trial in patients with PNP, capsaicin 179 mg patch provided non-inferior pain relief compared with an optimized dose of pregabalin, as well as a reduction in dynamic mechanical allodynia, faster onset of action, fewer systemic side effects, and greater treatment satisfaction. Adverse events associated with capsaicin patch are mainly application site reactions, compared with systemic and central nervous system effects with pregabalin. Studies indicate that capsaicin 179 mg patch is associated with a lower burden of therapy than pregabalin in terms of improved tolerability, lack of a daily pill burden, lack of drug–drug interactions, and increased regimen flexibility.ConclusionIn localized neuropathic pain, evidence supports a pragmatic approach of using a local treatment before considering a systemic treatment. For treatment selection, the patient profile (eg, concomitant medication use, age) and the treatments’ efficacy and tolerability profiles should be considered.

Phosphate binders usage, patients knowledge, and adherence. A cross-sectional study in 4 centers at Qassim, Saudi Arabia.

Objectives:To assess phosphate binders’ usage, knowledge regarding their utilization, and adherence among hemodialysis patients in Qassim, Saudi Arabia.Methods:A prospective cross-sectional study conducted at 4 dialysis centers in Qassim, Saudi Arabia with inclusion of 237 patients’ undergoing hemodialysis between November 2018 to January 2019. The study involved interviewing the patients, reviewing their medical records for biomarkers used to assess kidney function, and assessing the patients’ knowledge-based regarding dietary phosphate control, as well as adherence to phosphate binders’ usage.Results:Out of 237 included patients, male to female ratio was 54:46. The prevalence of prescribing non-calcium phosphate binders was 82.7% whereas prescribing calcium phosphate binders was 73.8%. A total of 63% of patients showed a medium level of adherence to phosphate binders. Although adherence level was not poor, therapeutic efficacy was affected by other factors such as administration time adherence positively correlated with the serum phosphate level (p=0.00).Conclusion:Phosphate binders usage is frequent among hemodialysis patients in Qassim centers. Circulating phosphate level was affected by the extent of patients’ knowledge of dietary control and adherence to the usage of phosphate binders. Thus, we recommend enhancing patient education in reference to high- and low- phosphate-rich diet to take wise dietary decisions, lower pill burden, and improve adherence toward the control of hyperphosphatemia

S0385 Implementation of a Deprescribing Tool to Reduce Inappropriate Proton Pump Inhibitor Use

INTRODUCTION: Recent perceptions of inappropriate PPI use have led to an increased interest in deprescribing; however, evaluation of different PPI deprescribing methods have been inconsistent. Inappropriate use of a PPI usually occurs either in the absence of an absolute indication or for non-absolute indications without considering or attempting PPI cessation. The purpose of this project was to study the effectiveness of a deprescribing algorithm to reduce inappropriate use of PPIs in an outpatient gastroenterology clinic. METHODS: This project recruited adult patients seen in the outpatient gastroenterology clinic that were on PPI therapy for more than 8 weeks. Patient’s eligible for study completed an initial GerdQ and were contacted at 2-week and 4-week post intervention for follow up. The primary outcome measure was symptom control, defined as a change in positive predictor GerdQ difference of ≤ 2 at 4 weeks. Baseline variables were assessed with descriptive statistics for analysis and project evaluation. RESULTS: The baseline (week 0) mean GerdQ (1.6 ± 2.09762) was marginally increased at week 2 (1.6667 ± 2.19306) and remained stable at week 4 (1.6667 ± 2.25726). A paired-samples t tests was calculated to compare the mean GerdQ score at baseline to the mean change in GerdQ score at 4 weeks. A significant change from baseline to week 4 was found (t(14) = 2.860, P < 0.05). Of the 15 participants, 13 (87%) had a score change ≤2. CONCLUSION: Overall, most participants (87%) had a statistically significant stability in their GerdQ scores at 4 weeks after having their PPIs deprescribed. These results are considerably higher than the predetermined goal of at least 25% participants with symptom control used to evaluate project effectiveness. It has been widely accepted in the medical community that PPIs are often prescribed inappropriately. The appeal for evidence-based guidelines has been expressed among many medical practitioners to improve their deprescribing capabilities. The potential reduction in health care expenditures, adverse effects, and pill burden strengthens the need to deprescribe PPIs used inappropriately. Results from this study will hopefully encourage clinicians to routinely evaluate use of ongoing medications and deprescribe where appropriate.Figure 1.: PPI deprescribing algorithm. Please note that participants were monitored at 2 and 4 weeks rather than 4 and 12 weeks. Reprinted with permission.Table 1.: GerdQ tool used to measure clinical data at baseline (Week 0), Week 2, and Week 4Table 2.: Comparison of outcome measures assessed by GerdQ score at baseline (week 0), week 2, and week 4. (a) Total of difference in GerdQ scores. Negative values indicate increase in positive predictors in GERD symptoms while positive values indicate decrease in positive predictors in GERD symptoms

Retrospective observational study of adverse events (AEs) in women with ovarian cancer (OC) switching from olaparib capsules to tablets: U.S. health care claims database study

Objective: Olaparib (Lynparza®) was first FDA-approved as a capsule (400 mg bd) for the treatment of women with BRCAm recurrent OC after ≥3 lines of therapy. To reduce pill burden, a tablet (300 mg bd) was approved for this indication, and for maintenance treatment in platinum-sensitive recurrent (PSR) OC, regardless of BRCAm status. Despite dosing and bioavailability differences between olaparib capsules and tablets, clinical trial results suggest similar efficacy and tolerability profiles; real-world data are of interest.