Awards & Grants - National Paul Ambrose Scholars Program

Paul Ambrose Scholars Program: This past year, I applied for and was awarded the Paul Ambrose Scholars Program Grant by the Association for Prevention Teaching and Research. The grant focused on a preventive health project. Here is my project proposal addressing medication adherence in migrant farm workers and some materials I developed for the project. 

Paul Ambrose Scholars Program - Developed Materials

 Adherence questionnaire - english version

 Adherence questionnaire - spanish version

 Wallet medication card front - english version

 Wallet medication card front - spanish version

 Wallet medication card back - english version

 Wallet medication card back - spanish version

Paul Ambrose Scholars Program - Project Proposal

Title

Controlling blood pressure in migrant farm workers by encouraging medication adherence

Project Description

The Leading Health Indicator that I will address is Clinical Preventative Services HDS-12 to “increase the proportion of adults with hypertension whose blood pressure is under control.  I will coordinate this project with the community partner, Proteus, an organization providing health services to migrant and seasonal farm workers across Iowa and I have partnered with Lacey Naaktgeboren, Migrant Health Program Director, and Emily Sinnwell, Bilingual Clinical Director at Proteus for this project. 

The Paul Ambrose grant will provide support for medication boxes, medication list pocket cards, and educational materials related to medication adherence to the mobile health clinic site in Williamsburg, IA during Summer 2014.  The Williamsburg clinic serves 300 migrant farmworkers who are mostly bilingual residing in three camps with their families.  Some common conditions that the workers face are diabetes, high blood pressure, and high cholesterol.  Patients also tend to be non-adherent to their medication and this is an opportunity for pharmacy students to improve patient care.  Following the physician visit, I will interview patients using the Drug Adherence Work Up (DRAW) tool to assess the cause of medication non-adherence. I will then educate patients about the importance of medication adherence, provide an educational pamphlet, and a medication pill box to encourage adherence.  Patients will also be provided with a medication list pocket card with their most recent labs (hemoglobin A1c, blood pressure, and cholesterol) to be available for emergencies and to help ensure continuity of care when the farm workers leave the state. The health education materials will be selected or designed according to the CDC Simply Put Health Literacy guide and will be available in both English and Spanish at a basic reading level, and I will ensure that pictograms are used for patients who are unable to read. 

My passion for this project stems from my experience of trying to communicate with a Hispanic patient who only spoke Spanish and understanding the difficulties that can result due to cultural and language barriers.  Since then, I have made it a priority to increase opportunities for pharmacy students focusing on foreign languages and international issues and I recently developed a six week medical Spanish workshop for pharmacy students to improve our ability to conduct medication counseling in Spanish.  In addition to improving the health of the patients, being a Paul Ambrose Scholar would allow me to expand opportunities for pharmacy students to be directly involved in migrant health care so that patients receive more comprehensive care.  I am also currently helping with Proteus’ long sleeve shirt drive to bring awareness to the dangers farmworkers face working with pesticides, a campus-wide food drive to benefit their food pantry, and a medication packaging service project.  It is my goal that through these opportunities, other pharmacy students and I will improve our clinical skills and become aware of some cultural differences that impact patient care.

DRAW Medication Adherence Tool:

http://millionhearts.hhs.gov/Docs/TUPD/DRAW_Tool.pdf

http://www.ncbi.nlm.nih.gov/pubmed/23945734

CDC Health Literacy Simply Put Guide: 

http://www.cdc.gov/healthliteracy/pdf/simply_put.pdf

Case - Breast Cancer

Clinical Presentation Skills 

Case Presentation - Breast Cancer 

CPS case 59 - breast cancer from shinypharmacy

Journal Club - Anticholinergic effects of antihistamines on movement

Journal Club Presentation for Drug Literature Evaluation 
(link to document in google drive)

Section 1, Group 2 - November 11, 2014

Naicker P, Anoopkumar-Dukie S, Grant GD, Kavanagh JJ. The effects of antihistamines with varying anticholinergic properties on voluntary and involuntary movement. Clinical Neurophysiology. 2013 Sep;124(9):1840-5.  

Article Background

Objective: Examine the effect of antihistamines with varying anticholinergic properties on voluntary and involuntary movement using a double blind, placebo-controlled, five-way crossover study design.

Source: Journal of Clinical Neurophysiology, Impact Factor = 2.979, Ranked 60 out of 194 in Clinical Neurology journals.

Authors: Authors were affiliated with Griffith University School of Pharmacy, the Centre for Musculoskeletal Research, and the Griffith Health Institute in Gold Coast, Australia.  Authors declared no conflicts of interest.

Funding: There were no external funding sources.

Current Knowledge & Relevance: Research indicates that antihistamines could affect reaction time and physiological tremors (Kavanagh et al., 2012). The pathophysiology of tremors is complex and may be modulated by cholinergic and histaminic pathways.  The current study provides insight on select antihistamines and their effect on movement dysfunction.

Rationale: Antihistamines are one of the most commonly used over-the-counter medications.  Antihistamines are known to cause varying degrees of sedation, but there is relative lack of information on the anticholinergic properties of particular antihistamines and their effect on movement.

Methods & Design

Design:  Double-blind, placebo-controlled, five-way crossover study in 11 subjects (7 female, 4 male, mean age: 24 ± 4 yrs).

Randomization: No randomization reported.

Inclusion Criteria: Healthy individuals from the university community.

Exclusion Criteria: Individuals with epilepsy, cardiopulmonary, metabolic, or neuromuscular disorders. 

Intervention: Eleven subjects were administered placebo, first generation antihistamines (promethazine 25mg), or second generation antihistamines (loratadine 10mg, desloratadine 5mg, or fexofenadine 180mg). Blinding was ensured using crushed drug in an opaque capsule.  Six of the eleven subjects participated in an additional experiment with hyoscine butylbromide 10mg to understand the contribution of this peripheral antimuscarinic drug on neuromotor function.  All testing sessions commenced at 12:30pm, and participants avoided intense exercise, caffeine, and alcohol 5 hours prior to each study with a one week washout period between experiments.

Main Outcomes: Assessments were performed pre-ingestion and 1, 2, and 3 hours post-ingestion. Drowsiness was assessed using a unipolar visual analogue scale (VAS), with end points being ‘not drowsy’ and ‘very drowsy,’ as well as the Stanford Sleepiness scale (SSS).  Voluntary movement was assessed using reaction time tests and involuntary movement was assessed by examining physiological tremor.

Statistical Analysis: Calculations for power or sample size were not reported. All statistical analyses were performed using SAS version 9.2. Level of significance was set at 0.05. Wilcoxon Mann-Whitney tests and ANOVA were performed.

Advantages: Outcome measures for motor functioning and tremor magnitude were studied objectively.  For each crushed drug, the dissolution testing and elution rates were comparable to the tablet form.

Disadvantages: Drowsiness outcomes were based on subjective data, the sample size was very low, and the study population was only young healthy individuals.

Main Results

Primary Outcome: To determine if the antihistaminergic or anticholinergic properties of antihistamines contribute to deficits in neuromotor function.  Outcomes studied were effects on self-perceived drowsiness, reaction time, and physiological tremor in response to the ingestion of promethazine, loratadine, desloratadine, and fexofenadine.  There were no dropouts reported.  Per protocol analysis was conducted.

Self-perceived drowsiness: Neither the VAS nor the SSS showed a significant change for the testing sessions involving the placebo.  Visual analog scale showed that promethazine was the only drug to induce drowsiness.  VAS scores were significantly greater than placebo at the intervals of 2 hours (z=2.27, p=0.023) and 3 hours (z=2.15, p=0.031) after the ingestion of promethazine.   The SSS indicated that promethazine, desloratadine, and fexofenadine, induced drowsiness.  Promethazine significantly increased SSS scores at 1 hour (z=2.00, p=0.04), 2 hours (z=3.11, p=0.01), and 3 hours (z=3.07, p=0.01) after ingestion.  SSS scores were significantly greater than placebo at the time point of 2 hours post-ingestion of desloratadine (z=2.39, p=0.01) and fexofenadine (z=2.10, p=0.04).

Reaction Time:  The simple reaction time (SRT) and choice reaction time (CRT) post-ingestion of the placebo did not change from pre-ingestion.  SRT was significantly slower than placebo at the time point of 3 hours post-ingestion of loratadine (p=0.013) and promethazine (p=0.034).  CRT was significantly slower than the placebo condition at 2 hours post-ingestion of loratadine (p=0.0047), while desloratadine increased CRT at 2 hours (p=0.007) and 3 hours (p=0.039) post-ingestion.  CRT was slower than placebo at 1 hour (P=0.007), 2 hours (p=0.001), and 3 hours (p=0.001) post-ingestion of promethazine.  The antimuscarinic hyoscine butylbromide that was administered in the additional experiment had no significant effect on SRT or CRT, indicating that the effects on movement were centrally rather than peripherally mediated.

Physiological tremor:  One hour after ingesting desloratadine, acceleration root mean square (RMS) (p=0.021) and total power (p=0.031) change scores were significantly lower than placebo, indicating that tremor amplitude increased.  Two hours after ingesting promethazine, acceleration RMS (p=0.020), total power (p=0.029), and peak power (p=0.008) change scores were significantly greater than placebo, indicating that tremor amplitude and the neural component of tremor generation decreased.  Hyoscine butylbromide had no significant effect on any of the tremor-related variables.

F values for all point estimates were large, between 4.00 and 16.11, and the p-values were small, indicating statistically significant results. The absolute values of the effect size estimates for each group mentioned above are between 1.22 and 2.11.  The large effect size indicates that there is a large magnitude of difference with treatment compared to placebo.

Evaluation: Based on this study results, we can conclude that different antihistamines have distinct effects on sedation as well as voluntary and involuntary movements.  All antihistamines studied affected reaction time to some degree.  The peripherally-acting antimuscarinic agent hyoscine butylbromide did not affect reaction time, indicating that the effects of antihistamines on involuntary and voluntary movement are likely centrally-mediated.

Conclusion

Summary: The effects on voluntary and involuntary movement between antihistamines with varying anticholinergic properties differ between first and second generation. Promethazine had the largest effects on drowsiness and some impairment on voluntary and involuntary movement. While the second generation antihistamines, loratadine, fexofenadine, and desloratadine, had a dissociation between their effects on drowsiness and reaction times.

Evaluation: The authors argue that the current study has merit because it supports their previous publication by Kavanagh et al., 2012 showing that low dose promethazine and loratadine negatively affect neuromotor function. This conclusion is not well defined because the antihistamine effects are limited to the small population size and drugs dosages used in this trial.

Strengths: Double blind and placebo-controlled study with a crossover design to examine differences between similar treatments where the effects are small and reversible.  The effects of antihistamines are immediate and can be studied in a short time period.  A carryover effect is avoided due to short half-life of antihistamines and a wash out period of 7 days.

Limitations: The younger study sample and the small sample size limits the generalizability of the results.

Bottom Line: The results of this study show that some second generation antihistamines such as fexofenadine provide a safe alternative to first generation antihistamines in regards to movement. However, caution should be used because the central anticholinergic and antihistaminergic properties of these antihistamines differ.

Study Analysis and Critique

Useful References/Practice Guidelines:

      1.            Baumann-Birkbeck L, Grant GD, Anoopkumar-Dukie S, Kavanagh JJ. Drowsiness and motor responses to consecutive daily doses of promethazine and loratadine. Clin. Neurophysiol. 2014 Apr;S1388-2457(14)00180-1. PMID: 24791618.

      2.            Stergiou N, Decker LM. Human movement variability, nonlinear dynamics, and pathology: Is
there a connection? Hum Mov Sci. 2011 Oct;30(5):869-88. PMID: 21802756.

      3.            Reich MM, Volkmann J. Deep brain stimulation for hyperkinetic movement disorders. Nervenarzt. 2014 Feb;85(2):147-55. PMID: 24452308.

      4.            Yoneda H, et.al. Roles played by histamine in strenuous or prolonged masseter muscle activity in mice. Clin Exp Pharmacol Physiol. 2013 Dec;40(12):848-55. PMID: 24138758.

      5.            Hindmarch I, et.al. A double-blind, placebo-controlled investigation of the effects of fexofenadine, loratadine and promethazine on cognitive and psychomotor function. Br J Clin Pharmacol. 1999 Aug;48(2):200-206. PMID: 10417497.

      6.            Kavanagh JJ, Grant G, Anoopkumar-Dukie S. Low dosage promethazine and loratadine negatively affect neuromotor function.Clin Neurophysiol. 2012 Apr;123(4):780-6. PMID: 21880544.

Future Research: Investigate voluntary and involuntary movement effects of additional antihistamines and their dose-related responses in a wider age range study population and a larger sample size. 

Conferences & Meetings - Iowa Pharmacy Association College Night

My speech for Iowa Pharmacy Association College Night 
(I was asked to be a IPA College Night panelist to discuss IPA student opportunities)

Good evening everyone! I am Shiny Parsai and I am a third year pharmacy student.

So I like to think of IPA as a good craft beer.  Just like a good beer there are so many flavors to fit everyone’s palette and also you can brew your own.  Iowa Pharmacy Association is very similar because there are opportunities in IPA that would fit your own personal palette and you can brew your personal brand of advocacy.

So how did I become involved in IPA?

I became involved in IPA by attending College Night two years ago and listening to how other pharmacy students and pharmacists have been involved. I was impressed by all the unique opportunities and I wanted to learn more about pharmacy at the state level.  Each year, IPA has several committees and task forces for students to be involved in and I began by serving as a student on the Health System Liason Board.

Serving on the board helped me gain a deeper understanding about the Pharmacy Practice Model Initiative.  This summer, I called pharmacy directors across the state of Iowa, encouraging them to complete the hospital self-assessment survey created by the American Society of Health System Pharmacists. The survey assesses how pharmacists provide care in the health system setting.  It looks at what services pharmacists should be providing and what technology can be used to enhance those services with the ultimate goal of advancing pharmacy practice.

In addition to serving on the Health System Liason Board, I also attended the IPA annual meeting and recently the Bill Burke Leadership Conference.  Though I did not realize it at the time, being involved in IPA has helped me be more aware and passionate about issues in the pharmacy profession such as PPMI, provider status, tech-check-tech, and tele pharmacy.  IPA is a great way for you to engage and to learn about these and numerous other pharmacy issues. 

So as you sit here today, wondering if and how you should become involved in IPA…I encourage you to try something new within IPA and to gain a deeper understanding of our profession.  I know pharmacy school is hard, there a lot of long days and nights as we all work towards our goals.  If you are waiting for the right time to be involved, to engage, and to learn…I am here to tell you that the time is now.  And while you work on your dreams to become a pharmacist, remember that IPA is right there with you…working to develop the practice setting, the job, and the recognition that you want as pharmacists when you graduate.  So I challenge you to dream big, innovate, and to brew your personal brand of advocacy in pharmacy.  Thanks for your time. 

Poster - 2014 American College of Clinical Pharmacy Annual Meeting

My poster for the 2014 American College of Clinical Pharmacy Annual Meeting

My abstract for the 2014 American College of Clinical Pharmacy Annual Meeting

Systematic Literature Review of Randomized Controlled Trials to Evaluate the Efficacy of Medical Marijuana for Analgesia

Shiny Parsai, M.S., Pharm.D. Candidate, Ronald A. Herman, Ph.D.; The University of Iowa College of Pharmacy, Sarah J. Johnson, Pharm.D., BCPS-AQ ID; The University of Iowa Healthcare

Purpose: Medical marijuana has had an evolving and controversial role for the treatment of pain.  This review summarizes and evaluates the current evidence from randomized controlled trials to examine the efficacy of medical marijuana as an analgesic. Methods: A systematic literature review was conducted using PubMed, IDIS, IPA, and CINAHL databases.  Articles were included if analgesia was a measured outcome in humans, the intervention involved tetrahydrocannabinol (THC) or derivative, was a randomized controlled trial, and was in English. Two authors did an initial screen of the abstracts to eliminate irrelevant articles and then a detailed review of the full text to identify the articles to be included in the evidence tables.  The third author reconciled differences if there was not a consensus. Data extraction included author name, date, type of pain, sample size, study design, intervention, efficacy, and adverse effects.  Evidence was organized and analyzed in separate evidence tables by type of intervention: inhaled cannabis, oral cannabis extracts, dronabinol, THC+CBD spray, and synthetic analogs. Results:  The initial literature search produced 133 unique articles.  Systematic review of abstracts, yielded 66 for full text review and 67 were excluded.   Full text review resulted in 48 articles to be included in the evidence tables. Conclusions:  Across each intervention type at least half of the studies showed a reduction in pain scores when compared to placebo.  There were 11 of 48 studies that indicated no difference from placebo for analgesia, with at least one study in each intervention type. There were 6 studies that compared the THC compound to another analgesic. It was not different from ibuprofen in one study, diphenhydramine in another study, and it was equivalent to codeine in two studies.  It was inferior to dihydrocodeine and to morphine in separate studies.  Adverse events were a concern in some of the studies.

Abstract - 2013 Obesity Society Annual Meeting

My abstract for the 2013 Obesity Society Annual Meeting

Subjective and Objective Methods to Examine Sleep Amount in Free-Living Families

Shiny Parsai, Randal Foster, Lorraine M. Lanningham-Foster Ames, IA

Background: Obesity and sleep insufficiency appear to be linked, possibly due to excess energy intake during wake time contributing to weight gain. To better understand the relationship between insufficient sleep and obesity, we need accurate and practical tools to quantify sleep. The purpose of this study was to compare two objective tools and one subjective tool to study sleep in free-living families. Methods: The study included 18 families (10 men, 17 women, 11 boys, and 5 girls). Subjects participated in a week-long study to monitor their sleep using an accelerometer (MSR145), a pattern-recognition system (SenseWear WMS® Mini armband), and sleep logs. BMI was calculated using height and weight and body composition was measured using air displacement plethysmography (BOD POD®). The objective tools were compared to the sleep log using regression analyses. Post-hoc tests were used with ANOVA and ANCOVA with a Bonferroni correction applied to give an overall significance level of P < 0.05. Results: The objective tools estimated similar sleep duration data from the subjects when compared with the sleep log. The accelerometer had a better correlation than the pattern recognition system when compared with the sleep log (0.399 vs. 0.1785, respectively).  Sleep duration was inversely correlated with age for all measurement tools. Conclusions: Future additional studies targeting free-living families to study sleep amount and obesity using these objective tools would be beneficial. It is also possible that the relationship between sleep duration and obesity may be explored in existing data sets where these objective measurement tools have been employed for other purposes such as physical activity assessment.

Awards - Diversity Stimulus Award and APhA-ASP/IPSF Leadership Position 2013-2014

University of Iowa College of Pharmacy
Diversity Stimulus Award

Proud to say that the APhA Medical Spanish Program was recently recognized for the Diversity Stimulus Award award!  Criteria for the award: Designed to honor individuals, programs, divisions and student organizations engaged in diversity initiatives which promote the development of an inclusive, diverse community.

APhA-ASP/IPSF Leadership Position 2013-2014

In the past years, the IPSF chapter at the University of Iowa College of pharmacy organized one event per semester.  We significantly changed that this year by implementing several innovative programs to educate student pharmacists about topics in international health.  The United States is a global melting pot, but it is important to appreciate that there is still a wide variety of cultural segments which speak their own languages and have their own cultural sensitivities when it comes to healthcare.  After seeing the difficulties that can result due to cultural differences and language barriers, we have made it a priority to increase opportunities for student pharmacists focusing on foreign languages and international issues.  We are excited to be a part of the pharmacy profession, to continue to learn and be involved in global health efforts.  We especially look forward to becoming pharmacists and being an essential part of the healthcare system so we can directly address issues of diversity and disparities in healthcare.  

Our goals and objectives for IPSF this year included the following:

·         Educate student pharmacists on pharmacy and health care issues around the globe

·         Promote the pharmacy profession in the community

·         Increase Spanish proficiency and cultural competency among student pharmacists

·         Promote inter-professional collaboration with other health care students and non-health care students

·         Provide opportunities for community service and involvement

·         Foster relationships with faculty and staff

·         Develop promotional materials for APhA-ASP/ IPSF

We began the year by educating student pharmacists about Pharmacy in the United Kingdom.  Pharmacist Sara Salem was originally licensed and practiced in hospital and community pharmacies in the United Kingdom.  She presented on her pharmacy experience in the UK and pharmacy education in the United Kingdom.  She provided information on the regulatory body, The General Pharmaceutical Council and the professional body, The Royal Pharmaceutical Society of Great Britain.  Student pharmacists learned about the National Health Service in the United Kingdom and global career opportunities in pharmacy.

During the month of October, American Pharmacists Month KRUI Radio Spot was developed to promote  pharmacy to the community.  The spot included the following information: Did you know that October is American Pharmacists Month?  At the University of Iowa College of Pharmacy we want to celebrate by letting you know that pharmacists are medication experts and your most accessible health care provider.  Stop by your local pharmacy today to learn about how your pharmacist can provide a range of services from medication counseling to selecting over-the-counter medications, and giving immunizations.  This October take the time to “Know Your Pharmacist, Know Your Medicine.”  This was a message from student pharmacists at the University of Iowa College of Pharmacy.

To prepare for APhA-ASP Mid Year Regional Meeting, we developed APhA-ASP Promotional Materials, which included thank you cards with the APhA-ASP logo to thank all the donors, speakers, and preceptors for all APhA-ASP events.  During our November meeting, we took 10 minutes to advertise the IPSF Student Exchange Program and the opportunity to learn about pharmacy around the globe. 

We spent over six months developing the Medical Spanish Pilot Program, for student pharmacists.  Developing the program involved surveying students, finding a professor, fostering support from faculty and students, and appropriating funding.   The six week workshop began in January and met two hours per week during the evening.  We had originally planned to only have one group of 15 students but due to demand, added a second group of 15 students.  After gaining approval from faculty, students were able to submit the cost of the Medical Spanish fee to the College of Pharmacy for reimbursement.  The college provided $1800 in reimbursements for students to enroll in the workshop.  With the increasing Spanish speaking population both in Iowa and the US, the goal of the program is to prepare student pharmacists to communicate effectively with Spanish speaking patients.  Through this workshop, the students not only learn the language, but also cultural differences that impact a patients' care.  At the conclusion of the six week program, a Mock Medical Spanish Clinic, was organized for student pharmacists to practice their newly gained skills with fluent Spanish speakers.  We developed patient cases and the students worked to assess the patient’s ailments and recommend an appropriate medication in Spanish. 

We worked with Proteus to organize a Long Sleeve Shirt Drive for Farm Workers Awareness Week for migrant farm workers in Iowa. We collected 30 shirts that were donated to migrant farm workers this summer during their pesticide training.  For World Tuberculosis Day we arranged for a video screening of Exposed: The Race Against Tuberculosis and a presentation by Andy Weigel, Disease Prevention Specialist for Johnson County Public Health, focusing on infectious disease control and prevention.

We applied for and were awarded the Paul Ambrose Grant through the Association for Prevention and Teaching. The $350 grant assisted with Proteus Migrant Farm Workers Mobile Clinics.  The grant provides support for medication boxes, medication list pocket cards, and educational materials related to medication adherence to the mobile health clinic site in Williamsburg, IA during Summer 2014.  Student pharmacists have signed up to help at 6 summer clinics to serve a total of 300 migrant farmworkers.   Prior to the summer mobile clinics, we organized a Proteus Medication Packaging Service Event during which student pharmacists spent a full day dispensing medications for the summer clinics. 

For World Malaria Day Fundraising Event we had a yogurt parfait breakfast bar sale to raise money for the UNICEF Nothing But Nets charity to provide malaria nets in developing countries.  We collaborated with Students for Interprofessional Education to organize a campus wide Interdisciplinary Book and Food Drive that raised over 700 books and 150 items of food.  The books were donated to World Wide Books and the food was donated to Proteus migrant farm workers food pantry.

All events and efforts were new this year and have had a significant impact on both student pharmacists and the community.  

Drug Information - Statins in patients with ESRD

Question: Hyperlipidemia

Statins are often prescribed for both primary and secondary prevention of cardiovascular disease. Patients with end-stage renal disease (ESRD-dialysis) are at significantly increased risk for cardiovascular disease and are often prescribed statins. What is the evidence to support or refute using statins in patients with ESRD?

Answer

Patients with end-stage renal disease are at significantly increased risk for cardiovascular disease than the general population¹.  Since statins have shown to reduce cardiovascular events in patients at high cardiovascular risk, it is important to consider the evidence of statin therapy in patients with end stage renal disease². The 4-D and AURORA trials have studied the use of statins in patients with end-stage renal disease

The 4-D study by Wanner and colleagues, was a multicenter, randomized, double-blind, prospective study of 1255 subjects with type 2 diabetes mellitus receiving maintenance hemodialysis.   Patients from ages 18 to 80 years of age were randomly assigned to atorvastatin 20 mg/day or placebo.  Adherence rates of around 80% were similar in both study groups.  The primary end point included death from cardiac causes, nonfatal myocardial infarction, and stroke.  After four weeks of treatment, the atorvastatin group had a 42 percent decrease in low density lipoprotein (LDL) cholesterol compared to the placebo group that had a 1.3 percent reduction.  Though atorvastatin decreased the rate of all cardiac events combined (relative risk 0.82; 95 percent confidence interval 0.68 to 0.99; P = 0.03), it did not affect total mortality (relative risk, 1.12; 95 percent confidence interval, 0.81 to 1.55; P=0.49).  Overall, atorvastatin did not significantly affect the primary end point that included cardiovascular death, nonfatal myocardial infarction, and stroke in diabetic patients who received atorvastatin at the median follow up period of four years³.  The study had very low rates of adverse drug reactions, with no rhabdomylysis or severe liver disease in either group.  The Aurora trial consisted of 2776 hemodialysis patients in a multicenter, randomized, double-blind, prospective trial.  Patients from ages 50 to 80 were randomly assigned to rosuvastatin 10mg/day or placebo.  The combined primary end point was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke.  At three months, the rosuvastatin group had lowered LDL by 43% (100 to 58 mg/dL) compared to no change with placebo (99 to 98 mg/dL).  At a median follow-up period of 3.8 years, the reduction in LDL cholesterol level did not have a significant effect on the composite primary end point of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke.  Increased incidence of adverse events was not associated with rosuvastatin therapy⁴.  Results of a 2013 meta-analysis by Nemerovski et al included clinical trials evaluating cardiovascular end points of statins in patients with End Stage Renal Disease (ESRD).  The meta-analysis reported that “statin therapy has failed to significantly alter the course of cardiovascular disease events in patients with ESRD.⁵”

Conclusion

Although atorvastatin in the 4-D study and rosuvastatin in the Aurora trial significantly lowered the levels of LDL cholesterol in dialysis patients, statins overall did not significantly affect the primary end point in both studies that included cardiovascular death^3,4.  Even though statins were well tolerated, they have failed to significantly affect cardiovascular disease in patients with end stage renal disease and should not be recommended.

Author: Shiny Parsai, Pharm.D. Candidate 2016

Date: May 9, 2014

References

1.      Foley RN, Parfrey PS, Sarnak MJ. Clinical epidemiology of cardiovascular disease in chronic renal disease. Am J Kidney Dis. 1998 Nov;32:Suppl 3:S112-S119.

2.      Baigent C, Keech A, Kearney PM, et al. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet. 2005 Sept 27;366:1267–1278. 

3.  Wanner C, Krane V, Marz W, et al. Atorvastatin in patients with type 2 diabetes mellitus undergoing hemodialysis. N Engl J Med. 2005 July 21;353:238–248.

4.     Fellstrom BC, Jardine AG, Schmieder RE, et al. Rosuvastatin and cardiovascular events in patients undergoing hemodialysis. N Engl J Med. 2009 April 2;360:1395–1407.

5.     Nemerovski CW, Lekura J, Cefaretti M, et al. Safety and Efficacy of Statins in Patients with End-Stage Renal Disease. Ann Pharmacother. 2013 July 18; 47(10) 1321–1329.

Conferences & Meetings - Opiod use and abuse deterrent strategies

Special Event

Cold Night/Hot Topic – Opiod use and abuse deterrent strategies – 1/24/2014

Last night I attended a special event put together by professors at the University of Iowa College of Pharmacy. The event speakers discussed various aspects of opiod abuse.  We had a pharmacist discuss his experience in using opiods in pain management and using pain contracts as a way to prevent abuse. There were also speakers from the Iowa Prescription Monitoring Program, a lieutenant from the Johnson County Sheriffs office, a compounding pharmacist, and a lawyer from a Mallinckrodt Pharmaceuticals.  Currently, there are challenges to developing a national prescription monitoring database so the PMP is working to develop a program with bordering states and then hopefully expand to other states. The compounding pharmacist spoke about how he does not accept insurance but rather patients pay him directly and then the patients can submit the claim to their insurance company.  He is able to do this by establishing his compounding business as a separate corporation. The lawyer was very interesting as he discussed opiod use from a manufacturers perspective and all the efforts their company is involved in to reduce drug abuse. One such effort is creating dummy medications with no active pharmaceutical ingredient and loaning them to law enforcement for drug busts. I am glad to see that even manufacturers are thinking about this issue and I really enjoyed hearing from all the other speakers.