Yosprala: Coordinated Delivery of a Proton Pump Inhibitor and Aspirin.

Objective: Review the pharmacology, pharmacokinetics, efficacy, and safety of Yosprala (aspirin and omeprazole). Data Sources: A literature search was conducted using PubMed with the terms "Yosprala," "PA8140," and "PA32540" from the initial year through May, 2019. Additional sources were gathered through bibliographies. Aralez Pharmaceuticals Inc was contacted for manufacturer information. Study Selection and Data Extraction: The sources were narrowed to studies done in English language between 1990 and 2019. All viable clinical trials for the use of Yosprala in the secondary prevention of cardiovascular events were included. Data Synthesis: Yosprala is a coordinated delivery system of immediate-release omeprazole 40 mg and enteric-coated aspirin (325 mg or 81 mg). In 2016, the Food and Drug Administration approved Yosprala for the secondary prevention of cardiovascular or cerebrovascular events (ie, stroke or myocardial infarction). While it is recommended that patients take low-dose aspirin for secondary prevention of these events, many patients cannot tolerate the gastrointestinal (GI) adverse effect profile of the drug. Phase 3 clinical trials have proven that Yosprala significantly lowers the occurrence of GI bleeds and ulcers versus aspirin alone (3.2% and 8.6%, respectively; P ≤ .001). The most common adverse effects include infection, diarrhea, and dyspepsia. Conclusion: Yosprala significantly reduces the occurrence of GI ulcers and seems to be a safe and effective option for the secondary prevention of cardiovascular events.

The pharmacist role in the development and implementation of a naloxone prescription program in Alabama.

OBJECTIVE: The purpose of this report is to describe the development and implementation of a pharmacist-led naloxone-training and prescription service at a county health department. SETTING: Jefferson County Department of Health, Birmingham, Alabama. PRACTICE DESCRIPTION: This service was developed in response to the overwhelming heroin and opioid epidemic that is currently affecting the entire nation and which is highly prevalent in the state of Alabama. Because of this epidemic, new state laws have been established regarding prescriptive authority, liability, and possession of naloxone. PRACTICE INNOVATION: Through a collaborative protocol, pharmacists at the Jefferson County Department of Health were responsible for prescribing and educating the public about naloxone. EVALUATION: Between 2014 and 2015 the Jefferson County Coroner reported a 131% increase in opioid prescription-related deaths indicating the continued need for the naloxone prescription program. RESULTS: In total, 83 clients were trained and 150 naloxone kits were distributed among heroin and opioid users, concerned family members or friends, and those who work closely with users. CONCLUSION: This service and its extending arms were developed in response to the need for naloxone education among heroin and opioid users, their family members, civil servants who work with users, and family practice physicians who prescribe opioids.

Pharmacist-led biometric screenings: A retrospective chart review in a community pharmacy.

BACKGROUND: Biometric screenings have gained popularity in employer-based wellness programs and are increasingly offered at community pharmacies. OBJECTIVE: This study aimed to analyze biometric screening data collected at a community pharmacy in North Alabama to examine the prevalence of risk factors and the role of pharmacist-led screenings in identifying at-risk individuals and facilitating referrals to primary care providers. METHODS: A retrospective chart review was conducted using biometric screening data collected between 2020 and 2021. Descriptive statistics were calculated to analyze the data. RESULTS: A total of 801 patients were included in the analysis. The mean age was 45.4 years, and 56.2 % were female. The mean systolic blood pressure was 132 mmHg, and the mean diastolic blood pressure was 84 mmHg. Mean total cholesterol was 174 mg/dL, and the mean blood glucose was 109 mg/dL. Mean BMI was 35.1 kg/m2. Among the screened patients, 22.5 % were referred to a primary care provider due to an elevated level of at least one of the measured variables, with BMI being the most common reason for referral. CONCLUSION: This study provides valuable insights into the prevalence of risk factors in a population undergoing pharmacist-led biometric screenings in a community pharmacy. The findings emphasize the important role of pharmacists in identifying at-risk individuals and facilitating appropriate referrals to primary care. Further research is needed to evaluate the long-term impact of these referrals and explore the feasibility of similar programs in diverse healthcare settings.

Pregabalin for the treatment of generalized anxiety disorder.

OBJECTIVE: To evaluate the efficacy and tolerability of pregabalin in the treatment of generalized anxiety disorder (GAD). DATA SOURCES: A search of PubMed (1966-December 2011) and International Pharmaceutical Abstracts (1970-December 2011) was conducted using the MeSH and free-text terms pregabalin, anxiety disorders, and anxiety. STUDY SELECTION AND DATA EXTRACTION: All English-language articles identified through the search were evaluated for inclusion. Only randomized controlled trials involving the use of pregabalin for the treatment of GAD were included in the review. DATA SYNTHESIS: Eight published trials were identified through the search strategy. Successful treatment of GAD with pregabalin versus placebo and active comparators has been reported in clinical trials. Pregabalin lowered total Hamilton Rating Scale for Anxiety scores within 1 week and was effective against both somatic and psychic subcomponents. In 1 controlled clinical trial, pregabalin was found to be effective in patients aged 65 years and older. Another trial demonstrated improved relapse rates when pregabalin, compared with placebo, was used for up to 6 months. The most commonly experienced adverse events were somnolence, dizziness, headache, and dry mouth. CONCLUSIONS: Available evidence suggests that pregabalin is effective and well tolerated in the treatment of GAD. As somnolence and dizziness are common adverse effects, caution should be used in elderly patients. Pregabalin rapidly relieves anxiety, a benefit that it may have over many other currently available therapeutic options besides benzodiazepines. While not a first-line therapy in GAD, pregabalin offers another treatment option in patients who do not respond to or who suffer intolerable adverse effects from other agents.

Linaclotide: a novel approach to the treatment of irritable bowel syndrome.

OBJECTIVE: To review the pharmacology, pharmacokinetics, efficacy, and safety of linaclotide for irritable bowel syndrome (IBS). DATA SOURCES: A literature search using PubMed (1966-August 2011) and International Pharmaceutical Abstracts (1970-July 2011) was conducted using the terms linaclotide and MD-1100. Additional publications were identified by reviewing bibliographies. Abstracts were included in the absence of published full studies. Product information was requested from the manufacturer. STUDY SELECTION AND DATA EXTRACTION: The search was limited to English-language publications. All available clinical trials of linaclotide pertinent to the pharmacology, pharmacokinetics, efficacy, and safety of linaclotide as a treatment for IBS were included. Animal studies were included in the absence of data in humans. DATA SYNTHESIS: Linaclotide is a guanylate cyclase-C agonist currently being studied in Phase 3 trials for the treatment of IBS with constipation. Controlled clinical trials have found that linaclotide significantly improves the number of complete spontaneous bowel movements per week, in addition to symptoms such as abdominal pain/discomfort, bloating, and straining. The most common adverse event associated with linaclotide is diarrhea. CONCLUSIONS: Linaclotide appears to be a safe and effective treatment for IBS. Additional clinical trials will more fully elucidate the safety profile of linaclotide and better define its place in therapy.

Pitavastatin: a new HMG-CoA reductase inhibitor.

OBJECTIVE: To review pitavastatin, the 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor and determine its place in the treatment of hypercholesterolemia. DATA SOURCES: Literature was accessed through PubMed (1948-December 2009). Pitavastatin, itavastatin, nisvastatin, NK 104, and NKS 104 were used as search terms. Results were limited to articles written in the English language. STUDY SELECTION AND DATA EXTRACTION: All articles identified from the data source were reviewed for inclusion. Articles included were those pertaining to the pharmacology and pharmacokinetic properties of pitavastatin, in addition to original research evaluating the clinical efficacy of pitavastatin for hypercholesterolemia. DATA SYNTHESIS: Pitavastatin is an oral HMG-CoA reductase inhibitor recently approved by the Food and Drug Administration for the treatment of primary hyperlipidemia and mixed dyslipidemia. Pitavastatin 2 mg has been shown to be noninferior to atorvastatin 10 mg and simvastatin 20 mg with respect to low-density lipoprotein cholesterol (LDL-C)-lowering ability. Additionally, pitavastatin 2 mg was shown in one study to lower LDL-C significantly more than pravastatin 10 mg. As with other HMG-CoA reductase inhibitors, primary safety concerns are related to myopathies and alterations in liver enzyme levels. While efficacy regarding beneficial effects on lipid parameters is comparable to that of other agents, a potential advantage of pitavastatin is its cytochrome P450 (CYP450) independent elimination, thereby reducing the likelihood of clinically significant drug-drug interactions. However, this is not a unique property, as pravastatin and rosuvastatin also possess this property. CONCLUSIONS: In light of the lack of outcome data, pitavastatin offers no clear advantage over other drugs in this class.

Evaluation of Vitamin B12 Monitoring in Patients on Concomitant Metformin and Proton Pump Inhibitors.

BACKGROUND: Type 2 diabetes mellitus and gastroesophageal reflux disease are highly prevalent in the United States. First-line therapies for these disease states include metformin and proton pump inhibitors, respectively. Both of these medications have been associated with a decreased absorption of vitamin B12. OBJECTIVE: The objective of this study was to assess the prevalence of B12 monitoring and supplementation in patients receiving concomitant metformin and PPI therapy. METHODS: A retrospective data analysis was performed at a single federally qualified health center. Patients receiving concomitant metformin and PPI therapy (specifically omeprazole and pantoprazole) over the past year were included. Data collected included demographics, dosing, therapy duration, and vitamin B12 level. Data were analyzed using descriptive statistics. RESULTS: A total of 104 patients met the inclusion criteria for this study. Metformin 1000 mg immediate release tablets was the most common dose and formulation prescribed. Omeprazole and pantoprazole were the most commonly prescribed PPIs. The most frequent duration of therapy was 1 to 4 years. Fourteen patients had a documented B12 level and no patients were categorized as deficient. Seven patients were prescribed a B12 supplement during the study period. CONCLUSION: In this single center, retrospective chart review of patients receiving concomitant metformin and PPI therapy, the average duration of therapy for both agents was 1-4 years. Only 13.5% of patients had a documented B12 level. Of those patients, none were categorized as deficient. Though routine monitoring of B12 levels may be important for patients on long-term therapy with both agents or who present with symptoms of B12 deficiency, this study does not support routine monitoring of B12 levels for patients with duration of therapy of 4 years or less.

Role of metformin in the treatment of gestational diabetes.

OBJECTIVE: To evaluate the safety and efficacy of metformin in the treatment of gestational diabetes mellitus (GDM). DATA SOURCES: A literature search was conducted via PubMed (1948-December 2008), International Pharmaceutical Abstracts (1970-December 2008), and Cochrane Library (up to 2008) using the search terms gestational diabetes and metformin. No limits were applied to the search. Reference citations from relevant publications identified were also reviewed. STUDY SELECTION AND DATA EXTRACTION: All articles identified from the data sources were reviewed for inclusion. Original research and retrospective cohorts were included in the review. Thirty-three articles were selected for review; 6 met the inclusion criteria. Trials evaluating the use of metformin in pregnant women with polycystic ovarian syndrome were not included. DATA SYNTHESIS: Metformin has been found largely to be effective in the treatment of GDM. One retrospective study reported that preeclampsia and neonatal mortality are increased with the use of metformin. The largest randomized trial to date found that neonatal and maternal complications did not differ between patients treated with metformin and those treated with insulin; however, rates of preterm birth were increased in the metformin group. In all studies reviewed, patients treated with metformin tended to be overweight or obese and required varying doses of metformin. CONCLUSIONS: Metformin appears to be effective for the treatment of GDM, but safety concerns may limit its use. Due to these concerns, insulin should remain the drug of choice if dietary measures alone fail.

Bazedoxifene: a third-generation selective estrogen receptor modulator for treatment of postmenopausal osteoporosis.

OBJECTIVE: To review clinical studies and other available literature regarding the development, pharmacology, toxicology, pharmacokinetics/pharmacodynamics, adverse effects, and place in therapy of bazedoxifene, a selective estrogen receptor modulator (SERM), currently in Phase III clinical trials for the treatment and prevention of postmenopausal osteoporosis. DATA SOURCES: A literature search was performed of PubMed (1966-February 2007), International Pharmaceutical Abstracts (1970-February 2007), Web of Science (1975-February 2007), Biological Abstracts (1926-2007), and Google Scholar (2001-February 2007) databases, using the search terms bazedoxifene, TSE-424, Indole-33, WAY-140424, selective estrogen receptor modulator, and SERM. In addition, product information was requested from the manufacturer, and www.clinicaltrials.gov was searched for unpublished Phase III clinical trials in progress. STUDY SELECTION AND DATA EXTRACTION: Articles on Phase I and II trials were selected for review, as well as articles discussing preclinical development of bazedoxifene. At the time of writing, no articles on Phase III trials were available for review. Abstracts of unpublished data were reviewed, as was information provided by the manufacturer. DATA SYNTHESIS: Bazedoxifene is a third-generation SERM currently in Phase III clinical trials. It has been found to act as an agonist on skeletal tissue, with bone turnover reduced by 20-25% with doses of 20 or 40 mg daily. In addition, bazedoxifene has been found to be an antagonist on breast tissue and uterine tissue, demonstrating inhibition of breast tissue proliferation and decreased endometrial stimulation as the dose is increased. CONCLUSIONS: Current literature suggests that bazedoxifene will likely be safe and effective when used in the treatment of postmenopausal osteoporosis. Completion of Phase III clinical trials will more fully elucidate the safety and efficacy profile of bazedoxifene, as well as more clearly define its place in therapy.

Vilazodone for the treatment of major depressive disorder.

Major depressive disorder (MDD) affects 121 million people globally and is one of the leading causes of functional disability worldwide. As a recurrent disorder, MDD is associated with significant morbidity and functional disability as well as high direct and indirect costs to the health care system. Although several drug therapies are available for treating MDD, many patients do not achieve a sustained remission. Vilazodone was approved by the United States Food and Drug Administration in 2011 and has a distinctive pharmacology profile, as the drug is a selective serotonin reuptake inhibitor and serotonin 5-HT(1A) receptor partial agonist. In two 8-week, double-blind, placebo-controlled trials, vilazodone's overall rate of response was similar to other antidepressants for the treatment of MDD. Compared with placebo, remission rates were not significantly different in one trial and were not reported in the second trial. Vilazodone was generally well tolerated, with nausea and diarrhea being the most frequent adverse events reported. Postmarketing studies and further active comparative studies will provide additional insight to the potential benefits and safety of this novel drug.

Denosumab for the prevention of skeletal-related events in patients with bone metastasis from solid tumor.

Most patients with advanced malignancy develop bone metastases during the course of their disease. For the remainder of the patient's life, these bone metastases lead to skeletal-related events such as pathologic fractures and spinal cord compression, as well as bone pain or lesions requiring palliative radiation therapy or surgery to prevent or treat fractures. Skeletal-related events result in increased morbidity, mortality and health care costs. For the past decade, intravenous bisphosphonates (zoledronic acid, pamidronate) have been recognized as the primary pharmacologic options in the prevention or treatment of skeletal-related events in patients with bone metastasis. Recently, the United States Food and Drug Administration approved denosumab, a fully human monoclonal antibody, for the prevention of skeletal-related events in patients with bone metastases from solid tumors. Three prominent clinical trials were conducted to establish the efficacy of denosumab. In two of three trials, denosumab was found to delay the time to first skeletal-related event significantly more than zoledronic acid in patients with breast or castration-resistant prostate cancer with bone metastasis. The third trial found denosumab to be noninferior to zoledronic acid in patients with metastases from solid tumors, excluding breast and prostate solid tumors. Overall survival and progression-free survival were similar between zoledronic acid and denosumab. Thus, evidence is insufficient to prove a greater efficacy of one agent over the other. According to the American Society of Clinical Oncology and the National Comprehensive Cancer Network, patients with bone metastasis should have zoledronic acid, pamidronate, or denosumab (with calcium and vitamin D supplementation) added to their chemotherapy regimen if they have an expected survival of 3 months or longer and have adequate renal function.

Effects of denosumab on bone mineral density and bone turnover in postmenopausal women.

Osteoporosis is a degenerative bone disease affecting approximately 10 million American adults. Several options are available to prevent development of the disease or slow and even stop its progression. Nonpharmacologic measures include adequate intake of calcium and vitamin D, exercise, fall prevention, and avoidance of tobacco and excessive alcohol intake. Current drug therapy includes bisphosphonates, calcitonin, estrogen or hormone therapy, selective estrogen receptor modulators, and teriparatide. Denosumab, a receptor activator of nuclear factor-K B ligand (RANKL) inhibitor, was recently approved by the United States Food and Drug Administration for treatment of postmenopausal osteoporosis. Patients treated with denosumab experienced significant gains in bone mineral density, rapid reductions in markers of bone turnover, and a reduced risk for new vertebral fracture. Compared with placebo, patients receiving denosumab 60 mg subcutaneously once every 6 months experienced gains in bone mineral density of 6.5-11% when treated for 24-48 months. One trial demonstrated the superiority of denosumab compared with alendronate, but the differences were small. The most common adverse reactions to denosumab include back pain, pain in extremities, musculoskeletal pain, and cystitis. Serious, but rare, adverse reactions include the development of serious infections, dermatologic changes, and hypocalcemia. The recommended dosing of denosumab is 60 mg every 6 months as a subcutaneous injection in the upper arm, upper thigh, or abdomen. Although beneficial effects on bone mineral density and fracture rate have been established in clinical trials, the risks associated with denosumab must be evaluated before therapy initiation. Of concern is the risk of infection, and denosumab should likely be avoided in patients taking immunosuppressive therapy or at high risk for infection. Therefore, bisphosphonates will likely remain as first-line therapy. Denosumab should be considered in patients unable to tolerate or who have adherence issues or contraindications to other therapies.