Terri M. Wensel

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.

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 patients 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.

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‐HT1A receptor partial agonist. In two 8‐week, double‐blind, placebo‐controlled trials, vilazodones 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.

Assessment of Electronic Drug Information Resource Availability in Alabama Pharmacies

The two primary objectives of this study were to identify available electronic drug information (DI) resources in licensed Alabama pharmacies and to identify common electronic resources to teach in the doctor of pharmacy curriculum at the McWhorter School of Pharmacy. A survey consisting of 10 questions was mailed to all licensed medication-dispensing pharmacy practices in Alabama (N = 1,562), of which 699 (44%) were returned for analysis, primarily by community and hospital practices (78.8% and 10.7%, respectively). The survey identified type of pharmacy, demographics, and availability and usage of electronic DI resources. Drug Facts and Comparisons, Internet search engine, the Pharmacists Letter, and Clinical Pharmacology were the most available electronic DI resources (59.5%, 48.6%, 42.3%, and 31%, respectively) among responding pharmacies. Drug Facts and Comparisons was the most common print-based resource; Lexi-Comp and Epocrates were the most utilized handheld DI resources.

Measuring Pharmacy Student Attitudes Toward Prayer: The Student Prayer Attitude Scale (SPAS)

ABSTRACT The objective of this study was to develop and validate an instrument to assess the attitude of student pharmacists toward prayer in general and in particular as it relates to their academic performance. To fulfill the study objective, faculty from seven colleges of pharmacy located at Christian universities collaboratively developed the Student Prayer Attitude Scale (SPAS). The items were used to assess the attitudes of student pharmacists toward prayer as well as the effects of prayer on personal lives and academic performance. Faculty investigators asked 1,563 students to complete the survey and received 677 valid responses. A principal components analysis with promax rotation was conducted and revealed a two-factor structure: (a) general attitude toward prayer and (b) specific attitude regarding the impact of prayer on academic performance. Analysis of variance was used to compare student responses by religious identity. Students identifying as atheist or agnostic were significantly different in their responses than students from theistic religions; however, the responses of students from various theistic religions were not significantly different from one another. Faculty concluded that SPAS is a reliable tool for measuring student attitudes toward prayer. The use of such a tool could help faculty tailor educational opportunities to allow pharmacy students to explore prayer more fully and be aware of its impact on the patients they serve.

Antidepressant Pharmacology: Introduction for the Pharmacy Technician

Objective: To review the pharmacology of antidepressants and describe clinical applications of antidepressants in the treatment of depression. Data Sources: A MEDLINE/PubMed search (1995–July 2011) was conducted for English-language articles using the terms pharmacology, antidepressant, tricyclic antidepressants, monoamine oxidase inhibitors, selective serotonin reuptake inhibitors, venlafaxine, desvenlafaxine, duloxetine, bupropion, trazodone, nefazodone, mirtazapine, vilazodone, efficacy, adverse effects, and drug interactions. Book chapters related to the pharmacology of antidepressants were also searched. Study Selection and Data Extraction: Articles and book chapters relevant to the pharmacology of antidepressants were reviewed. Data Synthesis: Antidepressants exert pharmacologic actions via enzyme inhibition, reuptake inhibition, receptor antagonism, and receptor partial agonism. These actions can cause both therapeutic and adverse effects. Each antidepressant possesses a unique blend of pharmacologic actions, which helps to differentiate antidepressants and aids in the understanding of their particular efficacy profiles, adverse effect profiles, and pharmacodynamic drug interaction profiles. Conclusions: There are important clinical applications of the pharmacologic properties of antidepressants. Gaining familiarity with antidepressant pharmacology will enable the pharmacy technician to develop a more thorough understanding of the drug class.