Use of gabapentin for the management of natural or surgical menopausal hot flashes.

OBJECTIVE: To review the literature examining the use of gabapentin for treatment of hot flashes during natural or surgically induced menopause. DATA SOURCES: A literature search was conducted via PubMed, MEDLINE, and International Pharmaceutical Abstracts (1948-November 2010) using the search terms gabapentin, hot flashes, and menopause. Literature was limited to English-language, human studies. Additional material was identified by reviewing reference citations of the articles retrieved. STUDY SELECTION AND DATA EXTRACTION: Studies with data describing gabapentin for hot flash management during natural or surgically induced menopause were included. Any studies including women with a history of breast cancer were excluded. Four studies met the inclusion criteria. DATA SYNTHESIS: Gabapentin significantly decreased hot flash frequency and hot flash composite scores by 45-71% from baseline in the 4 trials included in this review. In 2 of the trials, gabapentin was comparable to hormone replacement therapy (71% vs 72%, respectively, p=0.63) in decreasing hot flash composite scores at the end of 12 weeks and in decreasing hot flash frequency at the end of 8 weeks (58.9% vs 70.1%, p>0.05). In all trials, the most common adverse effects with gabapentin were somnolence/drowsiness, unsteadiness, and dizziness. These adverse effects were most pronounced during the first 1-2 weeks of therapy, but resolved and were similar to those reported with placebo by week 4. These trials were short (<12 weeks) and had small sample sizes; however, their results appear to show that gabapentin is safe and effective for short-term treatment of hot flashes in women who have entered menopause either naturally or surgically. CONCLUSIONS: Gabapentin 600-2400 mg/day in divided doses may be a viable option for treating hot flashes in menopausal women who do not want to use hormone replacement therapy.

Evaluating the evidence for over-the-counter alternatives for relief of hot flashes in menopausal women.

OBJECTIVE: To review the literature on alternative over-the-counter (OTC) therapies for the treatment of hot flashes in menopausal women. DATA SOURCES: A literature search was conducted using PubMed, International Pharmaceutical Abstracts, and Medline from inception to June 2010, combining the term hot flash individually with black cohosh, isoflavones, red clover, soy, vitamin E, ginseng, dong quai, evening primrose oil, wild yam, kava, and melatonin. All publication types including human participants and published in English were eligible for review. These articles, relevant abstracts, and additional references were used to collect pertinent data. STUDY SELECTION AND DATA EXTRACTION: Clinical trials comparing the above single-ingredient agents with placebo or active treatment were selected. In addition, only studies assessing the effects of these single-ingredient agents on vasomotor symptoms in menopausal women were included. DATA SYNTHESIS: Since the Women's Health Initiative and Heart and Estrogen/Progestin Replacement Study II, women have sought lifestyle changes and other drug therapies as alternatives to menopausal hormone therapy to relieve hot flashes associated with menopause. The currently available literature is conflicting in regard to efficacy and does not support the use of alternative OTC therapies for hot flash management associated with menopause. In addition, long-term safety data are lacking for any of these therapies. CONCLUSION: Women should be encouraged to implement therapeutic lifestyle changes to assist them with hot flash management. Based on the current literature, alternative OTC therapies do not have consistent, beneficial data to support their use in hot flash management.

Insulin glulisine: an evaluation of its pharmacodynamic properties and clinical application.

OBJECTIVE: To evaluate the pharmacodynamic properties, efficacy, safety, and clinical application of insulin glulisine, a rapid-acting insulin analog, in the treatment of diabetes mellitus in ambulatory and hospitalized patients. DATA SOURCES: Searches were performed with the headings glulisine, insulin analog, [LysB3, GluB29] insulin, insulin glulisine, rDNA insulin, rapid-acting insulin, SoloStar, safety, efficacy, pharmacodynamics, and cost analysis within MEDLINE and PubMed, American Diabetes Association (ADA), the Food and Drug Administration (FDA), and Sanofi-aventis Pharmaceuticals (1990-August 2008). STUDY SELECTION AND DATA EXTRACTION: Phase 1, Phase 2, Phase 3, and postmarketing trials examining the efficacy and safety of glulisine in type 1 or type 2 diabetes were reviewed. Studies published as abstracts and the manufacturer's product information supplemented data absent from clinical trials. DATA SYNTHESIS: Insulin glulisine is a rapid-acting insulin with relative equivalence in efficacy and safety to other short- and rapid-acting insulins. Glulisine's onset of action of 20 minutes and 4-hour duration of action allow for bolus administration 15-20 minutes prior to or up to 20 minutes after meals. Clinical trials have demonstrated the safety and efficacy in adults with type 1 or type 2 diabetes. Several studies indicated a statistically significant decrease of hemoglobin A1C (A1C) with glulisine compared with regular insulin (0.10 decrease); however, no difference in A1C control was found compared with insulin aspart or lispro. Significant adverse effects appear to be limited to localized and systemic allergic reactions and hypoglycemia. CONCLUSIONS: Insulin glulisine is a safe and effective rapid-acting insulin analog for the treatment of adults with diabetes. Clinical benefit over other short- and rapid-acting insulin products is not established. Addition of insulin glulisine to a formulary should be based on institution-specific availability and cost differences between glulisine, lispro, and aspart in the absence of superiority of clinical efficacy or safety and data beyond 26 weeks.

Development and Validation of a Rubric to Evaluate Diabetes SOAP Note Writing in APPE.

Objective. To develop and establish validity for a grading rubric to evaluate diabetes subjective, objective, assessment, plan (SOAP) note writing on primary care (PC) advanced pharmacy practice experiences (APPEs), and to assess reliability and student perceptions of the rubric. Methods. Ten PC APPE faculty members collaborated to develop a rubric to provide formative and summative feedback on three written SOAP notes per APPE student over a 10-month period. Correlation analyses were conducted between rubric scores and three criterion variables to assess criterion-related validity: APPE grades, Pharmaceutical Care Ability Profile Scores, and Global Impression Scores. Inter-rater and intra-rater reliability testing were completed using Cohen's kappa and Intraclass Correlation Coefficients (ICC). Student perceptions were assessed through an anonymous student survey. Results. Fifty-one students and 167 SOAP notes were evaluated using the final rubric. The mean score significantly increased from the first to second SOAP note and from the first to third SOAP note. Statistically significant positive correlations were found between final rubric scores and criterion variables. The ICC for inter-rater reliability was fair (.59) for final rubric scores and excellent for intra-rater reliability (.98 to1.00). Students responded that the rubric improved their ability (84.9%) and confidence (92.4%) to write SOAP notes. Conclusion. The rubric may be used to make valid decisions about students' SOAP note writing ability and may increase their confidence in this area. The use of the rubric allows for greater reliability among multiple graders, supporting grading consistency.

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.

A review of current treatment strategies for gestational diabetes mellitus.

Approximately 90% of diabetes cases in pregnant women are considered gestational diabetes mellitus (GDM). It is well known that uncontrolled glucose results in poor pregnancy outcomes in both the mother and fetus. Worldwide there are many guidelines with recommendations for appropriate management strategies for GDM once lifestyle modifications have been instituted and failed to achieve control. The efficacy and particularly the safety of other treatment modalities for GDM has been the source of much debate in recent years. Studies that have demonstrated the safety and efficacy of both glyburide and metformin in the management of patients with GDM will be reviewed. There is a lack of evidence with other oral and injectable non-insulin agents to control blood glucose in GDM. The role of insulin will be discussed, with emphasis on insulin analogs. Ideal patient characteristics for each treatment modality will be reviewed. In addition, recommendations for postpartum screening of patients will be described as well as recommendations for use of agents to manage subsequent type 2 diabetes in patients who are breastfeeding.

Treatment of lithium-induced diabetes insipidus with amiloride.

A 63-year-old African-American woman was admitted to the hospital with urosepsis and altered mental status. She had a history of schizophrenia and was treated with olanzapine 5 mg/day and lithium carbonate 300 mg 3 times/day. During her hospital stay, her sodium level and serum osmolality increased and her urine osmolality decreased, whereas her lithium levels remained within normal limits. Based on these findings, the patient was diagnosed with diabetes insipidus secondary to lithium therapy and was treated successfully with amiloride. Clinicians have been aware of lithium toxicity for many years and traditionally have administered thiazide diuretics for lithium-induced polyuria and nephrogenic diabetes insipidus. Recently, amiloride, a potassium-sparing diuretic, has been reported as a successful treatment for nephrogenic diabetes insipidus.

Review of metformin and glyburide in the management of gestational diabetes.

BACKGROUND: Worldwide, gestational diabetes affects 15% of pregnancies. It is recommended in patients with gestational diabetes to initiate diet therapy and if this is not adequate, insulin is the next treatment modality. While insulin is the preferred drug therapy to manage gestational diabetes in the majority of women, it may not always be the best option for all women. OBJECTIVE: The purpose of this review is to assess the efficacy and safety of oral agents for treatment of gestational diabetes. METHODS: A literature search of the MEDLINE, Ovid databases and Google Scholar was performed using the search term "gestational diabetes" combined with each "metformin" and "glyburide". The time frame for the search was inception through August 2014. Randomized controlled trials and cohort (both prospective and retrospective) trials, published in English, with human participants were included. Studies included only pregnant women diagnosed with gestational diabetes. RESULTS: There were no significant differences in preterm deliveries, delivery modes, macrosomia, and birth weights and large for gestational age when utilizing glyburide vs insulin for gestational diabetes management. There were significantly higher neonatal intensive care unit admissions as well as longer lengths of stay for hypoglycemia and respiratory distress in babies whose mothers were treated with glyburide versus insulin. For the studies comparing metformin to insulin, there are no significant differences reported for birth weight, gestational age, delivery mode, prematurity and perinatal deaths. Women taking metformin may require supplemental insulin more frequently than those taking glyburide. CONCLUSION: Glyburide and metformin appear to be safe and effective to manage blood glucose in patients with gestational diabetes who prefer to not utilize insulin or who cannot afford insulin therapy. All other oral therapies to manage blood glucose levels during gestational diabetes should be reserved until additional evidence is available regarding safety and efficacy to both mother and fetus.

The role of aclidinium bromide in the treatment of chronic obstructive pulmonary disease.

INTRODUCTION: Inhaled bronchodilators remain a cornerstone of treatment for chronic obstructive pulmonary disease (COPD); current guidelines recommend initiating inhaled bronchodilators as either monotherapy or combination therapy depending on disease severity and exacerbation risk to improve air flow and reduce breathlessness. Aclidinium bromide is a twice-daily, long-acting muscarinic antagonist recently approved in the United States and Europe and carries significant promise as an alternative long-acting inhaled antimuscarinic agent for the treatment of moderate-to-severe COPD. OBJECTIVE: This review describes the pharmacology, pharmacokinetics, clinical efficacy, and adverse effects of aclidinium bromide. DISCUSSION: Clinical trials have demonstrated improvement in forced expiratory volume in 1 second, nighttime symptom control, disease-related quality of life, and delay in time to first COPD exacerbation with aclidinium use compared with placebo. Commonly reported adverse effects include headache, nasopharyngitis, and cough. One trial reported narrow-angle glaucoma; however, no other serious adverse events have been reported to date. CONCLUSION: Overall, aclidinium bromide has been found to be safe and effective for the treatment of moderate-to-severe COPD. Further clinical trials comparing aclidinium bromide to standard therapies are needed to fully elucidate its role in the treatment of COPD.

Use of antidepressants for management of hot flashes.

A growing body of evidence suggests that antidepressant therapies, particularly selective serotonin reuptake inhibitors and venlafaxine, are effective in the management of hot flash symptoms. Several of these agents have the support of the American College of Obstetricians and Gynecologists and the North American Menopause Society. To review the literature on antidepressants for the treatment of hot flashes in women, we searched the PubMed, International Pharmaceutical Abstracts, and MEDLINE databases from inception through May 2009. All publication types that included human participants and that were published in English were eligible for review. These articles, relevant abstracts, and additional references were used to collect pertinent data. Although initial small pilot trials were conducted solely in breast cancer survivors, additional studies have been conducted both in breast cancer survivors and in relatively healthy menopausal women. Data on the benefits with many of these agents are conflicting. Venlafaxine and paroxetine have been studied more extensively than any of the other antidepressants and are more consistent in effectively reducing the frequency and severity of hot flashes, based on these study results. Desvenlafaxine, sertraline, fluoxetine, and citalopram should be considered second- or third-line options if patients fail therapy with or cannot tolerate venlafaxine or paroxetine, based on the current published data. Duloxetine, escitalopram, fluvoxamine, and mirtazapine should be reserved as last-line therapy until more rigorous studies are conducted assessing their use in the management of hot flashes.

Addressing competencies for the future in the professional curriculum.

This paper reviews the literature, analyzes current and future practice, develops a list of competencies necessary for future pharmacists, and provides recommendations to pharmacy's academic enterprise regarding curricula of the future. Curricula of the future will center around 3 functional roles for pharmacists: patient-centered care, population-based care, and systems management; and must also foster the development of 5 cross-cutting abilities in student pharmacists: professionalism, self-directed learning, leadership and advocacy, interprofessional collaboration, and cultural competency. Future curricula must be developed in an evidence-based manner, focus less on information storage and retrieval, engage student pharmacists in a variety of highly interactive learning experiences, and expand experiential learning opportunities throughout all years.

A comparison of diabetes care in rural and urban medical clinics in Alabama.

This study sought to determine the differences in the level of diabetes care of patients in a rural family practice clinic and an urban internal medicine clinic in Alabama. Medical records of patients with diabetes were reviewed and management practices were compared to current American Diabetes Association (ADA) standards of care. The rural practice had fewer patients at goal A1c, goal LDL, and goal blood pressure. Rural patients were also less likely to receive screening and preventative services such as lipid profiles, eye examinations, microalbumin screening, aspirin therapy, and vaccinations than urban patients. Although, adherence to the ADA standards of care was lower with rural patients, the results suggest that there exists significant opportunity to improve the delivery of diabetes care services to both patient populations.