L. Brian Cross

Spironolactone for Hirsutism in Polycystic Ovary Syndrome

OBJECTIVE: To evaluate the level of evidence for treatment of hirsutism associated with polycystic ovary syndrome (PCOS) with spironolactone. DATA SOURCES: Studies and reports were located in MEDLINE (1966–January 2005%), EMBASE, and International Pharmaceutical Abstracts through the second week of January 2005. DATA SYNTHESIS: Hirsutism is a common clinical problem and is often associated with PCOS. Research has been performed to assess the efficacy of spironolactone therapy in patients with hirsute characteristics. Five studies that evaluated the effectiveness of spironolactone for hirsutism in PCOS were identified and reviewed. CONCLUSIONS: The effects of multiple treatment options on the subjective and objective measures of hirsutism have displayed varying results. The outcomes reported to date have shown a positive trend toward using spironolactone in women with PCOS and hirsutism.

Treatment of Migraine Headaches with Sumatriptan in Pregnancy

OBJECTIVE To review the literature for treatment of migraine headaches with sumatriptan during pregnancy. DATA SOURCES Studies and reports were located in International Pharmaceutical Abstracts (1970-September 2003) and MEDLINE (1966-week 3 September 2003). DATA SYNTHESIS Research has been performed to evaluate the risk of teratogenesis after sumatriptan exposure in pregnant patients. Data have been collected in areas including placental transmission of sumatriptan, prospective pregnancy registries, open-labeled and controlled prospective studies, and a retrospective prescription-linked study. As of August 6, 2004, no randomized controlled trials have been conducted with exposure to sumatriptan during pregnancy. CONCLUSIONS Teratogenesis occurs in approximately 150 000 births per year which represents an incidence of 3–5%. Available literature to date indicates that exposure to sumatriptan during pregnancy has no additional risk of birth defects compared with the incidence in the general population.

Combination Drug Therapy for Gastroesophageal Reflux Disease

OBJECTIVE: To evaluate the role of combination therapy with proton-pump inhibitors (PPIs) and histamine2 receptor antagonists in gastroesophageal reflux disease (GERD). DATA SOURCES: Clinical literature identified through MEDLINE (January 1966–August 2001). Key search terms included gastroesophageal reflux, benzimidazoles; omeprazole; lansoprazole; pantoprazole; rabeprazole; receptor antagonists, histamine2; therapy, combination drug; therapy, combined modality; and combinations, drug. DATA SYNTHESIS: Approximately 80–90% of patients show healing of reflux esophagitis after 8 weeks of once-daily PPI therapy. Patients taking PPI therapy twice daily still have nocturnal acid breakthrough (periods of gastric pH <4 lasting for ≥60 min during the night) as much as 70% of the time. The clinical application of this finding has not been shown. One trial has shown that omeprazole in the morning plus ranitidine at bedtime is not as effective as omeprazole twice daily given before the morning and evening meals at controlling nocturnal acid breakthrough. Further, 1 small trial in healthy subjects without GERD showed that the addition of a 1-time dose of ranitidine at bedtime to a twice-daily regimen of omeprazole may decrease the occurrence of nocturnal acid breakthrough. However, the clinical significance of this finding is not clear. CONCLUSIONS: No studies in patients with GERD demonstrate that the addition of histamine2 receptor antagonists to twice-daily PPI therapy provides any further benefit above that derived from PPIs alone. The parameter used to measure the efficacy of combination regimens for GERD thus far — Nocturnal acid breakthrough — Has not been proven to correlate with improvement of GERD symptoms in any controlled or prospective clinical trials. Further investigation is needed to determine optimal therapy in patients refractory to standard doses of PPIs.

Retrospective Analysis and Patient Satisfaction Assessment of Insulin Pump Therapy in Patients with Type 2 Diabetes

Objectives: To evaluate and assess glycemic control, total daily insulin requirements, weight, and patient satisfaction after changing from multiple daily injections (MDI) to continuous subcutaneous insulin infusion (CSII) therapy in patients with type 2 diabetes. Methods: This was a retrospective cross-sectional cohort analysis of an electronic medical records database from a private physicians clinic. Patients over 18 years of age who had type 2 diabetes and who utilized CSII for at least six months were analyzed. Variables of interest included glycosylated hemoglobin, total daily insulin requirements, and weight at the time of conversion from MDI to CSII. Patients were also asked to complete a satisfaction survey comparing MDI to CSII. Results: Thirty patients who met the inclusion criteria were identified. Hemoglobin A1c (HbA1c) decreased from 9.25% ± 2.20 to 7.94% ± 1.65 (P < 0.001) at six months, total daily insulin dose decreased from 1.33 ± 0.66 u/kg/day to 1.08 ± 0.70 u/kg/day (P < 0.001) at six months, and weight increased from 106.66 ± 19.17 kg to 109.75 ± 18.01 kg (P < 0.001). After twelve months, HbA1c did not significantly change and weight returned to baseline; however, total daily insulin dose significantly decreased. 95% of patients preferred CSII therapy to previous injection regimen for various reasons. Conclusion: Insulin pump therapy provided better glycemic control and reduced the total amount of insulin utilized. Patients who utilized CSII thought that the treatment was more convenient, less burdensome, and provided better control of fluctuations in blood glucose. CSII was preferred by patients over multiple daily injections.

Elevated Hepatic Enzymes Potentially Associated with Sitagliptin

TO THE EDITOR: We describe a patient with elevated hepatic enzyme levels after initiation of sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated for use in patients with type 2 diabetes. Upon discontinuation of the medication, hepatic enzyme levels returned to baseline. Case Report. A 58-year-old male with a history of type 2 diabetes and nonalcoholic steatohepatitis (diagnosed in 2006) presented to the clinic for diabetes management. At the time, the patients aspartate aminotransferase (AST) was 53 U/L (normal <40 U/L) and alanine aminotransferase (ALT) was 102 U/L (normal <40 U/L). The patient was started on rosuvastatin JO mg once daily. Baseline total cholesterol was 146 mg/dL, triglycerides were 245 mg/dL, high-density lipoprotein cholesterol was 33 mg/dL, and low-density lipoprotein cholesterol was 75 mg/dL. One month following therapy, AST and ALT had declined to 35 U/L and 64 U/L, respectively. Two months after the initiation of rosuvastatin, the patient was started on sitagliptin 100 mg once daily due to elevated hemoglobin A1c of 8.2%. The patients other medications included amlodipine 5 mg once daily, benazepril 20 mg once daily, aspirin 81 mg once daily, glucosamine 500 mg once daily, chondroitin 400 mg once daily, and indomethacin 25 mg once daily as needed. One month after initiation of sitagliptin, liver enzymes were monitored and revealed an AST and ALT of 71 U/L and 127 U/L, respectively. Four days later the AST and ALT levels were 70 U/L and 137 U/L, respectively. All other corresponding hepatic function results were within normal range for the patient. A full medication review was performed. Sitagliptin was discussed as a possible cause of increased liver enzyme levels and promptly discontinued. Reexamination of liver enzymes a month after discontinuing sitagliptin revealed a significant decrease in AST and ALT (48 U/L and 90 U/L, respectively). Most recently, 6 months after discontinuation, AST and ALT were 35 U/L and 62 U/L, respectively. Discussion. The efficacy and safety of sitagliptin have been well documented in clinical trials of patients with type 2 diabetes, either as monotherapy or in combination with other oral hypoglycemic agents.Mi Raz et al. examined the safety and efficacy of sitagliptin as monotherapy at JOO-mg and 200-mg doses versus placebo. The researchers found no mean change from baseline in AST or ALT between treatment groups.1 The effect of sitagliptin in combination with metformin has also been studied.3-5 Charbonnel et al. examined the efficacy and safety of sitagliptin 100 mg versus placebo added to ongoing metformin therapy. They found no difference between treatment groups in the occurrence of elevations of AST or ALT.3 Nauck et al. conducted a study in which patients received either sitagliptin 100 mg and metformin, or glipizide and metformin. The researchers found a slight mean decrease in ALT in the sitagliptin group versus a slight increase in ALT in the glipizide group, which was not statistically significant.5 Although no significant elevation of hepatic enzymes has been reported in the literature, most of the trials involving the safety of sitagliptin were small and short in duration. Monitoring hepatic function in individuals with a history of nonalcoholic steatohepatitis or elevated hepatic enzymes may need to be considered in patients initiated on sitagliptin.

Falsely Low Hemoglobin A1c Levels in a Patient Receiving Ribavirin and Peginterferon alfa‐2b for Hepatitis C

The effect of treatment for hepatitis Cviral infection on hemoglobin A1c(A1C) levels is not well described in the literature. We describe a 59‐year‐old man with type 2 diabetes mellitus whose A1C level became falsely low when ribavirin and peginterferon alfa‐2b therapy were started for treatment of hepatitis C. After treatment was discontinued, the patients A1C returned to its previous baseline value. Use of the Naranjo adverse drug reaction probability scale indicated a probable relationship (score of 7) between the patients low AIC level and his ribavirin‐peginterferon alfa‐2b therapy. Clinicians should be aware that combination therapy for hepatitis C may affect A1C values. To maintain accurate glucose control in patients with diabetes who are receiving treatment for hepatitis C, it is important that they self‐monitor their blood glucose levels in conjunction with A1C data, especially when A1C values become falsely low.

Clinical Outcomes Associated with Pharmacist Involvement in Patients with Dyslipidemia: A Review

The burden of cardiovascular disease in America continues to be the leading cause of death and costs significantly more to treat (

Gender differences in the use of peak flow meters and their effect on peak expiratory flow.

US298.2 billion in 2002) than any other disease in the US healthcare system. Incontrovertible evidence links elevated levels of total and low-density lipoprotein-cholesterol and reduced levels of high-density lipoprotein-cholesterol with an increased risk for coronary heart disease. The subsequent treatment of hyperlipidemia has been shown to dramatically decrease morbidity and mortality related to cardiovascular disease. Research continues to show that many candidates for lipid-lowering therapy are not offered therapy and many never attain recommended National Cholesterol Education Program (NCEP) guideline goals. Increased pharmacist involvement in the treatment of patients with hyperlipidemia may represent one way to help bridge the treatment gap that exists in these high-risk patients. Limited evidence has shown that lipid values, NCEP goal attainment, and medication compliance improve when a pharmacist contributes to patient care in dyslipidemia. However, larger randomized controlled studies need to be performed to confirm the results of previous smaller retrospective trials.

Student Peer Mentorship: Addressing Faculty Workloads Now and for the Future

Study Objective. To determine if gender differences in the skill of using peak flow meters affect peak expiratory flow (PEF).