The use of letter communication for patients enrolled in a pharmacist managed anticoagulation clinic.

WHAT IS KNOWN AND OBJECTIVE: It is unknown how letter communication vs. telephone communication compares in terms of affecting outcomes in patients followed in a busy anticoagulation clinic. This study was performed to determine if sending letters to communicate laboratory results and future appointments with patients enrolled in a pharmacy managed anticoagulation clinic is an effective alternative to telephone communication. METHODS: A retrospective review of quality assurance data currently collected at our facility was performed. Data were analyzed 4 months before and 4 months after the implementation of the letter notification. Data on percent international normalized ratio (INR) in therapeutic range, missed laboratory draw frequency and major bleeding events were collected daily, compiled monthly and then compared between the telephone and letter groups. RESULTS: There was no statistical difference in the percentage of INRs that were within goal range before and after letter initiation. There was a slight increase in the percentage of INR laboratory draws that were missed after the implementation of the letters (23% vs. 26%, P = 0·002). There were more major bleeding events after letter initiation, but this did not reach statistical significance. Approximately 80% of the patients received letters as the method of communication in the letter group. WHAT IS NEW AND CONCLUSION: The use of letters to notify warfarin patients with laboratory results is an effective method of communication without adversely affecting patient outcomes.

A case of sulphasalazine potentiating the hypoprothombinemic effect of warfarin resulting in bleeding.

WHAT IS KNOWN AND OBJECTIVE: One case report demonstrated warfarin resistance associated with sulphasalazine therapy. Our objective is to report on a case of warfarin potentiation rather than resistance, associated with sulphasalazine therapy. CASE SUMMARY: The patient was taking warfarin for two mechanical heart valves and was prescribed sulphasalazine for inflammatory bowel disease. He had stable international normalized ratios (INRs) before sulphasalazine administration. Approximately 3 weeks after starting sulphasalazine, he presented to the anticoagulation clinic with bruising and an INR of 6·1. The sulphasalazine was stopped, and the warfarin was held for 3 days; then the previous dose was resumed. Three weeks later, the INR returned to a therapeutic level. WHAT IS NEW AND CONCLUSION: This is the first case of sulphasalazine potentiating the effect of warfarin. Sulphasalazine may potentiate the hypoprothombinemic effect of warfarin.

Effect of atorvastatin 15 mg/week on serum lipids in patients with hypercholesterolemia.

Atorvastatin 15 mg/week was administered to 21 patients with hypercholesterolemia for 2 months. The mean low-density lipoprotein concentration decreased by 20% after treatment.

A pilot study exploring the effect of kudzu root on the drinking habits of patients with chronic alcoholism.

PURPOSE: The objective of this study was to assess if kudzu root extract influences the drinking habits of veterans who entered a substance abuse treatment program. DESIGN: Prospective, randomized double-blind controlled clinical trial. SETTING: A nonacademic Veteran Affairs Medical Center. METHODS: Patients with the diagnosis of alcoholism were randomly assigned to receive either kudzu root extract 1.2 g twice daily or a matching placebo. Patients completed questionnaires that focused on craving for alcohol and sobriety status on a monthly basis. OUTCOME MEASURES: Sobriety level and craving for ethanol were assessed on a visual analogue scale from 0 to 10. RESULTS: Thirty-eight patients completed 1 month of the study; 21 randomly assigned kudzu, 17 to placebo. No statistically significance difference in craving and sobriety scores were noted after 1 month between kudzu and placebo, or at later stages with smaller numbers (15-19) of patients. CONCLUSION: In this small patient population, kudzu root appeared to be no better than placebo in reducing the craving for alcohol or promoting sobriety.

Bipolar permanent magnets for the treatment of chronic low back pain: a pilot study.

CONTEXT: Chronic low back pain is one of the most prevalent and costly medical conditions in the United States. Permanent magnets have become a popular treatment for various musculoskeletal conditions, including low back pain, despite little scientific support for therapeutic benefit. OBJECTIVE: To compare the effectiveness of 1 type of therapeutic magnet, a bipolar permanent magnet, with a matching placebo device for patients with chronic low back pain. DESIGN: Randomized, double-blind, placebo-controlled, crossover pilot study conducted from February 1998 to May 1999. SETTING: An ambulatory care physical medicine and rehabilitation clinic at a Veterans Affairs hospital. PATIENTS: Nineteen men and 1 woman with stable low back pain of a mean of 19 years' duration, with no past use of magnet therapy for low back pain. Twenty patients were determined to provide 80% power in the study at P<.05 to detect a difference of 2 points (the difference believed to be clinically significant) on a visual analog scale (VAS). INTERVENTIONS: For each patient, real and sham bipolar permanent magnets were applied, on alternate weeks, for 6 hours per day, 3 days per week for 1 week, with a 1-week washout period between the 2 treatment weeks. MAIN OUTCOME MEASURES: Pretreatment and posttreatment pain intensity on a VAS; sensory and affective components of pain on the Pain Rating Index (PRI) of the McGill Pain Questionnaire; and range of motion (ROM) measurements of the lumbosacral spine, compared by real vs sham treatment. RESULTS: Mean VAS scores declined by 0.49 (SD, 0.96) points for real magnet treatment and by 0.44 (SD, 1.4) points for sham treatment (P = .90). No statistically significant differences were noted in the effect between real and sham magnets with any of the other outcome measures (ROM, P = .66; PRI, P = .55). CONCLUSIONS: Application of 1 variety of permanent magnet had no effect on our small group of subjects with chronic low back pain.

Randomized, controlled trial of glucosamine for treating osteoarthritis of the knee.

OBJECTIVE: To determine the effectiveness of glucosamine in reducing pain from osteoarthritis of the knee. DESIGN: Randomized, double-blind parallel trial of glucosamine 500 mg three times daily or a placebo for 2 months. SETTING: Veterans Affairs Medical Center, Prescott, AZ. PARTICIPANTS: Ninety-eight patients aged 34 to 81 being treated for osteoarthritis of the knee. MAIN OUTCOME MEASURES: Pain intensity both at rest and while walking as assessed by a visual analog scale at baseline and after 30 and 60 days of treatment. RESULTS: Forty-nine patients were randomly allocated to each group. There was no statistical difference between the two groups in scores on the visual analog scale at 30 days for resting (mean [SD] score placebo group 3.5 [2.7] vs 3.3 [2.4] glucosamine group, P = 0.66) or walking (5.1 [2.6] vs 5.3 [2.4], P = 0.69); there was also no difference at 60 days for resting (3.4 [2.5] vs 3.2 [2.5], P = 0.81) or walking (4.9 [2.2] vs 4.9 [2.8], P = 0.90). There was also no statistical difference between groups in the mean change from baseline in scores on the visual analog scale (mean [SD] change for walking at 60 days placebo group -1.5 [2.5] vs glucosamine group -1.4 [3.0], P = 0.77). Two participants taking glucosamine and 4 taking placebo withdrew from the study due to adverse side effects (P = 0.67). CONCLUSION: Glucosamine was no better than placebo in reducing pain from osteoarthritis of the knee in this group of patients.

The outcome of very low dosages of simvastatin in patients with hypercholesterolemia.

A retrospective study evaluated the success of dosages of simvastatin lower than the 10-20 mg/day recommended by the manufacturer in patients with hypercholesterolemia. Records of 95 patients enrolled in a pharmacist-managed lipid clinic receiving stable dosages of simvastatin were reviewed. Data collected were demographics, number of simvastatin refills, dosage distribution, baseline and posttreatment lipid profiles, and proportion of patients with low-density lipoprotein (LDL) levels below target as recommended by the National Cholesterol and Education Program. Dosages for 62% of patients were less than 20 mg/day. Percentages of patients at goal LDL were 98%, 89%, and 83% for patients taking 2.5, 5, and 10 mg/day, respectively. Patients taking 40 mg/day were least likely to be below the goal. There was an even distribution of patients taking each dosage. No statistical difference in compliance was noted among dosages based on prescription refills. Most patients taking less than the recommended initial dosage of the agent had satisfactory lipid control.

Gemfibrozil-warfarin drug interaction resulting in profound hypoprothrombinemia.

The following describes a patient on a stable regimen of warfarin who developed severe hypoprothrombinemia and bleeding 4 weeks after starting gemfibrozil. Despite a warning by the manufacturer, only one report of this interaction has been published in the literature. This interaction may be overlooked by clinicians, which may result in a serious bleeding risk for patients on warfarin.

A comparison of fluvastatin 40 mg every other day versus 20 mg every day in patients with hypercholesterolemia.

STUDY OBJECTIVE: To assess the efficacy of fluvastatin administered every other day versus an equivalent dose given daily in patients with hypercholesterolemia. DESIGN: Randomized, nonblinded, crossover study. SETTING: Veterans Affairs Medical Center. PATIENTS: Twenty-three patients with low-density lipoprotein (LDL) levels above 160 mg/dl despite diet therapy INTERVENTION: Patients received fluvastatin 40 mg every other day or 20 mg/day, all doses taken at bedtime. Each treatment arm was 6 weeks in duration. MEASUREMENTS AND MAIN RESULTS: A lipid profile was determined at baseline and after each regimen. Both regimens significantly lowered total cholesterol and LDL versus baseline. The LDL levels were lowered by 24% and 21% by fluvastatin 20 mg/day and 40 mg every other day, respectively. There was no statistically significant difference in lipid components between regimens. CONCLUSION: Fluvastatin 40 mg every other day is effective in lowering total cholesterol and LDL in patients with hypercholesterolemia.

A gentamicin order form improves its use.

To assess the effects of implementing a standardized order form on the prescribing and monitoring of gentamicin sulfate at a nonteaching Veterans Affairs Medical Center, we prospectively evaluated the prescribing and monitoring of gentamicin for 14 months after the use of such a form was implemented. The data collected included dosing, initial serum gentamicin concentrations, and serum creatinine measurements. These data were compared with similar data obtained during a period of 6 months before the order form was used. A total of 76 patient records were reviewed, 39 before the use of the order form and 47 after the order form was implemented. Gentamicin peak concentrations were statistically higher in the group treated after the order form was implemented. No differences were seen in gentamicin trough concentrations. The timely measurement of serum gentamicin concentrations and serum creatinine levels was improved in the group for whom the order form was used. The order form was completed satisfactorily in 44 patients (94%). We conclude that implementing a standardized order form improved the use of gentamicin.

Conversion from fluvastatin to simvastatin therapy at a dose ratio of 8 to 1: effect on serum lipid levels and cost.

The objective of this study was to assess the effect on serum lipid levels of the substitution of simvastatin for fluvastatin at a dose ratio of 8:1 (fluvastatin to simvastatin). A secondary objective was to determine the number of patients at goal lipid levels before and after this substitution. The study included 60 outpatients with hyperlipidemia who had received a constant dose of fluvastatin for at least 6 weeks. After a baseline 12-hour lipid profile (total cholesterol, triglycerides, high-density lipoprotein, and low-density lipoprotein [LDL]) was obtained, patients were switched from fluvastatin to simvastatin at an 8:1 dose ratio. Patients were instructed to split the simvastatin tablets in half with a pill splitter and to take one half-tablet at bedtime. A repeat lipid profile and liver function testing were performed after 6 to 8 weeks of simvastatin therapy. Lipid components were compared before and during simvastatin therapy using a paired t test. Target LDL levels were based on guidelines issued by the National Cholesterol Education Program. Fifty-six patients completed the study. No change in lipid components was observed, except for a statistically significant decrease in LDL. The majority of patients had a decrease in LDL levels, rather than an increase, after the conversion to simvastatin. Six patients required a dose increase of simvastatin in response to increased LDL levels. Forty-one percent of patients achieved goal LDL levels with simvastatin, compared with 30% with fluvastatin. Four patients withdrew from the study, two because of troublesome side effects and two for failure to complete the protocol. The results show that simvastatin can be substituted for fluvastatin at a dose ratio of 8:1 without loss of lipid control in the majority of patients and that by using this ratio and splitting tablets, significant cost savings can be realized.

Experience with crystalline niacin as the preferred drug for dyslipidemia in a specialty clinic.

To determine the tolerability and efficacy of crystalline niacin in reaching target lipid goals, we conducted a retrospective review of medical records of 62 patients treated with the agent over 2 years in a lipid clinic at a nonacademic veterans hospital. Most patients received niacin for hypercholesterolemia. Thirty-one patients (50%) stopped therapy due to adverse events, principally, intolerable cutaneous reactions. Twenty-nine withdrew from therapy during the first 6 weeks of treatment. Of those who tolerated niacin, 23 did not achieve target lipid serum concentrations at the maximum tolerated dosage; 8 did achieve target concentrations. Thus crystalline niacin was largely ineffective in treating patients with dyslipidemia.

Changes in serum lipids when fluvastatin is substituted for lovastatin in the same doses.

This study evaluated changes in serum lipids when fluvastatin was substituted for lovastatin using equivalent doses. Results showed that serum lipids, especially low-density lipoprotein cholesterol, significantly increase with this substitution.

Effect of home blood glucose monitoring on the management of patients with non-insulin dependent diabetes mellitus in the primary care setting.

The purpose of the study was to determine whether blood glucose monitoring strips influence the management of patients with non-insulin dependent diabetes (NIDDM) in the primary care setting. The medical records of 115 patients with NIDDM taking a sulfonylurea drug (oral hypoglycemic agent) during the review period were randomly selected for review. Patients were divided into two groups: those who did not receive a prescription for blood glucose monitoring strips during 1995 and 1996 and those who did for the same 2 years. The main outcome measures were hemoglobin A1c, blood sugar, number of laboratory tests ordered, and number and type of treatment interventions. No statistically significant differences between groups were noted for any measured parameter. Glucose control was independent of number of strips dispensed. Home glucose monitoring strips did not affect the management of patients with NIDDM taking a sulfonylurea agent in the primary care setting.

Lack of effect of fluoxetine on the hypoprothrombinemic response of warfarin.

The purpose of this study was to assess the effect of fluoxetine on the hypoprothrombinemic response of warfarin in patients chronically anticoagulated. Patients receiving low-intensity anticoagulation with warfarin were recruited. All patients were taking stable dosages of warfarin and had two baseline prothrombin times (PTs) within 10% of each other. Each patient received fluoxetine (20 mg daily) for 21 days. PTs were measured on days 2, 5, 8, 12, 15, 19, and 22 of fluoxetine administration. Six patients completed the study. There was no significant difference in mean PTs before and during fluoxetine administration. Fluoxetine at the dosage studied does not predictably effect the hypoprothrombinemic response of warfarin.

Effect of melatonin on serum lipids in patients with hypercholesterolemia: a pilot study.

BACKGROUND: Indirect evidence suggests that melatonin may lower serum cholesterol. We undertook a pilot study to assess the effect of melatonin on serum lipids in patients with hypercholesterolemia. METHODS: Patients with a low-density lipoprotein (LDL) level greater than 160 mg/dL despite a 3-month trial of a low-fat diet were enrolled. Patients were randomized in a single-blind, cross-over fashion to receive placebo, 0.3 mg melatonin, or 3 mg melatonin at bedtime for 6 weeks. Serum lipids (total cholesterol, triglycerides, high-density lipoprotein, LDL) were obtained at baseline and after each treatment arm. The means of the lipid components were compared between placebo and each active treatment arm. Statistical analysis was performed using repeated-measures analysis of variance. RESULTS: Twenty-one patients were enrolled in the study. Five patients dropped out of the study, two because of side effects to melatonin and three because of protocol violations. There was no statistically significant difference in lipid components between placebo and both melatonin doses. There was a trend toward a decreased total cholesterol and LDL with the 3-mg dosage. Three patients had significant decreases in LDL on 3 mg melatonin. CONCLUSION: At the dosage studied, melatonin had no uniform effect on serum lipids in patients with hypercholesterolemia.

Effect of lovastatin administered every other day on serum low-density lipoprotein cholesterol > 160 mg/dl.

We undertook a pilot study examining the efficacy of lovastatin 20 mg every other day in patients with hypercholesterolemia, and found lovastatin to be effective in lowering low-density lipoprotein (LDL) levels in patients with serum LDL > 160 mg/dl.

Low-dose fluconazole therapy potentiates the hypoprothrombinemic response of warfarin sodium.

BACKGROUND: Fluconazole has been reported to interact with many medications. This study examined the effect of low-dose fluconazole therapy on the hypoprothrombinemic response of warfarin sodium in patients. METHODS: Patients receiving low-intensity anticoagulation therapy with warfarin were recruited. All patients were taking stable doses of warfarin and had two baseline prothrombin times (PTs) within 10% of each other. Each patient received 100 mg of fluconazole daily for 7 days. Prothrombin times were measured on days 2, 5, and 8 during fluconazole administration. RESULTS: All patients had a progressive increase in PTs. Mean (+/- SD) of PTs increased from 15.8 +/- 1 seconds before the administration of fluconazole to 18.9 +/- 1.9 seconds on day 5 and 21.9 +/- 2.2 seconds on day 8. Fluconazole therapy was stopped early in the three patients due to high PTs. The largest change in PT was 9.7 seconds. No bleeding was noted during the study. CONCLUSION: Fluconazole predictably potentiates the hypoprothrombinemic response of warfarin. Prothrombin times must be monitored when fluconazole is administered to patients taking warfarin.