Impact of the cost of prescription drugs on clinical outcomes in indigent patients with heart disease.

STUDY OBJECTIVE: To measure the impact that economic relief for prescription drugs to indigent patients with cardiovascular disease has on indicators of disease control. DESIGN: Prospective cohort study. SETTING: University inner-city outpatient clinic. PATIENTS: One hundred sixty-three indigent patients with heart disease who were uninsured or whose insurance plan did not provide prescription drug coverage and who had baseline data. INTERVENTION: Patients were assisted in obtaining prescription drugs, free of charge, in an attempt to improve adherence to their drug regimens. MEASUREMENTS AND MAIN RESULTS: The primary end point was to determine if cardiovascular outcome measures (i.e., international normalized ratio [INR], blood pressure, low-density lipoprotein [LDL] cholesterol, and hospitalizations) and drug adherence improved in all patients after 6 months of prescription assistance compared with a 6-month baseline period. In patients receiving warfarin, mean INR increased from 2.44 +/- 0.64 at baseline to 2.61 +/- 0.53 at 6 months (p<0.05). In patients with hypertension, mean blood pressure decreased from 138 +/- 20/80 +/- 11 mm Hg at baseline to 138 +/- 19/78 +/- 12 mm Hg at 6 months (p<0.05 for diastolic blood pressure only). The mean LDL level for patients on lipid-lowering drugs significantly decreased from 126 +/- 39 mg/dl at baseline to 108 +/- 38 mg/dl at 6 months (p<0.001). For each disease measure, the improved disease control seen at 6 months persisted throughout 24 months of follow-up. Hospitalizations for the entire cohort decreased from 85 at baseline to 49 at 6 months. Patient drug adherence improved from 48.5% at baseline to 72.7% at 6 months (p<0.001). CONCLUSIONS: Drug adherence and clinical outcomes improved, and the number of hospitalizations declined when cardiovascular drugs were obtained for patients who could not afford to pay for them. Health care insurance plans that do not provide coverage for cardiovascular prescription drugs may be more costly secondary to poor disease control and increased hospitalizations.

Rationale, development, and clinical outcomes of a multidisciplinary amiodarone clinic.

OBJECTIVES: To review the rationale and development of a multidisciplinary amiodarone clinic, and document the clinical outcomes resulting from its implementation. METHODS: A clinic was established to provide an ambulatory setting in which patients receiving amiodarone could be followed according to published guidelines by a multidisciplinary team of cardiovascular health care specialists. Patients receiving amiodarone were referred to the clinic by their primary physicians. A data base containing each patient's medical history, current drug therapy, and baseline laboratory values was developed during the initial visit. Liver function tests, thyroid function tests, and chest radiographs were performed every 6 months, and pulmonary function tests were scheduled on an annual basis. Dosage adjustments were performed in select patients. RESULTS: Since November 1996, 60 patients have been referred to the amiodarone clinic. Mean length of follow-up before and after referral was 16.3+/-25.5 and 9.2+/-5.5 months, respectively. Laboratory tests were performed according to accepted guidelines in 14 (23%) patients before referral compared with 54 (90%) patients after enrollment (p<0.001). Previously unrecognized adverse events were detected in 21 (35%) patients, including pulmonary fibrosis, QT prolongation, liver enzyme elevation, hypothyroidism, hyperthyroidism, and asthma exacerbation. Amiodarone was discontinued in six patients, four of whom had suspected pulmonary toxicity. The dose of amiodarone was adjusted in 29 (48.4%) patients. CONCLUSION: Many patients receiving amiodarone are not being followed according to published recommendations. Implementation of a specialized, multidisciplinary amiodarone clinic improves outcomes by monitoring for early detection of drug-related toxicities and by facilitating proper dosage modifications.

Efficacy of 3-hydroxy-3-methylglutaryl coenzyme a reductase inhibitors in the treatment of patients with hypercholesterolemia: a meta-analysis of clinical trials.

Recent studies have documented the long-term impact of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors on mortality and morbidity related to coronary heart disease, establishing the link between lowering cholesterol levels and reducing cardiac events. Our study was a comparative literature review and meta-analysis of the efficacy of four HMG-CoA reductase inhibitors-fluvastatin, lovastatin, pravastatin, and simvastatin-used in the treatment of patients with hypercholesterolemia. The data sources for our meta-analysis of the efficacy of these cholesterol-lowering agents were 52 randomized, double-masked clinical trials with at least 25 patients per treatment arm. The results showed all four agents to be effective in reducing blood cholesterol levels. We computed summary efficacy estimates for all published dose strengths for the four agents. Fluvastatin 20 mg/d reduced low-density lipoprotein cholesterol (LDL-C) levels by 21.0% and total cholesterol (total-C) levels by 16.4%; fluvastatin 40 mg/d reduced these levels by 23.1% and 17.7%, respectively. Lovastatin 20 mg/d reduced LDL-C levels by 24.9% and total-C levels by 17.7%; lovastatin 80 mg/d reduced these levels by 39.8% and 29.2%, respectively. Pravastatin 10 mg/d reduced LDL-C levels by 19.3% and total-C levels by 14.0%; pravastatin 80 mg/d reduced these levels by 37.7% and 28.7%, respectively. Simvastatin 2.5 mg/d reduced LDL-C levels by 22.9% and total-C levels by 15.7%; simvastatin 40 mg/d reduced these levels by 40.7% and 29.7%, respectively. The results of our meta-analysis can be used in conjunction with treatment objectives and comparative cost-effectiveness data for these agents to decide appropriate therapeutic alternatives for individual patients.

Lipid management: an opportunity for pharmacy service.

Pharmacists are ideally suited to perform lipid management services. For many patients, hyperlipidemia is a symptomless disorder that requires knowledgeable laboratory interpretation, application of treatment guidelines, and appropriate drug therapy selection and monitoring. With the recent availability of portable lipid analyzers, pharmacists have a great opportunity to use their skills in drug therapy management to assist patients and their physicians with lipid management directly in the clinic or pharmacy. Evidence exists that appropriate lipid therapy can improve patient outcomes and save lives, and that delegating this responsibility to a qualified health care practitioner is cost-effective.

Serum nifedipine concentrations and response of patients with pulmonary hypertension.

In patients with primary pulmonary hypertension who respond to nifedipine during acute drug testing, there is a significant linear correlation of serum nifedipine concentration with pulmonary artery pressure and resistance. Although most demonstrate an initial response at readily attainable nifedipine concentrations with conventional dosages, a subset of patients seem to display delayed or incomplete oral absorption; these results may facilitate the clinical use of nifedipine in patients with primary pulmonary hypertension.

Ambulatory care certificate program for pharmacists.

An ambulatory care certificate program tailored to meet the educational needs of Department of Veterans Affairs (VA) and Navy pharmacists is described. In 1992, the College of pharmacy, University of Illinois at Chicago, worked with the VA and the Navy to design an ambulatory care certificate program for pharmacists in VA and Navy hospitals. The pilot course consisted of 103 hours of didactic and experiential education. The 10 didactic modules covered both disease management and clinical skills. The experiential component incorporated pharmaceutical care steps as applied to therapeutic areas taught in the course. Although the pilot course met most of the original objectives, several unanticipated problems emerged, including distance learning issues, the number of hours for completing the course requirements, learner variance, the impact of institutional support on participants' academic success, participants' difficulty in assimilating education into practice, and difficulty with the clinical evaluation tool developed for the course. The course was modified over the next year to address these problems. Now in its fourth year, the course is offered nationally to the VA and the Department of Defense. In the first three years, 72 of 99 enrolled pharmacists completed the course. An ambulatory care certificate program helps Navy and VA pharmacists develop patient care skills.

Bioavailability of total and unbound disopyramide: implications for clinical use of the immediate and controlled-release dosage forms.

This study further characterized the impact of concentration-dependent protein binding on the bioavailability and clinical use of the immediate-release (IR) and controlled-release (CR) dosage forms of disopyramide after single doses and during steady-state conditions in ten healthy volunteers. Consistent with the clinical use of these products, steady state has incorporated an IR to CR conversion step. Side effects and electrocardiographic actions were quantitated using a visual analog scale and serial Holter monitor recordings, respectively. Significant decreases resulted in area under the curve for total disopyramide between single dose and steady state: IR, 47.8 +/- 13.6 versus 33.0 +/- 6.4 mg/Lxh (P < .05); and CR, 46.9 +/- 9.5 versus 31.7 +/- 5.9 mg/Lxh (P < .05). In contrast, there were no differences in area under the curve for unbound disopyramide between phases or products. During conversion, the mean IR peak significantly decreased (P < .05) to the nadir before the first CR dose for total (37%) and unbound (60%) concentrations. There were no major differences in change in QT interval or side effects detected between products or phases. These findings indicate that, because of concentration-dependent protein binding, unbound, not total, concentrations should be used to estimate the bioavailability of disopyramide. Also, although the previously recommended conversion method (first CR dose 6 hours after the last IR dose) should provide an adequate transition in most, an alternative method (combined first CR with last IR dose) is indicated in select patients.

Practical optimisation of antiarrhythmic drug therapy using pharmacokinetic principles.

The optimisation of antiarrhythmic drug therapy is dependent on the definitions and methods of short term efficacy testing and the characteristics of those drugs used for rhythm disturbances. The choice of an initial antiarrhythmic drug dosage is highly empirical, and will remain so until the measurement of free concentrations, enantiomeric fractions and genetic phenotyping becomes routine. However, the clinician can devise an efficient initial dosage for efficacy testing procedures based on pharmacokinetic principles and disposition variables in the literature. In this regard, a nomogram for commonly used agents and dosages was constructed and is offered as a guide to accomplish this goal. Verification of the accuracy and usefulness of this nomogram in a prospective manner in patients with symptomatic tachyarrhythmias is still required. On a long term basis, dosage regimens can be modified by the use of pharmacokinetic principles and patient-specific target concentrations, in accordance with the methods used to monitor arrhythmia recurrence and drug-related side effects.

Evaluation of the pharmacokinetics and electrocardiographic effects of intravenous verapamil with intravenous calcium chloride pretreatment in normal subjects.

To evaluate the effects of calcium pretreatment on the disposition and electrocardiographic effects of verapamil, 8 healthy male volunteers received treatment in each of 3 phases in a randomized, double-blind, crossover manner. Phase I denoted 10 ml of 0.9% intravenous sodium chloride followed by 10 mg of intravenous verapamil; phase II denoted 10 ml of 10% intravenous calcium chloride followed by 4 ml of 0.9% intravenous sodium chloride; and phase III denoted 10 ml of 10% intravenous calcium chloride followed by 10 mg of intravenous verapamil. Blood samples for the determination of verapamil concentrations were drawn at 5, 10, 15, 20, 30, 45, 60 and 90 minutes, and at 2, 4, 6, 10 and 24 hours. Blood pressure, heart rate and PR intervals were also measured at these times. Pretreatment of verapamil with intravenous calcium did not alter the disposition of intravenous verapamil. Blood pressure was not significantly altered in any treatment phase, although calcium tended to increase mean arterial pressure and verapamil abolished this effect. Calcium had no significant affect on verapamil-induced PR prolongation (maximum percent change in PR interval: phase I = 19 +/- 11%, phase III = 18 +/- 7%; time to maximal prolongation: phase I = 0.38 +/- 0.21 hours, phase III = 0.37 +/- 0.26 hours; and area under the percent change in PR vs time curve: phase I = 15.5 +/- 10, phase III = 21 +/- 9). Verapamil caused a reflex increase in heart rate of similar magnitude in both phases I and III (24 +/- 10% and 21 +/- 7%, respectively).(ABSTRACT TRUNCATED AT 250 WORDS)