The Consultant Pharmacist is published by the
American Society of Consultant Pharmacists.

Senior Care Pharmacy ‘99
ASCP 30th Annual Meeting and Exhibition Contributed Papers
    Thursday, November 11
    2:00 pm - 3:30 pm

    Sponsored by Searle

Editor’s note: Abstracts of posters and contributed posters are evaluated by a committee composed of ASCP members. Submissions are not evaluated through the editorial review process of The Consultant Pharmacist.


An Evaluative Report on the Effectiveness of Megestrol Acetate for the Treatment of Anorexia/Cachexia in Geriatric Residents
Bruno Wroblewski

Megestrol acetate is a progestational agent that, among other indications, is approved by the Food and Drug Administration (FDA) for the treatment of anorexia, cachexia, or an unexplained significant weight loss in patients with a diagnosis of acquired immune deficiency syndrome (AIDS) (suspension formulation only). Although increasingly used in geriatric residents to stimulate appetite and promote weight gain, there is little literature on appropriate use and efficacy in this population to guide the clinician. Thus, the use of megestrol acetate for this purpose was evaluated in a debilitated elderly inpatient population by means of a retrospective chart review of residents at one skilled nursing care center (currently ongoing).

The study population comprised 18 consecutive elderly residents (age range 75-90 years) administered megestrol acetate over a six-month period to promote weight gain. Other methods (dietary changes, pharmacologic interventions) had proven to be ineffective.

Of the original 18 residents, four were lost to follow-up and unevaluable. Of the 14 evaluable residents, eight (57%) have demonstrated at least a 5% weight increase attributed to megestrol acetate, including four residents with a >10% weight increase. Of the six residents who did not benefit from megestrol acetate, only one (17%) received the FDA-approved dosage of 800 mg/day; whereas four of eight (50%) who benefited received the 800 mg/day dosage. Only one resident was discontinued from megestrol acetate for a potential adverse effect (pedal edema).

Although small in population, the trend of results of this on-going evaluative study appears to demonstrate improvement of appetite and concomitant weight gain for some geriatric residents. Studies in geriatric residents are scarce, in particular, concerning dosage, adverse effects, and length of treatment. In the results presented here, only one resident was withdrawn for adverse effects, while most were able to tolerate the 800 mg/day recommended dose.


Economic Impact of Influenza Among Long-Term Care Facility Residents: A Comparison of Costs Associated With Outbreaks
Norman V. Carroll, K. Lynn McClure, Jeffrey C. Delafuente, Diane Weakley

Influenza is a major cause of morbidity and mortality in the United States, and its toll is especially great on the elderly. Elderly patients in long-term care facilities may be at special risk for influenza-related problems. In 1999, influenza outbreaks peaked in early March. We chose to study and compare the pharmacoeconomic and clinical outcomes in long-term care facilities that did and did not have serious outbreaks of influenza occurring in March 1999.

Specific objectives of the study are as follows:

  1. to estimate the direct medical and medically-related costs incurred in four long-term care facilities as a result of influenza-like illness
  2. to estimate and compare the direct medical and medically-related costs of influenza-like illness in facilities that experienced outbreaks with costs in facilities that did not experience outbreaks
  3. to compare the effects of influenza vaccination rates between the long-term care facilities that did and did not have influenza outbreaks.
Data will be collected on residents of four long-term care facilities that serve approximately 480 patients. Two of the selected facilities experienced an outbreak during March 1999; two did not experience outbreaks during the 1998-1999 influenza season. Data will be collected on all patients who were residents of the facilities as of 1 March 1999. Data will be collected for the period of 1 March 1999 through 31 May 1999.

Data collected for each resident will include demographic information; documentation of influenza-like illness status from progress notes, medication administration records, and other notes in the resident’s chart; vaccination status for influenza; health variables; and use of health care services. Influenza-like illness will be defined using the CDC’s definition of fever of 37.8°C or greater accompanied by cough, coryza, or sore throat. Standard Medicare reimbursement rates will be used to estimate the costs of health care services.

We will estimate the costs of influenza by identifying influenza-specific costs. Influenza-specific costs will be defined as those that can reasonably be attributed to influenza considering both time (influenza immediately precedes service) and the diagnosis associated with the service. Costs will be adjusted to reflect outbreak-related costs. When outbreaks occur, many facilities treat all residents prophylactically with amantadine or rimantidine. In these cases, the costs of antiviral treatment for residents not having influenza-like illness will be viewed as additional influenza-related costs. Influenza-related costs will be calculated as mean and median costs per resident who contract influenza-like illness and as mean and median facility costs.


Insulin Aspart (IAsp) Improves Postprandial Glycemic Control Compared to Regular Human Insulin (HI) in Patients with Type 1 Diabetes
Philip Raskin, Lois Jovanovic, Jerzy Kolaczynski

The substitution of aspartic acid for B28 proline in the insulin molecule reduces its propensity to form hexamers and results in rapid absorption from the subcutaneous depot, with kinetics that better resemble the postprandial physiological insulin secretory profile than the subcutaneously injected regular human insulin (HI).

We studied the safety and efficacy of insulin Aspart (IAsp) in a six-month, multicenter, randomized (preceded by a four-week run-in period), open-label study in 884 adult patients (age >18 years) with established type 1 diabetes (>24 month duration). During the four-week run-in period, all patients were required to follow a multiple-injection regimen (basal NPH/30-minute premeal regular insulin boluses). Thereafter, the patients were randomized to continue with 30-minute premeal dose-adjusted boluses of HI (n = 257) or switch to IAsp (n = 533) injected immediately before meals. Efficacy was assessed by comparing the eight-point diurnal glucose profiles (before three meals, after three meals, at bedtime, and at 2:00 a.m.) after six months of treatment and HbA1c levels. Safety was assessed based on the severity and frequency of hypoglycemic episodes and on the occurrence of adverse events.

At six months, the IAsp group demonstrated lower (P < 0.05 for all comparisons) blood glucose (BG) values after breakfast (156 ± 3 vs. 185 ± 5 mg/dL), lunch (137 ± 3 vs. 162 ± 4 mg/dL), dinner (153 ± 3 vs. 168 ± 4 mg/dL), and before lunch (126 ± 3 vs. 138 ± 4 mg/dL) compared to HI-treated group. Prandial BG increments were also significantly lower for the IAsp group compared to the HI-treated group (2.2 ± 2.2 vs. 28.4 ± 2.9 mg/dL; P < 0.001). At baseline, HbA1c was similar between treatment groups (7.9 ± 1.1 vs. 8.0 ± 1.3% IAsp vs. HI, respectively; P = ns). At six months, the HbA1c was maintained; although it was slightly lower in IAsp-treated patients (P = 0.005). The safety of IAsp versus HI in the multiple injection regimen was comparable. Similar frequencies of hypoglycemic (mild and severe) episodes were reported for both treatment groups. However, the IAsp-treated group experienced fewer nocturnal (12:00 a.m. to 6:00 a.m.) hypoglycemic episodes (16% of all episodes for IAsp, 34% for HI).

The results of this study indicate that IAsp, as a component of a multiple-injection regimen in type 1 diabetic patients, provided significantly improved postprandial glycemic control compared to HI. Both treatments were well-tolerated.


Pharmacokinetics and Pharmacodynamics of an 85/15 Premixed Insulin Compared to NPH and a 70/30 Premixed Insulin
Sunder Mudaliar, Pharis Mohideen, Mary Joyce, Deborah Armstrong, Poul Strange, Robert Henry

Insulin therapy for many patients with diabetes includes the use of both short- and long-acting insulins. Many of these patients use commercially available 70/30 premix. However, for some patients (older individuals, thin adults, children), regular insulin component of this premix may result in postprandial glucose excursions and hypoglycemia in the early hours after administration.

Using the euglycemic clamp model, the pharmacodynamics and pharmacokinetics of an insulin premix containing a small amount of regular insulin (85/15) were compared to insulin NPH and a 70/30 premix. Thirty-six healthy male subjects (mean age 28.4 ± 5.5 years) were enrolled in this double-blind, three-period crossover study. The subjects’ blood glucose levels were clamped at baseline via repeated adjustments of the glucose infusion rate. Subjects received a single injection of NPH, premix 70/30, or premix 85/15.

The total amount of glucose infused in the first four hours after injection (AUCGIR0-4), maximal glucose infusion rate (GIRmax), area under the curve (AUC) for insulin in the first four hours after injection AUCins(0-4), and Cmax(ins) were determined (see table).

The results of this study indicate that the pharmacodynamic and pharmacokinetic profile of 85/15 premix was intermediate between, and significantly different from, NPH and the 70/30 premix. The 85/15 premix, therefore, may offer an alternative to those insulin-requiring patients for whom a 70/30 premix provides too much rapid-acting insulin.

Pharmacodynamic and Pharmacokinetic Parameters (n = 34)
Parameters (mean values) NPH85/15 Premix 70/30 Premix
AUCGIR(0-4) 659 ± 314859 ± 444a,b 1,140 ± 549
GIRmax (mg/min/kg) 7.0 ± 3.48.0 ± 3.3a,b 9.0 ± 3.4
AUCins(0-4) 5,935 ± 1,5707,448 ± 2,795a,b 9,869 ± 2,261
Cmax(ins) (µU/ml) 35.3 ± 1043.7 ± 14.3a,b 54.8 ± 12.9

a significantly different (P £ 0.05) from NPH; b significantly different (P £ 0.05) from 70/30.

Combination Therapy With Repaglinide and Troglitazone Improves Glycemic Control in Patients With Type 2 Diabetes Compared to Monotherapy
Philip Raskin, Peter G. Mueller

This open-label, randomized, multicenter study was designed to evaluate the efficacy and safety of a combination of repaglinide and troglitazone compared to either of the two drugs used as monotherapy. Patients with type 2 diabetes (n = 256) inadequately controlled by sulfonylureas, acarbose, or metformin were randomized to one of three treatment groups: repaglinide/troglitazone (n = 88), repaglinide alone (n = 83), or troglitazone alone (n = 85). After screening and a six-week washout period, the 22-week study consisted of three segments: three weeks of forced titration to fixed dose, eleven weeks of fixed-dose treatment, and eight weeks of titration to maximum dose. The following percentages of patients discontinued treatment: repaglinide/troglitazone (20%); repaglinide (11%); troglitazone (28%). Combination therapy produced reduction of HbA1c values by -1.7%, a greater response than either monotherapy (repaglinide, -0.8%; troglitazone, -0.4%). Reduction of fasting plasma glucose values was likewise greater for combination therapy (-80 mg/dL) than for either monotherapy (repaglinide, -43 mg/dL; troglitazone, -46 mg/dL. Adverse events were similar in all groups. Repaglinide/troglitazone combination therapy leads to better glycemic control than either repaglinide monotherapy or troglitazone monotherapy in these patients with type 2 diabetes that had shown declining glycemic response to oral hypoglycemic agents.


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The Consultant Pharmacist is published by the
American Society of Consultant Pharmacists.