|Doxycycline is a cost-effective therapy for hospitalized patients with community-acquired pneumonia
|Ailani R K, Agastya G, Ailani R K, Mukunda B N, Shekar R
This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn.
Doxycycline for hospitalised patients with community-acquired pneumonia. The dosage was 100mg given intravenously every 12 hours. This was switched to 100mg orally every 12 hours for patients in the intervention group who improved.
Economic study type
Hospitalised patients with mild to moderately severe CAP. Patients were eligible if they had a clinical and radiological diagnosis of CAP before hospital admission. Patients were excluded as follows: younger than 18 years, pregnant or lactating women, history of allergic reaction to the use of tetracycline or doxycycline, suffering from severe hepatic or renal dysfunction, human immunodeficiency virus infection, immunocompromised state, clinical sepsis, requiring intubation, or from a nursing home or a long-term care facility.
A 371 bed community teaching hospital. The study was set in the USA.
Dates to which data relate
Effectiveness, resource use, and cost data were collected from August 1995 to December 1997. The price year was not reported.
Source of effectiveness data
Effectiveness data were derived from a single study.
Link between effectiveness and cost data
The costing was undertaken on the same patient sample as that used in the effectiveness study. The costing was carried out prospectively alongside the effectiveness analysis.
43 patients were randomised to receive doxycycline and 44 patients were assigned to the control group. The randomisation process was carried out by predetermined numbered sequence. No power calculations were reported in the determination of sample size.
The study was a prospective, randomised trial carried out at a single hospital. Patients were followed up until hospital discharge. No patients were lost to follow-up. The study was not blinded.
Analysis of effectiveness
The analysis of the clinical study was based on intention to treat. Primary health outcomes used included time to resolution of morbidity, length of hospital stay, adverse effects from the use of antibiotics, and number of antibiotics used per patient. The time to respond to treatment was defined as the number of days between day of randomisation and the time at which the last of the following parameters was met:
(1) oral temperature 37.9 degrees or lower over 3 consecutive 8-hour periods;
(2) Beginning of a decrease in total white blood cell counts (tendency toward normal in patients with leukocytes;
(3) subjective improvement in the symptoms that caused admission;
(4) resolution of hypoxia in those patients with no underlying disease (such as chronic obstructive pulmonary disease or congestive heart failure) who were hypoxic on admission.
The two patient groups were comparable in their clinical and laboratory profiles.
The time to respond to treatment was 2.21 (+/- 2.61) days in the doxycycline group and 3.84 (+/- 6.39) days in the control group, (p=0.001). The length of hospitalisation was 4.14 (+/- 3.08) days in the doxycycline group and 6.14 (+/- 6.65) days in the control group, (p=0.04). The number of antibiotics used, including those given on discharge, was 1.16 (+/- 1.04) in the doxycycline group and 2.43 (+/- 1.59) in the control group, (p<0.001). The number of patients experiencing adverse effects was 6 in the doxycycline group and 11 in the control group, (p=0.19). The number of patients requiring a change in the antibiotic regimen was 3 in the doxycycline group and 8 in the control group.
Doxycycline is an effective option for the treatment of patients admitted to hospital with mild or moderately severe CAP.
Measure of benefits used in the economic analysis
No summary benefit measure was used in the economic analysis and, as such, a cost-consequences approach was adopted. The benefits are therefore associated with the clinical outcomes reported in the effectiveness results.
Direct costs were not discounted given the short time frame of the study (less than 1 year). Quantities and costs were not reported separately. Direct costs included drug costs and hospitalisation costs. The quantity/cost boundary adopted was that of society. The estimation of quantities and costs was based on actual data. Drug and hospitalisation costs were collected from the authors' hospital. The price year was not reported.
Statistical analysis of costs
Patient groups were compared using the student's two-sample t test, Wilcoxon rank sum test, and the chi-squared test.
Indirect costs were not included.
No sensitivity analysis was reported.
Estimated benefits used in the economic analysis
The reader is referred to the effectiveness results reported above.
The cost of antibiotics during hospitalisation was $33 for the doxycycline group compared with $170.9 for the control group, (p<0.001). The cost of hospitalisation was $5,126 for the doxycycline group compared with $6,528 for the control group, (p=0.04).
Synthesis of costs and benefits
Costs and benefits were not combined into a cost-effectiveness ratio, because of the cost-consequences approach.
Doxycycline is an effective and inexpensive therapy for the empirical treatment of hospitalised patients with mild to moderately severe community-acquired pneumonia.
CRD COMMENTARY - Selection of comparators
A justification was given for the comparator used, namely it was the current therapy. The findings of the study might have been enhanced if a standard comparator had been chosen, although it is possible that this may not be clinically feasible or ethical. You, the user of the database, should decide if these health technologies are relevant to your setting.
Validity of estimate of measure of benefit
The analysis was based on a prospective, randomised trial, which was appropriate for the study question. The study sample was representative of the study population. Patient groups were shown to be comparable at analysis. The estimation of benefits was obtained directly from the effectiveness analysis.
Validity of estimate of costs
All relevant cost categories appear to have been included. However, limitations in the cost analysis were that quantities and costs were not reported separately, no sensitivity analyses were conducted and drug cost estimates were based on patient charges (which do not reflect opportunity costs). The price year was not reported. This, in addition to the points noted above, limits the generalisability of the cost results.
The authors did not make appropriate comparisons of their findings with those from other studies and the issue of generalisability to other settings was not addressed. The authors did not, however, present their results selectively. The study enrolled hospitalised patients with mild to moderately severe community-acquired pneumonia and this was reflected in the authors' conclusions. Further limitations of the study were that it was not blinded, patients with severe disease requiring intubation were excluded, the cause of pneumonia was not established in most of the patients and the authors did not perform antibacterial susceptibilities of the organisms isolated against doxycycline.
Implications of the study
Doxycycline should be considered in the empirical treatment of hospitalised patients with mild to moderately severe CAP.
Ailani R K, Agastya G, Ailani R K, Mukunda B N, Shekar R. Doxycycline is a cost-effective therapy for hospitalized patients with community-acquired pneumonia. Archives of Internal Medicine 1999; 159: 266-270
Other publications of related interest
Comment in: Archives of Internal Medicine 1999;159(15):1814-5.
Subject indexing assigned by NLM
Adult; Aged; Aged, 80 and over; Anti-Bacterial Agents /administration & Community-Acquired Infections /drug therapy /economics /microbiology; Doxycycline /administration & Female; Hospitalization; Humans; Infusions, Intravenous; Male; Middle Aged; Pneumonia /drug therapy /economics /microbiology; Severity of Illness Index; Treatment Outcome; dosage /economics /therapeutic use; dosage /economics /therapeutic use
Date bibliographic record published
Date abstract record published