: the International Prostate Symptom Score (I-PSS) and the peak urinary flow rate (Qmax). The I-PSS consists of seven questions that assess the severity of both irritative (frequency, urgency, nocturia) and obstructive (incomplete emptying, stopping and starting, weak stream, and pushing or straining) symptoms, with possible total scores ranging from 0 to 35. The Qmax was measured in both studies just prior to the next dose. The results for total symptom score are given in Table 2, and for maximum urinary flow rate in Table 3.
TABLE 2 TOTAL INTERNATIONAL PROSTATE SYMPTOM SCORE (IPSS)* N MEAN BASELINE (±SD) MEAN CHANGE (±SE)†
*
Derived from IPSS questionnaire (range 0–35)
†
Mean change from baseline to Week 13
‡
Statistically significant difference (p <0.001) vs. placebo
STUDY 1
Placebo 151 17.9 ± 4.3 -6.1 ± 0.41
CARDURA XL 310 17.7 ± 4.3 -8.0 ± 0.30‡
Doxazosin IR 311 17.8 ± 4.5 -8.4 ± 0.29‡
STUDY 2
CARDURA XL 330 18.4 ± 5.0 -8.1 ± 0.30
Doxazosin IR 313 18.4 ± 4.8 -7.9 ± 0.31
TABLE 3 MAXIMUM FLOW RATE (mL/sec) N MEAN BASELINE (±SD) MEAN CHANGE (±SE)*
*
Mean change from baseline to Week 13
†
Statistically significant difference (p <0.001) vs. placebo
STUDY 1
Placebo 151 9.8 ± 2.6 0.8 ± 0.32
CARDURA XL 300 10.3 ± 2.6 2.6 ± 0.24†
Doxazosin IR 303 10.1 ± 2.7 2.2 ± 0.23†
STUDY 2
CARDURA XL 322 10.5 ± 2.6 2.7 ± 0.27
Doxazosin IR 314 10.6 ± 2.6 2.7 ± 0.27
Mean changes in IPSS scores for CARDURA XL and placebo in Study 1 is summarized in Figure 2.
Mean changes in maximum urinary flow rate (Qmax) for both Cardura XL and placebo in Study 1 is summarized in Figures 3.
INDICATIONS AND USAGE
CARDURA XL is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
CARDURA XL is not indicated for the treatment of hypertension.
CONTRAINDICATIONS
CARDURA XL is contraindicated in patients with a known sensitivity to other quinazolines (e.g., prazosin, terazosin), doxazosin, or any of the inert ingredients.
WARNINGS
Postural hypotension with or without symptoms (e.g., dizziness) may develop within a few hours following administration of CARDURA XL (doxazosin mesylate extended release tablets). However, infrequently, symptomatic postural hypotension has also been reported later than a few hours after dosing. As with other alpha-blockers, there is a potential for syncope, especially after the initial dose or after an increase in dosage strength. Patients should be warned of the possible occurrence of such events and should avoid situations where injury could result should syncope occur. Care should be taken when CARDURA XL is administered to patients with symptomatic hypotension or patients who have had a hypotensive response to other medications.
PRECAUTIONS
General
Prostate Cancer
Carcinoma of the prostate causes many of the same symptoms associated with BPH and the two disorders frequently co-exist. Carcinoma of the prostate should therefore be ruled out prior to commencing therapy with CARDURA XL.
Gastrointestinal Disorders
As with any oth |
