p;10% 9%
Asthenia 8% 8%
Pruritus 5% 9%
Monilia, oral 5% 10%
Abdominal pain 4% 7%
Constipation 3% 17%
Dizziness 3% 8%
Patients discontinuing therapy due to an adverse experience 9% 24%
Patients reporting at least 1 adverse experience 63% 65%
Although an equal percentage of patients receiving MEPRON and TMP-SMX reported at least 1 adverse experience, more patients receiving TMP-SMX required discontinuation of therapy due to an adverse event. Twenty-four percent of patients receiving TMP-SMX were prematurely discontinued from therapy due to an adverse experience versus 9% of patients receiving MEPRON. Four percent of patients receiving MEPRON had therapy discontinued due to development of rash. The majority of cases of rash among patients receiving MEPRON were mild and did not require the discontinuation of dosing. The only other clinical adverse experience that led to premature discontinuation of dosing of MEPRON by more than 1 patient was vomiting (<1%). The most common adverse experience requiring discontinuation of dosing in the TMP-SMX group was rash (8%).
Laboratory test abnormalities reported for ≥5% of the study population during the treatment period are summarized in Table 9. Two percent of patients treated with MEPRON and 7% of patients treated with TMP-SMX had therapy prematurely discontinued due to elevations in ALT/AST. In general, patients treated with MEPRON developed fewer abnormalities in measures of hepatocellular function (ALT, AST, alkaline phosphatase) or amylase values than patients treated with TMP-SMX.
Table 9. Treatment-Emergent Laboratory Test Abnormalities in the TMP-SMX Comparative PCP Treatment Study
Percentage of Patients Developing a Laboratory Test Abnormality
Laboratory Test Abnormality MEPRON TMP-SMX
Anemia (Hgb<8.0 g/dL) 6% 7%
Neutropenia (ANC<750 cells/mm3) 3% 9%
Elevated ALT (>5 x ULN) 6% 16%
Elevated AST (>5 x ULN) 4% 14%
Elevated alkaline phosphatase (>2.5 x ULN) 8% 6%
Elevated amylase (>1.5 x ULN) 7% 12%
Hyponatremia (<0.96 x LLN) 7% 26%
ULN = upper limit of normal range.
LLN = lower limit of normal range.
Table 10 summarizes the clinical adverse experiences reported by ≥5% of the primary therapy study population (n = 144) during the comparative trial of MEPRON and intravenous pentamidine, regardless of attribution. A slightly lower percentage of patients who received MEPRON reported occurrence of adverse events than did those who received pentamidine (63% vs 72%). However, only 7% of patients discontinued treatment with MEPRON due to adverse events, while 41% of patients who received pentamidine discontinued treatment for this reason (P <0.001). Of the 5 patients who discontinued therapy with MEPRON, 3 reported rash (4%). Rash was not severe in any patient. No other reason for discontinuation of MEPRON was cited more than once. The most frequently cited reasons for discontinuation of pentamidine therapy were hypoglycemia (11%) and vomiting (9%).
Table 10. Treatment-Emergent Adverse Experiences in the Pentamidine Comparative PCP Treatment Study (Primary Therapy Group)
Percentage of Patients with Treatment-Emergent Adverse Experience
Treatment-Emergent
Adverse Experi |
