April 2003

Jane S. Ricciuti, RPh, MS

April 22, 2003

Antidiabetic Agents

Avandia

(rosiglitazone maleate) Tablets

Manufacturer: SmithKline Beecham Pharmaceuticals

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 2/27/03)

New Indication: This supplemental new drug application for Avandia (rosiglitazone maleate) is approved for the use of Avandia in combination with insulin for the treatment of patients with type 2 diabetes mellitus.

Adverse Effects: In clinical trials with Avandia and insulin, patients with preexisting edema were more likely to have adverse events associated with edema.

In 26-week double-blind clinical studies, edema was reported with higher frequency in the Avandia plus insulin combination trials (insulin, 5.4%; and Avandia in combination with insulin, 14.7%). Reports of new onset or exacerbation of congestive heart failure occurred at rates of 1% for insulin alone, and 2% (4 mg) and 3% (8 mg) for insulin in combination with Avandia.

Avandia (rosiglitazone maleate) Tablets Labeling

Avandia (rosiglitazone maleate) Tablets

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Cite this: April 2003 - Medscape - Apr 23, 2003.

Table 1. Moxifloxacin Efficacy in the Treatment of Penicillin-Resistant *Streptococcus pneumoniae* CAP
Pathogen	Moxifloxacin		Comparators
Pathogen	n/N	%	n/N	%
All S pneumoniae	230/244	94	138/162	85
S pneumoniae bacteremia	53/58	91	35/41	85
S pneumoniae with penicillin MIC penicillin ≥ 2 mcg/mL	21/21	100	5/5	100
S pneumoniae bacteremia with penicillin MIC penicillin ≥ 2 mcg/mL	7/7	100	2/2	100

Table 2. Adverse Events Reported in Pediatric Cooperative Group Trial
	*No. (%) of Temodar* Patients (N = 122)**
Body System/Organ Class Adverse Event (AE)	All Events	Grade 3/4
Subjects reporting an AE body as a whole	107 (88)	69 (57)
Central and Peripheral Nervous System
Central cerebral CNS cortex	22 (18)	13 (11)
Gastrointestinal System
Nausea	56 (46)	5 (4)
Vomiting	62 (51)	4 (3)
Platelet, Bleeding, and Clotting
Thrombocytopenia	71 (58)	31 (25)
Red Blood Cell Disorders
Decreased hemoglobin	62 (51)	7 (6)
White Cell and RES Disorders
Decreased WBC	71 (58)	21 (17)
Lymphopenia	73 (60)	48 (39)
Neutropenia	62 (51)	24 (20)

Table 3. Outcomes of Randomized Treatment at Week 24 (Pooled Studies T20-301 and T20-302)
Outcomes	Fuzeon + Background Regimen 90 mg Twice Daily	Background Regimen
	N = 661	N = 334
HIV-1 RNA log change from baseline (log₁₀ copies/mL)	-1.52	-0.73
CD4+ cell count change from baseline (cells/mm²)	+71	+35
HIV RNA ≥ 1 log below baseline	342 (52%)	86 (26%)
HIV RNA < 400 copies/mL	247 (37%)	54 (16%)
HIV RNA < 50 copies/mL	151 (23%)	30 (9%)
Discontinued due to adverse reactions/labs*	40 (6%)	12 (4%)
Discontinued due to injection site reactions*	20 (3%)	N/A
Discontinued due to other reactions*	36 (5%)	14 (4%)

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April 2003

Antidiabetic Agents

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