ARESTIN safety and adverse events

The safety and efficacy of ARESTIN (minocycline HCl) Microspheres, 1 mg has been demonstrated as an adjunct to scaling and root planning (SRP) for the reduction of pocket depth in patients with adult periodontitis.1 

Adverse Events (AEs) reported in ≥3% of the combined clinical trial population of 3 multicenter US trials by treatment group1

Treatment-emergent AEs SRP alone 
N=250
SRP + placebo 
N=249
ARESTIN + SRP
N=423
Periodontitis 25.6% 28.1% 16.3%
Tooth Disorder 12.0% 13.7% 12.3%
Tooth Caries 9.2% 11.2% 9.9%
Dental Pain 8.8% 8.8% 9.9%
Gingivitis 7.2% 8.8% 9.2%
Headache 7.2% 11.6% 9.0%
Infection 8.0% 9.6% 7.6%
Stomatitis 8.4% 6.8% 6.4%
Mouth Ulceration 1.6% 3.2% 5.0%
Flu Syndrome 3.2% 6.4% 5.0%
Pharyngitis 3.2% 1.6% 4.3%
Pain 4.0% 1.2% 4.3%
Dyspepsia 2.0% 0% 4.0%
Infection Dental 4.0% 3.6% 3.8%
Mucus Membrane Disorder 2.4% 0.8% 3.3%

Feel confident knowing that in clinical studies, ARESTIN + SRP provided better results than SRP alone.1*

The change in clinical attachment levels was similar across all study arms, suggesting that neither the vehicle nor ARESTIN compromises clinical attachment.

*Two single-blind, Phase III trials comparing ARESTIN + SRP to SRP alone and SRP + placebo (n=748). SRP was performed for all groups at baseline. ARESTIN or vehicle was administered to periodontal pockets ≥5 mm in the adjunctive therapy groups at baseline, 3 months, and 6 months. Efficacy was evaluated over 9 months.

REFERENCE: 1. ARESTIN® (minocycline hydrochloride) Microspheres, 1 mg. Prescribing Information. OraPharma; Bridgewater, NJ.

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