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.1