Dentaltown March 2022 - 18

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In a new, single-dose study, Aleve®
was proven
as strong* as HYD+APAP for dental pain1
* In hours 0 to 4 of a single-dose dental study of Aleve® (440 mg), HYD+APAP (10 mg + 650 mg), or placebo.
Aleve® is an OTC pain reliever indicated for temporary relief of minor aches and pains including arthritis pain,
headache, muscular aches, and toothache.2
Learn how non-addictive OTC NSAIDs like Aleve®
can help you reduce risk factors that contribute to
the US opioid crisis1,3,4
Did you know that up to half of opioid prescriptions at dental
visits are inconsistent with the guidelines on appropriate use
of opioids?4
In response to the overuse of opioids, there is an
increasing interest in the effectiveness of OTC NSAIDs in
alleviating pain-to reduce the need for opioids. Growing
evidence supports Aleve® as a powerful* non-opioid OTC
treatment for minor dental pain.1,2,5,6
In the study, Aleve® was as
effective* for dental pain, lasted
longer, and was better tolerated
vs a widely prescribed opioid
combination, HYD+APAP1
In a recent single-center, randomized, double-blind,
parallel, placebo-controlled study, Aleve®, a non-opioid
OTC NSAID, was compared with hydrocodone plus
acetaminophen (HYD+APAP) for dental pain relief1
* Patients experiencing moderate or severe pain (N=221) after
surgical removal of impacted third molars were randomized
to receive either a single dose of Aleve® (440 mg [n=90]),
HYD+APAP (10 mg + 650 mg [n=87]), or placebo (n=44)1
* The primary objective was to compare Sum of Pain Intensity
Difference from 0 to 12 hours (SPID0-12
- Secondary objectives were to compare the total pain
relief (TOTPAR) over 6 and 12 hours (SPID0-6
), time to onset
of pain relief, time to first use of rescue medication, and
duration of pain intensity at least half gone over 6 and
12 hours1
- SPID0-4
was also assessed
Aleve® was as effective as HYD+APAP in hours 0 to 4 at
reducing pain intensity (based on SPID from 0 to 4 hours,
or SPID0-4
).1
The primary endpoint was met1
* SPID0-12 was statistically significant for Aleve® vs HYD+APAP1
) after a single oral dose
RESCUE MEDICATION FROM HOUR 3 ONWARD1
0.0
0.2
0.4
0.6
0.8
1.0
2
4
6
Time (Hours)
NapS
HYD+APAP
Placebo
70%
50%
20%
8
10
12
Key secondary endpoints also showed statistical
significance in favor of Aleve® compared with
HYD+APAP1
:
* Total pain relief (0 to 6 and 0 to 12 hours; P<0.05)1
* Median time to rescue medication (P<0.001)1
* Duration of pain at least half gone over 12 hours (P<0.001)1
Both active treatments were significantly more effective
than placebo.1
HYD+APAP was not statistically superior to
Aleve® for any endpoint (NapS 440 mg vs HYD+APAP
10 mg + 650 mg).1
MEAN PAIN INTENSITY DIFFERENCE1
10
8
6
4
2
0 1 2 3 4 5 6 7 8 9 10 11 12
Time (Hours)
NapS 440 mg (n=86)
HYD+APAP 10 mg + 650 mg (n=83)
Placebo (n=43)
In the study, Aleve® was also better tolerated
than HYD+APAP1
More treatment-related adverse events were reported with
HYD+APAP (n=18) than Aleve® (n=1) and placebo (n=1),
including nausea, vomiting, and dizziness.1
Probability of First Use of
Rescue Medication
Mean Pain Intensity
Difference
Dentaltown March 2022

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