Aleve® Demonstrates More Pain Relief Than Acetaminophen for Menstrual Cramps, Study Shows

Bayer Consumer Health Announces New Data at American Academy of Family Physicians' Family Medicine Experience

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Sep 25, 2019, 10:00 ET

WHIPPANY, N.J., Sept. 25, 2019 /PRNewswire/ -- Bayer today announced data demonstrating that a single maximum non-prescription dose of Aleve^® (naproxen sodium) provided more pain relief over 12 hours than acetaminophen for menstrual cramps due to primary dysmenorrhea. The results were presented at the American Academy of Family Physicians (AAFP)'s Family Medicine Experience (FMX) annual meeting.

Aleve^® is an over-the-counter (OTC) pain reliever indicated for temporary relief of minor aches and pains including minor arthritis pain, headache, muscular aches, toothache, and menstrual cramps. Women aged 15 to 35 with at least moderate menstrual pain were randomized to one of two blinded treatment sequences for two cycles – a single dose of Aleve^®440 mg (two 220 mg tablets) crossing over to a single dose of acetaminophen 1000 mg (two 500 mg tablets) or vice versa – and were asked to rate their pain levels over 12 hours during each cycle. From the five-hour mark onward, patients who took Aleve^® reported significantly decreased pain intensity compared to those taking acetaminophen. Aleve^® also outperformed acetaminophen on summed pain intensity difference (SPID) 4 to 6, showing that Aleve^® was more efficacious than acetaminophen over the four to six hour post-dosing period. The 12-hour strength of Aleve^® also gave patients more sustained pain relief per dose than acetaminophen, with fewer patients on Aleve^® needing remedication during the 12 hours of monitoring (p<0.001).

"Over-the-counter pain relievers, such as naproxen sodium and acetaminophen, are safe and effective for treating menstrual pain when used at their recommended doses. In this crossover study, naproxen sodium, found in Aleve^®, provided more pain relief from menstrual cramps for a longer period of time than acetaminophen," said Azita Tajaddini, PhD, Associate Director Medical Affairs, Analgesics, Bayer Consumer Health, who presented the data. "The results show that non-prescription naproxen sodium is an effective alternative to acetaminophen for relieving pain from periods with less frequent need for remedication."

Nearly three-quarters of women experience cramping pain during a menstrual period.¹ The pain usually develops just before the start of menstruation and intensifies as the flow becomes heaviest during the first one to two days of the cycle.^1,2 Menstrual pain can range from a few days of mild discomfort to several days of severe pain that interferes with daily activities.^1,3,4Simple analgesics, such as non-steroidal anti-inflammatory drugs (NSAIDs) like naproxen, have been shown to relieve menstrual pain in up to 70 percent of women.^⁵

"Bayer is pleased to share these data with internists, primary care physicians, and family practitioners who treat this very common problem in some of their female patients," said Dr. Tajaddini. "Patients and healthcare providers may benefit from understanding the differences among the various over-the-counter pain-relief options. The study shows that, over 12 hours, one OTC dose of Aleve^®provides more durable pain relief than acetaminophen for menstrual cramps."

About the Study
The study included 201 adolescent and adult women of childbearing age (mean age of 25 years) who had reported moderate to severe period pain in four of their last six cycles. Patients administered treatment only if they experienced at least moderate pain (>5 on a 0-10-point numerical rating scale [NRS]) at the beginning of their cycle. They used an eDiary to record baseline pain as well as pain relief at 30 minutes and every hour up to 12 hours after treatment. The primary endpoint was patients' 12-hour total pain relief (TOTPAR) scores based on a five-point categorical scale; higher scores indicated greater pain relief. A secondary endpoint measured changes in patients' sum of pain intensity differences (SPID) scores based on an 11-point NRS; positive and higher pain intensity difference (PID) scores indicated greater reduction in pain severity.

The study was sponsored by Bayer. The full study is available in print in the August issue of Current Medical Research and Opinion and online.

Key Results:

12-hour TOTPAR scores for Aleve^®were 4.31 points higher (least squares mean [LS-mean], p<0.001) than those for acetaminophen. The difference in TOTPAR scores between the treatment groups became significant at approximately hour six and was maintained thereafter over 12 hours (p<0.05).
The average pain intensity level for patients at baseline was 7.3±1.46 standard deviation (SD) (range of 5-10 on an 11-point NRS). After 12 hours, SPID scores were higher for Aleve^® versus acetaminophen (LS-mean difference of 9.80; p<0.001). The difference in pain intensity scores between treatments showed significance at hour five and was maintained thereafter over 12 hours (p<0.05) with SPID4-6 significantly higher with Aleve^® (p=0.020).
Aleve^® provided more sustained pain relief than acetaminophen, as fewer patients taking Aleve^® needed to remedicate during the 12 hours post dosing (12 percent vs. 28 percent of acetaminophen-treated patients).
For each dosing cycle, patients rated their satisfaction with treatment at 12 hours post dosing or immediately before their first remedication, if necessary. Significantly more patients rated Aleve^® as good-to-excellent at relieving pain in each menstrual cycle compared to patients taking acetaminophen (71 percent vs. 63 percent, p=0.002).

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2018, the Group employed around 117,000 people and had sales of 39.6 billion euros. Capital expenditures amounted to 2.6 billion euros, R&D expenses to 5.2 billion euros. For more information, go to www.bayer.com.

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Media Contact:
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¹ Marjoribanks J, Ayeleke RO, Farquhar C, et al. Nonsteroidal anti-inflammatory drugs for dysmenorrhoea. Cochrane Database Syst Rev. 2015, Issue 7. Art. No.: CD001751. DOI: 10.1002/14651858.CD001751.pub3.
^²Deligeoroglou E. Dysmenorrhea. Ann N Y Acad Sci.2000;900:237-244.
^³ Iacovides S, Avidon I, Baker FC. What we know about primary dysmenorrhea today: a critical review. Hum Reprod Update. 2015;21:762-778.
⁴ Daniels SE, Paredes-Diaz A, An R, et al. Significant, long-lasting pain relief in primary dysmenorrhea with low-dose naproxen sodium compared with acetaminophen: a double-blind, randomized, single-dose, crossover study. Curr Med Res Opin. 2019. DOI: 10.1080/03007995.2019.1654987.
^⁵ Proctor M, Farquhar C. Diagnosis and management of dysmenorrhea. BMJ. 2006;332(13):1134-1138.