Editorials

New Contraceptive Options: Patient Adherence and Satisfaction

LAURA B. HANSEN, PHARM.D.
JOSEPH J. SASEEN, PHARM.D.
University of Colorado Health Sciences Center Denver, Colorado

See article on page 853.

More than 10 million women in the United States use oral contraceptive pills (OCPs) to prevent pregnancy.¹ However, OCPs have a 6 percent failure rate within the first year.¹ Data^1-4 have shown that unintended pregnancy with this method of contraception often is related to incorrect or inconsistent use, side effects, or patient dissatisfaction. Adolescents are less likely than adult women to adhere to OCP regimens, and only 12 percent of adolescents continue OCP use beyond one year.⁵ It is clear that patient adherence and satisfaction are critically important for effective contraception. Recently introduced contraceptive options should improve both of these factors.

In this issue of American Family Physician, Herndon and Zieman⁶ review newer contraceptive methods, including the combined hormonal vaginal ring (NuvaRing), combined hormonal injection, combination contraceptive patch (Ortho Evra), and levonorgestrel intrauterine system (Mirena). These contraceptive methods have approximately the same efficacy and safety as OCPs, but they use delivery systems that have been designed to encourage adherence and improve patient acceptability.

The vaginal ring provides once-a-month contraception, with one cycle consisting of three weeks of ring use and one ring-free week. This contraceptive method avoids first-pass metabolism and gastrointestinal interference, thereby allowing use of lower hormone doses. The vaginal ring also provides more uniform hormone concentrations than OCPs. In a study⁷ evaluating user acceptability in North America and Europe, 96 percent of women stated that they were satisfied with the vaginal ring, and 97 percent indicated that they would recommend this method of contraception to a friend. Reasons for preferring the vaginal ring included not having to remember daily dosing, ease of use, and effectiveness of contraception. More than 90 percent of the women in the study thought that the instructions for vaginal ring use and storage were simple, and 93 percent were pleased with cycle control. In the small number of women who disliked or discontinued using the vaginal ring, primary reasons were interference with intercourse and ring expulsion. Previous worldwide studies^8,9 support these findings, with most women considering the vaginal ring easy to use, effective, and convenient. The vaginal ring has not been directly compared with OCPs for adherence, but it seems logical that adherence would improve with a once-monthly contraceptive method that has straightforward instructions for use.

The combined hormonal injection provides monthly contraception without the need to take a pill or insert and remove a device. The injection is administered every 28 to 30 days and supplies a steady concentration of hormones.¹⁰ Compared with women who use triphasic combined OCPs, women who use the hormonal injection report more discomfort but less interference with daily and social activities.¹¹ Interestingly, only 60 percent of injection users and approximately 80 percent of OCP users planned to continue their method, but more than 90 percent of the women indicated that they would recommend their respective contraceptive method to a friend.¹¹ The combined hormonal injection appears to have a niche, in that it eliminates daily adherence and the use of a device or medication; however, treatment burden may be increased because of the need for monthly office visits. Furthermore, the hormonal injection, marketed as Lunelle, currently is not available. Prefilled syringes were voluntarily recalled in October, 2002, by the manufacturer because of concerns about full potency resulting in an increased risk of contraceptive failure. Vials of the injection were not affected by this recall but became unavailable in October, 2003. The status of future availability is unknown.

Randomized controlled trials^12,13 comparing the contraceptive patch with a combination OCP have demonstrated similar efficacy rates, higher early discontinuation rates, and increased side effects (breast tenderness, application site reactions, dysmenorrhea) with use of the patch. Contraceptive patch users report more cycles of adherence than OCP users (odds ratio, 2.1; 95 percent confidence interval, 1.8 to 2.3); furthermore, age does not affect compliance among women 18 to 45 years of age.¹⁴ Complete or partial patch detachment is rare (5 percent incidence), and replacement patches are readily accessible. It should be noted that the efficacy rate for the patch may be lower in patients who weigh more than 90 kg (198 lb), but OCP failure has been reported in women weighing 70.5 kg (155 lb) or more.¹⁵ The contraceptive patch provides once-weekly dosing (to improve compliance), avoids first-pass metabolism, and provides consistent hormone concentrations. However, patch use requires reliable skin adhesion, even in active lifestyle conditions.

The acceptability of the levonorgestrel intrauterine system has been studied in numerous countries (e.g., Austria, Finland, Brazil, France).^16-19 Women who choose this method of contraception tend to be older, to desire long-term contraception, or to have been dissatisfied with a different form of contraception. This contraceptive method is effective and safe, and is associated with decreased blood loss in women with menorrhagia. Compared with other intrauterine devices, the levonorgestrel intrauterine system is better tolerated, although use may be discontinued because of hormone-related side effects (e.g., mood changes, acne, headaches, weight gain). Adherence is high because there is no user involvement once the device is inserted; patient satisfaction increases when detailed information is provided at the insertion visit.¹⁷ The longest acceptability study to date found that 69 percent of women were very satisfied with this contraceptive method after six months of use and 77 percent were very satisfied after 36 months of use.¹⁶ The levonorgestrel intrauterine system is well accepted and is appropriate for use in women who desire long-term, reversible contraception.

The effectiveness of any contraceptive depends on the ability and willingness of the user to comply with the chosen method. The newer contraceptive methods have not yet been evaluated in adolescents. It is rational to assume that these contraceptive methods can improve unintended pregnancy rates in adolescents, although access and affordability may be problems.

The accompanying table^20-24 summarizes the newer contraceptive methods. When determining whether a newer option is better than a traditional contraceptive method, patient characteristics and contraceptive benefits and risks must be evaluated.

Characteristics of New Contraceptive Options Contraceptive method Failure rate Side effects Office visits Easily reversible Dosing User controlled Discreet Combined hormonal vaginal ring (NuvaRing) One to two pregnancies per 100 women-years21 Estrogen and progestin related Yes (prescription) Yes Every 4 weeks Yes Yes Combination hormonal injection* < 1% per year22 Estrogen and progestin related Yes (monthly) Yes Monthly No Yes Combination contraceptive patch (Ortho Evra) One pregnancy per 100 women-years23 Estrogen and progestin related Yes (prescription) Yes Weekly Yes Maybe Levonorgestrel intrauterine system (Mirena) 0.2% per year, or 0.7% per 5 years24 Progestin related Yes (insertion) Yes Every 5 years No Yes *--The combined hormonal injection marketed as Lunelle is no longer being manufactured in the United States. Adapted with permission from Wild RA. Contraception now: new options, better choices. Slide no. 7. Accessed January 23, 2004, at http://www.contraceptiononline.org/slides/, with additional information from references 21 through 24.

REFERENCES

1. Contraceptive use. New York, N.Y.: Alan Guttmacher Institute, 1998. Accessed January 22, 2004, at: from http://www.agi-usa.org/pubs/fb_contr_use.pdf.
2. Rosenberg MJ, Waugh MS, Meehan TE. Use and misuse of oral contraceptives: risk indicators for poor pill taking and discontinuation. Contraception 1995;51:283-8.
3. Rosenberg MJ, Waugh MS. Oral contraceptive discontinuation: a prospective evaluation of frequency and reasons. Am J Obstet Gynecol 1998;179(3 pt 1):577-82.
4. Rosenberg MJ, Burnhill MS, Waugh MS, Grimes DA, Hillard PJ. Compliance and oral contraceptives: a review. Contraception 1995;52:137-41.
5. Zibners A, Cromer BA, Hayes J. Comparison of continuation rates for hormonal contraception among adolescents. J Ped Adolesc Gynecol 1999; 12:90-4.
6. Herndon EJ, Zieman M. New contraceptive options. Am Fam Physician 2004;69:853-60.
7. Novak A, de la Loge C, Abetz L, van der Meulen EA. The combined contraceptive vaginal ring, NuvaRing: an international study of user acceptability. Contraception 2003;67:187-94.
8. Roumen FJ, Apter D, Mulders TM, Dieben TO. Efficacy, tolerability and acceptability of a novel contraceptive vaginal ring releasing etonogestrel and ethinyl oestradiol. Hum Reprod 2001;16:469-75.
9. Szarewski A. High acceptability and satisfaction with NuvaRing use. Eur J Contracept Reprod Health Care 2002;7(suppl 2):31-6.
10. Rahimy MH, Ryan KK, Hopkins NK. Lunelle monthly contraceptive injection (medroxyprogesterone acetate and estradiol cypionate injectable suspension): steady-state pharmacokinetics of MPA and E2 in surgically sterile women. Contraception 1999;60:209-14.
11. Shulman LP, OleenBurkey M, Wilke RJ. Patient acceptability and satisfaction with Lunelle monthly contraceptive injection (medroxyprogesterone acetate and estradiol cypionate injectable suspension). Contraception 1999;60:215-22.
12. Audet MC, Moreau M, Koltun WD, Waldbaum AS, Shangold G, Fisher AC, et al. Evaluation of contraceptive efficacy and cycle control of a transdermal contraceptive patch vs an oral contraceptive: a randomized controlled trial. JAMA 2001;285:2347-54.
13. Dittrich R, Parker L, Rosen JB, Shangold G, Creasy GW, Fisher AC. Ortho Evra/Evra 001 Study Group. Transdermal contraception: evaluation of three transdermal norelgestromin/ethinyl estradiol doses in a randomized, multicenter, dose-response study. Am J Obstet Gynecol 2002;186:15-20.
14. Archer DF, Bigrigg A, Smallwood GH, Shangold GA, Creasy GW, Fisher AC. Assessment of compliance with a weekly contraceptive patch (Ortho Evra/Evra) among North American women. Fertil Steril 2002;77(2 suppl 2):S27-31.
15. Holt VL, Cushing-Haugen KL, Daling JR. Body weight and risk of oral contraceptive failure. Obstet Gynecol 2002;99(5 pt 1):820-7.
16. Baldaszti E, Wimmer-Puchinger B, Loschke K. Acceptability of the long-term contraceptive levonorgestrel-releasing intrauterine system (Mirena): a 3-year follow-up study. Contraception 2003; 67:87-91.
17. Backman T, Huhtala S, Luoto R, Tuominen J, Rauramo I, Koskenvuo M. Advance information improves user satisfaction with the levonorgestrel intrauterine system. Obstet Gynecol 2002;99:608-13.
18. Dubuisson JB, Mugnier E. Acceptability of the levonorgestrel-releasing intrauterine system after discontinuation of previous contraception: results of a French clinical study in women aged 35 to 45 years. Contraception 2002;66:121-8.
19. Diaz J, Bahamondes L, Monteiro I, Petta C, Hildago MM, Arce XE. Acceptability and performance of a levonorgestrel-releasing intrauterine system (Mirena) in Campinas, Brazil. Contraception 2000; 62:59-61.
20. Wild RA. Contraception now: new options, better choices. Slide no. 7. Accessed: January 23, 2004, at: http://www.contraceptiononline.org/slides/.
21. NuvaRing [Package insert]. West Orange, N.J.: Organon Inc., 2001.
22. Lunelle [Package insert]. Kalamazoo, Mich.: Pharmacia & Upjohn Company, 2001.
23. Ortho Evra [Package insert]. Raritan, N.J.: Ortho-McNeill Pharmaceutical, Inc., 2003.
24. Mirena [Package insert]. Berlex Laboratories, Inc., 2000.

Physical Activity Goals for Sedentary Patients

LORI MOSCA, M.D., M.P.H., PH.D.
New York-Presbyterian Hospital
New York, New York

RONALD MCKECHNIE, M.D.
University of Michigan
Ann Arbor, Michigan

Fewer active persons develop coronary heart disease (CHD) than those who are sedentary, and the beneficial effects of exercise on risk factors for CHD are well documented.¹ Despite this, inactive lifestyles and overeating remain the norm for most Americans, as illustrated by the rising epidemic of obesity over the past three decades.² In response to this situation, the Institute of Medicine recently raised the bar for sedentary Americans, suggesting that we all engage in at least 60 cumulative minutes of moderate-intensity physical activity on most, and preferably all, days of the week rather than the 30 minutes suggested by other organizations.^3-6 Besides restricting calorie intake and portion size based on each person's height, weight, and gender, increasing the cumulative duration of daily activity to 60 minutes could help reduce the risk of several chronic diseases and premature mortality.

The added benefit of increasing daily physical activity is supported by prospective data showing a graded benefit of brisk walking for more than an average of 30 minutes daily (i.e., for those walking at least three hours per week).^7,8 The new recommendations suggest that 60 minutes of continuous daily activity is not necessary to derive benefit, but that the accumulated amount can be spread over a given day from several shorter episodes. For example, in one study,⁹ similar cardiovascular risk reduction was achieved when comparing longer versus shorter durations spent on each episode of daily exercise after accounting for a person's average weekly amount of expended energy. Initiation of a lifestyle change that includes a structured dietary approach and an episode of low-to-moderate physical activity 5 to 10 minutes a day (above a patient's baseline sedentary level) could establish modest risk reductions if ultimately ramped up to the goal of 60 cumulative minutes.

Several strategies can be used to help patients achieve the new physical activity recommendations. For example, use of a stationary bicycle for 20 to 30 minutes daily could be combined with household and occupational activities, such as walking up and down stairs once a day at work, an hour of weekly housework, and gardening for an hour per week. The accompanying table lists other activities that could be performed to achieve these goals.¹⁰ Note that vigorous activities are not necessary to achieve the recommended amount of physical activity, and that patients may be more compliant with lower intensity activities that they perceive as enjoyable.

Despite the apparent simplicity of the new recommendations, initiative and commitment from the patient are required to increase physical activity to 60 minutes daily and to maintain at that level. Starting with small, achievable steps can facilitate the adoption of the new national recommendations for physical activity and nutrition to promote health.

An initial step on the pathway to improved compliance with the new lifestyle recommendations is raising awareness about a patient's current actual level of physical activity versus the recommended level.

Active Alternatives for Sedentary Patients Sedentary Active alternative Desk work or watching television, seated (1 to 2 METs) Using foot pedals while seated (3 METs) Riding escalator, standing (2 METs) Walking upstairs (4 METs) Driving to work (1 to 2 METs) Standing on a moving walkway (2 METs) Walking 3 miles per hour (3 to 4 METs) Cutting lawn using riding lawnmower (2 to 3 METs) Cutting lawn using push lawn mower (3 to 5 METs) Golfing, riding in cart (2 to 3 METs) Golfing, carrying clubs (4 to 5 METs) Washing car, sitting in drive-through car wash (1 to 2 METs) Washing car by hand (6 to 7 METs) Sitting, limited mobility (1 to 2 METs) Swimming slowly (4 to 5 METs) Wheelchair, sitting (1 to 2 METs) Wheelchair, wheeling (3 to 4 METs) Lying down, sunbathing (1 to 2 METs) Canoeing, leisurely pace (2 to 3 METs) MET = metabolic equivalent, or one unit of sitting/resting oxygen uptake. Information from reference 10.

REFERENCES

1. McKechnie RS, Mosca L. Physical activity and coronary heart disease: prevention and effect on risk factors. Cardiol Rev 2003;11:21-5.
2. Mokdad AH, Borman BA, Ford ES, Vinicor F, Marks JS, Kaplan JP. The continuing epidemics of obesity and diabetes in the United States. JAMA 2001; 286:1195-200.
3. Dietary reference intakes for energy, carbohydrates, fiber, fat, protein and amino acids (macronutrients). The Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, Food and Nutrition Board. Accessed January 22, 2004, at: http://nap.edu/books/0309085373/html. National Academies' Institute of Medicine 2002: 697-736.
4. U.S. Department of Health and Human Services. Physical activity and health: a report of the surgeon general. Atlanta, Ga.: Dept. of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, 1996.
5. Pate RR, Pratt M, Blair SN, Haskell WL, Macera CA, Bouchard C, et al. Physical activity and public health: a recommendation from the Centers for Disease Control and Prevention and the American College of Sports Medicine. JAMA 1995;273(5): 402-7.
6. NIH Consensus Development Panel on Physical Activity and Cardiovascular Health. Physical activity and cardiovascular health. JAMA 1996;276: 241-6.
7. Manson JE, Hu FB, Rish-Edwards JW, Colditz GA, Stampfer MJ, Willett WC, et al. A prospective study of walking as compared with vigorous exercise in the prevention of coronary heart disease in women. N Engl J Med 1999;341:650-8.
8. Manson JE, Greenland P, LaCroix AZ, Stefanick ML, Mouton CP, Oberman A, et al. Walking compared with vigorous exercise for the prevention of cardiovascular events in women. N Engl J Med 2002;347: 716-25.
9. Lee I, Sesso HD, Paffenbarger RS Jr. Physical activity and coronary heart disease risk in men: does the duration of exercise episodes predict risk? Circulation 2000;102:981-6.
10. Fletcher GF, Balady GJ, Amsterdam EA, Chaitman B, Eckel R, Fleg J, et al. Exercise standards for testing and training. A statement for healthcare professionals from the American Heart Association. Circulation 2001;104:1694-740.

Laura B. Hansen, Pharm.D., is a board-certified pharmacotherapy specialist and assistant professor in the Department of Clinical Pharmacy and the Department of Family Medicine at the University of Colorado Health Sciences Center, Denver.

Joseph J. Saseen, Pharm.D., is a board-certified pharmacotherapy specialist and associate professor in the Department of Clinical Pharmacy and the Department of Family Medicine at the University of Colorado Health Sciences Center.

Address correspondence to Laura B. Hansen, Pharm.D., University of Colorado Health Sciences Center, 4200 E. 9th Ave., Box C238, Denver, CO 80262 (e-mail: laura.hansen@uchsc.edu). Reprints are not available from the authors.