An approach to postmenopausal osteoporosis treatment: a case study review

PURPOSE: To review and discuss the clinical evaluation and therapeutic options for a postmenopausal woman with osteoporosis. DATA SOURCES: Review of scientific literature, practice guidelines, and a case study. CONCLUSIONS: To prevent and treat postmenopausal osteoporosis, women should be encouraged to perform weight-bearing exercise, to not smoke, and to optimize calcium and vitamin D intake through diet and supplements. Drug regimens are effective and well tolerated in postmenopausal women with osteoporosis. IMPLICATIONS FOR PRACTICE: Drugs currently approved by the U.S. Food and Drug Administration for the treatment of postmenopausal osteoporosis include the bisphosphonates risedronate and alendronate; the selective estrogen receptor modulator, raloxifene; and intranasal calcitonin-salmon spray. Bisphosphonates have demonstrated the most impressive fracture risk reduction in prospective clinical trials of women with postmenopausal osteoporosis. Risedronate has consistently demonstrated significant reductions in vertebral fracture risk at 1 year and in vertebral and nonvertebral fracture risk at 3 years. Alendronate has demonstrated significant reductions in vertebral and nonvertebral fracture risk after 3 years.     

The impact of estrogen replacement therapy and raloxifene on osteoporosis, cardiovascular disease, and gynecologic cancers

OBJECTIVE: To compare the clinical utility of estrogen replacement therapy (ERT) and raloxifene in osteoporosis and cardiovascular disease in postmenopausal women and to evaluate the contrasting adverse effects of these therapies. DATA SOURCES: A MEDLINE search was performed for January 1980 through September 1998 using the key terms raloxifene, estrogen, CVD, lipoproteins, and osteoporosis. STUDY SELECTION AND DATA EXTRACTION: All clinical studies assessing ERT and raloxifene in cardiovascular disease or osteoporosis were evaluated. DATA SYNTHESIS: ERT remains the standard for prevention and treatment of osteoporosis in women. Its use increases total bone mineral density (BMD) up to 12.1% and reduces hip fracture risk by 66-73%. It reduces low-density lipoprotein (LDL) cholesterol by 15-19% and increases high-density lipoprotein (HDL) cholesterol by 6-18%. Raloxifene, an alternative to ERT in the prevention of osteoporosis, increases total BMD by 2.2%. It reduces LDL by 6.2-14.1% and increases HDL by 1.5-5.7%. Preliminary data suggest that raloxifene has contrasting effects on gynecologic cancers compared with the increased risk posed by ERT. CONCLUSIONS: Clinical trials have illustrated greater effects on BMD with ERT than with raloxifene. Studies of significant duration assessing raloxifene and its fracture risk effects are lacking. ERT appears to have greater beneficial cardiovascular risk factor effects than raloxifene. Prospective, primary prevention studies evaluating overall cardiovascular risk reduction do not exist for either intervention. Raloxifene, while more costly, is an alternative that may have a lower associated risk of breast cancer compared with ERT.     

Analgesic efficacy of calcitonin for vertebral fracture pain

OBJECTIVE: To evaluate the analgesic efficacy of calcitonin for treating the pain of vertebral fractures associated with osteoporosis. DATA SOURCES: Searches of MEDLINE (1966-July 2002), Cochrane Library, International Pharmaceutical Abstracts (1977-July 2002), and an extensive manual review of journals were performed using the key search terms calcitonin, analgesic, osteoporosis, vertebral fracture, and pain. STUDY SELECTION AND DATA EXTRACTION: All articles identified from the data sources were evaluated and all information deemed relevant was included for this review. DATA SYNTHESIS: Fractures, especially vertebral fractures, are a common complication of osteoporosis, leading to significant pain. Calcitonin has been studied for its analgesic properties. Fourteen double-blind, placebo-controlled trials that evaluated the analgesic efficacy of calcitonin for osteoporosis-related vertebral fracture pain were identified and reviewed. Thirteen of these studies demonstrated statistically significant improvement in pain or function in calcitonin-treated patients. CONCLUSIONS: Calcitonin has proven efficacy in acute pain associated with osteoporosis-related vertebral fractures. Analgesic effects are seen with intranasal, parenteral, and rectal administration. Future studies comparing calcitonin with other commonly used analgesics are needed to more clearly define its place in therapy.     

Hip fracture prevention. Drug therapies and lifestyle modifications that can reduce risk

The annual number of hip fractures sustained worldwide is expected to increase dramatically as the population ages. Adequate calcium and vitamin D intake and exercise are fundamental to any program for bone loss prevention or osteoporosis treatment. Fall prevention programs, weight-bearing and resistance exercise, hip protector use, and calcium and vitamin D supplementation can reduce hip fracture risk. Among the available antiosteoporosis agents, the bisphosphonates risedronate and alendronate have produced the greatest reductions in hip fracture risk in postmenopausal women. Nasal calcitonin and raloxifene have not demonstrated significant reductions in nonvertebral or hip fracture risk. The role of parathyroid hormone (1-34) in the treatment of hip fractures remains uncertain until more experience is gained about its use and studies with sufficient statistical power are performed. Data indicate that bisphosphonates consistently reduce hip fracture risk in patients with osteoporosis, especially those with an existing vertebral fracture. In addition to pharmacologic intervention, adequate nonpharmacologic preventive strategies should be included to ensure maximal reduction in risk of hip fracture.     

Pharmacologic and nonpharmacologic management of osteoporosis

Fractures that occur as a result of osteoporosis are associated with significant morbidity, mortality, and cost. A treatment regimen consisting of both nonpharmacologic and pharmacologic interventions can be used to decrease the risk of fracture. Nonpharmacologic interventions include calcium and vitamin D supplementation, weight-bearing exercise, muscle strengthening, and fall prevention. Pharmacologic options include: the bisphosphonates, estrogen therapy, raloxifene, salmon calcitonin, and the anabolic agent teriparatide. Although bone mineral density is used clinically to diagnose osteoporosis, it is of limited value when evaluating pharmacologic treatment; the primary indicator of treatment efficacy is fracture risk reduction. The bisphosphonates are the preferred therapy for osteoporosis. Studies have demonstrated that in postmenopausal women, both risedronate and alendronate are associated with reductions in vertebral and nonvertebral fracture risk. The newest approved bisphosphonate, ibandronate, reduces vertebral fracture risk. Studies also support a reduction in fracture risk when alendronate and risedronate are used in men with osteoporosis and patients with corticosteroid-induced osteoporosis. When used appropriately, the bisphosphonates are well tolerated. Estrogen and raloxifene decrease fracture risk in postmenopausal women with osteoporosis but are associated with thromboembolic events. Use of estrogen therapy is also limited by concerns about the safety of this type of therapy. Although the anabolic agent teriparatide is associated with reductions in vertebral and nonvertebral fractures, its use has been limited by the necessity of subcutaneous administration and its cost relative to other agents. Regardless of which treatment regimen is selected, health care providers need to emphasize the importance of compliance and adherence to improve persistence with therapy, and subsequent fracture reduction efficacy.     

Secondary prevention of osteoporosis: when should a non-vertebral fracture be a trigger for action?

The burden of non-vertebral fractures is enormous. Hip fractures account for nearly 10% of all fractures (and a much greater proportion in the elderly), while wrist fractures may account for up to 23% of all limb fractures. The best available predictors of non-vertebral fracture risk are low BMD and a tendency to fall. Hip, forearm, proximal humerus and rib fractures have all been associated with low BMD, though ankle fracture is not strongly related to osteoporosis. Although clinical risk factors identify only about one-third of postmenopausal women at increased risk of osteoporotic fracture, the occurrence of one fracture commonly predicts a second fracture. Guidelines are presented for identifying and treating patients at risk of non-vertebral osteoporotic fractures, especially those with a previous fracture, based on the algorithm recently published by the Royal College of Physicians and the Bone and Tooth Society. Prevention of falls and use of external hip protectors may reduce the occurrence of hip fracture. Treatment options for patients presenting with hip fracture include HRT, bisphosphonates, and calcium plus vitamin D, and for Colles' fracture include general measures, HRT, bisphosphonates, or calcitonin plus calcium.     

Review of treatment modalities for postmenopausal osteoporosis

This review summarizes and updates data presented at recent annual Southern Medical Association conferences on postmenopausal osteoporosis. As part of any osteoporosis treatment program, it is important to maintain adequate calcium and 25-hydroxyvitamin D levels either through diet or supplementation. Among the available pharmacologic therapies, the bisphosphonates alendronate and risedronate have demonstrated the most robust fracture risk reductions-approximately 40 to 50% reduction in vertebral fracture risk, 30 to 40% in nonvertebral fracture risk, and 40 to 60% in hip fracture risk. Ibandronate, a new bisphosphonate, has demonstrated efficacy in reducing vertebral fracture risk. Salmon calcitonin nasal spray and raloxifene demonstrated significant reductions in vertebral fracture risk in pivotal studies. Teriparatide significantly reduced vertebral and nonvertebral fracture risk. Drugs on the horizon include strontium ranelate, which has been shown to reduce vertebral and nonvertebral fracture risk, and zoledronic acid, an injectable bisphosphonate that increased bone density with once-yearly administration.     

Etidronate and alendronate in the treatment of postmenopausal osteoporosis.

OBJECTIVE: To review the clinical trials evaluating the efficacy of etidronate and alendronate in the treatment of established postmenopausal osteoporosis. DATA SOURCE: A MEDLINE search was performed (from 1966 through September 1998) using the search terms bisphosphonates, etidronate, alendronate, and postmenopausal osteoporosis. English-language articles were considered for review. STUDY SELECTION AND DATA EXTRACTION: Prospective, randomized, double-blind, placebo-controlled clinical trials using fracture as an end point were selected to review the efficacy of etidronate and alendronate in the treatment of postmenopausal osteoporosis. Results for the outcomes of bone mineral density (BMD) and fracture are summarized. DATA SYNTHESIS: Etidronate and alendronate increase spinal BMD in postmenopausal women with osteoporosis. In one study, etidronate decreased the number of women sustaining new radiographic vertebral fractures over two years, but this effect was lost after three years of treatment. Alendronate reduces the number of radiographic vertebral fractures in postmenopausal women with a low bone mass. In women with preexisting fractures, alendronate decreases the number of patients with radiographic vertebral fractures, clinical (i.e., symptomatic vertebral and nonvertebral) fractures, and hip fractures. A significant reduction in the overall number of nonvertebral fractures has not been demonstrated in clinical trials evaluating either alendronate or etidronate. CONCLUSIONS: No studies have directly compared the efficacy of alendronate and etidronate and the results of long-term clinical trials (i.e., >5 y) have not been published. Based on the results obtained in clinical trials using fracture as an end point, alendronate appears to be the bisphosphonate of choice. Safety profiles and cost should also be considered in the choice of etidronate or alendronate for the treatment of postmenopausal osteoporosis.     

骨质疏松症患者激素替代治疗的临床证据

目的评估绝经后骨质疏松症激素替代治疗的有效性。方法计算机检索Cochrane Library（2008年第4期）、MEDLINE（1978～2008）、Clinical Evidence中有关的系统评价和Meta分析。检索词为postmenopausal（post-menopausal）osteoporosis、therapy、vertebral fracture、hormone replacement therapy、randomized controlled trial、meta-analysis、female、human。结果在Cochrane Library共检索到4篇研究方案和9篇系统评价全文,在MEDLINE检索到1篇Meta分析。结果表明,采用激素替代治疗（HRT）后,骨皮质和骨松质的骨密度（BMD）均明显增加,椎体和非椎体骨折的发生率有下降趋势。结论激素替代治疗能增加骨密度,预防骨质疏松性骨折的发生。但患者在获得骨密度增加的同时其他疾病和不良事件风险增加,因此在进行激素替代治疗前应从多方面权衡得失。     

How can osteoporosis patients benefit more from their therapy? Adherence issues with bisphosphonate therapy

OBJECTIVE: To review the evidence on adherence with bisphosphonates and evolving dosing strategies for osteoporosis treatment. DATA SOURCES: Articles were identified by searching MEDLINE (1975-December 2005) using the following terms: osteoporosis, postmenopausal, fracture, adherence, compliance, persistence, drug therapy, bisphosphonates, alendronate, risedronate, ibandronate, and zoledronate. Additional data included bibliographies from identified articles. STUDY SELECTION AND DATA EXTRACTION: All pertinent English-language articles that discussed adherence issues in patients with osteoporosis were included. Both those that reviewed overall issues of medication adherence in osteoporosis and those that focused specifically on adherence to bisphosphonates were included, as were articles that addressed strategies for overcoming nonadherence. DATA SYNTHESIS: Inadequate diagnosis and treatment of osteoporosis result in a higher risk of fractures than is necessary. Even patients who are diagnosed and beginning treatment often do not persist with their osteoporosis medication because they perceive their fracture risk to be low and, given the asymptomatic nature of osteoporosis, do not experience the benefit of symptom reduction after taking the drugs. Factors that affect adherence to osteoporosis therapy include drug costs, adverse effects, dosing frequency, disease education, patient follow-up, and patient involvement in treatment decisions. CONCLUSIONS: By considering and implementing strategies that can improve adherence and persistence, primary care providers and pharmacists (via counseling) may enhance long-term outcomes for patients with osteoporosis.     

Prevention and treatment of osteoporosis in women with breast cancer

Women who have had breast cancer may be at higher risk for osteoporosis than other women. First, they are more likely to undergo early menopause, due to chemotherapy-induced ovarian failure or oopherectomy. In addition, chemotherapy may have a direct adverse effect on bone mineral density (BMD), and osteoclastic activity may increase from the breast cancer itself. While estrogen therapy is considered standard for the prevention and treatment of osteoporosis, use of estrogen in women with a history of breast cancer is usually contraindicated. The approach to osteoporosis in women with breast cancer is also affected by the use of tamoxifen in many, as this drug appears to have opposite effects on BMD in premenopausal and postmenopausal women. We have reviewed therapeutic alternatives for the prevention and treatment of osteoporosis, focusing on patients with a history of breast cancer. Alendronate and raloxifene are currently approved in the United States for the prevention of osteoporosis; alendronate, raloxifene, and calcitonin are approved for treatment. Alendronate has the greatest positive effect on BMD and reduces the incidence of vertebral and nonvertebral fractures. Raloxifene and calcitonin appear to reduce the incidence of vertebral fractures; their effects on the incidence of nonvertebral fractures are not yet proven. Although no published studies specifically address the use of these approved agents for osteoporosis in women with breast cancer, understanding their relative effects on BMD in postmenopausal women in general will facilitate therapy selection in this population. Postmenopausal women with a history of breast cancer should undergo bone mineral analysis. Normal results and absence of other risk factors ensure that calcium and vitamin D intake are adequate. If osteopenia or other risk factors are present, preventive therapy with alendronate or raloxifene should be considered. For osteoporosis, treatment with alendronate should be strongly considered. Raloxifene and calcitonin are alternatives when alendronate is contraindicated. Further studies are needed to evaluate the optimal timing of initial bone mineral analysis in premenopausal women after breast cancer diagnosis and to determine the value of preventive treatment in women scheduled to undergo chemotherapy.     

Is treatment of early postmenopausal women with bisphosphonates justified?

The decision to treat women in the early postmenopausal period has come under scrutiny because of the low occurrence of fractures in this population and the possible lack of cost-effectiveness for individual patients. This article focuses on the potential use of bisphosphonates for the prevention and treatment of osteoporosis in the early postmenopausal period. Studies have determined that there is a relationship between bisphosphonate treatment and bone mineral density (BMD) gains, even in women in the early postmenopausal period without a diagnosis of osteoporosis. These patients receive benefit from treatment, including improvements in BMD levels and fracture protection. Using BMD scores, rates of bone turnover, and risk-based diagnostic criteria as part of the decision to initiate therapy may allow for the identification of an early postmenopausal patient population that would benefit from preventative therapy. This would improve the cost-effectiveness of using bisphosphonates for the prevention of osteoporosis in this population. The evaluation of women at risk for developing osteoporosis should include an assessment of both BMD scores and additional risk factors. Early postmenopausal women who are in a high-risk group should be considered candidates to receive bisphosphonate therapy.     

Estrogen, SERM

Osteoporosis is uncommon before menopause and dramatically increases in prevalence thereafter. That is why estrogens provide protection against osteoporosis. Studies of women receiving estrogen replacement have demonstrated improvements in bone mineral density (BMD) as well as endothelial function. Recent randomized trials, however, have produced equivocal results and raised questions about whether combined hormonal replacement therapy (HRT) prevents later cardiovascular events. Investigations of alternatives to HRT have suggested that selective estrogen receptor modulators (SERMs) may confer cardiovascular and osteoporosis protection. Raloxifene is a second-generation SERM used for the prevention and treatment of postmenopausal osteoporosis. Raloxifene decreases the incidence of vertebral fractures by 30-50% in postmenopausal women with osteoporosis. We also studied its effect on postmenopausal elderly women with osteoporosis.     

Significance of a decline in bone mineral density while receiving oral bisphosphonate treatment

BACKGROUND: Oral bisphosphonates are routinely prescribed for the treatment of postmenopausal osteoporosis. In clinical trials, oral bisphosphonates have been found to increase bone mineral density (BMD) and decrease fracture risk in the majority of the treated population. However, in both clinical trials and clinical practice, not all patients experience significant increases in BMD. In clinical trials, nonresponse is often defined as a BMD change of 相似文献   

Homocysteine in postmenopausal women and the importance of hormone replacement therapy.

Homocysteine (Hcy) has been shown to damage the vascular endothelial cells, contributing to atherothrombosis. The increase in plasma Hcy levels with natural menopause suggests a close relationship between Hcy metabolism and estrogen status and proposes one of the mechanisms through which menopause unfavorably affects cardiovascular disease risk in women. In addition to the prevention of osteoporosis, hormone replacement therapy (HRT) lowers Hcy levels in postmenopausal women. The first report by van der Mooren et al., demonstrated in an uncontrolled study a significant reduction (11%) in fasting serum Hcy level after 6 months of treatment with sequentially combined estradiol-dydrogesterone therapy in 21 healthy postmenopausal women. This effect was particularly evident in women with initially elevated baseline serum Hcy concentrations. Similar results were found in other studies in which women were treated with various transdermal as well as oral HRT regimens, although two studies could not confirm these findings. All these studies were uncontrolled, and three of them consisted of a relatively small number of participants. Therefore, they remained inconclusive. Three randomized controlled trials on HRT and Hcy were published to date, confirming that postmenopausal HRT reduces circulating levels of Hcy. Current and recent HRT use is associated with a slight increased risk of breast cancer. As a result of this, research has centered on finding compounds that can prevent the consequences of estrogen deficiency, without the potential risk of HRT. Raloxifene, referred to as a Selective Estrogen Receptor Modulator (SERM), has the potential as a viable alternative to HRT. Recently, two randomized controlled trials demonstrated that raloxifene lowers plasma Hcy levels in postmenopausal women, similar to the reduction obtained with HRT. Little is known about the mechanisms underlying the HRT-associated lowering of plasma Hcy. Proposed mechanisms relate to an increase in kidney methionine synthase activity or may be related to the transamination of methionine. We conclude that HRT decreases plasma Hcy levels in postmenopausal women and that the strongest reductions can be achieved in women with the highest concentrations.     

Osteoporosis: Evaluation and treatment

Osteoporosis is a common and costly disease. This article discusses the pathophysiology, diagnosis, and treatment of osteoporosis, including hormone replacement, bisphosphonates, calcitonin, raloxifene, and alternative therapies. As our population ages, osteoporosis will become an even more common disease.     

Diagnosis and management of osteoporosis in postmenopausal women: clinical guidelines. International Committee for Osteoporosis Clinical Guidelines.

The authors, all physicians involved in clinical research on bone and practicing clinicians, propose practical guidelines for identifying persons with osteoporosis or those at high risk of developing the disease and for managing patients who may benefit from therapy. These guidelines are based on an analysis of peer-reviewed articles published before November 1998. A flowchart of women who might benefit from treatment is provided, including clinical presentation (recent fracture of the spine, hip, or other bone or no fracture; risk factors for osteoporosis); relevant investigations (bone mineral density measurement and laboratory tests required for the differential diagnosis); and therapeutic management (general measures such as calcium and vitamin D supplementation and specific pharmacologic interventions such as estrogen, bisphosphonates, intranasal calcitonin, raloxifene, fluoride salts, and other compounds that have been assessed in randomized clinical trials). The strongest evidence for antifracture efficacy (reduction of vertebral and nonvertebral fracture risk) was observed with alendronate.     

Effect of teriparatide on bone mineral density and fracture in postmenopausal osteoporosis: meta-analysis of randomised controlled trials

To determine the efficacy of teriparatide supplementation for improving bone mineral density (BMD) and fracture risk in postmenopausal osteoporosis and if effects vary with factors. We identified eight randomised controlled trials (n = 2388) using electronic databases, supplemented by a hand-search of the reference lists. All trials aimed to evaluate the efficacy of daily subcutaneous teriparatide injection in postmenopausal osteoporosis. The main outcomes were fracture risk and percentage change of BMD from baseline. Data were pooled by employing a random-effect model. In trials that reported BMD as an outcome, treatment was associated with an increase of bone mass of 8.14% [95% confidence interval (CI): 6.72-9.55%; eight trials, n = 2206] in spine and 2.48% (95% CI: 1.67-3.29%; seven trials, n = 1303) at the hip. In trials that reported fracture as an outcome, treatment was associated with a 70% risk reduction in vertebral fractures (risk ratio 0.30, 95% CI: 0.21-0.44; three trials, n = 1452) and 38% risk reduction in non-vertebral fractures (risk ratio 0.62, 95% CI: 0.44-0.87; three trials, n = 1842). The PTH treatment with total calcium intake more than 1500 mg was related to a significant increase in BMD gains at total hip (1.40% vs. 3.72%; p = 0.004). However, long-term duration did not appear to contribute to differences in responsiveness to teriparatide. Evidence supports the use of teriparatide in treatment of women with postmenopausal osteoporosis who are at risk for fracture. Further studies directly comparing concurrent therapy and calcium supplement with long-term duration are warranted.     

Risedronate: a new oral bisphosphonate

BACKGROUND: Bisphosphonates have been effective in the treatment of osteoporosis and Paget's disease of bone. Risedronate, the newest oral bisphosphonate, is approved by the US Food and Drug Administration for the prevention and treatment of postmenopausal osteoporosis and glucocorticoid-induced osteoporosis and the treatment of Paget's disease of bone. OBJECTIVE: This article reviews current studies of risedronate in osteoporosis and Paget's disease of bone and, to the extent possible, compares risedronate with other bisphosphonates and other therapies. Information on the pharmacokinetics and adverse effects of risedronate, and the drug's use in other disorders, is also reviewed. METHODS: Clinical studies and review articles concerning the use of risedronate published in the English-language literature from 1966 through October 2000 were identified through searches of MEDLINE, PREMEDLINE, and International Pharmaceutical Abstracts using the search terms risedronate and NE 58095. Recent clinical studies, review articles, and consensus statements regarding the use of other bisphosphonates were identified through searches of the same databases for this period using the search terms bisphosphonates, alendronate, osteoporosis, and Paget's disease of bone. RESULTS: The use of risedronate therapy in patients with postmenopausal osteoporosis has been shown to increase bone mineral density (BMD) and decrease the incidence of fractures compared with placebo. In glucocorticoid-induced osteoporosis, risedronate has been shown to increase BMD without having a consistently significant effect on the risk of fractures. Although there are no direct comparisons between bisphosphonates in glucocorticoid-induced osteoporosis, risedronate appears to be less effective than alendronate and more effective than etidronate in terms of effects on BMD and/or fracture risk. In Paget's disease of bone, risedronate has been reported to be more effective than etidronate in decreasing serum alkaline phosphatase levels and bone pain. Finally, risedronate has been associated with a lower incidence of gastric ulcers than alendronate. CONCLUSIONS: In terms of efficacy in the prevention and treatment of osteoporosis and the treatment of Paget's disease of bone, risedronate is comparable to alendronate, the other orally available bisphosphonate. It appears to have better gastrointestinal tolerability than alendronate and may be preferred for patients in whom this is a concern. However, direct comparative and pharmacoeconomic studies are necessary to determine risedronate's relative place in the therapy of osteoporosis and Paget's disease of bone.     

Desloratadine: a nonsedating antihistamine

OBJECTIVE: To review information on desloratadine, a nonsedating antihistamine. DATA SOURCES: An English-language MEDLINE search was conducted (1966-July 2002). References of identified articles were subsequently reviewed for additional data. Schering Corporation provided unpublished information. STUDY SELECTION/DATA EXTRACTION: Articles and abstracts pertaining to desloratadine were considered for inclusion, with emphasis on randomized, placebo-controlled, double-blind trials. DATA SYNTHESIS: Desloratadine is approved for the treatment of symptoms associated with seasonal allergic rhinitis (SAR), perennial allergic rhinitis (PAR), and chronic idiopathic urticaria (CIU) in patients aged > or =12 years. In placebo-controlled trials, desloratadine demonstrated superior efficacy as a once-daily treatment of SAR, PAR, and CIU. Data suggest that desloratadine has antiinflammatory and decongestant activity. CONCLUSIONS: Desloratadine appears to be a "me-too" agent, with no major differences compared with other second-generation antihistamines.