Calcitonin (injection): Difference between revisions
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The incidence of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of a positive antibody test result may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of antibodies among different calcitonin-salmon products may be misleading. | The incidence of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of a positive antibody test result may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of antibodies among different calcitonin-salmon products may be misleading. | ||
|drugInteractions=No formal drug interaction studies have been performed with Miacalcin injection. | |||
Concomitant use of calcitonin-salmon and lithium may lead to a reduction in plasma lithium concentrations due to increased urinary clearance of lithium. The dose of lithium may require adjustment. | |||
|FDAPregCat=C | |||
|useInPregnancyFDA=Risk Summary | |||
There are no adequate and well-controlled studies in pregnant women. Miacalcin injection should be used during pregnancy only if the potential benefit justifies the use as compared with potential risks to the patient and fetus. Based on animal data, Miacalcin is predicted to have low probability of increasing the risk of adverse developmental outcomes above background risk. | |||
Animal Data | |||
Calcitonin-salmon has been shown to cause a decrease in fetal birth weights in rabbits when given by subcutaneous injection in doses 4-18 times the parenteral dose recommended for human use (of 54 International Units/m2). | |||
No embryo/fetal toxicities related to Miacalcin were reported from maternal subcutaneous daily doses in rats up to 80 International Units /kg/day from gestation day 6 to 15. | |||
|useInNursing=It is not known whether this drug is excreted in human milk. No studies have been conducted to assess the impact of Miacalcin on milk production in humans, its presence in human breast milk, or its effects on the breastfed child. Because many drugs are excreted in human milk, caution should be exercised when Miacalcin is administered to a nursing woman. Calcitonin has been shown to inhibit lactation in rats. | |||
|useInPed=Safety and effectiveness in pediatric patients have not been established. | |||
|useInGeri=Clinical studies of Miacalcin injection did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. | |||
|administration=* Subcutaneous | |||
* Intramuscular | |||
* Nasal spray | |||
|monitoring=* Serious hypersensitivity reactions have been reported in patients receiving Miacalcin injection, e.g., bronchospasm, swelling of the tongue or throat, anaphylactic shock, and death due to anaphylaxis. Appropriate medical support and monitoring measures should be readily available when Miacalcin injection is administered. | |||
* In patients at risk for hypocalcemia, provisions for parenteral calcium administration should be available during the first several administrations of calcitonin-salmon and serum calcium and symptoms of hypocalcemia should be monitored. | |||
|overdose=The pharmacologic actions of Miacalcin injection suggest that hypocalcemic tetany could occur in overdose. Therefore, provisions for parenteral administration of calcium should be available for the treatment of overdose. | |||
A dose of calcitonin-salmon l000 International Units subcutaneously may produce nausea and vomiting. Doses of 32 International Units per kg per day for 1-2 days demonstrate no other adverse effects. Data on chronic high-dose administration are insufficient to assess toxicity. | |||
|mechAction=Calcitonin-salmon is a calcitonin receptor agonist. Calcitonin-salmon acts primarily on bone, but direct renal effects and actions on the gastrointestinal tract are also recognized. Calcitonin-salmon appears to have actions essentially identical to calcitonins of mammalian origin, but its potency per mg is greater and it has a longer duration of action. | |||
The actions of calcitonin on bone and its role in normal human bone physiology are still not completely elucidated, although calcitonin receptors have been discovered in osteoclasts and osteoblasts. | |||
|structure=Calcitonin is a polypeptide hormone secreted by the parafollicular cells of the thyroid gland in mammals and by the ultimobranchial gland of birds and fish. | |||
Miacalcin (calcitonin-salmon) injection, synthetic is a synthetic polypeptide of 32 amino acids in the same linear sequence that is found in calcitonin of salmon origin. This is shown by the following graphic formula: | |||
[[File:Calcitonin structure.png|thumb|none|400px|This image is provided by the National Library of Medicine.]] | |||
It is provided in sterile solution for subcutaneous or intramuscular injection. Each milliliter contains: calcitonin-salmon 200 International Units. | |||
Inactive Ingredients (per mL): acetic acid, USP, 2.25 mg; phenol, USP, 5.0 mg; sodium acetate trihydrate, USP, 2.0 mg; sodium chloride, USP, 7.5 mg; water for injection, USP. | |||
The activity of Miacalcin injection is stated in International Units based on bioassay in comparison with the International Reference Preparation of calcitonin-salmon for Bioassay, distributed by the National Institute for Biological Standards and Control, Holly Hill, London. | |||
|alcohol=Alcohol-Calcitonin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication. | |alcohol=Alcohol-Calcitonin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication. | ||
}} | }} | ||
Revision as of 16:27, 17 March 2015
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Turky Alkathery, M.D. [2]
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Overview
Calcitonin (injection) is a calcitonin receptor agonist that is FDA approved for the treatment of Paget's disease of bone, hypercalcemia, and postmenopausal osteoporosis. Common adverse reactions include flushing, injection site reaction, nausea, arthralgia, epistaxis, rhinitis, and sinusitis.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
Treatment of Paget’s Disease of Bone
Miacalcin injection is indicated for the treatment of symptomatic Paget’s disease of bone in patients with moderate to severe disease characterized by polyostotic involvement with elevated serum alkaline phosphatase and urinary hydroxyproline excretion. There is no evidence that the prophylactic use of calcitonin-salmon is beneficial in asymptomatic patients. Miacalcin injection should be used only in patients who do not respond to alternative treatments or for whom such treatments are not suitable (e.g., patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies).
Treatment of Hypercalcemia
Miacalcin injection is indicated for the early treatment of hypercalcemic emergencies, along with other appropriate agents, when a rapid decrease in serum calcium is required, until more specific treatment of the underlying disease can be accomplished. It may also be added to existing therapeutic regimens for hypercalcemia such as intravenous fluids and furosemide, oral phosphate or corticosteroids, or other agents.
Treatment of Postmenopausal Osteoporosis
Miacalcin injection is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause. The evidence of efficacy for calcitonin-salmon injection is based on increases in total body calcium observed in clinical trials. Fracture reduction efficacy has not been demonstrated. Miacalcin injection should be reserved for patients for whom alternative treatments are not suitable (e.g., patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies).
Important Limitations of Use
Due to the possible association between malignancy and calcitonin-salmon use, the need for continued therapy should be re-evaluated on a periodic basis.
Dosage
Paget’s Disease of Bone
The recommended dose of Miacalcin injection for treatment of symptomatic Paget's disease of bone is 100 International Units (0.5 mL) per day administered subcutaneously or intramuscularly.
Hypercalcemia
The recommended starting dose of Miacalcin injection for early treatment of hypercalcemia is 4 International Units/kg body weight every 12 hours by subcutaneous or intramuscular injection. If the response to this dose is not satisfactory after one or two days, the dose may be increased to 8 International Units/kg every 12 hours. If the response remains unsatisfactory after two more days, the dose may be further increased to a maximum of 8 International Units/kg every 6 hours.
Postmenopausal Osteoporosis
The recommended dose of Miacalcin injection for treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause is 100 International Units (0.5 mL) per day administered subcutaneously or intramuscularly. The minimum effective dose of Miacalcin injection for the prevention of vertebral bone mineral density loss has not been established.
Preparation and Administration
Visually inspect Miacalcin vials. Miacalcin injection is a clear, colorless, solution. If the solution is not clear and colorless, or contains any particles, or if the vial is damaged, do not administer the solution.
If the volume of Miacalcin injection to be injected exceeds 2 mL, intramuscular injection is preferable and the total dose should be distributed across multiple sites of injection.
Instruct patients to use sterile injection technique when administering Miacalcin injection, and to dispose of needles properly.
Recommendations for Calcium and Vitamin D Supplementation
Patients who use Miacalcin injection for treatment of postmenopausal osteoporosis should receive adequate calcium (at least 1000 mg elemental calcium per day) and vitamin D (at least 400 International Units per day).
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Calcitonin in adult patients.
Non–Guideline-Supported Use
- Cancer pain
- Subcutaneous 400 international units per day by continuous infusion[1]
- Prophylaxis of fracture of bone[2]
- Osteoporosis due to corticosteroids
- 100 international units every other day subcutaneously[3]
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Safety and effectiveness in pediatric patients have not been established.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Calcitonin in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Calcitonin in pediatric patients.
Contraindications
Hypersensitivity to calcitonin-salmon or any of the excipients. Reactions have included anaphylaxis with death, bronchospasm, and swelling of the tongue or throat.
Warnings
Hypersensitivity Reactions
Serious hypersensitivity reactions have been reported in patients receiving Miacalcin injection, e.g., bronchospasm, swelling of the tongue or throat, anaphylactic shock, and death due to anaphylaxis. Appropriate medical support and monitoring measures should be readily available when Miacalcin injection is administered. If anaphylaxis or other severe hypersensitivity/allergic reactions occur, initiate appropriate treatment [see Contraindications (4)].
For patients with suspected hypersensitivity to calcitonin-salmon, skin testing should be considered prior to treatment utilizing a dilute, sterile solution of Miacalcin injection. Healthcare providers may wish to refer patients who require skin testing to an allergist. A detailed skin testing protocol is available from the Medical Services Department of Novartis Pharmaceuticals Corporation.
Hypocalcemia
Hypocalcemia associated with tetany (i.e., muscle cramps, twitching) and seizure activity has been reported with Miacalcin injection therapy. Hypocalcemia must be corrected before initiating therapy. Other disorders affecting mineral metabolism (such as vitamin D deficiency) should also be effectively treated. In patients at risk for hypocalcemia, provisions for parenteral calcium administration should be available during the first several administrations of calcitonin-salmon and serum calcium and symptoms of hypocalcemia should be monitored. Use of Miacalcin injection for the treatment of Paget’s disease or postmenopausal osteoporosis is recommended in conjunction with an adequate intake of calcium and vitamin D [see Dosage and Administration (2.5)].
Malignancy
In a meta-analysis of 21 randomized, controlled clinical trials with calcitonin-salmon (nasal spray or investigational oral formulations), the overall incidence of malignancies reported was higher among calcitonin-salmon-treated patients (4.1%) compared with placebo-treated patients (2.9%). This suggests an increased risk of malignancies in calcitonin-salmon-treated patients compared to placebo-treated patients. It is not possible to exclude an increased risk when calcitonin-salmon is administered long-term subcutaneously, intramuscularly, or intravenously. The benefits for the individual patient should be carefully considered against possible risks [see Adverse Reactions (6.1)].
Antibody Formation
Circulating antibodies to calcitonin-salmon have been reported with Miacalcin injection. The possibility of antibody formation should be considered in any patient with an initial response to Miacalcin injection who later stops responding to treatment [see Adverse Reactions (6.3)].
Urine Sediment Abnormalities
Coarse granular casts and casts containing renal tubular epithelial cells were reported in young adult volunteers at bed rest who were given injectable calcitonin-salmon to study the effect of immobilization on osteoporosis. There was no other evidence of renal abnormality and the urine sediment normalized after calcitonin-salmon was stopped. Periodic examinations of urine sediment should be considered.
Adverse Reactions
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of calcitonin-salmon injection was assessed in open-label trials several months to two years in duration. The most common adverse reactions are discussed below.
Nausea: Nausea with or without vomiting has been noted in about 10% of patients treated with calcitonin-salmon. It is most evident when treatment is first initiated and tends to decrease or disappear with continued administration.
Dermatologic Reactions: Local inflammatory reactions at the site of subcutaneous or intramuscular injection have been reported in about 10% of patients. Flushing of face or hands occurred in about 2%-5% of patients. Skin rashes and pruritus of the ear lobes have also been reported.
Other Adverse Reactions: Nocturia, feverish sensation, pain in the eyes, poor appetite, abdominal pain, pedal edema, and salty taste have been reported in patients treated with calcitonin-salmon injection.
Malignancy
A meta-analysis of 21 randomized, controlled clinical trials with calcitonin-salmon (nasal spray or investigational oral formulations) was conducted to assess the risk of malignancies in calcitonin-salmon-treated patients compared to placebo-treated patients. The trials in the meta-analysis ranged in duration from 6 months to 5 years and included a total of 10883 patients (6151 treated with calcitonin-salmon and 4732 treated with placebo). The overall incidence of malignancies reported in these 21 trials was higher among calcitonin-salmon-treated patients (254/6151 or 4.1%) compared with placebo-treated patients (137/4732 or 2.9%). Findings were similar when analyses were restricted to the 18 nasal spray only trials [calcitonin-salmon 122/2712 (4.5%); placebo 30/1309 (2.3%)].
The meta-analysis results suggest an increased risk of overall malignancies in calcitonin-salmon-treated patients compared to placebo-treated patients when all 21 trials are included and when the analysis is restricted to the 18 nasal spray only trials (see Table 1). It is not possible to exclude an increased risk when calcitonin-salmon is administered by the subcutaneous, intramuscular, or intravenous route because these routes of administration were not investigated in the meta-analysis. The increased malignancy risk seen with the meta-analysis was heavily influenced by a single large 5-year trial, which had an observed risk difference of 3.4% [95% CI (0.4%, 6.5%)]. Imbalances in risks were still observed when analyses excluded basal cell carcinoma (see Table 1); the data were not sufficient for further analyses by type of malignancy. A mechanism for these observations has not been identified. Although a definitive causal relationship between calcitonin-salmon use and malignancies cannot be established from this meta-analysis, the benefits for the individual patient should be carefully evaluated against all possible risks.
Postmarketing Experience
Because postmarketing adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following adverse reactions have been reported during post-approval use of Miacalcin injection.
Allergic / Hypersensitivity Reactions: Serious hypersensitivity reactions have been reported in patients receiving calcitonin-salmon injection, e.g., bronchospasm, swelling of the tongue or throat, anaphylactic shock, and death due to anaphylaxis.
Skin and subcutaneous tissue disorders: Urticaria
Hypocalcemia: Hypocalcemia with tetany (i.e. muscle cramps, twitching) and seizure activity have been reported.
Body as a Whole: influenza-like symptoms, fatigue, edema (facial, peripheral, and generalized)
Musculoskeletal: arthralgia, musculoskeletal pain
Cardiovascular: hypertension
Gastrointestinal: abdominal pain, diarrhea
Urinary System: polyuria
Nervous System: dizziness, headache, paresthesia, tremor
Vision: visual disturbance
Immunogenicity
Consistent with the potentially immunogenic properties of medicinal products containing peptides, administration of Miacalcin may trigger the development of anti-calcitonin antibodies. Circulating antibodies to calcitonin-salmon after 2-18 months of treatment have been reported in about one-half of the patients with Paget’s disease in whom antibody studies were done. In some cases, high antibody titers are found; these patients usually will have a loss of response to treatment.
The incidence of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of a positive antibody test result may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of antibodies among different calcitonin-salmon products may be misleading.
Drug Interactions
No formal drug interaction studies have been performed with Miacalcin injection.
Concomitant use of calcitonin-salmon and lithium may lead to a reduction in plasma lithium concentrations due to increased urinary clearance of lithium. The dose of lithium may require adjustment.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA): C Risk Summary
There are no adequate and well-controlled studies in pregnant women. Miacalcin injection should be used during pregnancy only if the potential benefit justifies the use as compared with potential risks to the patient and fetus. Based on animal data, Miacalcin is predicted to have low probability of increasing the risk of adverse developmental outcomes above background risk.
Animal Data
Calcitonin-salmon has been shown to cause a decrease in fetal birth weights in rabbits when given by subcutaneous injection in doses 4-18 times the parenteral dose recommended for human use (of 54 International Units/m2).
No embryo/fetal toxicities related to Miacalcin were reported from maternal subcutaneous daily doses in rats up to 80 International Units /kg/day from gestation day 6 to 15.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Calcitonin (injection) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Calcitonin (injection) during labor and delivery.
Nursing Mothers
It is not known whether this drug is excreted in human milk. No studies have been conducted to assess the impact of Miacalcin on milk production in humans, its presence in human breast milk, or its effects on the breastfed child. Because many drugs are excreted in human milk, caution should be exercised when Miacalcin is administered to a nursing woman. Calcitonin has been shown to inhibit lactation in rats.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatic Use
Clinical studies of Miacalcin injection did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Gender
There is no FDA guidance on the use of Calcitonin (injection) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Calcitonin (injection) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Calcitonin (injection) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Calcitonin (injection) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Calcitonin (injection) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Calcitonin (injection) in patients who are immunocompromised.
Administration and Monitoring
Administration
- Subcutaneous
- Intramuscular
- Nasal spray
Monitoring
- Serious hypersensitivity reactions have been reported in patients receiving Miacalcin injection, e.g., bronchospasm, swelling of the tongue or throat, anaphylactic shock, and death due to anaphylaxis. Appropriate medical support and monitoring measures should be readily available when Miacalcin injection is administered.
- In patients at risk for hypocalcemia, provisions for parenteral calcium administration should be available during the first several administrations of calcitonin-salmon and serum calcium and symptoms of hypocalcemia should be monitored.
IV Compatibility
There is limited information regarding the compatibility of Calcitonin (injection) and IV administrations.
Overdosage
The pharmacologic actions of Miacalcin injection suggest that hypocalcemic tetany could occur in overdose. Therefore, provisions for parenteral administration of calcium should be available for the treatment of overdose.
A dose of calcitonin-salmon l000 International Units subcutaneously may produce nausea and vomiting. Doses of 32 International Units per kg per day for 1-2 days demonstrate no other adverse effects. Data on chronic high-dose administration are insufficient to assess toxicity.
Pharmacology
There is limited information regarding Calcitonin (injection) Pharmacology in the drug label.
Mechanism of Action
Calcitonin-salmon is a calcitonin receptor agonist. Calcitonin-salmon acts primarily on bone, but direct renal effects and actions on the gastrointestinal tract are also recognized. Calcitonin-salmon appears to have actions essentially identical to calcitonins of mammalian origin, but its potency per mg is greater and it has a longer duration of action.
The actions of calcitonin on bone and its role in normal human bone physiology are still not completely elucidated, although calcitonin receptors have been discovered in osteoclasts and osteoblasts.
Structure
Calcitonin is a polypeptide hormone secreted by the parafollicular cells of the thyroid gland in mammals and by the ultimobranchial gland of birds and fish.
Miacalcin (calcitonin-salmon) injection, synthetic is a synthetic polypeptide of 32 amino acids in the same linear sequence that is found in calcitonin of salmon origin. This is shown by the following graphic formula:
It is provided in sterile solution for subcutaneous or intramuscular injection. Each milliliter contains: calcitonin-salmon 200 International Units.
Inactive Ingredients (per mL): acetic acid, USP, 2.25 mg; phenol, USP, 5.0 mg; sodium acetate trihydrate, USP, 2.0 mg; sodium chloride, USP, 7.5 mg; water for injection, USP.
The activity of Miacalcin injection is stated in International Units based on bioassay in comparison with the International Reference Preparation of calcitonin-salmon for Bioassay, distributed by the National Institute for Biological Standards and Control, Holly Hill, London.
Pharmacodynamics
There is limited information regarding Calcitonin (injection) Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Calcitonin (injection) Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Calcitonin (injection) Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Calcitonin (injection) Clinical Studies in the drug label.
How Supplied
There is limited information regarding Calcitonin (injection) How Supplied in the drug label.
Storage
There is limited information regarding Calcitonin (injection) Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Calcitonin (injection) |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Calcitonin (injection) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Calcitonin (injection) Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Calcitonin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Calcitonin (injection) Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Calcitonin (injection) Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
- ↑ Mystakidou K, Befon S, Hondros K, Kouskouni E, Vlahos L (1999). "Continuous subcutaneous administration of high-dose salmon calcitonin in bone metastasis: pain control and beta-endorphin plasma levels". J Pain Symptom Manage. 18 (5): 323–30. PMID 10584455.
- ↑ Kanis JA, McCloskey EV (1999). "Effect of calcitonin on vertebral and other fractures". QJM. 92 (3): 143–9. PMID 10326073.
- ↑ Ringe JD (1989). "Glucocorticoid-induced osteoporosis". Clin Rheumatol. 8 Suppl 2: 109–15. PMID 2667865.