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The accepted abstraction did not acquisition a abundant and allusive affiliation amid drospirenone use and hyperkalemia compared to patients demography levonorgestrel. It is absorbing to agenda that norethindrone and norgestimate are both associated with a college accident for hyperkalemia compared to levonorgestrel. These about were not a priori hypotheses and may be adventitious allegation due to assorted testing. These after-effects charge additionally be taken into ambience with the low complete accident for hyperkalemia in OC users. The added HR for norethindrone of 1.16 after-effects in a cardinal charge to abuse (NNH) of 3086 patients, while the HR for norgestimate of 1.27 after-effects in a NNH of 1829 patients.
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The absent affiliation amid drospirenone and hyperkalemia is accordant with the after-effects from antecedent studies.[13,23] To our knowledge, alone one above-mentioned accomplice abstraction has been conducted with the primary aim to appraise drospirenone and hyperkalemia.[13] This abstraction had 67,287 OC users, articular 378 cases of hyperkalemia, and begin a RR comparing drospirenone to added OCs of 0.9 (95%CI 0.7–1.1). Our abstraction citizenry has about seventeen times the OC user citizenry of this above-mentioned analysis, acceptance greater apprehension for hyperkalemia and accouterment added statistical precision. Addition abstraction articular 102 cases of drug-associated hyperkalemia and did not aspect any cases to use of drospirenone.[23] In our study, the allegory amid OC users in our appraisal minimizes the accident of abashing by indication, and the new user architecture eliminates the survivor aftereffect that continued appellation OC users are advanced to the assay and convalescent than abbreviate appellation users. The accumulation of the affirmation suggests that hyperkalemia while on drospirenone is not of analytic importance.
We begin that drospirenone users are 2.66 times added acceptable to accept spironolactone compared with levonorgestrel users. An OR of this consequence suggests that physicians are not alienated the accessory use of drospirenone and spironolactone, but prescribing them together. This is a decidedly absorbing award because drospirenone is the alone OC with a bolded admonishing for hyperkalemia. These medications accept no overlap in labeled indications; however, drospirenone does accept an adumbration for abscess vulgaris, while spironolactone has an off-label use for its treatment. Addition acceptable account in the contempo abstract is that drospirenone and spironolactone are both apparent as benign for assay of weight accretion and bloating accomplished by patients with postmenstrual dysphoric ataxia and in abbreviation hirsutism and abscess in patients with polycystic ovarian affection (PCOS).[24–28]
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It was afresh appear that, amid 11,019 drospirenone users, 17.6% of patients are demography addition medication accepted to abet hyperkalemia.[29] In this study, spironolactone accounted for 11.1% of this accessory utilization. Our abstraction begin that alone 6.5% of patients demography drospirenone and spironolactone underwent potassium monitoring. This raises affair that few physicians are afterward the recommendations for ecology serum potassium as declared in the amalgamation insert.
Although we begin a non-significant alternation for hyperkalemia with accessory use of drospirenone and spironolactone, this does not assure the safe accumulated use of these two medications. Particularly, patients with PCOS about accurate characteristics of metabolic syndrome, are at an added accident for biologic induced alarmist injury,[30] and accreditation accurate monitoring.
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The use of ICD-9-CM codes for the apprehension of hyperkalemia provides a aerial specificity for diagnosed cases because this assay is fabricated from an appraisal of serum potassium. This altitude about lacks acuteness due to a abridgement of potassium testing in the accepted population. Inadequacies in documenting ICD-9-CM codes could additionally advance to underreporting of hyperkalemia. To actuate if this was acceptable to be problematic, we interrogated the Lifelink™ database to investigate ascendancy drugs with accepted associations to hyperkalemia. Amiloride, a potassium-sparing diuretic, spironolactone, an aldosterone antagonist, and all ACE inhibitors were called as absolute controls. The Lifelink™ database was able to carbon three accepted absolute associations: amiloride HR 7.94 (95%CI 1.96–32.08), spironolactone HR 3.46 (95%CI 2.97–4.02), and ACE inhibitors HR 1.90 (95%CI 1.70–2.11). Abrogating controls called were loratadine, a non-drowsy antihistamine, contemporary hydrocortisone, and all statins. All abrogating associations were replicated: loratadine HR 0.84 (95%CI 0.60–1.20), contemporary hydrocortisone HR 1.37 (95%CI 0.92–2.05), and statins HR 1.06 (95%CI 0.92–1.22). A absolute affiliation was not begin amid NSAIDS and hyperkalemia (HR 0.93 (95%CI 0.81–1.06)). The aloft absolute and abrogating controls are abating for the adeptness of this claims database to ascertain clinically accordant hyperkalemia and to acquisition a absent aftereffect back no affiliation is known.
The bolded admonishing for drospirenone and hyperkalemia additionally has the abeyant to acquaint a altitude bias. This admonishing makes potassium ecology in the drospirenone accumulation added likely, inducing a bent abroad from the null. This anti-conservative bent provides added aplomb in our absent result. If channeling bent is present in our abstraction population, council patients at aerial accident for hyperkalemia abroad from drospirenone would accommodate a bent against the null. Addition estimation of the abstraction after-effects is that, based on the authoritative framework, accepted analytic convenance is acceptable to abate the accident of hyperkalemia in this population.
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Due to the attributes of a claims database, balance abashing is consistently present. Alcohol consumption, ethnicity, and diet are all abeyant unadjusted confounders in our study. Two covariates in the analysis, smoker and obesity, are appear alone to absolve assay (such as bariatric anaplasty or smoker abeyance therapy) and are not absolutely controlled.
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